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TRIPs and India’s intellectual property rights regime

The TRIPs (Trade Related Intellectual Property) regime has emerged as the basic framework for ensuring intellectual property rights across the world. It is not the universal Intellectual property law. But it provides a basic framework. Every member of WTO should include TRIPs provisions in their domestic intellectual property legislations.

Intellectual property regime is anchored by legislations in the corresponding fields. With the establishment of WTO and the international enforcement of its various provisions; India also has made corresponding changes in the intellectual property regime.

The intellectual property right regime of the country has been modified by a number of legislation since 1995. For India, the WTO’s TRIPs agreement became binding from 2005 onwards as the country has got a ten-year transition period (1995-2005) to make the domestic legislation compatible with TRIPs. Here, India has got additional five-year transition period because of not having product patent regime in critical sector like pharmaceutical. Hence, existing laws were amended and fresh legislations were introduced during this period.

Different amendments to the various existing Acts- Patent Amendment Act (2005), Copy right Amendment Act (2010), are made to strengthen domestic legal framework to fulfill the harmonization with the WTO’s TRIPS agreement. Similarly, a number of fresh legislations are made to upgrade the country’s intellectual property regime. The following are the main legislations made to accommodate the TRIPs envisaged IPRs rights.

1. Patents: Patent Amendments: Patent amendment Act 1999, 2002 and 2005

2. Protection of Traditional Knowledge under Patent Amendment Act 2002

3. Industrial Designs: the Design Act, 1999

4. Trademarks: A new Trademarks Act 1999 has been enacted (The Trade and Merchandise Marks Act, 1958).

5. Copyrights: The Copyrights Act 1957 has been amended in 1983, 1984, 1992, 1994, 1999 and 2010. The latest amendment of 2010 became effective from 2012 onwards.

6. Geographical indications: The Geographical Indications of Goods (Registration and Protection Act) 1999.

7. Layout design of integrated circuits: The Semiconductor Integrated Circuit Layout Design Act, 2000

8. Plant Varieties: The Protection of Plant Varieties and Farmers’ Rights Act 2001.

                          The Biological Diversity Act, 2002 also supports the IPR regime of the country. Several modifications are also expected in the immediate future to fine tune the country’s IPR regime in the post TRIPs environment.

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TRIPS Agreement and Its Effect on Intellectual Property Laws in India: An Analysis

The TRIPS Agreement is known to be a paradigmatic milestone in intellectual property law because it is the reason behind the way India is moving toward economic growth and global recognition. Signed in 1994, the agreement revolutionized India's IP policy, particularly the patent law , by creating a twist in the nation's approach to protecting and fostering innovation. So, are you ready to take a glimpse at the transformative impact of the TRIPS Agreement on India's intellectual property regime? Then let's begin with understanding the TRIPS Agreement and its intricate relationship with Indian IP law.

TRIPS Agreement: An Overview

On January 1st, 1995, the TRIPS Agreement which is considered to be the most comprehensive multilateral agreement on intellectual property rights to date, came into effect as a landmark move by the World Trade Organization (WTO) . The TRIPS Agreement, which stands for Trade-Related Aspects of Intellectual Property Rights has three significant roles to play:

• helping trade with knowledge and innovation,
• getting rid of trade disputes related to members,
• and being flexible so they can get their own intellectual property and WTO policy objectives.

TRIPS is a set of rules concerning intellectual property rights that members of the World Trade Organization (WTO) must follow. A variety of intellectual property protections are included in these provisions, including patent protection, copyright , trademark protection, geographical indication protection, industrial design protection, and trade secret protection.

TRIPS stipulates several minimum standards for protecting and enforcing intellectual property rights. It aims to promote innovation, technology transfer, and the general public's welfare. There are also guidelines stating how member states of the WTO should protect and enforce intellectual property rights within their territories. These guidelines are designed to ensure that intellectual property rights are respected and protected within global trade and that the public is not adversely impacted by trade in intellectual property.

By delivering a collection of provisions, such as the right to prevent others from making, selling, or importing copies of a patented invention, the TRIPS Agreement provides a clear blueprint for how to harmonize intellectual property laws globally and facilitate international trade and ensure that member countries have consistent rules and obligations in place to protect intellectual property, thereby promoting fair competition and encouraging innovation and creativity.

TRIPS Agreement and Its Effect on Intellectual Property Laws in India

The TRIPS Agreement has had a big impact on India's intellectual property laws and regulations. As a member of the WTO, India had to make its intellectual property laws match the agreement's standards, which included giving patent protection for 20 years from the date of filing for any new invention, including pharmaceuticals. This provision has affected access to affordable medicines in India, as it has prevented the availability of generic drugs.

India's effort in complying with the TRIPS agreement is worth praising because several amendments and revisions were made to the Indian IP laws, especially in the patent law. Among such significant changes, a few that grabbed attention were - the introduction of product patent protection for pharmaceuticals and the establishment of a system for granting exclusive marketing rights for certain drugs, which were enforced with an aim to create a balance between incentivizing innovation and promoting access to affordable medicines.

In India, the patent registration process is governed by the Patents Act. Inventors or applicants have to follow a systematic procedure to obtain a patent which includes conducting a patent search, drafting a patent application with the help of a patent attorney, filing it with the Indian Patent Office, and undergoing examination and grant stages.

The Indian Patent Office plays a crucial role in the patent registration process. It examines patent applications for compliance with the statutory requirements and conducts a thorough review of the invention's novelty, inventive step, and industrial applicability. Once granted, the patent provides exclusive rights to the inventor, enabling them to prevent others from using, making, or selling the patented invention.

Challenges and Implementation Issues

Despite the collective and constant efforts to align Indian intellectual property laws with the WTO-negotiated TRIPS Agreement, India faces challenges and implementation issues. One of the main concerns is in forming a fair balance between protecting intellectual property rights and promoting access to affordable healthcare and essential medicines. In fact, India has been involved in patent-related disputes, particularly in the pharmaceutical sector, where the issue of affordable access to life-saving drugs arises.

In order to overcome these challenges, India is actively implementing a range of initiatives. conducting awareness campaigns, fostering capacity building, and streamlining enforcement mechanisms. Collaboration between stakeholders, including ‌ government, industry, and academia, is also essential to finding the right balance and fostering innovation in the country.

How TRIPS Affected the Indian Pharmaceutical Industry?

India had more flexible patent laws in the past that allowed for the production and sale of generic versions of patented drugs. Especially in countries with limited healthcare budgets, generic drugs which are lower-cost versions of brand-name drugs, provide affordable and accessible medicines

A system existed in India prior to the TRIPS Agreement that permitted generic manufacturers to manufacture and sell patented drugs by making small modifications to their manufacturing processes. In this way, "process patents" enabled India to produce affordable generic medicines and become a "pharmacy of the developing world." After the TRIPS Agreement was implemented, India switched to a "product patent" system, which granted exclusive rights to the specific drug, regardless of how it was manufactured.

The shift to product patents had a direct impact on the availability and affordability of medicines in India. The introduction of stronger patent protection increased the prices of patented drugs, making them less accessible to the general population. This posed challenges, particularly in the healthcare sector, where access to affordable medicines is crucial.

Access To Affordable Medicines In India Under Trips

The TRIPS Agreement included flexibilities and safeguards to address public health concerns. One such provision is the ability for countries to issue compulsory licenses, which allow the government to grant licenses to third parties to produce generic versions of patented drugs without the consent of the patent holder. This provision helps ensure access to affordable medicines, especially in situations of public health emergencies or when patented drugs are unaffordable or inaccessible to a significant portion of the population. This was demonstrated in 2012 when India granted a compulsory license for a patented cancer drug; to ensure its availability at an affordable price.

Furthermore, India has been supportive of efforts to promote access to affordable medicines globally. It has been actively involved in discussions at international forums, advocating for policies that prioritize public health and access to medicines, including initiatives like the Doha Declaration on TRIPS and Public Health.

Overall, the impact of the TRIPS Agreement on the Indian pharmaceutical industry can be best defined as an assortment of various things. While it has raised challenges for generic drug manufacturers and access to affordable medicines, it has also pushed India to widen its research and development capabilities and has opened up a door of opportunities for Indian companies to innovate and protect their own intellectual property. Additionally, the flexibilities within the TRIPS Agreement provide avenues for India to balance the protection of intellectual property rights with the goal of ensuring access to essential medicines for its population.

In Conclusion,

The TRIPS Agreement has significantly influenced intellectual property laws in India. Its implementation has brought about changes in the patent system, copyright protection, trademark regulations, and access to medicines. While it has provided a framework for protecting intellectual property rights, it has also posed challenges in balancing these rights with the need for affordable medicines and promoting innovation.

As India continues to navigate the complexities of intellectual property laws and the TRIPS Agreement, it is essential to strike a balance that promotes innovation, safeguards public health, and ensures access to essential medicines for its population.

To understand more about the TRIPS Agreement and its impact on Indian IP Law, get in touch with the IP lawyers of Parker and Paker Co. LLP .

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India’s TRIPS-Compliant Patent Decade – The Tumultuous Journey in Search of a Pragmatic Equilibrium

• Published: 12 February 2019
• Volume 50 , pages 161–195, ( 2019 )

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• V. K. Unni 1  

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During the first decade of India’s TRIPS compliance (2005–2015), the country witnessed numerous patent-related disputes, mostly from the pharmaceutical sector on various issues pertaining to patent protection, enforcement of patent rights and compulsory licensing of granted patents. Even the non-pharmaceutical sector saw an increase in the number of various patent disputes. India, while enacting its three amendments, had tried to leverage the flexibility provided by the TRIPS Agreement to its member states, and to a great extent these amendments have resulted in an increase in patent-related disputes. This paper focuses on the patent disputes which have come up in the last ten years in order to analyse the approach of the Indian Patent Office and other quasi-judicial bodies such as the Intellectual Property Appellate Board and the higher judiciary.

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“Projected GDP Ranking 2018–2023”, details available at http://statisticstimes.com/economy/projected-world-gdp-ranking.php . See also “India Overtakes France to Become World’s Sixth-Largest Economy”, https://www.bloomberg.com/news/articles/2018-07-11/india-pips-france-to-become-world-s-sixth-largest-economy-chart .

Mueller ( 2007 ), pp. 68, 491, 502.

According to Art. 141 of the Indian Constitution, the law declared by the Supreme Court shall be binding on all courts within the territory of India, full text at http://lawmin.nic.in/olwing/coi/coi-english/coi-4March2016.pdf .

Dalhman and Utz ( 2005 ), pp. 1–2.

Greene ( 2007 ).

Agreement on Trade-Related Aspects of Intellectual Property Rights, 15 April 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments – Results of the Uruguay Round Vol. 31, 33 I.L.M. 81 (1994) [hereinafter TRIPS].

India has witnessed a substantial increase in the number of patent litigations after its law was made TRIPS compliant.

Mueller, supra note 2, p. 536.

Sharma ( 2005 ). See also Sikka ( 2005 ).

For a detailed analysis regarding the history of India’s patent law see Reddy and Chandrasekharan ( 2017 ), pp. 1–16.

See Sagar ( 2007 ), pp. 164, 166. In England patents were essentially Royal grants issued by Queen Elizabeth (1558–1603) for monopoly privileges that advanced her economic and industrial policies. Mossoff ( 2001 ), p. 1255.

Ragavan ( 2006 ), pp. 10, 273, 279.

Rajagopala Ayyangar ( 1959 ).

Reddy, supra note 10, p. 7.

The Patents Act, 1970, Act No. 39, Parliament, 1970 (India) (hereinafter the IPA). See also History of Indian Patent System, Intell. Prop. India at para. 8, available at http://www.ipindia.nic.in/ipr/PatentHistory.htm (last visited 10 June 2016).

Id. § 5(a)–(b).

Details about WTO agreements are available at Understanding the WTO: The Agreements, Overview: A National Guide, World Trade Org., https://www.wto.org/english/thewto_e/whatis_e/tif_e/tif_e.htm (last visited 26 May 2016).

TRIPS, supra note 6.

TRIPS, supra note 6, Art. 65.

Id. Art. 70.8(a).

Thomas ( 2005 ), pp. 609–610.

TRIPS, supra note 6, Art. 70.9.

Article 123 of the Indian Constitution grants the power to the President of India to issue an executive order called an “Ordinance” when the Parliament is not in session. Details at https://indiankanoon.org/doc/1090693/ .

The Patents (Amendment) Ordinance, No. 13 of 1994, available at http://www.wipo.int/edocs/lexdocs/laws/en/in/in001en.pdf . 

Ragavan ( 2003 ), pp. 35, 117, 144.

Okediji ( 2003 ), pp. 17, 819, 890–893. Reddy, supra note 10, at 58–59.

Appellate Body Report, India-Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS50/ABIR (4 December 1997), hereinafter DSB, available at http://www.wto.org/english/tratop-e/dispu-e/caseselds50_e.htm . See also WTO Appellate Body Report Action by the Dispute Settlement Body, India-Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS50/9 (27 January 1998) (hereinafter the DSB decision), available at https://www.wto.org/english/tratop_e/dispu_e/79r.pdf .

The Patents (Amendment) Act 1999 (hereinafter the 1999 Amendment), § 24B(1)(a)–(b), available at http://ipindia.nic.in/ipr/patent/patact_99.PDF .

The Patents (Amendment) Act, 2002, (hereinafter the 2002 Amendment), available at http://www.ipindia.nic.in/ipr/patent/patentg.pdf (amending Sec. 53). Accessed 26 May 2016).

The IPA, supra note 15, § 53(1).

Id . § 104A.

Id . §§ 84–87.

Reddy, supra note 10, at 63.

Id . at 64.

Patents (Amendment) Act 2005 (hereinafter the 2005 Amendment), http://ipindia.nic.in/ipr/patent/patent_2005.pdf .

https://www.indiatoday.in/magazine/cover-story/story/20040531-left-front-forced-to-support-congress-to-counter-bjp-790037-2004-05-31 .

https://archives.peoplesdemocracy.in/2004/1003/10032004_snd.htm .

http://archives.peoplesdemocracy.in/2005/0327/03272005_patent%20left.htm .

https://www.thehindu.com/2005/03/24/stories/2005032408720100.htm .

See DSB decision, supra note 27.

TRIPS, supra note 6, Art. 33.

The IPA, supra note 15, § 84(1)(c).

TRIPS, supra note 6, Art. 27.1

“Drug Patent: A Viagra for Indian Pharmaceutical Industry”, Deccan Herald, 4 April 2005, available at http://archive.deccanherald.com/Deccanherald/Apr42005/93626200543.asp .

The IPA, supra note 15, § 3(d).

Id. § 25(1). It should be noted that pre-grant opposition of patent applications has been recommended even for the US patent system by scholars, see Kesan ( 2002 ), pp. 763, 776.

Chalmers ( 2006 ), 20, 29.

Kristina M. L. Acri, et. al., “Evergreening of Pharmaceutical Exclusivity: Sorting Fact from Misunderstanding and Fiction”, paper available at https://ssrn.com/abstract=3170628, at 38.

Singh ( 2005 ), pp. 67, 69.

See Art. 10(2)(b), Directive 2001/83/EC of the European Parliament and of the Council on the Community Code Relating to Medicinal Products for Human Use (6 November 2001), available at http://ec.europa.eu/health/files/eudralex/vol-1/dir_2004_27/dir_2004_27_en.pdf .

Fyan ( 2010 ), pp. 15, 199, 207.

Ho ( 2009 ), pp. 46, 1047, 1049.

Reddy, supra note 10, at 74.

Arup and Plahe ( 2010 ), pp. 1, 15–43, at 27–28.

Lee ( 2008 ), pp. 23, 206.

Burk and Lemley ( 2005 ), pp. 47, 371, 373.

Schering Corp. v. Geneva Pharms., Inc. , 339 F.3d 1373, 1379 (Fed. Cir. 2003), rehearing denied, 348 F.3d 992 (Fed. Cir. 2003) (en banc) (hereinafter the Schering decision).

Chisum ( 2004 ), § 3.03.

The Schering decision, supra note 59, at 1380.

[1996] R.P.C. 76 (UKHL 1995).

Merck & Co Inc v. Arrow Pharmaceuticals Ltd , [2006] FCAFC 91; Aktiebolaget Hassle v. Alphapharm Pty Ltd [2002] HCA 59; H Lundbeck A/S v. Alphapharm Pty Ltd , [2009] FCAFC 70.

The IPA, supra note 15, § 25.

Id. § 25(1).

Id. § 25(l)(a)–(k).

The IPA, supra note 15, § 25(2).

Id. § 2(1)(t).

Id. § 25(2)(a)–(k).

Id. § 25(3)(b).

Id. § 25(4).

The 2005 Amendment, supra note 36, §11A(7).

Chaudhuri ( 2005 ), p. 69.

The 2005 Amendment, supra note 36, § 2(ja).

EPC, supra note 166. Article 56 states: “An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art.”

Mueller, supra note 2, at 563.

Full text available at http://www.who.int/intellectualproperty/documents/Report4thCommission.pdf .

http://indiancourts.nic.in/ .

The IPA, supra note 15, § 104.

Id. pro viso to § 104.

http://www.polityadda.com/district-court/ .

Bombay, Calcutta and Madras were the Chartered High Courts set up as a result of the enactment of the Indian High Courts Act 1861 by the British Parliament. These three, along with the Delhi High Court, have Original Civil Jurisdiction over matters, which will enable them to hear civil suits including those dealing with intellectual property in the first instance subject to certain limitations on territorial and pecuniary jurisdiction.

This was a remedy provided when high courts were first set up by way of Letters Patent in the 1860s.

Appeals from High Court go to the Supreme Court in civil matters if the High Court concerned certifies: (a) that the case involves a substantial question of law of general importance; and (b) that, in the opinion of the High Court, the said question needs to be decided by the Supreme Court. Constitution of India, Art. 133, available at http://lawmin.nic.in/olwing/coi/coi-english/coi-4March2016.pdf .

Id . Art. 136.

The IPA, supra note 15, § 117A(2).

Constitution of India, Art. 226.

Novartis AG v. Union of India MANU/TN/2158/2015, para. 8.

MANU/DE/0297/2010.

Id. at para. 22.

Id. at para. 18.

The IPA, supra note 15, § 64(1)(a)–(q). The power of IPAB is to only deal with stand-alone revocation; whereas, in many patent infringement suits the defendant may raise a counter-claim to revoke the patent. In that case the High Court will decided both the matters.

Dr. Aloys Wobben v. Yogesh Mehra & Ors. (Civil Appeal No. 6718 of 2013, Supreme Court), available at http://supremecourtofindia.nic.in/outtoday/ac671813.pdf .

Id. at para. 21.

MANU/SC/0281/2013 (hereinafter the Novartis SC decision).

Id. at para. 11.

Id . at para. 12.

Id. at para. 13.

Id . at para. 14.

Id. at para. 15.

Id. at para. 16.

Id. at para. 17.

Id. at para. 157.

Id. at para. 158.

Id. at para. 163.

Id. at para. 170.

Id . at para. 180.

Id . at para. 181.

Id. at para. 180. Since the subject matter under consideration was a drug to treat a disease, the Court held the relevant test here would be to find out the "therapeutic efficacy".

Id. at para. 175.

Wertheimer and Santella ( 2005b ), p. 8.

Id . at para. 175.

Id. at para. 191.

Ghoshray ( 2014 ), pp. 13, 719, 733.

Decision available at https://docs.google.com/file/d/0Bxi2TzVXul5ZYVF0SDhiTWF6ZzA/edit?pref=2&pli=1 .

F. Hoffmann-La Roche Ltd. v. Cipla (hereinafter the Roche Division Bench decision), MANU/DE/3672/2015. As noted above, this judgment was substituted with the another judgment issued on 8 December 2015 available at http://delhihighcourt.nic.in/dhcqrydisp_o.asp?pn=258821&yr=2015 , Roche was the licensee of the Erlotinib patent.

MANU/DE/0517/2008, at paras. 1–5. Cipla was manufacturing the drug under the brand name “Erlocip”, which was a particular polymorphic form (Polymorph B) of the erlotinib hydrochloride compound that had been patented by Roche, (hereinafter the Erlotinib patent).

Id . at paras. 9–10.

CS (OS) No. 89/2008 and C.C. 52/2008, http://lobis.nic.in/ddir/dhc/MAN/judgement/10-09-2012/MAN07092012S892008.pdf (hereinafter the Roche Single Bench decision).

Id. at paras. 302–303.

The IPA, supra note 15, § 8 mandates that the patent applicants disclose all information relating to the corresponding foreign applications of the Indian application being prosecuted.

The Roche Division Bench decision, supra note 124, at para. 38.

Id. at para. 40.

Id. at para. 105. This, according to Cipla, could motivate any person skilled in the art to use the “226 patent” as a starting point. Cipla also pointed out that the “226 patent” was the first patent document to disclose the use of quinazoline derivatives for their anti-cancer properties. The only difference between a large number of compounds exemplified in EP_226 and those exemplified in the suit patent was a mere substitution of methyl with ethynyl on the 3 meta position. Id.

Id. at para. 106

Id. at para. 118.

Id . at para. 136.

Id. at para. 82. Cipla argued Roche ought to have disclosed to the Indian Patent Office that it had filed an application for grant of patent for polymorph B of erlotinib hydrochloride in US while prosecuting its Indian application, which was eventually granted in 2007.

Id. at para. 88.

Roche Division Bench decision, supra note 124, at para. 91.

Id. at para. 34(xiv)

Id . at para. 74.

Id. at para. 76.

Natco Pharma Ltd v. Bayer Corp (2012) C.I.A. No. 1 of 2011 (hereinafter the Natco Controller decision), http://www.ipindia.nic.in/ipoNew/compulsory_License_12032012.pdf .

Id. at para. 3.

Id. at para. 4.

Id . at 22.

Id . at 23–24.

Id . at 36.

Id . at 45.

Bayer v. Union of India and Natco OA/35/2012/PT/MUM, http://www.ipabindia.in/Pdfs/Order-45-2013.pdf (hereinafter the Bayer Bombay High Court decision).

W.P. No. 1323/2013. Full text at https://indiankanoon.org/doc/28519340/ .

Petition for Special Leave to Appeal (C) NO(S). 30145/2014. See also http://www.lawyerscollective.org/updates/supreme-court-says-no-to-bayer-upholds-compulsory-license-on-nexavar.html .

Basheer ( 2005 ), pp. 3, 309, 310.

http://articles.economictimes.indiatimes.com/2013-09-12/news/42011558_1_dasatinib-compulsory-licence-sprycel .

http://www.ipindia.gov.in/iponew/compulsoryLicense_Application_20January2016.pdf .

Roche v. Ranbaxy http://ipindiaservices.gov.in/decision/959-MAS-1995-462/207232.pdf .

The Roche Division Bench decision, supra note 124.

the Novartis SC decision, supra note 98.

https://www.msfaccess.org/our-work/addressing-medical-challenges/article/467 .

The Novartis SC decision, supra note 98, para. 8.

http://www.livemint.com/Companies/nAHUvoEXEzEXXiC66jG6ZI/India-revokes-patent-for-Pfizers-Sutent.html .

https://indiankanoon.org/doc/181905163/ para. 6.

http://ipindiaservices.gov.in/decision/IN-PCT-2002-00785-DEL-2255/Post%20Grant%20final%20decision%20IN%20%20209251.pdf .

http://www.thehindu.com/business/Industry/relief-for-pfizer-in-sutent-patent-case/article4781998.ece .

MANU/TN/0174/2008, (hereinafter the TVS case)

The IPA, supra note 15, § 106. TVS plead before the court to declare that the threats held out by the defendant Bajaj on 1 and 3 September 2007 that the plaintiff was infringing the defendant's patent No. 195904 and that the defendant’s proposing to take infringement action against the plaintiff were unjustified. Id. at para. 3.

Id. at para. 73.

MANU/TN/0976/2009.

MANU/SC/1632/2009.

Id . at para. 13.

Id. at para. 11, Supreme Court directed the Madras High Court to decide the case of infringement by trial on 30 November 2009.

https://summerslg.com/patent-infringement-litigation-in-the-us-district-courts-part-3/ .

https://uk.practicallaw.thomsonreuters.com/3-623-0277?transitionType=Default&contextData=(sc.Default)&firstPage=true&comp=pluk&bhcp=1 .

http://ftp.zew.de/pub/zew-docs/dp/dp13072.pdf at 4.

http://www.prsindia.org/uploads/media/Commercial%20courts/Commercial%20courts%20Act,%202015.pdf .

MANU/IC/0034/2009 ( Novartis IPAB decision).

Id. at para. 10.V.

Id. at 10.II

Id. at para. 10.III

Id . at para. 10.III

Id . at para. 10.V

However, the finding regarding anticipation of imatinib mesylate is not very important as the Court held that the beta crystalline version of imatinib mesylate (the subject matter of the Indian patent application) to be novel.

The Novartis Supreme Court decision, supra note 98, at para. 124.

Zimmerman patents claim No. 23 read as follows: “The compound according to claim 1 of the formula I, said compound being N-{5-[4-(4-Methyl-piperazino-methyl)-benzoylamido]-2-methyl-phenyl}-4-(3-pyridyl)-2-pyrimidine-amine or a pharmaceutically acceptable salt thereof.”

The Roche Single Bench decision, supra note 127.

The TVS case, supra note 172.

The Novartis Supreme Court decision, supra note 98.

The IPA, supra note 15, at § 8.

The IPA, supra note 15, § 8(2).

ORA/18/2010/PT/MUM, decision at http://www.ipabindia.in/Pdfs/Order-166-2012-ORA-18-2010-PT-MUM.pdf .

Id. at para. 107. Another important decision of the IPAB where noncompliance of § 8 was accepted as one of the grounds for revoking a patent is Ajanta Pharma v. Allergan Inc ., ORA/20/2011/PT/KOL available at http://www.ipabindia.in/Pdfs/Order%20No.172-2013-ORA-20-2011-PT-KOL.pdf .

MANU/DE/2785/2014.

Id. at para. 38.

Id . at para. 40.

The Roche Division Bench decision, supra note 124, para. 91.

The Novartis IPAB decision, supra note 183.

The Roche Single Bench decision, supra note 127, paras. 84–86.

Id . para. 85.

(1975) RPC 513, the points to be satisfied are plaintiff having a prima facie case and balance of convenience in favour of plaintiff.

Such injunctions are given to restrain wrongful acts which are threatened or imminent but have not yet begun.

http://archivepharma.financialexpress.com/latest-updates/3738-novartis-granted-injunctions-against-four-other-generic-makers-over-galvus . See also Vishwanathan ( 2014 ).

Id . at para. 2. Apart from the two injunctions, two generic companies gave statements before the court that they would not manufacture or market the said drug untill the next hearing, Id para 3.

Novartis AG v. Cipla , MANU/DE/0019/2015.

Id. at para. 83.

Id . at para. 131.

Merck Sharp and Dohme Corporation and another v. Glenmark Pharmaceuticals , MANU/DE/0852/2015, the relief was granted in an appeal filed by Merck against the Delhi High Court single bench decision which denied it an injunctive relief.

Id at para. 30.

Id. at para. 78.

http://indianexpress.com/article/business/companies/sc-restrains-glenmark-from-selling-copy-of-mercks-diabetes-drug/ .

Merck Sharp and Dohme Corporation v. Glenmark Pharmaceuticals , MANU/DE/2963/2015.

Id. at para. 108.

http://ipindiaservices.gov.in/decision/2382-CHENP-2004-2477/237489%20post%20grant%20opposition.pdf (hereinafter Novartis Post Grant Opposition).

550 U.S. 398 (2007).

Id. at 421. Novartis post-grant opposition, supra note 225, at 17.

480 F.3d 1348 (Fed. Cir. 2007) (hereinafter the Pfizer case).

Id. at 1364. Novartis post-grant opposition, supra note 225, at 17.

T 0287/99 ( Aerosol medicaments/GLAXO ).

Novartis post-grant opposition, supra note 225, at 16.

Ajanta Pharma , supra note 373, para. 25.

Therasense, Inc. v. Becton, Dickinson & Co ., No. 2008-1511 (Fed. Cir. 2011).

Ajanta Pharma , supra note 202 para. 72.

367 F.3d 1381 (Fed. Cir. 2004).

Ajanta Pharma , supra note 202, paras. 83–87.

Apotex Inc v. Sanofi-Synthelabo Canada Inc , [2008] 3 S.C.R. 265.

The General Tire & Rubber Company v. The Firestone Type and Rubber Company Ltd , [1972] R.P.C. 457. This UK decision is cited in many courts and IPAB judgments while dealing with novelty and obviousness in patent law.

Janssen Pharmaceutica v. Mylan Pharmaceuticals , 456 F.Supp.2d 644 (D.N.J. 2006), Innogenetics N.V. v. Abbott Labs. , 512 F.3d 1363 (Fed. Cir. 2008).

Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries , MANU/SC/0255/1978MANU/SC/0255/1978.

(1967) R.P.C. 297, id . para.26.

MANU/WB/0049/1996, paras. 55–56.

[1913] 30 RPC 465.

(1985) RFC 59.

The Novartis SC decision, supra note 98, para. 154. References were also made to UK case law such as in A.C. Edwards Ltd. v. Acme Signs and Displays Ltd . (1992) R.P.C.

315 F.3d 1335 (Fed. Cir. 2003)

363 F.3d 1247 (Fed. Cir. 2004).

The Roche Division Bench decision, supra note 124, para. 114.

383 U.S. 1 (1966).

550 U.S. 398(2007).

T 0467/94 ( Pyridinium compounds/EISAI ) of 4.11.1999.

eBay v. MerckExchange , 547 U.S. 388 (2006). Scholars point out that eBay set the trend for a major reconsideration regarding the manner in which property rights, remedial doctrines and IP commercialisation relate to one another, Claeys ( 2015 ).

Novartis AG v. Cipla , supra note 214.

MANU/DE/0774/2015.

Ali et al. ( 2018 ).

In one of the largest mergers in Indian pharmaceutical sector, Ranbaxy Laboratories, controlled by the Japanese pharma major Daiichi Sankyo, merged into Sun Pharma in March 2015, http://articles.economictimes.indiatimes.com/2015-03-24/news/60439136_1_new-delhi-sun-ranbaxy-year .

http://www.business-standard.com/article/companies/cipla-bms-settles-patent-dispute-115061700840_1.html . See also Unni ( 2015 ), pp. 165, 169.

“Gilead Licenses Hepatitis C Drug To Cipla, Ranbaxy, Five Others”, http://in.reuters.com/article/gilead-sciences-india-idINKBN0HA0TI20140915 .

http://www.ip-watch.org/2016/03/09/gilead-solvaldi-case-reveals-patent-health-fissures-in-india/ .

One good example could be the emergence of Indian companies like Suven Life Sciences, which has already achieved a strong presence in the drug discovery sector, http://www.thehindu.com/business/suven-life-sciences-gets-product-patent-in-australia-canada/article8256995.ece .

Details at http://cis-india.org/a2k/blogs/compilation-of-mobile-phone-patent-litigation-cases-in-india .

Koninklijke Philips Electronics N.V. v. Rajesh Bansal And Ors. , https://indiankanoon.org/doc/156062069/ .

Id. para. 14.

Id. para. 13.13.

Nuziveedu Seeds Ltd. and Ors. v. Monsanto Technology LLC and Ors ., full text at http://lobis.nic.in/ddir/dhc/SRB/judgement/12-04-2018/SRB11042018FAOOSCOMM862017.pdf .

“Bayer to Slash by Nearly Half Price U.S. Pays for Anthrax Drug”, http://www.wsj.com/articles/SB1003966074330899280 .

https://www.usitc.gov/secretary/fed_reg_notices/337/337-794_notice06042013sgl.pdf .

“Obama Vetoes Apple Sales Ban in U.S.” http://www.cnet.com/au/news/obama-vetoes-apple-sales-ban-in-u-s/ .

http://www.androidauthority.com/apple-wins-obama-administration-doesnt-veto-itc-import-ban-samsung-281586/ .

561 U.S. 593 (2010).

132 S.Ct. 1289 (2012).

133 S.Ct. 2107 (2013).

134 S.Ct. 2347 (2014).

Ali F, et. al. (2018) Pharmaceutical patent grants in India: how our safeguards against evergreening have failed, and why the system must be reformed, https://www.accessibsa.org/media/2018/04/Pharmaceutical-Patent-Grants-in-India.pdf

Arup C, Plahe J (2010) Pharmaceutical patent networks: assessing the influence of India’s paragraph 3(d) Internationally, I.P.Q. pp 1, 15–43, at 27–28

Basheer S (2005) “Policy style” reasoning at the Indian patent office. Intell Prop Q 3(309):310

Google Scholar  

Burk DL, Lemley MA (2005) Inherency. Wm Mary L Rev 47(371):373

Chalmers R (2006) Evergreen or deciduous? Australian trends in relation to the “Evergreening” of patents. Melbourne U L Rev 20:29

Chaudhuri S (2005) The WTO and India's pharmaceuticals industry: patent protection, TRIPS and developing countries (OUP 2005)

Chisum DS (2004) Chisum on patents. § 3.03. LexisNexis, New York

Claeys ER (2015) The conceptual relation between IP rights and infringement remedies, 22 Geo. Mason L. Rev. 825, 825

Dalhman C, Utz A (2005) The World Bank, India and the knowledge economy: leveraging strengths and opportunities. pp 1–2 http://documents.worldbank.org/curated/en/375181468041958316/pdf/329240India0Knowledge01not0external1.pdf

Fyan S (2010) Pharmaceutical patent protection and Sec. 3(d): a comparative look at India and the U.S. VA. J.L. & Tech. 15, 199, 207

Ghoshray S (2014) 3(D) view of India’s patent law: social justice aspiration meets property rights in Novartis v. Union of India & Others. J Marshall Rev Intell Prop L 13:719, 733

Greene W (2007) The emergence of India’s pharmaceutical industry and implications for the U.S. generic drug market 19 (U.S. Int’l Trade Comm’n, Office of Econ., Working Paper No. 2007-05-A)

Ho CM (2009) Unveiling competing patent perspectives. Hous L Rev. 46:1047, 1049

Ho CM (2015) Should all drugs be patentable? A comparative perspective. Vand J Ent Tech L 17(295):325

Kesan JP (2002) Carrots and sticks to create a better patent system, 17 Berkeley Tech. L.J. pp 763, 776

Lee L (2008) Trials and TRIPS-ulations: Indian patent law and Novartis AG v. Union of India , 23 Berkeley Tech. L.J. pp 281, 296 (2008)

Mossoff A (2001) Rethinking the development of patents: an intellectual history, 1550–1800, 52 Hastings L.J. pp 1255, 1255

Mueller J (2007) The tiger awakens: the tumultuous transformation of India’s patent system and the rise of Indian pharmaceutical innovation. U Pitt L Rev 68(491):502

Mueller JM, Chisum DS (2008–2009) Enabling patent law’s inherent anticipation doctrine. Hous L Rev 45:1101, 1106

Okediji RL (2003) Public welfare and the role of the WTO: reconsidering the TRIPS Agreement. Emory Int’ll Rev 17:819, 890–893

Ragavan S (2003) Can’t we all get along? The case for a workable patent model. Ariz St LJ 35(117):144

Ragavan S (2006) Of the inequals of the Uruguay round. Marq Intell Prof L Rev 10(273):279

Rajagopala Ayyangar N (1959) Report on the Revision of the Patents Law (Ministry of Commerce and Industry 1959)

Reddy P, Chandrasekharan S (2017) Create, copy, disrupt India’s intellectual property dilemmas, pp 1–16 (OUP 2017)

Sagar R (2007) Introduction of exclusive privileges/patents in colonial India: why and for whose benefit, 2 Intell. Prop. Q. pp 164, 166

Sharma D (2005) When death becomes cheap. Herald D (16 April 2005), http://archive.deccanherald.com/deccanherald/apr162005/editpage1614452005415.asp

Sikka HS (2005) Is the new patents bill good for us? http://www.rediff.com/money/2005/mar/23debate.htm (23 March 2005)

Singh M (2005) India’s patent law-is it TRIPS compliant? Managing intell. Prop 67:69

Thomas JR (2005) Pharmaceutical patent law. Bureau of National Affairs, Arilington, pp 609–610

Unni VK (2015) India’s tryst with pharma patent settlements: whether a turbulent decade of litigations would give way to meaningful compromises? 6 W.I.P.O.J. (2) pp 165,169

Vishwanathan M (2014), It’s raining injunctions: novartis granted injunctions against four other generic makers over Galvus, http://spicyip.com/2014/04/its-raining-injunctions-novartis-granted-injunctions-against-four-other-generic-makers-over-galvus.html

Wertheimer AI, Santella TM (2005b) Pharmacoevolution: the benefits of incremental innovation. IPN Working Paper on Intellectual Property, Innovation and Health, p 8

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I would like to express my sincere thanks to the “Center for the Protection of Intellectual Property”, the Antonin Scalia Law School, George Mason University, Virginia, USA for their phenomenal support and guidance in the preparation of this paper through a Thomas Edison Innovation Fellowship (2016–2017). For comments on earlier drafts, many thanks to Adam Mossoff, Mark Schultz, Matthew Barblan, J. Devlin Hartline, Jay Kesan, Ted Sichelman, Eric Claeys, Michael Risch, Robert Cooter, Zorina Khan, Peter Yu, Ryan T. Holte, Michael Mireles, all Thomas Edison Innovation Fellowship awardees (2016–2017), and my colleagues at the Indian Institute of Management Calcutta. Finally, I gratefully acknowledge the constructive feedback given by the anonymous referees of IIC.

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Unni, V.K. India’s TRIPS-Compliant Patent Decade – The Tumultuous Journey in Search of a Pragmatic Equilibrium. IIC 50 , 161–195 (2019). https://doi.org/10.1007/s40319-019-00783-3

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Trips and its Impact on the Indian IP Regime

• Author(s): Journal of Legal Studies and Research
• Publication Date: September 26, 2019
• Tags: Berne Convention , Doha Declaration , Exclusive Marketing Rights (EMR) , General Agreement on Tariffs and Trades (GATT) , Mail Box , Marakesh agreement , Paris convention of 1967 , Rome Convention , Treaty on Intellectual Property in respect of Integrated Circuit , Uruguay Round of negotiations

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Written by Ivin George

5th Year BBA LLB(Hons.) Student, NMIMS University, School of Law

The post-colonial world in the late 20 th century and early 21 st century witnessed a change in the global economic setup, international trade and investment was on the rise and there was a need for its regulation. This led to the formation of General agreement on Trades and Tariffs in 1947, and it remained the regulatory agreement till 1995, in 1995 as a result of the Uruguay Round of negotiations, through the Marakesh agreement an international body to regulate the world trade was instituted, known as the World Trade organisation. Under its ambit, the agreement on the Trade Related aspects of Intellectual Property Rights was also adopted in 1995. This research paper tries to analyse the impact of TRIPS on the Indian laws on intellectual property, in the first part of this research paper the researcher analyses the circumstances which led to the adoption of TRIPS and how the ambit of the agreement has been broadened to encompass not only the trade related aspects of IPR but also the entire regulation of the IP laws. The researcher also analyses the method of implementation of the obligations laid upon India through this agreement, the researcher touches upon the concepts of Mail Box, and Exclusive marketing rights granted by the Indian IP regime during the transitional phase. The researcher also touches upon the proponents of the Doha Declaration and the impact on the pharmaceutical industry. Subsequently the researcher analyses the provisions of the TRIPS plus plus agreement, upon the IPR regime in place and in conclusion the researcher tries to determine the overall effect the TRIPS and the TRIPS Plus Plus would have on the Indian economy, which is the world’s fastest growing economy with huge IP potential

Keywords : TRIPS, Implementation, world politics, impact, Doha Declaration.

INTRODUCTION

At the turn of the 21 st century, the global landscape saw a gradual change from a colonial setup, led by the power bloc of mostly European Nations, to a global setup, dubbed as an era of globalization. As the global economy boomed, capital and labour flowed across the national borders at a rapid pace and international bilateral trade prospered. [i] It was at this time that the global community felt a need for a global regulation of international trade, and this culminated in the General Agreement on Tariffs and Trades (GATT) in 1947. [ii]

However, in the period from 1980 till 1994 was one of international turbulence, the global economy was dominated by the world powers like USA. In 1980s, USA felt threatened by losing its competitive edge to countries like Mexico, Taiwan and Singapore because of their increasingly sophisticated industries and technical advancements. [iii]

In 1982, USA instituted a GATT ministerial meeting, this meeting led almost a decade of international controversies, first there was the ‘working program’ generated by the ministerial conference which tried to increase the ambit of the GATT by including Services within its ambit. The developing countries formed a bloc of 24 countries to resist this move, but to little avail. By 1986 this bloc was reduced to only 10 developing nations led by Brazil and India, who put up an unyielding opposition. This issue was referred to the ministerial meeting to be held in Punta Del Este (Uruguay) in September of 1986. [iv]

It was in this meeting that a compromise was met between the developed nations, led by US and “the group of ten”, led by India and Brazil. While it was agreed that ‘services’ was outside the ambit of GATT, and that a different negotiation stream was needed which respected the national laws and regulation of the developing nations, it was in the Punta Del Este Meeting that the issue of trade related intellectual property rights were tackled as being within the framework of GATT.

Soon after the launch of the Uruguay round a coalition of American, European and Japanese drugs and pharmaceutical companies launched an offensive to include the issues of regulation standards and norms under the ambit of the GATT negotiation, this was primarily done with an intention to compel the national regimes of developing countries like India, Brazil and South Korea to fall in line with a global regime doctored to their favour. [v] This was resisted by the group of ten, as they emphasised that only the trade related aspects of Intellectual Property are under the ambit of the GATT. [vi]

However, in 1989 the negotiating group on TRIPS was given a full mandate thereby, including within the ambit of GATT not only the trade related aspects but also the mandate to, in general, negotiate rules on the Intellectual property laws, and is the basis of the current TRIPS agreement. [vii]

This research paper tries to analyse the impact of TRIPS on the Indian laws on intellectual property, in the first part of this research paper the researcher analyses the method of implementation of the obligations laid upon India through this agreement, the researcher touches upon the concepts of Mail Box, and Exclusive marketing rights granted by the Indian IPR regime during the transitional phase. The researcher also touches upon the proponents of the Doha Declaration and the impact on the pharmaceutical industry. Subsequently the researcher analyses the provisions of the TRIPS plus plus agreement, upon the IPR regime in place, in conclusion the researcher tries to determine the overall effect the TRIPS and the TRIPS Plus Plus would have on the Indian economy, which is the world’s fastest growing economy with huge IP potential.

TRIPS AND ITS IMPACT

The nature and scope of the obligations under the TRIPS agreement, hereinafter referred to as the ‘agreement’, permits the implementations of more extensive provisions for the protection of Intellectual Property Rights, than the ones provided in the agreement. [viii] The agreement is meant as a framework for minimum level of protection which has to be granted for the protection of intellectual property.

The agreement further puts an obligation upon the nations to comply with the provisions of the Paris convention of 1967, the Berne Convention, the Rome Convention and The Treaty on Intellectual Property in respect of Integrated Circuit. [ix] The agreement also provides for the generally accepted principles of International Law such as those of National Treatment and Most Favoured nations. [x]

The agreement, brought about significant changes to the Indian Intellectual Property regime. The patents law was amended to include the product patents under the ambit of the Indian patents law, furthermore inventions in the field of agriculture, pharmaceuticals and non-natural and genetically engineered life forms have been included under the ambit of patentable invention provided that the inventions demonstrate characteristics like novelty, inventive step, utility and written description. Lastly the term of patents was increased from 14 years to the now universally acknowledged 20 years. [xi]

India was given an exemption to from implementing pharmaceutical and agrochemical product patents till 2005, but during this period of transition India was required to implement a ‘Mailbox’ provision which aimed to assign each application filed during this transition period with a filing date. India was also under an obligation to grant Exclusive Marketing Rights (EMR) for these patent applications which were in the mailbox.

However India, was not able to comply with these obligations immediately, although it tried to implement the Mailbox provision and the Exclusive Marketing Rights through Presidential order, the failure to implement an amendment for these provisions, prompted the US to use the WTO dispute settlement process to get the Indian parliament to comply with the obligations. The Indian government ultimately implemented the Mailbox provision and EMR via an amendment in 1999, this amendment then became obsolete after the 2005 amendment and have been repealed since. [xii]

During India’s ten-year TRIPS transition period, 8926 mailbox applications were filed in the four branches of the Indian Patent Office, there were then deposited in a ‘black box’ and were not examined until 2005. [xiii] Some applicants however did seek additional protection by way of the EMR for example, pharmaceutical companies like Novartis applied for the grant of EMR over their drugs, which was needed keeping in mind the highly competitive nature of the pharmaceutical industry.

EMR was however not granted without due process, the Indian law required that EMR could only be granted to applications which showed that:

• an examination by the Indian Patent Office had established that the invention did not fall within any of the categories of subject matter considered as non-patentable inventions like business methods, frivolous inventions, mere admixture, or within the scope of the prohibition on patenting inventions relating to atomic energy. [xiv]
• the mailbox/EMR applicant had filed a patent application for the same invention, claiming the “identical article or substance” in a “convention country” on or after January 1, 1995. [xv]
• the mailbox/EMR applicant had been granted a patent by the convention country on or after the date it filed its mailbox application in India. [xvi]
• the convention country had issued “approval to sell or distribute the article or substance” in the convention country, “on the basis of appropriate tests conducted” in the convention country on or after January 1, 1995. [xvii]
• an authority on behalf of the Indian government had given approval to sell or distribute the article in India. [xviii]

The Indian Patent amendment of 2005, was not however free from its controversy, it included provisions specifying certain subject matters as non-patentable, it also added a new definition for ‘inventive-step’ and also provided for procedures for pre- and post-grant opposition to the patent-application. The amendment also liberalised the framework for compulsory licencing of essential patents. [xix]

Under the copyright laws provisions were amended to include Computer programs under the ambit of the copyright laws per article 10 of the agreement, this was change was brought to bring the copyright laws to the digital era. It also made commercial rental of computer programs the proprietary right of the owner of the copyright owner, thereby recognizing that computer programs not only have copyrightability, but also a commercial aspect. [xx]

Under the trademark laws, well known trademarks, collective marks and service marks were included within its ambit, the scope of trademarks was enlarged to include figurative elements like shape, packing and combination of colours. [xxi]

The Doha Declaration:

The TRIPS agreement had a huge impact on the world and the pharmaceutical industry, by adding pharmaceutical drugs under the category of patentable inventions, the big pharma companies rushed to file patents in the least developed and developing countries, these were the countries with the largest market for their products.

This was a matter of grave concern for the developing nations, the impact of the TRIPS agreement on the prices of the drugs, this was the age when diseases like typhoid, malaria and tuberculosis were rampant. [xxii] The pharma companies have always had a say in the matters of international and national politics, the work these pharma companies conduct are responsible increasing the average life expectancy of the entire world and are constantly trying to evolve and innovate to combat the mother nature and the pathogens that are responsible for diseases.

The flip side to the TRIPS agreement is that while, it ensures the protection of the efforts of these pharmaceutical companies in ensuring increased efficacy of drugs and incentivises them for continued research and development. It also puts the lease developed countries at a risk of having to pay exorbitant prices for such lifesaving drugs. This was the growing concern post the TRIPS agreement. [xxiii]

This concern was put to rest by the Doha Declaration where it was recognized that all the nations have the right to ensure public health by using procedures like compulsory licencing, the freedom to determine the grounds on which the licence would be granted and enhance access to medicine for poor countries. The Doha Declaration also extended the deadline for least developed countries to implement the TRIPS agreement from 2006 till 2016. [xxiv]

TRIPS plus provisions:

While the developing countries were still coming to grips with the TRIPS agreement, the developed nations are already raising the bar for IPR protection by way of Free Trade Agreements. The frontrunner in this is none other than USA. These provisions which provide for more protection for intellectual property rights have been dubbed as the TRIPS plus provisions.

One aspect of TRIPS plus provisions are the increasing demand for protection by the developed nations for data exclusivity. Data exclusivity provision tries to protect the clinical test data submitted to a regulatory agency to prove the safety, quality and efficacy of a new drug. This would help prevent the generic drug manufacturers from relying on such data in their own application and subsequently relying on such data while applying for licences. [xxv]

The demand for protecting exclusive data that have high commercial value is a major demand from the developed world which doesn’t usually come under TRIPs. This move triggers a much larger debate between the inventor’s proprietary rights and the fair use doctrine for public welfare. India has tried to resist the implementation of TRIPS plus standards, being a developing country, it has always emphasised on the need to maintain a balance between the proprietary right of the inventor and public welfare. Which is evident from India’s FTA negotiations with countries like Japan etc.

It is evident that through the TRIPS agreement the US has successfully widened the ambit of the GATT and the WTO over Intellectual Property Rights . the current TRIPS agreement covers not only the trade related aspects of Intellectual Property but the entire regulation of the Intellectual Property regime. This move was initially resisted by India but to little avail and the US was successful in its efforts. However, the developing nations voiced their concerns through the Doha Declarations and were successful in ensuring the protection of the public health aspect for pharmaceutical patents.

The developing nations are now again under duress as the developed countries want higher standards of protection for intellectual property, than those enshrined in the TRIPS agreement. The developing nations like India, however have the opportunity to ensure that their interests are protected. Countries like India have huge man-power and also have equally huge base for intellectual development. It is the need of the hour for developing nations to invest substantially on increasing the knowledge economy of their country. TRIPS plus provisions are aimed to maintain the gap between the developed and the developing nations, they need to put a unified front in resisting this change.

[i] Jeffrey G. Williamson, “Globalization, Convergence and History ”, Journal of Economic History, vol. 56, no. 2 (June 1996): pp. 1.

[ii] S.P. Shukla, “From GATT to WTO and beyond”, (UNU/World Institute for Development Economics Research, Paper no. 195), available at https://www.wider.unu.edu/sites/default/files/wp195.pdf.

[iii] Ibid .

[iv] Williamson, supra Note 1.

[v] Shukla, supra note 2.

[vi] Williamson, supra note 1.

[vii] Unni, V.K., “Indian Patent Law and TRIPS: Redrawing the Flexibility Framework in the Context of Public Policy and Health” (January 2, 2012). Pacific McGeorge Global Business & Development Law Journal, (2012) Vol. 25, No. 1, 323.

[viii] TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Article 1, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994).

[ix] TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Article 2, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994)

[x] Supra Note 9, at Art 3,4.

[xi] P. Narayanan, Patent Law (4th ed. 2017).

[xii] Mart Leesti, “Historical Background, General Provisions and Basic Principles of the TRIPS Agreement and the Transitional Arrangement”, Journal of Intellectual Property Rights, Vol 3, Mar 1998. pp 66-73.

[xiii] Unni, supra note 7.

[xiv] The Patents (Amendment) Act, 2002, No. 38 sec. 24A(2), Acts of Parliament, 2002 (India)

[xvi] Id at sec. 24B(1)(a).

[xviii] The Patents (Amendment) Act, 2002, No. 38 sec. 24A(2), Acts of Parliament, 2002 (India).

[xix] Narayanan supra note 8.

[xx] TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994)

[xxii] Carlos M. Correa, “Implications of the Doha Declaration on the TRIPS Agreement and Public Health”, WHO, available at https://www.who.int/medicines/areas/policy/WHO_EDM_PAR_2002.3.pdf.

[xxiii] Charles Clift , “A Guide to Assessing the Impact of TRIPS-Plus Provisions on Drug Prices in Developing Countries” , A Study Commissioned by the International Centre for Trade and Sustainable Development (ICTSD).

[xxv] Sandeep Mittal, “Effect of TRIPS plus provisions in International Trade Agreements upon access to medicines in Developing Countries”, JIPR, Vol 22 November 2017 pp 295-302.

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Role of the TRIPS agreement and its scope in India

Trips agreement in india:, role of trips agreement in shaping india's intellectual property regime:.

• Patents: One of the important impacts of the TRIPS Agreement on India's intellectual property command was in the area of patents. India had historically granted process patents in its place of product patents for pharmaceuticals, allowing local manufacturers to produce common versions of patented drugs at a lower cost. However, under TRIPS, India was required to evolve to a product patent regime and also this change led to challenges for the Indian pharmaceutical industry in terms of admission to affordable medicines and the convenience of generic drugs.  
• Copyrights: The TRIPS Agreement also influenced India's copyright law. It introduced minimum standards for copyright protection, including the term of protection, rights of authors, and limitations and exemptions and India amended its Copyright Act in 1999 to align with TRIPS requirements and extend copyright protection to computer software, digital works, and performances in the digital environment.  
• Trademarks and Industrial Designs: The TRIPS Agreement set minimum standards for the protection of trademarks and industrial designs and also required India to provide satisfactory protection to trademarks and establish a system for the registration and enforcement of industrial designs as India amended its Trademarks Act in 1999 to comply with TRIPS obligations and habituated provisions for the registration and guard of well-known trademarks.  
• Geographical indications: Customarily, some commercial items have been manufactured in a geographically defined territory and commercial relations, the geographical indicator becomes the dependable "carrier" of qualifying product features when these items are credited to certain criteria basically due to their geographical provenance. The purpose and value of geographical indications are subsequently given to trademarks, and they are allowable legal protection.

Importance of TRIPS

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COVID-19 Vaccine, TRIPS, and Global Health Diplomacy: India's Role at the WTO Platform

Vijay kumar chattu.

1 Division of Occupational Medicine, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada M5G 2C4

2 Department of Public Health, Saveetha Medical College, Saveetha Institute of Medical and Technical Sciences, Saveetha University, 600077, Chennai, India

3 Institute of International Relations, The University of the West Indies, St. Augustine, Trinidad and Tobago

4 Department of South and Central Asian Studies, School of International Studies, Central University of Punjab, PIN-151401, Bathinda, India

Jaspal Kaur

5 Department of law, Guru Nanak Dev University, Regional Campus, Jalandhar, Punjab 144007, India

Mihajlo Jakovljevic

6 Department of Global Health Economics and Policy, Faculty of Medical Sciences, University of Kragujevac, Kragujevac 34000, Serbia

7 Institute of Comparative Economics, Hosei University, Tokyo 194-0298, Japan

8 Department of Public Health and Healthcare named after N.A. Semashko I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia

Associated Data

The data presented in this study are available on request from the corresponding author.

In light of the devastation caused by COVID-19, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and vaccine research and development (R&D) have been occupying a prominent position in the field of global health diplomacy (GHD). Most countries, international organizations, and charitable organizations have been engaged in the R&D of COVID-19 vaccines to ensure timely affordability and accessibility to all countries. Concomitantly, the World Trade Organization (WTO) provides some provisions and enforcements regarding copyrights, patents, trademarks, geographical indications, and industrial designs. Given these safeguards, it is considered that intellectual property rights (IPRs) have become major barriers to the affordability and accessibility of vaccines/medicines/technology, particularly to the developing/least developed countries. Realizing the gravity of the pandemic impact, as well as its huge population and size, India has elevated this issue in its global health diplomacy by submitting a joint proposal with South Africa to the World Trade Organization (WTO) for a temporary waiver of IPRs to ensure timely affordability and accessibility of COVID-19 medical products to all countries. However, the issue of the temporary waive off had become a geopolitical issue. Countries that used to claim per se as strong advocates of human rights, egalitarianism, and healthy democracy have opposed this proposal. In this contrasting milieu, this paper is aimed at examining how the TRIPS has become a barrier for developing countries' development and distribution of vaccines/technology; secondly, how India strategizes its role in the WTO in pursuant of its global health diplomacy? We conclude that the IPRs regime should not become a barrier to the accessibility/affordability of essential drugs and vaccines. To ensure access, India needs to get more engaged in GHD with all the involved global stakeholders to get strong support for their joint proposal. The developed countries that rejected/resisted the proposal can rethink their full support.

1. Introduction

In the context of COVID-19, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been identified as one of the most significant barriers to vaccine and medicine affordability, particularly for developing and least developed countries. TRIPS is a hard law instrument that is enforceable and binding; it mandates patent protection for pharmaceutical products for up to 20 years, and any violations result in trade sanctions [ 1 ]. Apart from the lack of pharmaceutical research and development (R&D), patents on pharmaceutical products and processes and poverty used to become double whammies for third world countries. Given the monopolies over vaccine production, marketing and fixing the higher prices maximize profits by the multinational pharmaceutical and drug companies/developed countries. Global health diplomacy is an integral part of Indian foreign policy. Recognizing the urgency of the situation, India and South Africa have jointly submitted a draught request to the World Trade Organization (WTO) for a temporary waiver of intellectual property (IP) rights to make COVID-19 medications affordable and accessible to all. [ 2 ]. In this scenario, the main focus of this paper is to examine how the pharmaceutical TRIPS have become a barrier to the development and distribution of vaccines/technology to the poor countries. The paper also argues why the developed countries (advocates of health, democracy, egalitarianism, and protection of human rights) are refusing to support the temporary IP waiver proposal for the humanitarian cause. Even though international trade cooperation has suffered from geopolitical shifts and competition in the midst of the pandemic crisis, governments can align their trade and health policies to serve the global community by engaging in GHD [ 3 ].

Because of this COVID-19 pandemic and the consequent lack of vaccines/medicines, many developed countries are actively engaged in vaccine R&D. According to recent findings from a country pandemic risk exposure measurement model, the national risk management strategies in Italy and Spain have anticipated these needs [ 4 ]. On the contrary, public criticism in many developing nations has grown exponentially, as issues about the legitimacy of patents on life-saving vaccines have been raised. This has contributed to the call for modifications or amendments to the TRIPS, which many claims are too strongly favoring private and commercial rights and interest, and against public interests. However, developing countries such as India and South Africa, which are seen as the emerging leaders of third world countries, are concerned that TRIPS may prevent the patients from these countries' from accessing essential COVID-19 vaccines/medicines/technologies. Given this context, we conducted a review to examine how TRIPS has become a barrier to the development and distribution of vaccines/and technology in developing countries. Second, we looked at how India strategizes its involvement in the WTO through its global health diplomacy.

2. Methodology

A literature search was done in all the major databases, namely, PubMed, Web of Science, Scopus, and Google search engine for the terms “COVID-19” OR “COVID-19 Vaccine” OR “Trade-Related Aspects of Intellectual Property Rights (TRIPS)” OR “World Trade Organization” OR “Global Health Diplomacy” AND “India.” All relevant titles were screened, and essential information was extracted in preparation for this review. A total of 40 full-text articles and eight other reports were reviewed, and the findings are discussed in three main sections, namely, (1) COVID-19 medical products and TRIPS, (2) COVID-19 Vaccine and TRIPS, and (3) Global Health Diplomacy: India's Role at the WTO Platform.

3.1. COVID-19 Medical Products and TRIPS

The economic and social disruptions caused by the COVID-19 pandemic are devastating. Millions of people are at the risk of falling into extreme poverty. Globally, there have been 115,653,459 cases, including 2,571,823 deaths reported to WHO as of March 6, 2021 [ 5 ]. It had become a critical challenge for the developing and least developed countries where healthcare systems are not adequate to care for the affected people. With its great toll of lives and strain on the healthcare systems, COVID-19 has been a great challenge for such countries and even the developed countries. On December 2, 2020, WHO has published its official release of “Draft Landscape of COVID-19 Candidate vaccines 2020,” which contained a total of 51 Candidate Vaccines in Clinical Evaluation with more additions coming in [ 6 ]. Treatments available for patients suffering from an active clinical form of the disease also remain scattered and without firm consensus on efficiency ranging from old antimalarial drug chloroquine [ 7 ] over convalescent plasma [ 8 ] up to novel targeted monoclonal antibodies [ 9 ]. Secondly, it had left indelible imprints on unemployment, poverty, hunger, undernourishment, etc. Thirdly, whatever the efforts are being made for vaccines R&D [ 10 ] that would likely remain beyond common people's reach, given the high prices of the same due to TRIPS. A number of studies have already proven that the most developed non-OECD South Asian countries confront significant impediments to the financial affordability of pharmaceuticals for the general public, even in the richest coastal and metropolitan districts of their major cities [ 11 ]. Now, how TRIPS is one of the major concerns for the availability of the medicines is the moot question in this context?

The intellectual property rights (IPRs) started taking place during the late 19 th century, formally concretized in 1995. The IPRs are meant for protecting the creators/agencies' exclusive rights over the creation/s for a certain period. While the agreement establishes minimum standards for intellectual property right (IPRs) protection in the form of patents, trademarks, geographical indications, industrial designs, and the enforcement of those rights in all WTO member countries, it is primarily concerned with reducing distortions and impediments to international trade.

The TRIPS has been conceived very beneficial for society, particularly given the imposition of temporary monopolies and other limitations resulting from private IPRs [ 12 , 13 ]. By putting legal protections in place and tackling piracy and counterfeiting through the IPs, the creation of new knowledge, innovation, and creativity is being encouraged. Therefore, the costs associated with the R&D can be retrieved, and remuneration would be earned. Matthews [ 14 ] argues that the IP regime not only stimulates domestic innovation but also promotes knowledge diffusion, technology transfer and licencing, and Foreign Direct Investment (FDI) to developing and least developed countries, thereby promoting trade and economic development in those countries. On the contrary, Sell and Prakash [ 1 ] have argued that the TRIPS has also been subjected to severe criticism since their inception. Recently, on October 16, 2020, during the WTO TRIPS Council meeting, nine WTO members, including the European Union, did not support the proposal though 100 countries showed support for the proposal. Though Canada became the first country worldwide to reform its domestic law to enhance developing countries' access to patented medicines [ 15 ], it did not support the IP waiver proposed by India and South Africa recently in October 2020. It was proposed that Canada should assist developing countries in their calls for greater access to existing pharmaceuticals and technologies, as well as access to new treatments and equipment. Furthermore, it is an excellent time for global solidarity, and Canada should take advantage of this chance to reassess its position on IP acquisition in relation to other domestic and international policy levers [ 16 ].

3.2. COVID-19 Vaccines and TRIPS

Since the introduction of research and development in the biological sciences, vaccines have been given a vital place and role in saving millions of lives each year. Vaccines are used to prepare the body's natural immune system to combat viruses and bacteria. On December 2, 2020, WHO published its official release of “Draft landscape of COVID-19 candidate vaccines 2020,” which contains a list of 51 candidate vaccines in clinical evaluation [ 6 ]. Yet, we mentioned ongoing efforts to foster early marketing approvals by shortening phase III development duration, with the first global official launch in Russia [ 17 ] for emergency use authorization. However, it has not received fully marketing approval in Russia. Similar accelerated development pathways currently occur in the US, China, India, Germany, UK, and possibly Israel [ 18 ]. Against this backdrop, the COVID-19 vaccine R&D program has been ongoing at an unprecedented pace to make a preventable disease vaccine [ 19 ]. Even assuming this ends up with several agents of acceptable efficiency–toxicity profile, it remains an open-ended question of public acceptance of massive vaccination. Public opposition to such an epidemiological strategy to achieve herd immunity is notable globally, with a huge population of Pakistan being a convenient example [ 20 ].

Many scholars such as Thanh et al. [ 21 ] and Fau et al. [ 22 ] argued that soon after coronavirus detection in December 2019, the genetic sequencing of COVID-19 was published on January 11, 2020 which has necessitated an urgent international reciprocation to develop a preventive vaccine immediately. Schmidt [ 23 ] has reported in one of his opinions that about 80 companies, and institutes in 19 countries have been engaged in COVID-19 vaccine R&D. According to Thanh et al. in their report in the Coalition for Epidemic Preparedness Innovations (CEPI), in terms of R&D of COVID-19 vaccine from a geographical standpoint, North America covers 40%; Europe covers approximately 26%; and South America, Africa, Asia, and Australia collectively cover only 30%. These figures indicate that the developed countries monopolize the R&D of the vaccine.

International organizations have taken the lead in this direction and formed international alliances to expedite the R&D of vaccines. International organizations such as the World Bank, WHO, along with the Bill and Melinda Gates Foundation and other International NGOs, have raised a fund of US$ 8.1 billion and introduced the WHO COVAX plan for the fair and equitable distribution of an eventually licensed vaccine. CEPI has also created another fund of US$2 billion from the global partner for the fast-tracked research and clinical testing. Several countries like Belgium, Canada, Germany, Norway, the Netherlands, Switzerland, the UK, and charitable organizations like The Bill and Melinda Gates had contributed about US$ 915 and US$250 million, respectively, in support of CEPI research and public education support for COVID-19 vaccines [ 24 ]. In these times, where vaccine nationalism is on the drive due to the scarcity of vaccines, initially, the COVAX initiative is an instrument for a fairer global distribution [ 25 ]. Concomitantly, the Global Research Collaboration for Infectious Disease Preparedness (GLoPID-R) and the International Severe Acute Respiratory and Emerging Infection Consortium have been working toward COVID-19 research and eventual vaccine distribution. A virtual summit was organized with private and government representatives of 52 countries, including 35 heads of state from G7 and G20 nations, who supported the Global Alliance for Vaccines and Immunization (GAVI). For example, the European Commission had invested about €80 million in CureVac. Here, we must emphasize a crucial role in global health funding by a set of huge non-OECD actors nicknamed Emerging Markets. Notably, the five nations have been known under the acronym BRICS (Brazil, Russia, India, China, South Africa) or Emerging Markets Seven (EM7-Brazil, Russia, India, China, Mexico, Indonesia, Turkey) [ 26 ]. Real GDP growth rates among the EM7 remained substantially higher than G7 during the entire decade of the last global macroeconomic crisis, 2007-2016. Worldwide economic growth accelerating again in 2017 had roughly half of this growth being attributable to the EM7 and only one quarter to the G7 nations. Thus, the health sector's investment and their huge impact on the demand and supply of medical goods and services during the COVID-19 pandemic period shall play an inevitably colossal role. Furthermore, these long-term health expenditure trends are likely to become even more prominent as we approach the mid-2020s as per some prominent forecasts [ 27 ].

Some countries have been working in the direction of developing COVID-19 vaccines. The Canadian government pooled about CA$ 275 million for 96 vaccine research projects at Canadian companies and universities, along with a commitment for CA$ 850 million to the WHO for COVID-19 vaccines and preparedness [ 28 ]. The Chinese government has been providing low-rate loans to vaccine companies and research institutes. It had also pledged on May 18 to provide about US$ 2 billion to the WHO for the latter's COVID-19 vaccine plans, as well as a US$ 1 billion loan to Latin America and the Caribbean countries to make its vaccine accessible [ 29 ]. France had committed a US$ 4.9 million investment in COVID-19 vaccine research undertaken by the CEPI. Germany committed to investing about €300 million investment in CureVac. Several countries like Belgium, Canada, Germany, Norway, the Netherlands, Switzerland, and the UK had contributed about US$ 915 for the COVID-19 vaccines. The other vaccines rolled out with more support from the EU, US, and the UK that are from the Pfizer/BioNTech, AstraZeneca, Moderna, and Johnson & Johnson in early 2021.

The US's federal agencies like Biomedical Advanced Research and Development Authority (BARDA) had announced that about US$ 1 billion would be invested in vaccines. An additional amount of US$ 4 billion would be spent on vaccine development with companies like Sanofi Pasteur and Regeneron. The “Operation Warp Speed” fast-track program announced that it would collaborate with seven businesses to produce COVID19 vaccines, including Johnson & Johnson, Moderna, Merck, Pfizer, and the University of Oxford in partnership with AstraZeneca [ 30 ].

From the above discussion, it is clear that most of the countries, international organizations, and charitable organizations engaged in the R&D of COVID vaccines are from the Western world. Currently, the TRIPS has been providing many IPs related to vaccines. TRIPS Article 7 explains the objectives in terms of protection and enforcement of the IPs as “the promotion of technological innovation,” “the transfer and dissemination of technology” to the mutual advantage of both “producers and users of technological knowledge,” and “social and economic welfare.” Article 8 obligates the member countries to protect public health and nutrition and promote the public interests congruent to the TRIPS Agreement provisions [ 31 ]. Moreover, it is the fundamental responsibility of sovereign governments to protect their citizens' health and safety. The Article 73 of the TRIPS Agreement may justifiably be invoked to override IP protections because the pandemic constitutes an emergency in international relations within the meaning of Article 73 (b) [ 32 ].

Brooke and Sherris [ 33 ] had argued that the availability of vaccines, particularly in the low and middle-income countries, depends mainly on the prior evaluation by the developed countries/regions like the US or European drug regulatory agencies. Moreover, the pharmaceutical manufacturers used to receive a large chunk of revenues from the developed countries. Therefore, there are scanty financial incentives available if the same is not sold in the same markets. Additionally, poorer countries' health agencies used to take green signals from the developed countries before approving/not approving the new products in the market. Though this is an independent regulatory approval guaranteeing the safety and effectiveness before the use, under such paradigms, the TRIPS can still become a hurdle for the availability of vaccine technology.

Guimon et al. [ 34 ] stated that the pandemic will not recede until the COVID-19 vaccine is viewed as a global public good. Even the UNAIDS Executive Director Winnie Byanyima, in an open letter to the global pharmaceutical industry leaders, also called on the global pharma industry “to unlock the secrets to their COVID-19 vaccine technologies” to produce a cheap and accessible “People's Vaccine” and not a profit vaccine [ 35 ]. Even a working paper by WTO staff highlighted that the evidence-based debate on the scope and effect of the TRIPS policy options is a task more important today than ever [ 36 ].

4. Discussion

4.1. global health diplomacy: india's role at the wto platform.

The outbreak of COVID-19 had taken place in December 2019 in Wuhan, China. Consequently, the same was declared a Public Health Emergency of International Concern (PHEIC) and “Pandemic” by the WHO on January 30 and March 11 in 2020, respectively [ 37 ]. Concomitantly, the WTO has also cautioned that the “Pandemic represents an unprecedented disruption to the global economy and world trade, as production and consumption are scaled back across the globe.” The absence of vaccines/medicines for the ongoing pandemic became a more critical challenge for the entire globe. In this scenario, there was an overwhelming consensus for international collaboration to expedite vaccine development, manufacturing, a supply of effective medical technologies to ensure the protection of all patients across the globe. Even heads of several states urged the world leadership to treat the COVID-19 medical products as global public goods.

India has been known as the world's pharmacy, given its role in producing generic medicines [ 38 ]. Global health diplomacy has remained an important part of India's foreign policy. India has pursued the same at the peak of the pandemic. It had provided more than 150 countries with a wide range of medical and healthcare services, including medicines (hydroxychloroquine and paracetamol) and vaccines (Covishield and Covaxin). It has also collaborated with international organizations for vaccine R&D. It has contributed to the Global Alliance for Vaccines and Immunization (GAVI) [ 39 ].

In this backdrop, once again realizing the gravity of the situation, India and South Africa proposed a temporary waiver (IP/C/W/669) before the WTO's TRIPS Council as part of its global health diplomacy to expedite the development of medicines, vaccines, and diagnostics for prevention, containment, and treatment of COVID-19 [ 2 ]. Furthermore, the proposal casts a wide net, as practically any medical device required to diagnose, treat, or prevent COVID-19 could be eligible for such a waiver [ 40 ]. More than 350 civil society organizations and activists worldwide asked WTO member countries to support the Indian and South African joint proposal. Under the proposal's provisions, countries need to “waive off” the patents, copyrights, and other IPs not only for the products themselves but also for their underlying technologies—without facing WTO charges or penalties for violation of international trade rules. To take the lead further, India and South Africa had argued before the Council for TRIPS that “Given the current global emergency, WTO Members must work together to ensure that intellectual property rights such as patents, industrial designs, copyright, and the protection of undisclosed information do not obstruct timely access to affordable medical products such as vaccines and medicines, or the scaling-up of research, development, manufacturing, and distribution of medical products essential to combat COVID-19” [ 2 ]. Many access-to-medicines movements were organized by patient activists, civil society, and health-right groups who stood up to governments' passivity in the past to resist the pharmaceutical industry's monopolies for HIV medicines and eventually succeeded in gaining patent relief. These movements have resulted in a significant decrease in the prices of HIV medicines (over $10,000/person/year) dropped by 99% over a decade by allowing generic drugs in developing countries. Currently, the COVID-19 pandemic situation also presents a similar situation as the pandemic has affected every nation. Though in the case of HIV epidemic, it affected the global south more than the north and thus the support came in from the rich nations in Western Europe and North America. However, in the current COVID-19 pandemic, the rich nations have been affected more, with more cases and deaths resulting in global competition, lack of solidarity, and nationalist movements in addressing the domestic economic and health crises. There is a lack of global leadership and international cooperation in the current scenario, with geopolitical shifts leaving behind the interests of the developing nations. Hence, in this current scenario, vaccine nationalism has taken precedence over global cooperation and solidarity. Therefore, if the TRIPS waiver proposal is approved, the access to essential COVID-19 medicines, technologies, and diagnostics will improve drastically [ 41 ].

The proposal was also supported by UNAIDS, UNITAID, MSF (Medecins Sans Frontieres), academics, researchers, and numerous civil society organizations [ 42 ]. The WHO wholeheartedly lent its support to the Indian and South African proposal. WHO chief had welcomed India and South Africa's proposal and said “To ease international & intellectual property agreements on #COVID19 vaccines, treatments & tests to make the tools available to all who need them at an affordable cost.” The Indian leadership/health authorities realized that IPs are becoming barriers in the way of “scaling up production of test kit reagents, ventilator valves, N95 respirators, therapeutics, fluorescent proteins and other technologies used in the development of vaccines, etc.” Moreover, the waive-off argument has been advanced, realizing that the existing flexibilities in the TRIPS Agreement are “not adequate to address the fast-changing landscape of COVID19.” The fact that provisions under “compulsory licenses” are limited only to pharmaceutical products rather than the crucial medical devices required for combating the ongoing pandemic. The existing system became extremely onerous and time-consuming and of no practical use when exporters and importers have to comply with the existing provisions. In this backdrop, the joint proposal argued that the IP waiver has been very important, particularly for the developing countries with insufficient or no manufacturing capacities/finance for producing the vaccines/medicines [ 43 ]. However, these two are correlated but ultimately different problems. However, the financial resources are currently being raised for ensuring sufficient doses, but not the manufacturing capacities.

However, the proposal did not go through, given the rejection and lack of consensus among the developed countries. Rather, the WTO members have been divided into three groups. The first category including Chad, Tanzania, other African nations, Southeast Asia, and South American countries supported the proposal on behalf of the LDC countries and African Group. The second group of countries (China, Costa Rica, Chile, Columbia, Jamaica, El Salvador, Senegal, etc.) welcomed the proposal, but they did seek more clarifications. The third category comprises developed countries like Brazil, Canada, Norway, the UK, the US, Switzerland, and the EU, which outright rejected the proposal [ 42 ]. Chattu et al. have highlighted that though it is easy to talk of inequalities and inequities and include them in policies, and further added that, here is an opportunity for the world to show its solidarity for “Health For All” and nations should strive to find solutions to ensure equitable access to the COVID-19-related drugs, medical supplies, and vaccines [ 41 ].

From the above discussion, it becomes crystal clear that most vaccine R&D has been taking place in the developed countries' private and public institutions as it requires huge investments. However, at this juncture, the question is moot: which is more important, making money or saving a human life? This is weighing heavily on the minds of the public, especially in light of the ongoing critical issues of health and human security. Surprisingly, the developed countries, which are viewed as the main advocates of egalitarianism, democracy, health, and human rights by the global community, have not supported this humanitarian cause in the larger context. These 35 developed countries Australia, Brazil, Canada, Japan, Norway, Switzerland, the UK, the US, and the EU (27-member block) have rejected India's and South Africa's proposal. However, the other 100 nations have welcomed or fully supported it. This disagreement has resulted in rich vs. poor in the race of getting access to the COVID-19 medical equipment, treatment, and vaccines [ 43 ].

Have the TRIPS become a tool for the expansion of capitalism? Are these countries concerned about the 20 illnesses that can be prevented or treated, including COVID-19? If this is the case, why not put the question of returns, remuneration, profits, and so on to the side for the time being and focus on considerations, sensitivities, and humanitarian cause when whole humanity is suffering due to lack of access to COVID-19 vaccines and medicines?

To substantiate the above argument, it can be seen through the prism of deaths of millions of people due to infectious diseases every year. These diseases are perceived to be preventable or treatable. About 45% of deaths in Africa and Southeast Asia have occurred due to infectious diseases [ 44 ]. The death toll is unprecedentedly and unacceptably high in developing and the least countries. In the context of African nations, which depend on the development aid from rich nations, it would be prudent for the Africa Centers for Disease Control and regional bodies to embrace global health diplomacy to strengthen their capacity for disease preparedness and response [ 45 ]. During this crisis, the developing countries, especially in Asia and Africa, need to realign themselves and strengthen their health systems. A recent systematic review by Chattu et al. has emphasized that African Union needs to refocus and prioritize the continent's health challenges by innovatively adapting the canons of GHD towards attracting more funding and developing collaborative partnerships with relevant actors in the global health domain [ 46 ]. Although, the health crisis is due to given interlinked factors such as lack of healthcare facilities, poverty, unemployment, lack of sanitation but the critical factor for the same is unaffordability [ 47 ], inaccessibility, monopolization of production, and distribution of vaccines/medicines in the backdrop of the agreement on TRIPS.

On public health, trade, human rights, and the environment, governments seem to have lost faith in the value of working together. As highlighted by Jones Bruce, in the absence of credible great-power leadership from the US or China, the “middle powers” such as France and Germany have led to coordinating health and economic responses. Though the concept of “middle powers” is imprecise and inchoate, it refers to nations from the top 20 economies and lack large scale military power (or chose not to have a lead role) and is energetic in diplomatic and multilateral affairs such as France, Canada, Netherlands, Sweden, Germany, and the United Kingdom which were trying to fill the gaps in the international leadership [ 48 ]. They have shown their commitment and dedication by raising over $14 billion for providing free vaccines through the Vaccine Alliance to the countries that cannot afford them [ 49 ]. As Gostin et al. highlight the complexity of global health coordination and universal access to the COVID-19 vaccine, global health law's role is very critical as it supports global solidarity and reaches agreements to secure equitable access [ 50 ]. Moreover, there is an immediate need for cooperation and collaboration, an understanding of shared responsibility, and critical aspects such as transparency, accountability, trust, and fairness to overcome this COVID-19 pandemic [ 51 ].

5. Conclusions

COVID-19 had left indelible imprints and taught us several lessons such as the importance of global solidarity, international cooperation, and focusing on inequities and inequalities exposed during the ongoing pandemic. Given the monopoly of private ownership over vaccines/medicines/medical technology, the aspects of access and affordability to essential health care services will be compromised, violating the universal right to health. During this COVID-19 pandemic, the numerous facets of many healthcare systems' unpreparedness and fragile state were exposed. India, with its good infrastructure for pharmaceutical production and development, can become a hub for supplying generic medicines and essential medical equipment to the world, thereby improving access to the essential drugs, medicines, kits, and vaccines in many low- and middle-income countries (LMICs). There is a great need for cooperation and support from the developed nations to ensure the enjoyment of “right to health” by everyone. India must engage in global health diplomacy with a variety of global players to circumvent or obtain specific waivers for intellectual property rights (IP/IPRs) to safeguard the supply of life-saving and necessary pharmaceuticals and vaccines while maintaining equity and fairness. Every citizen has the right to health and human security. Therefore, the IP regime should not become a barrier to the availability and affordability of COVID-19 medical equipment and vaccinations. A large group of intellectuals, social activists, altruistic people, civil society organizations, nongovernmental organizations, international organizations, and other LMICs consider IPRs for COVID-19 essentials to be barriers during this pandemic. Hence, the countries that rejected the joint proposal of TRIPS waiver by India and South Africa should reconsider. Furthermore, those countries that claim to be strong supporters of human rights, egalitarianism, democracy, global health, and human security must rise to the occasion and lend their full support to India at the WTO for this great cause that prioritizes humanity over the business interests of the pharmaceutical industry.

Data Availability

Conflicts of interest.

The authors declare that they have no competing interests.

Authors' Contributions

VKC conceived the study and prepared the initial draft. BS, KK, and VKC did the literature search and data analysis. MJ reviewed the manuscript, and edited and provided critical comments. VKC edited the final version of the manuscript. All the authors have approved the final version before submission.

What is the Impact of TRIPS on Pharmaceutical Industry in India? A Comprehensive Analysis

This article is a nuanced understanding of the impact of TRIPS on pharmaceutical Industry and the right to health. Since its making, the TRIPS Agreement or Trade-Related Aspects of Intellectual Property Rights Agreement has affected IPR, especially in developing countries. The article gauges how the pharmaceutical industry functions and interact with India’s Patent Act and its subsequent amendments. Abinaya K does a detailed analysis of practices like ‘evergreening of patents’. She also provides alternatives such as compulsory licensing and price ceilings to balance and protect the right of health for the consumer at large.

By Mani Abinaya K, an Advocate and graduate from School of Excellence in law, Chennai. 

Introduction

Patent grants exclusive monopoly rights to the patent holder or inventor for twenty years. After the expiry of such a period, the innovation falls into the public domain.

In 1995, the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS Agreement) mandated developing countries to protect product patents. The TRIPS Agreement sets out minimum standards of patent protection and its implementation, and the same brought a radical shift in the pharmaceutical industry. Since its formulation, the intellectual property (IP) regime of member nations of the World Trade Organisation (WTO) witnessed a change. And so did India.

As a member of WTO, India had to amend the Indian Patent Act 1970 and fulfil its obligation in three amendments to the Indian Patent Act 1999, 2002 and 2005.

The 2005 amendment to the Indian Patent Act struck down the process patent regime and introduced the product patent system. After the Amendment, the generic industries that succeeded in patents and reverse engineering were not allowed.

As the pharmaceutical industries spend billions on research and development, the same reflects on the price of the product.

While access to affordable medicine constitutes a fundamental part of the right to health,  rising prices affect accessibility in developing countries like India, which has a significant population under the poverty line. Therefore, to ensure maximum access to health services, India has implemented the TRIP flexibilities and effective utilisation of compulsory licensing.

The recent decisions of the Supreme Court on this subject indicate that the Indian judiciary has been trying to strike a balance between public need and scientific progress.

This paper will analyse the impact of the TRIPS agreement on the pharmaceutical industry in India and the role of Indian Patent law. It also discusses how India uses the flexibilities under TRIPS for the effective implementation of compulsory licenses. Finally, the piece will understand the role of the Indian judiciary, which attempts to strike a balance between the right of the patentee and the fundamental right of health.

TRIPS and its Flexibilities

The TRIPS Agreement was negotiated during the Uruguay Round [1] of the General Agreement on Tariffs and Trade (GATT) between 1986 and 1994 [2] . Before TRIPS, IPRs were administered through several treaties by the World Intellectual Property Organization (WIPO). The TRIPS Agreement stipulated conditions dealing with patent eligibility, patent quality and patent protection. In addition, it sought to ensure adequate security of IPRs in line with the public health of the developing countries. [3]

The developing countries argued that the patent laws might limit their citizen’s access to affordable drugs. They were also unsure of the extent of the TRIPS flexibilities and its impact on their rights. Due to such concerns, the Council for TRIPS, in June 2001, systematically dealt with the relationship between public health and TRIPS. [4]

The concerns of the developing countries concerning pharmaceutical patents were explained and clarified by the 2001 Doha Declaration on TRIPS and public health.

The 2003 decision enabled the countries which cannot manufacture medicines themselves to import the medicines made under a compulsory license [5] . The Doha Declaration affirmed that the provisions of the TRIPS Agreement were to be read in the light of promoting ‘access to affordable medicines for all’. [6] This declaration highlighted the potential of a nation to exploit the flexibilities included in the TRIPS Agreement, including the compulsory licensing and agreed to expand exemptions to protect pharmaceutical patents for least developing countries by 2016.

Apart from compulsory licensing, the other flexibilities are parallel importation, provisions relating to the patentable subject matter, research exception, provisions relating to data protection, competition and control of anti-competitive practices and bolar provision. The Doha Declaration on the TRIPS and Public Health Agreement further expanded and reaffirmed the flexibilities.

Amendment of Indian Patent Law and Overall Impact of TRIPS on Pharmaceutical Industry

From 1995 to 2005, Indian Patent law was amended thrice to comply with TRIPS. [7] The Patents (Amendment) Act 1999 implemented the mailbox procedure as per Article 70.9 of the TRIPS Agreement that enabled pharmaceutical inventions to be accepted and put away in a mailbox, to be examined in 2005.

The Second Amendment in 2002 introduced a 20-year patent term. [8] Here, the burden of proof for process patent infringement got reversed, and requirements for compulsory licensing also got modified [9] .

The Third and the latest Amendment, in 2005, the Patents (Amendment) Act 2005, gave full patent protection to pharmaceutical products [10] .

Before the 2005 Amendment, there was no product patent for pharmaceutical products. This Amendment introduced product patent instead of process patent, allowing a broader system for a compulsory license. Further, it introduced a mechanism covering both ‘pre-grant’ and ‘post-grant’ opposition to patent applications, including provisions on ‘patentable subject matter’ and ‘exhaustion of patent rights,’ and most notably observe creating an ‘inventive step’ for patentability within the patent regime.

Granting product patents to pharmaceutical innovation has affected developing countries like India by directly restricting the availability of affordable drugs and by indirectly eliminating the generic competition that had survived so long by providing patented medicines at an affordable price.

The Pharmaceutical industries in India, before 1970, were under the control of foreign companies. However, between 1970 and 2005, the Indian pharmaceutical industries had enormous growth. This development was due to the adoption of the Patent Act of 1970.

This Act introduced the process patent and also shortened the term of pharmaceutical patents. The absence of the product patent enabled the production of drugs at the original cost. It also allowed generic companies to cut drug production costs which declined the growth of foreign pharmaceutical companies in India. [11] As a result, by 1990, India was self-sufficient in the production of bulk drugs.

After the 2005 Amendment, the product patent regime was allowed in India. However, the Indian generic industries were not allowed to ‘reverse engineer’ the patented drugs, resulting in increased medicines prices.

Evergreening of Patents

While ensuring that the inventors are given their patent rights and their accompanying benefits, it is also vital to keep in mind the rights of the people.

Article 21 of the Constitution guarantees protection of life and personal liberty to every citizen. Since the right to health is integral to the right to life, the government has a constitutional obligation to provide health facilities [12] . Therefore, the government must ensure that the patent holders do not exercise their exclusive right over their patented products for a long time, giving them unfair exploitation of the patent.

People must be able to access and afford life-saving drugs.

Section 3(d) of the Patents Act, 1970 was amended to ensure that patented products do not stay patented for a long time by making minor or insignificant modifications. This Amendment had aimed to prevent ‘patent evergreening’.

Evergreening refers to the practice whereby pharmaceutical firms extend the patent life of a drug by obtaining additional 20-year patents for minor reformulations or other iterations of the drug without necessarily increasing the therapeutic efficacy. [13] And the Novartis case very well highlights the importance of this provision.

In 1998, Novartis AG, an international pharmaceutical company, filed an application as per the TRIPS agreement before the Madras Patent Office for granting a patent for an anticancer drug named ‘Glivec’.

The fact was that another drug under the name Zimmerman patent existed used for the same purpose as ‘Glivec’. The Madras Patent Office rejected the application on the grounds that the innovation lacked novelty and failed to satisfy the test of non-obviousness. It was held that the drug is not patentable under Section 3(d) of the Patents Act as it did not have any significant therapeutic efficacy over its already existing form.

In its two writ petitions filed before the Madras High Court under Article 226 in 2006, Novartis stated that Section 3(d) of the Patents Act was unconstitutional. It reasoned the same by arguing that the Section violated Article 14 of the Constitution and was also non-compliant with the TRIPS agreement.

In 2007, the case got transferred to the Intellectual Property Appellate Tribunal (IPAB). In its decision, the tribunal stated that the drug had passed the test of novelty and non-obviousness, but it could not be patented as it was held as a non-patentable drug by way of Section 3(d).

In 2009, Novartis filed a Special Leave Petition (SLP) before the Supreme Court. The issue was to ascertain the meaning of a known substance and efficacy under Section 3(d). The Supreme Court in 2013 held that the beta crystalline form of Imatinib Mesylate is a new form of the known substance, that is, Imatinib Mesylate and that the word efficacy referred to therapeutic efficacy. As a result, the Novartis drug showed no increase in therapeutic efficacy and hence cannot be patented. Thus, the Supreme Court’s judgment attempted to avoid the evergreening of patents.

Large pharmaceutical companies tend to make small and inconsequential changes to the already patented drugs, claiming patent rights over 20 years. This is an unsustainable practice, especially in a developing country like India, where the population is high, and there is a need for life-saving drugs every day. Moreover, the availability of medicines at a cheaper rate is critical, which would not be possible if the companies continued to hold patent rights.

But this could lead to another problem. If only one company held the right to produce and distribute drugs with a specific function, no other company could make drugs with the same effect. Thus these drugs under product patent will continue to have a high price. However, one can attempt to solve this issue by ‘compulsory licensing’.

Compulsory License

Compulsory licensing is

“authorisations, permitting a third party to make, use or sell a patented invention without the patent owner’s consent.” [14]

Section 84 of the Indian Patents Act, 1970 provides for the conditions under which a compulsory license can be granted regarding the invention. The conditions are, when:

• The reasonable requirements of the public concerning the patented invention have not been satisfied, or
• The patented invention is not available to the public at a reasonable price or
• The patented invention is not used in India.

One such case of granting a compulsory license is NATCO vs Bayer . Bayer was a pharmaceutical company that held the patent rights over an ingredient ‘Nexavar’, which was used to treat liver and kidney cancer in 2008.

Natco then applied to the controller for a compulsory license to manufacture this drug. It reasoned that Bayer had failed to meet the adequate medicine supply. Furthermore, it stated that the drug wasn’t available at a reasonable price and wasn’t manufactured in India. The controller considered the conditions and made the following observations:

Reasonable requirements of the public:

Even after the expiry of three years from the date of grant of the patent, the drug was not imported as per the requirement. Further, it was available only to 2% of the consumers. Hence the public’s demand remained unfulfilled.

Affordability of the drug:

A primary reason why consumers didn’t purchase the drug was its cost, Rs.2,80,000 per month.

Not utilised in India:

Functioning in Indian territory would also require manufacturing to a reasonable extent in India. Yet, even after four years, Bayer failed to manufacture the drug in India and only imported it.

As the conditions in Section 84 were satisfied, the controller granted a compulsory license to NATCO. Thus, granting a compulsory license is an important provision provided for in the Act.

When a patent holder hasn’t made the necessary steps to provide the drugs at a reasonable price, the controller or any other person interested in the product can step in and offer or apply for a compulsory license.

This ensures that the patent-holding company doesn’t have unmitigated power to manufacture and distribute the drug. Moreover, the patent holders can guarantee that such compulsory licenses will not be granted unless they satisfy the conditions under Section 84.

Section 92 is another provision for granting a compulsory license. This Section provides for the application for a compulsory license by the controller of the patent. It states that an application can be filed under (i) a circumstance of national emergency, (ii) a circumstance of extreme emergency (iii) a case of public non-commercial use.

Thus, if the controller feels that a condition has arisen requiring the grant of the compulsory license, they can do so by way of this Section. The issue with this Section is that there is no standardised definition for the term ‘national emergency’ internationally.

No two countries are similar in their demography, geography, environmental conditions, resources etc. Thus it would be impossible to fix a standard or a mark to be deemed a national emergency for all the countries. Furthermore, if only one per cent of the population gets affected, the same cannot be termed a national emergency in another country. Thus, there cannot be a fixed international definition for a national emergency.

Drug Prices Control Order

The Drug Prices Control Order (DPCO) is an order issued under section 3 of the Essential Commodities Act (ECA), 1955. It seeks to regulate the prices of pharmaceutical drugs. It also comes up with the list of drugs to which the price ceiling shall apply and the formula or method for calculating the ceiling price.

The National List of Essential Medicines (NLEM) lists the pharmaceutical drugs that fall under price control, and the present order consists of 680 drug formulations. This aims to ensure that essential medicine and drugs don’t get priced exorbitantly to the extend of unaffordability. The government decides the essentiality of medicine based upon the country’s disease burden, priority health concerns, affordability concerns etc.

Until 2013, the ceiling price was fixed based on the cost-based pricing method. The ceiling price was calculated as a multiple of the cost that it took producers to promote and distribute a pharmaceutical drug.

In 2013, India adopted market-based pricing, whereby the government determined the ceiling prices, that is, the maximum mark-up that a retailer can charge over the reference price. The same is the simple average of the prices of all the brands with a market share of greater than or equal to 1 per cent based on market data provided by a market research firm, IMS Health. [15]

In the economic survey (2018-19,) the impact of the DPCO on the price and quantity of essential drugs was examined. Two drugs, Glycomet and Glimiprex-MF were taken for comparison.

Both are used for controlling high blood sugar.

Even though Glycomet came under the price control in DPCO in 2013 and Glimiprex did not. Also, the price of the former increased more than that for the latter after DPCO 2013.

The prices of the drugs that came under the DPCO 2013 increased on an average of Rs.71 per mg of the active ingredient and by Rs.13 per mg of the active ingredient for the drugs that did not.

DPCO, 2013 successfully reduced the prices of the essential drugs by retailers and chemists but impacted the drugs that were sold in hospitals. The DPCO thus had an opposite effect than what it intended to do. It increased the prices for the more expensive formulations more effectively than, the cheaper ones.

It ultimately failed in its attempt to make the drugs affordable.

  Finding a Balance

Justice Rajagopala Ayyangar, in his report on the revision of the patent laws in India in 1959, observed the Swan Committee’s view:

“The theory upon which the patent system is based is that the opportunity of acquiring exclusive rights in an invention stimulates technical progress in four ways: first, that it encourages research and invention; second, that it induces an inventor to disclose his discoveries instead of keeping them as a trade secret; third, that it offers a reward for the expenses of developing inventions to the stage at which they are commercially practicable; and fourth, that it provides an inducement to invest capital in new lines of production which might not appear profitable if many competing producers embarked on them simultaneously. Manufacturers would not be prepared to develop and produce important machinery if others could get the results of their work with impunity” [16] .

If labour and the time that a person spends on an invention is not rewarded, they may lose the desire to work. Therefore, just like physical labour is rewarded, intellectual labour must be rewarded too.

The question is whether laurels and praise are enough encouragement for inventors. Given the economically competitive nature of the world, the answer is a resounding no. First, there must be a significant financial benefit to encourage further research and invention.

Second, an inventor might keep the inventions for personal reasons alone, even if such an invention could be of significant use to others. That would be the basic human instinct. In the absence of a reward, inventors would not be ready to disclose their inventions and make them known to the world.

Thirdly, there must be compensation for the expenses incurred by the inventor to get their invention to the stage of being employed commercially.

Finally, giving exclusive rights to produce a product and sell them would significantly push companies to invest capital in such a new line of products under no pressure of any competition. They can reap the rewards if they succeed. These are the reasons why patent rights and benefits must be given to inventors. It is both for personal and societal benefit.            

With respect to medicines and pharmaceutical products, there must be a more sensitive and lax approach. Article 7 of the TRIPS Agreement states that the protection and enforcement of IPRs should contribute to the promotion of technological innovation and in a manner conducive to economic and social welfare [17] .

Article 8 states that the members may adopt necessary measures to protect public health and nutrition and prevent the abuse of intellectual property rights by the rights holder while formulating or amending their laws and regulations [18] .

Even Article 7, which lays down the agreement’s objectives, consider the economic and social well-being of the people. Although limited exceptions can be provided to the exclusive rights conferred by a patent as long as the patent owners’ interests are not violated. This is provided in Article 30 of the TRIPS [19] .

Article 31 further provides the WTO member countries to allow the use of the patented product without the authorisation of the patent holder. These provisions are in place so that while conferring exclusive rights to the patent owners, the well-being of the public is not sacrificed.

It is an attempt to uphold the rights of the patent holders and the welfare of the people at large. Additionally, the legislature took certain steps to avoid patent evergreening. Fixing the ceiling prices for certain essential drugs and compulsory license work in this regard is an attempt to further public and patent holders’ interests at the same time.

Shortcomings of Granting Compulsory License

When it comes to providing compulsory licenses, specific issues arise in its implementation and monitoring. Sometimes, when a manufacturer is granted a compulsory license to produce a drug in a particular situation, it might pave the way to creating grey markets.

When legitimate medications make their way to distribution channels not authorised by the drug manufacturers, it is considered a grey market. Thus when a manufacturer gets the compulsory license to produce a drug, they may sell the drugs to people other than the target public, that means to the people for whom the compulsory license was given in the first place.

The generic company (licensee) may manufacture the drugs and sell them in another country due to reasons such as higher value for the drugs etc. This leads to economic loss to both the government and the patent owners. Also, when a compulsory license is given to fulfil the need for many drugs/medicines, the royalty given to the patent owners might be of a lesser value than the one they may be entitled to under normal circumstances. A royalty payment will be higher in high and middle-income countries with a lower burden of diseases [20] .

Section 3(d) attempts to curb patent evergreening. But the issue with it is that the controller of patents has unfettered power and has the sole authority to decide upon the question of whether granting a particular patent would lead to patent evergreening or not.

They may decide if the new invention has an innovative step and if it increases the therapeutic efficiency. In some instances, Section 3(d) is being deliberately ignored and not being applied correctly while granting secondary patents [21] .

Suggestions and Conclusion

A proper application of Section 3(d) is necessary to ensure that no essential drugs remain patented for an unreasonable amount of time.

Governments must make domestic patent laws more flexible. And they must promulgate provisions that ensure that the disadvantaged populations of the country also have access to essential drugs priced expensive. In addition, the government must exercise flexibility in granting compulsory licenses to protect the patent holders’ rights so as to make sure that the patent owners get a reasonable amount of royalty for their inventions.

Also, they must track the distribution of drugs manufactured by the generic manufacturers after granting compulsory licenses to avoid creating grey markets.

Patent holders can be encouraged to license out their drugs at a lower price. They could also be given tax benefits as further encouragement.

Government can further acquire the patent rights of certain life-saving drugs and enable the manufacture of these drugs by generic companies. By taking similar steps, the governments, especially in underdeveloped and developing countries, can ensure that the patent holders’ rights are protected. And thus also ensuring that the public’s health is protected by providing the public access to patented drugs.

[1] The Uruguay round was the eighth round of multilateral trade negotiation, and took over seven years to complete.

[2] “WTO | Understanding the WTO – Intellectual property: protection and enforcement” Intellectual property: protection and enforcement, www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm .  Accessed 20 Apr. 2021.

[3] Guennif, Samira and N Lalitha. “TRIPS Plus Agreement and Issues in Access to Medicines in Developing Countries”. Journal of Intellectual Property Rights, vol 12, 2007. pp. 471-479., Accessed 16 Apr. 2021.

[4] The World Health Assembly had in 1996 examined the relationship between public health and the TRIPS Agreement, as it was mandated to report on the impact of the work of the WTO with respect to national drug policies and essential drugs. This was addressed in a resolution on the reverse drug strategy resolution WHA49.14www.who.int/phi/WHA49.14.pdf. Accessed 19 Apr. 2021.

[5] verkey, Elizabeth. law of patents 565 2nd ed., eastern book company, 2012.

[6] “Blic Health” THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PU, www.who.int/medicines/areas/policy/doha_declaration/en/ .  Accessed 15 Apr. 2021.

[7] Chaudhuri, Sudip. The WTO and India’s Pharmaceutical Industry: Patent Protection, TRIPS, and Developing Countries Oxford University Press, 2005, 65.

[8] Prior to the 2002 Amendment, pharmaceutical process patents issued under the 1970 Act lasted for a period of five years from sealing, or seven years from the date of the patent, whichever was less.

[9] The Patent (Amendment) Act 2002, No.38, Acts of Parliament, India, 2002 http://www.wipo.int/wipolex/en/text.jsp?file_id=207496 accessed on 15 Apr. 2021.

[10] Basheer, Shamnad. “Indias Tryst with TRIPS : The Patents (Amendment) Act, 2005”. The Indian Journal of Law and Technology, vol 12005, 2005. pp. 15., Accessed 15 Apr. 2020.

[11] Mehta, Pradeep S. “TRIPS and Pharmaceuticals: Implications for India”. vol 12005, 1998. pp. 97-106., Accessed 15 Apr. 2020.

[12] State of Punjab vs Mohinder Singh Chawla (1997) 2 SCC 83.

[13] R, Sushmita. “EverGreening: An Abuse of the Patent System” academike, 16 Jan. 2015, https://www.lawctopus.com/academike/evergreening-an-abuse-of-the-patent-system/. Accessed 15 Apr. 2021.

[14] Sharma, Aayush. “India: Compulsory License: The Most Happening Section Of The Patents Act, 1970” mondaq, 15 Oct. 2015, https://www.mondaq.com/india/Intellectual-Property/435044/. Accessed 14 Apr. 2021.

[15] “Economic survey 2020-2021” indianbudget, https://www.indiabudget.gov.in/economicsurvey/doc/echapter.pdf. Accessed 14 Apr. 2021.

[16] Ayyangar, Shri Justice N. Rajagopala. “Report on the revision of the Patents Law” https://spicyip.com/wp-content/uploads/2013/10/ayyangar_committee_report.pdf. Accessed 15 Apr. 2021.

[17] World Trade Organization, https://www.wto.org/english/docs_e/legal_e/27-trips_03_e.htm .  Accessed 15 Apr. 2021.

[19] Anurag, Akshay. “Pharmaceutical Patents And Healthcare: A Legal Conundrum” scconline, 9 Mar. 2019, https://www.scconline.com/blog/post/2019/09/03/pharmaceutical-patents-and-healthcare-a-legal-conundrum/ .  Accessed 14 Apr. 2021.

[20] Kaur, Amanpreet and Rekha Chaturvedi. “Compulsory Licensing of Drugs and Pharmaceuticals: Issues and Dilemma”. Journal of Intellectual Property Rights, vol 20, 2015. pp. 279-289., Accessed 14 Apr. 2021.

[21] Chatterjee, Patralekha. “Five Years After The Indian Supreme Courts Novartis Verdict” Intellectual Property Watch, 20 May 2018, https://www.ip-watch.org/2018/05/20/five-years-indian-supreme-courts-novartis-verdict/ .  Accessed 15 Apr. 2021.

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TRIPS And IPR Regime In India

The TRIPS regime has been developed as a fundamental instrument for assessing intellectual property rights worldwide. This is not the universal constant of intellectual property. Yet, it offers a fundamental structure that each member state of the World Trade Organization should incorporate within it’s domestic laws. 

Table of Contents

Introduction

The TRIPS agreement came into effect on January 1, 1995. The TRIPS agreement, i.e. Agreement on Trade Related Aspects of Intellectual Property Rights, includes various categories of intellectual property that are patents, trademarks, copyrights, industrial designs, trade secrets, etc. The privileges granted to individuals and organizations for their originality and advancements are a form of intellectual property. Within a certain amount of time, such rights typically offer the producer an exclusive privilege to use his or her invention. Throughout all levels-statutory, bureaucratic and judicial-the value of intellectual property in India is quite well known. This sets up minimal rules for the treatment and promotion of the rights in the member States that, with a view to reduce distortions and hindrances to world commerce, are expected to facilitate effective and consistent protection of intellectual property. The responsibilities resulting from the TRIPS Agreement correspond to the establishment of basic requirements of security within the legal structures and procedures of the Member States.

Laws Conforming With The TRIPS Agreement

Following are the three laws brought into the Intellectual Property Rights regime of India in consonance with the TRIPS Agreement:

The Copyright Act, 1957

Like the title suggests, copyright law is the fundamental concept that indicates that if someone makes anything, they own it and then they can decide the outcome. The purpose of this copyright law is essentially twofold: first to guarantee the right of their original expression to writers, composers, musicians, creators and other creative minds who risk their resources in bringing their products well before world, and secondly to enable others to openly expand on the skills and theories expressed by a work. 

https://legalreadings.com/human-rights-of-manual-scavengers/

Works which are not established in a concrete form of speech under copyright law, such as a compositional work that is not registered or recorded in any form, titles, list of items, methods, principles, proposals, etc., really aren’t qualified for copyright law protections. In conjunction, creations consisting of knowledge widely accessible to all and absent of any actual writings are also not covered, such as schedules, height/weight graphs that can be obtained from relevant documentation and other common forms, etc.

The Trademarks Act, 1999

A trademark is a word, a string of words, a logo or a mixture thereof which separates one rival’s goods from those of other competitors in the industry. It must be special, distinctive and worthy of becoming visually depicted. In addition, a name can be licensed under trademark law and therefore should be able to differentiate the products or services of one seller from those of another. It preserves and assists in the development of a brand that is extremely critical for the development of a business.  

The Act provides a full description of the word infringement that is often used. It offers sanctions and penalties for perpetrators under the Trademark Act. Where the registration of a trademark is legitimate, the registered owner shall have an exclusive privilege to use the trademarks in relation to the products and services in consideration of which the trademark is registered and also to claim compensation for the misuse of the trademark. 

The patent act, 1970.

Among the most significant intellectual property rights that serve as an opportunity for companies to innovate is the patent. Not only do they help the developer earn money, they benefit the community in which the patented invention is produced. It gives the nation a push in terms of economic performance. It is essentially giving a monopoly offer to the creator through which the inventor regulates and governs the general accessibility of the innovation. 

There are two categories of patents, namely product patents and process patents, under the Patents Act 1970. The product patent is the final outcome or creation of a product and the process patent is the direction of the development of a patent. Under the Patent Act, all methods and goods, if they are new, require an innovative phase and are worthy of practical use are qualified to register as inventions. For e.g., Tylenol pills can be treated as a product patent, whereas the process patent is the production of the pills. In a District Court with jurisdiction to prosecute the suit, a patentee has the option to initiate litigation for breach of the patent. 

Impact Of TRIPS Agreement

The agreement brought in radical alteration to the Intellectual Property Regime in India. In addition, developments in the area of agriculture, pharmaceutical companies and non-natural and genetic modification living organisms have also been included into the scope of the patentable innovation, given that the discoveries illustrate attributes such as ingenuity, imaginative phase, usefulness and detailed descriptive definition. India was granted a waiver from the enforcement of patents for pharmaceutical and agrochemical products until 2005, but India was forced to introduce a ‘Mailbox’ clause throughout this conversion era to allocate a processing deadline to every request submitted throughout that implementation period. India was also obliged to award Exclusive Marketing Rights (EMR) in respect of certain patent claims in the mailbox.  

However, the 2005 Indian Patent Amendment was not exempted from its dissensions, this involved clauses defining some of the  matters as non-patentable, added a new meaning of ‘inventive step’ and also established a framework for the patent application before and after grant. Regulations underneath the copyright rules have been modified which included software programs under Article 10 of the deal there under copyright rules, these were altered to offer the copyright rules to the digital world. This also decided to grant the rightful claim of the commercial rental of computer software to the copyright owner, thereby recognizing that computer software not only have copyright, but also a commercial element.[1] Within trademarks, well-known trademarks, collective marks and service marks are included within their context, and the framework of trademarks has been expanded to also include symbolic features such as form, packaging and color variations.

The Doha Declaration

Through bringing pharmaceutical drugs underneath the range of patentable innovations, major pharmaceutical firms hurried to register patents in the lowest advanced and emerging nations, these being the regions that have the biggest demand for their products, the TRIPS agreement had a significant influence on the society and the drug industry. It was a major area of problem for developing countries, the consequence of the TRIPS deal on drug costs, it was the period where illnesses such as typhoid, malaria and tuberculosis were widespread. In foreign and national politics, pharmaceutical firms do seem to have an influence. Throughout the functions that these pharmaceutical companies do, they are accountable for raising the average life expectancy rates of the whole planet and are thus always progressing to fight against nature’s order and organisms that carry these diseases. The Doha Declaration recognized that all countries also had the responsibility to maintain population health through using processes such as mandatory licensing, the rights to choose the criteria upon which authorization will be issued, and to expand coverage for underdeveloped nations to medication.  

The Provision of Trips Plus

Although emerging nations are still coming to terms with the TRIPS agreement, by means of free trade deals, developed economies already are setting the stakes for Intellectual property rights security. The leader here is nothing but the United States of America. These clauses allowing for better enforcement of intellectual property rights are being called the regulations of TRIPS plus. Another dimension of TRIPS plus agreements is the growing market for database exclusivity by emerging economies for security. In order to show the security, consistency and effectiveness of a new drug, data confidentiality clause intended to safeguard the medical performance data presented to the regulatory body. This will help discourage generic drug producers from depending on these details through their own request and then focusing upon these data when filing for licenses.[2] A booming market from the developing countries which typically does not fall within TRIPs seems to be the need for the security of exclusive content that has high economic value. Such a step sparks a much greater controversy here between exclusive rights of the creator and the principle of appropriate use for social benefit. India, as a developing economy, also managed to fight the introduction of TRIPS plus norms and has often stressed the requirement to find an  equilibrium between both the creator’s own privilege and social welfare. And that’s apparent from the FTA negotiations between India and countries such as Japan.  

Drawbacks Of TRIPS Agreement In India

The removal of the cultural heritage system could theoretically be detrimental to the status of India. The reason for it is that, for decades, agricultural practices have indeed been expanding around the globe, making it hard to know the sources of a plant and even to trace its original inhabitants for redress. This condition is aggravated by the fact that several assets have been gathered and stored in international gene banks over the ages. Anyone seeking to have entry would therefore have to compromise with a variety of nations, and therefore would note that they are not the only providers. The status of India is not merely that of a supplier. India will also need to deal for resources needed to fulfil its requirements as a source of genetic information from many other nations. Thus, it will appear to be a huge and  massive task to the total legal and financial costs incurred on monitoring and prosecuting proceedings for Intellectual Property Rights.

Public suspects that the product patent could lead to higher prices, rendering medications prohibitively expensive to the impoverished. The creator would continue to increase his gain with the implementation of product patents and thus the product cost is higher if there would be no patents. Consequently, the drug’s intake would be less. This reflects an implicit deterioration of benefits for Indian customers’ high prices regarding the implementation of patents for products.

Partnership with international companies is the rule throughout the area of research and development, without any Indian pharmaceutical industry qualified to take a prospective product from the experimental way to the end product initiation stage, leading to prejudices in the preference of patient groups regarding lifestyle related diseases.[3] In developing nations like India, such diseases kill thousands of individuals every year.  Instead of proceeding with all of those medicines previously created by industrialized nations in the past, the reform in intellectual property laws could enable many companies in India to carry out research than to develop more products.

The prospects for global drug manufacturers to operate in or partner with research and innovation units located in developing countries are not likely to be improved by TRIPS. This is clearly non likely to occur, but this does not happen because of some of the challenges involved with providing infrastructure, rapidly obtaining accurate data to ensure adherence to agreements.

In addition to the trade related elements of intellectual property, the new TRIPS agreement encompasses the entire framework of the intellectual property regime. Via the Doha Declarations, the developing countries articulated their fears and were active in safeguarding the global health element of pharmaceutical patents. Because industrialized nations need greater levels of security for intellectual property than any of those embodied in the TRIPS agreement, developing countries are now again experiencing extreme pressure. Nevertheless, developing countries such as India do have a chance to guarantee that their rights are secured. Countries like India have enormous manpower and labor and an even enormous foundation for intellectual growth. Emerging economies also require participating significantly in growing their nation’s skilled workforce.

References:

[1] TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights , Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994).

[2] Sandeep Mittal, “Effect of TRIPS plus provisions in International Trade Agreements upon access to medicines in Developing Countries”, JIPR, Vol 22 pp 295-302.

[3] Jha Ravinder, Options for Indian Pharmaceutical Industry in the Changing Environment- Review of industrial Management- VOL 42.

BY- TVISHA GUPTA | BENNETT UNIVERSITY

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Trade Related Aspects of Intellectual Property Rights (TRIPS)

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement is in the news now because of the recent US decision to support the temporary waiver of patent rules for the coronavirus vaccines. This is an important topic from multiple perspectives for the UPSC exam including economy, international relations, current affairs, etc. 

TRIPS Agreement

Trade Related Aspects of Intellectual Property Right (TRIPS) is an agreement on international IP rights.

• TRIPS came into force in 1995, as part of the agreement that established the World Trade Organisation (WTO) .
• TRIPS establishes minimum standards for the availability, scope, and use of seven forms of intellectual property namely, trademarks, copyrights, geographical indications, patents, industrial designs, layout designs for integrated circuits, and undisclosed information or trade secrets. 
• It applies basic international trade principles regarding intellectual property to member states.
• It is applicable to all WTO members.
• TRIPS Agreement lays down the permissible exceptions and limitations for balancing the interests of intellectual property with the interests of public health and economic development.
• TRIPS is the most comprehensive international agreement on IP and it has a major role in enabling trade in creativity and knowledge, in resolving trade disputes over intellectual property, and in assuring WTO members the latitude to achieve their domestic policy objectives. 
• It frames the IP system in terms of innovation, technology transfer and public welfare. 
• The TRIPS Council is responsible for administering and monitoring the operation of the TRIPS Agreement.
• TRIPS was negotiated during the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1986–1994.
• The TRIPS Agreement is also described as a “Berne and Paris-plus” Agreement.

Read about other WTO Agreements in the link.

What are Intellectual Property Rights?

Intellectual property rights are the rights given to persons over the creations of their minds. Intellectual property rights (IPRs) are legal rights that protect these creations. In contrast to rights over tangible property, IP rights give their owners rights to exclude others from making use of their creations only for a limited period. IP rights entitle the owners to receive a royalty or any sort of financial compensation or payment when another person uses their creations.

What is Intellectual Property?

“Intellectual property” refers to creations of the mind. These creations can take many different forms, such as artistic expressions, signs, symbols and names used in commerce, designs and inventions. 

IP rights are generally classified into two categories:

• Copyright and rights related to copyright: This rights relates to rights protecting art works, literary works, computer programmes, films, musical compositions, sculptures, paintings, etc. Related rights also include rights of performers, broadcasting organisations, and producers of phonograms (sound recordings). The main purpose of protection of copyright and related rights is to encourage and reward creative work.
• The protection of distinctive signs, especially trademarks (which differentiate the goods or services of one organisation/establishment from those of other undertakings) and geographical indications. These rights are aimed at protecting and ensuring fair competition consumer protection.
• The second type of industrial property rights are protected primarily to stimulate innovation, design and the creation of technology. These rights protect innovations by patents, trade secrets and industrial designs.

Read more on intellectual property rights in the linked article.

TRIPS Significance

The TRIPS Agreement makes protection of intellectual property rights an integral part of the multilateral trading system, as embodied in the WTO. The agreement is often termed one of the three “pillars” of the WTO, the other two being trade in goods (the traditional domain of the GATT) and trade in services.

Before TRIPS, the extent of protection and enforcement of IP rights varied widely across nations and as intellectual property became more important in trade, these differences became a source of tension in international economic relations. Therefore, it was considered prudent to have new trade rules for IP rights in order to have more order and predictability, and also to settle disputes in an orderly manner.

TRIPS Agreement Latest News

In view of the COVID-19 pandemic, India and South Africa had proposed to the WTO in October 2020 that the TRIPS Agreement (that included patent protection to pharmaceutical products including COVID vaccines) be waived off for COVID vaccines, medicines and diagnostics for the time period of the pandemic in order to make vaccines and drugs for COVID available to a maximum number of people worldwide.

If the vaccines are patent protected, only a few pharmaceutical companies from developed western countries would be able to manufacture it, making such drugs unavailable or inaccessible due to the high costs to people of other countries, especially, developing and least developed countries.

The US, which was opposed to any TRIPS waiver, has backed this proposal, along with the EU. This move has been welcomed by many since it might lead to the manufacture of more volumes of COVID vaccines enabling the whole world to get rid of the coronavirus at the earliest. However, pharmaceutical companies have protested the move saying this would not necessarily ensure vaccine availability since developing countries did not have the capability to produce the vaccines.

Arguments in favour of relaxing TRIPS rules 

• This would make the vaccines more available to people of developing countries and also LDCs.
• Life-saving drugs and vaccines should be made available to everyone and pharmaceutical companies should not be looking to make profits out of these. There is an ethical and moral issue here.
• With particular reference to the COVID-19 pandemic, it is said that no one is safe unless everyone is safe. In this respect, it is imperative that vaccines are made available to everyone in countries affected since it can easily spread to all countries as seen in the first wave.
• Rules granting monopolies that place the right to access basic healthcare in a position of constant peril must end.

Arguments made by opponents of TRIPS waiver

• Unless corporations are rewarded for their inventions, they would be unable to recoup amounts invested by them in research and development.
• Without the right to monopolise production there will be no incentive to innovate. 
• They also claim that companies in the developing world do not have the capacity to manufacture vaccines or drugs on a large scale.

Just a waiver of the IP rights rules without further assistance such as technology transfer to generic pharmaceutical companies in developing countries would render the move useless. This is because there would also necessitate tech transfer for the pharmaceutical companies to start the production since vaccines like the mRNA vaccines require highly sophisticated manufacturing equipment. Not only technology and equipment, raw materials and probably personnel would also need to be transferred for developing countries to be able to produce vaccines on a large scale.

It could also take several years before the generic pharmaceutical companies’ plants become operational at optimal capacity and produce vaccines, which is a problem because it is doubted whether vaccines produced today would be effective against any new strain of the virus.

TRIPS Agreement:- Download PDF Here

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India Connects Southeast Asia and Middle East, Says IndiGo Chairman – India Report

Bulbul Dhawan , Skift

April 22nd, 2024 at 11:00 PM EDT

Indian airlines are forging international partnerships and boosting connectivity at a rapid scale. These collaborations are helping India become an international hub.

Bulbul Dhawan

The Skift India Newsletter is your go-to platform for all news related to travel, tourism, airlines, and hospitality in India.

India is becoming a convenient hub for travel between Southeast Asia and the Middle East, IndiGo Chairman V Sumantran said during his address at a college in Chennai. He also cited the example of several airlines carrying passengers from places such as Bangkok to Jeddah or Dubai by connecting through Indian cities.

“India is slowly becoming a convenient hub for travel between South East Asia and the Middle East,” news agency PTI quoted him as saying.

Sumantran said there is huge growth that IndiGo can see coming out of this, as a result of which the airline has placed an order of 500 aircraft.

Speedy development in India: During his address, he asserted India is quickly undertaking infrastructural development. “We have about 140 operating airports now and this would increase to 220 by 2030. We are seeing a huge increase in regional travel,” he said. He added that many of the domestic routes are used by airlines for connectivity. 

Increasing partnerships: Indian airlines such as full-service carriers Vistara and Air India have a robust international network of interline and codeshare partners . Air India is also a part of the Star Alliance . IndiGo is also actively increasing its roster of international partners . 

These partnerships are playing an important role in making India the hub for international connectivity as well as making regional destinations in the country accessible for international passengers.

Air India to Debut New A350 on Delhi-Dubai Route

Full-service carrier Air India is set to debut its new A350 aircraft on the Delhi-Dubai route from May 1. The aircraft would feature Air India’s new livery, which was unveiled last year as part of the airline’s rebranding. With this, Air India becomes the only carrier to operate the A350 between India and Dubai, the airline said in a statement. 

Meanwhile, Air India sold its last four Boeing 747-400 jumbo jetliners . The last of the jumbo jets flew from Mumbai on Monday . Historically, the aircraft had served as the primary carrier for Air India’s international operations. 

Indian Railways Operates Record Number of Additional Trains in Summer 2024

The Indian Railways is operating a record 9,111 trips during this summer season, it has said in a statement . This is a 43% year-on-year increase in the number of trips operated by Indian Railways during the summer. 

Summer travel rush has been observed in Maharashtra, Gujarat, Rajasthan, Tamil Nadu, Andhra Pradesh, Telangana, Odisha, West Bengal, Bihar, Madhya Pradesh, and Delhi. 

IndiGo Set to Fly Direct From Chennai to Durgapur and Bangkok

Budget airline IndiGo is set to operate direct flights between Chennai and Durgapur in West Bengal from May 16. The airline is also set to resume flying the Chennai-Bangkok sector from May 15. 

The move will not only connect the tier II city of Durgapur with the Chennai metropolitan, but also allow passengers to fly between Durgapur and Bangkok via Chennai. Serving more than 125 routes, IndiGo is playing a key role in enhancing regional and international connectivity in India. 

“The enhanced accessibility and connectivity provided by these flights will not only strengthen  regional and international connectivity, but also create new trade and tourism opportunities,” said IndiGo head of sales Vinay Malhotra. With this, IndiGo is set to operate 69 direct flights to Thailand from seven Indian cities. 

Air India Suspends Flights to Tel Aviv Until April 30

Former national carrier Air India has suspended flights to Tel Aviv in Israel until April 30. This has come amid tensions between Israel and Iran as Iran attacked Israel on April 13 followed by Israel’s retaliation .

Air India said that it is monitoring the situation and “extending support to passengers who have confirmed bookings for travel to and from Tel Aviv during this period, with a one-time waiver on rescheduling and cancellation charges.”

Last week, the Indian civil aviation ministry had advised Indian airlines to assess risks before flying internationally. 

Cinnamon Hotels Appoints Palak Shah as Sales Vice President

Sri Lankan luxury hotel chain brand Cinnamon Hotels and Resorts has appointed Palak Shah as vice president of sales. Shah has been tasked with leading the company’s strategic sales initiatives, particularly focusing on India and key source markets. 

Prior to this, Shah was regional sales director for Southwest Asia at IHG (InterContinental Hotels Group). At Cinnamon, he will also lead and oversee the company’s global sales offices in India, China, and the United Kingdom. 

Skift India Report

The Skift India Report is your go-to newsletter for all news related to travel, tourism, airlines, and hospitality in India.

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Tags: air india , airlines , airport , airports , aviation , aviation industry , aviation news , dubai , hotels , india , india budget , india outbound , india travel , indian airlines , indian railways , indigo , indigo airlines , international tourism , international travel , iran , israel , Israel travel , tourism , trains , Travel Trends

Photo credit: The IndiGo chairman said that many domestic routes in India are used by airlines for connectivity. Rudy and Peter Skitterians / Pixabay

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ANA and Air India to launch codeshare partnership

All Nippon Airways (ANA) and Air India, the national flag carrier of India, have entered into a commercial agreement marking the beginning of a codeshare partnership that will connect Japan and India.

Beginning May 23, this partnership between the two Star Alliance members will enhance flight selection options for travelers, allowing passengers to more easily fly to their desired destinations by combining flights across the two airlines into a single ticket. In addition, both travelers flying on codeshare flights can enjoy premium services such as lounge access and priority boarding that Star Alliance offers to its premium members.

ANA will apply its "NH" code to Air India's flights between Narita and Delhi and Air India will add its "AI" code to ANA's flights between Haneda and New Delhi as well as Narita and Mumbai.

"We look forward to building this strategic partnership with Air India, as it is a significant step towards furthering stronger air connectivity and enhancing customer experience between Japan and India," said Katsuya Goto, Executive Vice President of Alliances and International Affairs. "This collaboration is a testament to ANA's commitment to improving the air travel experience for all of its travelers and we hope this will lead to a seamless travel environment between our two nations."

The two airlines are considering expanding its cooperation by adding additional destinations in the near future. This agreement will contribute to expanding the economic and commercial relations between India and Japan, by offering travelers from both countries new opportunities to discover the wonders of both countries.

Codeshare flights will be available for sale through the airlines' respective websites, reservation systems and travel agencies.

"This codeshare agreement with All Nippon Airways marks an important step forward in connecting India and Japan," said Nipun Aggarwal, Chief Commercial & Transformation Officer, Air India. "This collaboration broadens our network connectivity and offers our guests seamless travel experiences and a wider choice of flights between the two countries. We look forward to a successful collaboration with ANA and exploring further avenues for cooperation in the future."

Source: ANA

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3 Comments Login to comment

alex Today 08:25 am JST

In no other industry is this kind of bait-and-switch marketing acceptable. Imagine booking a comparatively expensive flight on ANA, with its exemplary service and excellent safety record, only to be herded onto a dirty old Air India airplane, with its poor service and notorious time-keeping.

/dev/random Today 12:14 pm JST

Imagine booking a comparatively expensive flight on ANA, with its exemplary service and excellent safety record, only to be herded onto a dirty old Air India airplane

Then you didn't pay attention. Airlines are, by regulations and consumer protection laws, required to state the operating carrier(s) when a codeshare is sold.

EvilBuddha Today 12:30 pm JST

Imagine booking a comparatively expensive flight on ANA, with its exemplary service and excellent safety record, only to be herded onto a dirty old Air India airplane, with its poor service and notorious time-keeping.

Air India was privatized a couple of years ago, and it is undergoing merger with another airline in which Singapore Airlines has a 49% stake. Post merger, SIA will have 25% stake in Air India.

Also I am assuming that the maximum flyers on this route will be Indian nationals who are already aware of the kind of service that the (old state-owned) Air India used to give, so any improvement from those depths will be welcome.

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European Union adopts more favourable Schengen visa rules for Indians

Indian Nationals can now apply for a multiple entry Schengen visa with longer validity

On 18 April 2024, the European Commission adopted specific rules on the issuing of multiple entry visas to Indian nationals, which are more favourable than the standard rules of the Visa Code that applied to date. This new visa ‘cascade’ regime for Indian nationals residing in India who apply for Schengen (short-stay) visas in India will provide easier access to visas with multi-year validity for travellers with an established travel history, if the passport validity allows. 

According to the newly adopted visa “cascade” regime for India, Indian nationals can now be issued long-term, multi-entry Schengen visas valid for two years after having obtained and lawfully used two visas within the previous three years. The two-year visa will normally be followed by a five-year visa, if the passport has sufficient validity remaining. During the validity period of these visas, holders enjoy travel rights equivalent to visa-free nationals.

This decision comes in the context of strengthened relations under the EU-India Common Agenda on Migration and Mobility, which seeks comprehensive cooperation on migration policy between the EU and India, with facilitation of people-to-people contacts being of key aspect due to the importance of India as a partner for the EU. 

Schengen visas allow the holder to travel freely in the Schengen area for short stays of a maximum of 90 days in any 180-day period. The visas are not purpose-bound, but they do not grant the right to work. The Schengen area consists of 29 European countries (of which 25 are EU states): Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Luxembourg, Hungary, Malta, Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, Finland and Sweden, along with Iceland, Liechtenstein, Norway and Switzerland.

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Travel to multiple destinations on a single ticket: Air India and Japan's All Nippon Airways sign codeshare agreement

Commencing on May 23, the codeshare agreement will allow passengers of both airlines to seamlessly navigate their travel itineraries by combining flights between the two countries under a single ticket. 

• Updated Apr 23, 2024, 3:38 PM IST

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