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The TRIPS Waiver Decision at the World Trade Organization: Too Little Too Late!

Published online by Cambridge University Press:  28 October 2022

Prabhash RANJAN  and
Praharsh GOUR
Prabhash RANJAN*
Affiliation:
Jindal Global Law School, O.P. Jindal Global University
Praharsh GOUR
Affiliation:
Directorate General of Trade Remedies, India
*
Email: pranjan@jgu.edu.in
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Abstract

The recently adopted Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver decision at the World Trade Organization is a grossly inadequate and insincere response to the COVID-19 pandemic. This paper criticizes the TRIPS waiver for being faulty on several fronts such as: excluding COVID-19 diagnostics and therapeutics from its fold and focusing only on COVID-19 vaccines; restricting its coverage to only patents and leaving out other intellectual property rights; excluding developed countries that possess manufacturing and technological capability from being eligible exporters of COVID-19 vaccines; and its perplexing silence on the transfer of technology. It will have negligible impact on fighting the pandemic, sets an enfeebled example for the future, and is a classic case of “too little too late”.

Keywords

TRIPSWTOCovidPublic HealthWaiver
Type
Notes and Comments
Information
Asian Journal of International Law , Volume 13 , Issue 1 , January 2023 , pp. 10 - 21
Copyright
Copyright © The Author(s), 2022. Published by Cambridge University Press on behalf of the Asian Society of International Law

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References

1 JOSEPH, Sarah, Blame it on the WTO: A Human Rights Critique, 1st ed. (Oxford: Oxford University Press, 2011) at 241CrossRefGoogle Scholar.

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4 Council for Trade-Related Aspects of Intellectual Property Rights, “Waiver From Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19: Communication from India and South Africa (IP/C/W/669)” (2 October 2020), online: WTO <https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True>.

5 Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 U.N.T.S. 3 (entered into force 1 January 1995) [WTO Agreement], arts. IX.3 and IX.4. Articles IX.3 and IX.4 establishing the WTO allow for waiving an obligation imposed on a WTO member country by the WTO Agreement or any other multilateral trade agreement given in Annexes 1A, 1B, or 1C in “exceptional circumstances”, subject to the terms and conditions that shall govern the working of the waiver.

6 Electronic Information for Libraries, “Statement on Copyright and Proposal of a Waiver from Certain Provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement for the Prevention, Containment and Treatment of COVID-19 (IP/C/W/669)” (22 March 2021), online: EFIL <https://www.eifl.net/system/files/resources/202103/civil-society-statement-on-copyright-and-proposed-trips-waiver.pdf>.

7 The London School of Economics and Political Science, “Waive Intellectual Property Protection for COVID vaccines and related technologies urge over 100 IP academic experts” (13 July 2021), online: LSE <https://www.lse.ac.uk/News/Latest-news-from-LSE/2021/g-July-21/Waive-intellectual-property-protection-for-COVID-vaccines> (the first author is one of the signatories to the letter). See also Siva THAMBISETTY, Aisling MCMAHON, Luke MCDONAGH, Hyo Yoon KANG, and Graham DUTFIELD, “The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic” LSE Legal Studies Working Paper No. 06/2021 (2021), Online: SSRN <https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3851737#>; Prabhash RANJAN, “The Case for Waiving Intellectual Property Protection for COVID-19 Vaccines” ORF Issue Brief No. 456 (2021), online: ORF <https://www.orfonline.org/wp-content/uploads/2021/04/ORF_IssueBrief_456_TripsWaiver.pdf>. However, some contend that waiving the agreement is needless because countries can rely on the existing TRIPS flexibilities such as compulsory licensing and parallel importation to augment the supply of COVID-19 medical products. See MERCURIO, Bryan, “WTO Waiver from Intellectual Property Protection for COVID-19 Vaccines and Treatments: A Critical Review” (2021) 62 Virginia Journal of International Law Online 9Google Scholar.

8 Council for Trade-Related Aspects of Intellectual Property Rights, supra note 4.

9 David LEVINE, “COVID-19 should spark a Re-examination of Trade Secrets’ Stranglehold on Information” The Centre for Internet and Society (10 July 2020), online: Stanford Law School, Centre for Internet and Society <http://cyberlaw.stanford.edu/publications/COVID-19-should-spark-reexamination-trade-secrets%E2%80%99-stranglehold-information>.

10 Ministerial Decision on The TRIPS Agreement, WT/L/1141 (2022) [the TRIPS waiver].

11 “MC12 outcomes” World Trade Organization (2022), online: WTO <https://www.wto.org/english/thewto_e/minist_e/mc12_e/mc12_e.htm#outcomes.

12 The TRIPS waiver, supra note 10, para. 6.

13 See also Bryan MERCURIO and Pratyush Nath UPRETI, “From Necessity to Flexibility: A Reflection on the Negotiations for a TRIPS Waiver for COVID-19 Vaccines and Treatments” (2022) World Trade Review (First View).

14 Agreement on Trade Related Aspects of Intellectual Property Rights, 15 April 1994, online: WTO <http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm> [TRIPS], art. 28.1, which provides: “A patent shall confer on its owner the following exclusive rights: (a) where the subject matter of a patent is a product, to prevent third parties not having the owner's consent from the acts of: making, using, offering for sale, selling, or importing6 for these purposes that product; This right, like all other rights conferred under this Agreement in respect of the use, sale, importation or other distribution of goods, is subject to the provisions of Article 6. (b) where the subject matter of a patent is a process, to prevent third parties not having the owner's consent from the act of using the process, and from the acts of: using, offering for sale, selling, or importing”.

15 The TRIPS Waiver, supra note 10, para. 1.

16 Council for Trade-Related Aspects of Intellectual Property Rights, supra note 4.

17 World Health Organization, “WHO recommends two new drugs to treat COVID-19” (14 January 2022), online: WHO <https://www.who.int/news/item/14-01-2022-who-recommends-two-new-drugs-to-treat-COVID-19#:~:text=The%20first%20drug%2C%20baricitinib%2C%20is,it%20is%20given%20with%20corticosteroids>.

18 Médecins Sans Frontières, “MSF responds to latest WHO recommendation for a COVID-19 therapeutic, baricitinib” (14 January 2022), online: Reliefweb <https://reliefweb.int/report/world/msf-responds-latest-who-recommendation-COVID-19-therapeutic-baricitinib>.

19 A compulsory license is an authorization given by the Member to a third party for the exploitation, i.e. production, importation, sale, or use of the patent product, without the consent of the patent owner to attain certain public policy objectives. See Carlos M CORREA and World Health Organization, “Guide for the Granting of Compulsory licenses and Government Use of Pharmaceutical Patents” World Health Organization (2009), online: WHO <https://apps.who.int/iris/handle/10665/70096> at 13.

20 As per art. 5(A) of the Paris Convention, if a patentee does not “make” the patented invention in the territory of the country where it enjoys patent protection within three years of getting patent protection, then a compulsory license can be issued against it. Provisions of the Paris Convention have been incorporated into the TRIPS Agreement by art. 2(1).

21 To permit the government or its contractors to make noncommercial public use of the patents without the consent of the right holders. See ARMOUTI, Wael, “Grounds for Compulsory license with Selected Cases Granted for Pharmaceuticals” (2018) 26 Tulane Journal of International and Comparative Law 381 at 392Google Scholar.

22 When the license is issued for use of subsequent patents without infringing an earlier patent. See YOSICK, Joseph A., “Compulsory Patent Licensing for Efficient Use of Inventions” (2001) 5 University of Illinois Law Review 1275 at 1293–4Google Scholar.

23 Armouti, supra note 21 at 388.

24 See generally WONG, Hilary, “The Case for Compulsory Licensing during COVID-19” (2020) 10 (1) Journal of Global Health 1CrossRefGoogle ScholarPubMed.

25 Yosick, supra note 22 at 390.

26 TRIPS, art. 31(a).

27 Some other requirements given in art. 31 of the TRIPS Agreement for the issuance of compulsory licenses are: the scope and duration of the license must be limited only to the purpose for which they were authorized (art. 31(c)); these licenses should be non-exclusive (art. 31(d)); the licenses should be non-assignable (art. 31(e)); and if the patent owner is aggrieved then the decision of grant and remuneration governed by art. 31(h) is subjected to judicial review (art. 31(i)).

28 Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2 (14 November 2001).

29 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WT/L/540 and Corr.1 (30 August 2003) [2003 August decision].

30 Agreement on Trade-Related Aspects of Intellectual Property Rights (as amended on 23 January 2017), online: WTO <https://www.wto.org/english/docs_e/legal_e/31bis_trips_01_e.htm>.

31 Oxfam International, “Patents versus Patients, Five years after the Doha Declaration” (November 2006), online: Oxfam <https://oxfamilibrary.openrepository.com/bitstream/handle/10546/114562/bp95-patents-versus-patients-doha-q-and-a-141106-en.pdf?sequence=8&isAllowed=y>.

32 Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, WT/L/540 and Corr.1 (2003).

33 See Holger P. HESTERMEYER, “Canadian-Made Drugs for Rwanda: The First Application of the WTO Waiver on Patents and Medicines” American Society of International Law (10 December 2007), online: American Society of International Law <https://www.asil.org/insights/volume/11/issue/28/canadian-made-drugs-rwanda-first-application-wto-waiver-patents-and>; Carlos M CORREA, “Will the Amendment to the TRIPS Agreement Enhance Access to Medicines?” (2019), online: South Centre <https://www.southcentre.int/wp-content/uploads/2019/01/PB57_Will-the-Amendment-to-the-TRIPS-Agreement-Enhance-Access-to-Medicines_EN-1.pdf>.

34 Hestermeyer, supra note 33. See also Correa, supra note 33.

35 The TRIPS waiver, supra note 10 at para. 3(c).

36 Ibid.

37 “New Study Shows Rich Country Shopping Spree for COVID-19 Vaccines Could Mean Fewer Vaccinations for Billions in Low-Income Countries” Duke Global Health Innovation Centre (2 November 2020), online: Duke Global Health Innovation Centre <https://dukeghic.org/wp-content/uploads/sites/20/2020/11/COVID19-Vax-Press-Release__28Oct2020-1.pdf>.

38 Oliver J. WOUTERS, Kenneth C SHADLEN, Maximilian SALCHER-KONRAD, Andrew J POLLARD, Heidi J LARSON, Yot TEERAWATTANANON, and Mark JIT, “Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment” (2021) 397 (10278) The Lancet 1023 at 1025.

39 HO, Cynthia M. “Patent Breaking or Balancing: Separating Strands of Fact from Fiction Under TRIPS” (2009) 34 North Carolina Journal of International Law 371 at 407 and 409Google Scholar

40 David SHORE, “Divergence and Convergence of Royalty Determinations between Compulsory Licensing under the TRIPS Agreement and Ongoing Royalties as an Equitable Remedy” (2020) 46(1) American Journal of Law and Medicine 56 at 69. See also MOON, Suerie and HEIN, Wolfgang, Informal Norms in Global Governance (Routledge, 2013) at 113–14 and 132–3Google Scholar.

41 The TRIPS waiver, supra note 10 at para. 3(d). Instances of existing good practices cited in the Decision are WHO-WIPO-WTO Study on Promoting Access to Medical Technologies and Innovation (2020), and the Remuneration Guidelines for Non-Voluntary Use of a Patent on Medical Technologies published by the WHO.

42 Ibid., at para. 4.

43 Mercurio and Upreti, supra note 13 at 7.

44 Christopher GARRISON, “What is the ‘know-how gap’ problem and how might it impact scaling up production of COVID-19 related diagnostics, therapies and vaccines?” Medicines Law and Policy (16 December 2020), online: Medicines Law and Policy <https://medicineslawandpolicy.org/2020/12/what-is-the-know-how-gap-problem-and-how-might-it-impact-scaling-up-production-of-COVID-19-related-diagnostics-therapies-and-vaccines/>.

45 TRIPS, art. 29.1.

46 POSNER, Richard and LANDES, William, The Economic Structure of Intellectual Property Law, 1st ed. (Harvard University Press, 2003) at 294Google Scholar.

47 “The information content of test data can be viewed (and regulated) at several levels: (i) as empirical information about the physical properties of chemical substances; (ii) as information that test data establish a substance as safe, acceptably non-toxic, sufficiently efficacious, etc.; (iii) as information that the substance is approved for use by a certain regulator on the basis of test data submitted.” See TAUBMAN, Antony, “The International Patent System and Biomedical Research: Reconciling Aspiration, Policy and Practice” (2008) 10(4) American Association of Pharmaceutical Scientists Journal 526Google ScholarPubMed.

48 A trade secret may consist of any formula, pattern, device or compilation of information which is used in one's business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it. See RISCH, Michael, “Why do we have trade secrets?” (2007) 11 Marquette Intellectual Property Law Review 1 at 6Google Scholar.

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50 “Who are the developing countries in the WTO?” World Trade Organization online: WTO <https://www.wto.org/english/tratop_e/devel_e/d1who_e.htm>.

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52 Jeff CRAVEN, “COVID-19 Vaccine Tracker” Regulatory Focus (24 June 2022), online: Regulatory Focus <<https://www.raps.org/news-and-articles/news-articles/2020/3/COVID-19-vaccine-tracker>.

53 Prabhash RANJAN and Praharsh GOUR, “Amend the Patents Act to execute TRIPS waiver” Hindustan Times (26 June 2022) online: Hindustan times <https://www.hindustantimes.com/opinion/amend-the-patents-act-to-execute-trips-waiver-101656255517110.html>.

54 See also Mercurio and Upreti, supra note 13 at 14.

55 2003 August decision, supra note 29 at para. 2(a)(ii).

56 SELL, Tara Kirk, GASTFRIEND, Daniel, WATSON, Matthew, WATSON, Crystal, RICHARDSON, Lauren, CICERO, Anita, INGLESBY, Tom, and CONNELL, Nancy, “Building the global vaccine manufacturing capacity needed to respond to pandemics” (2021) 39(12) Elsevier Public Health Emergency Collection 19Google ScholarPubMed.

57 See Victoria PILKINGTON, Sarai Mirjam KEESTRA and Andrew HILL, “Global COVID-19 Vaccine Inequity: Failures in the First Year of Distribution and Potential Solutions for the Future” Frontiers (7 March 2022), online: Frontiers <https://www.frontiersin.org/articles/10.3389/fpubh.2022.821117/full>.

58 See James LOVE, “The June 17, 2022 WTO Ministerial Decision on the TRIPS Agreement” Knowledge Ecology International online (17 June 2022), online: KEI Online <www.keionline.org/37830>.