By Sanchit Sharma
(A Student of HPNLU and Research Associate at Lex Jura Law)
INTRODUCTION
Last year in October, India and South Africa submitted a joint communication to the Trade Related Intellectual Property Rights (“TRIPs”) Council of the World Trade Organisation[1], seeking patent waiver in view of preventing, containing, and treating the COVID-19 pandemic.[2] In this context, it is essential to mention that in May this year, the Centre, through a press release, declared the tool of compulsory licensing (“CL”) for vaccine procurement as not attractive.[3]
Even though, prima facie, this move sharply contradicted India’s position at the global level for IP waivers[4], it nevertheless, has merits of its own (as we will observe further). But the said decision also begs for us to consider an important question of policy: Why are we seeking international co-operative assistance despite the fact that India is sufficiently capable of, and armed with legal instruments (namely, a compulsory license) to fight the battle against COVID-19?
Ergo, in this article, we shall ponder upon this question by understanding the relevance of CL’s in the Indian context against the background of Intellectual Property Rights and Human Rights Law to ascertain their need in the pandemic. This would be done by presenting two contrasting viewpoints on the discourse of CL’s in India, wherein one protests against its use, while the other puts it forward as a plausible option.
WHY THE WAIT?
Compulsory Licensing: Provisions and Position so far
A compulsory license is a license granted by the government to use patents or other types of intellectual property to broaden its access for public use.[5] The Indian Patents Act, 1970 (”Act”) is tailor made to be used in the COVID-19 pandemic[6], as amendments made to its provisions are pursuant to the Doha Declaration,[7] thereby not only granting adequate power to the centre for grant of CL’s in cases of national or extreme emergencies, or in cases of public non-commercial use[8], but also enough room to manoeuvre to allow non-compliance in cases of emergencies arising out of, inter alia, epidemics.[9]
A CL in India could also be granted on the grounds which are, inter alia, when reasonable requirements of the public with respect to the patented invention have not been satisfied.[10] Therefore, on the front of legislative competence, and in the terms of granting waivers for life saving drugs, it would appear that India is competent to tackle the pandemic on its own. Further, these provisions are not merely dead-letter; but instead, they have been promptly invoked in the past.[11] Not to mention, earlier this year, suggestions were made for the use of CL’s by the Supreme Court[12] and the High Court of Delhi.[13] Hence, due to these reasons, the discourse to “invoke” these provisions in the Indian situation is very prominent. Not to mention, Indian allies like Israel[14] and Canada[15] have already invoked CL provisions to remedy the COVID-19 situation, thereby giving the centre all the more reason for thinking and adopting this course of option.
Compulsory Licensing: Testing its Efficacy
Everything considered, a CL, prima facie, appears to be an important tool that could, in all likelihood, assist India (and the world) from the woes of COVID-19. But unfortunately, that may not just be the entire picture.
On the first count, the complexities a CL proposes are indeed massive[16], as even though the waiver for vaccine manufacturing could be sought, the technologies related to its production are wrapped in several layers of IP.[17] Meaning that, in order to manufacture a vaccine which is effectual to its objective, multiple counts of information such as trade-secrets, know-how, test results etcetera are required[18], and in absence of them, the outcome will be unsought; therefore, contrary to any belief, a compulsory license will not solve the problem of vaccines in its entirety, and the point of availing “effective” vaccines for the populace would get rendered moot to this degree. This could be further corroborated by the fact that even though American Pharmaceutical giant Moderna made it clear that they will not enforce patent waiver in the COVID-19 pandemic[19], the same offers little to no help if other information such as trade-secrets, know-how, test results etc., are not shared.[20] As a matter of fact, Moderna has accepted that those who wish to produce the same vaccine without the necessary know-how would face significant hurdles.[21]
On the second count, and moving beyond the scope of Intellectual Property, invoking the CL provisions in India would come riddled with unresolved and unaccountable institutional issues, which include, inter alia, scarcity of trained and skilled personnel, scarcity of raw materials and other inputs[22], and a lack of manufacturing capabilities.[23]These issues will cause a major hindrance in complete realization of the sought goal, since even if we acquire the necessary know-how, the requisite infrastructure for its development and distribution is missing.
On the third count, it is pertinent to observe that invoking CL provisions at this stage would be counterproductive, as the centre is actively attempting to acquire the vaccine through various diplomatic channels[24], and any wrong move at this point may attract repercussions in the long run, and India – although speculative, plausible nevertheless – may find itself in the web of sanctions, or other forms of reprimand at an international level for invoking its CL provisions.
However, with that being said, the necessity and neglect of IP waivers are being understood throughout the world—but especially in the Indian context, they could be scrutinized by putting Intellectual Property Rights and Human Rights Law on the same pedestal.
IPR v. Human Rights Law, 2021
Looking at the Indian side of things, we observe that the government has maintained that not only the main constraint is in the availability of raw materials and essential inputs, but the future trend of the pandemic is also uncertain.[25] Therefore, any additional permissions and licenses may not result in increased production immediately.[26] In the light of the technical and institutional challenges we perused so far, this position does sound cogent, but it falls short on the front of uncertainty. Earlier this year, the government made a purchase of 11 million doses of vaccine from the Serum Institute[27] and was negotiating for better prices[28], and after a brief pause of rising cases, the second wave of COVID wreaked havoc upon the nation, and the unfortunate case of shortage of vaccine came to fore.[29] Therefore, the centre’s decision (or rather priority) became known. In that context, it could be argued that even though the grant of compulsory license may not trigger an immediate boost in vaccine (or medicine) production, it would nevertheless have the potential to protect the nation for all future events, and prepare us for any similar catastrophic waves we have witnessed in the past.
Not to mention, the international waivers sought by the world were made in October last year, and even after ten months, no ‘considerable advancements’ have been made on that front so far, and they are only expected to take longer.[30] The discourse between altruistic solution and capitalist gain is not only explicit at this point[31], but it intensifies sharply as, if the waiver sought by India on the international level goes through, it would not have to pay any compensation, but if it issues CL’s at a national level, it would necessarily have to.[32] Therefore, the imperative question of government responsibility (and policy) comes to the fore here. In this regard, it is to be noted that the government has a constitutional obligation to provide health facilities in accordance with its responsibility under Article 21 of the Constitution[33], and dereliction on any front would not only be contravention said responsibility, but it would also set a bad precedent[34]; therefore, the counterplay of IPR and Human Rights Law is of importance here to ensure that there is a harmonious result towards the end.
CONCLUDING REMARKS
“One should not forget that patents represent an interventionist instrument, ultimately for the sake of community welfare. Thus intervention to restrict some of the effects of patents may be required, when the community welfare is no longer served.”[35]
The imperative need of the COVID-19 vaccine was realized relatively early on by the global community on the pandemic timeline; and subsequently, countless efforts were made in the interest of dismantling the virus in its tracks by calling for an international harmonized effort on the front of vaccine development and procurement.[36] But alas, the efforts have not yielded any considerable outcomes so far[37], and we find ourselves aground to the contrasting, yet urgent discourse of Intellectual Property Rights versus the Human rights law.[38] Looking from the Indian perspective, the proposal does seem to have received considerable mileage[39], thereby limiting the need of granting IP waivers at a national level – but it has to be understood that emergencies tend not to wait for cumbersome bureaucracies.[40]
Further, and it is important to see that, the present decision needs to be looked at from the contours of policy whereby balancing of human rights was done by seeking international waivers for IP, instead of invoking the CL provisions of the nation. Lastly, it is to be emphasized that India is again on the verge of experiencing a third COVID wave this year,[41] and there has been much emphasis that turnaround to build vaccine stock takes take time,[42] and therefore, we are in need of a better policy which is not only planned in the long run[43] rather one which also takes into account the idea of protecting the health of the citizens.
To summate, the words of Pandit Nehru come to mind when he said: “real progress of the country means progress not only on….the economic plane, but also on the social plane.”[44]
Footnotes
[1] 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, WTO (May 25. 2020), https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669R1.pdf&Open=True
[2] Id.
[3] Press Information Bureau, Myths & Facts on India’s Vaccination Process, NITI Aayog (May 27. 2021, 12:01 pm), https://pib.gov.in/PressReleasePage.aspx?PRID=1722078
[4] Arul George Scaria, NITI Aayog’s Position on Compulsory Licensing Fails Both Niti and Nyaya, Science the Wire (May. 29, 2021), https://science.thewire.in/health/niti-aayog-position-compulsory-licensing-covid-19-vaccines-ip-waiver/; Deepa Tiku & Jyoti Sagar, For India and other countries, an IP waiver is a distraction not a solution to the covid-19 vaccine crisis, iam https://www.iam-media.com/law-policy/india-has-golden-opportunity-re-invent-its-policies-around-innovation-and-ip
[5] Elizabeth Verkey, Intellectual Property 473 (EBC 2005).
[6] Biswajit Dhar, ‘India’s vaccine woes could end with compulsory licensing’ The Federal. (June. 20, 2021, 6:30 am), https://thefederal.com/opinion/importance-of-invoking-compulsory-licensing-to-boost-vaccine-production/
[7] Prashant Reddy T., In India, Covid-19 Vaccines Face A More Urgent Problem Than IPR, BloombergQuint (April. 20, 2021, 12:53 pm),https://www.bloombergquint.com/coronavirus-outbreak/in-india-covid-19-vaccines-face-a-more-urgent-problem-than-ipr
[8] The Act, Section 92(1)
[9] The Act, Section 92(3)
[10] The Act, Section 84(1)(a)
[11] Bayer v Natco 2012 (50) PTC 244 (India).
[12] In Re: Distribution of Essential Supplies and Services During Pandemic, at page 61.
[13] Id., at page 60;
[14] Thiru, Israel issues compulsory license to allow the government to import generic versions of Kaletra, keinonline (March. 23, 2021), https://www.keionline.org/32503
[15] Justice Laws Website, COVID-19 Emergency Response Act (S.C. 2020, c. 5), Government of Canada, https://laws-lois.justice.gc.ca/eng/annualstatutes/2020_5/
[16] Brook Baker, THE IMPRACTICALITY OF RELYING ON COMPULSORY LICENSES TO EXPAND PRODUCTION CAPACITY FOR COVID-19 VACCINES, infojustice (June. 6, 2021), http://infojustice.org/archives/43195. See also: Kavita Chawla & Priyamvada Singh, COVID-19: How Credible Is the EU’s Alternate Proposal to the Global IP Waiver?, the Wire (June. 22, 2021), https://thewire.in/trade/covid-19-eu-alternate-proposal-global-ip-waiver; Praharsh Gour, Compulsion for Compulsory Licenses for Covid Vaccines Climbs: But Are They the Cure?, Spicy IP (May. 24, 2021), https://spicyip.com/2021/05/compulsion-for-compulsory-licenses-for-covid-vaccines-climbs-but-are-they-the-cure.html
[17]Arul, Supra note 4.
[18] Thambisetty, Siva and McMahon, Aisling and McDonagh, Luke and Kang, Hyo Yoon and Dutfield, Graham, The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic (May 24, 2021). LSE Legal Studies Working Paper No. 06/2021, Available at SSRN: https://ssrn.com/abstract=3851737 at page 16.
[19] Deepa, Supra note 4.
[20] Thambisetty, Supra note 18.
[21] Id at page 17.
[22] Deepa, Supra note 4.
[23] Reuters, World Bank opposes Covid-19 vaccine intellectual property waiver as WTO talks resume, The Times of India (June. 9, 2021, 12:24 am), https://timesofindia.indiatimes.com/business/international-business/world-bank-opposes-covid-19-vaccine-intellectual-property-waiver-as-wto-talks-resume/articleshow/83363503.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cpps
[24] In Re: Distribution of Essential Supplies and Services During Pandemic, Supra note 12, at page 29.
[25] Id., at 64.
[26] Supra note 24 at 64.
[27]Euan Rocha, Sachin Ravikumar, India signs purchase order with Serum for AstraZeneca vaccine – source, reuters (January. 11, 2021, 4:26 pm), https://www.reuters.com/article/health-coronavirus-vaccine-india/india-signs-purchase-order-with-serum-for-astrazeneca-vaccine-source-idUSKBN29G126
[28] Lauren Frayer, India Is The World’s Biggest Vaccine Maker. Yet Only 4% Of Indians Are Vaccinated, npr (June. 29, 2021, 12:52 pm), https://www.npr.org/sections/goatsandsoda/2021/06/29/1011022472/india-is-the-worlds-biggest-vaccine-maker-yet-only-4-of-indians-are-vaccinated
[29] Id., Lauren Frayer; Timothy Huzar, Why COVID-19 vaccines should be free for all in India, Medical News Today (June. 4, 2021), https://www.medicalnewstoday.com/articles/why-covid-19-vaccines-should-be-free-for-all-in-india; Holly Ellayatt, India is the home of the world’s biggest producer of Covid vaccines. But it’s facing a major internal shortage, cnbc (June. 5, 2021), https://www.cnbc.com/2021/05/05/why-covid-vaccine-producer-india-faces-major-shortage-of-doses.html; FE Online, Covid-19: Why India is facing vaccine shortage, Financial Express (May 10. 2021, 9:07 AM), https://www.financialexpress.com/lifestyle/health/covid-19-why-india-is-facing-vaccine-shortage/2248748/; Neeta Sanghi, How the Modi Government Overestimated India’s Capacity to Make COVID Vaccines, Science the Wire (April. 22, 2021), https://science.thewire.in/health/narendra-modi-government-overestimated-india-covid-vaccine-manufacturing-capacity-shortage/
[30] Deepa, Supra note 4.
[31] Reuters, Supra note 23. see also: Bloomberg, Merkel pushes back on vaccine patent waiver in row with US, mint (6 May. 2021, 10:10 PM), https://www.livemint.com/news/world/merkel-pushes-back-on-vaccine-patent-waiver-in-row-with-us-11620319077361.html; Arul, Supra note 4.
[32] Praharsh Gour, Wishful Thinking? Analyzing India and South Africa’s Joint Statement to Waive Key Provisions of TRIPS- Part II, Spicy IP (October. 20, 2020), https://spicyip.com/2020/10/wishful-thinking-analyzing-india-and-south-africas-joint-statement-to-waive-key-provisions-of-trips-part-ii.html
[33] State of Punjab v. Mohinder Singh Chawla (1997) 2 SCC 83 (India); State of Punjab v. Ram Lubhaya Bagga (1998) 1 SCR 1120. (India); Paschim Bangal Khet Mazdoor Samity & Others v. State of West Bengal & Others (1996) 4 SCC 37. (India)
[34] Sanchit Sharma, COVID-19 Vaccine: A double-edged sword, Lex Lura Law (January. 9, 2021), https://lexjuralaw.wordpress.com/2021/02/09/covid-19-vaccine-a-double-edged-sword/
[35] Michael Kern as cited in Elizabeth Verkey, Law of Patents 367 (EBC 2005).
[36] World Health Organisation, https://www.who.int/initiatives/covid-19-technology-access-pool
[37] Thambisetty, Supra note 18, at 13.
[38] Rebeca Furtado, The Interrelationship Between Human Rights And Intellectual Property Rights, ipleaders (August. 12, 2016), https://blog.ipleaders.in/interrelationship-human-rights-intellectual-property-rights/
[39] PTI, India, South Africa’s patent waiver proposal in WTO achieved tremendous mileage, progression: Commerce Secretary, The Hindu (June. 10, 2021, 3:21 pm), https://www.thehindu.com/news/national/india-south-africas-patent-waiver-proposal-in-wto-achieved-tremendous-mileage-progression-commerce-secretary/article34778668.ece
[40] Kavita, Supra note 16.
[41] Manvi Kapur, When will India’s third wave of Covid-19 begin?, quartz (June. 23, 2021), https://qz.com/india/2023971/when-will-indias-third-wave-of-covid-19-begin-and-peak/
[42] FE Online, Supra note 29.
[43] Kavita, Supra note 16.
[44] Ramchandra Guha, India After Gandhi 233 (Picador India 2018).