A Global Call To Waive Off Patent Over COVID Vaccines: A Comprehensive Analysis On Challenges And Remedies

Introduction

The Pandemic has indubitably disoriented lives around the world bringing everything to a standstill. However, the formulation of a vaccine against the exceptional timescale of scientific wonders, with the first ‘fully-tested immunization’ of Pfizer and BioNTech on 2^nd December 2020[1], certainly brought hopes to many.

Nevertheless, the presence of the cure is only half the success. The emerging need of vaccinating citizens globally is met with myriad challenges as the variants of the virus itself. The existence of the vaccination is not synonymous with its accessibility. This essentially renders vaccination as divisive in its availability for the utility of the masses.

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention of the US, observed that the outbreak is developing as “a pandemic of the unvaccinated”[2] resonating, especially in the low-income and middle-income countries (LMICs) with socioeconomic disparity. The scenario is concerning, especially, when the crisis itself is global while the cure is only available or controlled at the disposal of a few selective.

The pandemic is exfoliating the deeper niches of global vulnerabilities where besides being a health crisis, it has emerged as a global crisis affecting more than just the sector of health. The deliberations in this article will be limited to a vaccine as intellectual property and its repercussions in these trying times and beyond.

The Unbalanced Arch between Right to Health & Right over Intellectual Properties

Intellectual property refers to creative manifestations of intellect that add value to the modern economy.[3] Section 2(1)(j) of the Patents Act, 1970[4] of India in compliance with the Trade-Related Aspects of Intellectual Property (TRIPS)[5], provided an invention must include ‘novelty, inventive step and capable of industrial applicability to be patented.[6]

Vaccines invented for the COVID pandemic suit these essentials of a patent and the intellectual property rights thereto are conferred with the respective patent holder generally for 20 years from the date of filing. It is with his consent that the vaccine can be “commercially made, used, distributed, imported or sold by others.”[7]

While protection of vaccines as an intellectual property gives way to lucrative incentives for the researcher who is catering to the demand of innovations. On the other hand, it assures the pharmaceutical industry to invest in complex research and risk-ridden innovations in areas promising profit.[8] As a result, this approach raises the price of the drugs and the areas in dire need of them to fall at a lower hierarchy to access it. This inequality in accessing vaccines stands at a crossroad with the Right to Health fundamental to human rights as ingrained in the Constitution of World Health Organization, 1946[9] as well as in article 25 of the Universal Declaration of Human Rights, 1948 (UDHR)[10] besides other international covenants.[11]

In the national periphery, the right to health has been recognized as sine qua non to Right to Life under Article 21[12] of the Indian Constitution. The Supreme Court, in the case of Bandhua Mukti Morcha v. Union of India[13], addressed a Public Interest Litigation against the inhuman and exploitative conditions of work for bonded labourers and provided that the right to live with dignity in its scope accommodates the protection of health. It is in adherence to the directives enlisted in Part IV of the Constitution that the State is obligated to effectuate.  In the case of Consumer Education and Research Centre v. Union of India,[14] the Apex Court explicitly recognised the right to health and medical care as a fundamental right. Medical care also includes the provision of medical facilities by the State as an obligation under Part IV  of the Constitution of India[15]. Furthermore, the Delhi High Court while elaborating on the vision of a welfare state, provided that the State is obligated to ascertain that everyone can experience a condition of congenial good health which the State authority is constitutionally directed to create and maintain to provide these basic essentials.[16] These arrangements are significant to recognize human life as more than just an animal existence.

Challenges In Waiving Off the Patent Over Vaccine: An emerging crisis

Statistics attest that only 12.3% of the people in the lower-income nations are vaccinated with only one dose where 10.65 Billion doses have been administered globally.[17] In India itself, a study by Max Healthcare reported sixty percent of lives lost to COVID in the third wave were the ones who were unvaccinated.[18] Inequitable access to vaccines, especially in the low-income countries with constrained resources like in the global south, has facilitated the transmission and prolonged the prevalence of the COVID pandemic.

Intellectual Property Rights essentially are hindering the actualization of the global vaccination by conferring exclusive rights with the pharmaceutical industry to determine the price. This is propelling a way for vaccine capitalism due to little competition in the market. The cruelest brunt is faced by the developing or lower-income nations who cannot afford to substantially purchase them because of the differential pricing. For instance, the AstraZeneca vaccine is priced at $5.25 in South Africa while it is only $2.16 for members of the EU.[19] The disparity in the purchasing power of the nations is brought to prominence by this global pandemic where nations at an advantage, seal the best deals.

World Trade Organization in its objective to regulate international trade amongst its member-nations formed the TRIPS agreement to render a homogeneous system of regulation and protection of the intellectual property as well as to stabilize the international economic relations.[20] However, to obtain a global immunity against the Coronavirus, it is pertinent to facilitate the equitable and universal access of vaccines instead of legally protecting the industry and its profit motive over public health.

Therefore, in October 2020, India and South Africa floated the need of waiving off patent on the vaccine which the United States conceded to later under President Joe Biden.[21] Nevertheless, it was resisted by several world powers and imperatively the profit-oriented pharmaceutical industries. This is because culminating vaccine from discovery to supply can cost more than $1 billion[22] and waiving off the patent would dilute the incentive and surface insecurities of such volatile attempt. Moreover, the Chairperson of WHO Solidarity Trial of Covid-19 Treatment, Røttingen, contended that Intellectual Property is one of the least barriers.[23] It is pertinently because COVID-19 vaccines and medications need refined infrastructure and production facilities which would take years to establish in order to accelerate the process of production.

While the aforesaid contention is irrefutable, however, the patent on a vaccine is one of the significant barriers obstructing the universalisation of vaccines and therefore to win the ultimate war with the Pandemic, it is implicit that such significant battles must be overcome victoriously on the front of human rights. 

Other concerns adhering to the waiving of the patent include that once the rights are waived off, the vaccine production requires substantial sharing of data including the trade secrets.[24] This is threatening to the trade as there are no Indian laws pertaining to trade secrets and manufacturers might give in to alternative ways to protect the information which will resultantly be more cumbersome to extract. Moreover, the disclosure of information about vaccine production requires the handing down of clinical data in order to ascertain ‘safety, quality and efficiency’ of the vaccines produced. While such provisions are lacking in the Indian Laws, TRIPS Agreement in the international domain explicitly mandates the sharing of clinical data in situations of emergency.[25]

Nevertheless, it is further submitted that India being a party to the international agreement, in absence of any contrary legislation, the municipal courts in India will honour the rules of international law.[26] It is also inferred from the general presumption of compliance with international law when the domestic laws are silent on it and do not provide anything on the contrary. This essentially should invoke confidence in the said parties while balancing the equation of health and intellectual property rights.  

Compulsory Licensing & Parallel Importing: A Cure For The ‘Cure’

While the cure for the pandemic emerges as promising, obtaining the same has developed as a bigger problem. However, not all hopes are lost. Tentative solutions are available to resolve this global crisis through the legal cure of compulsory licensing and parallel importing.

TRIPS agreement provides for these two mechanisms under Article 31 and Article 6 for ‘compulsory licensing’ and ‘Parallel Importing’ respectively.

Compulsory Licensing entitles the member government to grant a license to a willing party in order to commercialize the patented product or process without the consent of the owner or the patent holder. Once it is issued by the member nations to commercialize the production of the vaccine, the prices would reduce effectively for affordable scaling since the research and development expenditures on vaccines are eliminated. 

However, such non-exclusive use without the authorization of the patent holder is permitted only in situations of a ‘national emergency’ or ‘other circumstances of extreme emergency’ or ‘in cases of public non-commercial use’.[27] The said provision can be invoked only after frustrating all possible means to seek a voluntary license from the patent holder within a reasonable time frame.[28] This exception also comes with a concern that such authorisation for commercial production is only applicable for the supply of the domestic market of the member nation limited for that particular purpose. For the same, the member nation authorizing it essentially requires to have jurisdiction over the vaccines per se.

This inherent lacuna in the agreement was further acknowledged and addressed in the historic declaration at Doha, Qatar in November 2001.[29] In the advancement of public health in the developing world, the Doha assignment exempted the least developed countries from adhering to the said requisite of domestic jurisdiction under paragraph 6.[30] Moreover, the countries beyond the scope of least developed nations can issue compulsory licensing for supplying vaccines to the countries with specific health situations.

The Indian laws in adherence to the criteria enumerated in the TRIPS Agreement have incorporated a non-obstante clause under section 92 of the Patents Act[31] for authorizing compulsory license. Furthermore, through the 2005 amendment to the legislation, India introduced a provision for exporting pharmaceutical products through compulsory licensing,[32] including manufacturing equipment and diagnostic kits besides the patented product or process. Countries without any effective manufacturing units to resolve their public health crisis can apply to the Controller (Controller General of Patents, Designs and Trade Marks) for grant of the said license.

However, it is pertinent to realise that in India no COVID vaccines are granted with the patent license per se. Nevertheless, the underlying technology to develop the vaccines has been accorded with the patent. In light of this development, a compulsory license for the vaccines cannot be effectuated.[33] However, the technology for the production of the vaccines can be accessed through the same for which further deliberations are imminent.   

Parallel Importation is based on the fundamental doctrine of ‘exhaustion’ of rights over the intellectual property once it has been legally made available in the market with the authorization of the patent holder. Subsequently, once sold with the authorization of the patentee, the said product is available for re-sale.

Article 6 of the TRIPS Agreement explicitly exempts itself from addressing any issue related to the ‘exhaustion’ of intellectual property rights.[34] Therefore, the member nations of WTO are at liberty to decide upon their discretion the exhaustion period of the said rights in their national law without any enforceable objections from other members.

In India, section 107A(b) of the Patents Act, 1970[35] absolves any case of infringement of right over the intellectual property if it is imported from a person who is already authorized by the patentee to possess the same. This implicitly legalises the parallel importation of the patented product.

Thus, parallel importing utilises ‘exhaustion’ of patent-holder’s rights over re-sale, which empowers the developing countries to purchase the vaccines from nations with lower prices legally due to tier-pricing or differential pricing.[36] This enables low-income countries to obtain the vaccines at the cheapest global price.

Conclusion and Way Forward

Besides the legal remedies available for the world to actuate to dismantle this global crisis of vaccines, several diplomatic actions were also advanced for the cause. COVAX is a prominent collaboration of WHO with delivery partner UNICEF and co-led by Gavi and CEPI[37] to ensure “global equitable access to COVID-19 vaccines” as its foundational objective.

The COVAX programme attempted to resolve this schism of accessibility by providing one billion vaccine doses to 92 non-funding lower-income countries. However, the philanthropic endeavour seldomly reflects its aim in reality to curb the resurgence of the pandemic due to insufficient funding. The support of the US bolstered its crippling reality yet securing vaccine doses in surplus by rich countries, like Canada, through COVAX defeats the very purpose of the programme.[38]

In a recent judgement of the Supreme Court of India, the Apex Court took suo moto cognizance of the extra-ordinary circumstances in public health and issued an order[39] directing the Centre to invoke ‘compulsory license’ under section 92 of the Patents Act[40] with a sunset clause that circumscribes its validity only to the period of the pandemic.[41]

In a positive development, the recently authorized inoculation for emergency use in India, COBREVAX, is a patent-free vaccine as has been claimed by Dr. Peter Hotez, one of the leading researchers in its development.[42] This was intended to close the global vaccine equity gap and is promising in supplying cheap, stable and easy-to-scale products. It is setting a global model to imbibe for the world in light of the concerning global consensus on waiving the patent over vaccines.  

The resolution 32/L. 23 of United Nations Human Rights Council[43] has upheld that access to medicines is fundamental to human rights and has iterated the primacy of the right to health over trade and Intellectual Property rights. Justice Prabha Sridevan contending on the same has opined, Intellectual Property right integral to human rights is nevertheless a right granted and therefore can be subsequently ‘ungranted’. However, the right to life and dignity is the right we are born with and therefore weighs heavier in the balance of justice.[44]

There is a global urgency in recognizing this primacy of human rights over every other right not only for the contemporary global crisis around the present pandemic but for every unprecedented crisis, pandemic or not, imminent in the future.

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References

[1] Philip Ball, The Lightning-fast quest for COVID vaccines – and what it means for other diseases, Nature, (Feb. 21, 2022, 4:04 P.M.) https://www.nature.com/articles/d41586-020-03626-1.

[2] VOA News, https://www.voanews.com/a/covid-19-pandemic_us-experiencing-pandemic-unvaccinated/6208369.html (last visited Feb. 21, 2022).

[3] World Intellectual Property Organisation, https://www.wipo.int/about-ip/en/ (last visited Feb. 20, 2022).

[4] The Patents Act, 1970, § 2(1)(j), No. 39, Acts of Parliament, 1970 (India).

[5] 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) [hereinafter TRIPS Agreement]

[6]Jaya Bhatnagar & Vidisha Garg, India: Patent Law in India, Mondaq (Feb. 21, 2022, 4:.36 PM), https://www.mondaq.com/india/patent/54494/patent-law-in-india.

[7]World Intellectual Property Organisation, https://www.wipo.int/patents/en/ (last visited Feb. 21, 2022).

[8] Junaid Subhan, Scrutinized: The TRIPS Agreement and Public Health, NCBI (Feb. 21, 2022, 4:21 PM), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2323529/.

[9] WHO CONST. Preamble

[10] Universal Declaration of Human Rights, G.A. Res. 217 (III) A, U.N. Doc. A/RES/217(III) (Dec. 10, 1948)

[11]Office of the United Nations High Commissioner for Human Rights, https://www.ohchr.org/documents/publications/factsheet31.pdf (last visited Feb. 21, 2022).

[12] India Const. art 21

[13] Bandhua Mukti Morcha v. Union of India, (1984) 3 SCC 161

[14] Consumer Education and Research Centre v. Union of India, AIR 1995 SC 636

[15] Paschim Banga Khet Mazdoor Samity v. State of W.B., (1996) 4 SCC 37

[16] Cellular Operators Association of India v. MCD, 2010 SCC OnLine Del 2131.

[17] Our World In Data, https://ourworldindata.org/covid-vaccinations  (last visited Feb. 24, 2022)

[18] Third COVID wave: Partial or unvaccinated account for 60% of deaths, says study, Live Mint (Jan. 22, 2022, 5:28 P.M. ) https://www.livemint.com/news/india/third-covid-wave-partial-or-unvaccinated-account-for-60-of-deaths-says-study-11642850060190.html

[19] Supra note 11

[20] Supra note 11

[21] Why Patents on COVID vaccines are so contentious, The Hindu (May 07, 2021, 12:04 P.M.) https://www.thehindu.com/sci-tech/health/explained-why-patents-on-covid-vaccines-are-so-contentious/article34504523.ece.

[22] Ibid.

[23] Ibid.

[24] Shrudula Murthy, India: Access to Medical Resources During COVID-19 And the Intellectual Property Rights Regime, Mondaq  (Feb. 23, 2022, 10:15 P.M.) https://www.mondaq.com/india/patent/1073616/access-to-medical-resources-during-covid-19-and-the-intellectual-property-rights-regime

[25] Ibid.

[26] National Legal Services Authority v. Union of India, (2014) 5 SCC 438

[27] Supra note 5, art. 31 (b)

[28] Ibid.

[29] Junaid Subhan, supra note 8

[30] World Trade Organisation, https://www.wto.org/english/res_e/booksp_e/ddec_e.pdf (last visited Feb. 25, 2022)

[31] The Patents Act, 1970, § 92(3), No. 39, Acts of Parliament, 1970 (India).

[32] The Patents Act, 1970, § 92A, No. 39, Acts of Parliament, 1970 (India).

[33] Supra note 21

[34] Supra note 5, art. 6

[35] The Patents Act, 1970, § 107A(b), No. 39, Acts of Parliament, 1970 (India).

[36] Junaid Subhan, supra note 8

[37] World Health Organisation, https://www.who.int/initiatives/act-accelerator/covax (last visited Feb. 25, 2022)

[38] Supra note 11

[39] Distribution of Essential Supplies and Services During Pandemic, In re, 2021 SCC OnLine SC 339

[40] The Patents Act, 1970, § 92, No. 39, Acts of Parliament, 1970 (India).

[41] Supra note 39, para 55.

[42] Evan Bush, From Texas to India, a patent-free Covid vaccine looks to bridge equity gaps, NBC News (Feb 24, 2022, 9:48 P.M.) https://www.nbcnews.com/science/science-news/texas-india-patent-free-covid-vaccine-looks-bridge-equity-gaps-rcna10911.

[43] Office of the United Nations High Commissioner for Human Rights, https://www.ohchr.org/en/hrbodies/hrc/regularsessions/session23/pages/resdecstat.aspx (last visited Feb. 25, 2022)

[44] Prabha Sridevan J., Patent and Patient Rights in COVID-19: Is the Right to Exclusivity a Hamlet Question?, The Leaflet (Feb. 21, 2022, 5:41 P.M.) https://www.theleaflet.in/patent-and-patient-rights-in-covid-19-is-the-right-to-exclusivity-a-hamlet-question/.   

Author: Ranita Jana (Xavier Law School, XIM University)