THE LEGAL AND POLITICAL TAPESTRY UNDERSCORING THE WAIVER OF COVID-19 VACCINE PATENTS

By: Stephen Kipkenda Kiplagat[1] & Chery Kichwen[2]

  1. Background

Intellectual property rights remains one of the main barrier towards affordable healthcare and access to medicines. The scourge of the Corona Virus Disease of 2019 (COVID-19) is no exception. The cost of developing vaccines and the resources employed in research and design translate to a high cost of producing and administering the vaccine. With the world fighting this novel virus, there have been calls to waive patents and the attendant intellectual property rights on COVID-19 vaccines in order to bolster the fight against the pandemic. The Federal Republic of India and the Republic of South Africa trail blazed this idea when they wrote to the World Trade Organisation suggesting the waiver/suspension.[3] Since then, the proposal has been met with both resistance and support informed by several considerations and geopolitics.

  1. International Legal Regime on Intellectual Property

International Intellectual Property Treaties cover various Intellectual Property Rights in varying degrees of detail and comprehensiveness. Hence the treaty obligations the Contracting parties must adhere to equally vary.[4]

           2.1. World Trade Organisation (WTO) TRIPS Agreement

Agreement on Trade Related Aspects of Intellectual Property (TRIPS) is a key legal instrument that harmonises intellectual property protection by imposing binding obligations on member countries to ensure a minimum level of protection and enforcement of intellectual property rights in their territories.[5] As part of World Trade Organisation (WTO’s) legal regime, the TRIPS Agreement also polices the enforcement of IP rights through a compulsory and enforceable dispute settlement mechanism.[6]

Since the inception of the TRIPS within the WTO system, international law has struggled to adequately account for human rights and development concerns. This has been evident in the compulsory licensing and access struggles over HIV-AIDS medication.[7] While HIV/AIDS patients in developed countries were able to afford antiretroviral (ARVs) treatments, which had been developed and approved and patented as early as 1987, many patients in Africa and other parts of the developing world could not afford treatment at that time.[8]

          2.2. World Intellectual Property Organisation (WIPO)

WIPO’s Paris Convention for the Protection of Industrial Property (1883) guides on patent registration and preceding waivers. A summary of the same Convention was provided for by the World Intellectual Property Organisation.[9] The Paris Convention provides that each Contracting State that takes legislative measures providing for the grant of compulsory licences to prevent the abuses which might result from the exclusive rights conferred by a patent may do so only under certain conditions. Article 5(5) states that a compulsory License may not be applied for on the ground of failures to work or insufficient working before the expiration of the period of four years from the date of filing of the patent application or three years from the date of the grant of the patent, whichever period expires last.[10]

The Paris Convention also provides for the right of priority.[11] This right means that, on the basis of a regular first application filed in one of the contracting state, the applicant may, within 12 months, apply for protection in any of the other contracting states. These subsequent applications will be regarded as if they had been filed on the same day as the first application.[12] One of the greatest practical advantages of this provision is that applicants seeking protection in several countries are not required to present all of their applications at the same time but have 12 months to decide in which countries they want to seek protection.[13]

Lastly, the Convention also provides that patents granted in different contracting states for the same invention are independent of each other;[14] the granting of a patent in one Contracting State does not oblige other Contracting States to grant a patent.

          2.3. World Health Organisation (WHO)

It is safe to say that the push to have companies voluntarily waive their Intellectual Property rights has been majorly by the by World Health Organization and developing countries. Despite such calls to make COVID-19 vaccines and related technologies a global public good, Western Pharmaceutical Companies have declined to loosen or temporarily suspend IP protection and transfer technology to generic manufacturers and governments.[15]

WHO Director General Dr. Tedros Adhanom Ghebreyesus has suggested that the flexibilities in trade regulations exist for emergencies. This pandemic is a top-tier emergency. To allow this flexibilities, Heads of States, international agencies and civil societies groups have already signed up to vaccine equity to speed up regulatory processes and boost manufacturing. Where it is a vaccine sharing, technology transfers, voluntary licensing as the Covid-19 Technology Access Pool Initiative encourages, or waiving Intellectual property rights as South Africa and India have suggested.[16]

  1. Implications of Patent Waiver on Access to Healthcare and Medicine

Limited access to medicines and vaccines in developing countries who are members of the World Health Organisation is a multi-dimensional problem. It is affected by factors like lack of public financing for health care and overreliance on out of pocket expenditure, fragile logistics, storage challenges and high transport and distribution costs and inadequate or inappropriate medicines regulatory framework. These factors are further exacerbated by strict patent laws, insufficient scientific technological and local manufacturing capabilities in the countries.

Patent waivers for purposes of ensuring universal access to free or affordable essential Covid-19 vaccines is one of the “core obligations” for fulfilling the right to health.[17] In theory, patent protection helps to ensure the continued development and availability of medicines in future, provided that markets can generate a return to the patent holder for their cost of research and development.[18] It is argued that patents are crucial for pharmaceutical innovations and that without them there will be no financial incentive to fund the cost of discovery and development of new medicines.[19] However, medicines prices in developing countries are often well above production costs. In many countries where payment for pharmaceuticals is “out of pocket” and health insurance is rare, escalating and unrealistic prices play an unfortunate role in denying patients access to life-saving medicines.[20]

From a human rights perspective, patent waiver on Covid-19 vaccines will ensure:

  1. Effective competition through multiplicity of potential suppliers;
  2. Provision for a wide range of pharmaceuticals to meet the basic health needs of the population
  3. Equality of opportunities for countries in need, irrespective of their level of technological capacity or lack of manufacturing capacity;
  4. Rapid and effective response to public health emergencies, needs and crises; and
  5. Supply of quality medicines at affordable prices.
  6. Compulsory Licencing v Voluntary Waiver

Voluntary Licensing is an authorization given by patent holder to a generic company, allowing it to produce the patent article.[21] Voluntary Licences are implicitly addressed in TRIPS[22] specifying the conditions for which compulsory licencing is permitted; there are three situations:

  1. In situations of public non-commercial use, specifying that in such situations, the right holder shall be informed promptly;
  2. In situations of production for countries lacking manufacturing capacities.[23]
  3. If, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time.

TRIPS, specified that the right holder shall be paid adequate remuneration in situations of compulsory licences[24] but this can be exempted in situations of voluntary licensing.[25] The main purpose of voluntary licensing agreements is to enhance production and distribution. This brings us to the present, should we do go the compulsory licencing way if voluntary licencing fails? How the dysfunction on Covid-19 patents and related subjects continues to be normalised in the current pandemic is unimaginative. Moderna, for example, has filed over 100 patents for the mRNA technology used in its vaccine despite receiving funds from the US government with its IP partly owned by the US National Institutes of Health. Pfizer and BioNtech pharmaceutical companies have also filed multiple patents on not only their Covid-19 vaccine product, but also on the manufacturing process method used and related technologies even though BioNtech Company was partly financed by the German government.[26]  It has become increasingly plain that IP makes private rights out of public funds while benefiting particular corporate interests. As a result, taxpayers are paying twice for the same shot; first for its development; and then on the finished product.[27]

The Doha Declaration on TRIPS and Public Health acknowledges the need to balance patent protection with a compulsory licensing system. However, the process set out under article 31 of TRIPS requires consultation and negotiation with the patent owner before any compulsory licensing and manufacturing of a drug can take place. This is likely to be a time-consuming process, ill-suited to the exigencies of a pandemic.[28]

Some quarters have attempted to by-pass the compulsory licensing. For example, the European Union has drafted a resolution in favour of voluntary patent pooling to permit the fast manufacture of any useful Covid-19 drugs. Canada has also circumvented the entire process under TRIPS Agreement by permitting the Health Minister to direct the Patents Commissioner to authorise the government to make exceptions in patenting to the extent needed for health emergencies.[29]

These moves, whether they will be adopted is a wait and see situation. The Litmus being whether the firms who have expended money on research, trials and manufacture of vaccines will agree to the voluntary waiver.

  1. Conclusion

The current imperative, we all must agree, is to scale existing vaccines as quickly as possible. Manufacturing companies and developed nations are under enormous commercial and geopolitical pressure to increase production of Covid-19 vaccines to meet immediate demands for Covid-19 vaccines. Their profit-driven preoccupation is in line with the global imperative to increase production. To do so, they need to cooperate with competitors and generic manufacturers alike through voluntary licences, contracted production and proactive technology transfers. Few companies are willing to thread on that part. Also, under existing TRIPS flexibilities, countries can issue compulsory licences to produce vaccines without permission from the patent-holder. None have done so.

Exempting Covid-19 vaccines from intellectual property rights is just a tip of the iceberg. To say that we will achieve global vaccination through patent waiver is perfunctory to say the least. What we need beside the patent waiver push is more global manufacturing capacity for all covid-19 vaccines platforms. Patent waiver only provides legal clarity to protect generic manufacturing against retribution, but without it being acted upon, we will remain stagnant. In the words of Michael Arndt, failure can only exist from stagnant perceptions.

[1] LL.B (UON), PGD (KSL), Certified Secretary (CS), Partner, Kipkenda & Company Advocates, Advocate of the High Court of Kenya.

[2] LL.B (KABU), PGD (KSL) (Student), Pupil, Kipkenda & Company Advocates.

[3] World Trade Organization. Waiver from certain provisions of the TRIPS agreement for the prevention, containment and treatment of covid-19: communication from India and South Africa. Oct 2020. <https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf> 10th May, 2021.

[4] Henning Grosse Ruse-Khan, The International Legal Framework for the Protection of Utility Models, Paper Prepared for the WIPO Regional Seminar on the Legislative, Economic & Policy Aspects of the Utility Models System, Kuala Lumpur (Malaysia) 3-4 September 2012

[5] Peter Van den Bossche and Werner Zdouc, The Law and Policy of the World Trade Organization (Cambridge: Cambridge University Press, 2013), pp. 952.

[6] Prabhash Ranjan, The Case for Requiring Intellectual Property Protection for Covid-19 Vaccines, ORF Issue Brief No. 456, April 2021, Observer Research Foundation

[7] Dilan Thampapillai, The Controversy to Come? Patent Laws and a Covid-19 Vaccine, United Nations Headquarters in New York, USA, Wednesday June 2020

[8] Amaka Vanni, On Intellectual Property Rights, Access to Medicines and Vaccines Imperialism, March 23, 2021, TWAILR: Reflections 32/2021

[9] https://www.wipo.int/treaties/en/ip/paris/summary_paris.html Summary of the Paris Convention for the Protection of Industrial Property (1883)

[10] Paris Convention for the Protection of Industrial Property (1883) (as amended on September 28, 1979) (official translation) article 5(5)

[11] Paris Convention for the Protection of Industrial Property (1883) (as amended on September 28, 1979) (official translation) article 4

[12] https://www.wipo.int/treaties/en/ip/paris/summary_paris.html  Summary of the Paris Convention for the Protection of Industrial Property (1883)

[13] https://www.wipo.int/treaties/en/ip/paris/summary_paris.html  Summary of the Paris Convention for the Protection of Industrial Property (1883

[14] Paris Convention for the Protection of Industrial Property (1883) (as amended on September 28, 1979) (official translation) article 4bis

[15] Amaka Vanni, On Intellectual Property Rights, Access to Medicines and Vaccines Imperialism, March 23, 2021, TWAILR: Reflections 32/2021

[16] https://www.who.int/news-room/commentaries/detail/waive-covid-vaccine-patents-to-put-world-on-war-footing

[17] United Nations Economic and Social Council, General Comment No 14: The right to the highest attainable

standard of health. United Nations document E/C.12/2000/4 (11 August 2000): para. 43(d); Hogerzeil H, Mirza

  1. The world medicines situation 2011: access to essential medicines as part of the right to health. Geneva:

World Health Organization; 2011.

[18] ibid

[19] WHO Drug Information Vol 19, No. 3, 2005

[20] ibid

[21] Hans Morten Haugen, Does TRIPS Prevent Covid-19 Vaccines as a global Public Good? First Published 18, Match 2021

[22] Article 31(b) Agreement on Trade‐Related Aspects of Intellectual Property Rights (TRIPS)

[23] Article 31 bis & Annex Agreement on Trade‐Related Aspects of Intellectual Property Rights (TRIPS

[24] Article 31(h) Agreement on Trade‐Related Aspects of Intellectual Property Rights (TRIPS)

[25] Hans Morten Haugen, Does TRIPS Prevent Covid-19 Vaccines as a global Public Good? First Published 18, Match 2021

[26] Amaka Vanni, On Intellectual Property Rights, Access to Medicines and Vaccines Imperialism, March 23, 2021, TWAILR: Reflections 32/2021

[27] Amaka Vanni, On Intellectual Property Rights, Access to Medicines and Vaccines Imperialism, March 23, 2021, TWAILR: Reflections 32/2021

[28] Dilan Thampapillai, The Controversy to Come? Patent Laws and a Covid-19 Vaccine, United Nations Headquarters in New York, USA, Wednesday June 2020

[28] Amaka Vanni, On Intellectual Property Rights, Access to

[29] ibid

BP2O3053(1)
STEPHEN KIPKENDA KIPLAGAT
Senior and Founding Partner, Advocate of the High Court of Kenya
Copying Not Allowed ! Contact Kipkenda & Company Advocates.