With the drastic effect of the COVID-19 virus on the entire world, countries and corporations all over have been looking for measures to mitigate or lessen the burden. Most of these have been stop gap measures such as social distancing and many others. Now, the recent development of vaccines has given humanity a final solution to a problem that has plagued it for just over a year. However, there is still a great hindrance arising on the distribution of vaccines by private corporations that have developed the vaccine. And this hindrance manifests itself via an intellectual property right known as a patent.
A patent is an exclusive right given to an individual who has developed a device, substance, method or process that involves a new and inventive step and is industrially applicable. The exclusive right protects both the manufacturing process and the products obtained directly from the process. It prevents others from manufacturing, using, selling or importing the protected invention for these purposes. In Kenya, patents and other intellectual property rights are issued by the Kenya Industrial Property Institute (KIPI) established under the Industrial Property Act, 2001 (“the Act”). In addition to the Act, Kenya as part of the World Trade Organization is a signatory to the Trade Related Aspect of Intellectual Property Rights (TRIPS) Agreement. It sets out the minimum levels of standards concerning intellectual property in various forms including patents.
Under the Act and the TRIPS agreement, patent owners are allowed to assign, transfer or conclude licensing contracts for the patents. However, they are still reluctant to share their patents on vaccines even in the face of the greater good for the following reasons:
- They claim that the granting of patents is an incentive to inventors. Patents encourage individuals to come up with inventions so as to receive protection and financial remuneration;
- They argue that a patent is not the only barrier in the way of efficiently developing vaccines. There exist other barriers such as the requirement for expertise, know-how and infrastructure, the cost of production and clinical studies; and
- There are in place sufficient existing measures, including voluntary licensing and technology transfer that can be used before patent owners are forced to share their patents.
For a long time, it has been argued that patenting under the TRIPs Agreement only focuses on rewarding and recognizing an individual and not the actual invention. Instead of focusing on the greatest happiness for the greater number of people, it focuses on private property rights and the private ownership of resources. It is for this reason that the developing countries in the past have lobbied for provisions within the TRIPS agreement to offer reprieves when it comes to patenting such as:
- Voluntary licensing by patent owners of the process or the product to third parties. However, such licensing contracts come with restrictions that hinder the proper distribution of the vaccine. For example, the license given by AstraZeneca to India’s Serum Institute, only allows India to supply developing countries instead of allowing Indian companies to manufacture and produce the vaccine themselves;
- Governments can act to prevent patent owners and other holders of intellectual property rights from abusing intellectual property rights, unreasonably restraining trade or hampering the international transfer of technology;
- Governments in developed countries have an obligation to provide incentives to enterprises and institutions to enable technology transfer;
- Governments can allow for the use of a patented process or product by someone else without the authorization of the right holder. This is known as compulsory licensing. It is justified for national emergencies, circumstances of extreme urgency and where a patent holder is engaging in anti-competitive practices. Compulsory licensing is subject to certain conditions such as reasonable effort must have been used to try and obtain a voluntary license from the patent holder, there must be payment of adequate remuneration to the patent holder, decisions may be subject to a judicial or other independent review by a distinct higher authority etc. These conditions can however be relaxed if it is determined that a party has engaged in anti-competitive practices. Countries have already amended their existing national intellectual property laws to allow for compulsory licensing and some have even gone ahead to do away with the need for prior negotiations with the patent holder if there is an urgency.
So, what is Kenya doing in this fight for access to vaccines or patents?
Rich and developed countries are vaccinating a large portion of their population while most African and developing countries sit and wait. Kenya, together with other member states from the Africa & Least Developed Countries Group, are currently requesting for a waiver or temporary suspension of provisions in the TRIPS Agreement relating to copyrights, industrial designs, patents, and protection of undisclosed information until the COVID-19 pandemic is brought under control. The waiver would cover obligations in four sections of the TRIPS Agreement including the section on patents and would suspend patents relevant to drugs and vaccines. This will then allow developing countries with the manufacturing capacity to produce them without restrictions from private corporations. It will also allow governments to better collaborate in developing, producing and supplying COVID vaccines and also give governments a policy option to facilitate increased distribution of the vaccinations instead of waiting for patent holders to voluntarily exercise measures or donations from developed countries.
In addition to the provisions of the TRIPS agreement, the World Health Organization (WHO) has also prepared a Vaccine Equity Declaration aimed at ensuring equitable and affordable access to drugs. Under this declaration, the WHO has developed a COVAX facility to which international organizations and countries contribute doses of the vaccine for distribution to African countries. It has also developed a COVID-19 technology access pool which encourages vaccine manufacturers to share their know how so as to scale up vaccine manufacturing.
Hopefully, with these two efforts from the WHO and the WTO, developing countries will soon have access to sufficient vaccines so as to protect and uphold the health of its citizens. We also wait to see how the other WTO member states will respond to the request by Kenya and the other countries on the waiver of the certain provisions of the TRIPS Agreement.
COVID has proven that the TRIPS Agreement may not be adequate or sufficient when it comes to dealing with pandemics. While it does provide for some measures such as compulsory licensing, the same may not be enough and hopefully the pandemic will open up further talks on reforms to the Agreement in favour of African and other developing countries.
Article by Allison Llyod, who is a Junior Associate in the Employment and Pensions practice areas.
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