Pharmaceutical Companies worldwide are rushing to develop a safe and effective vaccine against COVID-19, the disease caused by the coronavirus. Some are testing previously developed vaccines for other viruses, whereas others are approaching clinical trials for the newly discovered vaccines. This global rush to find a potential coronavirus vaccine raises many legal and regulatory issues, including balancing speed with efficacy, understanding the ownership, and vaccine costs. A unique challenge that has emerged along with vaccine development is how to balance Intellectual Property Rights with serving the public good.
Questions of patent protection and its access has prompted an international group of scientists and lawyers to establish the Open COVID Pledge, a movement that calls on organisations to freely make available their existing IPR associated with vaccine research to create an open patent pool to solve this global problem. However, for now, there are very few biotechnology and pharmaceutical corporations participating in the pledge, raising questions over the success of the initiative.
So, if an institution does develop a viable vaccine, this raises other questions that need to be addressed:
- Ownership of Intellectual Property Rights
- Sources of funding
- Role of governments in ensuring global access
In order to address these questions, the first task is to understand the role of Intellectual Property Rights (IPR) in innovation and how to address the barriers associated. The Intellectual Property Rights works as an incentive and provide exclusive rights to control commercial exploitation of the innovative work for a specified period of time. IPR, in such a scenario of scientific R&D rush, can incentivize or hinder companies to respond to the pandemic. Huge amount of investment has already been done for the innovative solutions. If a vaccine is developed, the next challenge will be the large production in short period of time. There also may be chances of companies limiting the supply to drive up the prices or to deny the affordability of the product. The innovators often differentiate IP protection from pricing but also explain it as a reward for the funds and time & energy invested in research, as without the same there would be no original drugs. This argument can be contested if a publicly-funded institution had done the original research on the drug which was later bought by the company and commercialized at a high price. That’s how the pandemic adds a new
layer of complexity to public-health and trade discussions as governments confront new realities.
There may be the case that some companies could try to characterize a vaccine as a trade secret. This has its own advantages, like the company then would not have to undergo rigorous governmental registration process like going through the Patent Office, and there would be no limit on the duration of trade secret protection as in this case it won’t expire after 20 years. Trade secrets are generally immune from government intervention, unlike patents, as there are federal laws, like march-in rights, that give the government right to demand licensing rights from patented products in certain extreme situations. However, if the code can be cracked and the product can be reverse engineered in a trade secret, then the company is left without a legal defence.
Now is the important part of financing the vaccine development. For most of the newly developed drugs, a company is given the IP rights that allow sole control over the drug’s manufacturing and retailing, subject to some T&C based on the fact whether they are publicly funded or privately funded. When key patents of a company for the approved vaccine are publicly funded, charging too high a price for its patented vaccine or incapability to produce sufficient quantities to satisfy the needs, the government, in such a scenario, can exercise the March-In Rights that exist under the Bayh-Dole act (enacted in 1980), which might apply as a safety net. The government can compel the patent holder to grant a license under the patent to others. For the patents of vaccine developed with private funding, the second option that the federal government can use is Compulsory licensing of patents under Section 1498. It is a legal measure practiced by governments to suspend patents on a particular product in the public interest or in times of emergency. It allows governments to grant itself and third parties, the right to use a patent and manufacture a patented drug without the consent of the patent holder. This can be seen as a possible mechanism to obtain equal and affordable access to COVID-19 treatment worldwide. This provision is reflected in a section of a World Trade Organization document, the Trade-Related Aspects of Intellectual Property Rights (TRIPS). Many countries like, France, Chile, Germany, Canada and Israel have already passed additional legislation to prepare themselves for the use of compulsory licensing during the COVID-19 pandemic.
Although manufacturers have a lot to potentially gain from protecting their health-treatment and vaccine IP, it is unclear how they will react in the context of a global pandemic. There are many difficulties in deciding which IP defence mechanism will be the best fit for the manufacturer. Since faced with the global pandemic, companies will more strongly consider forgoing their IP defences to quickly save more lives. It is important for funders and WHO members to rapidly find agreement on measures to avoid intellectual property barriers and
promote openness. Voluntary licensing models can promote access but it requires agreement by the right holders, which may cause delay and may not be possible to obtain on the terms demanded. The international health community should reassert the right of governments to use TRIPS flexibilities to protect public health in the scenario of global emergency.
Daniel Medwed, Intellectual Property Law In The Race To A Coronavirus Vaccine (May 26, 2020). Available at: https://www.wgbh.org/news/science-and-technology/2020/05/26/intellectual-property-law-in-the-race-to-a-coronavirus-vaccine
Joel Wallace, Mad Dash to Coronavirus Vaccine May Face Legal Hurdles (March 12, 2020). Available at: https://www.ipwatchdog.com/2020/03/12/mad-dash-coronavirus-vaccine-may-face-legal-hurdles/id=119790/
Michael Liu, William B. Feldman, Jerry Avorn, Aaron S. Kesselheim, March-In Rights And Compulsory Licensing—Safety Nets For Access To A COVID-19 Vaccine, Health Affairs (MAY 6, 2020). Available at: https://www.healthaffairs.org/do/10.1377/hblog20200501.798711/full/
PT Jyothi Datta, Covid opens a new flank in the IP vs public health stand-off (April 25, 2020). Available at: https://www.thehindubusinessline.com/specials/pulse/covid-opens-a-new-flank-in-the-ip-vs-public-health-stand-off/article31426837.ece#
Rory Horner, Any attempt to develop a Covid-19 vaccine can’t afford to overlook India and China’s role, Coronavirus Crisis (May 25, 2020). Available at:
Sari Schreiber, Raija Horstman, IP and the Novel Coronavirus: Developing a Vaccine. Available at: https://www.lexology.com/library/detail.aspx?g=18b27676-c3b7-480e-ad64-96a72f93f9b8