“Who owns the patent on this vaccine?’ ‘Well, the people, I would say. There is no patent. Could you patent the sun?”Jonas Salk, the inventor of the polio vaccine
“Anything under the sun that is made by man is patentable.”Diamond vs Chakrabarty, 447 U.S. 303 1980
The intellectual property (IP) response to COVID-19 has been one of the key issues in domestic and global legal forums. Most of the discussion has focused on patents for medical products, yet the pandemic has impacted on many sectors. Parenthetically, it is relevant to note that fashion houses, many of whom own the most valuable trademarks, have been facing a critical question: can their cancellations of orders from the manufacturing factories, largely located in developing countries, be challenged based on the trademark licensing ground, amongst others? In this comment, however, I will briefly address two of the most pressing issues: first, the challenges and options which the IP regime in general, and pharmaceutical patents in particular, offer in combating COVID-19, and second, the policy models available to achieve the common good, i.e. making treatment for COVID-19 accessible and affordable for the highest number of people possible.
Challenges and Options
To date, the key strategy of the global community according to the World Health Organisation in dealing with COVID-19, amongst others, is to test, treat and prevent. In doing so, many areas of IP have serious ramifications both in terms of access and affordability, including in relation to, inter alia, patenting of medicines, vaccines, testing kits, and even trade secrets, test data protection and know how. In manufacturing personal protective equipment (PPE), 3D printing has already proved to be very useful; however, it tends to conflict with relevant intellectual property rights (IPRs) such as copyright, patent and designs. Through 3D printing, reproduction of IP-protected PPE could take place without the proper authorization of relevant IPR-holders which in turn would infringe the relevant IPRs.
Aside from PPE, the main challenge right now, as the Director-General of the World Intellectual Property Organization has pointed out, is not access to a vaccine, but rather the ‘absence of any approved vaccines, treatments or cures to have access to’. However, as soon as vaccines or treatments are developed for COVID-19, the inherent tension between patent law and public health might come into play. The issue of conflicting interests between pharmaceutical patents and access to medicine is nothing new, yet it will need to be navigated with new lens and perspectives. And, in case of access to medicines and public health crisis, countries may take diverse lessons from the experiences of other nations.
The world has already witnessed the scale and stature of this pandemic in a way which is quite different from the previous public health crises such as HIV/AIDS and Ebola. The HIV epidemic has resulted in resilience and resistance from the developing world and Least Developed Countries (LDCs) which in turn helped to achieve better clarifications on flexibilities under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) including compulsory licensing (article 30 of TRIPS), to craft more public interest-friendly exceptions (article 31bis of TRIPS) and to adopt supplementary legislation of TRIPS, namely, the Doha Ministerial Declaration on Public Health, 2001.
Public health responses globally have varied. A number of countries including Germany, Israel, Canada and Chile have either exercised, or initiated legal reforms to exercise, compulsory licensing. Furthermore, by adopting measures which are permissible under the flexibilities of the existing IP framework, countries like Bangladesh, which are manufacturing capacities of generic drugs, can be a good source of supplier medicines such as Remdesivir or dexamethasone urgently needed for domestic use and for countries with lack such capacity. However, the focus on national interest adopted by the large number of developed countries could be dangerous for the common good. It has been observed that countries like the United States of America and the United Kingdom have signalled that they may stockpile vaccines and treatments for their own nationals, which would be ethically wrong and may threaten the multilateralism or international trading system. Moreover, it should be noted that ‘an outbreak anywhere is an outbreak everywhere’. This essentially suggests that ‘no-one is safe until everyone is safe’; therefore, there are humanitarian and utilitarian aspects of developing a coordinated approach to make the COVID-19 vaccine available and accessible to all. From the anthrax crisis (where the United States warned that it would use the compulsory licensing against Cipro manufacturer Bayer AG, if the price of the potential treatment for anthrax was not reduced) to the COVID-19 response, developed countries have reinforced the principle of state sovereignty in law-making. However, this pandemic may spur developed countries to rethink their historically restrictive outlooks on public interest measures such as compulsory licensing or government use.
The world is now looking for a single solution: the development of a COVID-19 vaccine. China has already granted the first COVID-19 vaccine patent to its domestic biopharmaceutical firm, CanSino Biologics Inc. It is therefore important to explore how the patent could impact on incentivizing the inventive process and the access to a potential COVID-19 vaccine for poor and marginalized segments of the society. What could be the ideal model of innovation and invention for ensuring the common good? When emphasising common good, there are various options and models available.
Firstly, States can take the approach of sharing “whatever we have”, as initiated by the WHO through the ‘Voluntary IP Pool’. This is unlikely to directly produce any vaccine or treatments for COVID-19. However, this will provide a means and platform for cooperation and collaboration between the member states. The second approach focuses on reorientating collaboration for the common good. It has been observed that there are collaborative initiatives by public funded and philanthropic institutions, universities, research institutes and pharmaceutical companies (the collaboration between Oxford University and AstraZeneca being the most promising at this stage). Each of the parties has a demarcated role to perform: in funding, researching or manufacturing the vaccine and making it accessible to the people. The policy concerning ownership of the inventive processes underpinning a potential vaccine remains critical. Ideally, any vaccine of COVID-19 should be completely free, declaring it as the ‘common good’ of humankind. In my view, the traditional approach of university and industry collaboration would therefore need to be revisited. It would no longer be justified for large pharmaceutical companies to reap large profits from COVID-19 vaccines carried out of public money, public funding or philanthropic grants. Instead, funding authorities, universities and research institutes should put public interest-friendly conditions in their technology transfer agreements which enable the developed products and research to be accessible to all. This would enable the intellectual property framework to create benefits for broader society, rather than hindering the same. This process, however, is not without its challenges, given the traditional model of incentivizing the pharmaceutical companies to conduct research and development, through patent protection.
Thirdly, if a patent-free regime is not possible, the next best possible model could be one which recognizes the patent rights for vaccines but makes it freely accessible or not enforceable against the people who need it, and not driven by a profit motive. The vaccines, treatments and other medical equipment could be made available to the people through the royalty-free licensing framework during this pandemic. Fourthly, states could adopt a model to moderate the negative effects of IP. For example, even in the privately owned patent regime, the necessity of striking a balance for public interest consideration is still well recognized. The countries which do not have manufacturing capacities or with less economic capabilities could be provided a reasonable portion of vaccines or drugs, free of costs, by the pharmaceutical companies as a gesture of their commitment to the common good. Similarly, a certain amount of vaccine could be shared by the pharmaceutical companies with LDCs or developing countries in exchange for their partnership or collaboration, such as conducting human trials of vaccines in those countries. Furthermore, the pricing of vaccines could be means-tested, and based on the GDP income of the countries, to ensure that it is affordable to all.
Fifthly, the vaccine or treatment could be made available through non-exclusive voluntary licensing containing reasonable, affordable and accessible terms. This would create a balance between companies’ desire to obtain profits and the interest of reducing prices for the common good. Finally, if none of the proposed models serves the common good, States could reserve a right to issue compulsory licensing or use other flexibilities under the international IP regime to combat this pandemic.
So far, the IP response to COVID-19 can be seen as the reflections of both hopes and hindrances, and calls for making innovations accessible to people and the associated debate on redesigning, renovating and/or manoeuvring existing flexibilities of the IP regime for a public health purpose are unlikely to abate, particularly if the response to COVID-19 is not properly managed.
Mohammad Ataul Karim holds an LLM in Intellectual Property Law from WIPO Academy, Turk Patents and Ankara University. He is an Advocate of the Supreme Court of Bangladesh and Senior Lecturer in Law, East West University, Dhaka, Bangladesh.