VACCINE PATENTS VS HUMANITY?
21 Haziran 2021 Pazartesi

The pandemic we are experiencing not only brought about important changes in our professional and social lives, but also caused numerous debates. After Joe Biden’s statement that ‘intellectual property rights (especially patent rights) in vaccines should be waived’, we had a brand-new agenda: Patents are against humanity…

But indeed, are they?

Is it really patents that are the sole responsible for the current situation of particularly the underdeveloped or developing countries?

Right at this point, as professionals of this field, we have to approach the situation realistically rather than emotionally and educate the society with an objective perspective.

As is known; patent is essentially a property right and has an indispensable place in the development of the technology. For instance, behind the process for an original medication to enter the market are R&D studies of years and hundreds of millions of dollars spent. However, such a medication can be imitated with much less effort and cost once it is marketed. If this situation is not legally prevented, it is not possible for such a pharmaceutical company to pursue its R&D studies. Therefore, if there was no patent protection, several medication, vaccines, diagnosis, medical treatment equipment and sophisticated devices that saves or at least increases the quality of our lives would not exist. If we look at the matter in terms of COVID-19, I would like to state that more than 2000 patent applications have been filed so far for the diagnosis, treatment, and vaccination studies of this disease, and that several inventions protected by these patents have, and will continue to have, a vital role in humanity’s fight against the pandemic.

At this point, I think Biden’s approach is not sound and indeed, and I am concerned that such an approach will deepen the problems even more. We should also keep in mind that, even if under special circumstances, the possibility of patent rights, through which the companies protect the output of the R&D studies they will conduct with a high financial burdens, to be suspended in line with the initiative of the nation states will substantially decrease the R&D motivation of these corporations. In this matter, leading intellectual property organizations of the World such as AIPPI also express similar opinions. [1]

There also is a reality we all know. Even if patent rights of vaccines are waived, this problem will continue as many countries do not have technical capabilities to produce these vaccines. Moreover, the motivation and power of the companies either this or that way providing the world with the vaccines and committing to provide in larger amounts will be broken and this may result in the world to face a scenario even worse than now.

In addition to that, I also think that the possibility to execute an agreement to suspend the patent rights is low, and even if it happens, it will take months. And I think it is also possible that the uncertainty to be experienced in this process will end up with the negative results I mentioned before.

Then, what to do in this situation?

Do you think it is possible that measures are not taken in intellectual property regulations against the use of the patent right in a way to damage the benefit of the society?

Of course not…

I will try to explain it to you as briefly as possible, keeping the legal details at minimum. First, I wish to talk about TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement. TRIPS is a comprehensive international legal agreement enacted in 1995 after it was signed between the member countries of World Trade Organization (WTO). One of the 3 main pillars of the TRIPS Agreement is the intellectual property rights, and the purpose of this pillar is to determine the minimum standards in protection of intellectual property rights and to ensure that the processes of implementation of intellectual property rights do not pose an obstacle in international trade. Turkey also enforces TRIPS provisions since 2000.

Another point I would like to mention is the concept of “compulsory licence”. The main framework of this concept is stipulated in the 31st article of TRIPS Agreement. In our country, “compulsory licence” matter is addressed in detail between the 129th and 137th articles of Industrial Property Law No 6769.

Accordingly, patents have a requisite called compulsory use and under normal circumstances, if an invention of a patent is not used within a certain period of time (within 3 years of registration or 4 years of application whichever expires later), third parties gain the right to demand compulsory licence. However, if the fact that the invention of the patent cannot be used or is used insufficiently causes troubles in public health or national security, in our country, a compulsory licence decision can be taken with Presidential approval for the public interest, even if the conditions of the compulsory use are met by the patent owner. By this right which is also clearly supported by the 31st article of TRIPS, the public grants a third party the right to use the invention of the patent within certain limits even if the owner of the patent does not consent to it. On the other hand, the compulsory licence does not mean free of charge use of the patent right (see TRIPS Article 31(h)). A reasonable licence fee definitely needs to be paid to the patent owner.

Did you know that a similar circumstance was experienced years ago due to the problems related to HIV virus and in this regard, some important steps were taken in addition to TRIPS to bend the patent rights?

How?

Namely, the situation of not being able to reach the main medication on HIV virus causing a public health issue in Africa has triggered a process to make the Doha Declaration on TRIPS Agreement in 2001. Doha Declaration, with the essential purpose to make the compulsory licence provisions of TRIPS even more flexible if a threat against public health is present, underlines two essential matters.

The first one is the matter that member countries shall not be hindered by TRIPS provisions in taking the necessary precautions to protect the public health and that each country has the right to decide how to grant the compulsory licence.

The second one is the parallel import authorization. This one is particularly important for countries that do not have the technology and infrastructure to produce the medication or vaccine even if they are granted with the licence to produce. As is known, the sales prices of a medication or another product can vary between countries and with the parallel import authorization granted by Doha Declaration, it is possible to procure the vaccine or medication for instance from a country where these are sold for cheaper prices.

In the light of all these information, I propose the following solutions in relation to the current circumstance:

  • Taking Doha Declaration into consideration, the rules may be flexed a little to improve the conditions of access of certain countries to the vaccine patents in line with the 31st article of TRIPS Agreement and compulsory licence provisions of the national intellectual property regulations of the countries.
  • Accordingly, countries like Turkey, where local companies exist having the technology to produce the vaccine in a short period of time with lower cost compared to EU or US, can grant a compulsory license to such local companies that requires them to pay a minimum possible license fee to original vaccine patent owners.
  • The countries that do not have the possibility to produce the vaccines can also refer to the Doha Declaration and procure these vaccines from countries like Turkey through parallel import.
  • In addition to all of the above, instead of discourses on waiving the patent rights, the developed countries can partially or fully fund the losses of the vaccine companies that undertake waiving from their profits to facilitate the access to vaccines and can support the process of establishment of vaccine production facilities in countries.

As is seen, these debates have indeed been going on for years and solutions were set forth in both national and international regulations. I do not think it is good for anyone for the leaders of the developed countries to utter discourses and take actions that will break the innovation motivation of the profit-oriented companies, while these solutions are available and given that there is no evidence proving that it is the patents that prevents access to Covid-19 vaccines.

I wish you healthy and peaceful days with the hope to meet in the pandemic-free days and to leave all these discussions on the dusty shelves of history.

Erdem Kaya

Turkish and European Patent Attorney

e.kaya@erdemkayapatent.com

[1] https://aippi.org/wp-content/uploads/2021/05/AIPPI-Position-Paper-on-WTO-Waiver_12May2021.pdf