COVID-19 Vaccines and Compulsory Licensing

Updated: Aug 26



The joyous news regarding the COVID-19 vaccines have started to be heard. There still exists a disquieting concern for undeveloped and developing countries since these vaccines are not directly accessible. Therefore, compulsory licensing continues to become a current issue in Intellectual Property Law.


Several countries have already adopted compulsory licensing before the COVID-19 pandemic. Some countries amended the existing provisions to comply with the conditions of COVID-19. Although Turkey has not performed any amendments, compulsory license is a possible pathway to ensure public interest as of the Article 129 of Industrial Property Code No. 6769 (“the Code”).


The scope of public interest is determined by either of the two main requirements according to Article 132 of the Code:


1) The invention is essential to provide public health or national defense,

2) In case the sufficient use of invention could be provided by the patent holder, the invention may conditionally be considered within the scope of compulsory licensing


The use of vaccines is subject to a patented invention, which is significant to the terms of public health. For this reason, licensing of COVID-19 vaccines is covered by the first requirement.


The compulsory license is granted under certain conditions. For instance, the duration, price, and usage area of compulsory license cannot be unlimited. The limits must all be determined separately in the agreement[1]. Moreover, the proposal for compulsory licensing should be submitted to the Civil Courts for Intellectual and Industrial Property Rights. The approval is made by the proposal to the Ministry of Health and to the approval of the President of the Republic in order to complete the procedure of compulsory licensing.


The court considers the economic value of the patent while determining the price of vaccines, expenses for labor and procurement. The economic value should be taken into consideration according the importing country, including non-commercial and humanitarian purposes.

If the trust relationship arising between the patent owner and the licensee is violated by the patent owner, the licensee may request a reduction from the license fee that the patent owner may request, depending on the effect of the violation on the evaluation of the invention[2].


In principle, compulsory licenses cannot be exclusive. Nevertheless, such licenses to be granted for public interest may be exclusive. If the licensee is authorized to import for public benefit, the subject of the patent may be imported. The authority for importing is given only as needed and for a temporary period.


Despite the negative impression due to being compulsory and non-patent friendly, compulsory licensing has many advantages. For instance, it helps the pharmaceutical sector in developed and underdeveloped countries develop even during contingency periods. Such licensing also contributes to transfer of technology, which leads research and development costs to relatively decrease[3].


Even though compulsory licensing is not commonly exercised in Turkey, COVID-19 vaccines reawaken the topic. Ethical debates on the exclusive rights of the patent owner continue in the academic world.


KAYNAKÇA

[1]https://pharmaboardroom.com/legal-articles/compulsory-licensing-public-health-during-the-covid-19-pandemic-in-turkey/

[2] http://www.jogh.org/documents/issue202001/jogh-10-010358.pdf

[3] https://www.lawnn.com/compulsory-licencing/


YAZAR

Bilgi Teknolojileri Birimi