Call For Open License
The Corona virus (COVID-19), influencing the world, has brought about global patent wars. Owing to this situation where intellectual property law and the right to live are in clash, today millions of people around the world buy drugs, vaccines, etc. all being under patent protection, and cannot access products needed, being deprived of the fundamental right of access to health.
The purpose of the patent system is to reward the inventors and encourage them to make more inventions and to publicize their knowledge. While the patent holder has 20 years of protection, it also means that no one can manufacture, sell or import the invention during this period. The patent protection of drugs / vaccines is mandatory with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In accordance with the cited Agreement, a variety of obligations and standards regarding intellectual property rights have been imposed on the members of the World Trade Organization. Extending the patent right to medicines has fueled the conflict between the right to health care and the patent right. This situation has caused countries that have facilities and manpower to produce vaccines, not being able to use these resources and attain the right to life, which is a fundamental right.
The reason why we specified our article title as “open license” is that the license in question should be open to use of all humankind and should be presented to the benefit of all humanity. Open license is called “compulsory license” in the legal literature, and our information and views on compulsory license are included in the article.
II. TRIPS AGREEMENT AND DOHA DECLARATION
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets standards for the protection of intellectual property, including vaccine patents. With the entry into force of the agreement, patent holders have sole production, distribution and sales rights for 20 years. With the COVID-19 epidemic, which significantly affected public health, this situation has taken a turn that affects the right to life.
On the other hand, the Doha Declaration was adopted on 14 November 2001, emphasizing the need to focus on the public good and the right to health. The most important regulation brought by the Doha Declaration is that the measures imposed by TRIPS cannot be valid when it comes to public health and it is important to develop new drugs / vaccines for the protection of intellectual property law.
In addition, in his speech at the UN General Assembly in 2009on the right to health, the UN special rapporteur stated that “intellectual property rights laws continue to seriously affect access to drugs, and the inclusion of underdeveloped countries into TRIPS laws may mean a violation of the right to health“.
III. COMPULSORY LICENSING
In order to ensure balance between access to health and intellectual property rights, some restrictions may be imposed on some rights of the patent holder. Namely, this mechanism, called compulsory licensing, will come into effect with the occurrence of some special cases and is included in the 31st article of the TRIPS Agreement. Pursuant to the said article, it is stipulated that the state or persons authorized by the state can use the invention protected by a patent through a compulsory licensing without the consent of the patent holder. Some conditions must be met for operation of this article;
- In the event of force majeure circumstances such as an epidemic, it is not necessary to request the right to use from the patent holder beforehand for the compulsory licensing. However, the patent holder should be informed of the situation as soon as possible and in an appropriate manner.
- The compulsory license should be evaluated according to the nature of the event, and the conditions and duration of the event should be considered in the said evaluation.
- The compulsory license cannot be transferred to anyone else.
- A reasonable payment must be made to the patent holder in exchange for the compulsory license. The said payment varies according to the nature of the present case.
In addition, in the TRIPS Agreement, it is stipulated that states can produce vaccines by informing the patent holder and making a reasonable payment in case of a national emergency. Compulsory licensing can only be applied for public benefit and health matters. In cases where usage is vital for the benefit of society; For example, the production or copying of vaccines required for the prevention of epidemics or their use is permitted to overcome serious obstacles to the development of the country.
Although, the use of the invention under the compulsory license, is restricted within the country where the patent is registered, the Doha Declaration sets an exception to such restriction. Similarly, in the 31st article included subsequently in the TRIPS Agreement, the export of vaccines to importer countries fulfilling certain criteria has been allowed. Therefore, in countries that the TRIPS Council accepts as importing countries with appropriate conditions, it will be possible to issue a compulsory license and manufacture for COVID-19 vaccine. However, in the 5th article of the Doha Declaration, it has been confirmed that “members of the World Trade Organization have the freedom to grant compulsory licenses and to determine the reasons for granting such licenses“.
In addition, we would like to point out that in case of national emergencies, governments can grant compulsory licenses without negotiating with the patent holder. In the continuation of the same article, “epidemic disease” is defined as a national emergency.
However, as the aim of the compulsory licensing is to eliminate a national emergency case, the compulsory license should be terminated immediately once the emergency is brought under control.
IV. COMPULSORY LICENSING IN TURKISH LAW
Regulations have been made in Turkish law on compulsory licensing, and provisions regarding compulsory licensing are included in the article 129 and subsequent articles of the Industrial Property Law. Compulsory Licensing for the Public Interest is included in Article 132 of the Industrial Property Law, and the cited article of the Law is given below.
Compulsory license arising from the public interest
ARTICLE 132- (1) If use of the invention forming the subject of patent, increase of its use, dissemination of it in general, improvement of it for a beneficial use have a great importance by the reason of public health or national security issues or if non-use of the invention forming the subject of patent or its insufficient usage in terms of either quality or quantity shall cause serious damages in terms of the economic or technological development of the country, it shall be decided by Council of Ministers upon the proposal of the relevant ministry that;
a) A compulsory license for the public interest is given,
b) There is public interest if invention is made conditionally the subject of compulsory license in the event that effective use of invention to satisfy the public interest can be realized by the patent owner.
(2) In case that a patent application or use of the invention forming the subject of patent have a great importance in terms of public health or national security, the relevant ministry shall put forward a proposal by means of taking approval of the Ministry of National Defense or the Ministry of Health.
(3) The compulsory licenses granted by the reason of public benefit may be exclusive. The compulsory license decision granted on the grounds that it has great importance in terms of national security may be limited to use of the invention by one or more businesses.
Accordingly, if the public interest and the inability to use the patent-protected invention cause significant damages for the country, then the compulsory licensing conditions occur. There is no doubt that an epidemic with global impact such as COVID-19 will create such conditions.
V. HISTORICAL DEVELOPMENT OF COMPULSORY LICENSE AND TODAY
There are countries that have successfully used compulsory licenses in the past to protect public health and provide vaccines to citizens. Compulsory licenses for antiretroviral drugs were granted for Brazil, Ecuador, Ghana, Malaysia and Thailand in the 2000s, and these experiences learned from the HIV / AIDS epidemic should also be applied in the fight against COVID-19.
Some countries have publicly stated that they are considering compulsory licensing in response to COVID-19. Israel made the first compulsory license decision in the COVID-19 process. As another example, Canada, Chile, Ecuador have introduced compulsory licensing for COVID-19 vaccines, medicines, and other medical devices, and they have removed the rights of patent holders for a period of time. The proposal to waive the patent right for COVID-19 vaccines proposed by South Africa and India will also be finalized in negotiations.
On the other hand, Katherine Tai, the US Trade Representative, stated that the pandemic requires extraordinary measures, and requested the temporary abolition of patent rights on COVID-19 vaccines. In addition, it is stated that it will take initiatives for an exceptional regulation in the World Trade Organization. US President Joe Biden’s announcement that he supports the waiver of “intellectual property protection” has shaken the shares of vaccine companies in the stock market.
It should be noted that 164 members must agree in order for the World Trade Organization, which has a unanimous mechanism, to make a decision. In the negotiations carried out so far, the members press for the relaxation of the TRIPS rules, being the agreement of the World Trade Organization. The proposers argue that the HIV / AIDS epidemic of previous years caused the deaths of at least 11 million Africans due to lack of access to medicine. However, it should be noted that the negotiations held right now have been inconclusive.
Paving the way for the elimination of the obstacles faced by the countries that have difficulties in accessing drugs or vaccines, in the name of public health, the Doha Declaration plays a pioneering rolefor the regulations made for application of compulsory patent licensing in pharmaceuticals. Turkey and other member countries, which have accepted the TRIPS Agreement, have to develop regulations in line with the universal principles and humanitarian ideas introduced by the Doha Declaration. Taking the public health into consideration, necessary steps should be taken for the production of vaccines through compulsory licensing, and thus, the opportunity to import vaccines should be provided for countries that do not have technical equipment. This is our call for a compulsory licensing.