COMPULSORY LICENSE LEGAL FRAMEWORK IN COVID


The protection of the patent right has positive consequences for both the inventors and the society. With the patent right, on the one hand, the invention of the inventor is protected against unauthorized use by third parties, on the other hand, the society is informed about the patented technology. The compulsory license system is a system that has been introduced to prevent the inventor from abusing this right. However, the compulsory license system can be introduced not only if the patent owner does not use the patent but also it is used to prevent the patent owner's use against competition rules, dependency between patents, the existence of public interest and health problems in other countries. In this research article I will try to seek and answer the question of "is the compulsory license is suitable in dealing with pandemic?" and mostly will refer to Turkey’s legal framework by comparing different jurisdictions.

About TRIPS

It was accepted in addition to the founding agreement of the WTO during the Uruguay Round negotiations between 1986-1994 and it is an agreement that regulates trade-related intellectual property rights. It is the most comprehensive internationally accepted agreement in the field of intellectual property to date. It protects not only under the existing agreements, but also those who do not benefit from any multilateral protection under "first time right". [1] The significance of the agreement is that, while referring to the Paris and Bern Agreements, it can also serve to fill the gaps left and it is accepted wider in terms of scope-sanction.

The purpose of the agreement is to reduce the barriers and irregularities in international trade and to ensure that the procedures and measures regarding the enforcement of intellectual property rights do not constitute an obstacle for trade. For this purpose, issues such as the recognition of intellectual property rights, the provision of the necessary protection, and the determination of minimum standards in the context of the protection of the intellectual property rights of the member states in the national plan and each other are included in the agreement. It can be said that it is a framework agreement member states must comply with the minimum standards adopted while preparing their national legislation.

Relationship between TRIPS and Epidemic Diseases

The barriers that prevent people from accessing health services and the medicines that are a part of it are among the biggest problems that public health policies should deal with. The problem is even greater when it comes to epidemics, infectious diseases, rare diseases. The lack of supply and/or high prices of medicines and vaccines, especially in these situations, make it difficult to cope with this problem. As with all intellectual property, patents need to find a balance between the rights owner and the general interests of society. In order to find this balance, some limitations should be imposed on some rights of the patent owner, and the interests of the society should prevail, especially when public health is at stake.

As a matter of fact, this need is addressed in article 31 of the TRIPS Agreement. [2] In this article, it is foreseen that the state or authorized persons can use the invention protected by a patent through a compulsory license without the consent of the patent owner, and the terms of this use are regulated. As a rule, the compulsory license is limited for the use of the invention in the country where the patent is registered. In other words, a compulsory license for export is not accepted. However, an exception has been made with the protocol known as the DOHA Declaration. [3] In this context, article 31bis, which was added to the TRIPS Agreement later, allows for the issuance of a compulsory license for the export of drugs to importing countries with appropriate conditions.

Thus, for instance, it is possible for a company in country X, where the invention is protected, to request a compulsory license to produce vaccines for export to country Y. If the patent is not protected in country Y, no further permission is required. However, if the patent is also protected in importer Y country, that country must take a mandatory license decision in order for the vaccine to be used in its territory.

Compulsory License Framework in Turkey

Intellectual Property Law in Turkey, the patenting of inventions and inventors protect their rights by allowing the use of these patents. Basically, a patent is an exclusive right that allows the owner of the patent right to prevent others from producing, using or selling the patented invention for a limited period of time. This exclusive right is subject to exceptions; compulsory license is one of these exceptional applications. The exclusive status of patent rights makes compulsory licensing very rare and exceptional. In accordance with the authority granted non-member states of the TRIPS Agreement that Turkey has made some arrangements in accordance with the TRIPS compulsory licenses. Articles 129 and following of the Turkish Intellectual Property Law [4] contain provisions regarding compulsory licenses. Especially two of them are important in terms of subject.

First of all, in cases where there is a public interest due to public health or national security, the use of the invention subject to a patent, increasing its use, generalizing it, improving it for a useful use is of great importance or not using the invention subject to the patent or in terms of quality or quantity. Compulsory license decision may be taken by the President in cases where insufficient use will cause serious damage to the economic or technological development of the country. In this case, the President of the Republic can directly decide on a compulsory license. In cases where it is possible for the patent owner to use the invention sufficiently and in a manner to meet the public interest, priority belongs to the patent owner according to the law. A compulsory license can only be possible if this condition is not fulfilled.

Another compulsory license state is to make a decision for the export of pharmaceutical products due to public health problems in other countries, if the conditions specified in the TRIPS 31bis article are met. [5] Thus, the TRIPS Council to be used in countries where the appropriate conditions as agreed with the importing country Covid-19 vaccine be given compulsory license may also be possible to produce in Turkey. Intellectual Property Law, where there is danger of national security or public interest, the Ministry of Health and the Republic of Turkey at the request of the Ministry of Defense organizes is entitled to a compulsory license of the President. Rights protected by patents benefit from this protection mainly due to their exclusive nature and are intended to be protected as strong as possible. Because of this nature, compulsory license is quite an exception. However, at some point this absolute protection can upset the balance of interests. The non-use of a patent or the actions of the patent owner that do not comply with the competition rules are relatively normal situations that lead to compulsory licensing to be granted by the Republic of Turkey.

Past and current experiences of Compulsory License

The compulsory licensing regime has been used by many countries as a successful policy tool in facilitating access to antiretroviral drugs in the face of the AIDS epidemic. There are several countries that have successfully used compulsory licenses to provide affordable medicines to their citizens during past public health crises. [6] In the 2000s some countries granted a mandatory license to one or more antiretroviral drugs to improve the health status of their HIV-infected citizens who cannot afford antiretroviral therapy. [7] For these reasons, the experiences learned from the HIV/AIDS epidemic should also be applied to the fight against COVID-19.

The legislative bodies in Canada, Chile and Ecuador in March 2020 prepared and put into effect a legal regulation for the issuance of compulsory licenses for COVID-19. [8] Necessary legal arrangements relating to compulsory licensing as many EU countries to Turkey this regard has already adapted to the patent law. Accordingly, most of the European countries such as Turkey allow compulsory licensing and EU member countries conditional to fulfilment of certain conditions, 816/2006 the EU Regulation must give permission in accordance drugs the least developed and be licensed as required to the developing countries.

Legal frameworks on compulsory license in different jurisdictions and the most effective one

In the Covid-19 process, the Israeli state made the first compulsory license decision. Israel allowed the State to import the generic of Abbvie's drug Kaletra from India for the treatment of coronavirus patients under Section 104 of the Patent Law [9], which allows licenses for national defense purposes. [10]

Germany has one of the strict compulsory licensing laws and requirements. According to section 24 of the German patent law, public interest and a state of significant technological progress are shown for granting a compulsory licensing. It also enacted the Law on the Prevention and Control of Communicable Diseases in Humans and gives the Federal Ministry of Health the authority to issue an administrative order for the use of a patent, which is a federal government authority under section 13 (1) of the German Patent Law [11]recognized. Thus, before Covid-19, in accordance with section 13 of the German Patent Law, the use of the invention subject to a patent by the government or any third party on the grounds of public interest was possible with an administrative decision to be issued by the federal government, and now the Federal Ministry of Health is also authorized to issue a mandatory license and in this way, the conditions for compulsory licensing were facilitated.

The French government, on the other hand, enacted the law numbered 2020-290 [12]. With this law, by making amendments to Article L.3131-15 of the Public Health Law, the Prime Minister of France, in this context, requires the implementation of fast compulsory licensing procedures and the seizure of all necessary goods and services to combat the public health emergency, and the provision of these services or the use of related goods. Wider powers are granted, includes to decide on the recruitment of any person required for It is clear that this regulation goes beyond compulsory license application.

Canada changed the compulsory license practice of Canada by enacting the "Bill C-13, COVID-19 Emergency Act" [13] and facilitated the issuance of the compulsory license. Section 12 of the Act amends the existing Patent Law to allow the Government of Canada, upon the application of the Ministry of Health, to produce, use and sell a patented invention sufficient to respond to a public health emergency and obliged him to give permission. However, in the new regulation that requires the federal government to notify the patent owner and pay the license fee, the government's obligation to notify the patent owner is removed.

Unlike others, the UK has not made any changes to amend or strengthen existing compulsory licensing laws, but has foreseen that the "Crown Use" [14] defense can be used in case of infringement of intellectual property rights on products that domestic companies would ask to produce in large quantities, such as masks and respirators, as part of the fight against the COVID-19 pandemic. According to Article 55 of the patent law[15], it is regulated that the government or a person appointed by the government can take part in acts that may constitute patent infringement to serve the crown, without the permission of the patent owner or exclusive license holder. In addition, at the request of the United Kingdom, it has been announced that companies producing respirators for use in the fight against the COVID-19 pandemic will be protected by the government against possible legal claims regarding intellectual property violations.

When we look at the USA, we see that there are legal regulations that will enable it to operate compulsory licensing mechanisms. In particular, the famous Bayh Dole law [16]makes it possible to obtain a compulsory license on a patented technology developed with federal funding for health and safety reasons. Another legal mechanism in the hands of the US is the Defense Production Act, which allows for some form of compulsory production. As a matter of fact, with the authorization given by this law US President D. Trump gave General Motors an order to prioritize the production of personal protective equipment and ventilators and to produce more ventilators at a more affordable price and faster.

Referring to the Republic of Turkey pandemic measures, the modification of the compulsory licensing provisions or strengthening not resort to additional measures as and current results for the pandemic mortality rates and health systems Turkey's process in terms of the load on it is seen that one of the best-managed countries. On the other hand, the existing compulsory licensing provisions in Turkey, "the public interest" in the interests of an emergency of any kind be of sufficient scope and power to be exceeded or suspension of patent rights should also be mentioned. In accordance with Article 132 of the Industrial Property Law [17]; The President of the Republic, for reasons of public health or national security, is responsible for the use of the invention subject to a patent, increasing the usage, generalizing it, improving it for a beneficial use, or not using the invention subject to the patent or using it insufficiently in terms of quality or quantity causes serious damages in terms of the economic or technological development of the country may decide to issue a compulsory license due to public interest.

Compulsory license to be granted by the Republic of Turkey, which has been anticipated for quite exceptional circumstances and urgency. The process of granting the license and the procedural steps to follow is relatively straightforward compared to other types of compulsory licenses. This is not surprising given that this type of license can only be used in situations with a national emergency and / or extreme urgency regarding public health or national security.

Compulsory license legal problems& solutions

Approaches of the EU countries and the United States to the compulsory license regime differ greatly. Unlike the United States, the European Union has implemented legislation [18]to address the public health problems of underdeveloped and developing countries through compulsory licensing of pharmaceutical products. EU Law, TRIPS art. As long as the mandatory licensing conditions foreseen in 31st are fulfilled, it stipulates that each EU country will grant a compulsory license to underdeveloped and developing countries for drug production and distribution. This could lead to greater international investment in vaccine development in the EU and speed up the process of supplying COVID-19 vaccine to the regions most needed in the EU and internationally. However, existing legal gaps in compulsory licensing in the United States may prevent vaccines developed by the EU from reaching the United States on time.

With a compulsory license, the state manufactures and distributes medicines and vaccines (either by itself or by people it deems appropriate); society is provided with access to medicines and vaccines to be used against the disease by paying sufficient and affordable prices. While this is the legal framework, there is no obstacle for a pharmaceutical company to develop different strategies. The patent owner demanding exorbitant prices for the vaccine produced or restricting the supply of the vaccine is not legally possible in the face of worldwide compulsory license regulations.

On the other end the company's can be adoption of an open innovation policy. Namely, a company developing the COVID-19 vaccine does not have to apply for a patent for it. Or, even if the vaccine has been patented, the patent owner does not have to use the blocking rights arising from the patent. The patent owner can choose to remain silent against those who produce the vaccine subject to the patent or announce that he will give a free license to produce the vaccine to everyone who makes a request.

It is unlikely that the company would prefer not to apply for a patent and to open the invention to the unlimited free use of the society. Indeed, in this case, the company loses control over its invention and anyone can use it for free. Thus, the company has to bear the costs of developing the vaccine alone. Even with the compulsory license, a price is paid to the patent owner, and the price to be paid for the vaccine to be produced and sold against a global pandemic will not be underestimated, the company does not want to lose it. Between these two extremes, it would be a realistic assumption that the company should pursue a strategy that takes into account legal obligations, and that will cause the least harm to itself in terms of both perception and the loss of profit.

Considering all the options, the most plausible solution can be seen as the patent and license holder company offering a contractual license to produce the vaccine during the pandemic, under very reasonable conditions, to anyone who wishes. Compulsory license applications seem inevitable, especially in the case of a worldwide epidemic, as we have experienced. The image of a company forced to license with an administrative decision should not be a highly desirable situation in terms of public relations.

As a result, as it seen legal framework of the compulsory license is handled and applied differently by each country in the international arena. However, as the epidemic affects the whole world, medical remedies must also be on a world scale, which makes international solidarity and cooperation inevitable. It seems that necessary for R&D studies for countries to share epidemic and medical combat data with each other. Compulsory licensing regimes in exceptional cases, the patent owner may seem restrictive however as seen for example in Turkey, it doesn’t create unfair to have to create an exceptional situation.

BIBLIOGRAPHY:

PRIMARY SOURCES:

Act n° 2020-290 2020

Amendment of the TRIPS Agreement 1995

Bayh–Dole Act 1980 (Pub L 96-517)

COVID-19 Emergency Response (Act SC 2020, c 5)

German Patent Act 1998

Industrial Property Law 2016 (Law No 6769)

Regulation (EC) No 816/2006 of the European Parliament and of the Council 2016

The Patents Act 1977

The Patents Act 5727-1967 1967

(TRIPS Agreement, 1994)

World Trade Organization. Declaration on the TRIPS Agreement and Public Health, 20 Nov. 2001

SECONDARY SOURCES:

Beall R, Kuhn R, ‘Trends in Compulsory Licensing of Pharmaceuticals since the Doha Declaration: A Database Analysis. PLOS Medicine’ 9

Dani Kass, ‘Israel Defies AbbVie IP To Import Generic Drugs For COVID-19. March 19, 2020’ Law360

Daniel J. Gervais, ‘European Intellectual Property Review 1999 Legislative Comment The Trips Agreement: Interpretation and Implementation’ Sweet&Maxwell Limited and Contributors Legislations 1

Federico Lo Bianco, ‘Comparative Patent Compulsory Licensing Under COVID-19’ [2020] SSRN

Hilary Wong, ‘The Case for Compulsory Licensing during Covid-19’ (2020) 10 University of California, Berkeley, School of Law, USA 3

[1] Daniel J. Gervais, ‘European Intellectual Property Review 1999 Legislative Comment The Trips Agreement: Interpretation and Implementation’ Sweet&Maxwell Limited and Contributors Legislations 1.

[2] (TRIPS Agreement, 1994).

[3] World Trade Organization. Declaration on the TRIPS Agreement and Public Health, 20 Nov. 2001.

[4] Industrial Property Law 2016 (Law No 6769).

[5] Amendment of the TRIPS Agreement 1995.

[6] Beall R, Kuhn R, ‘Trends in Compulsory Licensing of Pharmaceuticals since the Doha Declaration: A Database Analysis. PLOS Medicine’ 9.

[7] ibid.

[8] Hilary Wong, ‘The Case for Compulsory Licensing during Covid-19’ (2020) 10 University of California, Berkeley, School of Law, USA 3.

[9] The Patents Act 5727-1967 1967.

[10] Beall R, Kuhn R, ‘Trends in Compulsory Licensing of Pharmaceuticals since the Doha Declaration: A Database Analysis. PLOS Medicine’ 9.

[11] German Patent Act 1998.

[12] Act n° 2020-290 2020.

[13] COVID-19 Emergency Response (Act SC 2020, c 5).

[14] Federico Lo Bianco, ‘Comparative Patent Compulsory Licensing Under COVID-19’ [2020] SSRN.

[15] The Patents Act 1977.

[16] Bayh–Dole Act 1980 (Pub L 96-517).

[17] Industrial Property Law.

[18] Regulation (EC) No 816/2006 of the European Parliament and of the Council 2016.

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