PATENT PROTECTION AND COMPULSORY LICENSING SITUATIONS ON VACCINES
The most important issue on the global agenda in 2020 was the COVID-19 pandemic and the number of deaths from it. While countries have implemented measures such as quarantines, curfews, and states of emergency to combat the pandemic, experts have stated that the only way to protect against this virus is through vaccination or the mutation of the virus.

After the virus emerged and, in particular, became a pandemic, vaccine research began worldwide. Many people are thinking, "Whoever finds a vaccine will gain significant income and benefits." Therefore, numerous studies have been conducted worldwide regarding drugs developed for use in the treatment of COVID-19, and applications have begun to obtain patents for these drugs. This study aims to protect the drugs and vaccines used in the treatment of COVID-19 under patent protection and to protect the public interest against potential monopoly rights.
The compulsory license situation will be discussed on the grounds that:

General Information

Vaccination is considered the most effective method to eradicate the coronavirus, which has claimed more than 300,000 lives worldwide. Currently, more than 100 vaccines are being developed. The race to develop a vaccine also has another dimension: If one is found, who will get priority vaccination?
Following US President Donald Trump's statement, "If I'm paying for a vaccine, America will be the priority," French company Sanofi announced that it would prioritize the US. Sanofi CEO Paul Hudson stated that "the US government will have the largest order rights because it took a risk and invested in the company," but backtracked on this statement following backlash from the French government.
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This critical situation has escalated into a vaccine war between countries, with some countries making political moves and collaborating with others. Turkey recently announced that it will jointly conduct vaccine research with Russia, while the US also stated that it is working with India on vaccine development. While the Chinese president recently stated that if we find a vaccine, we will share it with other countries, being the first to find one is seriously whet the appetite of all countries.

A patent is a document granting the inventor the right to prevent third parties from producing, using, selling, or importing the product subject to the invention for a certain period of time. Countries around the world are hesitant to allow companies or governments to restrict the development of a COVID-19 vaccine with a patent. So, can a patent grant monopoly rights to a vaccine? In such a case, can states make certain decisions in the public interest? Let's look at the answers to these questions. Microorganisms that exist in nature cannot be patented. Because microorganisms exist in nature, as a part of nature, their discovery is not considered an invention (EPC Article 52 (2) and IPC Article 82 (2)). As in our country, the information available at the European Patent Office indicates that a discovery is not covered by a patent. The Austrian Patent Office and the Swedish Patent Office share the same opinion. However, this rule does not apply to products that can be produced or developed in a laboratory environment.< does not apply to microorganisms. In many developed countries, human-produced or developed microorganisms and biological materials are patentable. Bacteria,
Examples include viruses, fungi, and single-celled algae. According to the European Patent Convention, for an invention to be patented, it must meet three requirements: it must be new, involve an inventive step (inventive step), and have industrial applicability. For example, suppose an invention is made in which a natural microorganism can exhibit antibiotic activity; in such a case, exceptionally, the microorganism can be patented as part of the invention. In other words, if an invention involving a natural microorganism and other components is made, it can be patented.

When companies or individuals apply for a vaccine patent, they are applying for many aspects of the vaccine, not the microbe itself, but the resulting formula. As can be seen from the information provided above, it's possible that a vaccine, a very powerful drug, can be patented and potentially enjoy monopoly rights. While this is concerning, the powers of those who acquire patent rights can be limited by compulsory licensing in exceptional circumstances such as pandemics or war. This situation, which we call compulsory licensing, is regulated by Articles 129/1 and 132 of the Civil Procedure Code No. 6769. Compulsory licensing restricts the patent holder. Compulsory licensing involves the non-use of the invention for a certain period of time against the patent holder's will, and licensing is granted for reasons such as interdependence between patents and public interest. In extraordinary circumstances such as war or pandemics, compulsory licensing can be granted without the patent holder's consent, allowing third parties to produce products covered by the patent. Compulsory licenses are shaped by the domestic laws of countries, and certain principles and guidelines regarding compulsory licenses have been adopted through TRIPS (The Agreement on Trade-Related Aspects of Intellectual Property Rights). Countries participating in the agreement are obligated to comply with these principles and guidelines. Furthermore, regulations have been introduced for compulsory pharmaceutical licensing to remove barriers to access for countries experiencing access difficulties. Because compulsory licenses are granted in cases where the public interest is deemed necessary, they result in the public interest being prioritized when the interests of the patent holder conflict with those of the patentee. As can be understood from the explanations, even if a company or institution acquires rights to a drug through a patent, a compulsory license decision is made in the public interest when certain public interest situations arise. This is clearly explained in Article 132/1 of the Civil Procedure Code (CICP): "In cases where it is of great importance for the invention subject to patent to be put into use, to be increased in use, to be generally widespread, to be improved for a beneficial use for reasons of public health or national security, or where non-use of the invention subject to patent or inadequate use in terms of quality or quantity would cause serious damage to the economic or technological development of the country, the Council of Ministers shall decide upon the proposal of the relevant ministry."

The compulsory license proposal is then submitted by the Presidency rather than the Council of Ministers. Pursuant to the second paragraph of the aforementioned article, if the patent application or the use of the invention under patent is important for public health or national security, the proposal will be made by the relevant ministry after obtaining the approval of the Ministry of National Defense or the Ministry of Health. Furthermore, the compulsory license process can begin with an individual's application to the relevant ministry or with the administration's own initiative. In other words, it is in the public interest.< No court decision is required for granting a compulsory license on the grounds of direct patent >A contract can also be negotiated with the owner, and an agreement can be reached. Since there is no clear provision stipulating who will be granted the compulsory license, the licensee can be any legal entity, public entity, or individual.

Conclusion A vaccine for COVID-19, like all other drugs, could be protected by a patent. However, since public health is still considered, compulsory license applications for drugs that can be used in the treatment of COVID-19 can be made through license agreements designed to protect the public interest and ensure their production is free from single-party ownership.