Introduction
As I write these lines, the total number of COVID-19 cases worldwide is nearly counted as 400 million and almost 6 million people are dead because of the virus. Although there are many vaccines have been developed since the beginning of the pandemic, even they did responded to the terminal effects of the virus, as they lowered the number of ICUs and hospitalization still most part of the world does not have access to the vaccines. Access to the vaccine poses a serious problem for most of the underdeveloped countries although the EU, USA, China, and Russia have a solution to this deadly pandemic as they have their own vaccine developed. Then why do we still live under the shadow of the pandemic, if we have a formula to end this phenomenon? The simple answer to this question is that the vaccines are protected under intellectual property rights namely patent rights.
The patent holder enjoys an exclusive right to exploit his/her intellectual property for a limited period of time such as 20 years, 25 years, etc. depending on the jurisdiction. This exclusive right includes usage, distribution, import /export, and sale in commercial terms. It’s called a social contract between the patent holder and society. As it may seem restricting the competition by giving exclusive rights over an invention to its developer, on the other hand, the developer is rewarded for his/her dedication and work. In our case, should non- exclusive right be granted to a patent holder, there would be less company to invest in the vaccine R&D. Therefore, it would not be inappropriate for us to state that this exclusive right meant a huge carrot for the vaccine developers. However, the question we need to pose is that are there any limits to this exclusive ownership right and if so what are those restrictions? In this paper, we will delve into the question of whether non-voluntary licenses may resolve the patent problems regarding COVID-19 vaccines within the context of Turkish Law. To answer this, we will first begin with characteristics of patent right then followed by non-voluntary licenses and their place under Turkish Law. Secondly, we will investigate the TRIPS Agreement as to how they handled the question then we will finish with evaluations and discussions, and lastly conclusions.
Characteristics of Patent Right
Before delving into the characteristics of the patent right, we need to first define what is patent in literal terms. According to the dictionary of the Turkish Language Society (TDK) patent is defined as an invention document.[1] Then the definition of invention plays a crucial role. The invention is described as an intellectual product of a human mind that provides a solution to a technical problem.[2] As for the patent it is defined by Turkish scholars as “a document given by an official body upon the application of the inventor, describing the invention and stating that the invention is protected within the framework of legal provisions and that it is able to bestow exclusive powers on its invention for a limited period of time.”[3] Patent right is also described as a right bestowed by that patent.
The debate over whether Turkish Law qualifies patent as ownership is resolved by the Turkish Constitutional Court by its decision on April 9, 2014, with the merits number 2013/147, and decision number 2014/75. The issue plays an important aspect because international agreements dealing with human rights prevail over the national legislation in accordance with Article 90 of the Turkish Constitution. Since patent right is deemed ownership right which is protected under the Universal Declaration of Human Rights the provisions of international agreements dealing with the patent right shall have priority over national legislation. Since Turkey is a party to the TRIPS Agreement, its provisions shall prevail over the provisions of Industrial Property Law numbered 6769.
Patent right grants exclusive right to its holder over an invention.[4] This exclusive right includes exploitation in commercial terms especially, right to distribute, right to export/import, right to sale, right to manufacture. For a limited period of time which is prescribed by the jurisdiction in which the patent protection is sought, the patent holder enjoys the exclusive right. Patent right is a type of intellectual property right which derives from the ownership right. This ownership right can only be transferred by the consent of the owner as a rule however, in certain cases, the enjoyment of this exclusive right might be restricted due to public interest concerns. Public health is one of the grounds that enjoyment of patent rights can be limited without the consent of the patent owner. Non-voluntary license is one of the instruments for restriction.
Restriction to the Patent Exclusivity: Non-Voluntary License
The compulsory license is one of the instruments that may be used against patent exclusivity. As the term suggests that in that license, the consent of the patent owner is not required. States may decide that in case of higher public interest such as national security, public health, etc., the exclusivity that is granted to the patent owner may be waived.
i) Under Turkish Law
Non-voluntary license is regulated under Articles 129-137 of the Industrial Property Law numbered 6769. Pursuant to Article 129, the non-voluntary license may be given in case of non-usage of patent, interdependent patent, breed of a new plant, activities of patentee limiting the competition or public interest. Since the scope of this paper is limited to the non-voluntary license in the context of public health, it will only be dealt with the public interest exception.
The non-voluntary license in the case of public health is regulated under Article 132 of the Industrial Property Law. According to Article 132, the President is authorized to decree granting non-voluntary license for the purpose of dissemination and increase of the product forming the subject of the patent is of high importance due to the public concerns. This non-voluntary license may also be granted conditionally such as in cases where the patent owner has not manufactured enough product to fulfill the public interest. Pursuant to Article 133 as a rule non-voluntary license is granted non-exclusive yet it may be granted exclusively due to public concern.
ii) TRIPS Agreement
TRIPS Agreement contains many provisions with regards to the patent right in its relation to public health. For example, Article 27/1 of the Agreement does not specify the scope of the patentability and grants member states to determine its level of patentability. Therefore by setting a higher level of patentability countries eliminate the risk of “evergreening”. Article 27/2 of the Agreement states that countries may exclude from patentability inventions due to the ordre public concerns. Should there is not any available options such as non-voluntary license countries may resort to this exclusion of patentability? However, the scope of this paper will only be limited to the non-voluntary license therefore we will delve into Article 31 of the TRIPS Agreement.
The Agreement seeking a higher level of protection of IP rights sets forth the minimum protection standards. Article 31 states that;
“Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:
(a) authorization of such use shall be considered on its individual merits;
(b) such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;
(c) the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi-conductor technology shall only be for public non- commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive;
(d) such use shall be non-exclusive;
(e) such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use;
(f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;
(g) authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;
(h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;
(i) the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
(j) any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
(k) Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur; “
By such, countries shall be able to produce generic pharmaceutical products by granting the non-voluntary license. However, according to this provision, the products forming the subject of the non-voluntary license may only be supplied to the country’s internal market where the non-voluntary license is granted. Therefore, only the countries with the necessary know-how and production capacities will benefit from this provision. Access to pharmaceutical products posed a serious threat until the member states convened Qatar and published the Doha Declaration and later added 31bis Article to the TRIPS Agreement.
According to the Doha Declaration and further 31bis Article of the TRIPS Agreement, fair remuneration of the patent owner and the requirement of the supply exclusively to the internal market may be waived for pharmaceutical products. Therefore, access to vaccines by underdeveloped countries is facilitated. Further, we need to define whether the COVID-19 vaccines qualified as pharmaceutical products. Some Turkish authors claim that COVID-19 vaccines fall under this 31bis Article since Article states that “pharmaceutical products mean that any patented product, or product manufactured through a patented process”[5]
Evaluations and Discussions
Under Turkish Law, the non-voluntary license may be granted upon the decree of the President due to the public health concerns in accordance with the provisions of Industrial Property Law numbered 6769 and TRIPS Agreement. However, recently Turkey is not experiencing a vaccine shortage. Therefore, we are of the opinion that a non-voluntary license for the production of vaccines only for the internal market would not be necessary at the moment. However, that does not mean that in the future, Turkey will be able to access vaccines as easily as today’s conjuncture. Maybe in the future, let’s hope this would not be the case; Turkey would be willing to decree a non-voluntary BioNTech – Pfizer vaccine license.
The application of the provisions may also become relatable in case where Turkish vaccine Turkovac is under-supplied to the market. In the case where the developer of the Turkovac company does not have enough production capacities, the non-voluntary license may be applied. We would like to draw the readers’ attention because in the case where the possibility of a decision of non-voluntary license by authorities is spoken, the patent owners would be most likely to lower the prices.[6]
Another issue we need to handle is that when granting non-voluntary licenses to the State / 3rd parties, the maintenance of quality standards is of utmost importance. Because the m-RNA vaccines, which constitute a significant part of the COVID-19 vaccine, have been developed by new technology requiring higher expertise. If States use this non-voluntary license exception with too much eagerness, the quality of the vaccine may be disputable. In that case, instead of lowering the ICU and hospitalization number, State may contribute to the increase in the numbers.
Further, the evergreening issue must be taken into consideration. As explained above, the TRIPS Agreement granted member states to determine their own patentability standards, enabling them to battle against evergreening. Many variants of COVID-19 have been discovered against some of which the developed vaccines do not have effects. Therefore, vaccine developers started to work on the vaccine, which may be effective even against the variants. Further, some of them stated that the new vaccines might be produced with a bit of effort and deviation. However, when the new vaccines have been developed, the developers would like to have patent protection.
Conclusion
The patent right gives exclusivity to the patent owner, which is protected under international agreements and even under the category of human rights as it is deemed as an ownership right. However, this patent right, a prize for the developers, may be restricted due to public health concerns. Non-voluntary license is one of the instruments to restrict the exclusivity granted to the patent owner. States may resort to non-voluntary license to overcome the difficulties posed by pandemics. However, we need to take into consideration the interests of the patent holder, and they should be balanced with the public interest.
In accordance with the Turkish Law Industrial Property Law numbered 6769, the non-voluntary license may be bestowed in case of public interest. There should not be any slightest doubt whether this pandemic constitutes public interest. Further, when granting a non-voluntary license, the remuneration, the term, and the scope need to be specified. Until now, Turkey has not experienced any vaccine shortage. Therefore the application for a non-voluntary license may be postponed.
REFERENCES
Dr. Başak ÖZKÖK GÖKMEN, Covid-19 Aşıları Üzerindeki Patent Hakkının Kapsamının Kamu Sağlığı Açısından Değerlendirilmesi, Ankara Hacı Bayram Veli Üniversitesi Hukuk Fakültesi Dergisi C. XXV, Y. 2021, Sa. 3, sy.163
Arslan Kaya, “Türk Hukukunda Patentten Doğan Haklar”, 55 (4), İstanbul Üniversitesi Hukuk Fakültesi Mecmuası, 1997, s. 173
Fevzi Fırat, “Patent Konularının Bağımlılığı Hâlinde Zorunlu Lisans”, SÜHFD., C. 28, S. 2, 2020, s. 473-509.
Önder ÖZDEN, Covıd-19 Zorunlu Lisans Paradoksu
Hatice ERSÖZ SEÇER, Sevgi ŞAR, İlaçta Patent Ve Sağlığa Erişim Hakkı,
Burcu G. ÖZCAN BÜYÜKTANIR, Türk Hukukunda İlaç Patentine Genel Bakış
İlhami GÜNEŞ, Sınai Mülkiyet Kanunda Zorunlu Lisans,
Doç. Dr. Ali PASLI, M. Hamza ARSLAN
COVID-19 SALGINI ve PATENT HUKUKU: Salgın Nedeniyle Patentli Buluş, Üçüncü Kişilerce Hak Sahibinin Rızası Olmaksızın Kullanılabilir Mi?
[1] https://sozluk.gov.tr/
[2] Dr. Başak ÖZKÖK GÖKMEN, Covid-19 Aşıları Üzerindeki Patent Hakkının Kapsamının Kamu Sağlığı Açısından Değerlendirilmesi, Ankara Hacı Bayram Veli Üniversitesi Hukuk Fakültesi Dergisi C. XXV, Y. 2021, Sa. 3, sy.163
[3] Arslan Kaya, “Türk Hukukunda Patentten Doğan Haklar”, 55 (4), İstanbul Üniversitesi Hukuk Fakültesi Mecmuası, 1997, s. 173
[4]Fevzi Fırat, “Patent Konularının Bağımlılığı Hâlinde Zorunlu Lisans”, SÜHFD., C. 28, S. 2, 2020, s. 473-509.
[5] Dr. Başak ÖZKÖK GÖKMEN, Covid-19 Aşıları Üzerindeki Patent Hakkının Kapsamının Kamu Sağlığı Açısından Değerlendirilmesi, Ankara Hacı Bayram Veli Üniversitesi Hukuk Fakültesi Dergisi C. XXV, Y. 2021, Sa. 3, sy.188
[6] Önder ÖZDEN, Covıd-19 Zorunlu Lisans Paradoksu