Patent Rights Under Industrial Property Law and the Patentability of Pharmaceuticals

Industrial property rights ensure legal protection for products that a person or an enterprise puts out as a result of industrial or agricultural work and grant monopoly rights to the beneficiary for a certain period of time. Industrial property rights are composed of brands, geographical indications, designs, patents, and utility models. In Türkiye, these rights are regulated by Industrial Property Laws No. 6769.

In this article, patent rights will be discussed in general terms, followed by information about one specific type of patent, pharmaceutical patents.

Patent: An official document that grants the patent holder the rights to produce, sell, and use their invention for a specific period of time (20 years), and the authority to prevent third parties from engaging in these activities without the patent holder’s approval (monopoly right).

Historical Development of Patent:

In 1879, the Ottoman Empire translated the “French Patent Law” exactly as it is, and the “Ottoman Patent Law” came into force (GÖKOVALI & BOZKURT, 2006). In this context, the Ottoman Empire started granting patents to inventors that met the necessary conditions in the law. The Patent Law, which was in force for a long time, was repealed in 1995.

Türkiye signed the World Trade Organization Establishment Agreement (TRIPS) in 1994, and in 1995 this agreement came into force. The main purpose of this agreement is to establish a common structure among member countries to maintain trade relations. The European Patent Convention, which came into force in 2000, aimed to create a common European system for the registration of patents among its members (GÖKOVALI & BOZKURT, 2006).

Meanwhile, the Turkish Patent Institute was established in 1994 and began operations. Subsequently, in 2017, Industrial Property Law was enacted, and the foundations of patent law in Türkiye were strengthened. Today, Türkiye continues its patent-related activities in light of Industrial Property Law and international agreements to which it is a party.

In Türkiye, the necessary conditions for an invention to be granted a patent by the Turkish Patent and Trademark Office are given in Article 82/1 of the Industrial Property Law: “For inventions in every area of technology, a patent is granted under the conditions of being new, including an inventive step, and being adaptable to the industry.” Meaning, according to Article 82/1 of Industrial Property Law, a patent cannot be granted to an invention that does not meet the conditions of being new, including an inventive step, and being applicable to the industry.

1. Requirement of Novelty: An invention is considered new if it is not part of the state of the art. (Article 83/1 of Industrial Property Law). According to Article 7/2 of the repealed Decree-Law No. 551 on the Protection of Patent Rights, for an invention not to be considered state of the art, there must be no publicly accessible written or oral disclosure, use, or any other information about the invention anywhere in the world before the application date.
2. Requirement of Inventive Step: When the state of the art is taken into account, an invention is considered to involve an inventive step if it is not obvious to a person skilled in the related technical field. (Article 83/4 of Industrial Property Law).
3. Requirement of Industrial Applicability: An invention is considered applicable to the industry if it can be used or produced in any field of industry, including agriculture. (Article 83/6 of Industrial Property Law).

Rights of the Patent Owner:

1. Right to Monopolize
2. Right to Grant Licensing
3. Right to File an Infringement Lawsuit
4. Right to File a Compensation Suit

How to Obtain a Patent?

Inventors who want to obtain patent rights must apply for a patent. In Türkiye, patent rights are granted by the Turkish Patent and Trademark Office. To apply for a patent, all the documents listed below must be completed in full, and after that, these documents must be sent to the Turkish Patent and Trademark Office in file form. After the documents are submitted, the Turkish Patent and Trademark Office begins examining the inventor’s application.

According to Article 90 of Industrial Property Law, the necessary documents for a patent application are as follows:

1. Application form
2. Description of the invention
3. Claims
4. Drawings referenced in claims or descriptions
5. Abstract
6. Proof of payment of the application fee

After the examination is complete, the Turkish Patent and Trademark Office prepares a report about the application. If the application and the invention are deemed suitable according to the Industrial Property Law, the applicant qualifies for the patent. This decision and the patent are published in the bulletin. Within the six-month period after the decision is published in the bulletin, it is possible to file a patent opposition for patent applications that do not meet the requirements for a patent or that violate other existing patent rights. If no opposition is made within the six months, no further objections can be made. The bulletin is a publication used to announce information regarding the patent registry, and it is published by the Turkish Patent and Trademark Office. The bulletin includes information about patent applications, accepted registrations, rejected decisions, and objection processes. For third parties to submit their objections about a patent, the bulletin is a crucial publication that must be followed.

Additionally, Article 109/1 of Industrial Property Law states that “The right to request a patent belongs to the inventor or their successors, and the transfer of this right to others is possible.” As can be understood from the article, the patent right is a transferable right. The owner of the patent right may transfer the right to a real person or an organization. The patent holder has the option to transfer the patent right either completely or partially. The transfer is carried out through a written agreement between the transferor and the transferee. The validity of transfer agreements depends only on their being notarized (Article 148/4 of Industrial Property Law). The transfer agreement must be registered in the patent record. Otherwise, transfer processes do not apply to third parties. Upon completion of the transfer process, the transferor’s rights regarding the patent end completely or partially.

If an invention is produced, used, sold, multiplied, or imitated without the permission of the patent holder, patent infringement occurs. The plaintiff has the right to choose the competent court in infringement cases. The court of the defendant’s place of residence, the court where the infringement occurred, or the court where the effects of the infringement are observed can be competent. The responsible court for these cases is the Intellectual and Industrial Rights Court. In Türkiye, Intellectual and Industrial Rights Courts are located in Istanbul, Ankara, and Izmir provinces. In provinces that do not have an Intellectual and Industrial Rights Court, the Civil Court of First Instance or the Commercial Court of First Instance is responsible.

Available Legal Remedies for Patent Holders in Cases of Infringement:

1. Lawsuit for Determination of Infringement
2. Lawsuit for Prevention of Infringement
3. Lawsuit for Suspension of Infringement
4. Lawsuit for Compensation of Material and Non-Material Damages Caused by the Infringement
5. Lawsuit for Confiscation of Infringing Products, Modification of Their Form, or Destruction
6. Precautionary Measures

Expiration of Patent Rights:

According to Article 140/1 of the Industrial Property Law, patent rights expire under the following conditions:

1. Expiration of the protection period
2. The patent holder abandoning their patent rights
3. Annual fees not being paid within the period specified in Article 101

Article 140/2 of Industrial Property Law states that “The Institution publishes in the Bulletin that the patent rights have expired. The subject of the expired patent becomes public property from the moment the reason for expiration occurs.”

Up to this point in the article, the process from acquiring a patent to the expiration of patent rights has been outlined in general terms. In the remaining sections, information regarding one specific type of patent, pharmaceutical patents, will be provided.

Pharmaceutical Patent: A patent right that allows only the patent holder to use and commercially exploit a medicine that is new, has an inventive step, and applicable to the industry for 20 years from the date of application.

Historical Development of Pharmaceutical Patent in Türkiye:

Patent Law, which came into force in 1897 and remained in force until 1995, excluded the patent rights of medicine regarding human and animal health. Signed in 1994 and became official on January 1 in 1995, TRIPS Agreement, is one of the founding agreements of World Trade Organizations which Türkiye is a part of. As a result of this agreement, countries that previously did not gave patents to medicine have been obliged to examine the patent applications. This agreement has ensured the examination of all the pharmaceutical patent applications after January 1, 1995. Even though patent applications were taken after January 1, 1995, patent protection period, in practice, started after January 1, 1999. Patent applications between these dates were kept in suspense (KILIÇ, 2018).

Benefits of Pharmaceutical Patents to Patent Holder:

1. Monopolization
2. Generating Income
3. Ensuring Legal Protection
4. Contributing to Public Health
5. Pricing and Market Control

As mentioned above, patent grants pharmaceutical monopoly rights to patent holder. During the duration of the patent, production and sale of the medicine can only be carried out with the permission of patent holder. However, under the compulsory license provisions regulated by the Industrial Property Law, other pharmaceutical companies can be allowed to produce the drug during the patent duration in the cases of national security or public health. In conclusion, for compulsory license provision, content of the patent holder is not required.

It is also necessary to add that, even though it is accepted that pharmaceutical patent provides a protection for 20 years after the application date, a patented molecule takes around 10 to 15 years to complete all the necessary phases to be released, and consequently, a patent can protect the said medicine for only 5-10 years.

However, it is possible to extend this limited protection period of the pharmaceutical patent by obtaining a supplementary protection certificate. Burcu Özcan Büyüktanır states that “With supplementary protection certificate (SPC), expiring patent protecting period can be extended. Supplementary protection certificate is not regulated in our country. A patent holder can acquire a supplementary protection certificate regulated in European Patent Convention and can maintain its monopoly right on their invention.”  (BÜYÜKTANIR, 2012)

Types of Pharmaceutical Patents:

Pharmaceutical patents split into 4 different branches:

1. Product Patents
2. Formulation Patents
3. Indication Patents
4. Process Patents

Data Protection and Data Exclusivity:

One of the most important periods of pharmaceutical industry is the research and development process. The term “data” expresses the findings and information pharmaceutical manufacturer presents to regulatory authorities to acquire a license. Data protection and data exclusivity terms indicates the rights the person who produced the data have over that data (HUYSAL, 2009).

Data Protection: This term is regulated in the Article 39/3 of TRIPS. It states that “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.” This provision is designed to protect the data given to regulatory authorities by pharmaceutical manufacturers from being used for commercial purposes. Additionally, it prevents regulatory authorities to leaking this data to others (HUYSAL, 2009).

Data exclusivity: Patent right does not grant marketability to the product. A product is not marketable until it is registered by the authorities. Data exclusivity is the right that prevents another pharmaceutical manufacturer from referencing the test and clinical data submitted to regulatory authority by drug manufacturer when applying for a license of the same product. In Türkiye, data exclusivity prevents another drug manufacturer to apply for a license based on the identical data for 6 years after the first license application (HUYSAL, 2009).

Evaluation of Pharmaceutical Patent with regard to Individuals’ Right to Health and Public Interest:

Limitation to drugs that is required by individuals for survival is seen as a problem around the globe. Even though one of the United Nations Sustainable Development Goals is “ensuring access to safe, effective, high quality and affordable essential medicines and vaccines”, it is observed that approximately 2 billion people worldwide lack access to medicine. Although right to access medicine is a fundamental right for human health, many people living in underdeveloped and developing countries face this problem. Patents acquired by pharmaceutical companies to protect their own rights is one of the main factors limiting individuals’ access to medicines. Pharmaceutical patents provide the authority to pharmaceutical companies to price the medicine they produced the way they want. Because of this, a conflict occurs between interests of medicine companies under patent rights and interest of the public. Pharmaceutical companies evaluate the topic from an economic perspective and aims to generate a high income through drugs. However, public interest defends that the access to medicine that is necessary for survival must be easier (KARATEPE KAYA & KAYA, 2022).

Compulsory License application can be used to establish balance between patent right and public interest, therefore with the right of individuals’ health. According to the Article 31 of TRIPS, the decision to apply a compulsory license should be made on a case basis for each situation. For example, if an extraordinary situation the entire world is facing, such as the COVID-19 epidemic, is on the question, compulsory license application may be implemented without the patent holder’s consent. For this application it is necessary to inform the patent holder in a reasonable time and a payment must be made in return. (KARATEPE KAYA & KAYA, 2022).

Another method that can be used to establish a balance between patent rights with public interest, and consequently, individuals’ right to health is drug companies renouncing their patent rights. For example, if vaccine companies had renounced their patent rights over the COVID-19 vaccines, obstacles over the access of these vaccines would have been largely disappeared. However, companies carrying out activities regarding the vaccine avoided voluntary waiver. Even though proposal regarding the waiver of patent rights for the vaccination rate to be increased rapidly was received positively by the World Trade Organisation, since countries such as Norway, Canada, Sweden, USA, Australia, Japan, and UK opposed this proposal, development regarding this subject is hindered (KARATEPE KAYA & KAYA, 2022).

This article consists of some basic information on patent rights and the patenting of pharmaceuticals.

For detailed information on the subject, you can contact us here.

You can get detailed information about our office’s work in the fields of Information Technology Law and Contracts Law from our website.

H. Melike YILMAZ

Uçar Law & Consultancy Office

References:

1. BÜYÜKTANIR, B. G. (2012). Türk Hukukunda İlaç Patentine Genel Bakış. Hacettepe Hukuk Fakültesi Dergisi, 76-88.
2. GÖKOVALI, U., & BOZKURT, K. (2006). FİKRİ VE SINAÎ MÜLKİYET HAKKI (FSMH) OLARAK PATENTLER: DÜNYA VE TÜRKİYE AÇISINDAN TARİHSEL BİR BAKIŞ. Muğla Üniversitesi Sosyal Bilimler Enstitüsü Dergisi, 136-146.
3. HUYSAL, A. S. (2009). İlaç Patenti. Yayımlanmamış Doktora Tezi. İstanbul: MARMARA ÜNİVERSİTESİ SOSYAL BİLİMLER ENSTİTÜSÜ.
4. KARATEPE KAYA, M., & KAYA, S. (2022). PANDEMİ AŞILARI VE İLAÇLARINDA PATENT KORUMASININ DEĞERLENDİRİLMESİ. Ticaret ve Fikri Mülkiyet Hukuku Dergisi (TFM), 143-166.
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