Lifesciences industry
The life sciences industry in Turkey has been experiencing significant growth and development in recent years, and this trend is expected to continue into 2025. The sector covers pharmaceuticals, biotechnology, medical devices, and healthcare services, and plays a crucial role in the country’s economy and public health system.
According to the latest statistics, the Turkish life sciences industry is projected to grow at a compound annual growth rate (CAGR) of around 6% from 2021 to 2024. This growth is driven by various factors, including the increasing demand for healthcare services due to the country’s growing and aging population, as well as the government’s continued investment in the healthcare sector.
One of the key drivers of growth in the Turkish life sciences industry is the pharmaceutical sector. Turkey has a large and dynamic pharmaceutical market, with a strong domestic manufacturing base and a growing number of domestic and international pharmaceutical companies operating in the country. In 2020, the Turkish pharmaceutical market was valued at around $16 billion, making it one of the largest in the region.
The biotechnology sector is also experiencing growth in Turkey, with a focus on research and development in areas such as genomics, personalized medicine, and bioinformatics. The government has been supporting the development of the biotechnology industry through various incentives and initiatives, aiming to position Turkey as a hub for biotech innovation and entrepreneurship.
In the medical devices sector, Turkey has a strong manufacturing base and is a leading exporter of medical devices to markets around the world. The sector is expected to benefit from technological advancements and an increasing focus on healthcare infrastructure development in the country.
Looking ahead to 2024, the Turkish life sciences industry is expected to continue its growth trajectory, driven by factors such as the increasing demand for healthcare services, government support for the sector, and technological advancements. This growth presents opportunities for both domestic and international companies operating in the sector, making Turkey a key player in the global life sciences market.
International Agreements
European Patent Convention (EPC): Türkiye is a party to the EPC which allows applicants to obtain patent protection in multiple European countries through a single application. A patent granted by the EPO can be validated in Türkiye by submitting the Turkish translation of the patent to the Turkish Patent and Trademark Office.
Implementing Regulations to the Convention on the Grant of European Patents: This Regulation serves as both as the EPO rules applicable to applications before the EPC and as a source for the implementation and interpretation of the EPC.
Patent Cooperation Treaty (PCT): Türkiye is a party to the PCT. The PCT is an international treaty that simplifies the process of filing patent applications in multiple countries. The PCT application does not grant a patent but provides a streamlined process for seeking patent protection in multiple countries. By filing a patent application before the WIPO, it is facilitated to obtain patent registration in the member states by entering the national stage in the selected countries.
Paris Convention: Türkiye is a party to the Paris Convention. The convention establishes certain minimum standards for the protection of intellectual property rights among member countries including national treatment and priority rights.
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS): Türkiye is a party to the TRIPS. TRIPS sets out minimum standards for the protection of various forms of intellectual property, including patents. TRIPS requires member countries to provide effective protection and enforcement of patents and regulates topics such as patentability, the rights of patent holders, exceptions to patent protection, and compulsory license.
Strasbourg Agreement Concerning the International Patent Classification (IPC): Türkiye is a party to the Strasbourg Agreement. The Strasbourg Agreement relates to the international classification of patents according to the relevant technological field.
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure: Türkiye is a party to the Budapest Treaty. Administered by the World Intellectual Property Organization (WIPO), the Budapest Treaty establishes a framework for the global acknowledgment of deposits of microorganisms intended for patent procedures. This Treaty concerns the international deposit of microorganisms and ensures that patents related to microorganisms are sufficiently disclosed by way of depositing microorganisms.
International Union for the Protection of New Varieties of Plants (UPOV): Türkiye is a member of the UPOV. It is an international treaty designed to protect the intellectual property rights of plant breeders by granting them exclusive rights over the new plant varieties they develop.
Applicable Laws and Regulations
Industrial Property Law: The Industrial Property Code 6769 (IP Code) on 10 January 2017, which is set to profoundly change IP in Turkey as it affects the legislative, administrative and professional components thereof.
The IP Code made wide-ranging structural changes at:
the legislative level – regarding the establishment, prosecution, maintenance and enforcement of IP rights;
the administrative level – regarding the administrative structure and function of the Patent and Trademark Office (previously known as the Turkish Patent Institute);
the professional level – with new rules regarding the organisation and activities of patent and trademark attorneys, especially from a disciplinary standpoint; and
the judiciary level – concerning the Patent and Trademark Office’s judicial competences, such as the cancellation of trademark registrations on the ground of non-use.
Regulation on the Implementation of the Industrial Property Law: This regulation provides additional details and procedures related to the implementation and interpretation of the Industrial Property Law, including the rules for patent litigation.
Regulation on the Application of the European Patent Convention in Türkiye: This regulation aims to specify the principles and procedures for the implementation of the European Patent Convention in Türkiye, encompassing the relevant principles, rules, and conditions on the subject.
Regulation on Employee Inventions, Inventions Realised in Higher Education Institutions and Inventions Arising from Government-Supported Projects: As the name suggests, this regulation regulates various aspects of inventions in these contexts, with specific provisions for employee inventions, university inventions, and inventions stemming from public funding.
Judicial, Regulatory and Administrative Bodies
The court system in Turkiye for the enforcement of IP rights includes specialized courts and procedures.
The specialized courts for IP enforcement in Turkiye are the Intellectual and Industrial Property Rights Civil Courts. These courts have exclusive jurisdiction over civil cases relating to patents, trademarks, industrial designs, geographical indications, and unfair competition. They are located in Istanbul, Ankara, and Izmir, and have the authority to hear and decide cases related to IP rights and infringements, as well as to issue preliminary and permanent injunctions and orders for the seizure and destruction of infringing goods.
Disputes are first brought before the first instance courts located in almost every city and their counties in Turkey. Decisions of these local courts can later be appealed before the Regional Courts of Appeal. An appeal is heard by a panel of three non-technical judges. The outcome from the Regional Court of Appeal may either be to uphold the first instance decision or to overturn the first instance decision and to render a new decision. The Regional Court of Appeal may hold hearings during the appeal and refer the file to a new panel of experts, if it is thought that the matter needs further examination.
Decisions of the Regional Court of Appeal are appealed to the Supreme Court. The Supreme Court has a special chamber for IP matters and constitutes five non-technical judges. A decision approved by the Supreme Court is the final decision and cannot be appealed. If a decision is reversed by the Supreme Court, the case file is referred to the Court of First Instance or the Regional Court of Appeal (whichever decision is reversed).
Turkey has several administrative bodies and institutions involved in regulating, overseeing, and promoting life sciences, including biotechnology, agriculture, healthcare, and pharmaceuticals. These bodies cover areas such as research, regulation, innovation, and industry development. Here are some key administrative bodies related to life sciences in Turkey:
Turkish Patent and Trademark Office (TÜRKPATENT): TÜRKPATENT is the national office.
Turkish Medicines and Medical Devices Agency (TITCK): TITCK is an institution under the Ministry of Health. TITCK Regulates the pharmaceutical and medical device sectors, including licensing, clinical trials, and market authorization.
The Turkish Medicines and Medical Devices Agency TITCK is an entity affiliated with the Ministry of Health (MoH) and provides regulatory services as well as supervisory and guidance for
- pharmaceuticals,
- medical devices,
- traditional herbal products,
- biocidal products,
- homeopathic products,
- medical products for supportive and advanced treatment and
- cosmetic products.
The TITCK determines the rules and standards regarding the licensing, production, storage, sale, import, export, placing on the market, distribution, putting into service, collection, and use of the products in Turkiye and permits, licenses, inspects and, when necessary, imposes sanctions on public and private legal entities and real persons to carry out these activities.
General Directorate of Food and Control (GDFC): GDFC is an institution under the Ministry of Agriculture and Forestry. It plays a pivotal role in ensuring food safety, animal health, plant health, and regulating agricultural products. It is responsible for enforcing regulations and standards that safeguard the quality of food and agricultural products, protect public health, and support sustainable agricultural practices.
Scientific and Technological Research Council of Turkey (TUBITAK): TUBITAK is the primary government agency for funding and supporting scientific research and technological development in various fields, including life sciences. It promotes research projects, innovation, and collaboration between universities and industry.
Patentable Inventions
According to Art. 82(1) of IP Code, patents are granted to inventions in all fields of technology, provided that they are new, inventive and industrially applicable. However, some exclusions exist either for not being of invention quality or for being subject matter that is considered to be unpatentable.
The exclusions for not being an invention are defined in Art. 82(2) of IP Code as follows;
a) Discoveries, scientific theories and mathematical methods.
b) Plans, rules or methods with regard to mental activities, business activities or games.
c) Computer programs.
d) Aesthetic works, literary and artistic works as well as scientific works.
e) Presentation of information.
Regarding life science, the more relevant of these exclusions is the discoveries. Finding a product which occurs in nature or finding a new property of the product is considered to be a mere discovery and it is not patentable according to the legislation. However, if the invention is about the practical use of that discovery, it is possible to get a patent. For example, someone cannot patent the discovery of gravity or the chemical composition of a naturally occurring mineral. However, if someone discovers a new and useful method of that naturally occurring mineral, they may be able to patent that method.
The exclusions for being unpatentable subject matter are also defined in Art. 82(2) of IP Code, which are;
a) Inventions against public order or morality.
b) Plant or animal varieties or essentially biological processes for the production of plants or animals, excluding microbiological processes or the products thereof;
c) All therapeutic methods including diagnostic methods and surgical methods to be applied on human or animal body.
d) The human body including the human body at the various stages of its formation and development and the simple discovery of one of its elements, including the sequence or partial sequence of a gene.
e) Processes for cloning human beings; processes for modifying the germ line genetic identity of human beings; uses of human embryos for industrial or commercial purposes; processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.
Accordingly, immoral inventions or inventions against public order cannot be patentable. What constitutes an “immoral” invention can be subjective. Especially, the immorality exclusion is linked with the excluded biotechnological inventions concerning the modification of the genetic identity of human or animal. Herein, the legislation is to prevent the suffering of humans or animals. Methods for human cloning or genetic modification for unethical purposes are accepted as inventions that violate ethical norms or human rights.
Other examples of inventions that may be deemed immoral or against public order can include inventions that are harmful to public safety, such as methods for producing illegal drugs or weapons of mass destruction. Additionally, inventions that promote illegal activities or infringe on the rights of others, such as methods for committing fraud or hacking into computer systems cannot be patentable.
Patentability of second (and further) medical use claims
Patentability of second medical use patents have been debated in Turkey for years which eventually led to the Supreme Court case law on the matter.
- Patentability of European patents with filing dates before 12th December 2007
The 2021 decision of the Turkish Civil General Assembly of the Supreme Court (the case was related to the European patent which dated 2001) states that the second medical use claims could be patentable if drafted in Swiss-type claim format and whether other patentability conditions (novelty, inventive step, industrial applicability) are met should be interpreted within the scope of the EPC (1973) and the EPO case law.
- Patentability of European patents having filing dates after 12th December 2007
According to Article 54/ (4) and (5) the second medical use claims are explicitly protected in the EPC (2000) provided that said use is novel and inventive which avoided the interpretation concerning the protection of the second medical use patents.
Second medical use patents granted by the EPO are indeed validated in Turkey and granted by the Turkish Patent and Trademark Office without an interruption.
- Patentability of the national patents
The Turkish IP Code dated 2017 is silent on patentability of second medical uses. Articles 54/ (4) or (5) of the EPC 2000 was not incorporated in the Turkish IP Code.
The above-mentioned decision of the Civil General Assembly of the Supreme Court states that “If the “novelty” criterion is interpreted narrowly in a national patent for a second medical use, while the European patent for the second medical use continues to exist validly in Turkey, a situation may arise where the national patent for the second medical use, which is made to have effect only in Turkey, is not protected in Turkey. In addition, the fact that a European patent for a second medical use will be protected in Turkey, while a national invention will not, will lead to legal insecurity.”
Enforcement of second (and further) medical use patents
Second medical use patents are enforceable under the Turkish law.
According to the IP Code, every unauthorized production, sale, distribution, commercialization in any other way, import, storage, use, and offering of a patented second medical use constitute patent infringement.
There are some particularities as to the evidencing of the infringement of second medical use patents. The evidencing issue firstly lies with skinny labelling practice. Abridged application for generic pharmaceuticals allows generic pharmaceutical companies to apply for marketing authorization without submitting the results of toxicological and pharmacological tests and clinical studies if data exclusivity period for reference drug expired. In abbreviated applications, generic companies carve out the patent-protected use from the SmPC and PIL of the generic drug whereby the generic drug is approved with a skinny label. In Türkiye, the medical practice is to prescribe the drug with its commercial name and not with active ingredient. However, the fact that doctors and pharmacists can still prescribe/dispense drugs for the patented use has caused the skinny label practice alone to be insufficient in terms of preventing infringement of second medical use patents.
The parties can prove whether there is patent infringement by providing the court with the following evidence where there is skinny label based on precedent European courts’ decisions:
- whether there is sufficient extent of use of the generic drug for the patented use,
- whether the generic company exploits circumstances that lead to the drug’s use for the patented application,
- whether the generic company induces the use of the generic drug such as promoting the generic drug to doctors for patented indication,
- whether the generic company has proactive behaviour to prevent infringement.
In contrast to first medical use patents, which are infringed by the generic company as soon as the product is manufactured, second medical use is not carried out by the generic company directly when there is skinny labelling. As per the general rules of law, the objective liability of generic company shall arise in these cases. Where the accused generic company cannot demonstrate that it had taken precautions to avoid patent infringement, such a generic company should be held liable for direct patent infringement. Because such a generic company should have known that its generic drug would have been prescribed or distributed for the patented use.
If the evidence does not lead the court to direct infringement, the indirect infringement could be argued. As per the Turkish IP Code, indirect infringement occurs when a party supplies unauthorized parties with the means which are related to an essential part of the invention, and which make it possible implementation of the invention. The supplier must know, or it must be sufficiently obvious from the circumstances, that such means are suitable and intended for the implementation of the invention.
Disclosure of information which otherwise would be prejudicial to the grant of a patent exceptions
According to Art. 84 of IP Code, in the circumstances hereunder cited, disclosure of information which otherwise would be prejudicial to the grant of a patent or utility model to an invention shall not affect the grant of patent or utility model to that invention where the information was disclosed during the 12 months preceding the date of filing or, where priority is claimed, the date of priority of the application:
a) By the inventor.
b) By an authority to which the patent application was filed and the information was contained;
1) in another application filed by the inventor which application should not have been disclosed by the respective office.
2) in an application filed without the knowledge or consent of the inventor by a third party which obtained the information directly or indirectly from the inventor.
c) By a third party which obtained the information directly or indirectly from the inventor.
Accordingly, Turkish legislation provides a grace period of 12 months. When the invention disclosed to the public under the circumstances mentioned, the applicant can still obtain a patent protection.
Article 85/3 of the Intellectual Property Code no. 6769 (“IP Code”) reads:
(3) The following acts shall remain outside the scope of rights conferred by a patent:
a) Acts devoid of any industrial or commercial purpose which are limited to private purposes
b) Acts involving a patented invention for experimental purposes.
c) Acts involving a patented invention for experimental purposes including the authorization of pharmaceuticals and the necessary tests and experiments for this.
d) Acts with regard to preparations of medicines in pharmacies involving no mass production and carried out solely in making up a prescription and acts related to the medicines thus prepared.
e) Use of the patented invention in the manufacture or operation of ships or spaceships or airplanes or land transportation vehicles of countries signatory of the Paris Convention or for satisfying the needs of these, provided that said vehicles happen to be, temporarily or accidentally, within the boundaries of the Republic of Turkey.
f) Acts with regard to the aircraft of a state stipulated by Article 27 of the International Convention for Civil Aviation ratified by Law No. 4749 dated 5/6/1945 to which the provisions of this present Article shall apply.
Experimental use and Bolar exemption
Acts involving a patented invention for experimental purposes (experimental use) and acts involving a patented invention for experimental purposes including the authorization of pharmaceuticals and the necessary tests and experiments (Bolar exemption) are outside the scope of rights conferred by a patent.
Article 85/3 (b) and (c) of the Intellectual Property Code no. 6769 (“IP Code”) reads:
“(3) The following acts shall remain outside the scope of:
…
b) Acts involving a patented invention for experimental purposes.
c) Acts involving a patented invention for experimental purposes including the authorization of pharmaceuticals and the necessary tests and experiments for this. …”
In practice it is notably observed that the Bolar exemption is interpreted broadly by the Turkish courts although it should have been interpreted strictly and narrowly according to the general interpretation “singularia non sunt extenda” principle.
Particularities of experimental use and Bolar exemption
- Commercial purpose Experiments performed on a patented invention shall not have any commercial purpose. The action that can be deemed as an experimental use does not have to be stripped of all commercial aims such as improving the patented subject matter. On the other hand, e.g. the sale of products obtained as a result of the experimental use of a patent are of commercial nature and should be considered patent infringement.
There are no court precedents that discuss the limits and scope of experimental use.
- Market authorization, pricing, reimbursement listing Before entering the market, a generic drug obtains market authorization, sales permission, and may enter reimbursement list. Applying to and obtaining market authorization are within the scope of the Bolar exemption. The IP Code and the courts’ practice are clear and consistent in this aspect.
Different approaches arise about the interpretation of sales permission and reimbursement listing.
It is obligatory to obtain a sales permission for a drug which will be put on the market for the first time. The process of sales permission includes pricing of the generic drug. Obtaining a price for the drug has a commercial purpose and aimed at the actual sale of the drug. Referring to the Article 85/3 (c) and its preamble, the purpose of the legislator is to allow third parties to conduct tests and experiments for obtaining marketing authorization. Therefore, obtaining sales permission could be interpreted as patent infringing act that extends beyond marketing authorization. On the other hand, if a generic company is only allowed to apply for and obtain sales permission after the expiration of a patent, then sales permission process would de facto prolong the protection of the patent which would mean shift of scales in favor of the patent holder unjustly.
According to the Regulation on Licensing of Medicinal Products for Human Use (“Regulation”), marketing authorization is defined as the examination and approval procedures carried out by the Turkish Medicines and Medical Devices Agency to put a human medicinal product on the market.
Entering to the reimbursement lists is not required to put the product on the market. Applying to reimbursement list is in the discretion of the generic company. Based on the above explanations and “authorization” definition in the Regulation, acts of applying to and/or entering reimbursement lists are not within the scope of the Bolar exemption. Therefore, any decision that declares entering to reimbursement list is not patent infringement would be the interpretation of the law broadly and against the will of the legislator.
- Assistance of third parties Any person/entity assisting a third party in the performance of experimental activity that is within the experimental use exemption or Bolar exemption should not be liable for patent infringement, even if there is a commercial purpose of such person/entity to the extent it can show that the patented product is supplied solely for an exempted act.
- Burden of proof in experimental use and Bolar exemptionIn both exemptions, the burden of proof lies on the party which puts forward such an exception.
Supplementary Protection Certificate (SPC)
Turkey, as not a member of the European Union, is one of the third countries in which SPC does not exist. In addition, Turkish law does not allow for the extension of patent protection. Therefore, the patent term generally expires in Turkey at the earliest possible date. As the pharmaceutical industry in Turkey is based on the generic products and newly biosimilar products, the non-existence of an extension is preferred from the Turkish companies.
Data Exclusivity
Data Exclusivity is regulated by Art. 9 of Regulation on Licensing of Medicinal Products for Human Use in Turkey.
Accordingly, the data exclusivity period is six years starting from the date on which the market authorization is first granted in any member states of EU Customs Union and in any case is limited with the patent protection term. The fact that the six-year period starts from the first market authorization is a regulation that shortens the six-year period. For example, if the drug is licensed in Germany (which is a member of the EU Customs Union) on 01.01.2018, the six-year period starts from 01.01.2018 regardless of the market authorization date in Turkey.
Data exclusivity is only applicable for new active ingredients or new indications. Data exclusivity can not be applied to further indications of a known substance.
Compulsory License
Article 129 mentions six grounds on the basis of which compulsory licenses may be requested and granted:
- if the patent is not put to use (Article 117 of the Implementing Regulation mentions that “market conditions” and “the circumstances/conditions beyond patentee’s control and will” shall be taken into consideration when assessing non-use),
- the existence of dependent patents indicated in Article 131,
- the public interest described in Article 132,
- other exportation of pharmaceutical products for addressing public health needs in other countries (This ground is introduced on the basis of the Protocol amending the TRIPs Agreement – Additional Art 31 bis) (New Ground)
- if a plant breeder cannot develop a new plant variety without infringing an existing patent; and similarly if a patentee cannot make use of its patent without infringing an existing plant breeders right (in which case the Law No. 5042 on Plant Varieties will be applied); (New Ground)
- acts of patentee resulting in a restriction, distortion or breach of competition rules (New Ground)
The IP Code has introduced a new body, the “Competition Board” alongside the courts when the ground for requesting “compulsory license” is the restriction, distortion or breach of competition rules. (Art. 129/2) The request for compulsory license is heard and decided by the courts or when the ground is the restriction, distortion or breach of competition rules by the Competition Board. The compulsory license based on the public ,interest is decided by the Turkish Presidency. Therefore, we may say that the there are 3 main bodies which are entitled to decide in respect of the compulsory licensing.
IP Code provides the possibility to implement the compulsory licensing provisions during the Covid-19 pandemic especially in the existence of Public Interest (Art 132) and the TRIPs Agreement (Additional Art 31bis) which is referred under Article 126/ç.
Compulsory license based on public interest. Article 132 of the IP Code clearly states that the Turkish Presidency (formerly the decision was rendered by Ministry of Council) is entitled to grant a compulsory license in cases ;
- where an invention plays an important role with respect to public health or national defense or;
- where the non-use of a patent or its insufficient use in terms of quality or quantity causes serious damage to the country’s economic or technical development.
In case where the patent is important for the national defense of public health the IP Code the Ministry of National Defense or the Ministry of Health to trigger a compulsory licensing by making a proposal to the Presidency. The Presidency in such case can decide for the compulsory licensing (133a) upon which the related Ministry can ask for a compulsory license. The Presidency is also entitled to order a conditional compulsory license to the patent holder if the use of the invention can sufficiently satisfy public interest through the use realized by the patent holder (133b).
Exclusivity and Sub-Licensing The compulsory license which is granted on grounds of public interest can be an exclusive license depending the circumstances. In case a compulsory license is granted, the licensee has no right to grant sub-licenses on or import the subject-matter of the patent. However, IP Code allows the subject-matter of the patent to be imported only when the licensee is explicitly authorized in the compulsory license granted on grounds of public interest. The IP Code requires such authorization to import to be issued on a temporary basis and limited to meeting the demand.
Determination of License Fee : The compulsory license can be granted under specific conditions by taking into consideration the term, fee and field of use. The economic value of the patent into consideration when determining the fee. The IP Code provides the possibility to ask for a license fee reduction should the patent holder violates the mutual trust and confidence.
TRIPS : As referred above, the IP Code does also contain a provision which refers to the most recent amendment of the TRIPS agreement namely to Article 31bis of the Agreement which was a continuation of the Doha Declarations.
By being a party to the amended version of the TRIPS and by referring to the same provision in the IP Code, Turkey is also entitled to grant compulsory license for the export of the pharmaceutical products for addressing public health needs in other countries.
The IP Code provides an additional specific provision for the determining the fees in case of 31bis compulsory license, by stating that, the economic value of the use in terms of the importer country shall be regarded by taking into consideration non-commercial and humane purposes.
How frequently is the compulsory licensing being used in Turkey? The compulsory licensing is a very rare mechanism used in the Turkish practice. So far to our knowledge there have been two disputes in this aspect. However, the fact that the IP Code has now extended the possibilities and have a broader wording to ask for compulsory licensing, it is expected to the increase the compulsory license disputes.
Prepared by Okan Çan, Oya Yalvaç, Muazzez Korutürk, Basak Yigiter
