Introduction to Turkish Patent Law
Turkey's patent law is governed by the Code of Industrial Property (Law No. 6769, “CIP”), which was adopted in line with the EU acquis as part of Turkey’s accession process to the EU. This law integrates all relevant legislation into a single framework, regulating patent rights comprehensively[1][3].
Types of Pharmaceutical Patents
In Turkey, pharmaceutical patents are primarily divided into two categories:
Product Patents
These patents cover the pharmaceutical product itself, ensuring protection for the drug's composition and formulation.
Process Patents
These patents protect the methods and processes used to manufacture the pharmaceutical product[1][3].
Conditions for Patentability
For a biopharmaceutical patent to be granted in Turkey, it must meet the basic patent criteria:
- Novelty: The invention must be new and not previously disclosed.
- Inventive Step: The invention must involve an inventive step that is not obvious to a person skilled in the art.
- Industrial Applicability: The invention must be capable of industrial application[1][3].
Data Exclusivity
Data exclusivity is a critical form of IP protection in the pharmaceutical sector. In Turkey, this mechanism prevents third parties from using inventor-generated clinical data for six years, starting from the date of the marketing authorization for a human medicinal product within the Turkish-EU Customs Union area. This is regulated under Article 9(a)(3) of the Regulation on Licensing of Medicinal Products for Human Use[1][3].
Bolar Exemption
The Bolar Exemption allows generic pharmaceutical companies to complete the technical processes required for regulatory approvals before the expiration of the patent term. This exemption enables generic companies to file marketing authorization applications using the experimental data produced by the patentee, thereby reducing costs and facilitating the launch of generic drugs once the IP protection expires[1][3].
European Patent Convention (EPC) and Validation in Turkey
Turkey is a party to the European Patent Convention (EPC), which allows applicants to obtain patent protection in multiple European countries through a single application. A patent granted by the European Patent Office (EPO) can be validated in Turkey by submitting the Turkish translation of the patent to the Turkish Patent and Trademark Office[5].
Second Medical Use Patents
Second medical use patents, which involve new uses for existing drugs, are patentable in Turkey if they meet the conditions of novelty, inventive step, and industrial applicability. These patents are granted by the EPO and validated by the Turkish Patent and Trademark Office. The Turkish IP Code is silent on the patentability of second medical uses, but the Supreme Court has ruled that such patents are valid if drafted in the Swiss-type claim format[5].
Enforceability of Patents
Infringement and Litigation
Patent infringement in Turkey can be complex, especially for second medical use patents. The "skinny label" practice, where generic companies carve out the patent-protected use from the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) of the generic drug, is not sufficient to prevent infringement. Parties must provide evidence to the court to prove infringement, often relying on precedents from European courts[5].
Role of EPO and UPC Decisions
Turkish courts often wait for EPO decisions to avoid unnecessary judicial burdens. If the EPO revokes a patent, the Turkish court will consider the case devoid of essence without further examination. However, if the EPO maintains the patent, the Turkish court will proceed with national examination and decide on the validity or invalidity of the Turkish part of the patent. Decisions by the Unified Patent Court (UPC) can also influence Turkish proceedings, especially if they are rendered before the EPO's decision[2].
Scope of Claims
The scope of claims for biopharmaceutical patents in Turkey is defined by the CIP and aligned with EPC regulations. Patents can cover both the product and the process, and second medical use claims are valid if they meet the necessary patentability criteria. The claims must be clear, concise, and supported by the description in the patent application[1][3].
Compulsory Licensing
The Turkish IP Code provides for compulsory licensing provisions, particularly in cases of public interest, national defense, or public health. The Turkish Presidency can grant a compulsory license upon a proposal from the Ministry of National Defense or the Ministry of Health. This mechanism ensures that essential medicines are available even if they are under patent protection[5].
Statistics and Industry Impact
The Turkish life sciences industry is expected to continue growing, driven by increasing demand for healthcare services, government support, and technological advancements. This growth presents significant opportunities for both domestic and international companies, making Turkey a key player in the global life sciences market. For instance, the non-existence of patent term extensions in Turkey is preferred by local companies, as it promotes the development of generic and biosimilar products[5].
Key Takeaways
- Patent Types: Product and process patents are the primary types of pharmaceutical patents in Turkey.
- Patentability Criteria: Patents must meet novelty, inventive step, and industrial applicability criteria.
- Data Exclusivity: A six-year data exclusivity period protects clinical data from being used by third parties.
- Bolar Exemption: Allows generic companies to prepare for market entry before patent expiration.
- EPC and Validation: Patents granted by the EPO can be validated in Turkey.
- Second Medical Use Patents: Valid if they meet EPC criteria and are drafted in the Swiss-type claim format.
- Enforceability: Infringement cases require robust evidence, and EPO/UPC decisions significantly influence Turkish court rulings.
- Compulsory Licensing: Available in cases of public interest, national defense, or public health.
FAQs
Q: What types of pharmaceutical patents are recognized in Turkey?
A: Turkey recognizes product patents and process patents for pharmaceuticals[1].
Q: How does data exclusivity work in Turkey?
A: Data exclusivity prevents third parties from using clinical data for six years from the date of marketing authorization within the Turkish-EU Customs Union area[1][3].
Q: Can second medical use patents be granted in Turkey?
A: Yes, second medical use patents are valid in Turkey if they meet the EPC criteria and are drafted in the Swiss-type claim format[5].
Q: How do EPO and UPC decisions affect Turkish patent litigation?
A: Turkish courts often wait for EPO decisions and may be influenced by UPC decisions, especially if they are rendered before the EPO's decision[2].
Q: Under what conditions can compulsory licensing be granted in Turkey?
A: Compulsory licensing can be granted in cases of public interest, national defense, or public health, upon a proposal from the relevant ministries[5].
Sources
- Gurulkan Çakır, "Pharmaceutical Patents under Turkish Law," December 2020.
- Gün + Partners, "PATENT LAW IN TURKEY," 2023.
- Gurulkan Çakır, "Pharmaceutical Patents under Turkish Law," December 2020.
- TURKLEGAL, "Patents."
- JUVE Patent, "LIFESCIENCES PATENT MATTERS IN TURKIYE," October 30, 2024.
