PROTECTION OF INNOVATION; INTELLECTUAL PROPERTY RIGHTS
Industrial Property Law 6769 that came into effect on 10 January 2017 marks an important development in increasing the competitiveness of investment environment in Turkey. The Industrial Property Right Law includes several clauses introduced within the European Patent Convention framework that ensure compatibility of national legislation with the European Patent Convention.
While several positive arrangements are brought with the law in several areas, regulations concerning “compulsory license” bear risks which might yield consequences that contradict the principles of predictability and the protection of patent owners’ rights.
In the framework of developing Intellectual Property Rights (IPR) in Turkey and identifying related issues, the 9th IPR Working Group meeting between EU and Turkey was held on 28 January 2020 in Ankara with the following agenda:
- Trade secrets
- Trademark
- Copyright
- Free Trade Agreement between Turkey and Singapore
- Issues related to IPR
- IP exhausting regime
AIFD, represented in the session allocated to industry sectors, brought up once more the issues regarding Regulatory Data Protection (RDP- data exclusivity) , ‘compulsory licensing’ and increasing the capacity and number of IPR courts, and pointed out areas of improvement in IPR.
In this meeting, AIFD and EFPIA presented a more comprehensive joint position than the previous years. At the meeting the EU representatives side mentioned a
report prepared by the European Commission on problems encountered in IPR protection and implementation in third countries; it is stated that Turkey is classified in the second category (out of 3 categories) together with India, Indonesia and Russia. It was also stated that the countries in the 2nd category have the right to benefit from the IPR technical assistance provided by the EU.
A workshop to update and revise the 2015-2018 Intellectual Property Strategy Document to cover the following five years was organized by the Turkish Patent Institute on 24 January 2019. We had attended this workshop to discuss the latest developments in IPR in the World and Turkey, and took part in the preparation of the new Strategy Document.
We observe that the public authority includes in all public policy and strategy documents the importance of R&D, and specially IPR has been well recognized in the Industry and Technology Strategy Document for 2019-2023.
Data Exclusivity (RDP-Regulatory Data Protection)
In Turkey data exclusivity or RDP (Regulatory Data Protection), is regulated by the Regulation on Registration of Medicinal Products for Human Use. The Regulation stipulates that RDP period is six years starting on the first registration date in any country in EU Customs Union area. However, starting the RDP period on the first registration date in EU Customs Union area does not provide sufficient protection due to the long licensing procedures in Turkey, it is clear that the 6 (six) year protection given in the Regulation is not implemented in practice.
As AIFD we expect the data exclusivity period to be revised to start from the registration date in Turkey. We also believe that the data exclusivity period should be implemented as eight (8) years in concordance with EU acquis (2001/83/EC). In the same line, it is important to grant 2 (two) years market exclusivity for products that benefit from data exclusivity.
Moreover, in Turkey data exclusivity period for products under patent protection is limited by the patent duration. This is not de jure a fair approach as rights based on patent protection are distinct from rights obtained by data exclusivity. While patents protect the invention as an intellectual property, data exclusivity protects the study and test results obtained at clinical trials. In other words, since data-related rights are not covered by patent rights, it is contradictory to the logic of the Intellectual Property Law to associate clinical study and test data with patent rights. Therefore, it is essential that the patent right and the data exclusivity right be protected independently of each other and for separate durations, and that the duration of protection of one shall not limit that of the other.
No change regarding data exclusivity has been observed in the updated draft Regulation on the Registration of Medicinal Products for Human Use. The new draft, however, should be considered as an opportunity to end the incompatibility with international agreements regarding data exclusivity.
The effective protection of intellectual property rights is the most important prerequisite to incentivize development of innovative medicines. The current implementation of data exclusivity in Turkey unfortunately does not provide much needed effective protection.
On the other hand, another unfair practice breaching data exclusivity is the acceptance of abridged applications within data exclusivity timeframe and that licensing applications are permitted to be pursued.
The 8+2+1 rule for data exclusivity in EU regulation includes the eight years data exclusivity period during which no abridged applications shall be permitted, followed by a two years market exclusivity period in which abridged applications are accepted but related products are not allowed to be supplied to the market.
The protection introduced in the Registration Regulation concerns data exclusivity and it stipulates that during the six years timeframe, no reference is made to the original product data and that no abridged applications accepted by the Agency. We believe that this approach upholds the vision of the Turkish Medicines and Medical Devices Agency “to become one of the recognised reference authorities worldwide.”
A new administrative practice, clearly not compatible with the Regulation, introduced at the beginning of 2020 on the issue of data exclusivity further reduced the limited protection. Previously member companies were able to seek their rights in courts by obtaining information from the TITCK about the abbreviated applications submitted to the Agency that in violation of the legislation were referring to the exclusive data under the scope of data exclusivity and protection. However, with the implementation of the new practice, member companies were unable to obtain from the Agency the necessary information that would allow them to initiate legal processes. Thus a method used to stop an illegal process was no longer available. As the result of the intensive efforts of AIFD, this practice is withdrawn, our member companies can now access the necessary information as before that will allow them to seek their legal rights.
