Turkey. Intellectual Property Protections on the Pharmaceutical Market

Effective Patent Enforcement

Turkey does not provide an effective mechanism for resolving patent infringement matters. The Decree Law, currently in force, has some protective terms in favor of the patent holder; however in practice the IP Courts interpretation is quite narrow. For example, while the purpose of the Decree Law was to bring Turkish patent law into consistency with the European Patent Convention (EPC) and the Patent Cooperation Treaty (PCT), the manner in which Turkey‘s IP Courts interpret the Decree defeat that intent.

Draft Law, numbered 1/756 proposes amendments on the Decree Law concerning Protection of Patent Rights (―Patent Decree‖). While the proposed Bill would rectify a number of the industry‘s concerns regarding the manner in which Turkey‘s IP Courts interpret the existing Patent Decree, other provisions raise concerns under the Turkish Constitution, the European Human Rights Convention, EPC, PCT and TRIPS. For example, the proposed decrease on the upper limit of the judicial fine for the crime of infringement makes infringement more attractive by reducing the deterrent. Similarly, the proposed deletion of the provision which gives the applicant for a patent some rights to bring proceedings (particularly important for Turkish national route patents where there is a pre-grant opposition period that can be used abusively absent this provision) would weaken the existing level of patent protection. PhRMA and its member companies will continue to monitor the Bill as it moves through Parliament, likely later this year.

Regulatory Data Protection

In 2005, the Turkish Government took positive steps toward establishing protection for the commercially valuable regulatory data generated by innovative pharmaceutical companies, and now provides regulatory data protection for a period of six years for products registered in the EU, limited by the patent protection period of the product. Regulatory data protection is an independent and separate form of intellectual property protection that should not be limited to the period of patent protection.

A significant concern for the innovative industry is that the period of regulatory data protection currently begins on the first date of marketing authorization in any country of the European Customs Union. Considering the extended regulatory approval times, with an average of 934 days63 in Turkey, and with the delays stemming from the GMP certification approval period, current estimates are that it could take 4-5 years to register and reimburse a new medicine in Turkey. Under these adverse circumstances, new products will receive, in practice, no more than one to two years of protection, undermining incentives needed for innovators to undertake risky and expensive research. Regulatory approvals need to be granted by MOH within 210 days; if not, the six year period of regulatory data protection should commence when local regulatory approval for the product is obtained in Turkey.

Another concern of the innovative pharmaceutical industry is that the legislation governing regulatory data protection has been changed by the Regulation to Amend the Registration Regulation of Medicinal Products for Human Use.64 The change that has been introduced is incompatible with EU standards in that it eliminates regulatory data protection for combination products, unless the combination product introduces a new indication. Innovative companies invest considerable amounts of time and effort to develop products that provide increased efficacy and safety, as well as new indications, from new combinations of separate molecules. Such products are developed to benefit patients and should be eligible for data protection.

Source: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2014