Pharmaceutical Patents in Turkey
Adv. Dr. Cahit Suluk·
The Process of Incorporating Drugs under Patents
The first patent protection in Turkey was adopted during the Ottoman era under the Patent Law of 1879, this being the sixth patent law in the world. Inspired by the French Patent Law of 1844, the Law excluded pharmaceutical products from patent protection under article 3. The Ottoman Law was abolished by the Decree-Law No. 551 on Patents, in force as of 1995.
Important reforms in Turkey have almost always been introduced as a result of external influences. This tradition has also been followed with respect to intellectual property in general and protection for pharmaceutical patents in particular. Owing to Turkey having become a party to TRIPS, on the one hand, and having signed the customs union with the EU on the other, pharmaceuticals have been included under patents since 1 January 1999. However, as a developing country, Turkey was granted a transition period under TRIPS until 1.1.2000 in order to bring its drug manufacturing methods up to date and until 1.1.2005 in order to bring its products into compliance. The reason for this is that Turkey is obligated to the EU on this issue under Decision No. 1/95 of the EC-Turkey Association Council.
The Bolar Provision
Under Turkish law, the Bolar exemption adopted for pharmaceutical patents has been applied broadly. Accordingly, the “activities for trial purposes involving an invented drug, including registration of the drug as well as tests and trials required for registration,” are exempted from patent protection (Decree-Law on Patents, Art. 75/f).
As per the Bolar exemption, a generic firm is allowed to conduct a bioequivalence study and to apply for registration before the expiration of the patent term, so that a generic drug can be introduced to the market the day immediately following the expiration of the patent term. If the generic firm is unable to conduct the bioequivalence study and to apply for registration during the term of patent protection, the patent term of 20 years will extend automatically. Because such studies usually take several years, the generic drug cannot be introduced to the market in the meantime, despite the fact that the term of the patent has expired.
Neither the drug registration authority in Turkey, nor the Turkish judiciary, accepts the making of an abridged application, or even granting registration for a generic drug as a patent infringement. However, because sales permission for a generic drug granted by the registration authority automatically reduces the price of the original drug by 40%, this is accepted as a patent infringement.
When drafting TRIPS, it was proposed that drugs protected by patents in countries recognizing pharmaceutical patents, also be taken under patent protection in those countries, such as Turkey, which have subsequently recognized pharmaceutical patents. In this way it was intended that inventions which are not new but which have been patented in other countries also be registered in countries subsequently recognizing pharmaceutical patents. Turkey has not accepted this means of protection, referred to in the literature as pipeline protection, on the grounds that it is under no obligation to do so; neither under the terms of any international treaty nor under the terms of its relations with the EU.
1. Supplementary Protection Certificate
An average of 8 to 12 years passes from the date of application for pharmaceutical patent until the introduction of the drug onto the market. For this reason, a patent protection of 20 years can be used for only 10 to 12 years. In order to prevent this loss of time, which is called the “bitten term”, some developed countries have adopted supplementary protection certificate particular to drugs. The EU has mandated that Turkey introduce regulations concerning this supplementary protection, however Turkey has rejected this demand on the grounds that it has undertaken no commitment in this regard either under TRIPS, or Decision No. 1/95 of the Association Council. The supplementary protection certificate is not currently on the agenda in Turkey.
2. Data Exclusivity
Another intellectual property protection measure specific to drugs is data exclusivity. The discussions over Article 39/3 of TRIPS aside, the duration of data exclusivity protection was 6 years in the EU at the time when Decision No. 1/97 of the Association Council was adopted. For this reason, Turkey has accepted a data exclusivity period of 6 years. However, the EU subsequently extended this period to 8+2+1 years. The EU has mandated that Turkey adopt this regulation, however Turkey has refused to do so on the grounds that it is under no obligation in this regard under Decision No. 1/97 of the Association Council. Turkey has declared that it will fulfill this requirement only after attaining full membership of the EU.
The practice of data exclusivity under the Regulation on the Registration of Medicinal Products for Human Use 2005, which is still in effect, is as follows in summary:
Before 1.1.2005 – If the original firm within the EU-Turkey customs union registers a drug after 1 January 2001 but does not make any application for generic in Turkey until 1.1.2005, such a drug is granted data exclusivity for 6 years (but being limited to the term of the patent) from the date of first registration of the drug within the customs union.
After 1.1.2005 – If original drugs are registered for the first time within the customs union after 1 January 2005, such products are granted data exclusivity for a period of 6 years (but being limited to the term of the patent) from the date of first registration within the customs union.
As per the practice in Turkey, data exclusivity does not preclude the generic firm from making an abridged application for registration and carrying out the registration formalities. However, once the registration license has been obtained, right arising from data exclusivity may be claimed.
Apart from the patent law of 1879 passed during the Ottoman era, there has been no patent law enacted by the parliament of Turkey. Decree-Law No. 551 is not a law, but a disposition of the government. The basic reason for this is pharmaceutical patents. The reason why Turkey refrained from becoming a party to the European Patent Convention (EPC) for a prolonged time, although it was one of the founders of the International Patents Institute, is that the government wished to exclude pharmaceuticals from patent protection. As a result of the inclusion of pharmaceuticals under patents since 1 January 1999, after the establishment of the customs union with the EU in 1995, no excuse remained to Turkey for not accepting the EPC. Thus, Turkey has been party to this convention since 1 November 2000. During the discussions concerning TRIPS, which lasted nine years, the only issue brought forward by Turkey was pharmaceutical patents.
A draft law consisting of some 100 articles proposing amendments to the legislation on industrial property rights, including Decree-Law No. 551 on patents, has recently been submitted to the general assembly of the parliament. In the discussions over the draft, which bears the marks of an ad hoc, patchwork affair, the issue under discussion was, once again, predominantly pharmaceutical patents. In sum, there is, as yet, no patent law in sight on the horizon.
- Adv. Dr. Cahit Suluk, firstname.lastname@example.org; Istanbul Bar Association; Istanbul Bilgi University.