European Bolar Provisions in Turkey

The Bolar Provision is implemented by the Industrial Property Law No. 6769 (the “Law”). Pursuant to Article 85/3-c of the Law (the “Bolar Provision”), experimental acts for the licensing of medicinal products, including without limitation tests and experiments relating to the invention which is the subject matter of the patent in question, are not included in the scope of the rights granted to the patent proprietor and therefore do not give rise to an infringement of the patent in question per se. In other words, the protection granted to the patent proprietor by the patent itself does not extend to practical implementations by third parties relating to the subject-matter of the patent in question. 

According to the Law, the Bolar Provision applies to provisional measures and practice implementations such as tests and experiments that are required for the authorisation of medicinal products. Consequently, measures such as the serial production, storage and marketing of the medicinal product are not covered by the Bolar Provision, as they are not linked to or necessary for the marketing authorisation process. The measure benefiting from the Bolar Provision must be a provisional measure and it must be a compulsory measure to obtain the licence for the medicinal product concerned. 

There is no restriction on the scope of the Bolar provision with respect to generic or new branded drugs. The only restriction relates to the type of activities protected under the Bolar provision (i.e. provisional measures and practice implementations such as tests and trials required for the authorization of medicinal products).

Yes, the Turkish Court of Appeal has made several rulings regarding the Bolar Provision. The Turkish Court of Appeals has ruled in several judgments that applying for a marketing authorisation does not directly constitute a violation of the patent, since it is required to obtain an “sale authorisation” in order to put the product on the market. 

Yes, preliminary acts relating to the subject matter of the patent (i.e. not aimed at licensing medicinal products) are also exempt activities covered by the local exemption, as long as these acts do not serve a commercial purpose, irrespective of a marketing authorisation application in Turkiye. Such non-commercial activities include activities with educational purposes, technological advancements and research.

However, the current legislation does not regulate the possible outcome of a “tentative action” for the authorisation of medicinal products, should this not lead to a marketing authorisation application in Turkiye.

There are no restrictions on the exemption by the party benefiting from the Bolar Provision. Consequently, any third party assisting the marketing authorisation holder in carrying out the exempted activities should benefit from the Bolar Provision.