IP Topics & ArticlesBolar-type Exemption Interpreted


Challenging economic conditions and thus increasing competition drives patent wars before the courts in Turkey as all over the world. In particular, famous international players in the pharmaceutical industry review all patent rights in this war against others. including of course generic drugs manufacturers.

 


Turkey recognised explicitly the Bolar-type exemption by adding Article 75f, which allows generic drug manufacturers to carry out tests and experiments related to a patented drug in order to obtain marketing authorization even before the expiry of the patent right, on June 22 2004.


Moreover, the current legislation does not include any provision for a company to apply for a supplementary protection certificate (SPC) to increase the term for patent protection whereas there is a regulation on “data exclusivity”, which provides a six-year period of market exclusivity only for pharmaceuticals for use in humans to prevent the marketing of generic drugs. But this period starts from the authorization date in one of the member countries of the Customs Union and cannot exceed the patent term of 20 years. This means for instance it is not possible to obtain for an original drug a protection period of 20 plus six years.


Article 9 of the Turkish Implementing Regulations on Marketing Authorisations for Medicinal Products allows an official application for a generic drug to be filed (with or without the consent of a patentee, if available) unless the original drug is still within the protection period of data exclusivity.


Two recent court decisions ratify the facts that (1) a “restricted” application for marketing authorisation of a generic drug appropriately referencing an original drug protected with a granted patent is an allowed act according to the legislation in force unless the drugs are not put into commercial use even if the patent is still valid, and (2) Article 9 of the Implementing Regulations is inconsistent neither with Article 39 of the TRIPs Agreement nor national unfair competition provisions, and thus it will not be cancelled.


However, it should be emphasized that there are strong arguments against this interpretation of the relevant articles if the Bolar exemption is also valid for biological products or research tools, in particular on the legal consequences of generic drugs being stockpiled while a patent is in force.

(Ersin Dereligil)

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