Pharmaceutical products that are not licenced in Turkey and/or licenced but not have been made available to the market can be supplied by Turkish Pharmacists’ Association, Social Security Agency (SSA) and institutions and organizations that are deemed suitable for foreign drug supply by the Turkish Medicines and Medical Devices Agency (“Agency”) (“Foreign Drug Suppliers”) as per to the provisions of the Guideline on Drug Supply and Use from Abroad (“Guideline”).
Pursuant to the Guideline, the Agency publishes on its official website a “Foreign Drug List” for the drugs that can be supplied from abroad. Foreign Drug List consists of a list of “Active Ingredient List” which lists the active ingredients that can be supplied from abroad and a list of “Suppliable Drugs” which lists the human medicinal products including the active ingredients listed in the Active Ingredient List.
In order to supply the products listed in the Suppliable Drugs List from abroad, Foreign Drug Suppliers can either directly contact the foreign company or contact with the “intermediary institution/person” resident in Turkey.
However, the Agency doesn’t conduct an examination to determine whether the products listed in the Foreign Drug List infringes the patent rights, therefore the Agency does not get involved in private law disputes in this manner.
In the concrete case, an action filed with the demand of determination, prevention and cease of the infringement of the patents disclosing the active ingredients via the products listed in the Suppliable Products list of the Agency. The patent right holder also asked for a preliminary injunction decision as well. As a result of the court appointed expert examination made on the file, the experts and the court determined that the products listed in the Foreign Drug List are infringing the patents as it is doubtless through the lists that they include the patented active ingredient. The court granted a preliminary injunction in exchange of guarantee and briefly, decided to prevent the supply of the infringing products.
As a result of the trial, the court accepted the action, along with the determination of the patent infringement and removal of the infringing drugs form the Foreign Drug List. Besides, the court decided for prevention of the products that include the patented active ingredient from including in the Foreign Drug list regardless of their tradename, during the term of the patent protection.
In principle, it is essential to establish a decision only on the products that are the subject of the case. However, our defence against the possibility of inclusion of the infringing products in the Foreign Drug List by changing their name was accepted and the court prevented inclusion of the products with the same active ingredient to the list under any name and/or trademark.
Since the court considered the specialities of the exceptional drug supply procedure, the final verdict is an extremely important one serving to the effective protection of patent rights.
First published by IAM - International Report in Jan 19, 2022.
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