Supply of Pharmaceutical Products from Abroad and Patent Rights

The supply of pharmaceutical products to Turkey via the Named Patient Programme (the “NPP”) is one of the exceptional importation regimes for pharmaceutical products. Where a pharmaceutical product is not granted marketing authorisation in Turkey, or it is granted marketing authorisation but not found in the market, but patients need it, it can be supplied via this special route by physician request. The entities that are authorised to import pharmaceuticals within the scope of the NPP are the International Health Services Inc. (“USHAS”), the Turkish Pharmacists Association’s Economic Enterprise (the “TEB”) or the Ibn-i Sina Health Social Security Centre, established under the Social Security Institution (the “SSI”).

If the product is approved for the NPP, it is added to the Foreign Drug List of the Turkish Medicines and Medical Devices Agency (the “TMMDA”), and nowadays, mostly imported by the TEB and SSI on a named patient basis. If SSI decides the reimbursement of the relevant product, the product is published in Annex-4/C list of the Health Practices Communiqué of SSI.

This unique supply method causes some problems for the protection and enforcement of patent rights in Turkey. The patent owner, who also supplies the patented product via the NPP, is made aware of the competitor product by its inclusion on the foreign drug list.

In cases where the existence of a patent infringement is suspicious or unavoidable, the patent owner intends to exercise its legal rights but cannot access supplier information that is not publicly shared. The only known party to the patent owner who is causing the infringement would be either the TEB or SSI, the importer of the infringing products. The Courts of Appeal have ruled that for the cases of the supply of an infringing product via the NPP, the buyer of product in Turkey, the TEB, would be one of the potential named parties of the patent infringement action, as the importer of the infringing products. However, since the relevant institutions are the solution partners of the patent owner for the supply of its patented product via the NPP, it may not be preferred to bring an action against these institutions. In practice, TMMDA, TEB and SSI do not share the information about the product’s supplier, who carries the risk of infringement. In order to ensure that patent rights are used effectively in this field, the foreign drug supply and reimbursement processes should be carried out more transparently.

To give an example from a precedent that was held last year, in the particular case, an action with a request of preliminary injunction was filed for the determination, prevention, and cessation of infringement against a product included in the Foreign Drug List containing the active ingredients protected by the patents protecting molecules. Upon the investigation of the preliminary injunction claim made on the file, the Court found that the products included in the Foreign Drug List infringed both patents and granted a preliminary injunction in consideration of guarantee, in this context, in addition to other injunctions, it has decided to prevent the supply of products.

Following the trial, the Court accepted the action, the determination of the patent infringement and the removal of the infringing drugs from the Foreign Drug List. Besides, the Court decided to prevent the products with 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 decide only on the products 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 the inclusion of the products with the same active ingredient to the list under any name or trademark.

In this particular case, it is seen that the decision was held by taking into account the characteristics of this special drug supply method. Therefore, it is an extremely important decision that ensures the effective protection of patent rights through the court, according to the circumstances of the case.

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