Difficulties of Enforcing Patent Rights on NPP Products

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, but patients are in need of it, it can be supplied via this special route. The entities that are authorised to import pharmaceuticals within the scope of the NPP are the Turkish Pharmacists’ Association (the “TEB”) and the Ibn-i Sina Health Social Security Centre Warehouse, established under the Social Security Institution (the “SSI Warehouses”).

If the product is approved for the NPP, it is added to the Foreign Drug List of the Ministry of Health (the “MOH”), and the TEB and SSI will import the products on a named-patient basis.

This exceptional 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 some cases, the patent in question is a compound patent; therefore, an infringement claim as a result of the newly added NPP product is inevitable.

In these scenarios, the patent owner is quite certain of the patent infringement and is prepared to take legal action. However, the only known party to the patent owner who is causing the infringement would be either the TEB or SSI Warehouses, as the importer of the infringing products. The Courts of Appeal have ruled that in cases of the supply of an infringing product via the NPP, the TEB may be one of the potential named parties of the patent infringement action, as the importer of the infringing products.

However, the TEB or the SSI Warehouses are the business partners of the patent owner for supply of its patented product via the NPP. Consequently, the patent owner will prefer to bring an action against the company that offers the infringing product for sale to the TEB or SSI Warehouses. However, this information is not publicly available, and the authorities are reluctant to provide such information.  

Another problem that patent owners face regarding NPP products is the threat of a compulsory licence due to insufficient use of the patented product. In the case of a third party demanding a compulsory license, they shall apply to the patent holder first to ask for a contractual licence, and if this demand is rejected or not responded to within a reasonable time, the issue shall be resolved before the Turkish IP Courts.

Stay Informed

Subscribe to stay up to date on the latest legal insights and events of your choice.