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 particular route by physician request.
If the product is approved for the NPP, it is added to the Foreign Drug List of the Turkish Medicines and Medical Devices Agency ("Agency"), and nowadays, imported by the Turkish Pharmacists Association ("TEB") and the Social Security Institution ("SSI") on a named patient basis. If SSI decides on the reimbursement of the relevant product, the product is published in Annex-4/C list of the Health Practices Communiqué of SSI.
This exceptional supply method causes some problems in protecting and enforcing patent rights in Turkey. The patent owner, who 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 causing the infringement would be 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 the 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 also obligatory 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, the Agency, TEB and SSI do not share information about the product's supplier, who carries the risk of infringement. This information is only shared when requested through the court. Until February 2023, the fact that the NPP and the reimbursement processes were not carried out transparently led to the ineffective use of patent rights in this field.
The Guidelines on Supply of Pharmaceuticals from Abroad regulated the exceptional import regime in question, published by the Agency until recently. However, the Regulation on Supply of Medicines from Abroad ("Regulation") was published in the Official Gazette No. 32093, dated February 3, 2023, and the old guidelines were repealed. With the new Regulation, new provisions have been introduced regarding the registration of the persons and organisations involved in the procurement process and the traceability of the drugs supplied. In this way, the suppliers of the product residing abroad and the representatives of these suppliers residing in Turkey will also be registered with the Agency. In addition, the lists of drugs procured by this method will now be published by the authorised suppliers, the TEB and the SSI.
To give an example from a precedent that was held on last year, before the publication of the Regulation, in the particular case, an action with a request for 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 the 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, determining the patent infringement and removing 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 product 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 a crucial decision that ensures the effective protection of patent rights through the court, according to the circumstances of the case. With the effect of the provisions introduced by the new Regulation, it is hoped that effective protection of both patent and other intellectual property rights will be ensured in the field of the NPP, especially concerning the Industrial Property Law in Article 3 of the Regulation in which the legislation that the Regulation is based on are listed.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
