The dispute resulted from the breach of the Astellas’ exclusive rights to the registration information attributable to Prograf proprietary medicinal product (containing tacrolimus as the active agent), in particular from registration of a generic without Company’s consent to the use of its registration information regarding the reference (proprietary) product efficiency and safety.

 

The court has declared that the state registration of the generic drug undertaken by the Ministry of Health of Ukraine was unlawful due to misuse of the registration information regarding the proprietary product efficiency and safety.  

 

In particular, the Highest Administrative Court of Ukraine upheld the conclusions of the first instance court and the court of appeals and noted that in the absence of the consent of the manufacturer of the proprietary medicinal product for the use of respective registration information, the Ministry of Health had no proper grounds for registering the generic drug.  

 

The court stressed that the Ministry of Health had to be guided by the rules of law which were in effect at the time when it made its decision on the registration of the generic medicinal product and which prohibited the use of registration information pertaining to the proprietary medicinal product for the purposes of submitting an application for registration of another similar medicinal product regardless of the registration date of the proprietary medicinal product.  

 

The Highest Administrative Court of Ukraine also pointed to the lack of reason behind the arguments that the Ministry of Health did not act as a government administration entity in the context of the disputed legal relations. The court stressed that in the context of these relations, the Ministry of Health performed government administration functions associated with the registration of a medicinal product. Therefore, the dispute was rightfully treated by the courts as an administrative case.   

 

Oleksiy Filatov, Partner and Head of Litigation Practice at Vasil Kisil & Partners, commented on the court decision as follows: “We are proud of our successful cooperation with Astellas Pharma in matters relating to the protection of rights to proprietary medicinal products. This precedent serves as a perfect illustration of the fact that pharmaceutical companies can successfully defend their rights provided they adopt a proper legal approach to the resolution of commercial problems arising in the highly competitive pharmaceutical market.”

 

Vasil Kisil & Partners team, which successfully represented Astellas in court, consisted of Senior Counsellor Vadym Belyanevych, Leading Associate Oleg Kachmar and Associate Daria Abulova.