AMBASSADORS successfully defended the rights of the global pharmaceutical company Bayer in a patent infringement lawsuit

Case result:  In July 2024, AMBASSADORS achieved a significant victory for Bayer, a patent holder and reference product manufacturer, in a patent infringement case. The Supreme Court's decision in the dispute with a generic product manufacturer confirmed that seeking marketing authorization for a generic product while a valid patent exists is unlawful. 

Case details: The defendant, one of Europe's largest generic manufacturers, had applied for marketing authorization for a generic product even though Bayer's patent rights protecting its active ingredient were still valid. The defendant based its defense on legal provisions regarding permitted patent use, which included a partial implementation of the Bolar provision in Ukrainian law. While the permitted use clauses do not explicitly state whether obtaining marketing authorization for a generic product during the term of a valid patent is allowed, it is up to the courts to establish clear rules balancing the rights of patent holders and generic manufacturers. In this case, the Supreme Court upheld the decisions of both the first instance and appeal courts, all favoring Bayer. The courts ruled that the permitted use of a patent does not extend to actions such as requesting marketing authorization for a generic product or a biosimilar if the patent term has not expired. The full text of the decision is available in the official Unified Register of Court Judgments. 

Achievement: The legal opinion issued by the Supreme Court strengthens case law regarding the protection of patent rights against generic products attempting to enter the market. The timing of market entry for generics and biosimilars in relation to patent expiration can often be unclear for manufacturers. Thus, the Supreme Court of Ukraine clearly determined that requesting marketing authorization for a product covered by a valid patent constitutes patent infringement. As a result, the AMBASSADORS team achieved a favorable outcome for the client, and timely preliminary injunctions mitigated the risk of potential patent infringement during the litigation process. 

Involved Team: The litigation team for this project included counsel Olena Biloshuk, associate Gennadii Kochin, and managing partner Yaroslav Ognevyuk, who led the efforts.