The China National Intellectual Property Administration (CNIPA) has ruled in favor of German pharmaceutical giant Boehringer Ingelheim (BI) in a patent infringement dispute with HEC and its affiliate Yichang HEC Changjiang Pharmaceutical Co., Ltd. The ruling centers on BI’s patent protecting the linagliptin compound used in its Trajenta diabetes drug.
Ruling Details
CNIPA determined that HEC infringed BI’s patent and ordered the company to cease all infringing activities, including manufacturing, selling, and offering to sell generic versions of linagliptin. While HEC may file an administrative lawsuit against the ruling, the administrative order will remain in effect during the legal process.
Trajenta Background
Trajenta, a selective dipeptidyl peptidase-4 (DPP-4) inhibitor, was first approved in China in March 2013 for type 2 diabetes treatment. The drug is protected by five patents listed on the China Drug Administration’s patent information platform, with expiration dates ranging from February 2022 to April 2027.
Generic Landscape
Since 2020, HEC, CSPC, Yangtze River Pharma, Kelun Pharma, and Huahai Pharma have received approval for generic linagliptin in China. Minsheng Pharma has also filed for approval, alongside Category 2 and 3 patent claims, asserting that its product does not infringe on BI’s patents.-Fineline Info & Tech
