The Shanghai Sunshine Medical Procurement All-in-One (SMPA) platform has revealed that it has suspended the procurement qualifications for HEC Group’s linagliptin (5mg × 7 boxes). HEC’s product is a generic version of German major Boehringer Ingelheim’s (BI) Trajenta. The decision was taken to ensure that intellectual property (IP) rights are respected within China’s medical tendering and procurement sector.
Patent Infringement Finding
HEC was found to have infringed upon BI’s patent protecting linagliptin compounds by the China National Intellectual Property Administration (CNIPA) in July this year. CNIPA ordered HEC to cease all infringing acts, including manufacturing, selling, and offering to sell generic linagliptin. According to relevant laws and regulations, although HEC may file an administrative lawsuit appealing that ruling within the specified time limit, the execution of the administrative ruling will not be halted prior to the conclusion of any future appeal.
Trajenta Background
Trajenta, a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor, was first approved in China in March 2013 to treat type 2 diabetes. The product has five patents filed on the CDE’s Orange Book equivalent, with expiration dates ranging from February 2022 to April 2027. HEC, CSPC, Yangtze River Pharma, Kelun Pharma, and Huahai Pharma secured approvals for generic versions from 2020, while Minsheng Pharma has filed a generic for approval alongside Category 2 and 3 patent claims in relation to the product, indicating that the firm views its filing as non-infringing.-Fineline Info & Tech
