Shanghai’s Sunshine Medical Procurement All-in-One (SMPA) has released a notification to suspend the procurement status of two levornidazole specifications manufactured by Hunan Warrant Pharmaceutical Co., Ltd (SHA: 688799), citing the need for intellectual property (IP) protection. Additionally, Anhui province has also paused the procurement of two levornidazole specifications made by Warrant Pharma due to patent infringement allegations.
Marketing Approvals and Patent Litigation History
Warrant Pharma and Nanjing Sanhome Pharmaceutical Co., Ltd obtained marketing approvals for the antibacterial product in 2017 and 2020, respectively. Sanhome Pharma, who had obtained patents (ZL200510083517.2 and ZL200510068478.9) for the product back in 2005, sued Warrant Pharma for patent infringement in August 2019. The suit was over the manufacturing, selling, and promising to sell of products that violated its patents. In May 2020, Warrant Pharma lost the first instance and appealed to the Supreme Court, but by the end of 2021, the Supreme Court upheld the original judgment in the second instance.
Recall and Continued Disputes
Following the court’s decision, Warrant Pharma initiated a three-level recall process and halted the production and sales of levornidazole. However, the company was found to be promoting the drug in 2022, with online procurement active in multiple provinces. Subsequently, Sanhome Pharma filed a lawsuit demanding the destruction of all infringing products, the cancellation of drug approval numbers, and the removal of the bidding platform’s online listings, along with a claim for RMB 30.75 million (USD 4.44 million).
Regulatory Stance on Intellectual Property in Procurement
The National Healthcare Security Administration (NHSA) and the China National Intellectual Property Administration (CNIPA) issued an opinion paper in December last year titled “Strengthening the Protection of Intellectual Property Rights within Centralized Pharmaceutical Procurement.” The document emphasizes that drug or device companies participating in volume-based procurement (VBP) or standard centralized purchasing must independently ensure that their products do not violate the Patent Law or other IP laws/regulations. Applicants will be held responsible for any future repercussions in cases where a patent infringement dispute arises in relation to a tender winner. Previous instances include HEC’s linagliptin and Sinopharm Guorui Pharma’s alogliptin, both of which were stripped of their online procurement statuses due to IP disputes.-Fineline Info & Tech
