The National Healthcare Security Administration (NHSA) and the China National Intellectual Property Administration (CNIPA) have issued an Opinions paper titled “Strengthening the Protection of Intellectual Property Rights within Centralized Pharmaceutical Procurement.” The focus is on enhancing the protection of intellectual property (IP) rights during the drug procurement process.
Coordination and Consultation Mechanism
CNIPA and NHSA have established a coordination and consultation mechanism for the protection of IP rights in the medical field. This mechanism is centrally managed by the IP Protection Department of CNIPA and the Drug Price and Bidding Procurement Department of the NHSA, allowing for daily communication between the two bureaus.
Responsibilities of Drug and Device Companies
Drug or device companies participating in volume-based procurement (VBP) or standard centralized purchasing must independently guarantee 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.
Handling Patent Infringement Disputes
During VBP or centralized procurement tenders, if patent infringement disputes arise, the procurement agency should inform CNIPA’s management department, which will take prompt action. The centralized pharmaceutical procurement agency must verify the qualification of all products participating in online tendering. If clear infringements are found, the product must be withdrawn from the tender.
Research and Promotion of IP Protection Methods
CNIPA and the NHSA will also conduct research and jointly promote methods to improve IP protection in the medical field. This collaborative effort aims to enhance the overall protection of intellectual property rights during the centralized drug procurement process.-Fineline Info & Tech
