On 11 September 2020, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) published its proposed regulation on patent linkage, “Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Interim) (Draft for Comments).”  This proposal follows the National People’s Congress (NPC) July release of additional amendments to its draft patent law, which was first released in January 2019. The proposed rule provides details on how NMPA plans to implement its version of the “Hatch-Waxman.” I am highlighting a few provisions in the proposal below that are significant to manufacturers of innovative products. Comments to the proposal are due 25 October 2020.

• For chemical drugs, patent linkage applies to a new molecular moiety, new product formulation, or new indication. For biologics, the current proposal appears to limit the applicability to patents covering new sequence listings.
• From the date of the patent dispute case acceptance, NMPA will set a 9-month waiting period to approve the drug while the patent litigation is pending; however, this waiting period only applies to chemical drugs. For biologics, NMPA can approve the drug even if there is a patent dispute. 
• 12-month market exclusivity is offered to the first chemical generic that successfully challenged the patent. For biological products, no 12-month “monopoly period” is offered for the first successful generic challenger in the current proposal.