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 what is, in essence, a Chinese version of Hatch-Waxman—a regulatory scheme allowing reference product sponsors to assert their patents and at least temporarily block final approval of a generic competitor, and giving generic companies exclusivity against other follow-on products, as an incentive to challenge reference product patents. Below is a brief summary of key provisions; please contact us if you would like to know more.

• The proposed regulations would create a platform by which applicants seeking approval and companies already holding marketing authorizations would be required to identify patents related to their products.

  • For small molecule drugs, this would include patents related to the active moiety, product formulation, or indication.

  • For biologics, it appears to be limited to patents covering sequence listings.

• Applicants seeking approval of a generic or biosimilar product would have to submit a statement regarding the listed patents. If the applicant asserts that the patent should be invalidated or that the applicant’s product is outside the scope of the patent, the reference product sponsor has the opportunity to challenge that assertion with 45 days.

  • For small molecule drugs, this starts a 9-month period during which NMPA cannot approve the proposed product, although the agency’s technical review will continue.

  • For biologics, NMPA can approve the drug even if there is a patent dispute.

• The first applicant with a small molecule generic product who successfully challenges a reference drug patent receives a 12-month exclusivity period against approval of another generic version of the same drug.

  • There is no such exclusivity for the first biosimilar applicant successfully challenging a reference biologic patent.

There are many issues regarding the text of the proposal itself (i.e., what the proposed regulations do and don’t include), let alone questions of interpretation or application, that could significantly affect the impact of the regulations, if adopted. Comments to the proposal may be submitted through 25 October 2020. 

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