AIPLA Comments on the China National Intellectual Property Administration (CNIPA) Administrative Adjudication Measures for Early Resolution Mechanism for Drug Patent Disputes

On March 26, 2021, AIPLA submitted comments regarding the China National Intellectual Property Administration (CNIPA) Administrative Adjudication Measures for Early Resolution Mechanism for Drug Patent Disputes. In the comments, AIPLA requests clarification of handling of patent invalidity challenges, since substantial ambiguity remains concerning the handling of patent validity challenges.

AIPLA recommends amending the Draft Measures to clarify whether patent validity in linkage adjudications is limited to promptly incorporating determinations of invalidity by CNIPA RID under the established regulations. Otherwise, AIPLA requests that the Draft Measures specify precisely which tribunals are authorized to determine patent validity.

AIPLA requests that the Draft Resolution Mechanism be further revised to provide the patentee an opportunity to correct any non-critical deficiencies in its complaint. AIPLA is concerned that no deadline is specified to complete the adjudication in the Draft Measures, and as such, suggests an 8-month deadline. Additionally, AIPLA requests a clear statement that such mediation will not delay the administrative adjudication.

Article 11 provides a notice period of “at least 3 working days before the oral hearing,” which seems impractically short, particularly for foreign entities. AIPLA suggests extending this period to at least 10 working days. Article 17 provides: “15 days after receipt of the administrative adjudication decision” for filing an appeal to a court, whereas AIPLA suggests extending this period to 3 months.

AIPLA requests that the Draft Measures include a corresponding provision providing that if a case has been accepted by either CNIPA or the People’s Court, any case subsequently filed in the other tribunal shall not be accepted on the same asserted claims. AIPLA also requests that the Draft Measures provide that different claims, not asserted in the first accepted case, may be accepted in the second tribunal. Finally, AIPLA requests that all possible appeals have been resolved or the time within which to appeal has expired without an appeal being filed.