On 4th July, the NMPA and the CNIPA jointly released the implementation measures for early resolution mechanism of pharmaceutical patent disputes. The drug marketing license holder needs register its relevant patents in the Patent Information Registration Platform for Marked Drugs in China within 30 days from the date of the issued drug registration certificate. The applicant of chemical generic drug, Chinese medicine having the same name and prescription or biosimilar, when filing the request for its drug marketing license, should make a statement with reference to each drug patent whose information has already been registered with that Platform and notify its related drug marketing license holder with this statement. The patentee or an interested party contesting the statement may either file a lawsuit before the court or request an administrative adjudication before the CNIPA within 45 days from the publication date of the request for drug marketing license. The said administrative adjudication may be appealable for judicial review. As for the chemical generic drug, on the one hand, the request of its regulatory approval shall stay 9 months should a patent dispute arise in the approval process, while the relevant technical evaluation continues; on the other hand, 12-month exclusivity can be granted to the chemical generic drug applicant that succeeds in challenging the validity of the related drug patent and acquiring the first approval for drug marketing. It needs to be noted that the drug marketing license shall not be revoked if a dispute arises after its regulatory approval.

As a further new information, just today, the Supreme People’ Court released a judicial interpretation including the previsions on how to apply laws in trying civil cases of patent disputes in relation to the drugs for the request of regulatory approval.

Authored by Xiaoling Duan