Recently, CNIPA made approval decisions on 15 patents for multiple requests of pharmaceutical Patent Term Extension (PTE), which were concluded as "disagree with compensation". This decision involved several drugs, and the approval opinion pointed out that the patent term compensation requests for these drugs did not comply with Article 80 or Article 81 of the Implementing Regulations of the Patent Law (hereinafter referred to as the "Rules").

“Failing to submit drug registration certificate” "drug registration classification not conforming to Article 80 of the Rules" "failing to submit a request within 3 months from the date the drug obtains marketing authorization" are the reasons for the rejection of these patent PTE requests.

From Pharmcube Info

November 22nd, 2024