Tuesday, February 9, 2021
Article 76 specifies two routes for challenging a market authorization filing for a patented drug: litigation or administrative adjudication. The above-mentioned Supreme People’s Court’s litigation regulations cover the litigation route and this draft covers the administrative adjudication route. What is lacking from both though is a time limit to adjudicate these cases. The draft joint implementing measures set a 9-month deadline for challenging a marketing authorization and it is unlikely that a complex pharmaceutical litigation involving a foreign patentee could be completed within this timeframe.
An unofficial translation draft adjudication measures follows:
Article 1 In order to handle cases involving administrative rulings on patent disputes (hereinafter referred to as administrative rulings on drug patent disputes) in the process of review and approval of drug listings in accordance with the law, these Measures are formulated in accordance with the “Patent Law of the People’s Republic of China” and relevant laws, regulations and rules.