China Draft Patent Law Amendment Introduces Initial Framework for Patent Linkage for Pharmaceutical Patents and Patent Term Adjustment and Restoration

China Draft Patent Law Amendment Introduces Initial Framework for Patent Linkage for Pharmaceutical Patents and Patent Term Adjustment and Restoration

July 14, 2020, Covington Alert

On July 3, 2020, the Standing Committee of the National People’s Congress (“NPC”) of China published a second draft amendment (the “Draft”) on the Patent Law of the People’s Republic of China (“Patent Law”). Most notably among the Draft’s proposed 29 revisions to the Patent Law, the Draft includes high-level provisions that would establish a framework for early resolution of pharmaceutical patent disputes between patentees and interested parties of approved drug products and applicants for follow-on drug products,1 often referred to as a patent linkage system. Specifically, the Draft includes new provisions that could create a jurisdictional basis—both for civil and administrative proceedings—for early resolution of patent infringement disputes involving a marketed drug product, and might establish a nine-month stay of approval of the follow-on application while the patent dispute is being adjudicated. The Draft also introduces high-level provisions that would establish patent term adjustment (“PTA”) and, for “invention patents of new drugs,” patent term restoration (“PTR”) regimes.