On September 15, the Patent Reexamination Board (PRB) under the Staten Intellectual Property Office (SIPO) held an oral hearing for the patent invalidation request case numbered 4W105696. Reportedly, it is the fifth case in the batch of major cases pending for public trial. The No. 201110029600.7 invention patent is held by NOVARTIS. The request for invalidation declaration is filed by Dai Jinliang.
In July 26, 2017, the involved cardiovascular drug Sacubitril/Valsartan was approved to enter Chinese market. Three specifications of Sacubitril/Valsartan marketed under the name of Entresto® are researchable at the website of the China Food and Drug Administration (CFDA), which are imported drugs and manufactured by NOVARTIS. There are no relevant domestic drugs approved for marketing. A number of domestic pharmaceutical enterprises have filed applications for registration for Valsartan-Sacubitril with the CFDA, some of which have obtained the Drug Clinical Trial Approval. The decision of the court may have impact on the marketing of domestic generic drugs and expenditures of domestic patients.
PRB has established a five-judge panel for the trial of the case, including the examination experts and legal experts. The provisions the case is concerned with include Articles 26 (3) and (4) and 262 (3) of Patent Law and Article 20 (1) of the Implementation Rules of the Patent Law, which are common basis for request of invalidation of pharmaceutical patents. Both parties have submitted 24 types of evidences or in combination to prove the validity of the involved patent, covering patent examination documents, prior examination decision, patent documents, experimental data and so on.