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The China Food and Drug Administration on May 12 proposed for the public's comments a draft regulation entitled Relevant Policies for Encouraging Innovations on Drugs and Medical Devices and Protecting Innovators' Rights and Interests (No. 55 of 2017) at http://www.sda.gov.cn/WS01/CL0778/172606.html. Anyone can submit comments to firstname.lastname@example.org before the deadline June 10, 2017.
With this regulation, CFDA would formally adopt a formal patent linkage mechanism. It would also provide for the terms of data exclusivity in different scenarios.
The proposed patent linkage mechanism includes the following elements:
• The applicant for a drug registration should submit a declaration on involved rights he knows or should know.
• If the applicant intends to challenges an involved patent, he should declare that his drug does not infringe that patent and notify the owner of that patent within 20 days after filing the registration application.
• If the patent owner believes that this patent is infringed, he should file an infringement suit with the court within 20 days after receiving the registration applicant's notice, and also notify CFDA of the suit.
• CFDA, after receiving the court's acceptance document of the suit, may set an Approval Waiting Period not longer than 24 months, but it will not stop the technical review of the registration application.
• Within the Approval Waiting Period, if the parties reach a settlement or the court issues a judgment of infringement or no infringement, CFDA will approve or refuse the registration application according to the settlement or judgment.
• If the court has not made a judgment after the Approval Waiting Period expires, CFDA can approve the registration application.
• If the registration applicant successfully invalidates the involved patent, he will be given 18 months of data exclusivity.
• If a registration applicant does not disclose involved patents and a patent owner files an infringement suit, CFDA will also set an Approval Waiting Period on the registration application.
The proposed terms of data exclusivity are:
• 6 years for an innovative drug; • 10 years for an innovative drug that is also an orphan drug or pediatric drug;
• 3 years for an improvement drug that is also an orphan drug or pediatric drug;
• 10 years for an innovative therapeutic biologic;
• 18 months if a generic applicant invalidates a linked patent or if the drug is the first domestic generic drug based on an originator that has been marketed abroad.
Also, a new drug should be given a term of data exclusivity commensurate with its classification if an application for it is filed in China within 1 year after it was approved for marketing by the European Medicines Agency, the United States or Japan. If the application is filed in China beyond 1 year, a commensurate term should be given minus the lapsed time, and if the term minus the lapsed time is less than 1.5 years, the term is set to be 1.5 years.
The draft regulation makes it explicit that within the term of data exclusivity, CFDA will not approve other applicants' marketing application for a drug of the same type, unless the other applicants obtained their data on their own.