What are Chinas current provisions on patent linkage?
In the Drug Registration Regulation (Temporary) which was approved by SFDA on October 15, 2002 as SDA Order # 35, and was effective from December 1, 2002, there are three Articles related to the Patent Linkage: Article 11: Regarding the drug or its formula, processing, etc. the applicant shall submit documents explaining the China patent status and ownership rights. The applicant shall submit a letter of guarantee stating that the drug will not infringe on the patent rights of others and that the applicant assumes liability for any possible infringement. Article 12: If an infringement dispute occurs after completion of registration, the parties shall try to negotiate a resolution, or resolve the matter according to relevant laws, regulations, or rules through judicial organs or patent administration institutions. Article 13: For a drug that has obtained patent protection in China, another applicant may apply for registration within two years prior to the patent expiration. SFDA shall r
