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美国联邦巡回上诉法院判例法在医药专利诉讼中,明确采用了“先导化合物”分析方法决定小分子医药专利的显而易见性专利是创新医药公司的生命线。专利的有效性对于创新医药公司的生存和在市场上的竞争力至关重要。因此,医药领域美国专利的非显而易见性(即创造性)的判定也成为一个广受关注的议题。美国联邦巡回上诉法院(CAFC)判例法在医药专利诉讼中明确采用了“先导化合物”分析方法决定小分子医药专利的显而易见性。该方法的着手点是,判断专利有效性的异议人提出的在先技术化合物(“先导化合物”)是否是本领域普通技术人员选择作为后续创新出发点的化合物。
Case law of the U.S. Court of Appeals for the U.S. Court of Appeals explicitly adopts the “lead compound” analysis method in pharmaceutical patent litigation to determine the obviousness of small-molecule pharmaceutical patents. The patent is the lifeline of an innovative pharmaceutical company. The effectiveness of patents is crucial to the survival and competitiveness of innovative pharmaceutical companies in the marketplace. Therefore, the non-obvious (ie, creative) determination of U.S. patents in the field of medicine has also become a topic of great concern. The US Court of Appeals for the Court of Appeals for the Federal Circuit (CAFC) case law explicitly adopted the “lead compound” analysis method in pharmaceutical patent litigation to determine the obviousness of small-molecule pharmaceutical patents. The starting point of this approach is whether the prior art compound (“lead compound”) proposed by the opponent to determine the validity of a patent is a compound that one of ordinary skill in the art will choose as a starting point for subsequent innovation.