Dhulap Sivakami, Kulkarni Mohan
CSIR-Unit for Research & Development of Information Products, 'Tapovan' S. no. 113 & 114, NCL Estate, Pashan Road, Pune, Maharashtra 411008, India.
Academy of Scientific & Innovative Research (AcSIR), Ghaziabad, Uttar Pradesh 201002, India.
Pharm Pat Anal. 2019 Jul;8(4):91-107. doi: 10.4155/ppa-2019-0014. Epub 2019 Aug 15.
Nonobviousness is the most critical patentability criterion. Patents covering new molecular entities and second-generation molecules in the pharmaceutical industry are often challenged for obviousness during prosecution and/or litigation. In such situations, the patentee has to either reject or rebut the same by clear and convincing evidence or demonstrate unexpected results, to establish nonobviousness. This paper tries to show how the lead compound requirement is consistent with 35 U.S.C. § 103; the obviousness challenge can be overcome; the two-prong approach is consistent with the Supreme Court's KSR v. Teleflex, 2007 (KSR) decision. The showing is illustrated with the analysis of new molecular entities in the proton-pump inhibitor family.
非显而易见性是最关键的专利性标准。制药行业中涵盖新分子实体和第二代分子的专利在审查和/或诉讼期间常常因显而易见性而受到质疑。在这种情况下，专利权人必须通过清晰且有说服力的证据驳回或反驳该质疑，或者证明意外结果，以确立非显而易见性。本文试图说明先导化合物要求如何符合美国法典第35编第103条；显而易见性质疑如何能够被克服；双步骤方法如何符合最高法院2007年的KSR诉泰莱福公司（KSR）案判决。通过对质子泵抑制剂家族中的新分子实体进行分析来说明这一论证。
