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Abstract
Nonobviousness is the most critical patentability criterion. Patents covering new molecular entities and second-generation molecules in the pharmaceutical industry are often challenged for prima facie 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 prima facie 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.
Acknowledgments
The authors of this communication wish to take this opportunity to express our deep gratitude to Council of Scientific and Industrial Research (CSIR) – Unit for Research and Development of Information Products (URDIP), Pune, India and Academy of Scientific and Innovative Research (AcSIR), India for providing us with the required technical facility support and opportunity to work on this analysis, which is a part of the ongoing PhD Research Programme.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.