Avoiding IP Pitfalls in Life Sciences R&D: Patents, Disclosure, and Timing
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The script explains misconceptions and pitfalls in protecting life sciences R&D across long development cycles, emphasizing managing scientific, IP, and commercialization risks from basic research through drug discovery, preclinical work, clinical trials, and post-market uses. It outlines key IP assets (patents, trade secrets, know-how, trademarks) and patentability requirements, focusing on novelty, non-obviousness, and Section 112 written description and enablement, with examples from Ariad v. Eli Lilly and Amgen v. Sanofi showing that broad claims require commensurate disclosure. It warns against filing patents based only on targets/antigens or relying on provisional applications without full detail, and discusses timing issues when commercialization may exceed patent term, sometimes favoring trade secrets or licensing protections. It highlights patent opportunities beyond discovery, including methods of treatment, dosing, formulations, delivery, manufacturing, and new uses, noting unpredictability as important in non-obviousness (e.g., OSI v. Apotex).
00:00 Misconceptions and Risks
00:56 Life Science Development Cycle
01:59 IP Assets and Patent Pitfalls
02:37 Patentability and Disclosure
04:16 Written Description Case Law
05:37 Strategy Questions and Timing
08:16 Drug Discovery Patenting
09:01 Provisional Filing Myth
11:20 Preclinical and Clinical Patents
13:28 Wrap Up and Contact