『Avoiding IP Pitfalls in Life Sciences R&D: Patents, Disclosure, and Timing』のカバーアート

Avoiding IP Pitfalls in Life Sciences R&D: Patents, Disclosure, and Timing

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

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