Nuvo v. Dr. Reddy and the Patentability of Prophetic Pharmaceutical Inventions Based on Unexplained Inventive Insight
Biotechnology Law Report, 2019
13 Pages Posted: 27 May 2020
Date Written: July 1, 2019
In Nuvo v. Dr. Reddy, decided in 2019, the Court of Appeals of the Federal Circuit invoked the written description requirement to invalidate patent claims reciting a prophetic pharmaceutical invention that was purportedly based solely on the “inventive insight” of the named inventor, with no experimental data or other non-prior art information supporting its efficacy. To my knowledge, this is the first time the Federal Circuit has invoked the written description requirement in this context and for this purpose. On prior occasions, the court has invoked the utility and/or enablement requirements to invalidate claims of this type, perhaps most notably in the Federal Circuit’s controversial 2009 decision in In re '318 Patent Infringement Litig. Although the Nuvo court could have arrived at the same outcome by invoking the utility and/or enablement requirement, as was done in In re '318 Patent, there is something to be said for the analytic clarity provided by its decision to instead invoke the written description requirement. The written description requirement explicitly requires that the patent specification convey to the skilled artisan that the inventor was in possession of the invention as of the filing date, and if the sole basis for the inventor’s assertion of possession is “inventive insight,” unsupported by any external data or analytic reasoning, then it can be reasonably argued that the specification conveys nothing more than the inventor’s hope that the invention will work. This Article considers the patentability of prophetic pharmaceutical inventions, wherein the asserted efficacy is based solely on the purported inventive insight of the named inventor, but the rationale behind the insight is not explained in the patent application as filed.
Keywords: patents, patentability, drugs, written description requirement, inventive concept, Nuvo[comma separated]
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