Christopher Cowles was featured in the Life Sciences IP Review article “Amgen v Sanofi: Scotus Grapples with Enablement.” The article discusses the recent, highly anticipated US Supreme Court hearings between Amgen and Sanofi, two pharmaceutical companies, regarding the true definition and test of “enablement” under Section 112 of the US Patent Act.
Christopher shares, “The court was much more receptive to Sanofi counsel’s characterization of both the law (enablement requires that a skilled artisan would be able to make and use the claimed invention, without reliance upon undue experimentation) and the science (notably referring to an expert declaration penned by Sir Gregory Winter).”
Conversely, Amgen’s arguments did not reflect to gain traction with the court. Christopher adds, “Amgen’s counsel was in the unenviable position of attempting to support Amgen’s enablement of all such claimed antibodies, with Justice Thomas’ opening query—“would you take a minute and tell us exactly what the invention is?”—immediately showing the ambiguity and weakness of Amgen’s position.”
Significant change in enablement law is unlikely, and based on the hearing, it’s also unlikely the court will overturn the US Court of Appeals for the Federal Circuit’s decision that Amgen’s claims were invalid for lack of enablement. Chris concludes, “Both respectively undermine Amgen’s assertions regarding the predictability of the genus of antibodies claimed, thereby highlighting the lack of enablement of Amgen’s disputed claims. Sanofi’s counsel appeared to have fully aligned all Justices behind its position, and it would now be shocking for the court to overturn the Federal Circuit’s decision.”
Click here to read the full article – Please note: A subscription may be required.
For further information, please contact:
Christopher Cowles, Partner, Withersworldwide
christopher.cowles@withersworldwide.com
