Solid-form patents provide drug substance patent protection for many pharmaceutical small molecule programs. Many of the claims of such patents are drawn narrowly to cover the specific crystal form of the corresponding marketed drug product. However, solid form screens often reveal multiple solid forms of an API and, as with traditional chemical structure claims, the resulting data may warrant genus coverage. Because the ability to predict solid form structures and methods of producing are more limited generally than corresponding chemical synthetic structures, enablement presents as a common challenge to overcome. The Supreme Court addressed enablement concerns in genus patents in its recent Amgen v. Sanofi case, albeit in the context of antibody drugs.

On Thursday, October 5, at 12 PM ET, please join Gene Quinn, Founder, President & CEO of IPWatchdog, Inc., who will moderate an in-depth conversation with Eyal Barash, a U.S. Patent Attorney and Founder of Barash Law, LLC. During this webinar, Eyal will address the enablement of genus solid-form patent claims through the lens of the Amgen v. Sanofi case and how such claims may be supported to better withstand Section 112 challenges.

About Our Sponsor:

Barash Law is an intellectual property and business law firm founded by Eyal H. Barash. Barash Law represents mostly life science companies with small-molecule portfolios in various stages of development including in-licenses, out-licenses, public offerings, private sales and public exits.  In 2018, one of Eyal’s clients, Endocyte, Inc. was sold to Novartis for over $2B.  Eyal was chief patent counsel to Endocyte for almost 10 years.  In particular, a focus area of Eyal’s practice is in solid form intellectual property – protecting salts, cocrystals, amorphous forms, and the like as molecules move from medicinal chemistry to CMC and beyond.  Eyal is also a prolific speaker and lecturer, giving presentations primarily on solid form IP issues throughout the globe which includes drug repositioning and repurposing.