With Billions at Stake, Supreme Court Dips Its Toes Into Biologic Drug Patents

Director Jorge A. Goldstein, Ph.D., was mentioned in the article “With Billions at Stake, Supreme Court Dips Its Toes Into Biologic Drug Patents,” published by National Law Journal. From the article:

“Staking its claim to a multibillion-dollar market for improved cholesterol drugs, Amgen identified 26 antibodies that lower cholesterol by binding to a protein, called PCSK9. Its patents provided a ‘roadmap’ for persons of skill in the art to find all other antibodies that would fall within the claims. Jurors have twice found that Sanofi and Regeneron infringed Amgen’s patents. U.S. District Judge Richard Andrews threw out the second verdict, finding that Amgen’s roadmap led to millions of potential antibodies that could not be screened without undue experimentation.

At the Federal Circuit Amgen and amici curiae Bristol-Myers Squibb and Merck Sharp & Dohme said that simply patenting the 26 antibodies would have been futile. ‘The patentee, having invested enormous sums in discovering the underlying target, has provided a blueprint for others who, now aware of the targets, can quickly make their own version of an effective antibody,’ BMS and Merck argue in a brief signed by Sterne Kessler Goldstein & Fox partner Jorge Goldstein. ‘The scope of the invention in this space is therefore the genus of antibodies that successfully binds the target, rather than any particular antibody that serves as an example.'”