Siegmund Y. “Sige” Gutman

Gutman’s clients include Amgen Inc., Boehringer Ingelheim GmbH, Bachem Americas Inc., Peninsula Laboratories International Inc. and Oxford Immunotec Ltd. They turn to him for his 20 years of experience, his graduate degree in molecular and cell biology and biophysical chemistry, and his background as in-house counsel for biopharma giant Amgen. He is chair of Proskauer’s life sciences patent practice.

When rival Genentech Inc. accused Amgen of violating an information-exchange provision of the Biologics Price Competition and Innovation Act, Gutman won dismissal of that part of the case just two weeks later, on March 1.

The claim concerned Amgen’s development and commercialization of a biosimilar that threatened Genentech’s Avastin, a leading monoclonal antibody cancer therapy that is among the top 10 best-selling drugs in the world.

“Not a typical dismissal,” Gutman said. “Genentech feared our drug would cut into its $7 billion market. They sought an expedited resolution and an injunction to suspend their obligation under the BPCIA, but we were able to turn it around on them.”

The information-exchange provision is known as the “patent dance.”

It requires the maker of a biosimilar to give its files to the patent sponsor, which then comes back with possible infringement claims, leading to the biosimilar’s explanation of why the patent is unenforceable. The process can take up to 30 months.

Genentech wanted to enjoin Food and Drug Administration approval and commercial marketing of Amgen’s product, as well as a declaration that Genentech’s obligations under the “patent dance” provision were suspended.

The complaint, filed in the District of Delaware, came before U.S. District Judge Gregory M. Sleet. He granted expedited status and quickly ruled that Genetech’s complaint was barred by a landmark ruling by the U.S. Court of Appeals for the Federal Circuit that states the “patent dance” is optional.

“The biosimilar realm is a cutting-edge area in pharmaceutical patent law,” Gutman said. “The judge was particularly interested in this case.

Over the course of two weeks, we had several telephone hearings. On the final one, he decided he would order a dismissal.” Genentech Inc. v. Amgen Inc., 17-CV00165 (D. Del., filed Feb. 15, 2017).

“The dismissal of Genentech’s complaint allows Amgen to move toward commercial launch of its biosimilar product,” Gutman said. “It was great fun. This is such an exciting area of the law. We are seeing the creation of an entirely new industry with an entirely new statutory scheme. This case has been cited already because of the quick result we obtained.”

— John Roemer