Deborah Fishman

Deborah E. Fishman is a partner at Arnold & Porter Kaye Scholer LLP, who focuses on representing biopharmaceutical and medical device companies in IP and commercial disputes.

As a leader in life sciences litigation, she serves as an editor of ABA's Patent Litigation Strategies Handbook and authors the chapters on biotechnology and biosimilar patent litigation.

"The life sciences field is going gangbusters, and it has been since we all got busy during COVID," Fishman said. "There was a huge infusion of money into the sector and that hasn't stopped."

She's currently helping lead a team before the U.S. Supreme Court with a fundamental policy dispute over the scope of enablement disclosures in patents covering therapeutic antibodies. It arose from a defense win she and an Arnold & Porter team obtained for clients Sanofi Aventisub LLC and Regeneron Pharmaceuticals Inc. in a patent suit that targeted their cholesterol-reducing drug Praluent. Amgen Inc. v. Sanofi, 21-757 (S. Ct., argued March 27, 2023).

Lawyers called it one of the most closely watched biotechnology cases in recent years. The patent law term "enablement" refers to what a patent application must disclose so that others in the field can make and use the invention at issue after the patent expires.

A jury and a district court judge found invalid for lack of enablement the patent claims asserted by Amgen; the U.S. Court of Appeals for the Federal Circuit affirmed the defense win. Amgen appealed to the high court, claiming the Federal Circuit had changed the applicable legal standard.

"From our perspective, the Federal Circuit applied a 50-year-old precedent," Fishman said.

Fishman attended the argument and was encouraged. "They weren't buying what Amgen was selling," she said. Even Justice Clarence Thomas, famous for his habitual silence on the bench, spoke. "He asked about the number of antibodies Amgen was actually claiming, and I felt very relieved," Fishman said. "He struck right to the heart of our argument. Then Justice [Neil] Gorsuch said he didn't hear Amgen dispute the law. It sounded like he wasn't impressed."

The experience was positive, Fishman said. "We won below, and we weren't supposed to have to go to the Supreme Court. But it's pretty cool to actually be there. It's the first case I ever had that went this far. It's pretty unusual for cert to be granted in an IP case. There hasn't been a case on enablement in a hundred years."

--John Roemer