Siegmund “Sige” Gutman

Gutman, who chairs Proskauer’s life sciences patent practice, says he has the job he yearned for in his grad school molecular biology lab at UC Berkeley.

Then, in the early 1990s, he was close to developments in RNA molecular research that led to a Nobel Prize, plus breakthrough DNA mapping via the Human Genome Project. Next came law school. Now, he’s able to help advance the law as courts interpret the Biologics Price Competition and Innovation Act of 2009 (BPCIA), a statute designed to expand the availability of biosimilar drugs.

As Gutman worked to obtain his graduate degrees in molecular and cell biology and biophysical chemistry, he watched investors — including the government, private industry and academia — direct money into research.

“I started to think about who would own the rights to the results of the work we were doing,” he said. “IP issues got me interested in going to law school to be a patent lawyer. These days when I get up in the morning, I’m excited to start work.”

He served recently as lead counsel for biopharmaceutical multinational Amgen Inc. in BPCIA litigation involving dozens of patents in connection with his client’s Mvasi cancer drug, a biosimilar rival of Genentech’s Avastin product, one of the top ten most successful drugs. Genentech Inc. and City of Hope v. Amgen Inc., 17-CV01407 (D. Del., filed Oct. 6, 2017).

The case settled in 2020 after the U.S. Court of Appeals for the Federal Circuit rejected Genentech’s final efforts to block sales of Mvasi.

“This was a terrific outcome for our client,” Gutman said.

It validated Amgen’s at-risk launch of the drug even as the litigation was pending; if the case had turned against Amgen and willful infringement had been found, triple damages against his client could have resulted, Gutman said.

“The result speaks to the comfort level we had with our legal position,” he said.

“BPCIA has a complicated statutory scheme with issues that even today have not been fully vetted by the courts,” Gutman added. “Dealing with what’s unknown under the law, you can be very creative. And that makes it exciting. You are participating in the development of the law.”

The biologics statute is closely related to the Hatch-Waxman Act’s regulation of generic drugs. Gutman is heavily involved in that part of the pharma litigation realm too.

He is lead counsel for pharmaceutical companies Alvogen and Natco Pharma in their defense of AbbVie/Pharmacyclics’ suit over 18 patents involving Pharmacyclics’ imbruvica cancer therapy product. Pharmacyclics LLC v. Alvogen Pine Brook LLC, 19-CV00434 (D. Del., filed March 1, 2019).

“Alvogen wants to introduce a generic version,” Gutman said. He and his client participated in October in one of the few patent trials to take place virtually during the pandemic; post-trial briefing is completed and a judicial decision is pending.

— John Roemer