Catherine M. Polizzi

Polizzi wields her doctorates in molecular biology and biochemistry to protect her biotech and pharma clients’ innovative therapies, blockbuster drugs and novel technologies as they move from laboratories to the commercial realm.

“The training and depth you get working on Ph.D.s in this area carry with you,” she said of her current legal efforts.

For client Genentech Inc., her work includes developing strategy for its multibillion-dollar portfolios, including major cancer drugs Kadcyla, Perjeta, Gazyva and Tecentriq. She has taken the lead in matters that have allowed the company to obtain critical and valuable patent-term extensions for several of them.

In May 2016, the U.S. Food and Drug Administration approved Tecentriq to treat urothelial carcinoma, a type of bladder cancer. In May 2017, the FDA approved Actemra, the first drug to specifically treat giant cell arteritis, a group of disorders that result in inflammation of blood vessels. Polizzi worked on strategies for both approvals.

And she achieved a complete win in inter partes review proceedings targeting patents that protect Genentech’s revolutionary breast cancer therapeutic Kadcyla, developed in collaboration with ImmunoGen Inc. Rival Phigenix Inc. filed two IPR petitions to gain leverage against Genentech in a broader litigation dispute, Polizzi said, and she was tasked with developing strategy for the case. The Patent Trial and Appeal Board found Genetech’s drug patentable; Phigenix appealed. Genentech’s position at the U.S. Court of Appeals for the Federal Circuit was that Phigenix lacked standing to appeal. The circuit panel’s decision in January decision for the first time set forth the legal standard for demonstrating standing in an appeal from a final agency action. It held that parties seeking to appeal must show they have suffered a specific injury, and Phigenix had failed to do so. Phigenix Inc. v. ImmunoGen Inc., 2016-1544 (Fed. Cir. Jan. 9, 2017).

“Anyone can file an IPR,” Polizzi said, “but a petitioner cannot appeal an adverse decision unless it has a concrete injury, which ordinarily would have to stem from fear of a possible infringement lawsuit. A competitor, or a party that is interested in attacking another entity’s IP, is not necessarily facing that kind of injury.”

In the high-stakes world of lifesaving drugs, decisions like that have serious consequences, Polizzi said. “This Federal Circuit review is critical. I worked very closely with the litigators on the strategy for this case. Cases like this aren’t just about technology. I know the law is not just science-based. I don’t just sit in the corner with my quill pen.”

— John Roemer