Deborah E. Fishman

Fishman is an accomplished litigator who focuses on representing biopharmaceutical and medical device companies in both patent and commercial disputes. Since the pandemic, she has been very busy with litigation involving therapeutics, she said.

For instance, Fishman is defending PACT Pharma Inc., a privately funded Bay Area company developing T-cell cancer therapies, in a high-stakes arbitration with its collaboration partner, Lyell Immunopharma, Inc. A decision is pending.

A couple of her patent cases have raised novel issues. In one, the plaintiff asserted a new theory of infringement that could have changed how method-patent infringement actions are litigated. Fishman won dismissal of three of the four patents, which completely disposed of the issue, since the plaintiff chose not to amend its complaint. Seminis Vegetable Seeds Inc. v. Syngenta, 2:19-at-00940 (E.D. Cal, filed Sept. 30, 2019).

Another case has reached the U.S. Supreme Court on a petition for certiorari. Fishman led a team that won a victory for Sanofi and Regeneron over infringement allegations brought by Amgen against the cholesterol drug Praluent. A jury found two of Amgen's five patents invalid. The judge ruled the three remaining were as well, and in February 2021, the Federal Circuit affirmed in February 2021.

The issue at the Supreme Court concerns whether Amgen's patents adequately described a genus of antibodies, Fishman said, and whether they met the enablement requirement. "They've also raised a new issue that they had not briefed below, which is whether enablement should be decided as a matter of law," she said. "Our position is essentially there's nothing to see here." Amgen Inc. v. Sanofi Aventisub LLC, 21-757 (U.S., filed Dec. 22, 2021).

She is also defending Regeneron patents for its flagship vision drug Eylea against challenges at the PTAB brought by Mylan and other companies with biosimilar products.

Fishman is the editor-in-chief of BNA's Patent Litigation Strategies Handbooks, for which she writes the chapters on biotechnology and on biosimilar patent litigation.

One of her more interesting current litigation matters deals not with patents but with a complex commercial dispute between collaboration partners. Her client, Alexion Pharmaceuticals Inc., acquired a smaller company in order to develop that company's promising antibody asset, she said. As is typical in such deals, Alexion was to pay portions of the sale price upon achieving specified points in the development. But it ran into numerous problems, including some inherent in the product.

Now, the acquired company's shareholders are "Monday morning quarterbacking" the decisions Alexion made during development, and they have sued in Delaware Chancery Court to collect $800 million or more in payments. Fishman said her client has exercised commercially reasonable and diligent efforts, but that events beyond its control have made the product difficult to develop.

"Whatever the result, it's going to send a message to buyers and sellers about how to organize their business and their transactions," she said.

- Don DeBenedictis