Jonathan E. Singer

Singer heads Fish & Richardson’s life sciences litigation practice. In the past two years he has tried and won cases concerning several of the world’s top-selling drugs, including Harvoni, Humira and Combigan.

In February, Singer led the oral arguments in a crucial inter partes review for client Coherus BioSciences Inc. regarding AbbVie Biotechnology Ltd.’s rheumatoid arthritis drug Humira. In May, the Patent Trial and Appeal Board invalidated all claims of AbbVie’s cornerstone patent, the first time any Humira patent in AbbVie’s portfolio has ever been invalidated in the U.S.

“Humira, with $16 billion in global sales in 2016, is AbbVie’s biggest selling product,” Singer said. “This case concerns three patents you couldn’t get around, all related to a dosing regimen. The outcome doesn’t invalidate all of AV’s patents, and my client still has to get past the Food and Drug Administration, but it clears an important hurdle in the patent landscape. It’s a big deal. My client can now proceed to work on its biosimilar without this hurdle.” He said AbbVie is likely to appeal. Coherus BioSciences Inc. v. AbbVie Biotechnology Ltd., 2016-00172 (PTAB, filed Nov. 9, 2015).

In the Combigan case, Singer served as trial counsel in a Hatch-Waxman action over Abbreviated New Drug Applications for the glaucoma drug. In December 2016, he and his team won the case, blocking competitors from selling a generic version of client Allergan’s product until 2023. As part of the ruling, the court permanently enjoined the defendants from the commercial manufacture, use, offer to sell or sale of their proposed generic products. The case is on appeal. Allergan Sales LLC v. Sandoz Inc., 2:12-cv-207 (E.D. Tex., filed Feb. 17, 2012).

And in a third high-profile case, Singer represents Gilead Sciences Inc. in patent litigation over the hepatitis C treatment Harvoni. Following extensive proceedings, in 2016 the Fish & Richardson team — with Singer as co-counsel — convinced U.S. District Judge Beth Labson Freeman of San Jose that opponent Merck & Co. Inc. had forfeited its right to sue Gilead due to violations of the “unclean hands” doctrine, wiping out a $200 million damages award. “It is overwhelmingly clear to the court that [Merck’s in-house counsel] sought at every turn to create the false impression that Merck’s conduct was above board,” Freeman wrote in an order. In July, Freeman awarded Gilead $14 million in fees. Gilead Sciences Inc. v. Merck & Co. Inc., 13-cv-04057 (N.D. Cal., filed Aug. 30, 2013).

“This is no time to be modest,” Singer said. “This has been a very good year.”

— John Roemer