Hep C Pill Patent Too Broad to Protect, Federal Circuit Finds

A Federal Circuit panel refused to revive an overturned University of Minnesota patent covering a broad swath of hepatitis C treatments, upholding a Patent Trial and Appeal Board decision that found competitor Gilead Sciences Inc. discovered a specific compound first.

The court agreed Monday with Gilead that the school’s overturned US Patent No. 8,815,830, which could cover as many as 4 million working compounds, didn’t spell out exactly how a scientist might make a particular remedy—a concept that has the potential to impact drug research and development strategies.

“Following this maze-like path, each step providing multiple alternative paths, is not a written description of what might have been described if each of the optional steps had been set forth as the only option,” Judge Alan D. Lourie wrote in a precedential opinion.

“This argument calls to mind what Yogi Berra, the Yankee catcher, was reported to have said: ‘when one comes to a fork in the road, take it,’” Lourie wrote.

In 2016, the University of Minnesota launched a lawsuit alleging that Gilead’s sofosbuvir hepatitis C antiviral pills—marketed under the brand names Sovaldi, Harvoni, and Epclusa—infringe the ‘830 patent.

Gilead, in turn, asked the PTAB to examine the validity of the ‘830 patent, and in 2021, the tribunal canceled all of the challenged claims. It found them invalid based on a deficient written description and said they can’t backdate the Minnesota inventor’s work by years based on some of the university’s underpinning patent applications that trace back to 2004.

During January oral arguments, Gilead attorney Scott McBride told the Federal Circuit that the university’s priority applications benefited from hindsight, and he said the board rightly knocked out the ‘830 claims because their foundation was flawed. He suggested that the court would have to journey through “the tangled spider web” of the school’s dependent claims to find preexisting support for Gilead’s compound.

However, University of Minnesota attorney Edgar Haug said that filing a cascade of patent applications that zero in on specific treatments is a common and acceptable strategy in drug research and development.

Life sciences companies are currently fighting at the US Supreme Court over whether drug patents have to specify all potential antibodies that could have the same effect—or only spell out some of them to protect the entire category.

Haug said the strategy represents “typical pharmaceutical prosecution practice.”

The Federal Circuit disagreed. The opinion said that the Berra comment “was notable because of its indeterminacy, its lack of direction. Similarly, here, all those optional choices do not define the intended result that is claim 1 of the ’830 patent.”

Judges Timothy B. Dyk and Kara F. Stoll also sat on the panel.

Wolf, Greenfield & Sacks PC and Haug Partners LLP represent the university. Bartlit Beck Herman Palenchar & Scott LLP represents Gilead.

The case is Regents of the University of Minnesota v. Gilead Sciences, Inc., Fed. Cir., No. 21-02168, affirmed 3/6/23.