Baxalta Wins New Try at Hemophilia Drug Patent Infringement Suit

Genentech Inc. will have to face revived claims that its hemophilia treatment infringes Baxalta Inc.'s patent for an antibody that increases blood-clotting activity.

The U.S. Court of Appeals for the Federal Circuit held that a lower court misconstrued two key terms in the patent. The interpretation led the parties to agree Genentech didn’t infringe so Baxalta could appeal.

The decision overturns a ruling by Federal Circuit Judge Timothy B. Dyk, who was serving as a visiting judge for the case in the U.S. District Court for the District of Delaware. Dyk has volunteered 16 times to hear cases on lower courts since 2006, more than any of his colleagues besides Judge William C. Bryson at 17, according to Federal Circuit statistics.

The appeals court decision is a “rare instance in which the Federal Circuit has reversed one of its own judges sitting by designation,” Dechert LLP partner Kassie Helm in New York said via email. “Most if not all of J. Bryson’s rulings have been summarily affirmed.” Helm is a pharmaceutical intellectual property litigator and former Federal Circuit clerk.

Baxalta, a subsidary of Takeda and Shire Inc., alleged Genentech’s Hemlibra drug infringed U.S. Patent No. 7,033,590. Baxalta sought royalties for U.S. sales of the drug. Baxalta conceded that it wouldn’t be able to win on infringement based on the trial court’s construction of the terms “antibody” and “antibody fragment.”

The lower court’s interpretation of the terms was “inconsistent with the plain language of the claims,” the Federal Circuit said in reversing the ruling.

The Federal Circuit “found more wrong than right” with Dyk’s claim constructions here, Helm said. “Based on this opinion, some might say go big or go home, when reversing one of your own.”

Judge Kimberly A. Moore wrote the opinion, joined by Judges S. Jay Plager and Evan J. Wallach.

Morgan, Lewis & Bockius LLP represented Baxalta. Paul, Weiss, Rifkind, Wharton & Garrison LLP represented Genentech.

—With assistance from Susan Decker (Bloomberg)

The case is Baxalta Inc. v. Genentech, Inc., Fed. Cir., No. 19-1527, 8/27/20.