New Decision Tightens Venue Rules for Pharma Litigation

Fenwick litigation partner Robert Counihan spoke to The National Law Journal about a new ruling from the U.S. Court of Appeals for the Federal Circuit in Valeant Pharmaceuticals v. Mylan that will make it more difficult for pharmaceutical companies to bring Hatch-Waxman lawsuits in Delaware and New Jersey.

Counihan explained that branded pharmaceutical companies often bring Hatch-Waxman complaints in New Jersey and Delaware because the judges in those specific district courts are experienced with patents and the unique aspects of Hatch-Waxman, in which suits are based on an artificial act of infringement.

“You’re not looking at a product on a shelf. You’re looking at what a generic has told the FDA it will bring to market,” he told The National Law Journal.

New Jersey and Delaware judges are also diligent about resolving Hatch-Waxman cases before the 30-month automatic stay of FDA regulatory approval expires, eliminating the need for last-minute preliminary injunction motions, Counihan explained.

Because of Hatch-Waxman timing requirements, multiple generics often file ANDAs at the same time, bringing one suit against all of them in a single district the most efficient form of resolution—which has been another part of Delaware’s appeal, Counihan also noted.

“You want a single judge and not risk inconsistent verdicts,” he said.

The full article is available on The National Law Journal (subscription required).


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