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Robins Kaplan LLP Earns Trial Win for Client Amneal Pharmaceuticals LLC in Hatch-Waxman Lawsuit Over Blockbuster Kidney Disease Drug

Minneapolis—August 2, 2018Robins Kaplan LLP® secured a ruling of non-infringement of a proposed ANDA product in a Hatch-Waxman trial over the blockbuster kidney disease drug Sensipar®. The ruling, following a four-day trial in Delaware federal court, is a victory for Robins Kaplan’s client, Amneal Pharmaceuticals LLC.

“This was a hard fought case that required creativity and persistence from our legal team and from our client Amneal, and great cooperation among the defendants,” said Jake Holdreith, partner at Robins Kaplan and lead trial counsel for Amneal. “We faced a tough and motivated opponent. We are fortunate to have a great partnership with our client and a highly skilled legal team that allowed this win for Amneal.”

Amgen Inc., the manufacturer of Sensipar, originally sued Amneal and more than 15 other generic drug manufacturers, seeking to prevent them from introducing generic versions of Sensipar, which can lower the amount of calcium in the blood and is used to treat kidney disease in adults. Amgen’s U.S. sales of Sensipar exceeded $1.3 billion in 2017 alone. Its patent over Sensipar’s active ingredient expired on March 8, 2018, but a separate Amgen formulation patent, at issue in this case, remains in effect until 2026.

The Robins Kaplan team representing Amneal led a defense group that dwindled to nine at the final pretrial conference, five at the start of trial, and four during post-trial briefing, with others choosing to settle Amgen’s claims against them. Amneal proceeded to trial, and Judge Mitchell S. Goldberg ruled that Amneal, along with two other generic drug makers, did not infringe Amgen’s U.S. Patent 9,375,405.

Robins Kaplan principal Oren Langer and associate Kelsey Thorkelson played critical roles at trial on behalf of Amneal. “The most important mission we have is getting the best possible result for our clients. We are thrilled to be able to deliver that to Amneal in this case,” added Oren Langer.

The case, Amgen Inc. v. Amneal Pharms. LLC, was heard before the United States District Court for the District of Delaware by the Hon. Mitchell S. Goldberg, a visiting judge from the Eastern District of Pennsylvania.