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Victory on Appeal After Lengthy Litigation Over Cholesterol Inhibitor

The U.S. Court of Appeals for the Federal Circuit has upheld a victory in Hatch-Waxman patent litigation for innovative drug manufacturers and Mintz clients Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Corporation. The Mintz team was led by Intellectual Property Members David Conlin and Kathleen Carr, and included Adam Samansky, Thomas Wintner, John Bauer, Peter Cuomo, Jennifer Dereka, Sharon O’Brien, Joseph Rutkowski, and Nana Liu.

The District Court litigation involved eight different generic manufacturers in a series of litigations in the U.S. District Court for the Southern District of New York (Crotty, J.), relating to a unique statin called Livalo®. In addition, three petitions for inter partes review were filed before the U.S. Patent and Trademark Office, attacking one of the patents relating to Livalo®. After briefing on behalf of the patentee, the Patent Office denied institution with regard to all three petitions.

Mintz presented oral argument at the Federal Circuit on Thursday afternoon, December 6, 2018, and the Court issued its judgment early Monday morning, December 10. The decision by the Federal Circuit is the most recent victory in the litigation, which began in 2014 as the first of eventually 9 generic manufacturers filed abbreviated new drug applications (ANDAs) with the Food & Drug Administration.

The first decision, from the Southern District of New York in April 2017 upheld the validity of U.S. Patent No. 5,856,336, which covers the pharmaceutical product and its use for treating elevated cholesterol. The second decision, from September 2017, upheld the validity and infringement of U.S. Patent No. 8,557,993 which covers the polymorph of pitavastatin calcium contained in Livalo®.

The Federal Circuit judgment affirmed the District Court’s 98-page decision regarding the ‘993 patent.  By the time the appeal was filed with the Federal Circuit by defendants Amneal Pharmaceuticals LLC and Apotex Corp., Mintz had won or favorably settled everything else.  Amneal abandoned its appeal with regard to the ‘336 patent, and Apotex abandoned its attacks and settled during the appeal process.

As a result of this Federal Circuit victory, Amneal is prohibited from marketing its generic version of Livalo® until after the expiration of the ’993 patent on February 2, 2024.

For additional details on the earlier decisions, please click here.

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