Appeals Court Decision Affirms Patent Protection for LIVALO

Kowa Pharmaceuticals America announced the U.S. Court of Appeals for the Federal Circuit has affirmed the decision by the U.S. District Court for the Southern District of New York, upholding the validity of U.S. Patent No. 8,557,993 (the ‘993 patent) protecting the company’s cholesterol-lowering drug LIVALO (pitavastatin) tablets. This decision was the most recent in litigation involving challenges by eight generic companies to the patents protecting the statin LIVALO. Several of those defendants settled, and the U.S. District Court entered judgment against the two remaining defendants, the generic drug manufacturers Amneal Pharmaceuticals and Apotex, and Apotex.

"We are pleased with the U.S. Court of Appeals’ ruling upholding the validity of the ‘993 patent for LIVALO once again," said Ben Stakely, Chairman, CEO and President of Kowa Pharmaceuticals America, Inc. "Our focus continues to be centered around bringing LIVALO to patients with high cholesterol and the physicians who treat them, as well as continuing to increase awareness and education about the risks of high cholesterol."

The U.S. District Court issued two decisions – one in April 2017 upholding the validity and infringement of U.S. Patent No. 5,856,336 (the ‘336 patent), and the second in October 2017 upholding the validity and infringement of the ‘993 patent. The ‘336 patent, which expires on December 25, 2020, covers pitavastatin calcium, the active ingredient in LIVALO. The ‘993 patent, which expires on February 2, 2024, covers the polymorphic form of pitavastatin calcium in LIVALO.

The plaintiffs, which included Kowa Company, Kowa Pharmaceuticals America, and Nissan Chemical Corporation, prevailed on all issues in the U.S. District Court decisions. Amneal and Apotex both filed appeals to the U.S. Court of Appeals for the Federal Circuit. Apotex subsequently abandoned its appeal and settled, agreeing to license to market its generic version of LIVALO beginning on May 2, 2023, or earlier under certain circumstances. Oral argument on the Amneal appeal was held on December 6, 2018, and the Federal Circuit entered its decision affirming the District Court’s judgment on December 10, 2018. As a result of the Federal Circuit decision, Amneal will be precluded from marketing its generic version of LIVALO until after the expiration of the ‘993 patent in February 2024.

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