Kowa Pharmaceuticals America, Inc. Announces Agreement with Apotex to Resolve All Outstanding Litigation Related to Livalo (pitavastatin)

MONTGOMERY, Ala.--(BUSINESS WIRE)-- Kowa Pharmaceuticals America announced today that Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Industries, Ltd. (collectively, “Plaintiffs”) and generic drug manufacturer Apotex, Inc. and Apotex Corp. (“Apotex”) have finalized an agreement to resolve all outstanding litigation related to Livalo^®(pitavastatin).

Plaintiffs had brought suit against Apotex for patent infringement based on the filing of Apotex’s ANDA seeking Food and Drug Administration (FDA) approval to market 1 mg, 2 mg, and 4 mg pitavastatin calcium tablets, generic to Livalo^®. In response to this suit, Apotex had contended that the ‘993 patent was invalid as (1) anticipated based on prior art, under 35 U.S.C. § 102(b); and/or (2) obvious in view of prior art, under 35 U.S.C. § 103. Apotex also asserted non-infringement.

The Apotex litigation had been on appeal to the U.S. Court of Appeals for the Federal Circuit, along with a consolidated appeal filed by Amneal Pharmaceuticals LLP (“Amneal”), in which Apotex and Amneal have been appealing an adverse judgment entered against them in the U.S. District Court for the District of New York, in which the Court upheld the validity and infringement of U.S. Patents Nos. 5,856,336 and 8,557,993. The Apotex settlement leaves Amneal as the sole remaining appealing defendant.

Plaintiffs previously brought suit against seven other sets of generic defendants with respect to their ANDAs for generic versions of Livalo^®. Pursuant to agreements that resolved those lawsuits, each of those generic defendants agreed to license to market their generic versions of Livalo^® beginning on May 2, 2023, or earlier under certain circumstances. Apotex has now also agreed to license to market its generic version of Livalo^® beginning on May 2, 2023, or earlier under certain circumstances.

“We are very pleased with the District Court’s rulings upholding the infringement and validity of the patents for Livalo^®, and with the recent resolution of the Apotex litigation,” said Ben Stakely, Chairman, CEO and President of Kowa Pharmaceuticals America, Inc. “We look forward to continuing to supply Livalo^® to patients, and will continue to actively protect and defend our intellectual property.”

Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Industries, Ltd. are represented by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

About Kowa Company, Ltd. and Kowa Pharmaceuticals America, Inc.

Kowa Company, Ltd. (Kowa) is a privately held, multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various business fields including the trading of textiles, machinery, and construction materials, in addition to the manufacturing and sales of medicines, medical equipment, and energy saving products. Kowa’s pharmaceutical division is focused on research and development for cardiovascular therapeutics (dyslipidemia, type 2 diabetes and atherosclerosis), ophthalmology and anti-inflammatory agents. The company’s flagship product, LIVALO® (pitavastatin), is approved in 46 countries around the world.

Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, AL, is focused primarily in the area of cardiometabolic diseases. Established in September 2008, Kowa Pharmaceuticals America focuses its efforts on the successful commercialization of its current and near-term portfolio of pharmaceutical products, and business development activities. For more information about Kowa Pharmaceuticals America, visit www.kowapharma.com.

LIVALO is a registered trademark of the Kowa group of companies.

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