Kowa Pharmaceuticals America, Inc. Announces Court Decision to Uphold Patent Protection for Livalo®

MONTGOMERY, Ala.–(BUSINESS WIRE)–Kowa Pharmaceuticals America, Inc. announced today that the U.S. District Court, Southern District of New York, has found that the U.S. Patent 8,557,993 (the “’993 patent”) protecting Livalo® (pitavastatin calcium) is valid, and that generic drug manufacturer Apotex, Inc. and Apotex Corp. (“Apotex”)’s proposed Abbreviated New Drug Application (ANDA) product would infringe the ‘993 patent.

“We look forward to continuing to supply this life-saving product 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. (collectively, “Plaintiffs”), manufacturers of the cholesterol-lowering drug Livalo®, brought suit against Defendants Amneal Pharmaceuticals LLC, and Apotex, Inc. and Apotex Corp., for alleged patent infringement based on the filing of the Defendants’ ANDAs 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 these suits, the Defendants had contended that the ‘993 patent is 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. Only Apotex asserted non-infringement; Amneal conceded infringement.

The Court concluded that the Plaintiffs proved that Apotex’s proposed ANDA product literally infringes, or contributes to the infringement of, certain claims of the ‘993 patent. The Court further concluded that Amneal and Apotex failed to prove invalidity of the ‘993 Patent. The Plaintiffs are directed to submit a proposed judgment by October 6, 2017.

In addition to the Court’s decision on the ‘993 patent, the Court also recently upheld the validity of another patent which covers Livalo®, U.S. Patent 5,856,336, in a separate decision in April, 2017, relating to the same trial. Both Amneal and Apotex conceded infringement of the ‘336 Patent, and Apotex conceded its validity. The Court concluded that Amneal failed to prove invalidity of the ‘336 patent. The U.S. Patent Trial and Appeal Board had also previously rejected three separate petitions by other companies for inter partes review, challenging the ‘336 Patent.

Several additional lawsuits were brought against other generic companies, all of which settled.

“We are very pleased with the Court’s rulings upholding the infringement and validity of the patents for Livalo®,” said Ben Stakely, Chairman, CEO and President of Kowa Pharmaceuticals America, Inc. “We look forward to continuing to supply this life-saving product 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. were represented by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

About LIVALO

LIVALO is an HMG-CoA reductase inhibitor (statin).

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