Generics
Kowa Pharmaceuticals America Receives Favourable Appeals Court Decision Upholding Patent Protection for Cholesterol Drug
10 January 2019 - - The US Court of Appeals for the Federal Circuit has affirmed the decision by the US District Court for the Southern District of New York, upholding the validity of US Patent No. 8,557,993 (the '993 patent) protecting US-based Kowa Pharmaceuticals America, Inc.'s cholesterol-lowering drug Livalo (pitavastatin) tablets, the company said.

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 US District Court entered judgment against the two remaining defendants, the generic drug manufacturers Amneal Pharmaceuticals LLP and Apotex, Inc. and Apotex Corp.

The US District Court issued two decisions one in April 2017 upholding the validity and infringement of US 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, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Corp., prevailed on all issues in the US District Court decisions.

Amneal and Apotex both filed appeals to the US 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.

Kowa company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Corp. are represented by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Livalo is an HMG-CoA reductase inhibitor (statin). Livalo (pitavastatin) is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides, and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Kowa is a privately held, multinational company headquartered in Nagoya, Japan. Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, AL, is focused primarily in the area of cardiometabolic diseases.
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