Kowa Pharmaceuticals America, Inc. announced 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.
In response to these suits, 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.
This is a bad sign and could affect the decision for Impax merger.