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| Caraco Pharmaceuticals v. Forest Laboratories |
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Caraco Pharmaceutical Laboratories, Ltd.
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| A team of Winston & Strawn lawyers obtained a major victory on behalf of Caraco Pharmaceuticals, a subsidiary of Sun Pharmaceuticals. The case involves U.S. Patent No. 6,916,941, one of two critical patents that protects Lexapro, a $2 billion-per-year anti-depressant manufactured by Forest Laboratories. Under the Hatch Waxman Act, Caraco is prohibited from entering the market for generic Lexapro until it obtains an order stating that the ‘941 patent was invalid or not infringed. But when Caraco sought a declaratory judgment to that effect, Forest unilaterally granted Caraco a covenant not to sue for infringement, seeking to avoid trial and arguing that the covenant eliminated the case or controversy, thus depriving the district court of jurisdiction. The district court agreed and dismissed the case. On appeal, the Federal Circuit reversed and remanded, finding that an Article III case or controversy existed because, even though Caraco was not at risk of being sued on the ‘941 patent, Caraco suffered a cognizable injury-in-fact based on its inability to enter the market for generic Lexapro, an injury traceable to Forest’s action in filing a New Drug Application for Lexapro with the FDA. After further proceedings, Caraco should be able to market for generic Lexapro at least six months (and possibly several years) earlier than it otherwise could have, a potential gain of many millions in sales. |
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