Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc., No. 13-1335 (Fed. Cir. 2013)
Annotate this CaseSunovion owns the rights to the patent, which is directed to pharmaceutical compositions of the single-enantiomer drug eszopiclone, the active ingredient in the chiral drug marketed as a sleep medication with the brand name Lunesta®. The district court held, on summary judgment, that Dr. Reddy’s Laboratories did not infringe certain claims in that patent. The Federal Circuit reversed. Although the district court did not err in construing the claim term “essentially free” as containing less than 0.25 percent levorotatory isomer, Sunovion was entitled to a judgment of infringement as a matter of law under 35 U.S.C. 271(e)(2)(A). A generic manufacturer’s “certification” pledging not to infringe cannot override the conclusion that when a drug manufacturer seeks FDA approval to market a generic compound within the scope of a valid patent, it is an infringement as a matter of law.
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