Tyco Healthcare Grp. v. Mut. Pharm. Co, No. 13-1386 (Fed. Cir. 2014)
Annotate this CaseTyco owns patents directed to temazepam, a drug used to treat insomnia and marketed under the brand name Restoril. The patents claim 7.5 mg formulations of temazepam having a specific surface area between 0.65 and 1.1 square meters per gram (m2/g). Specific surface area is a measure of the surface area of a drug per unit of weight. Generally, as chunks of drug material are ground down into smaller particles, the specific surface area increases because more of the drug is exposed to the surrounding environment. Mutual filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking approval to manufacture and sell a generic 7.5 mg version of temazepam. The ANDA represented that its product would have a specific surface area of not less than 2.2 m2/g and included a certification representing that the generic drug was not protected by a U.S. patent (21 U.S.C. 355(j)(2)(A)(vii)). Mutual sent Tyco a “paragraph IV certification letter” claiming that the product would not infringe because its specific surface area would not fall within the 0.65-1.1 m2/g range claimed by the temazepam patents. Tyco filed an infringement action, 35 U.S.C. 271(e)(2)(A). Mutual raised antitrust counterclaims. The district court granted summary judgment of noninfringement. Tyco filed a citizen petition, urging the FDA to change the criteria for evaluating the bioequivalence of proposed generic temazepam products in order to “help ensure therapeutic equivalence.” The FDA approved Mutual’s ANDA; months later it denied the petition. The court granted summary judgment to Tyco on the antitrust counterclaims. The Federal Circuit court vacated the summary judgment that Tyco’s infringement claims were not a sham and the summary judgment that Tyco’s citizen petition was not a sham.
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