Merck v. Apotex (Fed. Cir. 2008) (non-precedential)
Apotex filed an abbreviated new drug application (ANDA) to begin making a generic version of the osteoporosis drug FOSAMAX. The drug brought in over $3 billion in 2007. Merck sued for infringement and Apotex filed counterclaims of invalidity and non-infringement.
After some discovery, Merck decided to end the case by filing a covenant not to sue Apotex for infringement of the patents-in-suit and moved to dismiss all claims and counterclaims. Wanting to keep the case alive, Apotex then moved to add a Sherman Act antitrust claim for Merck’s activities. The district court denied Apotex’s motion and dismissed the case.
Even though Merck agreed not to sue, Apotex could not begin manufacturing a generic version because another company – TEVA – held exclusive rights as the “first generic.” In particular, because TEVA was the first ANDA filer, that company holds 180 days of market exclusivity once it begins marketing its product. If Apotex had won its case, TEVA’s 180 days would be triggered by the court decision. While the appeal was pending, TEVA – on its own – triggered the 180 day exclusivity period by starting to sell its generic version.
Moot Appeal: On appeal, the CAFC found Apotex’s case moot. Because TEVA’s 180 days were already running, a judgment of invalidity would not allow Apotex on the market any sooner.
Interestingly, the Washington Legal Foundation (WLF) filed an amicus brief arguing that the case be dismissed because there was no dispute over validity or infringement: “permitting courts to exercise jurisdiction in cases of this sort would expand federal court jurisdiction well beyond limits imposed by Article III of the Constitution and would put federal courts in the business of rendering advisory opinions.”
Antitrust: The CAFC also affirmed the lower court’s refusal to hear the Apotex antitrust claims because those claims failed to sufficiently plead an antitrust injury.
Case ordered to be dismissed as moot.