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by Aaron F. Barkoff
Orange Book Blog



A year ago, Merck (MRK) sued Apotex alleging that Apotex's ANDA for generic Fosamax infringed nine patents on pharmaceutical formulations of alendronate, the active ingredient in Fosamax. Apotex answered with counterclaims of patent invalidity and noninfringement. Then, after Merck reviewed portions of Apotex's ANDA, Merck granted Apotex a covenant not to sue on the patents and filed a motion to dismiss for lack of subject matter jurisdiction. Last week, the U.S. District court for the District of Delaware granted the motion.

Apotex had opposed Merck's motion to dismiss because it sought a ruling that Merck's patents were invalid and not infringed. In its opposition brief, Apotex argued that dismissing its counterclaims would have "the collateral consequence of denying Apotex a court finding on invalidity or noninfringement that would trigger the first generic applicant's 180-day period of exclusivity." Merck replied that the collateral consequences doctrine does not apply and "[t]he fact that Apotex would be prevented from going to market by the 180-day exclusivity period that Barr (BRL) and Teva (TEVA) have as first ANDA filers does not create a case or controversy between Merck and Apotex."

After the Federal Circuit decided Teva v. Novartis last month, Apotex submitted a letter to the court arguing that the decision supported its position that Merck's motion to dismiss should be denied. Apotex argued that Merck's actions, like Novartis's, were meant to "frustrate the central purpose behind Hatch-Waxman, which was to enable competitors to bring cheaper, generic drugs to market as quickly as possible." Merck replied with its own letter, arguing that Teva v. Novartis actually supported its motion to dismiss because "the Teva court specifically noted that Novartis declined to give Teva a covenant not to sue."

Within days of receiving those letters, the district court granted Merck's motion in a single-page order, stating that "it will grant Merck's motion to dismiss for lack of subject matter jurisdiction in light of Merck's covenant not to sue Apotex." The court further indicated that an opinion "will follow at the court's earliest convenience."


Source: OrangeBookBlog.com



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