Intellectual Property Law

Federal Circuit Considers Whether Justiciable Case or Controversy Exists in Hatch-Waxman Case

By Brian Wm. Higgin

• Merck & Co. Inc. v. Apotex Inc., No. 2007-1362 (Fed. Cir. July 16, 2008) (non-precedential)

     In this appeal, the Federal Circuit affirmed and vacated a decision by the U.S. District Court for the District of Delaware (J. Sleet) in favor of Plaintiff-Appellee Merck & Co., Inc. (“Merck”). 

     Merck obtained approval from the FDA to market the drug FOSOMAX®. It sued Apotex for patent infringement when Apotex filed an Abbreviated New Drug Application (“ANDA”) seeking FDA approval to commercialize a generic version of FOSOMAX®.  Apotex counterclaimed for a declaratory judgment of patent invalidity and noninfringement.

     Following discovery, Merck granted Apotex a covenant not to sue for infringement of all patents-in-suit, and moved to dismiss all claims and counterclaims on the grounds that the case no longer presented an Article III case or controversy. Apotex then moved to amend its counterclaims to add a claim for a violation of the Sherman Antitrust Act, 15 U.S.C. § 2. The district court denied Apotex’s motion to amend its counterclaims, and granted Merck’s motion to dismiss all claims and counterclaims for lack of Article III jurisdiction.

     On appeal, the Federal Circuit affirmed the district court’s denial of Apotex’s motion to add an antitrust counterclaim, and vacated the district court’s decision regarding infringement and invalidity as moot and remanded with instructions to dismiss the claims as moot. In reaching those decisions, the Federal Circuit stated that a justiciable Article III controversy may continue to exist between a patentee drug company and an ANDA filer in the context of the Hatch-Waxman Act even after the patentee drug company has granted the Paragraph IV ANDA filer a covenant not to sue. Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 1296-97 (Fed. Cir. 2008).  However, in this case, two events after oral argument on appeal rendered the infringement and validity claims moot:

1. The FDA decided to treat the statutory automatic 30-month stay on Apotex’s ANDA as dissolved once the district court dismissed the case; thus Apotex's ANDA could be approved; and 
   
   
2. Teva, which filed the first ANDA against FOSOMAX®, began marketing its generic FOSOMAX® on or about February 6, 2008, so Apotex no longer suffered a delay in entering the market that is traceable to Merck and redressible by a court judgment.

Full post as published by Maryland Intellectual Property Law Blog on July 26, 2008 (boomark / email).