By Suresh Pillai --
Penwest and Endo Announce a Settlement of Opana® ER Litigation
On February 20, Penwest Pharmaceuticals, based in Danbury, CT, and Endo Pharmaceuticals jointly announced a settlement of their litigation with Morristown, NJ-based Actavis South Atlantic LLC over the production and sale of generic formulations of Opana® ER (oxymorphone hydrochloride) (see "Court Report," July 20, 2008). The patent in suit, U.S. Patent No. 5,958,486, which issued on September 28, 1999, covers a controlled release formulation of Albuterol.
In addition to Penwest and Endo agreeing to dismiss their suit with prejudice, Actavis has agreed to dismiss its counterclaims with prejudice. The settlement agreement grants Actavis a license and a covenant not to sue covering the patents in suit, clearing the way for Actavis to market a generic version of Opana ER on or after July 15, 2011.
Federal Circuit Orders District Court to Reopen Enzo Biochem, Inc. v. Applera Corp. Patent Suit
The Court of Appeals for the Federal Circuit issued an order directing the District Court for the District of Connecticut to reopen the patent litigation suit between Enzo Biochem, Inc. et al. and Applera Corp. In the original litigation, Enzo sued Applera for infringement of six patents, and Applera counterclaimed for noninfringement and invalidity of all six patents. The parties stipulated to the dismissal of two of the patents in suit, and the District Court entered summary judgment of invalidity with respect to three of the patents. Enzo decided not to press their claims related to the final patent in suit, U.S. Patent No. 4,711,955, and the District Court directed that the case be closed. However, prior to closing the case, the District Court did not rule on Applera's counterclaims directed to the final patent. Subsequent to the dismissal, Endo filed a notice of appeal and then a motion to voluntarily dismiss the appeal. The motion to dismiss was granted on January 30, 2008.
After the motion to dismiss was granted, Enzo filed a motion for entry of final judgment, but the District Court denied the motion on the grounds that, because the District Court had found invalid all of the patent claims that were the subject of Endo's infringement allegations, there was no need to rule on Applera's noninfringement claims.
The Federal Circuit ruled that the District Court's denial of the motion for final judgment failed to dispose of the Applera's invalidity counterclaim with regard to the '955 patent. Because of the absence of an express ruling on the counterclaim, the Federal Circuit concluded that it remained pending and that Enzo had met its burden of showing a clear and indisputable right to issuance of the writ of mandamus.
Federal Circuit Grants Permission for Appeal on Collateral Estoppel Issue Regarding Claim Construction
Sandoz, Inc. was granted permission to appeal to the Federal Circuit a district court's decision not to give preclusive effect to another district court's claim construction. In the case of Shire LLC v. Sandoz, Inc., Sandoz petitioned the Federal Circuit to consider the issue of whether a patentee who has settled an earlier infringement case post-Markman ruling is precluded from relitigating claim-construction issues from that prior case under the doctrine of collateral estoppel. The United States District Court for the District of Colorado granted summary judgment to Shire; in doing so, the Court refused to give preclusive effect to the first district court's claim construction. The District Court did, however, grant Sandoz's motion to certify on the grounds that, as to infringement of at least one of the patents in suit, the issue could be dispositive.
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