By Suresh Pillai —

Delaware District Court Invalidates Concerta® Patent

The U.S. District Court for the District of Delaware has ruled that Watson Pharmaceuticals, Inc.'s generic version of Concerta® (methylphenidate hydrochloride extended-release tablets) does not infringe ALZA Corporation's and McNeill-PPC's patent covering the drug.  The District Court also invalidated the patent at issue, U.S. Patent No. 6,919,373.  Before the trial commenced, the plaintiffs had offered Watson a covenant not to sue for Watson's practice of another patent at issue in the case, U.S. Patent No. 6,930,129.  However, rather than accepting the offer, Watson declined and requested that the Court find the patent invalid and not infringed.  Although the Court has not ruled on the validity of the '129 patent, Watson believes the '129 patent to be invalid on the same grounds as the '373 patent.

The original litigation began in 2005, when ALZA Corporation and McNeil-PPC, Inc. sued Andrx Corp. for infringement of the patents covering Concerta®.  Subsequently, in 2006, Watson purchased Andrx.  For more information regarding the case, please see the company's press release.

Cephalon Suit against Watson over Fentora ANDA Allowed to Move Forward

Earlier this year, Cephalon Inc., through its business unit CIMA Labs Inc., filed suit against Watson Pharmaceuticals, Inc. and its subsidiaries, contending that the defendants were liable for infringement of Cephalon patents covering Fentora® (see "Court Report," February 8, 2009).  The patents in suit — U.S. Patent Nos. 6,200,604 and 6,974,590 — cover tablet formulations of fentanyl buccal, Fentora's® active ingredient.  The U.S. District Court for the District of Delaware recently denied Watson's
motion to dismiss the suit due to a lack of jurisdiction and on the grounds that some
defendants were not involved in Watson's attempts to submit a
regulatory application for the drug.

As part of its argument seeking to have the suit dismissed, Watson contended that it was not involved in the submission of an ANDA to the FDA seeking to make generic Fentora® tablets.  The District Court dismissed these arguments, finding that Watson employees had been involved in the ANDA filing and that each Watson entity would, in the event the ANDA was approved, be involved in the marketing and distribution of the generic Fentora tablets.

The Court also found that it had personal jurisdiction over Watson Laboratories.  The Court reasoned that while laboratory activities alone would not be enough to establish jurisdiction, Watson Pharma sales activities in the state of Delaware could be attributed to Watson Labs, a separate Watson subsidiary, through an agency theory of liability.

With regard to the presence of a case or controversy, the Court found that because Watson had filed its ANDA and declared its intention to make, manufacture, and market generic Fentora®, this declared intent was sufficient to give rise to a case or controversy suitable for federal court adjudication. 

Settlement Announced in Schering-Plough and Mylan Suit over Clarinex

Mylan announced a settlement of all patent litigation (see "Court Report," March 8, 2009) stemming from its generic version of Schering-Plough's Clarinex® allergy medication, covered by U.S. Patent No. 7,405,223.  Under the terms of the settlement agreement, Mylan will have the right, as of July 1, 2012 (or earlier in certain circumstances) to market 5 mg Desloratadine Tablets, Mylan's generic version of Clarinex®, in the United States.  This permission is contingent upon FDA approval of Mylan's previously filed ANDA.  Depending on the status of Clarinex® at the time of the FDA's approval, Mylan will be allowed to market and distribute either the prescription form or over-the-counter form of Desloratadine.  Additional terms of the agreement were confidential, and the agreement is subject to review by the Department of Justice and the Federal Trade Commission.  For more information on the settlement, please see Mylan's press release.