Biotech Values

[rwdm]

Law360, New York (October 12, 2010) -- Teva Pharmaceuticals USA Inc. has lost its bid to force Sandoz Inc. and Momenta Pharmaceuticals Inc. to provide advance notice of their intent and ability to launch a generic version of Teva's multiple sclerosis drug Copaxone.

Judge Barbara S. Jones of the U.S. District Court for the Southern District of New York on Tuesday denied Teva's request for an order directing the generic-drug makers to provide the court and Teva with 10 days' notice prior to the launch of a copycat version, ruling that the defendants “are under no legal obligation” to provide this notice.

“While the court appreciates plaintiffs' desire to avoid saddling the court with an emergency and possibly unnecessary request for a temporary restraining order, the court is confident that Rule 65 of the Federal Rules of Civil Procedure [regarding the issuance of injunctions and restraining orders] provides more than ample recourse for addressing plaintiffs' concerns,” Judge Jones ruled.

The court held a hearing Sept. 24 to consider Teva's motion, which originally requested at least 90 days' prior notice of the defendants' ability and intent to launch their product. At the conclusion of that hearing, Judge Jones directed the parties to attempt to reach an agreement regarding Teva's request.

While the defendants agreed to provide Teva with notification of approval from the U.S. Food and Drug Administration within two hours of receipt and Teva backed off its request for at least 90 days' prior notice, the parties failed to reach an agreement to resolve their dispute.

Instead, Teva insisted that it needed a minimum amount of 10 days' prior notice to file a motion for a preliminary injunction and a temporary restraining order against the generic product, and it offered to post a bond to alleviate defendants' concerns regarding possible monetary loss during the notice period, an offer that also failed to coax a resolution.

While Judge Jones acknowledged that Teva “may ultimately be correct that defendants' unwillingness to provide plaintiffs with notice prior to launch means that defendants intend to take their product to market immediately upon receiving FDA approval and after the 30-month stay has expired,” the court could not find an adequate legal reason to order the defendants to provide the plaintiffs with “confidential business information” regarding the generic version's launch.

Teva and Yeda Research and Development Co. Ltd. originally launched the instant action in September 2008, claiming that Sandoz, its parent company Novartis AG and Momenta — which helped Sandoz manufacture its product and prepare the regulatory application to the FDA — infringed four patents for Copaxone by submitting an abbreviated new drug application seeking approval to manufacture a generic version of the drug.

The original complaint also claimed that the defendants used secret information from Lek Pharmaceutical and Chemical Co. — which distributed Copaxone for Teva from its base in Eastern Europe from 1997 to 2005 — to develop Sandoz's regulatory application for the copycat version, but Teva later dropped that contention along with an unfair competition claim in a November amended complaint.

Foreign defendants Sandoz International GmbH and Novartis were dropped from the suit Aug. 26, when Teva and Yeda filed a stipulation voluntarily dismissing the companies without prejudice, and Judge Jones rejected the remaining defendants' motion to dismiss the suit Sept. 7 after concluding that they had failed to adequately prove that the asserted patents were invalid due to indefiniteness.

The patents-in-suit are U.S. Patent Numbers 7,199,098; 6,939,539; 6,054,430; and 6,620,847.

Teva is represented by Goodwin Procter LLP and Kenyon & Kenyon LLP. Yeda is represented by Weil Gotshal & Manges LLP and Kenyon & Kenyon LLP.

Sandoz and Momenta are represented by Morrison & Foerster LLP.

The case is Teva Pharmaceuticals USA Inc. et al. v. Sandoz Inc. et al., case number 08-cv-07611, in the U.S. District Court for the Southern District of New York.