Though Teva Pharmaceutical Industries Ltd. (TEVA) won the right to sell a generic version of Wyeth's (WYE) Protonix, it remains unclear if it will actually move to launch the product immediately.
On Thursday, a federal court denied a preliminary motion to block Teva from launching a generic version of the treatment for erosive esophagitis associated with gastroesophageal reflux disease.
But complicating the matter is that the basis for the denial is unknown because the judge's opinion in the ruling, coming from the U.S. District Court for the District of New Jersey, was filed under seal pending review that it doesn't contain any confidential or proprietary information.
"Teva would obviously be much more willing to launch if the ruling was predicated on strong likelihood of success on the merits," writes Ken Cacciatore from Cowen & Co.
The full decision is expected to become available this coming Wednesday, according to a report from Bear Stearns.
"Teva intends to complete a thorough analysis of (Thursday's) decision before deciding upon its next course of action," the Israel company said in a statement.
Cacciatore said this is more cautionary language than usual from Teva following a preliminary injunction victory.
"Our best guess without seeing the ruling is that Teva and Wyeth may now reach a settlement and/or Teva will wait for a decision at trial," he said.
Though obviously, if the ruling does contain strong language on the merits of Teva's rationale for challenging the patent, then it may move to launch immediately.
Such a move is known as an "at-risk" launch because the generic maker can later be compelled to pay substantial damages to the branded-drug companies if their patent is upheld in court.
In its own statement, Wyeth said the court emphasized that its findings were preliminary and that the generic companies "would need to meet a higher burden of proof, clear and convincing evidence."
The court determined that Teva had raised sufficient questions about the validity of the patent to preclude issuance of the "extraordinary remedy" of a preliminary injunction, the Madison, N.J., company said.
Wyeth and Altana Pharma AG, recently acquired by Nycomed, sued Teva and Sun Pharmaceutical Industries Ltd. (524715.BY) for alleged patent infringement based on Teva's and Sun's filing of Abbreviated New Drug Applications seeking Food and Drug Administration approval to market generic Protonix before the patent expires July 19, 2010.
Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Teva's ANDA until Aug. 2, 2007, and Sun's ANDA until Saturday.
Teva received that approval, but agreed not to launch before a decision was issued on Wyeth's motion for a preliminary injunction to prevent the launch until the resolution of the lawsuit.
Teva will have a 180-day period of marketing exclusivity, which will begin to run from the date of first commercial marketing or a final court decision.
A trial date has not been set.
Protonix was Wyeth's third-best-selling product in 2006, with $1.8 billion in sales. Wyeth licenses the drug from Nycomed.
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