Novartis Wins Temporary Restraining Order Against Teva in Lotrel Case
Novartis v. Teva, No. 04-4473 (D.N.J. 2007)
More drama involving amlodipine--this time with Lotrel (made by Novartis), rather than Norvasc (made by Pfizer). Lotrel contains a combination of two active ingredients--amlodipine besylate and benazepril--whereas Norvasc contains only one. Both drugs are indicated for the treatment of high blood pressure and both are blockbusters.
Teva announced in a press release today that the FDA granted final approval to Teva's ANDA for generic Lotrel on Friday, Teva began shipping the product immediately, and the U.S. District Court for the District of New Jersey granted Novartis's motion for a temporary restraining order on Saturday, halting Teva's shipments.
Novartis and Teva have been locked in litigation over Teva's ANDA for generic Lotrel since 2004. The 30-month stay expired earlier this year and, probably sensing that Teva was close to obtaining final approval (and fearing an at-risk launch), Novartis moved for a preliminary injunction in March. The district court was set to hear arguments on that motion in July.
Novartis's TRO motion recounts the events leading up to the filing of the motion on Saturday, and reveals that Teva's only invalidity defense is obviousness. Although Novartis's TRO motion does not detail the parties' arguments (instead, it incorporates by reference Novartis's motion for preliminary injunction, which was filed under seal), I suspect that if obviousness is the primary issue in the litigation, Teva was emboldened to launch at-risk by the Supreme Court's recent decision in KSR v. Teleflex. Still, Teva seems to be laying it all on the line--especially considering that it is the 180-day exclusivity holder and its commercial launch triggered that exclusivity period. The clock is ticking.
Besides temporarily enjoining Teva from selling its generic Lotrel, the Order entered by the district court on Saturday requires Teva to immediately recall any generic Lotrel already shipped to customers. The court has scheduled a hearing on the matter for tomorrow at 11 am (eastern).
The patent-in-suit is U.S. Patent No. 6,162,802.
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UPDATE: Teva announced Monday that the district vacated the temporary restraining order during the hearing Monday morning. The court ordered Teva and Novartis not to sell any generic Lotrel until at least next Tuesday, May 29, when the court holds a status conference. Read the AP story.
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