Novartis' Temporary Restraining Order Halts Teva's Distribution of Lotrel

There is more drama involving amlodipine - this time with Lotrel (made by Novartis (NVS)), rather than Norvasc (made by Pfizer (PFE)). 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 (TEVA) announced in a press release on Sunday that the FDA had granted final approval to Teva's ANDA for generic Lotrel on Friday, and that Teva began shipping the product immediately. Then on Saturday, the U.S. District Court for the District of New Jersey granted Novartis's motion for a temporary restraining order thereby 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, by reference, it incorporates 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. And now, that 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 today at 11 am (eastern).

The patent-in-suit is U.S. Patent No. 6,162,802.

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Reuters