Lilly won another reprieve in its battle to block Teva from launching a generic version of its osteoporosis drug Evista (raloxifene). On March 9, a district court granted Lilly's request for a temporary restraining order prohibiting Teva's launch.

The TRO is in effect for only 10 days, however, and might have to be renewed if the trial lasts as long as scheduled, which could be more than two weeks. But if Teva agrees not to manufacture its product during the trial - as the company's trial counsel has advised - Lilly wouldn't need an extension.

The court issued the order during the first day of a bench trial over the validity of three Evista patents. Before the trial began, Teva had told the court it had learned a few hours earlier that FDA was prepared to approve Teva's generic version of Evista.

Judge Sarah Evans Barker, of the U.S. District Court for the Southern District of Indiana, found that based upon the parties' pretrial submissions and the opening statements at trial, Lilly showed "a reasonable likelihood of demonstrating the validity and enforceablility of at least one of the in-suit patents of which Teva concedes infringement."

The temporary restraining order is the second court-ordered extension of the automatic 30-month stay. Teva was preparing for an at-risk launch in November, when the 30-month stay on FDA approval was set to expire. But when Teva failed to meet a discovery deadline, the court extended the stay by four months until the day the infringement trial was to begin.

Teva had altered the methodology for measuring the particle size of the active ingredient in its raloxifene tablets and was late in delivering the changed samples to Lilly. Judge Barker extended the stay to give Lilly time to test them.

Teva appealed to the U.S. Court of Appeals for the Federal Circuit, which upheld the lower court's ruling. Judge Sharon Prost dissented, saying the Federal Circuit had not found that Teva failed to reasonably cooperate in missing the deadline by 18 days.

Of the three patents at issue, Teva has conceded infringement of two - 6,906,086 and RE39,050 - but challenges their validity on grounds of obviousness, lack of enablement and inequitable conduct.

Judge Barker ruled that Teva's launch would result in a rapid loss of market share and revenue that will be difficult, if not impossible for Lilly to recover, even if the court later ruled in Lilly's favor and Teva removed its product from the market. Evista is one of Lilly's top selling products with sales of $1.08 billion in 2008. By contrast, Barker said there would be relatively little harm to Teva from a brief additional delay in launching its generic.

-Brenda Sandburg (b.sandburg@elsevier.com)

Teva’s Generic Evista Launch Remains On Hold During Patent Trial

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