A federal court once again blocked Teva from launching a generic version of Lilly's osteoporosis drug Evista . On April 22, the U.S. Court for the Southern District of Indiana issued a preliminary injunction preventing the launch until the court issues a final ruling on the validity of three Evista (raloxifene) patents.

Judge Sarah Evans Barker had issued a temporary restraining order on March 9 stating that Lilly was likely to succeed in demonstrating the validity and enforceability of at least one of the patents (¹ Also see "Teva’s Generic Evista Launch Remains On Hold During Patent Trial" - Pink Sheet, 10 March, 2009.). Teva was prepared to launch at-risk in November but Barker extended the statutory stay on FDA approval of its generic - triggered when Lilly sued Teva for infringement - until the beginning of the trial.

On March 24, Teva told the court it would limit its launch to no more than one million bottles of raloxifene tablets between April 23 and Dec. 12. It contended that this limited launch would prevent irreparable harm to Lilly.

Judge Barker rejected Teva's argument. "Teva's promised limited launch will likely result in the same type of displacement of Evista in the marketplace as would a broader launch," she stated.

Teva had pointed out that Plavix regained and even surpassed its prior market share after a generic was on the market for a limited time. But Barker said Plavix held 91 percent market share of anti-platelet drugs while Evista has only 12 percent of the current osteoporosis market. In addition, the judge said that even if Lilly were able to fully recover its position in the market, Teva's launch would likely result in irreparable damage to Lilly's relationship with physicians and customers, a significant disruption or loss of research and reduction in R&D investment.

In a memorandum in support of its motion for a preliminary injunction, Lilly said Teva was mischaracterizing its proposed at-risk launch as a voluntary limitation.

"In reality, Teva's proposal is not a material limitation on its sales at all," Lilly said. "The at-risk launch proposed by Teva represents approximately five to six months of the sales that Teva would realize in the absence of any 'limitation,' because it may take approximately two months for a generic to capture 80 percent of the market, and it further represents a disruption of about eight months or more to Lilly's business."

Lilly added that the "the proposed 'limitation' appears to be but a thinly veiled attempt to dispose of prematurely and improvidently manufactured inventory."

In a declaration submitted to the court, Teva's expert, Gregory Bell, contended that harm from Teva's entry is not irreparable as it is "calculable and remediable through an award of money damages" which Teva is able to pay. Noting that Teva has total assets of $32.9 billion and market capitalization of $35.7 billion, he said Evista's $700 million sales in 2008 represent 2.1 percent of the book value of Teva's assets and 2 percent of its market capitalization.

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

Limited Launch Of Teva’s Generic Evista Rejected By Court

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