Kirkland Suffers Swift Defeat in Teva FDA Fight

Kirkland Suffers Swift Defeat in Teva FDA Fight lily/Fotolia

Well, that was fast.

Less than a week after Teva Pharmaceutical Industries Ltd. sued the U.S. Food and Drug Administration to block competitors from marketing generic versions of its blockbuster multiple sclerosis drug Copaxone, the company’s lawyers at Kirkland & Ellis are back where they started.

U.S. District Judge Ellen Segal Huvelle in Washington, D.C., dismissed Teva’s case without prejudice in a brief order on Wednesday, ruling that it was brought prematurely.

Teva could face generic competition to Copaxone as early as this month, thanks to an earlier string of setbacks in patent litigation with Mylan Inc. and Novartis AG’s Sandoz subsidiary.

Teva initially beat back a challenge from the generics in June 2012, persuading U.S. District Judge Barbara Jones in Manhattan to uphold Teva’s patents for the drug. That ruling barred Sandoz and Mylan from selling versions of Copaxone before September 2015, when the last of Teva’s patents was due to expire.

But in July 2013, the U.S. Court of Appeals for the Federal Circuit partially reversed Jones’ decision and invalidated the patent, shaving 15 months off of Teva’s market exclusivity.

Although the U.S. Supreme Court agreed to hear Teva’s appeal of the Federal Circuit decision, Chief Justice John Roberts last month denied the company’s request to block release of generic versions of Copaxone while the appeal is pending.

Teva filed its suit against the FDA on May 9, challenging the agency’s multiple refusals to impose clinical trial requirements on any generic versions of Copaxone. The FDA moved to dismiss the suit on Monday, arguing that Teva was asking for final merits decisions about its competitors’ drug approvals before the FDA had even finished reviewing them.

Judge Huvelle’s decision comes as welcome news to Sandoz and Mylan, which intervened in the case as defendants. The lineup for Mylan included Evan Chesler of Cravath, Swaine & Moore; Torsten Kracht of Hunton & Williams, and Shannon Bloodworth at Perkins Coie. Sandoz and its business partner for its version of the drug, Momenta Pharmaceuticals, had a Latham & Watkins team led by Philip Perry.

We reached out to Kirkland’s Jay Lefkowitz, who represents Teva, but didn’t immediately hear back.

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