Teva Loses Suit Against FDA Over Generic of Copaxone

Teva Pharmaceutical Industries Ltd. lost a bid to block approval of a generic form of Copaxone, a multiple sclerosis drug that may account for half the company’s profit, 10 days before the patent on the medication expires.

Teva’s lawsuit, accusing the Food and Drug Administration of improperly dismissing its calls for more testing of generic forms of Copaxone before they go on the U.S. market, was thrown out yesterday by a federal judge in Washington. Copaxone, the company’s bestselling drug, contributes more than 50 percent of earnings, according to analysts.

The May 10 suit was Teva’s latest move in a campaign to block rivals including Mylan Inc. and Novartis AG’s Sandoz unit from making a less-expensive generic drug. Last month, a U.S. Supreme Court justice rejected Teva’s bid for an injunction to prevent the sale of generic competitors’ products.

“Teva’s suit against FDA was simply a desperate, last-minute tactic,” Heather Bresch, chief executive officer of Canonsburg, Pennsylvania-based Mylan, said today in a statement. “We continue to see no barrier to FDA approval of Mylan’s generic Copaxone following patent expiry.”

Teva is appealing a judge’s 2013 dismissal of Teva’s suits against Mylan and Sandoz for infringing patents covering Copaxone. That case is pending before the Supreme Court.

U.S. District Judge Ellen Huvelle said in her order yesterday that the lawsuit was brought prematurely and as a result she lacked authority to hear it. The complaint can be refiled later, she said.

Teva is evaluating what it can do next, Denise Bradley, a spokeswoman for for the Petach Tikva, Israel-based company, said in an e-mailed statement.

‘Only Option’

The suit was “the only option available to us” because of a lack of transparency in the drug review process and the agency’s failure to offer a “meaningful response” to Teva’s requests for more extensive scrutiny of the generics its competitors plan to sell, Bradley said.

The FDA characterized the suit in court papers as an effort by Teva to extend its “monopoly” for Copaxone.

In the past six years, Teva has filed six petitions at the FDA “with various legal and scientific assertions and requests, each time making the same demand: that FDA not approve any generic competitor’s product without requiring, among other things, a full set of clinical trials,” agency lawyers wrote, urging Huvelle to dismiss the case.

Teva Conditions

The FDA said Teva wanted the court to decide that applications for generic Copaxone couldn’t be approved “without first meeting Teva’s additional ‘conditions.’” The agency called the demand “absolutely unprecedented, extra-statutory, and extra-judicial.”

A 20-milligram dosage of Copaxone is set to go off patent on May 24. A delay in approval of generic competition would give Teva more time to switch patients to a 40-milligram dose it says is covered by other patents until 2015.

The case is Teva Pharmaceutical Industries LTD v. Sebelius, 14-cv-00786, U.S. District Court, District of Columbia (Washington).

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