Teva Sues FDA to Block Approval of Generic Copaxone

Teva Pharmaceutical Industries Ltd. sued U.S. regulators, seeking to block approval of a generic version of its multiple-sclerosis drug Copaxone, a product that accounts for more than half the company’s revenue and is set to go off patent on May 24.

Teva, based in Petach Tikva, Israel, contends in the complaint that U.S. Food and Drug Administration officials improperly dismissed the drugmaker’s calls to subject competitors’ generic versions of Copaxone to extensive testing before they go on the U.S. market.

The suit, filed in federal court in Washington, is the company’s latest move in its campaign to block generic rivals such as Mylan Inc. and Novartis AG’s Sandoz unit from putting out a less-expensive version of Copaxone. Last month, a U.S. Supreme Court justice rejected Teva’s bid for an injunction to prevent the sale of generic competitors’ products.

“Unless this court acts now, the FDA’s gamesmanship will preclude Teva from obtaining meaningful judicial review before the FDA allows these putative generic products to overwhelm the market,” the company said in the complaint.

Copaxone brings in $3.2 billion in annual U.S. sales and accounts for more than half of Teva’s profit. A delay would give Teva more time to switch patients from the 20-milligram dose that is slated to come off patent protection to a 40-milligram dose it says is covered by other patents until 2015.

Supreme Court

Sandy Walsh, an FDA spokeswoman, didn’t immediately return a call for comment on Teva’s Copaxone suit.

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

Sandoz, based in Basel, Switzerland, and Canonsburg, Pennsylvania-based Mylan originally were sued by Teva after they asked the FDA for approval of generic drugs to compete with Copaxone, prescribed to reduce the frequency of relapses in MS patients.

In yesterday’s suit, Teva officials said they filed a petition to require generic versions of Copaxone to undergo clinical-trial studies before being approved for sale. The FDA rejected that petition May 2 without addressing the merits of Teva’s request, according to the complaint.

“There is no question that the agency’s actions violate Teva’s statutory right to receive a decision on the merits of its petition within the law’s statutory” deadline, the company said in the complaint.

Teva faces “irreparable harm” if the court doesn’t block Copaxone’s generic competitors, according to the complaint. The drugmaker “stands to lose hundreds of millions of dollars within months of the FDA approving” the generic products, the company said.

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

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