FDA denies Watson exclusivity on diabetes drug, prompting lawsuit

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Regulator action could give competitors six-month head start on sales of generic version of Actos, which an intellectual property expert called “a wrecking ball aimed at their house.”

Parsippany-based Watson Pharmaceuticals Inc. has sued the U.S. Food and Drug Administration for denying its exclusivity period with three other pharmaceutical companies to launch the first federally approved generic version of a diabetes drug.

Watson planned to introduce its generic version of Takeda Global Research & Development Center Inc.‘s brand-name Actos drug on Aug. 17 and share a six-month exclusivity period with Teva Pharmaceutical Industries Ltd., Mylan Inc. and Ranbaxy Laboratories Ltd., which all simultaneously submitted abbreviated new drug applications, or ANDAs, to the FDA for generic rights on July 15, 2003.

But the FDA refused to approve Watson’s ANDA, which could delay the launch of its generic candidate for at least six months.

“One player now has 100 percent of this market, and that’s Takeda with its Actos drug. You get up to 30 percent of the market share within a year of a generic’s launch, but each entrant after that period is only going to get a little piece of it — so that 180-day head start is huge,” said Gerard P. Norton, chair of the intellectual property department at Fox Rothschild LLP, in Lawrenceville. “If Watson has to wait those six months while the other three companies capture the market share, you can bet it’s going to be in a position to fight (in court). Every day your drug is not on the market, it’s a disadvantage to your company.”

In its refusal to grant Watson access to the six-month exclusivity period, the FDA argued the company did not properly reinstate certain patent certifications from its original ANDA, though Watson only altered its application under the FDA’s instruction — changes that ultimately caused Takeda to sue the company for patent infringement. Watson argues it did properly refile the certifications following the settlement agreement that resulted from Takeda’s lawsuit, and is entitled to at least shared exclusivity.

Norton said such arguments against the FDA are not uncommon, as similar controversy involving generic versions of multibillion-dollar brand-name profit engines like Pfizer Inc.‘s Lipitor and Teva subsidiary Cephalon Inc.’s Provigil have cropped up in the past year.

Takeda’s Actos had total U.S. sales of approximately $2.7 billion over a 12-month period ending May 31, according to IMS Health.

In addition to its complaint, Watson filed a motion for a temporary restraining order and a preliminary injunction in the U.S. District Court of Washington, D.C., to require the FDA to approve its generic Actos application if the agency grants final approval to any other company’s ANDA. The court today heard and denied the motion without prejudice, and Norton said it would be a smart move if Watson brought the motion again.

“Anytime the FDA rules like this, it’s adverse to the drug company,” Norton said. “There’s a wrecking ball aimed at their house. It’s a good idea for them to seek immediate relief.”

Still, Norton said, “by the time this case goes to trial, it’s going to be more than six months from now.”