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Updated Court Comments:


2:03pm EDT
Tue Aug 17, 2010 3:03pm EDT

* Judge will decide as soon as he can in Sanofi case

* Judge offers no other specifics after hearing (Adds remarks by judge, Sanofi and FDA lawyers; byline)

By Jeremy Pelofsky

WASHINGTON, Aug 17 (Reuters) - A U.S. judge said on Tuesday that he would rule as soon as possible on a request to block the sale of a generic version of Sanofi-Aventis' (SASY.PA) blood thinner drug being marketed by Novartis AG's (NOVN.VX) Sandoz unit and Momenta Inc (MNTA.O).

U.S. Judge Emmet Sullivan said he would "issue an appropriate decision as soon as I can" on Sanofi's request to block the generic version of Lovenox that Sandoz is already selling, but he offered no insight into which way he would rule.

The U.S. Food and Drug Administration approved the generic blood thinner last month and three days later Sanofi sought a preliminary injunction, saying the agency failed to follow its procedures or ensure the generic drug had the same active ingredient as its widely used Lovenox.

"Here the FDA took a shortcut," Emily Johnson Henn, a lawyer for Sanofi, told the judge, pointing to questions that the FDA raised about the safety of Sandoz's medicine during the approval process and testing it demanded of the company.

She said that because the FDA sought testing information, it should have used a different approval process which would have had more in-depth analysis of the proposed generic.

The FDA argued that the agency had an obligation to ask questions about the safety of the medicine during the approval process and that was permitted under the review process it used for Sandoz's generic blood thinner medicine.

It was "absolutely within the FDA's discretion," said Andrew Clark, a Justice Department lawyer arguing on behalf of the FDA. He also argued that the court owed the agency significant deference on such scientific matters.

The approval also marked the first time the FDA had approved a generic for that kind of complex medicine, which some analysts say could signal the agency is going to start clearing other generics that involve complex compounds.

However, the FDA's lawyer urged caution on that point, telling the court "we wouldn't share that view."

Sandoz began selling its generic blood thinning medicine immediately after winning FDA approval, which Sanofi argued to the court would cause the pharmaceutical company irreparable harm.

After the FDA's approval, Sanofi warned that its earnings would drop as much as 4 percent this year and saw its shares fall as a result. The company had net sales of 3 billion euros of Lovenox in 2009, 60 percent of which was in the United States.

Other companies are awaiting FDA action on their applications to produce their own generic versions of Lovenox, including Teva Pharmaceutical Industries Ltd (TEVA.O) and a partnership involving Watson Pharmaceuticals Inc (WPI.N) and Amphastar Pharmaceuticals.

But the government lawyer tried to cast doubt on how large of an impact it would have on Sanofi. "It's going to cost a lot of money, but it's not going to put them out of business," Clark said.

A lawyer for Sandoz said it too could suffer harm if an injunction was granted because it already has begun selling the drug.

The generic costs about 30 percent to 35 percent less than the Sanofi brand medicine, but neither Sanofi or Sandoz could tell the judge how much the medicine actually costs consumers, drawing laughter and some ire from the judge.

"I guess I'll have to call CVS," Sullivan said, referring to the No. 2 drugstore chain CVS Caremark (CVS.N). (Additional reporting by Susan Heavey; Editing by Lisa Von Ahn and Richard Chang)

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