Healthy Skepticism Library item: 13667

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Publication type: news

Dixon K.
US court affirms against Sanofi in Lovenox case
Reuters 2008 May 14
http://uk.reuters.com/article/health/idUKN1449475820080514?pageNumber=1

Full text:

WASHINGTON (Reuters) – A U.S. federal court on Wednesday affirmed a ruling that Sanofi-Aventis SA intended to deceive the patent office in its dispute over generic versions of its blockbuster drug Lovenox.

Sanofi, the world’s third-biggest drugmaker, has sued Teva Pharmaceutical Industries Ltd and Amphastar Pharmaceuticals over their bid to sell a generic version of Sanofi’s Lovenox, a blood-thinning drug that had sales of about $1.1 billion in the first quarter of 2008.

The U.S. Court of Appeals for the Federal Circuit ruled that French drugmaker Sanofi-Aventis had committed “inequitable conduct” for failing to inform the U.S. patent office of information relevant to patentability.

The federal court affirmed the ruling by a district court in California that there was an intent to deceive by Sanofi-Aventis in its failing to disclose dosages of the drug in certain studies.

“After a trial on the matter, the district court found there was intent to deceive and held the patents unenforceable for inequitable conduct,” the court wrote.

“Because we find no abuse of discretion by the district court in its holding of inequitable conduct, we affirm.”

One judge dissented the ruling, arguing that inequitable conduct should be reserved for only the most extreme cases of fraud and deception, which he said did not apply in this case.

The dissent said the failure to disclose details on certain data by an Aventis scientist “may have been careless, but hardly culpable.”

Sanofi spokesman Marc Greene said the company was disappointed by the ruling. The company will consider its options, including requesting a rehearing en banc, or before a full court, as opposed to a three-judge panel that had ruled on this case.

The U.S. Food and Drug Administration has not cleared any generic form of Lovenox yet. Making a generic of the treatment will not be as straightforward as copying a traditional chemical-based drug. Lovenox is a large biological molecule that must be given by injection.

But the decision clears the way for the FDA to make that decision, according to Deutsche Bank.

A Teva spokeswoman had no comment. A spokesman for Amphastar said the company is pleased with the decision.

Last year, the FDA rejected a bid by Momenta Pharmaceuticals Inc and a unit of Novartis AG to sell a generic form of Lovenox.

Momenta said then the FDA cited failure to fully address concerns about the drug’s impact on the immune system. Late last month the firm said the FDA was still reviewing its application and that it would submit additional data to the agency in the third quarter.