Replies to post #62618 on Biotech Values

[lewes]

Thanks - that was rather dry -
lewes

[DewDiligence]

Court Affirms Against Sanofi in Lovenox Case

[Does the dissenting vote in the 2-1 decision have any ramifications? Comments?]

http://www.reuters.com/article/marketsNews/idINN1449475820080514

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Wed May 14, 2008 2:37pm EDT

WASHINGTON, May 14 (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 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."

The ruling was accompanied by a dissent [i.e. the vote was 2-1], in which a judge argued 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.

A Sanofi spokesman did not have an immediate comment. A Teva spokeswoman had no comment. A spokesman for Amphastar said the company is pleased with the decision [LOL].

The U.S. Food and Drug Administration has not yet cleared any company to produce a generic form of Lovenox.

Making a generic form 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.

Last year, the FDA rejected a bid by Momenta Pharmaceuticals Inc (MNTA) and a unit of Novartis (NVS) 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 company said the FDA was still reviewing its application and said it would submit additional data to the agency in the third quarter.
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[DewDiligence]

Sanofi finally got around to announcing the Lovenox patent decision:

http://biz.yahoo.com/prnews/080515/nyth130.html

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District Court Decision Affirmed in U.S. Lovenox® (enoxaparin sodium) Patent Infringement Case

Thursday May 15, 12:28 pm ET

PARIS, May 15 /PRNewswire-FirstCall/ -- Sanofi-aventis announced that the U.S. Court of Appeals for the Federal Circuit has affirmed the February 8, 2007 decision by the U.S. District Court for the Central District of California in the sanofi-aventis Lovenox® patent infringement suit against Amphastar and Teva.

As a result of the Court of Appeals' ruling, the U.S. Lovenox® patent is deemed to be unenforceable.

Sanofi-aventis is considering all its legal options.

While several generic manufacturers have requested marketing approval from the FDA for their products alleged to be generic versions of Lovenox®, sanofi-aventis has not learned of any FDA approval of these requests.
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[DewDiligence]

North et al: What is the deadline for SNY to request a rehearing? T.i.a.