Tuesday, April 11, 2006

Sanofi defeats Teva in Lovenox case as to SJ of inequitable conduct

In a rather uncommon event, a judge in CD Cal had found, on summary judgment, a US patent (5,389,618) unenforceable for inequitable conduct. In a nonprecedential decision, the CAFC reversed and remanded on the basis that genuine issues of fact were present as to intent to deceive.

The CAFC reviewed the grant of summary judgment under the law of the regional circuit, citing to Collegenet, 418 F.3d 1225.

As to the contours of inequitable conduct, the CAFC cited to Purdue, 438 F.3d 1123.
For "balancing," the CAFC cited to Digital Control, 437 F.3d 1309. For the separate requirement of intent, the CAFC cited to GFI, 265 F.3d 1268.

The CAFC found that Aventis had met its burden of setting forth a plausible explanation for its failure to disclose material information, thereby defeating summary judgment. This, of course, does not mean Aventis will win at trial.

The CAFC found that the arguments of Aventis were not conclusory allegations and attorney arguments, citing to Ferring v. Barr, 437 F.3d 1181.


A U.S. federal court on April 10, 2006 reversed a lower court decision invalidating Sanofi-Aventis' patent for blood thinner Lovenox, a win for the world's third-largest drug maker. [IPBiz note: the district court had held the patent unenforceable, not invalid.]

The ruling is a setback to generic companies Teva Pharmaceutical Industries and privately held Amphastar Pharmaceuticals, which are trying to sell cheaper versions of the drug in the United States.

The ruling by the U.S. Court of Appeals for the Federal Circuit [CAFC] in Washington reversed the invalidation of Sanofi's Lovenox patent by a district court and threw the decision back to it for further proceedings.

In June, a U.S. District Court in California had granted the generic drug makers summary judgment invalidating the patent.

Lovenox was originally sold by Aventis, which Sanofi acquired in 2004. The drug generated U.S. sales of $1.4 billion that year.

The U.S. Court of Appeals said it was not convinced Aventis intended to deceive the U.S. Patent and Trademark Office, as the generic drug makers had claimed.

From TradingMarkets:

The U.S. District Court had previously ruled on summary judgment that the sanofi-aventis patent asserted in that suit was unenforceable. Sanofi-aventis filed an appeal of the District Court's decision on August 1, 2005.


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