U.S. COURT RULES AGAINST SANOFI-AVENTIS ON LOVENOX PATENT
A federal court has ruled against sanofi-aventis in its patent infringement suit against Amphastar and Teva, paving the way for the FDA to review generic versions of the anticoagulant drug Lovenox.
The U.S. District Court for the Central District of California ruled against sanofi-aventis in the firm's second legal defeat regarding Lovenox (enoxaparin sodium). Sanofi-aventis lost its first suit against Amphastar and Teva in a summary judgment, but an appeals court ruled in April that a full trial was necessary to determine if the patent was invalid due to inequitable conduct.
In that decision, the U.S. Court of Appeals for the Federal Circuit reversed and remanded a June 2005 summary judgment by the U.S. District Court for the Central District of California. The lower court had ruled the '618 patent on the active ingredient in Lovenox unenforceable because of inequitable conduct on the part of sanofi-aventis. The appellate court found that a full trial, rather than a summary judgment, was necessary to determine whether sanofi-aventis had engaged in inequitable conduct.
This month's trial was based on a reissued version of the '618 patent known as '743, sanofi-aventis said. While the reissued patent does not contain the section of the '618 patent around which the inequitable conduct claims were made, the '743 patent was still left vulnerable, Merrill Lynch analyst Graham Parry said last year.
Teva and Amphastar filed abbreviated new drug applications in June 2003 challenging
the Lovenox patent. Several companies have requested marketing approval from the
FDA for generic versions of Lovenox, sanofi-aventis said, but the company has
not learned of any FDA approvals of these requests.