The Supreme Court told Sanofi-Aventis to throw in the towel on Lovenox. The company has been fighting to protect its patent on the blood thinner, but the U.S. high court said it wouldn't even consider overturning a lower-court ruling against patent coverage.
As you may recall, that lower court decided that a Sanofi scientist had intentionally misled the U.S. Patent Office about Lovenox, by withholding evidence. Because of that deception, the court ruled the patent invalid under "inequitable misconduct."
It's a blow to Sanofi, which reaped some $3.5 billion from Lovenox last year, and a potential boon to a host of generics firms that are waiting in the wings with Lovenox copycats. None of the generics makers yet have FDA approval, however, so don't look for an immediate launch. Among those with versions awaiting the FDA nod are Teva Pharmaceutical Industries, Hospira and a Sandoz/Momenta Pharmaceuticals joint effort.
Amphastar Pharmaceuticals has first-to-file honors, so it had 180-day market exclusivity--but as the Wall Street Journal reports, that time period came and went before the FDA OK'd its version. Which generics maker will get to market first, then, is anybody's guess at this point.
- see the WSJ story