Sanofi-Aventis (NYSE: SNY) isn't giving up on protecting Lovenox from generic competition--not even after a federal judge refused its request for a preliminary injunction against the copycats. "The company's case against the FDA will continue to move forward," the company says in a statement.
Whether the case will get anywhere remains to be seen. The French drugmaker sued the FDA after the agency gave Sandoz the thumbs-up for its version of the blood thinner, an injectable drug that Sanofi considers too complex to be knocked off easily. Sanofi claims FDA didn't follow its own rules in approving the generic drug.
But Judge Emmet Sullivan disagreed. "Just because the FDA ... reached a conclusion at odds with the position advanced by Sanofi does not mean that the FDA's decision was arbitrary and capricious," Sullivan says in his ruling (as quoted by the Wall Street Journal).
Sanofi maintains the court didn't rule on the merits of its suit against FDA. In its statement, Sanofi notes that the case "poses a number of significant questions regarding the FDA review process for complex pharmaceutical products which are important to pursue." That's precisely why the industry is keeping such close tabs on this case.
- check out the Sanofi press release
- read Momenta's reaction
- see the news from Reuters
- read the WSJ story
- get more from Bloomberg