Sanofi-Aventis SA (SAN), France's biggest pharmaceutical company, lost an appeals court bid to revive patents on its biggest product, the blood-thinner Lovenox, so it could block generic competition.
U.S. Court of Appeals for the Federal Circuit today upheld a lower court ruling that the patents on the drug can't be enforced as punishment because Sanofi misled the Patent and Trademark Office in order to obtain them.
Lovenox generated 2.6 billion euros ($4 billion) in 2007 sales for Paris-based Sanofi. The patents cover enoxaparin sodium, the active ingredient in Lovenox and would have kept generic versions off the market until 2012.
The decision is a victory for Amphastar Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd. (TEVA:US) in their efforts to sell generic copies of the drug. It's also a victory for Cambridge, Massachusetts-based Momenta Pharmaceuticals Inc. (MNTA:US), which is seeking U.S. Food and Drug Administration approval to sell a variation of Lovenox.
Novartis AG's Sandoz unit, the world's second-biggest generic-drug maker behind Petah Tikva, Israel-based Teva, also has been sued by Sanofi over its bid to sell a Lovenox copy. That case is before U.S. District Judge Mariana Pfaelzer in Los Angeles, who had ruled the drug patents unenforceable in the Amphastar case and was upheld today.
No Generic U.S. Approval
Sanofi spokesman Marc Greene said the company may ask the Federal Circuit to reconsider its decision.
``The company is disappointed with the ruling and we are presently evaluating all our legal options,'' he said in an e- mail. ``To the best of our knowledge, the FDA has not approved anybody's generic enoxaparin sodium for the U.S. market.''
Teva spokeswoman Denise Bradley said the company had no comment.
Sanofi American depositary receipts, two of which represent one ordinary share, rose 59 cents to $37.54 in New York Stock Exchange composite trading. Teva ADRs, each representing one ordinary share, rose 12 cents to $44.97 in Nasdaq Stock Market composite trading.
Watson Pharmaceuticals Inc., which has an agreement with Amphastar over Lovenox, rose 81 cents to $28.55 on the NYSE. Momenta rose 27 cents to $13.70 on the Nasdaq.
The case is Aventis Pharma SA v. Amphastar Pharmaceuticals Inc., 2007-1280, U.S. Court of Appeals for the Federal Circuit. The lower court is Aventis Pharma SA v. Amphastar Pharmaceuticals Inc., 03cv887, U.S. District Court for the Central District of California (Los Angeles).
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