The Federal Circuit Court of Appeals invalidated two patents held by Paris-based Sanofi. In a ruling earlier this week, the appellate court concluded that the patents on the Taxotere cancer treatment drug were invalid.
The patents in question are patent numbers 5,714,512 and 5,750,561.
The ruling upholds a lower court ruling invalidating the patents and holding them unenforceable. The reasoning behind the lower court decision was that Sanofi obtained the patents improperly, reports Reuters.
The appellate decision stems from the 2008 lawsuit by Sanofi against Hospira and Apotex. Sanofi sued Hospira and Apotex after the two companies tried to get approval on a generic injectable form of docetaxel. Docetaxel is the active ingredient in Taxotere.
Taxotere has been a cash cow for Sanofi, bringing in $1.2 billion last year. But the two patents were obvious variations of earlier research, the Federal Circuit Court of Appeals ruled.
In its ruling, the Court of Appeals held that the patents were unenforceable for inequitable conduct. The standard for inequitable conduct was set in Therasense v. Becton Dickinson. Essentially, an applicant for a patent may not withhold any reference known to be inconsistent with a position taken by the applicant for a patent, if that reference could lead to a rejection of the patents.
Sanofi withheld the information on the earlier research from the USPTO; as a result, the court held the patents to be invalid.
The ruling could now open the door to generic versions of the drug, which is a huge win for the generic pharmaceutical industry, but a major blow to Sanofi.