A US federal court hasaffirmed a ruling that Sanofi-Aventis intended to deceive the US Patent & Trademark Office in its dispute over generic versions of its Lovenox blockbuster, Reuters writes. Sanofi had sued Teva and Amphastar over their attempt to sell a generic version of the best-selling blood thinner, which generated sales of $1.1 billion in this year's first quarter.
The US Court of Appeals for the Federal Circuit ruled that Sanofi had committed "inequitable conduct" for failing to inform the patent office of info relevant to patentability. The federal court affirmed the ruling by a district court in California that there was an intent to deceive by failing to disclose dosages of the drug in certain studies, Reuters reports.
"After a trial on the matter, the district court found there was intent to deceive and held the patents unenforceable for inequitable conduct," the court wrote. "Because we find no abuse of discretion by the district court in its holding of inequitable conduct, we affirm."
One judge dissented the ruling, arguing that inequitable conduct should be reserved for only the most extreme cases of fraud and deception, which he said did not apply in this case. The dissent said the failure to disclose details on certain data by an Aventis scientist "may have been careless, but hardly culpable."
Sanofi spokesman Marc Greene tells Reuters that the drugmaker was disappointed by the ruling, and will consider its options, including requesting a rehearing before a full court, as opposed to a three-judge panel that had ruled on this case.
The FDA hasn't cleared any generic form of Lovenox yet. Making a generic of the treatment will not be as straightforward as copying a traditional chemical-based drug, because Lovenox is a large biological molecule that must be given by injection, Reuters notes.
But the decision clears the way for the FDA to make that decision, according to Deutsche Bank. Spokespeople for Teva and Amphastar declined to comment to Reuters. Last year, the FDA rejected a bid by Momenta Pharmaceuticals and Sandoz to sell a generic form of Lovenox.
At the time, Momenta said the FDA cited failure to fully address concerns about the drug's impact on the immune system. Late last month, the drugmaker said the FDA was still reviewing its application and that it would submit additional data to the agency in the third quarter, according to Reuters.
Hat tip to the Orange Book blog