Federal Circuit Affirms Inequitable Conduct Judgment for Nondisclosure of Material References


The Court of Appeals for the Federal Circuit recently affirmed a District Court’s judgment of inequitable conduct based on the patent applicant’s failure to disclose to the U.S. Patent and Trademark Office (USPTO) references that rendered two patents invalid for obviousness under 35 U.S.C. § 103. The decision in Aventis Pharma S.A., et al. v. Hospira, Inc., No. 11- 1018 (Fed. Cir. Apr. 9, 2012) (available here), reaffirms the holding in Therasense, Inc. v. Becton, Dickinson & Co., No. 2008-1511 (Fed. Cir. May 25, 2011) (here) and provides additional guidance for conduct from which it may infer an intent to deceive the USPTO.

Aventis Pharma and Sanofi-Aventis U.S. (Sanofi) owns U.S. Patent Nos. 5,750,561 (“’561 Patent”) and 5,714,512 (“’512 Patent”) and is the New Drug Application holder for Taxotere. The ‘561 and ‘512 patents are pharmaceutical patents related to the administration of the chemotherapy cancer drug docetaxel, which is marketed under the brand-name Taxotere. Taxotere belongs to the class of compounds known as taxanes, which are administered intravenously by slowly delivering the drug in a diluted aqueous solution called a perfusion. Taxanes have low solubility in water and tend to precipitate. Surfactants and ethanol are added to Taxanes to stabilize the perfusion and delay the amount of time before precipitation occurs. In the prior art, the surfactant Cremophor was used with taxanes to form the stock solution, but it was known to trigger serious allergic reactions, including anaphylactic shock...

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