Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

Category: Inequitable Conduct

  • Motion to Amend Pleadings to Assert Inequitable Conduct Denied in Rapamycin Case

    Pfizer Inc. v. Sandoz Inc., No. 12-654-GMS-MPT (D. Del.)     by Malaika D. Tyson Undue delay that resulted in prejudice to Pfizer coupled with failure to demonstrate good cause are some of the reasons why on November 4, 2013, Magistrate Judge Mary Pat Thynge issued a report and recommendation denying Sandoz’s motion to amend its…

  • District of Delaware Invalidates Entecavir Patent as Obvious

    Bristol-Myers Squibb v. Teva Pharms., No. 10-805-CJB (D. Del.)     by Aaron F. Barkoff Today, in the District of Delaware, Judge Burke issued a 171-page opinion holding that claim 8 of U.S. Patent No. 5,206,244, covering the entecavir molecule, is invalid as obvious.  Entecavir is the active ingredient in Baraclude tablets, which are indicated for…

  • Federal Circuit Affirms Unenforceability of TAXOTERE Patents

    Aventis Pharma S.A. et al. v. Hospira, Inc. et al., No. 2011-1018 (Fed. Cir.) In a precedential decision earlier this week, the Federal Circuit affirmed a district court decision holding two patents on TAXOTERE (docetaxel), U.S. Patent Nos. 5,750,561 and 5,714,512, unenforceable for inequitable conduct.  The Federal Circuit also affirmed findings that claim 5 of the…

  • En Banc Federal Circuit Reins In Inequitable Conduct

    Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc)     by Nabeela Rasheed In a landmark en banc decision today, the Federal Circuit rewrote the law of inequitable conduct.  This case was of great interest to the patent community, as evidenced by the 33 amicus briefs submitted.  From the pharmaceutical industry, amicus…