Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

Month: October 2010

  • Federal Circuit Denies Andrx Mandamus Petition in Omeprazole Litigation

    In re Andrx Pharmaceuticals, Inc., Misc. Docket No. 943 (Fed. Cir. 2010) In 2002, Astra prevailed over Andrx in Paragraph IV litigation concerning Andrx's ANDA for a generic version of Prilosec (omeprazole).  Shortly before and during the course of the bench trial, Astra learned that Andrx had manufactured multiple batches of its ANDA product on…

  • Declaratory Judgment Jurisdiction for Subsequent Paragraph IV Filers

    Teva Pharms. USA v. Eisai et al., No. 2009-1593 (Fed. Cir. 2010) In a 3-0 decision last week, the Federal Circuit held that Teva has standing to challenge four of Eisai’s Orange Book-listed patents on Aricept (donepezil)–notwithstanding that Eisai statutorily disclaimed two of the patents and granted Teva covenants not to sue on the others.  The Federal…