Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

Month: July 2008

  • ACI “Biotech Patents” Conference, Boston, September 15-16

    ACI’s “Biotech Patents” conference will be held at the Royal Sonesta Hotel in Boston, September 15-16.  According to ACI, this is the “ONE place biotech patent practitioners come to learn and discuss the most recent and vital changes facing the industry today.” The agenda includes several talks that look interesting: “Navigating the Board of Patent…

  • Federal Circuit Affirms Validity and Enforceability of Eisai’s Compound Patent on Aciphex

    Eisai v. Dr. Reddy’s and Teva, Nos. 2007-1397, -1398 (Fed. Cir. 2008) Patents on chemical compounds are holding up well to obviousness arguments in the Federal Circuit, even after KSR.  In an opinion released today, the Federal Circuit affirmed the nonobviousness of rabeprazole, the active ingredient in Aciphex.  This follows a decision last year affirming the nonobviousness…

  • OBB News Briefs

    Teva announced Friday that it is acquiring Barr Pharmaceuticals for $7.5 billion plus $1.5 billion in debt.  For more:  AP; Reuters; WSJ. Zentiva, the Czech generic drug maker, announced Friday that it rejected a takeover bid from Sanofi-Aventis.  Sanofi already owns 25% of the company. Meanwhile, the WSJ Health Blog recently reported that the CEOs…

  • C5 “Biotech Patenting” Conference, London, September 23-24

    C5 will be bringing its popular “Biotech Patenting” conference to London on September 23-24. According to C5, the conference “provides updates on the latest developments in biotech patenting, including recent case law and regulatory developments.”  The conference is unique in offering an international perspective on biotechnology patent law:  experts from Europe, Asia and the United…

  • Federal Circuit Vacates Dismissal of Delaratory Judgment Counterclaims in Fosamax Case as Moot

    Merck & Co. v. Apotex, No. 2007-1362 (Fed. Cir. 2008) Fosamax (alendronate sodium) is one of the all-time best-selling drugs for the treatment and prevention of osteoporosis, with over $3 billion in U.S. sales last year.  Merck listed ten patents in the Orange Book for Fosamax:  U.S. Patent No. 4,621,077, which claims a method of inhibiting bone resorption…

  • AstraZeneca Wins Seroquel Case on Summary Judgment; Teva and Sandoz to Appeal

    AstraZeneca v. Teva Pharms. USA and Sandoz, No. 05-5333 (D.N.J. 2008) On July 1st, the U.S. District Court for the District of New Jersey granted AstraZeneca’s motion for summary judgment that its patent on quetiapine fumarate, the active ingredient in Seroquel, is not unenforceable for inequitable conduct.  The decision disposed of the last remaining issue in…

  • Federal Circuit Affirms Acular LS Decision in Favor of Roche and Allergan, and Against Apotex

    Roche Palo Alto and Allergan v. Apotex, No. 2008-1021 (Fed. Cir. 2008) In an opinion released today , the Federal Circuit affirmed a district court decision granting summary judgment that Roche’s U.S. Patent No. 5,110,493 is valid and infringed by Apotex’s ANDA for a generic version of Acular LS (ketorolac tromethamine opthalmic solution).  Acular LS, marketed…

  • Book Review: Generic Pharmaceutical Patent and FDA Law

    Shashank Upadhye has written a new text, Generic Pharmaceutical Patent and FDA Law, that anyone reading Orange Book Blog will certainly find useful.  Mr. Upadhye is Vice President & Global Head of Intellectual Property for Apotex. The book provides a nice overview of patent law–especially as applied to pharmaceuticals–and the drug approval process.  In addition, it includes…

  • OBB News Briefs

    On June 25, the Congressional Budget Office released a cost estimate for the Biologics Price Competition and Innovation Act of 2007 (S. 1695), concluding that the biosimilars bill would save American consumers $25 billion on prescription drug costs over the next ten years.  For more: statements from BIO and PhRMA; FDA Legislative Watch; Pharmalot; The Hill’s Congress Blog. Bayer…

  • In a “Surprising” Victory, Barr and Mylan Invalidate Boehringer Ingelheim’s Patent on Mirapex

    Boehringer Ingelheim v. Barr and Mylan, No. 05-700-JJF (D. Del. 2008) Last week, following a bench trial held in March, the U.S. District Court for the District of Delaware held that Boehringer Ingelheim’s patent on Mirapex (pramipexole dihydrochloride) is invalid for obviousness-type double patenting.  Mirapex, indicated for the treatment of Parkinson’s disease and Restless Leg…