Category: Hatch-Waxman

  • By Donald Zuhn — Last week, Senator Herb Kohl (D-WI) (at right) introduced the Preserve Access to Affordable Generics Act (S. 27) in the Senate.  The bill, which is co-sponsored by Senators Sherrod Brown (D-OH), Susan Collins (R-ME), Richard Durbin (D-IL), Al Franken (D-MN), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Bernard Sanders (I-VT), is…

  • By Kevin E. Noonan — An enduring trope in literature from all civilizations is the efforts of one generation to make conditions and prospects better for the next generation.  That parents care for their children has been explained as "human nature," sound economics, or biologically determined altruism (thereby extending the lifespan of one-half of one's…

  • By Donald Zuhn — Reflecting upon the events of the past twelve months, Patent Docs presents its fourth annual list of top biotech/pharma patent stories.  For 2010, we identified a dozen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent…

  • By Donald Zuhn — Last week, in Sanofi-Aventis v. Sandoz, Inc., the Federal Circuit vacated the entry of a consent judgment and an injunction by the District Court for the District of New Jersey, which enjoined Defendants-Appellants Sun Pharmaceutical Industries, Ltd. and Caraco Pharmaceutical Laboratories, Ltd. ("Sun") from manufacturing and selling a generic version of…

  • By Kevin E. Noonan — The Federal Trade Commission is nothing if not persistent in trying to eliminate "reverse payment" settlements in ANDA litigation, even going so far as to "forum shop" to do so, according to a brief by appellees Unimed Pharmaceuticals LLC, Abbott Products, Inc., and Watson Pharmaceuticals, Inc.  In their responsive brief in…

  • By Kevin E. Noonan — The Federal Circuit expanded the scope of Article III jurisdiction under the Declaratory Judgment Act (28 U.S.C. § 2201) in the Hatch-Waxman context in Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd.  Specifically, the Court held that listing patents on the Orange Book could provide a sufficient injury-in-fact for an…