Month: July 2007

  •     By Donald Zuhn — Last week, the U.S. Senate Committee on Health, Education, Labor & Pensions announced that it had passed the Biologics Price Competition and Innovation Act.  According to a Committee press release, the bill (S. 1695) "includes standards for the FDA to approve follow-on biologics, a procedure designed to help resolve…

  •     By Donald Zuhn — Last Thursday, the Federal Circuit upheld a judgment from a District Court that Defendant-Appellant Alphapharm Pty., Inc. had failed to prove invalidity and unenforceability of claims 1, 2, and 5 of U.S. Patent No. 4,687,777 (the ‘777 patent).  Specifically, the Federal Circuit held that the District Court did not…

  •     By Kevin E. Noonan — Although it is well past time to stop the hypocrisy over stem cell patents (see Part I and Part II of this series), the forces aligned against the Thomson human embryonic stem cell patents refuse to do so.  This was made evident again this week, when additional voices,…

  • American Conference Institute (ACI) will be holding its 9th Advanced Forum on Biotech Patents: Analysis, Insights and Strategies for New Challenges in Biotech Patent Practice on September 26-27, 2007 in Boston, MA.  The conference will provide practical and tactical advice for adapting current biotech practices to account for follow-on biologics, addressing ethical and practical concerns…

  •     By Donald Zuhn — Valeant Pharmaceuticals International announced today (July 2, 2007) that it has settled its patent infringement suit with Kali Laboratories, Inc. (which was acquired by Par Pharmaceutical in June of 2004).  Valeant’s patent infringement action involved Diastat®, which Valeant markets as the only FDA-approved at-home acute treatment for break-through epileptic…

  •     By Christopher P. Singer — In a July 2, 2007 press release, Introgen Therapeutics, Inc. announced that the U.S. Patent Office has issued U.S. Patent No. 7,235,391, entitled "Formulations of Adenovirus for Gene Therapy."  The general technology covered by the patent relates to pharmaceutical formulations containing adenoviruses that have improved shipping and long…

  • American Conference Institute (ACI) will be holding its fall session of the Pharma/Biotech Patent Boot Camp on September 18-19, 2007 in San Francisco, CA.  The conference will focus on the interplay of the Patent and Trademark Office (PTO) and Food and Drug Administration (FDA) in the patenting of drugs and biologics as well as on…

  •     By Jason Derry — On July 8, 2007, the Patent Office will release the next version of EFS-Web.  As indicated on the Patent Office website, the new features associated with the release will make it possible to: E-file Reissue and Reexam applications and follow-on documents; Select Accelerated Examination; Select only from a list…

  •     By Kevin E. Noonan — The hostility of The New York Times to patents in general (and gene patenting in particular) has been well documented (see "Anti-Patent (‘Sullivan?’) Malice by The New York Times" and "Science Fiction in The New York Times").  However, until now this bias has been confined to the editorial…

  •     By Sherri Oslick — About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Astrazeneca Pharmaceuticals LP et. al. v. Teva Pharmaceuticals USA, Inc. et. al.3:07-cv-03001; filed June 28, 2007 in the District Court of New…