Month: April 2012

  •     By David Boundy — The Patent Office recently requested comment on the paperwork that applicants submit during post-filing, pre-allowance patent prosecution (Patent Processing (Updating), 77 Fed. Reg. 16813, Mar. 22, 2012).  This is a highly significant opportunity to seek reform of problematic PTO regulations, one that only comes once every three years.  This comment period…

  • By Kevin E. Noonan — On April 17th, the Supreme Court overturned a Federal Circuit decision construing statutory language involving the 2003 Medicare Prescription Drug Improvement and Modernization Act, which amended the 1984 Drug Price Competition and Patent Term Restoration Act (colloquially known as the Hatch-Waxman Act).  The decision was certainly not a surprise, to…

  • By Donald Zuhn — In a Citizen Petition filed with the U.S. Food and Drug Administration on April 2, Abbott Laboratories requested that the FDA refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act (BPCIA) that cite reference products (biologics) for which a biologics license application (BLA) was submitted to the FDA…

  • By Sherri Oslick — About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases. Enzo Life Sciences Inc. v. Affymetrix Inc.1:12-cv-00433; filed April 6, 2012 in the District Court of Delaware Enzo Life Sciences Inc. v. Agilent Technologies Inc.1:12-cv-00434; filed April 6, 2012 in the District Court of Delaware …

  • April 24, 2012 – Patent Law in Light of Mayo v. Prometheus: Claims to Laws of Nature Are Not Patentable (American Bar Association) – 1:00 – 2:30 pm (EDT) April 24-25, 2012 – Paragraph IV Disputes*** (American Conference Institute) – New York, NY April 26, 2012 – Moving From First to Invent to First to…

  • American Conference Institute (ACI) will be holding the next session of its Hatch-Waxman Boot Camp conference on June 25-26, 2012 in San Diego, CA.  ACI faculty will help attendees: • Comprehend how recent biosimilars legislation is changing industry dynamics;• Understand the interplay of between the PTO and FDA in the patenting of drugs and biologics;•…

  • The George Washington University Law School (with Mayer Brown and Cornerstone Research) will be holding its annual GW Law Symposium on Intellectual Property on May 8, 2012 at The George Washington University Law School, 2000 H Street NW, Washington, DC.  The Symposium will offer presentations on the following topics: • Keynote Address — Janet Gongola,…

  • C5 (UK) will be holding its 11th International Forum on Pharma Patent Lifecycles on June 20-21, 2012 in London, England.  The conference will provide practical and strategic guidance on patent lifecycle extensions, including: • Recent SPC case law developments and their implications on the industry;• Maximizing exclusivity for new medical products in light of regulatory…

  • By Kevin E. Noonan — That rarest of rara aves issued from the Supreme Court yesterday, an affirmance of a Federal Circuit opinion in Kappos v. Hyatt.  Perhaps it is because, as in Stanford v. Roche one of the parties was the government (here, Director David Kappos representing the U.S. Patent and Trademark Office, perhaps…

  • By Sherri Oslick — In an effort to catch up with recently filed biotech and pharma cases, Patent Docs presents this additional installment of Court Report. AR Holding Co. Inc. v. Par Pharmaceutical Inc.1:12-cv-00419; filed April 4, 2012 in the District Court of Delaware Infringement of U.S Patent Nos. 7,619,004 ("Methods for Concomitant Administration of…