Month: August 2013

  • The Institute for International Research (IIR) will be holding its 14th Annual Business of Biosimilars conference from October 15-17, 2013 in Boston, MA.  The conference will allow attendees to: • Navigate the EMEA approval pathway for monoclonal antibodies• Conduct structural and PK/PD comparability assessments• Overcome the science and complexity of indication extrapolation• Define the role…

  • By Andrew Williams — As we previously reported, the Supreme Court granted certiorari in the Medtronic Inc. v. Boston Scientific Corp. case, where the sole issue on appeal is whether the burden of proof shifts in a declaratory judgment action brought by a licensee under Medlmmune, such that the licensee has the burden to prove…

  • By Kevin E. Noonan — The Federal Circuit vacated and remanded a District Court decision denying a preliminary injunction to patentee Sequenom over the claims of U.S. Patent No. 6,258,540.  While the Court rendered its decision based on traditional principles of claim construction and the lower court's balancing of the equitable factors considered for granting…

  • By Josh Rich — The first United States Intellectual Enforcement Property Coordinator ("IPEC"), Victoria Espinel (at right), has stepped down after four years in the position.  During her tenure, Ms. Espinel worked to strengthen enforcement of intellectual property rights in the United States, at its borders, and overseas.  Howard Shelanski, the recently confirmed administrator of…

  • By Kevin E. Noonan — The Federal Circuit's jurisprudence regarding obviousness as determined by the U.S. Patent and Trademark Office continues its post-KSR development in Leo Pharmaceutical Products, Ltd. v. Rea, which involves an obviousness determination by the Office in an inter partes reexamination.  The Court reversed the Office's obviousness rejection as a matter of…

  • By Donald Zuhn — In a paper published in March in the journal Genome Medicine, Dr. Jeffrey Rosenfeld of the University of Medicine & Dentistry of New Jersey and Dr. Christopher Mason of Cornell University contended that due to the non-specificity of sequence uniqueness across the genome and the broad scope of claims to nucleotide…

  • By Sherri Oslick — About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases. Exela Pharma Sciences, LLC v. EKR Therapeutics, LLC et al.5:13-cv-00111; filed August 8, 2013 in the Western District of North Carolina • Plaintiff:  Exela Pharma Sciences, LLC• Defendants:  EKR Therapeutics, LLC; Cornerstone Therapeutics Inc.; Cornerstone…

  • August 21, 2013 – Inducement to Infringe in Hatch-Waxman Litigation: Lessons from Commil USA v. Cisco Systems and Bayer Schering v. Lupin for Pharma Patents (Strafford) – 1:00 to 2:30 pm (EDT) August 22, 2013 – What are the Implications of CLS Bank Int'l v. Alice Corp. on Computer-Implemented Inventions? (McDonnell Boehnen Hulbert & Berghoff…

  • DuPont and the Widener University School of Law will be holding the 2013 Intellectual Property Continuing Legal Education Seminar on October 1, 2013 at The DuPont Country Club in Wilmington, Delaware.  Among the presentations being offered at the seminar will be: • Learning from the 2013 Supreme Court Decisions — to be presented by Patent…

  • By Andrew Williams — When assessing the validity of a patent, you cannot ignore the dependent claims.  That was the main takeaway from the recent Federal Circuit case, Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc.  In that case, the lower court had invalidated all of the asserted claims of two…