Month: May 2012

  • By Kevin E. Noonan — Less than a week after the Senate passed its version of a bill amending the user fee provisions of the Food, Drug and Cosmetic Act (FDCA) for funding FDA review of innovator and generic drugs, medical device and biosimilars (S. 3187; Food and Drug Administration Safety and Innovation Act), the…

  • By Kevin E. Noonan — One of the interesting and unresolved issues in the Association for Molecular Pathology v. U.S. Patent and Trademark Office case ("Myriad") involves whether the Federal Circuit, or any U.S. court, has jurisdiction to hear the case.  This issue is based on the Federal Circuit's determination, in its now-vacated decision in…

  • By Kevin E. Noonan — Much has been written about the biosimilar approval pathway contained in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  While the substantive provisions are still being worked out, one mundane and practical detail is how the government will pay for erecting and maintaining the regulatory edifice mandated under…

  • By Sherri Oslick — About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases. Cumberland Pharmaceuticals Inc. v. InnoPharma Inc.1:12-cv-00618; filed May 17, 2012 in the District Court of Delaware Cumberland Pharmaceuticals Inc. v. Paddock Laboratories LLC et al.1:12-cv-00619; filed May 17, 2012 in the District Court of Delaware…

  • June 1, 2012 – Understanding the America Invents Act: A Sweeping Change of U.S. Patent Prosecution Practice (American Bar Association (ABA) Section of Intellectual Property Law, Young Lawyers Division, and Center for Continuing Legal Education) – 1:00 – 2:30 pm (EDT) June 5, 2012 – Orange Book Use Codes: Impact of Caraco v. Novo Nordisk…

  • Technology Transfer Tactics will be offering a webinar entitled "The Elimination and Creation of Defenses in the Wake of AIA" on June 14, 2012 from 1:00 – 2:00 pm (Eastern).  U.S. and European patent attorney Robert Lelkes of Steffin Lelkes Azod, LLP will cover those portions of the Leahy-Smith America Invents Act that impact the…

  • American Conference Institute (ACI) will be holding its 6th National Tactical and Practical Guide to Freedom to Operate on July 30-31, 2012 in Philadelphia, PA.  The conference will allow attendees to: • Preserve privilege and confidentiality in freedom to operate opinions;• License your way out of trouble;• Analyze smart freedom to operate game plans post-America…

  • The U.S. Patent and Trademark Office has announced a revised agenda for the next biotechnology/ chemical/pharmaceutical (BCP) customer partnership meeting to be held on June 6, 2012.  New to the agenda is an afternoon session on the Recommendation for the Disclosure of Sequence Listings using XML (Proposed ST.26).  The time slots for a number of…

  • By Kevin E. Noonan — In April, the White House released a policy paper what was styled the "National Bioeconomy Blueprint."  Its presumptions are based on the idea that the portion of the economy "fueled by research and innovation in the biological sciences" is a "large and rapidly growing segment of the world economy that…

  • By Donald Zuhn — USPTO Releases Certain AIA Implementation Dates The U.S. Patent and Trademark Office recently updated its Leahy-Smith America Invents Act Implementation micro-site to announce several AIA implementation dates.  On the micro-site, USPTO Patent Reform Coordinator Janet Gongola (at right) indicated that the Office will submit its genetic testing study to Congress (pursuant…