Month: January 2013

  • By Donald Zuhn — Last month, the U.S. Food and Drug Administration released its annual report on innovative drug approvals, noting that the agency approved 35 novel medicines in FY 2012.  The 35 approvals equaled the number of approvals for FY 2011, and marked the highest number of approvals since the FDA approved 36 new…

  • By Donald Zuhn — Last Friday, the U.S. Patent and Trademark Office published a final rule in the Federal Register (78 Fed. Reg. 4212) setting and adjusting certain patent fees pursuant to the Office's fee-setting authority under § 10 of the Leahy-Smith America Invents Act.  The publication of the 80-page final rule (nearly) culminates a…

  • By Sherri Oslick — About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases. Cadence Pharmaceuticals, Inc. et al. v. Fresenius Kabi USA, LLC3:13-cv-00139; filed January 17, 2013 in the Southern District of California • Plaintiffs:  Cadence Pharmaceuticals, Inc.; SCR Pharmatop• Defendant:  Fresenius Kabi USA, LLC Infringement of U.S.…

  • January 22, 2013 – Top Patent Law Stories of 2012 (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT) January 22, 2013 – Patent Term Adjustments and Extensions: Recent Developments — Leveraging Exelixis, Other Court Decisions and Recent USPTO Rule Changes to Maximize PTAs and PTEs (Strafford) – 1:00 – 2:30 pm…

  • American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on March 19-20, 2013 in New York, NY.  ACI faculty will help attendees: • Master the basics of the application and approval processes for drugs, biologics, and devices;• Comprehend the structure of the FDA and the roles of the…

  • The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Patent Term Adjustment: An Update" on January 24, 2013 beginning at 2:00 pm (ET).  A panel consisting of Patricia Carson of Kirkland & Ellis, LLP; Adrian Looney of Pfizer, Inc.; and Eli Loots of Knobbe Martens Olson & Bear, LLP will consider: •…

  • The American Bar Association (ABA) Section of Intellectual Property Law, Section of Science and Technology, and Center for Professional Development will be offering a live webinar and teleconference entitled "Single Claim Restriction Requirements: 
The Interplay Between 35 USC Section 112 and 35 USC Section 121" on February 5, 2013 from 12:00 – 1:30 pm (Eastern). …

  • The Intellectual Property Law Association of Chicago (IPLAC) will be offering a program on "Coping With The New First-Inventor-to-File Prior Art Law: What Patent Prosecutors Need to Know and Do Before and After the Effective Date" on January 25, 2013 from 12:00 to 2:30 pm (Central) at the DePaul University Law School in Chicago, IL. …

  • By Kevin E. Noonan — As it has frequently in the past decade, the Federal Trade Commission on Thursday released a Report on the frequency of reverse payment settlement agreements in ANDA litigation between generic and branded drug makers, pursuant to its authority to scrutinize all ANDA agreements under the provisions of the Medicare Modernization…

  • By Donald Zuhn — Last month, the World Intellectual Property Organization (WIPO) issued a report indicating that worldwide intellectual property filings showed strong growth in 2011 despite a global economy that continued to underperform.  In particular, the report on 2012 World Intellectual Property Indicators notes that patent filings grew by 7.8% in 2011, the second…