Category: Biosimilars

  •     By Donald Zuhn — While the recession has certainly had an effect on biotech/pharma patent filings, the recession appears to have had little impact on lobbying expenditures in the biotech/pharma industry.  With the reporting period for first quarter lobbying now passed, many biotech/pharma companies and organizations not only kept pace with, but handily surpassed,…

  •     By Kevin E. Noonan — If behavior can inform belief, it may be getting less and less likely that H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act," has any reasonable chance of passing in this Congress.  The bill, introduced on March 11, 2009 by House Committee on Energy and Commerce Chairman…

  •     By Kevin E. Noonan — Last week, Biogen Idec sponsored a "Super Session" at the BIO 2009 International Conference entitled "Weathering the Perfect Storm of Financial Distress and Political Pressure."  The session was moderated by Stephen Sands, Lazard Freres & Co., for a panel consisting of Broderick D. Johnson, Bryan Cave; Scott Gottlieb M.D.,…

  •     By Kevin E. Noonan — Last week, Eli Lilly & Co. sponsored a "Super Session" at the BIO 2009 International Conference entitled "Biotechnology Intellectual Property at the Crossroads."  The session was moderated by John Lechleiter, President and Chief Executive Officer at Lilly, for a panel consisting of Robert Armitage, Lilly's General Counsel; Gregory Glover…

  •     By Sherri Oslick — In a Breakout Session held last Wednesday at BIO 2009, a panel consisting of David Bassett, a Partner at WilmerHale; Genia Long, Managing Principal at Analysis Group; David Ridley, Assistant Professor of Business Administration at the Fuqua School of Business at Duke University; David Korn, Sr. Assistant General Counsel for…

  •     By Kevin E. Noonan — Last Friday, the Biotechnology Industry Organization (BIO) presented its members-only 2009 Spring IP Policy Briefing to member companies, particularly directed to member law firms.  The presentation was moderated by Lila Feisee, BIO's Managing Director, Intellectual Property.  The briefing included discussions on Membership Benefits, U.S. court cases, biosimilars and patent…

  •     By Donald Zuhn — Earlier today, California Healthcare Institute president and CEO Dr. David Gollaher provided Patent Docs with an update regarding the status of patent reform and follow-on biologics legislation in the 111th Congress.  The California Healthcare Institute (CHI) is an independent organization comprising more than 250 biomedical companies and academic and research…

  •     By Donald Zuhn — Johnson & Johnson:  5-Year Exclusivity Period Would Kill Incentives to Innovate Last month, Amgen Inc. Vice President Stuart Watt asserted that any follow-on biologics regulatory pathway established by Congress would have to specify an exclusivity period of at least 12 years in order to provide incentives to innovator drug companies…

  •     By Donald Zuhn — For the past two years, much of the debate surrounding the various follow-on biologics bills that have been introduced in Congress has centered on the exclusivity periods provided by each bill.  So far, three follow-on biologics bills have been introduced in the 111th Congress:  H.R. 1427 and its companion bill,…

  •     By Donald Zuhn — Last Thursday, Senator Charles Schumer (D-NY) (at right) introduced the Promoting Innovation and Access to Life-Saving Medicine Act (S. 726), the first follow-on biologics bill to be introduced in the Senate and third follow-on biologics bill to be introduced in the 111th Congress.  The new bill is the Senate companion…