Category: Food and Drug Administration

  •     By Kevin E. Noonan — In a recent article in the journal Science, Sherry Knowles, the Chief Patent Counsel at GlaxoSmithKline, raises several interesting questions regarding the concept of "takings" of property in the patent context.  In a "Policy Forum" article entitled "Fixing the Legal Framework for Pharmaceutical Research," Ms. Knowles (at right) tackles…

  •     By Donald Zuhn — On Sunday night, the House of Representatives voted by a narrow 219-212 margin to agree to the version of the Patient Protection and Affordable Care Act (H.R. 3590) that the Senate passed on December 24, 2009 (see "Follow-on Biologics News Briefs – No. 11").  Less than an hour later, the…

  • Are the Courts or the FTC Misapplying the Law?     By Kevin E. Noonan — In its report on so-called "pay for delay" settlements of ANDA litigation (otherwise known as "reverse payments"), the Federal Trade Commission (FTC) is calling for an outright ban on such agreements.  Settlements containing "reverse payments" involved payments from the patent-…

  • Are the Courts or the FTC Misapplying the Law?     By Kevin E. Noonan — In its report on so-called "pay for delay" settlements of ANDA litigation (otherwise known as "reverse payments"), the Federal Trade Commission (FTC) is calling for an outright ban on such agreements.  Settlements containing "reverse payments" involved payments from the patent-…

  •     By Donald Zuhn — President Obama's new proposal for health care reform was unveiled on the White House website earlier this week.  According to the White House, the President's plan "builds off of the legislation that passed the Senate and improves on it by bridging key differences between the House and the Senate as…

  • Are the Courts or the FTC Misapplying the Law?     By Kevin E. Noonan — In its report on so-called "pay for delay" settlements of ANDA litigation (otherwise known as "reverse payments"), the Federal Trade Commission (FTC) is calling for an outright ban on such agreements.  Settlements containing "reverse payments" involved payments from the patent-…

  • Are the Courts or the FTC Misapplying the Law?     By Kevin E. Noonan — In its report on so-called "pay for delay" settlements of ANDA litigation (otherwise known as "reverse payments"), the Federal Trade Commission (FTC) is calling for an outright ban on such agreements.  Settlements containing "reverse payments" involved payments from the patent-…

  •     By Kevin E. Noonan — Last month, the Federal Trade Commission released a report about so-called "pay for delay" arrangements, agreements between branded pharmaceutical companies and generic drug companies that delay entry of generic versions of branded drugs.  The FTC's position is clear from the title of the Report:  "Pay-for-Delay: How Drug Company Pay-Offs…

  •     By Donald Zuhn — On Monday, the American Antitrust Institute (AAI) sent a letter to Speaker of the House Nancy Pelosi (D-CA) and Senate Majority Leader Harry Reid (D-NV), urging the House and Senate to include provisions in their health care reform bills that would prohibit exclusion payments in pharmaceutical patent settlements.  These payments,…

  •     By Kevin E. Noonan — With fresh life being breathed into its patent "reform" bill by the new Commerce Secretary and PTO management, the Senate Judiciary Committee on Thursday acted on another "reform" measure, voting in favor of sending to the floor of the Senate a bill prohibiting "reverse payments."  These are payments by…