The Senate Judiciary Committee has approved the Preserve Access to Affordable Generics Act, sponsored by Herb Kohl (D-WI), that would prohibit innovator drug companies from compensating generic drug companies to delay a generic drug’s entry into the market.
The bill would make it illegal for any person, in connection with the sale of a drug product, to directly or indirectly be party to any agreement resolving or settling a patent infringement claim in which an Abbreviated New Drug Application (ANDA) filer receives anything of value. And the ANDA filer would agree not to research, develop, manufacture, market or sell the ANDA product for any period of time.
The legislation also would require the Federal Trade Commission to study:
• The prevalence of agreements in patent infringement suits;
• The impact of such agreements on drug industry competition;
• The prevalence in the drug industry of other anticompetitive agreements among competitors or other practices contrary to the antitrust laws;
• And the impact of such agreements or practices on competition in the drug market in the last five years.