Generic Entry Reforms Gain Steam In Congress With House Committee Passage
Bills to reign in petitions, pay-for-delay, product hopping, and patent thickets clear House Judiciary Committee. Legislation may have better shot at enactment this time around given bipartisan support in both House and Senate Committees.
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Members of Congress, companies and government agencies want the Patent Office to change policies that they say impede generic drug competition. The latest effort is focused on PTO’s discretionary denial of inter partes review petitions, which is the subject of a bipartisan congressional letter and cert petition to the US Supreme Court.
Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’
Legislation to prevent pay-for-delay deals, product hopping and sham citizen petitions, and to require the FTC to study the role of pharmacy benefit managers in the drug supply chain get unanimous committee vote. They may have a good shot at passage given recent actions by President Biden and the FTC, and bipartisan interest in drug pricing.