A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufactures from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products.
Preserve Access to Affordable Generics and Biosimilars Act This bill amends the Federal Trade Commission Act to authorize the Federal Trade Commission to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement, with specified exceptions, is presumed to have anticompetitive effects and violates this bill if the filer of an abbreviated new drug (generic) application or a biosimilar biological product application: (1) receives anything of value; and (2) agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar biological product for any period of time.
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustContracts and agencyFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsLicensing and registrationsMarketing and advertisingPrescription drugs
A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufactures from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products.
USA115th CongressS-3792| Senate
| Updated: 12/19/2018
Preserve Access to Affordable Generics and Biosimilars Act This bill amends the Federal Trade Commission Act to authorize the Federal Trade Commission to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement, with specified exceptions, is presumed to have anticompetitive effects and violates this bill if the filer of an abbreviated new drug (generic) application or a biosimilar biological product application: (1) receives anything of value; and (2) agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar biological product for any period of time.
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustContracts and agencyFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsLicensing and registrationsMarketing and advertisingPrescription drugs