Senate Passes MMA Amendment Requiring FTC and DOJ Review of Biosimilar Patent Litigation Settlements

Yesterday, the Senate overwhelmingly (98-2) passed the “Patient Right to Know Drug Prices Act” (S.2554), which includes amendments to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) that require patent litigation settlements between a Reference Product Sponsor and a biosimilar applicant under section 351(k) to be submitted for review by the Federal Trade Commission (“FTC”) and the U.S. Department of Justice (“DOJ”).  The proposed legislation would impose on biosimilar-related patent litigation settlements and agreements the same FTC and DOJ disclosure requirements currently in place for ANDA litigation settlements under the MMA.

As we previously reported, a separate bill sponsored by Representatives Sarbanes and Johnson, the Biosimilars Competition Act of 2018, was introduced in the House of Representatives in July and proposes similar disclosure requirements for settlements of patent litigation between brand biologic and biosimilar applicants.