Tagged as: legislation

Trump Administration Announces Action Plan to Allow Safe Importation of Prescription Drugs

On July 31, the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (“Action Plan”) created with the Food and Drug Administration (FDA) to “allow the importation of certain prescription drugs originally intended for foreign markets,” particularly Canada. According to the HHS Secretary Alex Azar, “[the…

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Bill Introduced to Limit Patent “Evergreening”

On June 11, Representatives Hakeem Jeffries (D-New York) and Doug Collins (R-Georgia) introduced a bipartisan bill with the stated purpose of addressing the rising cost of prescription drugs. According to the press release, the “Terminating the Extension of Rights Misappropriated (TERM) Act of 2019,” H.R. 3199, would “significantly limit[] the…

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Proposed Amendment to Hatch-Waxman and BPCIA Could Curb IPRs by Generic and Biosimilar Applicants (Updated)

  On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals.  The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require…

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President Signs Bill Requiring FTC and DOJ Review of Biosimilar Patent Litigation Settlements

Following up on our prior reports, last week President Trump signed into law the “Patient Right to Know Drug Prices Act” (S.2554).  Among other changes, the bill amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require that Reference Product Sponsors and biosimilar applicants file patent settlement agreements…

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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…

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Congressman Sarbanes Introduces Bill to Curb "Pay-For-Delay" Agreements - UPDATED with Proposed Legislation

On July 23, 2018, Congressman John Sarbanes (D-Md.) introduced a bipartisan bill, the Biosimilars Competition Act of 2018, meant to curb “pay-for-delay” agreements entered into by biologic and biosimilar drug manufacturers.  According to Congressman Sarbanes, the purpose of the bill is to help lower the cost of prescription drugs by affirmatively giving…

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Vermont and Connecticut Enact Interchangeable Biosimilar Substitution Bills

Last month we reported that Vermont, Connecticut, New Hampshire, and Alaska were in the process of considering biosimilar substitution bills.  Vermont and Connecticut recently enacted their respective bills. On May 30, Vermont Governor Phil Scott signed bill S.92 into law as Act No. 193.  The Act directs pharmacists to dispense…

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