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Proposed Legislation Patents Biosimilars

Knobbe Martens

Senate Seeks to Reduce Biosimilar Prices by “Pruning” “Patent Thickets”

Knobbe Martens on

On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological...more

Jones Day

U.S. Senate Unanimously Passes Bill Limiting Number of Patents Asserted Against Biosimilar Applicants

Jones Day on

The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more

Goodwin

Senate Judiciary Committee’s Antitrust Panel Discusses and Advances Proposed Generics and Biosimilars Bill

Goodwin on

On July 13, 2021, the Senate Judiciary Committee’s antitrust panel met to discuss biologic and biosimilar competition and its impact on drug prices. A group of senators, led by Senator Amy Klobuchar, are sponsors of a Senate...more

Knobbe Martens

Proposed Legislation: The Hatch-Waxman Integrity Act

Knobbe Martens on

Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more

Fish & Richardson

Senator Hatch: Choose IPR or an Abbreviated Regulatory Pathway, But Not Both

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Last week, Senator Orrin Hatch of Utah introduced the “Hatch-Waxman Integrity Act of 2018,” which seeks “to restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development.” ...more

Goodwin

Four More States Consider Biosimilar Substitution Bills

Goodwin on

As we reported last month, many state legislatures have passed or are considering biosimilar substitution bills. Alaska, Connecticut, New Hampshire, and Vermont are the latest states to join this list....more

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