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Proposed Legislation › Prescription Drugs › Patents

Jones Day

Bill Seeks to Restrict 30-Month Stay in Hatch-Waxman Litigation to One Patent

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Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...more

Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

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President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

Knobbe Martens

Renewed Efforts in Congress for Pharmaceutical Patent Reform

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With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington. Prior to this political...more

Jones Day

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

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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

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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

Polsinelli

Update on Pending Legislation: Three New Bills Have the Potential to Affect Generic Pharmaceutical Companies

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In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies. ...more

Foley & Lardner LLP

Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

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On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on...more

Goodwin

Bipartisan PACED Act Introduced to Address Sovereign Immunity

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Yesterday, Senator Tom Cotton (R-Arkansas) announced the introduction of proposed legislation, Preserving Access to Cost Effective Drugs Act, which would permit the Patent and Trademark Office and the International Trade...more

Fish & Richardson

Legislative Developments in Post-Grant Proceedings

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Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

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