News & Analysis as of

Biden Administration Bayh-Dole Act

Mintz

Mintz IRA Update — Biden Administration Proposes Allowing Agencies to 'March-In' to Control Rising Drug Prices

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The Biden administration appears steadfast in its efforts to lower prescription drug costs and continues to explore multiple avenues — even as the Medicare Drug Price Negotiation Program continues to move forward — to tackle...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: March 2024

The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) are among a handful of groups “urging the Biden administration to rescind a policy proposal that would threaten the American...more

Troutman Pepper

FTC Promotes Next Front in Administration's Efforts to Lower Pharmaceutical Prices: Bayh-Dole Act's "March-In" Rights

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The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more

Knobbe Martens

Draft Framework for Exercise of March-In Rights under Bayh-Dole Act Targets High Drug Pricing

Knobbe Martens on

The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: Biden Administration Proposes Framework for Exercising Bayh-Dole March-in Rights to Control Drug Pricing

The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more

A&O Shearman

Senate Bill Introduced to Examine Bayh-Dole Reporting Requirements

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On January 10, 2024, Senators Chris Coons and Thom Tillis introduced a bill titled Improving Efficiency to Increase Competition Act (“IEICA”). The IEICA would require that the Comptroller General provide a report to certain...more

McDermott Will & Emery

Biden Administration Proposes New Framework for Exercising March-In Rights on Government-Funded Inventions; Drug Pricing May Be...

McDermott Will & Emery on

Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more

Sunstein LLP

When the NIH comes Marching In - Or Not

Sunstein LLP on

In an attempt to rein in rising drug prices, the Biden administration unveiled a proposed framework of factors that federal agencies should consider when choosing whether to exercise so-called “march-in rights.” March-in...more

Hogan Lovells

Biden Administration invites comments on new march-in rights framework

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On Friday, December 8, the U.S. Department of Commerce's National Institute of Standards and Technology (NIST) opened for public comment its Draft Interagency Guidance Framework for Considering the Exercise of March-in...more

King & Spalding

The Administration Takes Aim At Drug Prices Again – This Time Through A Controversial Framework for Exercising March-In Rights

King & Spalding on

The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more

Morrison & Foerster LLP - Government...

Biden Administration Proposes Novel Use Of Price As Justification For Agency Exercise Of March-In Rights For Government-Funded...

Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government...more

Fish & Richardson

Biden Administration Proposes March-In Rights Framework for Pharmaceutical Patents in Effort to Lower Drug Prices

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On December 7, the Biden administration announced a proposed framework for determining whether the government may exercise its march-in rights to license pharmaceutical patents to third parties if it determines that the price...more

A&O Shearman

Biden Administration Releases New Proposed Framework for the Exercise of “March-In” Rights under Bayh-Dole

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The Biden Administration’s recent publication of the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights and its request for comments on the draft guidance will impact how march-in rights...more

Seyfarth Shaw LLP

Pill Politics: Unveiling Biden’s Bold Blueprint for Affordable Drugs

Seyfarth Shaw LLP on

On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more

WilmerHale

White House Proposal Floats Pricing as a Basis for Allowing Alternative Manufacturers under "March-In" Rules

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A new Biden Administration proposal would provide a path for federal agencies to cite high prices as a reason for giving alternative producers rights to make products covered by federally funded inventions. On December...more

Axinn, Veltrop & Harkrider LLP

HHS to Go a March-In'

Following years of discussion and pressure being applied by certain policymakers (including Senate HELP Committee Chair Bernie Sanders), the Biden Administration announced that a framework is being put forward by HHS and the...more

Goodwin

Biden Executive Order Puts Focus on Domestic Manufacturing of Inventions Created Using Federal Funding

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President Biden recently signed Executive Order 14104, “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs,” which places greater emphasis on manufacturing products in the United...more

Mintz - Intellectual Property Viewpoints

Reduced Scope of March-in Rights Under Bayh Dole Rules Revisions

The Bayh Dole Act was enacted to provide incentives to promote commercialization of federally funded inventions and was designed to capitalize on the significant government investments in small business, university research,...more

Blank Rome LLP

What Could a DHHS Secretary Becerra Mean for the Pharmaceutical Industry?

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President-elect Biden plans to nominate California Attorney General Xavier Becerra to serve as Secretary of the U.S. Department of Health and Human Services (“DHHS”). The current Administration has frustrated the...more

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