Rob Sahr on the Administration’s Aggressive Approach to Bayh-Dole Compliance
In our previous Mintz IRA Update, we covered the Biden administration’s proposal exploring the use of “march-in rights” granted under the Bayh-Doyle Act (the “Act”) to seize pharmaceutical patents if the administration...more
U.S. universities and academic institutions rely heavily on federal grants to fund their research and generate innovations in life sciences. Universities often out-license patents protecting inventions created using federal...more
On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more
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
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
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
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
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
The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more
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
On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The following Q&A, in...more
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
On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The Bayh-Dole march-in...more
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
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
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
The continuing debate as to where to draw the line between encouraging innovation and lowering drug costs was front and center during a Senate HELP Committee confirmation hearing for NIH director nominee Monica Bertagnolli....more
In a letter dated March 21, 2023, the National Institutes of Health (“NIH”) again refused the request of petitioners to exercise march-in rights under the Bayh-Dole Act to control the price of a drug. Here, as before, the NIH...more
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
In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look...more
On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more
While companies in every industry are working hard to figure out the best response to this global pandemic, those in the pharmaceutical and medical device industries have been faced with some unique challenges related to the...more
In a letter sent earlier this month to Secretary Sylvia Mathews Burwell of the U.S. Department of Health & Human Services and Director Francis S. Collins of the National Institutes of Health, fifty members of the U.S. House...more
Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more
Most recent academic and some popular assessments of the effects of the Bayh-Dole Act have been critical. This has been due in part to political opposition to licensing university technology (and the purported soiling of the...more