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 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
In the Biden administration’s pursuit of increasing affordability of healthcare and prescription drugs, the National Institute of Standards and Technology (NIST) released in December 2023 its draft framework on the US...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
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
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 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 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
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