Rob Sahr on the Administration’s Aggressive Approach to Bayh-Dole Compliance
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
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
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
The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more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
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
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
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
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