Posts Tagged: "Bayh-Dole"

Proposed Framework on March-In Rights Dubbed ‘Unprecedented’ by U.S. Chamber

The National Institute of Standards & Technology (NIST) and the Department of Commerce today published a draft version of a Federal Register Notice seeking comments on a proposed framework for deciding whether and when to exercise march-in rights under the Bayh-Dole Act that would significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding. While Bayh-Dole contemplates march-in rights, the law strictly limits the situations in which they can be exercised and does not make any reference to pricing as a criterion for marching in. But under the proposed framework, an agency may consider “[a]t what price and on what terms has the product utilizing the subject invention been sold or offered for sale in the U.S.” and whether “the contractor or licensee [has] made the product available only to a narrow set of consumers or customers because of high pricing or other extenuating factors”.

U.S Manufacturing Requirement Changes the Landscape for Bayh-Dole Compliance Reporting

In recent months, two U.S. government executive initiatives have reshaped the landscape concerning intellectual property and the domestic production of products resulting from federally funded research. These initiatives are poised to bring substantial changes to the dynamics of academic-industry collaborations as inventions are brought to market.

NIH Tech Transfer Workshop Underscores Fight to Properly Characterize Federal Drug Pricing Authority

On July 31, the National Institutes of Health (NIH) hosted a virtual workshop titled Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer. Public comments submitted to the NIH ahead of the event reflect current tensions between advocates supporting either private commercialization or government pricing control of federally-funded medical breakthroughs commercialized by private companies.

Biden Executive Order on Domestic Manufacturing of Federally Funded Inventions Hits the Right Notes—But the Devil’s in the Details

On Friday, July 28, President Biden announced a new Executive Order titled “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs.” Rumors that the Administration was considering extending the deeply flawed Department of Energy (DOE) policy (see “More DOE Bureaucracy Equals Less Innovation” to all agencies had been swirling for months. Luckily, the new Executive Order doesn’t do that, but how it will be applied is subject to a convoluted interagency process, so it will be months before we see if it’s meeting its intended goal or not.

Senator Sanders’ Amendment Dooms NIH-Supported Innovation

Rattled by the failure of the Biden Administration to bow to pressure to misuse the march-in rights provision of the Bayh-Dole Act so the government can regulate prices on products based on federally funded inventions, Senator Bernie Sanders (I-VT) and his allies are doubling down. And the impact of National Institutes of Health (NIH)-supported research is now in jeopardy. Sanders taunted the Administration, pledging to hold up the nomination of Dr. Monica Bertagnolli to head the NIH until President Biden submits to his demands to do more to control drug prices, including requiring that any therapy-based on an invention arising from NIH funding must be sold at a “reasonable price.”