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Description:
Since its passage in 1980, the Bayh-Dole Act has played a critical role in encouraging innovation in the United States. Some have even characterized it as the most consequential legislation passed in the last quarter of the 20th century. But contained within its provisions is an oft-overlooked right permitting the government to march-in on the owner of a publicly funded patent and require it to be licensed to a competitor.
March-in rights have never been exercised in the forty-four years since the law’s passage, but it is now at the center of a heated debate over American industrial policy. On December 7, 2023, the National Institute for Standards and Technology within the Department of Commerce released its “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.” In this framework, the NIST proposed re-interpreting the statutory categories for exercising march-in and adding a consideration of price as a triggering factor.
This presentation goes through the details of the NIST’s proposal. We then address the legislative history of the Bayh-Dole Act, its objectives, and how the use of march-in rights have been handled in the past. With this context, we analyze two scenarios outlined in the NIST’s proposal, and then consider the public reaction to the proposal. Last, we consider impact that the adoption of this proposal could have on the pharmaceutical industry.
 | | Practice Areas: | | Healthcare & Pharmaceutical Law, Intellectual Property Law, Patent Law | | | Online Media Type: | | Video | | | Production Date: | | 03/18/2024 | | | Level: | | Intermediate | | | Category: | | Standard | | | Duration: | | 1 Hours, 0 Minutes | | | Online Format: | | On Demand | | | Course Type: | | Public |
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| | • | Tasha Gerasimow - Partner | Kirkland & Ellis LLP | | • | Jeanna Wacker - Partner | Kirkland & Ellis LLP | | • | Connor Donaldson - Associate | Kirkland & Ellis LLP |
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