Rob Sahr on the Administration’s Aggressive Approach to Bayh-Dole Compliance
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 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
A new Biden administration Executive Order proposes to enforce more rigorously U.S. manufacturing requirements attendant to federally funded inventions. While the aim of the Executive Order is to support domestic...more
Intellectual property (“IP”) rights can be one of the most valuable assets of a government contractor. There are several factors potential buyers can use to properly evaluate a government contractor’s IP in mergers and...more
Since its enactment in 1980, the Bayh-Dole Act has been credited with promoting the development of over 10,000 startup companies and at least 200 pharmaceutical drugs and vaccines, while contributing more than $500 billion...more
Organizations that receive federal funds or that license technology from third parties that receive Federal funds need to be aware of Federal funding obligations under the Bayh-Dole Act. Any invention conceived or reduced to...more
The COVID-19 pandemic has led many companies to marshal their resources to produce products such as coronavirus test kits, pharmaceutical treatments, vaccines, ventilators, and personal protective equipment. The urgent need...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
The Interagency Edison (“iEdison”) system is the principal mechanism for preserving rights to title in Government-funded inventions. Its use is now mandatory per 37 CFR 401.16, and we expect FAR 52.227-11, Patent Rights –...more
Federal grants are an important source of funding for many businesses and research institutions. The Bayh-Dole framework provides contractors the ability to retain title to an invention developed using federal funding, but...more
Rules affecting recipients of federal research and development funding have recently been revised, adding new deadlines and obligations. Changes to the regulations implementing the Bayh-Dole Act went into effect on May 14,...more
Businesses and nonprofits that receive funding under a federal government agreement (e.g., contract, cooperative agreement, or grant) executed after May 14, 2018, are subject to the updated regulatory provisions that...more
Buried in a grab bag of seemingly innocuous course-correcting changes to the Bayh-Dole Act regulations (effective May 14 of this year) is the removal by regulators of the sixty-day window between the federal agency’s notice...more
On May 14, 2018, several important revisions to regulations of the Bayh-Dole Act (University and Small Business Patent Procedure Act of 1980, codified as 35 U.S.C. § 200) went into effect. The final revisions were published...more
Several important changes to Bayh-Dole Act implementing regulations took effect on May 14, 2018, that will apply to funding agreements executed after that date and may apply to existing funding agreements modified after that...more
Effective May 1, 2018, newly issued federal government contracts, grants, and cooperative agreements will be subject to revised regulations implementing the Bayh-Dole Act, the federal statute governing title and license...more
The Patent and Trademark Law Amendments Act, better known as the Bayh-Dole Act, and the federal regulations implementing the Act permit government contractors to retain ownership of inventions developed with federal funding....more
Patent Intellectual Property (collectively, “IP”) rights represent a significant element of many government contracts, including those for research and development, whether by commercial, non-profit or educational...more
The Bayh-Dole Act and federal regulations implementing the Act permit government contractors to retain ownership of inventions developed with federal government funding. However, to retain ownership the contractor must take...more
On April 13, 2018, a final rule was published in the Federal Register adopting proposed rule changes from the National Institute of Standards and Technology (“NIST”)....more
Technical data, as defined by the FAR, is “recorded information (regardless of the form or method of the recording) of a scientific or technical nature (including computer databases and computer software documentation).” See...more
Given the recent PilieroMazza webinar on Data Rights in federal contracting, we have had a number of clients raise concerns or questions about the government’s “march-in” rights under the Bayh-Dole Act, which controls certain...more
In this presentation: - FAR AND DFAR - TYPES OF DATA - TECHNICAL DATA - COMPUTER SOFTWARE - COMMERCIAL COMPUTER SOFTWARE - TYPES OF RIGHTS - LICENSE RIGHTS - BAYH-DOLE...more
A decision by the Supreme Court of the United States on June 6, 2011 has a great impact on the interpretation of the Bayh Dole Act as well as assignment of contracts relating not just to the Bayh Dole Act but to assignments...more