2018 Bayh-Dole Updates

Rule changes went into effect May 14, 2018 that reduced regulatory burdens on recipients of federal research and development funding, including large and small businesses, universities, federal laboratories and non-profit organizations. The updates to sections of the Code of Federal Regulations (CFR) that implement the 1980 Bayh-Dole Act affect rights in inventions made with federal funding were issued by the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) (For a copy of the 2018 version of the regulations, please see Title 37 of the 2018 version of the Code of Federal Regulations, specifically Parts 401 and 404).

The rule changes clarified certain definitions, reduced compliance burdens, addressed co-inventions between funding recipients and federal agencies, and simplified the electronic reporting process. They also provided for automatic extensions of the requirement to file non-provisional patent applications and permit a business, university or other collaborator to rely on its Cooperative Research and Development Agreement (CRADA) with a federal laboratory to support an application for a license to a federal invention developed under that CRADA.

“Rights to Inventions Made by Nonprofit Organizations and Small Business Firms under Government Grants, Contracts, and Co-operative Agreements,” applies to funding agreements with all federal agencies and was the subject of a 2016 public comment opportunity. The rule changes affect new funding agreements executed after May 14, 2018, although existing agreements may be amended at a funding agency’s discretion to include the new provisions.

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