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AAMC, Higher Ed Groups Comment on Proposed Regulation for University Patents

April 9, 2021

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CONTACTS
Stephen Heinig, Director, Science Policy
Heather Pierce, Sr. Director, Science Policy & Regulatory Counsel
Christa Wagner, Senior Legislative Analyst

The AAMC joined four other higher education associations in an April 5 comment letter on a proposed rule that would update regulations implementing the 1980 Bayh-Dole Act (P.L. 96-517). That law permits federal grantees like universities and medical schools to patent inventions arising from federally sponsored research and license them for commercial development.

The five associations — the AAMC, the Council on Governmental Relations, the Association of American Universities, the Association of Public and Land-grant Universities, and the American Council on Education — specifically commented on a notice of proposed rulemaking (NPRM) from the National Institute of Standards and Technology (NIST), the federal agency that oversees implementation of the Bayh-Dole Act. NIST developed the NPRM after an extensive, governmentwide review began in 2017 on the state of all federal tech transfer efforts. A conclusion of that review, to which the AAMC and other associations also contributed, was the need to clarify some of the issues that have arisen over the 40 years of implementing the law.

In their comments, the associations largely endorsed the NPRM’s language clarifying the circumstances under which the government may “march in” to take possession of a subject patent for a public purpose. The associations agreed with NIST that the consumer price of a product resulting from an invention may not be used as a basis for march-in rights — an interpretation consistent with the act’s legislative history and funding agencies’ legal determinations. The associations also supported the NPRM’s provisions for exercising government-use licensing of an invention and providing for automatic waivers from U.S.-based manufacturing when an agency fails to act on a waiver request in reasonable time.

Patient advocates have previously called for exercising Bayh-Dole march-in rights over high drug prices, where the drugs in question were developed from university research. The associations stressed in their comments that drug pricing, which is a profound national concern shared by academic health systems, cannot be appropriately or adequately addressed by the rules under consideration — and that march-in attempts would make it far more difficult for academic institutions to license future drug discoveries. The associations wrote, “We believe other remedies need to be explored to address consumer pricing issues, that will better address the concerns without adversely affecting the successful Bayh-Dole Act balance that has resulted in the availability of drugs and therapeutics that would not have existed otherwise.”

The NIST NPRM was published by the outgoing Trump administration on Jan. 4, with the period for comment review and responsibility for finalizing the rule falling to the new Biden administration. The Biden administration has not publicly commented on a timeline for determination of the proposed rule.

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