Industry Tells USPTO Biden March-In Proposal Undermines Inquiry to Improve IP Commercialization

“We are convinced such a mistaken reinterpretation of law is not legal, will not be effective in reducing drug pricing, and will actually significantly inhibit the very goals this RFC raises.” – AUTM comments

USPTOTwo days after comments closed on the U.S. Patent and Trademark Office’s (USPTO’s) Request for Comments titled “Unlocking the Full Potential of Intellectual Property by Translating More Innovation to the Marketplace,” several groups have weighed in to urge the Office not to ignore the link between this topic and the Biden Administration’s recent proposal on march-in rights under the Bayh-Dole Act.

The RFC was announced on March 14, 2024, and focuses on how to better incentivize commercialization of innovation, particularly in green and critical or emerging technologies. According to the RFC, the comments received “will be used to evaluate possibilities for amplifying the impact of our current work, and to explore new ways to support the transfer of innovation to the marketplace.”

The RFC specifically asked respondents not to address controversial topics like the Biden Administration’s December 2023 proposal to expand march-in rights under the Bayh-Dole Act, the Office’s proposals on “robust and reliable patents,” and ongoing negotiations over an expansion of the waiver on IP rights under the Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPS). The RFC explained:

“While the USPTO is proud of our recent initiatives to ensure robustness and reliability of IP, as well as the role the agency is playing in the current dialogue on Bayh-Dole rights, pandemic preparedness, and Trade-Related aspects of Intellectual Property Rights waivers, those topics are beyond the scope of this request for comment. Here, we specifically focus on opportunities for positive public impact by bringing innovation to market through commercialization, for example via the licensing of IP rights.”

The Office ultimately suggested 15 questions for commenters to respond to, including what changes to IP policies and practices would help to streamline commercialization; what challenges exist to commercialization; and what laws or practices in other countries might be helpful as a model, among others.

The USPTO also included “bringing innovation to market” as one of the four cornerstones of its National Strategy for Inclusive Innovation, which was announced at a recent event on Capitol Hill.

Despite the plea for comments to stay away from the Biden march-in proposal, many organizations took the opportunity to point out the impossibility of ignoring the effects the proposal would have if implemented.

The Bayh-Dole Coalition used its submission to underscore the successes of the Bayh-Dole Act, which the organization said has been responsible for adding an estimated $1.9 trillion to U.S. industrial output between 1996 and 2020.  “While recent efforts to weaken the Bayh-Dole Act are not the subject of your request for comment, they cannot be ignored as they pose the gravest of threats to the U.S. innovation system,” the Coalition’s submission said.

AUTM, which represents tech transfer professionals, urged those in leadership at the USPTO to strongly oppose the march-in proposal and reiterated its view that “we are convinced such a mistaken reinterpretation of law is not legal, will not be effective in reducing drug pricing, and will actually significantly inhibit the very goals this RFC raises.” While acknowledging that the USPTO is not directly involved in the National Institute of Standards and Technology (NIST)-proposed framework, AUTM said “we believe this framework will have a crippling impact on the ability of universities and others to find licensees and investors willing to invest in high-risk, early-stage technologies.”

The U.S. Chamber of Commerce filed joint comments with The Business Alliance to Stop Innovation Confiscation, Judge Paul Michel (Ret.), Judge Susan Braden (Ret.), the Washington Health Innovation Council, the Maryland Chamber of Commerce, and the United Inventors Association that also discussed the march-in proposal and the Chamber’s view that it violates “the plain text of the law.”

The Chamber’s Global Innovation Policy Center (GIPC) filed an appeal in April with the U.S. Department of Commerce, which denied the GIPC’s January 2024 Freedom of Information Act (FOIA) request seeking more detail about the working group behind the framework. It also announced in March that it is partnering with entrepreneurs and other business advocates to counter threats to innovation due to “excessive government overreach,” including the march-in framework, through the launch of the Business Alliance to Stop Innovation Confiscation Coalition (BASIC Coalition). The Coalition lists stopping the Biden march-in proposal as its top goal.

“Perplexingly, at a time when the United States is focused on reshoring critical industries, the Administration’s property confiscation proposals would cast a pallor of uncertainty over public-private collaborations,” wrote the Chamber in its comments.

There were 45 comments posted on the RFC as of the time of publication.

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Author: kchungtw
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