
Biden asserts authority to claim patents of drugs developed with federal research
Gabrielle M. Etzel
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The Biden administration announced plans on Thursday to take aim at pharmaceutical prices by seizing patents of certain high-priced medications developed with federally funded research.
“The Administration believes taxpayer-funded medications should be reasonably available and affordable,” the White House said in a press release published Thursday.
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The Department of Health and Human Services and the Department of Commerce issued a regulatory framework allowing the agencies to utilize the Bayh-Dole Act of 1980 to claim “march-in” authority on patents for products or inventions created with research dollars from the federal government. Under this rule, the administration would be allowed to license such inventions to other parties.
Although the Trump administration proposed a rule to prevent the federal government from exercising this power with respect to pharmaceuticals solely on the basis of price, White House officials say they chose not to finalize Trump’s proposed rule on the grounds of market competition.
The move drew opposition from Republicans.
“The Biden administration does not have the legal authority for this use of march-in rights,” Senate Health, Education, Labor, and Pensions Committee ranking member Bill Cassidy (R-LA) said in response to the proposal. “This kind of short-sighted decision would kill American healthcare innovation and deny millions of Americans future lifesaving cures and treatments.”
Cassidy said the authors of the bipartisan legislation being leveraged by the administration, former Democratic Indiana Sen. Birch Bayh and former Republican Kansas Sen. Bob Dole, did not intend for their act to be used for price manipulation of pharmaceutical products.
In 2002, Bayh and Dole co-authored an opinion editorial in the Washington Post, writing that their bill “did not intend that government set prices on resulting products.”
“The law makes no reference to a reasonable price that should be dictated by the government,” Bayh and Dole wrote. “The primary purpose of the act was to entice the private sector to seek public-private research collaboration rather than focusing on its own proprietary research.”
The opinion editorial also said the law allows for patents to be revoked “only when the private industry collaborator has not successfully commercialized the invention as a product,” not for commercial product pricing.
Bayh and Dole died in 2019 and 2021, respectively.
The Biden administration has been sharply criticized as anti-free market by Republicans and the pharmaceutical industry for its actions this year, for its Medicare Drug Price Negotiation Program that sets Medicare Part D prices for the most expensive prescription drugs. Several pharmaceutical companies have challenged the constitutionality of President Joe Biden’s program in federal courts.
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“The best I can say about [Thursday’s action] is that they will lose in court,” Cassidy said.
The Commerce Department and HHS did not respond to the Washington Examiner’s request for comment.