The Biden administration has proposed a new rule that would let the government seize the patents of expensive drugs developed with federal funding.
The Biden administration has proposed a new rule that would allow federal authorities to seize the patents of costly drugs that were developed using taxpayer dollars and to let third parties use those patents to make the drugs available more cheaply.
The National Institute of Standards and Technology (NIST), an agency of the U.S. Department of Commerce, on Dec. 7 published a set of draft guidelines for government agencies to evaluate when it might be appropriate to invoke what are known as “march-in” rights under the legal framework of the Bayh-Dole Act.
The Bayh-Dole Act, which is shorthand for the University and Small Business Patent Procedures Act of 1980, grants the government the authority to suspend the patents of products of inventions that were developed with federal funding if those products or inventions are not made available to the public.
The new proposed guidelines, which were reviewed by The Epoch Times, seek to modify the Bayh-Dole Act in such a way as to make high price alone (of a product or invention developed using taxpayer dollars) a sufficient condition to trigger the government’s exercise of the act’s march-in provisions.
The march-in provisions—which the government has been asked to invoke in the past but never has—would let authorities seize the patents of drugs deemed too expensive (when offered for sale by the original patent holder) and grant licenses to third parties to produce those drugs to sell more cheaply.
“We’ll make it clear that when drug companies won’t sell taxpayer funded drugs at reasonable prices, we will be prepared to allow other companies to provide those drugs for less,” White House adviser Lael Brainard said on a call with reporters.
The draft will be published in the Federal Register on Dec. 8 and is being subjected to a 60-day public comment period.
President Joe Biden hailed the draft proposal as a way to rein in “Big Pharma price gouging,” while the main pharmaceutical industry trade group, the Pharmaceutical Research and Manufacturers of America, said it would be a loss to American patients by causing government-funded research to sit “on a shelf, not benefiting anyone.”
By Tom Ozimek
