President Biden is being warned to withdraw an unprecedented regulation that would allow the government to seize patents for prescription drugs that aren't "reasonably" priced.
Biden wants to use a 1980 law, the Bayh-Dole Act, that lets the government "march in" and relicense patents for inventions that are developed with federal tax dollars. Until Biden, this power has never been used.
A staffer who helped pass the law back in the 1980s urged Biden to pull back in a sharply worded letter for the Bayh-Dole Coalition.
Joseph Allen, the group's executive director and former Senate Judiciary Committee staffer to Senator Birch Bayh (D-In.), said Biden's gambit "violates both the letter and spirit of the Bayh-Dole Act and would cause untold harm to American companies, workers, and consumers if implemented."
He warned that Biden's reform would stifle innovation, without lowering drug prices. Allen also noted that Biden, as a senator, opposed efforts to include price controls in the 1980 law.
“Ironically, even the draft framework implicitly acknowledges that misusing the march-in provision for price controls will have little, if any, impact on lowering drug costs – the purported reason for this exercise,” said the letter.
The Bayh-Dole Act allows government contractors to own inventions that are developed with tax dollars, which includes over 99% of prescription drugs.
The law includes a provision - which has never been used until Biden - that allows the government to "march in" and relicense an invention if "good-faith efforts aren't being made to commercialize the research," according to pharmaceutical trade group PhRMA.
Biden's critics say the Bayh-Dole Act was never meant to set price controls.
"The threat that government agencies will ‘march-in’ and seize patents if prices exceed a vague and undefined threshold undermines the certainty that innovators need to make investments and bring complicated new technologies to market," Republican Senator Thom Tillis (Nc.) said.
The Trump administration proposed a rule that would bar the government from using price as a reason to "march in," but Biden scrapped it.
In a 2002 Washington Post piece, Senators Bob Dole and Birch Bayh - who have both passed away - noted the law "makes no reference to a reasonable price that should be dictated by the government."
Of course, Congress' intent has never deterred Biden from making creative use of the law to push his radical, draconian agenda.
Biden did the same thing with his sweeping student loan plan, which was ultimately curtailed by the Supreme Court.
