The pharmaceutical industry, Trump and Obama administration officials, and others are urging the Biden administration to reconsider a controversial plan for seizing patents on a drug when its cost gets too high, claiming the approach misinterprets decades-old law and threatens the delicate pipeline that produces innovative, life-saving drugs.
Over 500 comments were filed by the Feb. 6 deadline for groups and individuals to weigh in on the administration’s framework for the federal government to use its march-in rights. The proposal lays out the Biden administration’s stance in a longstanding debate over whether price is a justifiable reason for the government to “march in” and take over a patent on technology developed with the help of taxpayer dollars and then license it to an outside manufacturer.
The Biden plan is already drawing blowback from a broad swath of players in the innovation space. A collection of former US Patent and Trademark Office directors and other government officials under the George W. Bush, Obama, and Trump administrations wrote to warn that the proposed framework, if adopted, would prove destabilizing.
The Pharmaceutical Research and Manufacturers of America likewise is urging the administration to pump the breaks, calling the plan a misinterpretation of the Bayh-Dole Act, which established march-in rights.
“The proposed framework sounds politically sexy—grab patents of companies if their drug prices are too high. But the impact will disappoint consumers—even the most aggressive efforts to reinterpret march-in rights would not affect 99 percent of drugs,” the Council for Affordable Health Coverage wrote.
“While the Biden Administration talks tough, its approach will simply chill investment in new treatments and cures because the threat of the government stealing patents hangs over every new idea’s success,” the council said.
March-In Authority
The federal government isn’t a stranger to requests to march in to lower the cost of a drug.
Last year, the Biden administration rejected a request to initiate march-in proceedings on
In response to the administration’s proposed framework, Warren and over 70 other lawmakers in a Feb. 6 letter called march-in one of the Biden administration’s “most important authorities to prevent price gouging and provide taxpayer accountability.”
They noted, however, that the proposed framework “is only as meaningful as the resulting action” the administration takes, and asked that the final framework “include a directive to agencies to review all federally funded inventions under their purview within six months and determine whether to use march-in rights,” including alongside other authorities.
“The fact that agencies have failed to use march-in rights is not due to issues with implementation of the authority, but rather an indication of how industry narratives have negatively impacted agency behavior,” the letter said.
Other lawmakers who signed the letter included Reps.
Knowledge Ecology International, a group that focuses on intellectual property issues and has urged the government to exercise its march-in authority, said the Biden framework needs to address scenarios where one but not all the patents on a drug would be eligible for march-in authority.
‘Do Not Have This Power’
Some intellectual property experts are deeply concerned with the Biden proposal, dubbing it a reversal of how prior administrations have viewed march-in rights.
“The administrations of Presidents Bill Clinton, George W. Bush, Barack Obama, Donald Trump, and most recently, Joe Biden, in spring 2023, all rejected march-in petitions after concluding that they do not have this power,” wrote a group of former USPTO and National Institute of Standards and Technology officials, and secretaries of commerce. That includes Trump’s USPTO director, Andrei Iancu, and David Kappos, who led the patent office under Obama from 2009 to 2013.
“That price was never meant to be one of the triggers for march-in rights is not in doubt. In 2002, Senators Bayh and Dole—the original authors—made clear that this omission was purposeful,” the officials said.
Iancu and Kappos recently took part in a media briefing on the march-in framework hosted by the Bayh-Dole Coalition. In January, the coalition commented on the proposed framework, asking the Biden administration to withdraw it.
Former Sens. Birch Bayh (D-Ind.) and Bob Dole (R-Kan.) in 2002 wrote to the Washington Post that the 1980 law they co-authored wasn’t meant for the government to set prices.
However, advocacy group Governing for Impact argued in its own comments that these remarks—cited by opponents of the proposed framework—carry “no legal weight and should not be considered.”
“Both had left public service to spend years employed by firms that lobbied for pharmaceutical companies,” Governing for Impact wrote.
Policy Preference
Still, others are reluctant for the Biden administration to adopt the plan.
The Innovation Alliance, a research technology group that includes
“Encouraging government agencies to exercise march-in rights based on an administration’s policy preferences, and adding consideration of pricing, which is not in the statute, would significantly disincentivize companies from applying for federal R&D grants and from licensing inventions created with federal R&D funds,” the Innovation Alliance wrote.
The American Cancer Society Cancer Action Network said that “while pursuing affordable prices for prescription drugs is a laudable goal, Bayh-Dole march-in rights are not designed for this purpose.”
“While we share the administration’s goal of lowering drug costs, we remain concerned about the utilization of march-in authority as an avenue to lower prescription drug costs as well as its long-term potential to deter the private and public research ecosystem that has been key to our nation’s progress in the fight against cancer,” the group said.