USA —The White House has revealed an innovative plan to address soaring prescription drug prices by deploying “march-in rights” to license patent rights to other companies.
The strategy, outlined in a new roadmap by the Biden administration, signals a decisive step to ensure accessibility to medicines developed with taxpayer dollars.
White House National Economic Advisor Lael Brainard emphasized the administration’s commitment, stating, “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.”
Despite being a provision for 43 years, the authority to license a drug’s patent rights to another manufacturer has never been exercised for pharmaceuticals.
While specific high-priced drugs have not been identified for immediate action, the move follows a comprehensive year-long review of legal authorities under the Bayh-Dole Act, regulating the ownership of intellectual property arising from federally funded research.
Neera Tanden, director of the White House Domestic Policy Council, explained, “The agency that funded the research can then license the invention to a competitor that is able and willing to make it available on reasonable terms.”
The announcement signifies a shift in policy, challenging the prior Trump administration’s proposal to prevent march-in authority based solely on high prices.
Government officials are soliciting public comments on the proposed framework for invoking march-in rights.
While welcomed broadly, consumer advocacy organization Public Citizen urged more comprehensive measures, criticizing the framework as “far too restrictive.”
Legal challenges are anticipated from the pharmaceutical industry, with PhRMA spokesperson Megan Van Etten expressing concern about returning to an era when government research lacked broader benefits.
In March, the US National Institutes of Health rejected calls to use march-in rights for the prostate cancer drug Xtandi, citing the lengthy administrative process and limited impact on drug pricing.
The recent initiative aligns with the Biden administration’s ongoing efforts to lower drug prices, including the Inflation Reduction Act’s provision empowering Medicare to negotiate prices for certain high-cost therapies without generic alternatives.
Several pharmaceutical companies are challenging this provision in court, though all have reluctantly committed to participating in the negotiation process.
Simultaneously, the US Federal Trade Commission issued a policy statement threatening legal action against pharmaceutical companies employing improper patent listings in the FDA’s Orange Book to delay the entry of generic competitors.