Patients and innovators lose if the government pursues ‘march-in’
Utilizing march-in rights as proposed by the Biden Administration would chill innovation and undermine collaboration between the public and private sectors.
Utilizing march-in rights as proposed by the Biden Administration would chill innovation and undermine collaboration between the public and private sectors.
The Biden Administration this summer issued an executive order that seems to endorse the use of “march-in” – when the government seizes patent rights from an innovator to let competitors use that patented invention – in an effort to address medicine affordability. This policy could have a grave impact on the pipeline of new treatments and cures, while ignoring the reality that today more than 90% of prescriptions for drugs are filled with generics – up from 19% 35 years ago thanks to our competitive system that includes intellectual property (IP) protections, including patents.
Allowing for the use of march-in rights to address pricing of medicines would have a chilling effect on American innovation. The government would be asking innovators to risk decades of research and billions of dollars – not to mention the chance of failing – to then have those inventions stolen after they succeed and given to third parties who put nothing on the line. The truth is, without reliable and reasonable protections for inventions, innovators simply won’t be able to develop the next lifesaving treatment or vaccine. Not to mention that removing those protections would also reduce incentives for innovators to collaborate with government or universities moving forward.
Earlier this year, the National Institute of Standards and Technology's (NIST) proposed rulemaking that would have amended the regulations it follows to carry out the Bayh-Dole Act to emphasize the critical role IP protections play in continued innovation. PhRMA and experts agree, preserving the American IP system is essential.
Utilizing march-in rights as proposed by the Biden Administration would chill innovation and undermine collaboration between the public and private sectors, and is not the right solution for increasing competition or improving affordability. As you hear more discussion of this policy proposal, keep these basic facts in mind:
Misuse of the Bayh-Dole Act’s march-in provisions could significantly slow the pace of innovation not just in biopharmaceuticals, but across many different sectors. If America abandons our commitment to policies that have created the most collaborative and productive research ecosystem in the world patients will undoubtedly end up with access to fewer medicines, including generics. The biopharmaceutical sector supports common sense solutions that would lower out-of-pocket costs for patients that don’t risk the health and safety of patients or undermine future innovation. We are eager to work with the Biden Administration to pursue policies that protect access, choice and innovation.