As per the anonymous sources cited by Politico as well as STAT News, the Biden administration has confirmed that it happens to have the authority to exercise march-in rights so as to reclaim patents when it comes to certain costly medications that happen to be developed using federal research funding.
The White House in no way intends to encourage the extensive use of march-in rights, nor does it seem anyway that it will exercise this authority against any particular pharmaceutical product.
The Biden administration will instead go on to issue guidelines so as to assist the National Institutes of Health in making decisions with regards to the potential seizure of patents from pharma companies, which would pertain to products developed by way of using federally funded research. NIH can take into consideration numerous factors, like price as well as the availability of the product, when it comes to making decisions.
As per the sources, the Department of Commerce will go on to issue the proposed framework for the march-in authority, which will thereby allow the public to offer feedback on the framework.
Interestingly, the Bayh-Dole Act of 1980 offers the federal government residual rights over inventions thereby resulting from federally funded research, which means that under specific as well as reasonable conditions, the government can issue licenses to third-party developers, helping them to make the advantages of these inventions accessible to people.
It is well to be noted that this year, in March, the Department of Health and Human Services- HHS and the Department of Commerce went on to initiate a review to analyse march-in rights. The idea of this review is to establish guidelines so as to exercise this authority, which goes on to include defining particular criteria and also outlining the processes for its execution.
HHS Secretary Xavier Becerra, in a statement, went on to refer to the march-in authority as something like a powerful tool that will help in ensuring reasonable public access to the advantages of the American taxpayer’s investment when it comes to research and development.
The initiative is expected to face some major opposition from biopharmaceutical companies as well as other industry groups.
The fact is that the potential misuse of march-in rights, which has never been seen before, can go on to have drastic effects when it comes to medical innovation. It may lead to irreparable harm as well as discourage biopharmaceutical companies from funding their valuable research investments in developing future cures. The watchdog group Citizens Against Government Waste, in a statement, went on to express concerns that such steps would have negative outcomes, such as harming patients, curtailing economic growth, and also lessening America’s global leadership when it comes to biopharmaceutical research and development.
The Pharmaceutical Research and Manufacturers of America has gone to issue a warning with regards to potential negative consequences that could come from altering the march-in provision. Particularly, they express issues about the government being granted the right to seize patent rights that are based solely on product pricing.
The Biden administration’s efforts to continue to reduce drug prices have led to a novel approach to the government’s march-in authority. President Biden inked the Inflation Reduction Act-IRA into law in August last year. The idea behind this act is to bring in $25 billion when it comes to drug cost savings in the next eight years.
The IRA enables the Centers for Medicare and Medicaid Services to renegotiate the costs of commonly prescribed medications. Apparently, these new prices will come into effect in 2026. In August this year, CMS went on to release a list of the first 10 drugs that will be affected due to the Medicare Drug Price Negotiation Program.