MichBio Signs on to Letter Opposing March-In Rights Petition

A petition was refiled with the federal government, in this instance with the Department of Health & Human Services, seeking to grant march-in rights for the patents on Xtandi, a prostate cancer drug, because of its alleged exorbitant price. March-in rights are rights granted to the federal government. These allow the government to grant patent licenses to other parties or to take licenses for themselves if they helped fund the patent owner’s research and development. Such licenses can even be granted to competitors if the government deems it necessary.

Generally, these rights aren’t used unless there are some public safety threats that patent owners cannot handle themselves, like product shortages or that a patent owner or licensee can’t “alleviate health or safety needs” of the public.

MichBio joined others in signing on to a letter from the Bayh-Dole Coalition opposing the petition. Circumstances regarding Xtandi’s availability have not changed since a prior petition was declined by the Obama/Biden administration. As such, the current petition should be rejected similarly.

MichBio opposes the attempt to invoke march-in rights as a means to address drug affordability. The Bayh-Dole Act is not intended to address the costs of our healthcare system. Attempts to do so are misguided and can only undermine the development of critically needed discoveries, while doing nothing to solve the underlying issues.