What are "march-in" rights and why should you care?
Health Care Reform Forum
From the website Up-Counsel: 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 speaking, these rights won't be used unless there are some public safety threats that patent owners cannot handle themselves.
In February of this year, Senators Elizabeth Warren and Angus King, and Representative Lloyd Dogget sent a letter to Department of Health and Human Services Secretary Xavier Becerra to explain that:
March-in rights, established in the Bayh-Dole Act and codified at 35 U.S.C. § 203, allow the federal government, in certain cases, to grant licenses to “responsible applicants” for products developed with federal funds. Specifically, the government may exercise its march-in rights when “action is necessary to alleviate health or safety needs” or when an invention’s benefits are not “available to the public on reasonable terms” per the plain text of the statute. And as legal experts have repeatedly concluded, a product’s price plays a critical role in determining whether it is reasonably available to the public. “[T]he words ‘reasonable terms’ have uniformly been interpreted [by courts] to include price.” Or put another way, “if a drug company is not charging a reasonable price for a drug, or if its pricing harms public health by substantially restricting access to the drug, the federal government is well within its rights to ensure the availability of cheaper generic versions.”
Their letter, attached as a pdf below, requests march-in rights for enzalutamide (Xtandi), a drug used to treat prostate cancer.
The PACG Health Care Reform forum is working in coalition with other groups on a campaign called Make Meds Affordable. We believe that the march-in rights are a way to force the present administration to lower drug costs immediately. Over the next few weeks we will be sharing information to help educate our community about actions people can take help in this effort.
Deb Sperry
From the website Up-Counsel: 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 speaking, these rights won't be used unless there are some public safety threats that patent owners cannot handle themselves.
In February of this year, Senators Elizabeth Warren and Angus King, and Representative Lloyd Dogget sent a letter to Department of Health and Human Services Secretary Xavier Becerra to explain that:
March-in rights, established in the Bayh-Dole Act and codified at 35 U.S.C. § 203, allow the federal government, in certain cases, to grant licenses to “responsible applicants” for products developed with federal funds. Specifically, the government may exercise its march-in rights when “action is necessary to alleviate health or safety needs” or when an invention’s benefits are not “available to the public on reasonable terms” per the plain text of the statute. And as legal experts have repeatedly concluded, a product’s price plays a critical role in determining whether it is reasonably available to the public. “[T]he words ‘reasonable terms’ have uniformly been interpreted [by courts] to include price.” Or put another way, “if a drug company is not charging a reasonable price for a drug, or if its pricing harms public health by substantially restricting access to the drug, the federal government is well within its rights to ensure the availability of cheaper generic versions.”
Their letter, attached as a pdf below, requests march-in rights for enzalutamide (Xtandi), a drug used to treat prostate cancer.
The PACG Health Care Reform forum is working in coalition with other groups on a campaign called Make Meds Affordable. We believe that the march-in rights are a way to force the present administration to lower drug costs immediately. Over the next few weeks we will be sharing information to help educate our community about actions people can take help in this effort.
Deb Sperry
| letter_to_sec._becerra_on_xtandi_march-in_petition.pdf |
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