Jan 16 2024

WASHINGTON, D.C. – Senator Thom Tillis recently sent a letter to President Biden regarding his Administration’s recent announcement of a new policy framework based on an incorrect and inconsistent interpretation of the Bayh-Dole Act that will stop progress on new inventions. 

“Unfortunately, your Administration’s recent announcement of a new policy framework, based on incorrect and inconsistent interpretation of the Bayh-Dole Act, is at odds with Congressional intent. The threat that government agencies will ‘march-in’ and seize patents if prices exceed a vague and undefined threshold undermines the certainty that innovators need to make investments and bring complicated new technologies to market. The recent guidance will stop progress in its tracks with little discernible benefit to the public,” wrote Senator Tillis.

“Though Bayh-Dole allows the federal government to ‘march-in’ and require additional licenses under a narrow set of circumstances, ‘march-in’ was never intended to serve as a mechanism for regulating the pricing of any products. The law makes no reference to a ‘reasonable price’ that should be dictated by the government, and this omission was intentional. In the nearly four decades that the Bayh-Dole Act has been in place, the National Institutes of Health (NIH) has denied every march-in petition based on pricing that has been submitted to the agency. In each case, NIH consistently concluded that the products subject to a march-in petition had reached practical application and met health or safety needs,” continued Senator Tillis. 

“Your Administration’s proposed guidance will do profound harm to stakeholders in North Carolina as well as to U.S. competitiveness in general. I am therefore adamantly opposed and urge your Administration to reconsider,” concluded Senator Tillis. 

Read the full letter HERE.