North Charlotte Today

WASHINGTON, D.C. – Senator Thom Tillis has expressed his concerns over the Biden Administration's recent announcement of a new policy framework based on an incorrect interpretation of the Bayh-Dole Act. In a letter addressed to President Biden, Tillis emphasized that this new policy would hinder progress on new inventions.

In the letter, Senator Tillis stated, "Unfortunately, your Administration's recent announcement of a new policy framework, based on an 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."

Tillis further explained that the Bayh-Dole Act does allow the government to require additional licenses under specific circumstances, but it was never intended to regulate pricing. He highlighted that the law intentionally makes no reference to a "reasonable price" dictated by the government. Tillis pointed out that in the nearly four decades since the Bayh-Dole Act was enacted, the National Institutes of Health (NIH) has consistently denied every march-in petition submitted to the agency based on pricing. The NIH has concluded that the products subject to these petitions have reached practical application and met health or safety needs.

The Senator warned that the Biden Administration's proposed guidance would have significant negative consequences for stakeholders in North Carolina and U.S. competitiveness overall. He urged the Administration to reconsider its stance on this matter.

The full letter from Senator Tillis to President Biden can be found HERE.

This issue raises concerns about the impact of the Biden Administration's interpretation of the Bayh-Dole Act on innovation and investment. The uncertainty created by the potential for government intervention in pricing could deter innovators from bringing new technologies to market. It remains to be seen how the Administration will respond to Senator Tillis' letter and whether any adjustments will be made to the policy framework in question.