Overriding patent rights will harm California’s life sciences innovation


California Life Sciences President & CEO Mike Guerra releases statement on Biden Administration’s Proposed Framework on March-in rights:

“California Life Sciences is discouraged by the Biden administration’s proposed framework that would allow the use of Bayh-Dole “march-in” rights to license patent rights of drugs to other manufacturers when the price of the drug is arbitrarily deemed too high. While we support lowering health care costs, this policy won’t achieve that. Instead, it creates significant uncertainty in the innovation ecosystem, risking the loss of new cures that may no longer be developed and harming small biotechs who face a challenging investment climate and rising costs.

The Bayh-Dole Act laid the foundation for America’s world-leading, innovation-driven economy. According to a recent poll conducted by Morning Consult, an overwhelming majority of Americans find it very important to preserve the law in its current form. Earlier this year, the Biden administration stood by the government’s long-standing interpretation of the Bayh-Dole Act by rejecting petitions to use march-in authority solely on the basis of price. Pursuing this new framework abandons precedent and would not only undermine private-sector incentives for innovation but discourage public-private partnerships that have been responsible for spurring America’s leading role in global life sciences innovation. California Life Sciences is proud to represent and advocate for the entire life sciences innovation ecosystem, including California universities that benefit from our state receiving the most funding awarded by the National Institutes of Health and National Science Foundation. This policy could have the negative effect of discouraging investment in our member companies that partner with these universities or accept federal funding in the form of SBIR grants.

California Life Sciences encourages the Administration to change course and work to implement real solutions, such as addressing the insurer and PBM consolidation and their lack of transparency referenced in the announcement, that will protect patient access, help bring down health care costs, and support our ecosystem’s work to develop new cures.”