At the Salt Lake City headquarters of Clene, Inc., innovators are pioneering new drugs to fight MS and ALS, some of our most devastating diseases. Numerous other companies across the state are working to develop novel treatments for Alzheimer’s, cancer, inflammatory conditions, rare disease, endocrine and metabolic disorders and more. Together, these companies form the backbone of Utah’s thriving pharmaceutical industry.
In Utah, we are very fortunate to have the support of our state and local governments. Governor Spencer J. Cox has identified Utah’s life sciences sector as a strategic economic pillar, as has Salt Lake City Mayor Erin Mendenhall. The state legislature has established the Utah Innovation Fund to support entrepreneurs in their quest to advance healthcare solutions. However, no matter how favorable a state’s innovation landscape, misguided federal policies, such as the Medication Affordability and Patent Integrity Act (S. 2780), can undermine the most fertile ecosystem.
Sponsored by Senators Maggie Hassan (D-NH) and Mike Braun (R-IN), the bill would require life sciences companies to submit extensive new information to the U.S. Patent and Trademark Office (USPTO) that is already shared with the U.S. Food and Drug Administration (FDA) as part of the drug approval process. Masquerading as a simple coordination effort, this additional government bureaucracy could delay the innovation it claims to protect and jeopardize trade secrets without making medications more affordable. It is the ultimate in unnecessary “red tape”.
The reams of extraneous information that the USPTO would have to handle would only slow an already lengthy and expensive patent process. Bringing just a single new medicine to market costs, on average, $2.6 billion and takes 10-15 years. Only one in 10 cross the finish line. The significant reporting rules in the bill could mean that patients wait even longer for new treatments.
Moreover, the USPTO, unlike the FDA, typically discloses information it receives from inventors. By forcing companies to divulge clinical trial data and other confidential information to the USPTO, the bill risks exposing sensitive intellectual property (IP) and patient health data to competitors, including to our nation’s foreign adversaries.
Some claim the legislation is needed to ensure transparency and prevent companies from making contradictory statements to agencies. However, there’s scant evidence that this is happening, and current laws already protect against this kind of abuse. Companies that defraud the USPTO or FDA can have their patents revoked or drug approvals withheld.
Some have also suggested that the legislation is needed to promote more generic competition, but America’s generic drug industry is doing well. The FDA’s Office of Generic Drugs 2022 Annual Report notes that more than 32,000 generic drugs have been approved by the FDA to date and approximately 91% of all prescriptions in the U.S. are filled as generic drugs.
Utah’s life sciences industry is an economic powerhouse, generating $22 billion in state GDP and creating more than 180,000 high-paying jobs. It continues to grow thanks to a delicate balance of risk-taking entrepreneurs, smart policies and IP protections. The Hassan-Braun bill, despite its noble intentions, could disrupt this equilibrium.
Senator Mitt Romney (R-UT) sits on the U.S. Senate committee that could consider the bill in September. With his rare blend of business savvy and government experience, Romney is well-positioned to help safeguard Utah’s and America’s role in healthcare innovation.
Change matters, even if it seems small. It’s a lesson that Washington lawmakers, in their zeal to “fix” things, often forget. Utah — let’s remind them.
Kelvyn H. Cullimore, Jr. has been president and CEO of BioUtah, the trade association for the state’s life sciences industry, since October 2018. Prior to joining BioUtah, he co-founded and led Dynatronics Corporation, a manufacturer of physical therapy devices and products. Cullimore has served on the board of directors of the Medical Device Manufacturers Association and was mayor of Cottonwood Heights from 2004 to 2018.