In a letter sent today to members of the U.S. Senate Committee on Health, Education, Labor and Pensions, the Center for Individual Freedom urged strong opposition to two pieces of proposed legislation that would weaken critical patent protections: the “Medication Affordability and Patent Integrity Act” (S. 2780) and  “Biosimilar Red Tape Elimination Act” (S. 2305).  

Read the letter below.

August 27, 2024

Dear Senators:  

On behalf of over 300,000 supporters and activists across the nation, the Center for Individual Freedom (CFIF) writes to express our strongest opposition to two pieces of proposed legislation scheduled for markup before your committee in September: the “Medication Affordability and Patent Integrity Act” (S. 2780) and the “Biosimilar Red Tape Elimination Act” (S. 2305).  The danger of these proposals, which would weaken critical drug patent protections on which lifesaving pharmaceutical innovation depends, can scarcely be understated.  

Strong patent protections, which our Founding Fathers deliberately incorporated into the very text of the Constitution in Article I, provide the foundation for American pharmaceutical innovation, which historically accounts for up to two-thirds of all new drugs introduced to the world.  In the famous words of former patent attorney Abraham Lincoln, strong U.S. patent rights “added the fuel of interest to the fire of genius.”  

Inexplicably, however, some political leaders and commentators seek to undermine rather than protect patent rights by advocating such proposals as the bills at issue.  Pursuing their misdirected path would constitute a frontal assault against private pharmaceutical innovators, weakening their patent rights and the trillions of dollars of investments required over years and decades to conceive, perfect, produce and distribute those drugs.  

The provisions of S. 2780 would impose burdensome and duplicative new disclosure mandates on drug producers to provide information to the United States Patent and Trademark Office (USPTO) that would have been already submitted to the Food and Drug Administration (FDA) as part of the application process.  Worse, those new requirements would force innovators to surrender highly confidential information and trade secrets in a way that would increase the risk of public exposure not only to competitors, but also international adversaries such as China.  Additionally, existing law already prohibits concealment of material data from the USPTO or FDA, with penalties up to and including unenforceability of patents by companies found to engage in such conduct.  The proposed new bureaucratic burdens would also slow the patent application process and needlessly add new burdens upon the USPTO personnel already stretched thin.  

Similarly, S. 2305 would needlessly undermine strong, reliable patent protections upon which innovators depend.  By reducing FDA discretion regarding interchangeability determinations, the proposed legislation would have the effect of reducing competition in the realm of complex biologics as science advances and lowering applicable standards for substituting biosimilars relative to generics despite the inherent amplified complexity of biologics.  Notably, S. 2305 fails to correct actions by pharmacy benefit managers (PBMs) that inhibit consumer access to lower-cost biosimilars, and if anything amplifies their ability to game the system to the detriment of American consumers.  

Pharmaceutical innovation demands billions of dollars in research and development costs, not to mention potential product liability lawsuits for any errors.  Strong patent protections help ensure that those costs and risks will be fairly and sufficiently rewarded, and provide innovators and investors the incentives to create pharmaceuticals that save millions and even billions of lives worldwide.  That can propel investment and innovation in future decades, and offer the invaluable legal certainty upon which innovators rely to invest more robustly in research and development.  In turn, that investment results in lifesaving pharmaceutical innovations for the United States and the world.  

The real-world facts demonstrate indisputably that strong patent protections and free-market orientation provide the foundation for American pharmaceutical innovation, which continues to lead the world.  We must safeguard that legacy, not weaken it through destructive proposals such as the bills at issue.  Thank you very much for your attention to this important matter, and please contact me at your convenience with any questions or comments.