We write today as young adults living with chronic medical conditions to urge Congress to act on the need for meaningful pharmaceutical patent reform. While the Inflation Reduction Act marked a historic milestone, it predominantly benefits older patients, and it remains necessary to make significant reforms to the patent system that would make prescription drugs more affordable and accessible to patients across all age groups and demographics. We are committed to ensuring that the voices of young adult patients are included in this critical effort to reform the patent system.
Our young adult patient population is unique. We live with Crohn’s disease, lupus, arthritis, Ehlers-Danlos syndromes, frequent strokes, and numerous other health conditions. Many of these conditions are chronic, meaning we will likely live with them. The financial impact of these conditions can significantly impact the trajectory of our lives and futures. In addition, as young adults, we are experiencing times of transition, often marked by significant financial instability. We are pursuing education, developing independence, exploring our identities, and navigating complex health conditions, all while the devastating potential loss of health insurance looms over us. In addition to the physical, emotional, and social tolls of such severe, complex conditions, too often, the lifesaving medications we need to survive are unaffordable.
While reform to the patent system must ultimately include many reforms, we call on Congress to address the pharmaceutical industry’s abusive patent-thicketing tactics in January. Drug companies create patent thickets when they strategically apply for and accumulate dozens of approved patents on a single drug. This tactic essentially creates a “thicket” of patents around a product and makes it so that no generic company can challenge them all, thus delaying and preventing the entry of a lower-cost generic competitor drug from entering the market.
Consider Amgen’s Enbrel, which treats rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and moderate-to-severe juvenile idiopathic arthritis. According to the Initiative for Medicines, Access and Knowledge (I-MAK), Amgen filed 57 patent applications on Enbrel, which could block generic competition for the drug for 39 years. Victoria, a young adult patient, takes Enbrel to treat her chronic condition. The medication carries a list price exceeding $1,000 per month. Between her family’s insurance plan, for which she is still eligible, and a manufacturer-provided co-pay card, Victoria is able to afford the medication. Nevertheless, as a medical student without a steady source of income and student loans, Victoria worries constantly that the manufacturer support could end at any time about the options that will be available to her when she turns 26 and is no longer able to stay on her family’s insurance, and whether she will be able to afford Enbrel in the future.
Legislation to curb the anticompetitive practice of patent thicketing should include limits on the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company that seeks to sell a biosimilar version. These limits would speed the arrival of biosimilars to the market. Furthermore, legislation should incentivize and coordinate collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to close loopholes that brand manufacturers exploit. Finally, patent legislation should also address product hopping, which is the practice of a manufacturer switching to a follow-on product with a patent that expires later than when the patents on a reference product expire. Prohibiting this practice and including an enforcement mechanism in the legislation would speed the arrival of lower-cost generics to market and bring relief to patients.
When discussing the pharmaceutical patent system and the desperately needed reforms, it is essential to acknowledge that many patient groups remain relatively quiet on the issue. This reticence stems partly from the complexity surrounding the substantial funding that several major patient groups receive from the pharmaceutical industry, which has often hindered their active engagement. These conflicts of interest display Big Pharma's power to influence the issues many non-profit organizations choose to advocate for or against - or to stay “neutral.”As a community of young adult patients living with chronic medical disabilities, Generation Patient is one of the few patient groups free of pharmaceutical or other industry funding and influence.
We hope that you will prioritize meaningful patent reform for patients, not the interests of companies that have for too long from the conditions we will endure for a lifetime. We look forward to working together in the year's final weeks to ensure young adult patients' voices are represented in all policy decisions.