Each January, many Utahns and other Americans resolve to take steps to improve their health over the coming year. Why not also ask Congress to make a resolution that can help us all: voting to reform our prescription drug pricing system? While many of the world’s most important medical breakthroughs happen in U.S. labs, medicines developed there often cost too much for patients.

Utah often ranks among the healthiest U.S. states, but like everywhere else, its residents suffer from a variety of conditions requiring ongoing medication. Strokes — the third-leading cause of death in the U.S — are also the third-leading cause of death in Utah. More than 800 Utahns died from diabetes in 2021. Macular degeneration afflicted more than 20% of Utahns ages 65-84.

The manufacturers of important drugs to treat all three of these conditions have used a business strategy of creating “patent thickets” to game the U.S. patent system and ensure long-term profits. Eylea’s manufacturer, Regeneron, has 91 approved patents on the macular degeneration drug, creating a patent lifespan of 44 years — more than twice the standard market exclusivity of a patent. Most patients who need the medication today will never get a lower-cost, generic version in their lifetime. The prices for common drugs used to treat the other two of these conditions — Eliquis (to prevent stroke) and Trulicity (for diabetes) — have risen sharply, far exceeding inflation in recent years.

The U.S. Patent and Trademark Office (USPTO) gives inventors an initial 20-year monopoly for disclosing their innovation publicly. Expiring patents allow competition (in this case, from generic and biosimilar versions of drugs) to resume and for future inventors to build on the initial discovery.

When generics and biosimilars enter the market, Americans save $10 billion to $24 billion annually. But pharmaceutical companies block and delay generic competition by making minor changes (such as dosage or pill shape) to existing drugs and then apply for “secondary” patents, which the patent office often signs off on. We need the USPTO to stop approving patents without strong proof of a non-obvious innovation. Secondary patents rarely meet that test. In 2021, the 10 best-selling drugs boasted an average of 74 approved patents.

Competitors can only enter the market by invalidating those secondary patents. When generic and biosimilar competitors challenge patents in court, they win about 73% of the time, proving that patent examiners are making mistakes when approving new submissions. But these cases take years to litigate and are an expensive ($2.5 million median in 2019) burden for an upstart trying to compete with an established drugmaker. So, most competitors don’t sue, even if they think the patent is flawed and they could win in court. Therefore, drugs with these layers (thickets) of patents won’t face generic competition for decades — and high prices don’t fall without competitors.

When the Inflation Reduction Act passed in August 2022, the Centers for Medicare and Medicaid Services (CMS) regained the ability to negotiate lower prices for certain prescription medicines. In August 2023, the agency announced the first 10 medications subject to negotiation — including Eliquis. About 8 million people on Medicare will benefit from the federal government’s newly strengthened bargaining power. But others in Utah and across the country won’t.

The USPTO and the U.S. Food and Drug Administration have begun collaborating on other solutions. But Congress can do more to break down patent thickets, prevent product-hopping and end drugmakers’ pay-for-delay schemes. A handful of important health care spending packages are up for a vote by March 1.

Several bills offering solutions have passed the House and Senate Judiciary Committees in recent years with strong bipartisan votes. More than 80% of voters across party lines want federal agencies to encourage greater prescription drug competition. We hope that Senate Judiciary Committee member Mike Lee and Utah’s other representatives on Capitol Hill will heed that call to action.

We’ve diagnosed the ailment (high prescription drug prices) and the primary cause (pharmaceutical company abuse of the U.S. patent system). For our national health, Congress needs to reform our patent system. We need more lower-priced generic and biosimilar drugs at local pharmacies in Utah and across the country.

Patricia Kelmar directs the health care campaign work for U.S. PIRG and provides support to our state offices for state-based health initiatives. She represented U.S. consumers on the Centers for Medicare and Medicaid Services Advisory Committee on Ground Ambulance and Patient Billing.

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