Want to make drugs, including insulin, affordable? End patent abuse

• Published date: 09 March 2023
• Publication title: The Korea Times

Drugmaker Eli Lilly on Wednesday said it will drop prices on some versions of insulin, and cap monthly out-of-pocket costs at $35 per product for insured individuals not covered by Medicare's prescription drug program, which also maintains a $35 cap. The welcome move comes as lawmakers in both major parties seek to control rising drug prices, but our patients and the rest of the country can't afford to rely on the good will of the pharmaceutical industry to stem the crisis. That will take legislation. In the meantime, there are actions that U.S. patent- and drug- regulators can take now.

As President Joe Biden noted in his recent State of the Union address, the inventor of insulin "didn't even patent it because he wanted it to be available for everyone." It is true that Frederick Banting and his co-inventors sold the patent for insulin to the University of Toronto for $1 each in 1923, stating, "Insulin does not belong to me, it belongs to the world." It is also true that in the 100 years since that sale, the price of insulin has risen dramatically, as manufacturers have used the U.S. patent system to maintain exclusive rights over a variety of insulin products that account for billions of dollars in annual drug spending.

Current practices in the U.S. patent system incentivize companies to maximize the number of patents sought for drugs and biologics, creating "patent thickets" that enable aggressive litigation of patent infringement claims against generic versions of their products. Too frequently, these new patents represent incremental changes of little novelty, such as an update on an insulin autoinjector that does not clearly improve safety or efficacy for patients. Such maneuvers are legal, and often extend exclusivity for brand-name products beyond the expiration of their original patents, while delaying for years sometimes the availability of lower-cost, generic versions of their drugs.

That leads to difficult decisions. As many as one in four Americans has difficulty affording their prescriptions, and one in 10 has rationed drugs because of their cost. These decisions are borne most heavily by older, sicker and lower-income Americans, who in some cases risk life-altering consequences by forgoing essential medications. Diabetic patients without insurance, for example, are more likely to be prescribed older versions of insulin, which are less expensive but can lead to poorer diabetes control and greater risk of side effects.

As practicing physicians, we...