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 have found ourselves strategizing over which medication option might be least costly to our patients or prescribing necessary, high-cost medications while knowing patients may struggle to afford them. These problems are compounded when we cannot count on generic drugs and biosimilars (generic versions of biologics) to predictably become available after brand-name products have been marketed for years. When patients must choose between their physical and financial well-being, harm is unavoidable.
Building on their commitment to collaborate to reduce anti-competitive practices in drug development, the U.S. Patent and Trademark Office and the Food and Drug Administration can take several steps to reduce the unnecessary extension of patent regimes for approved drugs and biologics.
First, information sharing between USPTO and FDA should be formalized, to eliminate loopholes through which discrepant statements can be made separately to each agency. FDA already has the authority to publicly disclose full regulatory dossiers, and pathways could be developed to give USPTO access to information needed to evaluate claims of novelty while still protecting trade secrets.
FDA can also directly assist USPTO to assess pharmaceutical patent claims. Training on the use of publicly available FDA resources, supported by FDA’s scientific and technical expertise, will help patent examiners to corroborate the reported quality of evidence and the timing of key claims arising from the development of new products, to ensure that patent applications are truly new, novel and non-obvious.
Finally, USPTO should seek proactive public input on applications for new patents over approved drugs and biologics. Similar to how FDA convenes independent experts to address issues related to drug development in their regulatory reviews, USPTO could bring together independent stakeholders — such as patient advocates, academic experts, health professionals, and other representatives without financial conflicts of interest — to provide commentary on the real-world novelty and utility of claimed “inventions.” These expert panels could also assist USPTO and FDA to translate between aspects of claimed therapeutic benefit, such as “first-in-class” and “clinical benefit,” and USPTO’s standards for awarding new patents, such as “novelty,” “usefulness” and “non-obviousness.” A shared language among all stakeholders will be critical to identifying patent claims that represent true innovation.
Ultimately, new legislation will be required to limit the use of patents to indefinitely extend monopolies over drugs and biologics, toward which Congress has taken some initial steps. Until then, USPTO and FDA should seek every opportunity to ensure the U.S. patent system enables, rather than restricts, the development of truly effective and affordable medications.
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ABOUT THE WRITERS
Dr. Joshua Skydel (Twitter: @SkydelJ) is a resident physician in internal medicine at Dartmouth-Hitchcock Medical Center and a member of the Doctors for America FDA Task Force. Dr. Reshma Ramachandran (Twitter: @reshmagar) is a family medicine physician and assistant professor at Yale School of Medicine. She co-directs the Yale Collaboration for Regulatory Rigor, Integrity and Transparency and chairs the FDA Task Force for the independent, national nonprofit organization, Doctors for America.
