“Study Reveals Increasing Number of Patents on Insulin Products by Manufacturers Over the Years”
Insulin Manufacturers Extend Market Exclusivity through Increased Patent Listings
Insulin manufacturers have been found to extend their periods of market exclusivity on brand-name insulin products over the last four decades. This has been achieved through various strategies, including filing additional patents on their products after FDA approval and obtaining numerous patents on delivery devices for their insulin products. This conclusion is the result of a new analysis of FDA and patent records by William Feldman of Brigham and Women’s Hospital, USA, and colleagues. The study was published on November 16th in the open access journal PLOS Medicine.
The Role of Patents in Insulin Pricing
Insulin is the primary, life-saving treatment for type 1 and some type 2 diabetes. Despite being discovered over a century ago, insulin remains costly in the US. A 2021 Congressional report found that the three major manufacturers of insulin have consistently raised prices over the decades, often in sync with each other. These high prices are sustained by patents and regulatory exclusivity that limit competition on brand-name products. Patents, which are government-granted monopolies lasting 20 years, prevent the Food and Drug Administration (FDA) from approving generic versions of drugs for marketing until the patents have expired.
Study Findings on Insulin Patents
In the recent study, researchers used publicly available U.S. FDA and patent data to track all insulin products approved in the U.S. from 1986 to 2019. During this period, the FDA approved 56 brand-name insulin products. The researchers discovered that protection on insulin was enhanced by patents obtained after FDA approval, extending expected market exclusivity by a median of 6 years. Interestingly, many of these patents were on the insulin delivery devices rather than the drugs themselves. In two-thirds of drug-device combinations, the device patents were the last to expire, extending protection for a median of 5.2 years. Overall, manufacturers secured a median of 16 years of protection on their insulin products through patents and exclusivities, surpassing the median of 14 years observed in other studies of top-selling small-molecule drugs.
Longest Periods of Expected Protection
The insulin lines with the longest periods of expected protection from the first product approved to last-to-expire patent were Lantus (32.9 years), followed by Novolog (32.3 years) and Novolog 70/30 (30.9 years).
Call for Policy Reforms
The authors of the study call for policy reforms to promote timely competition in the pharmaceutical market and ensure that patients have timely access to drugs at fair prices. Feldman adds, “Our study highlights how manufacturers have listed an increasing number of patents on insulin products over the years. These patents can delay competition and keep prices high for patients.”
As the debate over insulin pricing continues, this study provides valuable insights into the role of patents in shaping the market. It underscores the need for policy reforms to ensure that life-saving treatments like insulin are accessible and affordable for all patients.
For more information, the full study is freely available in PLOS Medicine: http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004309
Citation
Olsen A, Beall RF, Knox RP, Tu SS, Kesselheim AS, Feldman WB (2023) Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019. PLoS Med 20(11): e1004309. https://doi.org/10.1371/journal.pmed.1004309
Author Countries: United States, Canada
Funding: see manuscript
Method of Research
Observational study
Subject of Research
People
COI Statement
Competing Interests: see manuscript
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