Using FDA and patent records, investigators uncovered how insulin manufacturers utilize regulatory exclusivity and patents to restrict competition from generic products.
Though insulin was discovered over a century ago, its cost remains high in the United States. Moreover, according to a 2021 Congressional report, three leading insulin manufacturers persistently hiked prices over the years, often coordinating these increases.
One aspect that may contribute to the high cost of insulin and other drug products is patent exclusivity. When a pharmaceutical company gains a patent on its new medication or medical device, it hampers the FDA's ability to authorize generic and often less expensive versions until the pattern expires.
For example, when Takeda Pharmaceutical's patent on Vyvanse expired this year, the FDA subsequently approved several generic versions of the ADHD drug.
However, pharmaceutical companies can potentially use tactics involving patents and FDA regulatory policies to extend their ability to monopolize the market on drugs or medical devices, and this could include insulin.
To investigate these strategies and determine if they may affect insulin prices, researchers from Brigham and Women's Hospital examined FDA and patent records of insulin products authorized in the United States between 1986 and 2019.
Their findings were published on November 16 in PLOS Medicine.
During the study period, the FDA approved 56 brand-name insulin products. The investigators found that patents obtained by pharmaceutical firms after FDA approval of their brand-name insulin increased product protection. This, in turn, extended their insulin product's market exclusivity by an average of six years.
What's more, many patents were on insulin delivery devices, and around two-thirds of patents on these devices expired after the insulin itself, which extended protection for about 5.2 years.
Overall, the researchers discovered that pharmaceutical companies extended market exclusivity on their insulin products for an average of 16 years — two years more than observed with other small molecule medications.
The study authors say insulin brands that had the most prolonged market exclusivity protection were Lantus (32.9 years), Novolog (32.3 years), and Novolog 70/30 (30.9 years).
"While such price reductions are a positive development, they apply only to a handful of insulin products. Price negotiation under the Inflation Reduction Act may also help lower brand-name insulin costs in Medicare, but the negotiated prices will not apply to commercial markets," the study's authors wrote.
They suggest that along with recently passed legislation to help reduce insulin prices, Congress, the FDA, and the United States Patent and Trademark Office (USPTO) should work towards reforming the patent and regulatory system to prevent these patent and exclusivity strategies.
Corresponding author William B. Feldman, M.D., D.Phil., M.P.H., an associate physician with the Division of Pulmonary and Critical Care Medicine at Brigham and Women's Hospital, told Healthnews, "In general, I think we need a higher bar at the USPTO for granting patents and a higher bar for manufacturers to list patents in the Orange Book."
Feldman says the FTC has recently raised concerns about manufacturers listing device patents on products in the Orange Book with no connection to the active ingredients, and these patenting practices can delay generic competition.
"In addition, the Biden administration has called on Congress to grant the FDA more flexibility in approving generic drug-device combinations with slight differences from brand-name versions (but the same active ingredients)," Feldman said.
Feldman believes these reforms could help facilitate more timely generic entry into the market and help patients afford their medications.
In response to a request for comment, Charlie Kohler, Trade Press Officer at the FDA's Center for Drug Evaluation and Research (CDER), told Healthnews, "Generally, the FDA does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health."
More unanswered questions
In a research letter published on November 13 in JAMA Network, researchers found that between 2004 and 2021, the Court of Appeals for the Federal Circuit ruled on 24 inequitable conduct cases regarding patents for FDA-regulated products, leading to the invalidation of 34 patents.
Of the 34 invalidated patents connected to FDA-regulated products, 15 were drug-related, 10 were device-related, and eight involved food. The most common type of invalidation was not submitting critical printed publications to the USPTO.
The authors wrote, "Although inequitable conduct appellate cases have affected few drug patents during the past 15 years, the prevalence of inequitable conduct is unknown because not all cases of inequitable conduct are identified or litigated."
- PLOS Medicine. Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019.
- FTC. FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book.
- JAMA Network. Inequitable Conduct and Invalidation of Patents Related to Food and Drug Administration–Regulated Products.