Patents Per Small-Molecule Drug More Than Tripled Since 1990, JAMA Study Finds
A JAMA study found the average number of patents on each approved small-molecule drug rose from 2.1 in 1990 to 6.9 in 2019, with most of the growth covering inactive ingredients, dosing changes and delivery devices rather than active ingredients.
The researchers counted patents per approved drug and found an average of 2.1 patents for medicines approved in 1990, compared with 6.9 for those approved in 2019.
Most of the increase came from what the study classifies as "nonprimary" patents, which generally do not cover a drug's active ingredient. They instead cover items such as minor changes to a drug's inactive ingredients, updates to the way the drug is used, or the design of specialty delivery devices including auto-injectors.
The accumulation of such patents on a single drug produces what researchers and regulators call a "patent thicket." According to the study as described by Ars Technica, these overlapping claims postpone the release of affordable generics, holding prices higher without any corresponding clinical advance.
The United States already pays more for prescription medicines than peer countries, and the high cost of drugs is a persistent pressure point in American healthcare spending. The JAMA study points to use of the US patent system as one factor behind that gap.
The report referenced the study's findings on patent counts and categories but did not include a response from pharmaceutical manufacturers or from the researchers beyond the published results.