The patents on medicines and devices approved by the U.S. Food and Drug Administration were more frequently invalidated due to information misrepresented or withheld from patent examiners than any other industry sector, according to a new analysis.
Between 2004 and 2021, a U.S. appeals court that handles patent litigation found 36 cases in which companies committed what is called inequitable conduct — failing to provide accurate or complete information to the U.S. Patent & Trademark Office. As a result, 75 patents filed by companies in various industry sectors were subsequently invalidated, according to the analysis in JAMA.
Of those 36 cases, two-thirds involved 34 patents that covered medical products regulated by the FDA. And of those 34 invalidated patents, 15 pertained to medicines and 10 to medical devices. Overall, there were more invalidated patents for products approved by the FDA than other types of products, such as cable modems, electric lighting, automobile multimedia systems, and magnetic purse clasps.