Amid debate over potential abuse of the U.S. patent system by the pharmaceutical industry, moves by some drugmakers to expand their patent claims appear to be delaying the arrival of lower-cost generic medicines to the marketplace, according to a STAT analysis.
At issue are use codes, which are brief descriptions of a type of patent claim that focuses on the specific use of a medicine, or the “method of use” in legal vernacular. Once the Food and Drug Administration approves a medicine, this information is filed in the Orange Book, a key registry that plays a crucial, behind-the-scenes role in sorting out the competitive landscape in the pharmaceutical industry.
The patents listed in the Orange Book are cited by brand-name drugmakers to put their generic rivals on notice about certain types of patents that are claimed for a medicine.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
