Posted by Michael Wonder on 22 Sep 2024
Inside the quiet strategy pharma giants are using to fend off generics and drive up the cost of medicines
18 September 2024 - Amid debate over potential abuse of the US patent system by the pharmaceutical industry, moves by some drug makers 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 FDA 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.
