The financial burden of high insulin costs that patients and insurers face is often blamed on the Food and Drug Administration’s ( FDA ) regulatory framework, but a new study suggests pharmaceutical companies have also been using patenting processes to unfairly maintain high costs.
In the FDA’s master list of approved medications, devices, and other therapeutics, a document known as the Orange Book, patent ownership of each item governs which companies are allowed to manufacture and sell which therapies. The FDA deals with drug approval, but patents are granted by another agency entirely, the U.S. Patent and Trademark Office (USPTO). Though there are rules governing which developments by pharmaceutical companies merit inclusion in the FDA’s Orange Book, experts have long said that the book remains full of improper patents that unfairly hamper market competitio
Insulin Pharmaceutical Companies Patenting Processes FDA Orange Book USPTO Market Competition
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