How Drug Makers Manipulate Patents to Keep Insulin Prices High

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). [time-brightcove not-tgx=”true”] 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 competition. Because patents in the Orange Book lock in a period of market exclusivity for the holder that’s stayed at least 30 months even in the face of legal challenges from smaller companies, filing additional patents on product lines can allow manufacturers to operate without competition—and thus sell at higher prices—for longer periods of time. While a patent remains in the Orange Book, the FDA cannot approve an equivalent generic.  A Nov. 16 study highlights how the ease of manipulating the Orange Book has caused pricing issues for o...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Drugs healthscienceclimate Source Type: news