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January 30, 2023 12:34 pm

A Drug Company Made $114 Billion Gaming America's Patent System

The New York Times looks at the AbbVie's anti-inflammatory drug Humira and their "savvy but legal exploitation of the U.S. patent system." Though AbbVie's patent was supposed to expire in 2016, since then it's maintained a monopoly that generated $114 billion in revenue by using "a formidable wall of intellectual property protection and suing would-be competitors before settling with them to delay their product launches until this year."AbbVie did not invent these patent-prolonging strategies; companies like Bristol Myers Squibb and AstraZeneca have deployed similar tactics to maximize profits on drugs for the treatment of cancer, anxiety and heartburn. But AbbVie's success with Humira stands out even in an industry adept at manipulating the U.S. intellectual-property regime.... AbbVie and its affiliates have applied for 311 patents, of which 165 have been granted, related to Humira, according to the Initiative for Medicines, Access and Knowledge, which tracks drug patents. A vast majority were filed after Humira was on the market. Some of Humira's patents covered innovations that benefited patients, like a formulation of the drug that reduced the pain from injections. But many of them simply elaborated on previous patents. For example, an early Humira patent, which expired in 2016, claimed that the drug could treat a condition known as ankylosing spondylitis, a type of arthritis that causes inflammation in the joints, among other diseases. In 2014, AbbVie applied for another patent for a method of treating ankylosing spondylitis with a specific dosing of 40 milligrams of Humira. The application was approved, adding 11 years of patent protection beyond 2016. AbbVie has been aggressive about suing rivals that have tried to introduce biosimilar versions of Humira. In 2016, with Amgen's copycat product on the verge of winning regulatory approval, AbbVie sued Amgen, alleging that it was violating 10 of its patents. Amgen argued that most of AbbVie's patents were invalid, but the two sides reached a settlement in which Amgen agreed not to begin selling its drug until 2023. Over the next five years, AbbVie reached similar settlements with nine other manufacturers seeking to launch their own versions of Humira. All of them agreed to delay their market entry until 2023. A drug pricing expert at Washington University in St. Louis tells the New York Times that AbbVie and its strategy with Humira "showed other companies what it was possible to do." But the article concludes that last year such tactics "became a rallying cry" for U.S. lawmakers "as they successfully pushed for Medicare to have greater control over the price of widely used drugs that, like Humira, have been on the market for many years but still lack competition."

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