How Pharmaceutical Companies Game The Patent System: The New York Times reported on how pharmaceutical companies legally abuse the patent system and hospital management software to earn billions from their patents that are expiring on their cash-cow drugs. By using lawsuits and settlement practices to prevent competing generic and biosimilar versions of these drugs from reaching the market, pharmaceutical companies can delay or stop the generic or biosimilar versions that benefit the patent holders at the expense of patients and taxpayers.
The New York Times recently reported on the large pharmaceutical company AbbieVie, which owned the patent on Humira, its best-selling anti-inflammatory drug, which was due to expire in 2016 (patents are good for twenty years from the date of application). Humira was initially approved to treat symptoms of rheumatoid arthritis and later approved to treat other autoimmune diseases, such as Crohn’s disease and ulcerative colitis.
AbbieVie has earned over $208 billion on Humira from worldwide sales since it was first approved in the United States in 2002. In 2021, Humira sales represented more than one-third of AbbieVie’s total revenue. The list price of Humira has steadily risen since 2016, from $50,000 to over $80,000. The New York Times reported that Medicare, which in 2020 covered the cost of Humira for 42,000 patients, spent $2.2 billion more on Humira from 2016 to 2019 than it would have if competing versions had been promptly allowed.
A competing version of Humira manufactured by Amgen was on the cusp of receiving FDA approval in 2016 when AbbieVie sued Amgen, alleging that Amgen was violating 10 of AbbieVie’s patents. Amgen initially defended by alleging that AbbieVie’s patents were invalid, but the two pharmaceutical giants later settled when Amgen agreed to delay entering the market with its biosimilar drug until 2023. Nine other manufacturers of versions of Humira also settled with AbbieVie during the following five years, also agreeing to delay their versions of Humira until 2023.
The New York Times reported that AbbieVie’s Humira has earned it $114 billion since 2016, and that AbbieVie will receive royalties from the manufacturers of versions of Humira once they become available in 2023, as agreed in the settlements reached with them.
AbbieVie is not alone in its tactics to protect its profits on expiring patents: for example, The New York Times reported that Amgen has many patents for its anti-inflammatory drug Enbrel, delaying a biosimilar version by 13 years after it obtained FDA approval; Merck and its partners have sought 180 patents related to its cancer drug Keytruda, and Merck is working on a new formulation that could extend its monopoly even further; Bristol Myers Squibb and AstraZeneca used similar tactics to maximize profits on their drugs for the treatment of cancer, anxiety, and heartburn.
If you or a loved one suffered injuries (or worse) as a result of a bad drug/defective drug in the United States, you should promptly seek the legal advice of a pharmaceutical claim lawyer in your state who may investigate your drug claim for you and represent you or your loved one in a claim against a pharmaceutical company, if appropriate.
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