AbbVie Inc., AbbVie Biotechnology Ltd., and Amgen Inc. find themselves on the receiving end of a proposed antitrust class action that focuses on the pharmaceutical companies’ alleged conspiracy to maintain a monopoly over the market for arthritis treatment Humira.
According to the lawsuit, the injectable anti-inflammatory drug adalimumab was launched by AbbVie under the brand name Humira in 2003 and went on to become a best-selling product worldwide with sales reaching $20 billion in 2018. The original patent for the drug was set to expire in 2016, the suit says, which would have opened the door for competition from manufacturers of biosimilar drugs. As the expiration date approached, however, AbbVie, the case claims, engaged in a “two-part scheme to keep Humira competition at bay.”
The complaint says AbbVie aimed to create as many hurdles as possible for possible competitors by filing more than 240 patent applications and obtaining over 100 patents that cover, among other things, the drug’s uses, manufacturing processes and ingredients. By filing these patents, the case explains, AbbVie made it difficult for any company to make drugs similar to Humira without infringing on at least some of its many patents.
The second part of the alleged scheme involved AbbVie paying off would-be competitors to delay their release of biosimilar products, the suit says. One such competitor is defendant Amgen, which was the first company to receive FDA approval of its biosimilar drug, adalimumab-atto, or Amjevita. The case charges that Amegen agreed to delay the release of its product in exchange for AbbVie “extending its Humira monopoly” to the company by assuring it five-month exclusivity in the market as a competitor.
In the end, the case argues, the defendants’ allegedly anticompetitive conduct deprived consumers of more affordable versions of their drugs. The suit adds that AbbVie’s market dominance allows it to charge each patient almost $50,000 per year for Humira.