This is another antitrust class action against AbbVie and other companies, filed just ten days after the first, for anticompetitive behavior in relation to AbbVie’s drug Humira. The complaint alleges that AbbVie tried to maintain its monopoly on the drug by making illegal arrangements with companies that might have brought out biosimilars, thereby keeping the price of the drug artificially high.
Two classes have been proposed for this action.
Humira (also known as adalimumab) is a long-term treatment for the pain and inflammation associated with autoimmune diseases. It is used to treat a variety of conditions, including rheumatoid arthritis, chronic plaque psoriasis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and non-infectious uveitis.
Humira has been hugely profitable for AbbVie. The blockbuster drug earned $13 billion in sales in 2018 alone. AbbVie gets half of its revenue from Humira, so it’s not surprising it would want to keep its monopoly on the drug even though its original patent has expired. The complaint alleges it approached this in two ways.
First, it created a “patent thicket” consisting of hundreds of patents surrounding the drug, under which it would sue any competitor that tried to bring to market a biosimilar. This considered of “nearly 250 patent applications surrounding Humira’s uses, manufacturing processes, ingredients, formulations, and processes … [a] number of which were overlapping and/or related to processes that AbbVie did not use but a Humira competitor might.”
The complaint goes on to say that AbbVie secured over 100 patents, “with an astounding 50 or more Humira patents being granted in 2015 and 2016 immediately before expiration of its original patent…” Whether the cases were “valid or supportable” did not matter, the complaint claims; the time and expense required to work through the thicket were discouraging in themselves.
Second, the complaint says, “AbbVie abused the FDA’s system for approval of biosimilars by repeatedly taking frivolous positions that could not have been maintained in good faith in order to create leverage it could use in negotiations with those biosimilar manufacturers.”
The agreements it did make with the makers of biosimilars were specific, the complaint says. AbbVie not only obtained “agreements not to enter the U.S. market until 2023, but also to coerce its competitors into a market division scheme under which biosimilar manufacturers would enter the European market in a synchronized fashion based upon the timing and sequence of their settlements with AbbVie.”