AbbVie Says Antitrust Case Over Humira Could "Chill Medical and Therapeutic Innovation"

In March of this year, United Food and Commercial Workers Local 1500 filed a class-action lawsuit against AbbVie for alleged use of a patent thicket to maintain a monopoly for its brand-name adalimumab, Humira. The complaint also alleges that AbbVie colluded with biosimilar developers Amgen, Samsung Bioepis, Mylan, Sandoz, Fresenius Kabi, Pfizer, and Momenta to divide the market for adalimumab between Europe and the United States.

Now, in a memorandum in support of its motion to dismiss the case, AbbVie says that the suit seeks to “upend the well-settled balance between the patent and antitrust laws,” that the complaint would end international early-entry patent settlements that do not have the same global market entry date, and that it would “chill medical and therapeutic innovation.”

In the memorandum, filed in the United States District Court for the Northern District of Illinois, AbbVie claims that its settlements with biosimilar developers allow biosimilar adalimumab to reach US patients years before its US patents expire, and states that its accumulation of patents on Humira is not itself illegal.

With respect to the allegation that international markets for Humira were unlawfully allocated, AbbVie stated that its settlements are entry-only settlements, not settlements that involve a payment flowing from the patent holder to the licensee, and these settlements are therefore not subject to antitrust scrutiny. It also states that the fact that AbbVie conducted 2 sets of settlements at the same time, in the US and European contexts, “does not somehow transform these settlements into unlawful reverse payments.”

It also called the allegation that AbbVie unlawfully provided a payment to Amgen in the form of an earlier market entry date than other products “demonstrably false,” as the agreement with Amgen does not have language concerning a 5-month exclusivity period on the US market. In fact, it maintains, AbbVie is free to grant other biosimilar developers the same market entry date, or even an earlier one.

The memorandum adds that the plaintiffs have not provided facts that indicate that any biosimilar adalimumab would be commercially available in the United States if not for AbbVie’s alleged conduct, pointing out that some products, like Samsung Bioepis’ Hadlima, had not even been approved by the FDA at the time the company settled with AbbVie. The memorandum also notes that Boehringer Ingelheim elected not to launch its product, Cyltezo, at risk while litigation was ongoing.

Finally, AbbVie said that the plaintiffs “assert their own thicket” in terms of state law claims, all of which AbbVie says fail as a matter of law on multiple grounds, including lack of standing and barred claims.