Earlier this summer, Judge Manish Shah of the United States District Court for the Northern District of Illinois dismissed a lawsuit against AbbVie and biosimilar manufacturers of the drug Humira (adalimumab). The lawsuit involved an antitrust claim against the Humira patent estate and made a novel antitrust claim that AbbVie used its “patent thicket” as part of an anticompetitive scheme to block biosimilar manufacturers in the market for Humira.
While the United States Food and Drug Administration (FDA) has approved five biosimilars of Humira, none have been marketed and in 2019 alone, Humira grossed nearly $20 billion in revenue.
Plaintiff’s Allegations
In their complaint, the indirect purchasers of Humira argued that AbbVie intentionally created a “minefield” of patents issued from applications filed after the launch of Humira. The plaintiffs noted that while the average new Orange Book-listed drug from three years leading up to Humira’s launch had an average number of 3.9 patents, Humira at more than 100 at the time the complaint was filed. The patents covered a range of technological aspects, including formulation and manufacturing methods. While that may be partially explained by the fact that Humira is a “large molecule drug,” and therefore a more complex structure and more challenging to characterize, that doesn’t seem to explain the large difference in patents.
The plaintiffs also alleged that AbbVie used its “seemingly impregnable fortress” of patents to deter patent challenges from biosimilar competitors while encouraging those same competitors to enter into settlements that granted early market entry in exchange for not challenging Humira’s patents.
District Court Dismissal
In his Memorandum Opinion and Order dismissing the case, Judge Shah found that most of AbbVie’s conduct was immunized under the Noerr-Pennington doctrine. The Noerr-Pennington doctrine protects use of the legal process from antitrust scrutiny, provided it is not a sham.
Judge Shah believed that AbbVie’s success with obtaining patents meant that those patent applications could not be considered a sham. Shah was also unable to find any antitrust violations in some of AbbVie’s less-justifiable patent assertions against biosimilar competitors, since there was no evidence presented that the patent assertions caused the biosimilar companies to delay a biosimilar launch.
Shah also found that AbbVie’s agreements with several biosimilar competitors (including Amgen, Samsung Bioepis, Sandoz, and Fresenius Kabi) actually served to increase competition by bringing competitors into the United States and European markets where the patents otherwise prohibited competition. This was possible based on a 2013 court ruling – FTC v. Actavis Inc. – especially because there was no allegation that AbbVie made a large or unexplained payment in exchange for biosimilar delay.
What Does This Mean?
It’s hard to estimate what this decision will mean so soon after it has been made. It is likely that biologics manufacturers will continue to use the complexity of the biologic synthesis and manufacturing processes to build so-called “patent thickets.” Those patent thickets can then be used both for and against biosimilar competitors.