A federal district court recently dismissed a lawsuit against AbbVie and biosimilar manufacturers of adalimumab involving a novel antitrust claim against the Humira patent estate. Attorneys with Haug Partners LLP take an in-depth look at the decision and discuss lessons learned and the path forward for biologic drug manufacturers.
In 2019, indirect purchasers of Humira (adalimumab) sued AbbVie and biosimilar manufacturers of adalimumab in the U.S. District Court for the Northern District of Illinois, advancing the novel antitrust claim that AbbVie utilized its so-called “patent thicket” as part of an anticompetitive scheme to block biosimilar manufacturers in the market for Humira.
Last year, Humira grossed nearly $20 billion in revenue, making Humira easily the best-selling drug in recent memory. While the Food and Drug Administration has approved five biosimilars of Humira—which would be cheaper, follow-on versions of the branded biologic drug—none have been marketed.
AN INTENTIONAL ‘MINEFIELD’
The indirect purchasers (plaintiffs) argued that AbbVie intentionally created a “minefield” of patents issued from applications filed after the launch of Humira, noting that while the average new Orange Book-listed drug from the three years leading up to Humira’s 2002 launch had a mean number of 3.9 patents, Humira had over 100 at the time their complaint was filed.
This difference is at least in part because Humira is not a “small molecule” drug (a chemically synthesized drug) but a “biologic” or “large molecule drug.” Biologics, which were relatively uncommon in 2002, tend to have complex structures that are more challenging to characterize.
The plaintiffs also alleged that AbbVie used its “seemingly impregnable fortress” of patents to deter patent challenges from biosimilar competitors Amgen, Samsung Bioepis, Sandoz, and Fresenius Kabi, while encouraging them to enter into settlements that granted early market entry in exchange for agreeing not to challenge Humira’s patents.
These agreements provided Amgen—the first biosimilar challenger—a de facto five-month exclusivity period against other biosimilar competitors, while other biosimilar competitors received staggered entry dates in order of their dates of settlement.
The biosimilar competitors were also permitted earlier entry into European markets than the U.S., which the plaintiffs alleged to be an unlawful “market division” requiring U.S. customers to subsidize lower Humira prices in Europe.
DISTRICT COURT DISMISSES LAWSUIT
On June 8, the district court dismissed the lawsuit, finding much of AbbVie’s conduct to be immunized by the Noerr-Pennington doctrine, a legal framework that protects use of the legal process (an exercise of free speech) from antitrust scrutiny so long as it is not a sham.
AbbVie’s 0.534 “batting average” in successfully obtaining patents at the U.S. Patent & Trademark Office convinced the court that those patent applications could not be considered sham, a conclusion supported by AbbVie’s even higher success rate during inter partes review proceedings challenging certain patents.
The court was also unable to find any antitrust violations in some of AbbVie’s arguably unjustifiable patent assertions against biosimilar competitors, since there was no evidence those patent assertions caused the biosimilar competitors to delay a biosimilar launch.
Furthermore, AbbVie’s agreements with Amgen, Samsung Bioepis, Sandoz, and Fresenius Kabi actually increased competition by bringing competitors into the U.S. and European markets when patents otherwise prohibited competition, an arrangement permissible under FTC v. Actavis Inc., 570 U.S. 136, 141 (2013), particularly because there was no allegation that AbbVie made a large or unexplained payment in exchange for biosimilar delay.
CONSEQUENCES OF THE DISMISSAL
In light of the district court dismissal, we envision several consequences.
First, biologics manufacturers will continue to exploit the complexity of biologics synthesis and manufacturing processes to build large patent estates, which can be used as both a sword and a shield against biosimilar competitors.
Second, biologics manufacturers may, like AbbVie, seek to grant a de facto exclusivity period for a first biosimilar to be approved by FDA and/or settle with the reference product sponsor, similar to the six-month Hatch-Waxman exclusivity awarded to the first generic to successfully challenge an Orange Book patent.
Third, private plaintiffs and the Federal Trade Commission will continue to scrutinize and seek to challenge biologics manufacturers that aggressively assert patents against biosimilars during the Biologics Price Competition and Innovation Act (BPCIA) “patent dance.”
For instance, the Humira court observed that AbbVie had asserted against Sandoz “nine formulation patents that…were objectively baseless to assert,” suggesting that while the instant plaintiffs did not prevail, antitrust interest in large biologics patent portfolios is likely to intensify going forward.
While much remains to be seen, AbbVie’s Humira patent estate lives to see another day.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
Originally published by The Bureau of National Affairs, Inc. on July 16, 2020. Reproduced with permission from Copyright 2020 The Bureau of National Affairs, Inc. (800-372-1033) www.bloombergindustry.com