By Ryan Knox and Gregory Curfman
Since receiving FDA approval for Humira® (adalimumab) in 2002, AbbVie, the drug’s manufacturer, has filed hundreds of submissions to the U.S. Patent and Trademark Office for secondary patents – almost half of which were filed after 2014, just two years before the expiration of its core patent.
These patents were largely directed to methods of use and potential formulation changes, but they did not include claims that affect the clinical efficacy of the biologic, which is used in the treatment of rheumatoid arthritis, Crohn’s disease, and psoriasis, among other conditions. Instead, the purpose of the secondary patent filings was to assemble a thicket of patents, 132 in all, to prohibit competition from biosimilar companies.
And so far, the strategy has worked. AbbVie remains the sole U.S. manufacturer of the biologic, and has successfully defended its domain: in June 2020, a federal district court judge in Chicago dismissed an antitrust lawsuit against AbbVie.
The Humira Patent Thicket
Humira’s core patent (patent ‘382) expired in 2016. Expiration of the core patent on a biologic agent would ordinarily trigger entry of biosimilar competitors.
But when a biosimilar manufacturer attempts to enter the market, it must do so without infringing the brand company’s patents on the original biologic. With such a dense thicket of patents surrounding Humira, it was virtually impossible for biosimilar companies to attempt market entry without infringing at least some of the patents.
Instead of attempting to defend themselves in expensive, time-consuming patent infringement litigation, all six of the companies with biosimilars for Humira in the pipeline chose to settle with AbbVie. According to the terms of the settlement, the biosimilar companies would stay out of the U.S. market for several more years, while AbbVie permitted them to enter the lucrative European market.
In this manner, AbbVie has been able to control the U.S. market and continue to increase the price of one of the world’s best-selling drugs relentlessly. In 2019 alone, Humira generated $19.7 billion in revenue, an impressive financial return attributable mainly to its high price of $72 000 per year.
Humira Antitrust Litigation
In 2019, a group of third-party payors for Humira (including union benefit funds, health insurers, and local governments) filed a novel class-action antitrust lawsuit against AbbVie, claiming that the Humira patent thicket and related settlements were anticompetitive in violation of §§ 1 and 2 of the Sherman Antitrust Act (In Re: Humira [Adalimumab] Antitrust Litigation).
One of the principal criteria defining anticompetitive conduct that may be a target for antitrust claims is whether the conduct harms consumer welfare. The consumer welfare standard, which was popularized by Judge Robert H. Bork, is based on whether consumers pay a higher price for goods and services as a result of the alleged anticompetitive conduct.
In the case of Humira, it is self-evident that the patent thicket, by stifling competition that would have resulted in a significant price reduction, fulfills the consumer welfare standard for anticompetitive conduct.
Yet, in June 2020, Judge Manish Shah of the U.S. District Court for the Northern District of Illinois dismissed the case.
The Judge’s ruling was based on a legal principle known as the Noerr–Pennington doctrine. The doctrine states that petitioning the government, as a form of speech, is protected by the First Amendment’s petition and free speech clauses and, even if the petitioning is anticompetitive, is immune from antitrust action. It is noteworthy that the court considered patent applications to the U.S. Patent and Trademark Office to be a form of “petitioning,” and therefore covered by Noerr-Pennington and immune to antitrust action.
The Judge also ruled that AbbVie’s settlements with the biosimilar companies delaying their U.S. market entry and permitting European market entry did not constitute pay-for-delay tactics, which may also be anticompetitive.
Despite the obvious anticompetitive activity and harm to consumers reflected by the exorbitant price of Humira, the company has walked away unscathed by the antitrust claim for now.
Should Noerr-Pennington Be Overturned?
Some scholars believe that the Noerr-Pennington doctrine has been misused in antitrust cases by some judges who apply it as a default in lieu of conducting a formal First Amendment analysis.
In In Re: Humira, the central question was whether petitioning the government with hundreds of secondary patent applications is protected by the First Amendment and therefore qualifies for Noerr-Pennington immunity. While political petitioning and political speech are strongly protected by the First Amendment, commercial speech, the purpose of which is solely to promote a commercial transaction or is related to the parties’ economic interests, receives lesser protection.
AbbVie’s thicket of patents, many of which were frivolous or invalid, resulted from petitioning that is tantamount to commercial speech, which does not receive as high a level of First Amendment protection and therefore should not warrant Noerr-Pennington immunity.
One antitrust authority, Timothy Wu, has called for Noerr-Pennington to be overturned. Professor Wu argues that Noerr-Pennington has been applied far beyond its intended scope and in a way that undermines the intent of the antitrust laws. Without the ability to claim Noerr-Pennington immunity as a default strategy, defendants, such as AbbVie in In Re: Humira, would have to show through a formal First Amendment analysis that their petitioning of the government qualifies for First Amendment protection and immunity from antitrust claims.
Implications of the Humira Antitrust Lawsuit
Although In Re: Humira was dismissed by the district court judge, the plaintiffs have appealed to the U.S. Court of Appeals for the Seventh Circuit. If the plaintiffs do not succeed in their appeal, companies like AbbVie will be free to amass patent thickets around lucrative pharmaceuticals and be shielded from antitrust litigation on the basis of Noerr-Pennington.
If, however, the plaintiffs prevail, this result would send a warning signal to AbbVie and other pharmaceutical manufacturers that the anticompetitive strategy of filing for numerous superfluous patents may no longer be sanctioned by the courts and immune from scrutiny under Noerr-Pennington. Patients would surely benefit from this outcome.
Ryan Knox, J.D. is a Senior Research Fellow with the Solomon Center for Health Law and Policy at Yale Law School.
Gregory Curfman, M.D. is the Senior Advisor and Physician Scholar in Residence for the Solomon Center for Health Law and Policy at Yale Law School. He is also the Deputy Editor of JAMA.
