A class action lawsuit brought by grocery workers, city officials, and police unions alleged that AbbVie, the maker of Humira, deliberately built a wall of 132 U.S. patents around the blockbuster drug to keep cheaper biosimilar alternatives off the American market for years. The lawsuit claimed this “patent thicket” strategy violated federal antitrust law and forced patients, insurers, and union health plans to keep paying Humira’s roughly $6,922 per month list price long after the drug’s core patent expired in 2016. However, AbbVie prevailed in court — a federal district judge dismissed the case in 2020, and the U.S. Court of Appeals for the Seventh Circuit affirmed that dismissal in August 2022, finding that accumulating patents is not inherently anticompetitive.
The case raised fundamental questions about where legitimate patent protection ends and monopolistic abuse begins, particularly in the pharmaceutical industry where a single drug can generate tens of billions in annual revenue. Although the plaintiffs lost, the underlying tension has not gone away. Eight biosimilars have now entered the U.S. market, some priced 85 to 86 percent lower than Humira, yet biosimilar market share only reached about 23 percent by November 2024.
Table of Contents
- How Did AbbVie Allegedly Use a Patent Thicket to Block Biosimilar Competitors?
- What the Courts Decided and Why AbbVie Prevailed
- Who Filed the Lawsuit and What They Sought
- How Biosimilar Competition Is Reshaping Humira Pricing Today
- The Broader Patent Thicket Problem in Pharmaceutical Markets
- What This Means for Patients Currently Taking Humira
- The Future of Biosimilar Access and Antitrust Enforcement
- Frequently Asked Questions
How Did AbbVie Allegedly Use a Patent Thicket to Block Biosimilar Competitors?
The term “patent thicket” refers to a dense web of overlapping patents that makes it prohibitively expensive and legally risky for competitors to enter a market. In AbbVie’s case, the company accumulated 132 U.S. patents on Humira (adalimumab), with some protections extending all the way to 2034 — nearly two decades past the 2016 expiration of the original patent. Nearly half of those patent filings were submitted after 2014, just two years before the core patent was set to expire. Critics argued the timing was no coincidence: AbbVie was allegedly fortifying its legal position precisely when generic-style competition should have been arriving. Crucially, the lawsuit alleged these later patents were largely directed at methods of use and formulation changes rather than genuine clinical efficacy improvements.
In other words, AbbVie was not patenting breakthrough medical advances but rather incremental tweaks that served primarily to extend its legal monopoly. By comparison, when a patent thicket works as alleged, any biosimilar manufacturer attempting to bring a competing product to market faces the prospect of defending against infringement claims on dozens or even hundreds of patents — a process that can take years and cost hundreds of millions of dollars in legal fees alone. The class action went further, alleging that AbbVie did not rely on patents alone. The plaintiffs claimed AbbVie entered illegal market-division agreements with seven biosimilar developers — Amgen, Samsung Bioepis, Mylan, Sandoz, Fresenius Kabi, Pfizer, and Momenta — in which each company agreed not to market a U.S. biosimilar before 2023. This was especially notable because biosimilar versions of Humira had already launched in Europe as early as October 2018, meaning American patients were allegedly paying inflated prices for years while European patients had access to cheaper alternatives.
What the Courts Decided and Why AbbVie Prevailed
In June 2020, U.S. District Judge Shah in the Northern District of Illinois dismissed the case, ruling that AbbVie’s patent filings were protected activity under the Noerr-Pennington doctrine. This legal principle provides immunity for parties who petition the government — including filing patent applications — even if the result is anticompetitive. The court found that obtaining patents, regardless of how many, constitutes protected petitioning of the U.S. Patent and Trademark Office. The Seventh Circuit affirmed that ruling on August 1, 2022, and the appellate court’s opinion was notably blunt in its reasoning.
The court stated: “But what’s wrong with having lots of patents? If AbbVie made 132 inventions, why can’t it hold 132 patents?” The judges found that AbbVie had “surrendered its monopoly” before all of its patents expired and that the biosimilar developers who entered settlement agreements were not paid to delay — a distinction that matters because “pay-for-delay” arrangements have been found anticompetitive in other pharmaceutical cases. However, this outcome does not mean that patent thicket strategies are always beyond legal challenge. The Noerr-Pennington doctrine has a “sham litigation” exception — if a company files patents it knows to be fraudulent or brings enforcement actions it knows have no merit, the immunity can be stripped away. The plaintiffs in this case were unable to meet that high bar. For consumers and health plans that believed they overpaid, the ruling effectively closed the door on recovering damages through this particular legal theory. It is worth noting that the decision is binding only in the Seventh Circuit, and other courts could theoretically reach different conclusions on similar facts.
Who Filed the Lawsuit and What They Sought
The lead plaintiff was United Food and Commercial Workers Local 1500, a New York-based grocery workers’ union whose health plan covered Humira prescriptions for members. They were joined by a coalition that included Baltimore city officials, police unions, Miami officials, and Minnesota trade workers — all entities that paid for Humira through employer-sponsored health plans and alleged they were harmed by artificially inflated prices. The plaintiffs alleged violations of the Sherman Antitrust Act, the foundational federal law that prohibits monopolistic practices and conspiracies in restraint of trade.
Their theory was twofold: first, that the patent thicket itself constituted illegal monopoly maintenance, and second, that the settlement agreements with biosimilar makers amounted to illegal market division. Had the case succeeded, it could have opened the door to significant damages, potentially trebled under antitrust law, representing the difference between what plan members paid for Humira and what they would have paid had biosimilar competition arrived on schedule. The breadth of the plaintiff coalition illustrated how the alleged conduct affected virtually every type of health plan purchaser — municipal governments, labor unions, and commercial insurers alike. When a drug costs roughly $83,000 per year and is the best-selling pharmaceutical product in the world, even modest delays in competition translate to billions of dollars in excess spending across the healthcare system.
How Biosimilar Competition Is Reshaping Humira Pricing Today
Eight biosimilars are now available on the U.S. market, and the pricing landscape has shifted dramatically. Some biosimilars, including Hadlima, Yusimry, and Simlandi, are priced 85 to 86 percent lower than Humira’s list price. For a patient paying out of pocket, that could mean the difference between roughly $6,922 per month and around $1,000 or less. In April 2025, the FDA granted interchangeable status to YUFLYMA, Celltrion’s citrate-free biosimilar, which allows pharmacists in many states to substitute it for Humira without requiring a new prescription from the physician. Despite these lower prices, biosimilar adoption has been slower than many expected.
Market share reached approximately 23 percent by November 2024, up from 14.1 percent earlier that year. Several factors explain the gradual uptake: physician and patient familiarity with Humira, AbbVie’s rebate strategies with pharmacy benefit managers, and lingering concerns about switching stable patients to a different product. The tradeoff for patients is real — while biosimilars offer substantial cost savings, switching from a medication that is working well carries some psychological weight, even when the clinical evidence shows biosimilars are equally effective. The financial trajectory tells the broader story. The global Humira market was estimated at $10.34 billion in 2024 but is projected to decline to $4.11 billion by 2030. Meanwhile, the Humira biosimilar market is expected to grow from $1.54 billion in 2025 to $7.72 billion by 2032, reflecting a compound annual growth rate of 25.9 percent. Competition is arriving — it is just arriving years later than it might have without the patent thicket.
The Broader Patent Thicket Problem in Pharmaceutical Markets
AbbVie’s strategy with Humira is not an isolated case. Patent thickets have become a recurring concern across the pharmaceutical industry, and policymakers, academics, and patient advocacy groups have increasingly scrutinized the practice. The core problem is that the U.S. patent system allows incremental innovations — a new formulation, a different injection device, a modified dosing regimen — to receive full patent protection, even when the underlying active ingredient is well established. The limitation for consumers and legal advocates is that current law offers few effective remedies.
As the Seventh Circuit’s ruling demonstrated, courts are reluctant to second-guess the patent office’s decisions to grant individual patents, and the Noerr-Pennington doctrine provides strong protection for the act of seeking patents. Legislative proposals have been introduced in Congress to address patent thickets, but none have been enacted. Until the legal framework changes, pharmaceutical companies have a strong financial incentive to continue the practice. For health plan sponsors and individual patients, the practical consequence is that they must navigate a system where competition may be delayed by legal strategy rather than genuine innovation, and the courts may offer no recourse. Separate from the class action, Alvotech filed its own lawsuit directly challenging AbbVie’s patent thicket, alleging the company deliberately extended its monopoly from 2016 to 2023 and beyond by blocking legitimate competition. That case represents a different legal theory and could produce different results, though the Seventh Circuit’s reasoning casts a long shadow over similar claims.
What This Means for Patients Currently Taking Humira
If you are currently on Humira and paying high out-of-pocket costs, the most immediate practical step is to ask your doctor or pharmacist about biosimilar alternatives. With eight options on the market and some priced 85 to 86 percent below Humira, the savings can be substantial. The FDA’s interchangeability designation for YUFLYMA is particularly relevant because it simplifies the switching process — in many states, your pharmacist can make the substitution directly.
That said, insurance coverage and formulary placement vary widely. Some insurers have negotiated favorable rebates with AbbVie that keep Humira as the preferred option on their formularies, which can mean that a biosimilar actually costs a patient more out of pocket despite having a lower list price. Checking with your specific plan about which products are covered and at what tier is essential before making a switch.
The Future of Biosimilar Access and Antitrust Enforcement
The Humira patent thicket saga is likely to influence pharmaceutical patent strategy and antitrust enforcement for years to come. As more biologic drugs face patent expiration — including other blockbusters in oncology and immunology — the template AbbVie established will be tested repeatedly. The Federal Trade Commission has signaled increased interest in pharmaceutical competition, and several state attorneys general have pursued their own investigations into patent abuse.
Looking ahead, the biosimilar market’s projected growth to $7.72 billion by 2032 suggests that competition will prevail, even if it arrives on a delayed timeline. For consumers, the lesson is that legal outcomes and market outcomes do not always align — AbbVie won in court, but the market is gradually delivering the price relief that the lawsuit sought to accelerate. Whether future antitrust challenges or legislative reforms will prevent similar delays for the next generation of biologic drugs remains an open and consequential question.
Frequently Asked Questions
What is a patent thicket and how did AbbVie use one for Humira?
A patent thicket is a dense cluster of overlapping patents on a single product that makes it difficult for competitors to enter the market. AbbVie accumulated 132 U.S. patents on Humira, many filed after 2014 and covering formulation changes and methods of use rather than new clinical breakthroughs. This web of patents meant any biosimilar maker would face years of potential infringement litigation before bringing a competing product to market.
Did the class action lawsuit against AbbVie succeed?
No. The case was dismissed by a federal district court in June 2020 and that dismissal was affirmed by the Seventh Circuit Court of Appeals on August 1, 2022. The courts found that AbbVie’s patent filings were protected under the Noerr-Pennington doctrine and that its settlement agreements with biosimilar companies did not constitute illegal pay-for-delay arrangements.
How much cheaper are Humira biosimilars compared to brand-name Humira?
Some biosimilars, including Hadlima, Yusimry, and Simlandi, are priced 85 to 86 percent lower than Humira’s list price of approximately $6,922 per month. However, actual out-of-pocket costs depend on your insurance plan’s formulary and negotiated rebates, so a biosimilar’s list price advantage does not always translate directly to patient savings.
Can my pharmacist switch me from Humira to a biosimilar without my doctor’s approval?
In many states, yes — if the biosimilar has received interchangeable status from the FDA. As of April 2025, the FDA granted interchangeability to YUFLYMA, Celltrion’s citrate-free biosimilar. State laws vary on notification requirements and substitution rules, so check with your pharmacist about what applies in your state.
Are there any ongoing lawsuits related to AbbVie’s Humira patent strategy?
Yes. Alvotech has filed a separate lawsuit challenging AbbVie’s patent thicket, alleging the company deliberately extended its monopoly from 2016 to 2023 and beyond by blocking legitimate competition. This case proceeds under a different legal theory than the dismissed class action.