Duplicate Patents Tie Up Regulatory Approval and Drive Drug Costs

Why It Matters

American patients are waiting years longer and paying significantly more for lower-cost versions of some of the most expensive drugs on the market. A study submitted to the House Judiciary Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet during a June 4 hearing titled "Medicines and IP: Balancing Innovation and Access" argues that biosimilar patent thickets (dense webs of overlapping, often duplicative patents) are a primary driver of that delay, and that the problem is uniquely American.

The study, by Rachel Goode and Bernard Chao of the University of Denver Sturm College of Law, compared patent assertions against the same 30 biosimilar drugs across the United States, Canada, and the United Kingdom. The findings are striking: on average, nine times more patents were asserted against biosimilars in the U.S. than in Canada, and 12 times more than in the UK. The mean delay between regulatory approval and biosimilar launch in the U.S. was 34 months, compared to 7.4 months in Canada and 4.7 months in the UK.

The Big Picture

Biologics are large, complex, cell-derived drugs used to treat autoimmune diseases and cancers. They are among the most expensive treatments available, often exceeding $100,000 per patient per year. Biosimilars are their generic equivalents, and when they reach the market, prices typically fall substantially. The Biologics Price Competition and Innovation Act (BPCIA) was designed to create a pathway for that competition, but the study argues the law is being undermined in practice.

The mechanism is straightforward: brand-name biologic manufacturers file dozens, sometimes hundreds, of overlapping patents around a single drug. Under U.S. Patent and Trademark Office rules, companies can obtain patents that are obvious variations of their own earlier patents (so-called "terminal disclaimers") without providing any additional innovation. Each duplicative patent can cost as little as $25,000 to obtain, but an average of $774,000 to challenge through inter partes review. That asymmetry makes it economically prohibitive for biosimilar companies to fight their way through large patent portfolios.

The BPCIA's "patent dance," a multi-step pre-litigation procedure under which brand-name manufacturers identify patents they intend to assert, compounds the problem by giving originators multiple waves of litigation to deploy against biosimilar entrants. The study notes that in the U.S., no biosimilar in the dataset was launched free from patent litigation or a pre-litigation settlement. In the UK, 37 percent did. In Canada, 13 percent did.

The Humira Case Study

The authors drilled into AbbVie's Humira (adalimumab), the world's best-selling biologic drug with $20.39 billion in 2020 global sales, as a case study in biologics market exclusivity through patent volume rather than patent quality.

Humira's U.S. core patent portfolio contains 73 granted patents derived from only eight patent families. Of those 73 patents, 59 are non-patentably distinct from one another, meaning they cover the same or essentially the same invention and are linked by terminal disclaimers permitted under USPTO rules. In Europe, the same drug is covered by eight non-duplicative patents.

AbbVie asserted as many as 63 of those patents against a single biosimilar competitor, Alvotech. Biosimilars of Humira entered the European market in October 2018. Patent settlements in the U.S. permitted biosimilar launch in 2023, five years later.

Political Stakes

For the Administration

The Trump administration has pursued drug pricing reductions primarily through executive orders targeting "Most Favored Nation" pricing benchmarks for Medicare. The Goode-Chao study points to a structural problem those pricing mechanisms do not address: biosimilar access in the United States is constrained not just by statutory exclusivity periods, but by patent thicket healthcare strategies that extend effective market exclusivity well beyond what Congress intended.

The study's proposed fixes (tightening USPTO written description and enablement rules under 35 U.S.C. § 112, reforming or eliminating terminal disclaimers, and limiting patent assertions per family) would require either regulatory action by the USPTO or legislation. The Trump administration's USPTO has generally been considered industry-friendly on patent policy, which may reduce the appetite for administrative reforms that would constrain patent portfolios. The study does not address the current administration's posture directly.

For Congress

The hearing before the House Judiciary Subcommittee signals that Republican-led oversight of the intersection between intellectual property law and drug pricing is active. The study provides a data-driven framework for legislative intervention, with specific statutory targets: terminal disclaimer rules under 37 CFR § 1.321(c), written description requirements under 35 U.S.C. § 112, and the BPCIA's patent dance procedures under 42 U.S.C. § 262.

The political challenge is that any reform tightening patent rights for biologics will face opposition from the pharmaceutical industry, which argues robust patent protection is necessary to fund the research and development of new drugs. The study does not resolve that tension but argues the current system has drifted past rewarding innovation and into rewarding litigation volume.

For the Public

The practical consequence of biological patent delays is that American patients pay more for biologic drugs and wait longer for lower-cost alternatives than patients in peer nations. The study does not quantify the total cost to patients or payers of the delays it documents, but the scale of the drugs involved (Humira alone generated over $20 billion in global sales in 2020) suggests the stakes are substantial.

The Bottom Line

The study's central finding is that biosimilar access in the United States is not constrained primarily by legitimate patent protection for genuine innovation, but by the accumulation of duplicative patents that exploit specific features of U.S. patent law unavailable in other countries. The data show that 80 percent of Humira's U.S. patent portfolio covers inventions that are not patentably distinct from one another, a condition that the EU's stricter patent rules prevent.

The result is a system in which brand-name manufacturers can use the sheer cost of patent litigation (not the strength of their underlying patents) to delay biosimilar competition. The authors argue that the problem is fixable and that Canada and the UK demonstrate that it is not an inevitable feature of protecting biologic innovation. Whether Congress or the administration moves to act on that argument is the question the June 4 hearing put on the table.

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