Clearing the Thicket: New Report Outlines Legislative Fixes to Boost Biosimilar Access

The promise of biosimilars to revolutionize patient access and affordability in health care faces a formidable adversary: patent thickets. A recent white paper from the Association for Accessible Medicines (AAM) laid bare how complex patent landscapes and protracted litigation were significantly delaying the entry of more affordable biologic alternatives, ultimately impacting patients and straining the US health care system.1

The report not only detailed these challenges but also outlined legislative solutions aimed at fostering a more competitive and sustainable biosimilar market.

The Costly Reality of Biologics and Patent Barriers

Biologic medicines have transformed the treatment of numerous diseases, offering life-changing therapies for many. However, their high cost remains a major concern. The AAM report highlighted that biologics accounted for more than half of all prescription drug spending, despite representing only a small percentage of total prescriptions.

Biosimilars were designed to address this imbalance, offering more affordable versions of these complex drugs. The report noted that prices typically dropped with each new biosimilar that entered the market, underscoring their potential for significant cost savings.

However, branded manufacturers often created "patent thickets,” which are essentially excessive webs of secondary patents filed as the original patents for a product neared expiry, often extending market exclusivity far past the intended date. Although some of these patents might have been genuinely innovative, many were not. The US Patent and Trademark Office was found to grant more secondary patents than its counterparts in other countries, contributing to this complex landscape.2

“Patent thickets, and the prohibitively complex, expensive and risky patent litigations they enable, are hobbling biosimilar competition and delaying public access to these vital, safe and effective lower-cost medicines. For example, thickets, not allowed in Europe and other developed nations, directly contribute to the US paying more for drugs than other countries,” explained the authors.1

The Anatomy of Costly Litigation

The white paper revealed a striking difference in patent litigation practices between the US and other nations.1 In the US, branded companies asserted a staggering number of patents in biosimilar litigation—between 11 and 65 patents per product, far exceeding the numbers seen in countries like Canada and the UK. This led to incredibly expensive and time-consuming legal battles, often costing millions of dollars and stretching for years.

The intricate "patent dance" process, coupled with lengthy court proceedings and extensive discovery phases, exacerbated these delays (Figure).3

“Overburdened federal courts are poorly equipped to resolve these patent pile-ons quickly, inexpensively, or fairly. Biosimilar manufacturers are left with the difficult choice of spending years and millions of dollars to challenge hundreds—or even thousands—of patent claims in court or waiting out the patents until they expire. Neither choice helps patients,” the authors emphasized.1

Furthermore, legislative proposals around patent settlements had inadvertently complicated matters, sometimes stifling procompetitive agreements and further delaying biosimilar launches.

“Even before biosimilar litigation commences, large patent estates thwart competition by requiring extensive freedom to operate challenges. Biosimilar companies must ‘clear the decks’ to compete with biologics without patent liability, and particularly when faced with large patent estates, must expend significant resources assessing such patents during development. In many cases, such patent landscaping analyses require time-consuming design around strategies and significant legal costs, ‘creating a moving target for its
biosimilar rivals,’” wrote the authors.

This means that patients continued to pay higher prices for branded biologics for longer than necessary, directly impacting their access to more affordable treatment options.

Paving the Way for a Sustainable Biosimilar Market

The AAM report didn't just identify problems; it proposed actionable solutions for Congress to consider. To accelerate biosimilar market entry and ensure long-term sustainability, the white paper suggested 3 key legislative changes.

First, Congress should cap the number of asserted patents in biologic patent litigation to a reasonable number. Legislation like HR 3269 (the ETHIC Act) and S 1041 (the Affordable Prescriptions for Patients Act) aimed to prevent brands from using excessive patent claims to block market entry.4,5

Second, biosimilar manufacturers needed the freedom to settle time-consuming and expensive patent litigation in a procompetitive manner.1 The report advocated for reforms that encouraged, rather than restricted, such agreements, allowing for earlier market entry.

Finally, Congress should provide a statutory safe harbor for carve-outs of patented methods of treating diseases. Authors of the report claim that this could protect biosimilars when they excluded patented treatment methods from their labels, enabling faster access to lower-cost options without infringing patent rights.

In essence, these legislative changes aimed to reduce litigation delays, limit the abuse of patent rights, and promote timely biosimilar market entry. By enacting these reforms, the authors believe that Congress could significantly lower health care costs and improve patient access to essential biologic medicines, fostering a more robust and equitable health care system for all.

References

1. Patent thickets and litigation abuses hinder all biosimilars. AAM. July 8, 2025. Accessed July 28, 2025. https://accessiblemeds.org/resources/press-releases/patent-thickets-and-litigation-abuses-hinder-all-biosimilars/

2. Sampat BN, Shadlen KC. Secondary pharmaceutical patenting: a global perspective. Res Policy. 2017;46(3):693-707. doi:10.1016/j.respol.2017.01.005

3. Jeremias S. Breaking down biosimilar barriers: the patent system. The Center for Biosimilars®. November 11, 2024. Accessed July 28, 2025. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-the-patent-system

4. ETHIC Act, HR 3269, 119 Cong (2025). Accessed July 28, 2025. https://www.congress.gov/bill/119th-congress/house-bill/3269

5. Affordable Prescriptions for Patients Act, S 1041, 119 Cong (2025). Accessed July 28, 2025. https://www.congress.gov/bill/119th-congress/senate-bill/1041