Earlier Patent Litigation Could Accelerate US Biosimilar Market Entry

Reforming patent litigation to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry. | Image Credit: © md3d - stock.adobe.com

The biosimilar market could be accelerated through patent litigation reforms that expedite biosimilar market availability throughout the US, according to a study published in Journal of Law and the Biosciences.¹

Between 2015 and 2021, the US only had 11 biosimilars marketed compared with the European Union, which had 55 biosimilars marketed between 2008 and 2021. Despite biosimilar approval growth in the US, delayed entry into the market due to patent litigation continues to be an issue.

Often, drug manufacturers hold patents for ingredients, known as primary patents. Other times, patents are filed based on the method of use or manufacture, formulation, route of administration, and sometimes the devices used to administer the drug.

The Current Biosimilar Litigation Framework

When biosimilars aim to enter the market, a biosimilar firm typically has 3 options. They can either preclear the patents prior to entering the market by engaging in a “patent dance” along with the associated patent litigations, launch “at risk,” or settle with the biologic brand to avoid any active patents.

Under the Biologics Price Competition and Innovation Act (BPCIA), the patent dance was designed. This process consists of a structured legal process that aims to streamline patent disputes among biosimilar manufacturers and reference product sponsors.² Created as part of the BPCIA, the patent dance helps expedite biosimilar entry into the market while balancing the interests of innovators who originally developed the biologic therapies.

The patent dance comes into play when a biosimilar manufacturer submits an FDA approval application and includes an exchange of information with the intention to provide clarity regarding which patents may be relevant for litigation.¹ Branded drug companies request preliminary injunctions to try to maintain the brand biologic’s market exclusivity until the completion of patent litigation. Once both litigation suits are resolved, the biosimilar firm will know if it can launch the product free from patent risk. 

When manufacturers launch the biosimilar during ongoing litigation, it is referred to as “launching at risk” because if the biosimilar is shown to have infringed on the patent, it could lead to lost profits totaling exceeding millions of dollars. This typically leaves biosimilar firms in difficult situations when they receive FDA approvals for products with litigation still pending.

Shifting Litigation for Expedited Biosimilar Market Entry

Early patent litigation during biosimilar phase 3 trials could facilitate timely market entry, mirroring generic drug practices. However, this approach could face judicial challenges related to ripeness; the Sandoz v Amgen case suggests these challenges are surmountable. The case led to the Supreme Court ruling declaring follow-on biologic companies are not required to share their licensing application with the innovator company, as long as there is an additional mandatory 180-day notice to the innovator prior to commercial marketing for the FDA to approve the product.³ However, altering clinical trial requirements to accommodate earlier litigation may be impractical due to the need for extensive data and potentially costly modifications.¹

By allowing patent litigation to begin earlier, biosimilars could have the opportunity to challenge patents at the beginning of the phase 3 clinical trials.This process would help with market entry during the primary patents’ expiration, a parallel of the generic market entry process.

To assess the potential benefits of earlier litigation, the present researchers analyzed biosimilar patent litigation data from 2010 to 2022 using the Lex Machina database to estimate potential cost savings.

Results

Of the 54 biosimilars that initiated phase 3 trials, 92% resulted in a sufficient amount of information to begin litigation without worry of wasting court resources. Between 2010 and 2022, 95 biosimilars were identified in association with 25 brand biologics that reached initiation phase 3 development. 

Data included 59 biosimilars that might have failed to receive FDA approval during a phase 3 trial. This comprised 61% that launched in the US, 31% undergoing litigation, 2% that failed the trial, and 7% that provided limited information. Overall, 92% went on to submit at least 1 dossier to the FDA, leaving court resources unwasted if patent litigation began at initiation of the phase 3 clinical trial.

There were 32 biosimilars that entered the market between 2010 and 2022 with completed judicial proceedings. Sixteen percent of them won in litigation against the brand biologic, 9% lost, and the remainikng 75% settled. On average, litigation duration is 2.9, 0.95, and 4.2 years for biosimilar wins, settlements, and losses, respectively. From patent expiry to biosimilar launch, the correspondig average duration is 2.3, 2.5, and 16.5 years when biosimilars win, settle, or lose litigation.

The BPCIA, intended to facilitate biosimilar market entry, has fallen short of achieving the same level of market penetration as generic drugs. This disparity largely stems from the stringent clinical trial requirements imposed on biosimilars, significantly delaying their market entry compared with generic medications.

Many European countries, including the United Kingdom, have the same patent litigation pathway for both generics and biosimilars. Both drug manufacturers are allowed to litigate the validity of patents at any point during the product’s development program. Experts like Sarfaraz K. Niazi, PhD, suggest the US adopt the same system as the UK’s Medicines and Healthcare Products Regulatory Agency surrounding unnecessary clinical efficacy testing.⁴

“To fulfill the intended objectives of the BPCIA, Congress should create a two-track system that grants biosimilars the option for earlier litigation,” the study authors concluded.¹

References

1. Tu S, Goode R, Turner M, Van de Wiele V. Accelerating biosimilar market access: the case for allowing earlier standing. J Law Biosci. 2025;12(1):1-16. doi:10.1093/jlb/lsae030

2. Jeremias S. Breaking down biosimilar barriers: the patent system. The Center for Biosimilars^®. November 11, 2024. Accessed January 7, 2025. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-the-patent-system

3. Sarpatwari A, Gluck AR, Curfman GD. The Supreme Court ruling in Sandoz v Amgen: avictory for follow-on biologics. JAMA Intern Med. 2018;178(1):5-6. doi:10.1001/jamainternmed.2017.6145

4. Niazi SK. BioRationality: a critical analysis of Pfizer views on sustainability of biosimilars. The Center for Biosimilars. December 23, 2024. Accessed January 8, 2025. https://www.centerforbiosimilars.com/view/biorationality-a-critical-analysis-of-pfizer-views-on-sustainability-of-biosimilars