Recent Changes in Biosimilar Patent Law

Recent Changes in Biosimilar Patent Law: A Shift Towards Greater Uptake and Simplification

The biosimilar industry has witnessed significant changes in patent law in recent years, aimed at simplifying the regulatory landscape and enhancing consumer confidence. These changes include limitations on asserted patents, the potential elimination of interchangeability requirements, and increased scrutiny of pharmacy benefit managers (PBMs). In this article, we will delve into these developments and their implications for the biosimilar sector.

Patent Shifts and Predictions

Ha Kung Wong, a partner at Venable LLP, highlights the need to keep an eye on potential shifts in patent law. He notes that while predictions are difficult, there are a few key areas to monitor. One such area is the limitation on the number of patents that can be asserted in a patent litigation. This could potentially have a practical effect, although it is uncertain whether it will make a significant difference.

The Biosimilar Red Tape Elimination Act

Introduced in July 2023 by Senators Mike Lee, Ben Ray Luján, Braun, and J.D. Vance, the Biosimilar Red Tape Elimination Act aims to eliminate the two separate designations of biosimilars and interchangables in the US. This move could lead to greater uptake of biosimilars due to the possibility of automatic substitution at the pharmacy level, similar to generic drugs. Additionally, the removal of interchangeability requirements could increase confidence in biosimilars, as they would be seen as closer to the reference product.

Patent Eligibility and Restoration Act

Another significant development is the Patent Eligibility and Restoration Act of 2023, reintroduced by Senators Thom Tillis and Chris Coons. This bill seeks to clarify which inventions are eligible for patenting in the US, potentially overturning Supreme Court decisions in Mayo, Alice, and Myriad. If passed, this could significantly impact the pharmaceutical and biologics industry.

Impact on Biosimilar Litigation

The legal landscape of biosimilar patent disputes has also seen significant changes. According to a recent webinar by Fish & Richardson, there were four new patent lawsuits in 2022. These cases ranged from partial to full participation in the patent dance process, with only two cases going through all steps. The Regeneron vs Mylan case resulted in a scheduled trial for June 2023, while the Biogen vs Sandoz/Polpharma Biologics case is currently seeking an expedited preliminary injunction proceeding.

Inter Partes Reviews and Post-Grant Reviews

Inter partes reviews (IPRs) and post-grant reviews (PGRs) have become increasingly important mechanisms for resolving biosimilar-related patent disputes. As of May 2023, there have been 144 biosimilar-related IPRs encompassing 70 patents and 14 reference products. PGRs, however, have been less popular, with only three biosimilar-related filings to date.

Conclusion

The recent changes in biosimilar patent law aim to simplify the regulatory landscape and enhance consumer confidence. While predictions are uncertain, these developments could lead to greater uptake of biosimilars and increased confidence in their quality. As the industry continues to evolve, it is crucial to monitor these changes and their implications for the future of biosimilars.

References

1. Patent Shift Predictions, Legal Landscapes of Biosimilars With Ha Kung Wong. The Center for Biosimilars. February 25, 2024.
2. Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S., 2023-2024 Edition. Goodwin. January 18, 2024.
3. Legal Experts Provide Updates on Biosimilar Patent Disputes in 2022. The Center for Biosimilars. January 19, 2023.
4. Biosimilars and biologics litigation in the United States. IAM. August 25, 2023.
5. Biologics and Biosimilars Landscape: IP, Policy, and Market Developments. FR. April 5, 2024.