Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, discusses how the STRONGER Patents Act could affect biosimilars.
Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto
Transcript:
Could the STRONGER Patents Act impact biosimilars?
That's an interesting act, actually. My understanding is that the STRONGER patents act, among other things, proposes to harmonize the burdens and claim construction standards between PTAB, the Patent Trial and Appeal Board, that hears IPRs, and the district courts that hear district court litigations. In particular, the bill proposes to change the burden of proving invalidity in IPR and a related action, called a PGR, or a post-grant review, to the clear and convincing evidence standard and to use the narrower ordinary meaning claim construction standard that is used in litigation. In other words, it would change the burdens and standards to match what you see in litigation.
The bill would also limit standing to those who had been sued by the patent owner. So it kind of limits who would have standing as well to actually raise the IPR.
Another thing that it does is that it allows for appeal of an institution decision, which is something that you don’t have today. Today, an institution decision, whether [an IPR] is instituted or not is not appealable. So this would give you another shot at saying the PTAB was wrong in instituting an IPR. Given the estoppel provisions already associated with IPR and PGR, these changes could greatly reduce the popularity of these proceedings.
Although in a macro sense, it’s possible that having more restrictive paths to invalidating patents may mean that some biosimilars take longer to clear the necessary IP to launch risk-free, It’s unlikely that this legislation, the STRONGER Patents Act, would affect the ability of biosimilars to reach the market. In some ways, due to the size of most biologics patent portfolios, a biosimilar company may even prefer going to district court where they can challenge a number of patents all at the same time.
PBM Evolution Toward Value-Based Care Shifts to Transparent Pharmacy Pricing
March 30th 2025Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, predict pharmacy benefit managers (PBMs) will evolve toward value-based care, mirroring the broader shift toward open-cost structures.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.