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.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?
September 17th 2023On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.
Dr Joseph Alvarnas Highlights the Current State of the Oncology Biosimilar Market
November 9th 2022Joseph Alvarnas, MD, vice president of government affairs at City of Hope and chief clinical adviser of AccessHope, explains what the recent FDA approvals of Stimufend and Vegzelma, 2 oncology biosimilars, says about the current state of the oncology biosimilar space.
Expert Opinion: What Factors Will Have the Greatest Impact on US Adoption of Humira Biosimilars?
April 12th 2022Jeffrey Casberg, vice president of pharmacy at IPD Analytics, weighs in on the factors he thinks will most affect market share among adalimumab biosimilars when they enter the US market in 2023.