Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses whether the PTAB might invalidate more patents concerning dosing and frequency of biologics, as it did with claims 1 to 5 of AbbVie's '135 patent for Humira.
Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto
Transcript
In my experience, since the PTAB—again, that’s the Patent Trial and Appeal Board—is more concerned about the facts and science of the issues specifically before them in each [inter partes review, IPR] more so than simply applying past precedent, I think it’s very hard to generalize across an entire subset of patents based on just one patent and what happened to it in the IPR.
It’s true that it appears that method claims haven’t fared as well as formulation claims in IPRs. But it’s important to note that this might just be a function of the patents that have been challenged so far. Method of treatment patents tend to be filed later in time, so petitioners may also be looking at them more often because they have later expiration dates in patent portfolios. And if you have more of a certain type of patent being challenged, of course you’re going to have a higher likelihood of seeing them invalidated, so it may be a product of what we’re seeing challenged.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.