- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Ha Kung Wong: Method of Treatment Patents
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.
Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals
January 11th 2025Korean drugmakers hold over 50% market share in the 6 best-selling biosimilar markets, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.
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 Top 5 Most-Read Policy Articles of 2024
December 28th 2024The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
