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 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.


Ha Kung Wong has extensive experience litigating a wide variety of pharmaceutical cases, including those concerning biologics used to treat rheumatoid arthritis and autoimmune disorders. He also has extensive experience consulting, conducting due diligence and licensing pharmaceutical portfolios. Ha Kung has a B.S. in Biochemistry and a B.S. in Chemistry.


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


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