Are Biosimilar Development Efforts Enough?
In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co. (here), the Federal Circuit was poised to explore the level of biosimilar legwork that could satisfy Article III standing for appeal from an adverse Patent Trial & Appeal Board (PTAB) decision. But, business developments of Momenta since the 2017 oral argument have now spoiled all of the fun.
The question as to how much investment/business exploration is enough in the biosimilar context for Article III standing remains an open question.
Continue Reading BPCIA & FDA Steps as Article III Standing from the PTAB?