Article III Review of Agency Action May Once Again Interest SCOTUS

A perceived lack of Article III standing in appeals from the Patent Trial & Appeal Board (PTAB) to the Federal Circuit can doom an appeal. More recently, the Court has had an opportunity to explore “competitor standing” as a potential avenue for standing of close competitors. But, the Court has applied a patent-specific view to distinguish from controlling precedent on the impact of the “government action” of competitor standing.

A few weeks back in Gen. Elec. Co. v. United Techs. Corp., (hereinafter “GE”) the court made clear that for the competitor standing doctrine to apply, the government action must change the competitive landscape by, for example, creating new benefits to competitors. Building on its earlier decision in AVX Corp. v. Presidio Components, Inc., the Court found that the government action with respect to a unique property right like a patent, militates in favor of a narrower application of the precedent, drawing competing views from the Court.

This debate seems destined for cert petition.Continue Reading Competitor Standing to Evolve for PTAB Appeals?

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?