BPCIA & FDA Steps As Article III Standing From The PTAB?

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.

Bristol-Myers Squibb ("BMS") holds a patent related to abatacept (Orencia®), a drug for immune system disorders like rheumatoid arthritis. Momenta, which had invested resources in developing a biosimilar product, filed an IPR petition against BMS's patent, but the PTAB upheld the challenged claims. When Momenta appealed, BMS argued that Momenta lacked Article III standing to appeal because the FDA had not approved