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Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co.

Cessation of Development for Competing Drug Leads to Lack of Standing

Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., __ F.3d __, 2019 WL 470177 (Fed. Cir. Feb. 7, 2019) (NEWMAN, Dyk, Chen) (PTAB) (2 of 5 stars)

Fed Cir dismisses IPR appeal for lack of standing and mootness. The PTAB had confirmed the claims of BMS’s patent relating its rheumatoid arthritis drug Orencia (abatacept). During the appeal’s pendency, Momenta had formally terminated its efforts to develop a competing biosimilar to Orencia. As such development was Momenta’s only potentially infringing activity, it now has “no legally protected interest in the validity of [BMS’s] patent, and per Warth, 422 U.S. 490 (1975), “there is no real need to exercise the power of judicial review.” Op. at 8. The opinion rejects Momenta’s argument that the AIA’s estoppel provisions relating to IPR constitute injury-in-fact. It also rejects as speculative Momenta’s argument that it “might at some time” receive royalties from a corporate partner that was considering development of an Orencia biosimilar. The opinion also rejects Momenta’s argument that its standing was perfected because it was engaged in potentially infringing activity at the start of the appeal. Per Arizonans for Official English, 520 U.S. 43 (1997), standing must exist at all stages of review.

KEYWORDS: INTER PARTES REVIEW; STANDING; APPELLATE JURISDICTION