Court Dismisses Biosimilar Petitioner's IPR Appeal For Lack Of Standing

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., the Federal Circuit dismissed Momenta's appeal from an adverse IPR decision for lack of standing after Momenta suspended its potentially infringing biosimilar development activity. Although Momenta had been pursuing such activity when appellate proceedings began, the court dismissed the appeal for mootness/lack of standing because Momenta had ceased its development program and "no concrete plans [were] afoot" implicating the patent claims challenged in the underlying IPR.1

Momenta's Procedural Evolution

In July 2015, Momenta petitioned the PTO for inter partes review of all claims in Bristol-Myers Squibb's U.S. Patent No. 8,476,239. The '239 Patent covers fluid formulations of CTLA4Ig, the active immunosuppressive agent in BMS's rheumatoid arthritis treatment ORENCIA®. Following IPR proceedings, the PTAB sustained patentability of all claims in the '239 Patent.2 Momenta appealed the Board's Final Written Decision to the Federal Circuit, under 35 U.S.C. § 319.3 Highlights from the appeal's procedural evolution are summarized below:

When Momenta petitioned for IPR in 2015, it was developing its ORENCIA® biosimilar in collaboration with Mylan N.V. However, when Momenta appealed the PTAB's decision in 2017, its proposed biosimilar product had failed Phase 1 clinical trials. BMS moved to dismiss for lack of standing because Momenta had not filed a Biologics License Application at the FDA and had publicly stated that development would proceed regardless of the outcome on appeal.4 On September 19, 2017, Momenta responded that it had standing because (1) it had invested "millions of dollars" into developing a formulation that potentially infringed the '239 Patent, (2) was forced to adjust its business strategy, and (3) was injured-in-fact by the AIA estoppel provisions of § 315(e).5 On October 1, 2018, Momenta filed a letter with the court including a press release announcing that "[t]he Company has initiated discussions with its collaboration partner, Mylan, to exit its participation in the development of ... M834, a proposed biosimilar to ORENCIA® ...."6 On October 23, 2018, the court issued an Order to Show Cause why the appeal should not be dismissed as moot. Momenta responded, citing its joint responsibility with Mylan for substantial product development costs and its potential right to royalties from Mylan should the product be developed.7 On December 10, 2018, BMS filed a letter...