Momenta Contends ORENCIA IPR Appeal Is Not Moot

On October 23, 2018, we previously reported that the Federal Circuit ordered Momenta to show cause as to why Momenta’s appeal of a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to BMS’s ORENCIA® (abatacept) product, should not be dismissed as moot.  Pursuant to Fed. R. App. P. 28(j), Momenta filed a letter earlier that month, with a press release stating that it “has initiated discussions with its collaboration partner, Mylan, to exit its participation in the development of . . . M834, a proposed biosimilar of ORENCIA®,” a statement which BMS alleged confirmed that Momenta lacked Article III standing.

On November 2, 2018, Momenta responded to that Order, stating that Momenta still had a “concrete interest, just as it did when it filed the appeal.” Momenta went on to state that “the companies [Momenta and Mylan N.V.] continue to be jointly responsible under that agreement for product development and for sharing the costs of that development, which are substantial.”  Momenta argued that it had only begun negotiating a potential exit of the development agreement, and that even if it did eventually exit, it would still maintain a royalty interest. Momenta also argued that because the estoppel provision (Section 315(e)(2)) had already been triggered, and the level of interest needed to preserve ongoing jurisdiction need not be the same as to establish standing, Momenta still had standing to maintain the action.

Download PDF