This morning, the Federal Circuit issued a precedential opinion dismissing Momenta’s appeal from the PTAB’s final written decision upholding the patentability of Bristol-Myers Squibb’s abatacept patents against Momenta’s IPR challenge. The Court dismissed Momenta’s appeal “for absence of standing/jurisdiction and for mootness.”
As we have previously reported, although the Federal Circuit had heard oral argument on the merits of Momenta’s appeal in December 2017, the oral argument raised the prospect that Momenta lacked Article III standing to appeal to the PTAB’s decision because Momenta was still years away from filing an aBLA for an abatacept biosimilar with the FDA. Over the next year, the parties submitted numerous letters to the court on the standing issue, and in October the Federal Circuit ordered Momenta to show cause as to why the appeal should not be dismissed as moot in view of Momenta’s public representations that it “has initiated discussions with its collaboration partner, Mylan, to exit its participation in the development of . . . M834, a proposed biosimilar of ORENCIA®.” That order was followed by additional submissions from the parties.
In today’s opinion, the Court ruled that “Momenta does not have standing to invoke federal appellant jurisdiction, and the appeal is mooted by Momenta’s discontinuance of any potentially infringing activity.” With regard to standing, the Court explained that, “[a]lthough Momenta had initially stressed that it had spent millions of dollars in its development of an Orencia® biosimilar, now upon Momenta’s termination of all potentially infringing activity, Momenta has not shown ‘an invasion of a legally protected interest’ that is ‘actual or imminent, not conjectural or hypothetical.’” The Court noted that “Momenta has now made clear that no concrete plans are afoot” and held that “[o]n abandoning development of this product, Momenta has no legally protected interest in the validity of the ’239 Patent, and there is no ‘real need to exercise the power of judicial review.’”
With regard to mootness, while the Court noted that “standing and mootness may not be coextensive in all cases,” the Court found that “[h]ere the cessation of potential infringement means that Momenta no longer has the potential for injury, thereby mooting the inquiry.”