Last week, the United States Court of Appeals for the Federal Circuit issued an opinion in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, 2017-1694 (February 7, 2019), dismissing Momenta’s appeal of a decision from the Patent Trial and Appeal Board (PTAB) sustaining patentability of several claims of a Bristol-Myers Squibb (BMS) patent Momenta challenged in Inter Partes Review (IPR).
The patent at issue covered an immunosuppressive protein molecule for treating immune system disorders, which BMS markets as Orencia. When Momenta filed its IPR petition, it was developing a generic version of Orencia. During the IPR, Momenta’s version failed Phase 1 clinical trials, and Momenta ceased its development efforts. The PTAB sustained the patentability of the challenged claims, and Momenta appealed. BMS moved to dismiss the appeal asserting Momenta lacked Article III standing. “Article III standing requires a concrete injury even in the context of a statutory violation.” BMS argued, without a competitive product, Momenta could not identify a sufficiently concrete injury to it from the PTAB’s decision. The Federal Circuit agreed.
The Court first rejected Momenta’s argument that it had standing based on its cooperation with another company, Mylan, to take over development of the Orencia alternative. While the agreement would have required Momenta to share development costs, which could be affected by the PTAB decision, Momenta’s 8-K SEC filing reported the collaboration with Mylan had been terminated. The Court also rejected Momenta’s argument that the estoppel associated with IPRs creates injury. The Court explained “[e]stoppel cannot constitute an injury-in-fact when Momenta is not engaged in any activity that would give rise to a possible infringement suit.” The Court considered Momenta’s argument that it might in the future seek to profit from an Orencia alternative, but concluded such hypothetical future injury is too speculative to support Article III standing. In addition to standing, the Court also addressed mootness. “In essence, mootness is the doctrine of standing set in a time frame; that is, the requisite personal interest that must exist at the time of commencement of the litigation (standing) must continue throughout its existence (mootness).” The Court explained, even if Momenta’s pursuit of potentially infringing activity had supported standing when the proceedings began, the abandonment of such activity eliminates the potential for injury, “thereby mooting the inquiry.”
