The US Court of Appeals for the Federal Circuit dismissed an appeal of an inter partes review (IPR), finding that the challenger lacked appellate standing because it had terminated its attempts to develop the infringing product. Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., Case No. 17-1694 (Fed. Cir. Feb. 7, 2019) (Newman, J).

Momenta Pharmaceuticals filed a petition for IPR of a Bristol-Myers Squibb patent describing formulations of Orencia® after Momenta began to develop an Orencia® biosimilar. The Patent Trial and Appeal Board (PTAB) ultimately upheld the validity of the claims, and Momenta appealed to the Federal Circuit under 35 USC § 319.

Bristol-Myers moved to dismiss the appeal, arguing that Momenta did not have standing in federal court under the requirements of Article III of the Constitution. In support of its argument, Bristol-Myers noted that Momenta’s Phase 1 clinical trial of its Orencia® biosimilar was unsuccessful and the drug was not being pursued. Momenta later filed a letter with the Federal Circuit in accordance with FRAP 28(j) that contained a press release indicating that Momenta was in discussions with its collaborator, Mylan, about discontinuing development of the Orencia® biologic. Bristol-Myers subsequently filed a letter with the Court containing documents that evidenced Momenta had made the decision to terminate its joint efforts with Mylan to develop the Orencia® biologic. Bristol-Myers argued that this demonstrated Momenta had no injury to assert and therefore lacked standing.

In response, Momenta presented several arguments to show it had the requisite standing. Momenta asserted that AIA estoppel provisions qualified as its injury in fact. The Federal Circuit found this argument unpersuasive since Momenta was no longer engaged in conduct that could lead to infringement litigation. Momenta also argued that it had standing based on a potential future royalty from Mylan should Mylan develop an Orencia® biosimilar. The Court found this possible injury to be overly speculative and unsupported by precedent. Momenta further argued that since it was initially engaged in infringing activity, it had standing for the entire appeal. Again, the Court found the argument unpersuasive, explaining that “an actual controversy must be extant at all stages of review, not merely at the time the complaint is filed.”

The Federal Circuit also explained that there is precedent for the proposition that there is no standing when a party is not engaged in any potentially infringing activity or is merely asserting possible future economic interest, but noted that standing may exist where a product is not yet on the market but there are concrete future plans for it to be there that create “a substantial risk of future infringement.” The Court found that this was not the case with Momenta, since it had no concrete plans to develop a product.

The Federal Circuit also recognized that there are relaxed standards with regards to standing in cases of statutorily authorized rights of appeal, such as appeals under § 319. Specifically, the immediacy and redressability components of standing may be relaxed in these cases. However, the Court clarified that there still must be an injury, in fact, to meet the constitutional requirements for standing, finding that “Article III standing requires a concrete injury even in the context of a statutory violation.” Thus, the Court dismissed the appeal for lack of standing.