In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017), BMS challenges Momenta’s standing to appeal a PTAB decision upholding the validity of BMS’s patent relating to a formulation of Orencia® (abatacept) in an IPR brought by Momenta before having filed a biosimilar marketing application. The Federal Circuit is expected to decide whether a petitioner must have filed a marketing application in order to have Article III standing to appeal from an unfavorable PTAB decision. As months have passed without a decision, Momenta and BMS have both used the time to further press their case.

On June 4, 2018, Momenta filed a letter arguing that Altaire Pharmaceuticals, Inc. v. Paragon BioTeck, Inc., 889 F.3d 1274 (Fed. Cir. 2018), supported its claim to Article III standing. Altaire was found to have standing to appeal from the PTAB even though it had not sought FDA approval to market. In a June 14, 2018 response, BMS argued that Altaire is factually distinguishable. Although Altaire had not filed its own marketing application, it had been commercially manufacturing under an FDA approval for years as part of an agreement with Paragon, whereas Momenta “is not close to filing for FDA approval.”

On August 9, 2018, BMS filed a letter identifying the Federal Circuit’s intervening decision in JTEKT Corp. v. GKN Auto., Ltd., 898 F.3d 1217 (Fed. Cir. 2018). According to BMS, JTEKT held that an IPR petitioner whose potentially competing product is only “in development” and “will continue to evolve” cannot show “concrete plans for future activity that creates a substantial risk of future infringement or likely cause the patentee to assert a claim of infringement,” and thus, cannot demonstrate Article III standing. Momenta responded on August 13, 2018 that JTEKT is distinguishable on the facts. The JTEKT appellants, Momenta argued, could “not establish that its planned product would create a substantial risk of infringing,” whereas Momenta “showed current development activity, costing millions of dollars, on a formulation that Momenta conceded infringes the challenged patent claims.”

The decision in Momenta will be significant, as it may impact strategy for some biosimilar makers. In particular, the decision may influence whether the trend of challenging innovator patents at the PTAB years before filing marketing applications will continue.