As we reported here, Momenta is appealing a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239 (“the ’239 patent”), which relate to BMS’s Orencia® (abatacept) product.  Momenta has not yet filed an aBLA for its abatacept biosimilar candidate, M834, so one of the key issues on appeal is whether Momenta has Article III standing to appeal from the PTAB’s unfavorable decision.  BMS argues that the appeal should be dismissed.

As we previously reported, on June 4, Momenta filed a notice of supplemental authority citing the Federal Circuit’s May 2, 2018 precedential panel decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., Case No. 17-1487 in support of Momenta’s Article III standing to appeal.  On June 14, BMS filed a response arguing that the “unique circumstances [of Altaire] are inapposite to Momenta” and “Momenta also mischaracterizes Altaire’s reasoning.”

On August 9, 2018, BMS filed a letter regarding the Federal Circuit’s August 3, 2018 precedential opinion in JTEKT Corporation v. GKN Automotive Ltd., Case No. 17-1828.  BMS argues that the court there found that JTEKT, the petitioner, lacked standing to appeal an adverse Board decision confirming the patentability of certain patent claims because the JTEKT product is in development and is not yet finalized.  BMS argues that Momenta similarly lacks standing because it “has not established at this stage of the development that its product creates a concrete and substantial risk of infringement or will likely lead to claims of infringement.”

On August 13, 2018, Momenta filed a letter in response arguing that “BMS endorses JTEKT’s outcome while ignoring the law and facts,” and that “Momenta has standing under JTEKT’s standard.”  According to Momenta, JTEKT is distinguishable because here, “[u]nlike there, Momenta showed current development activity, costing millions of dollars, on a formulation that Momenta conceded infringes the challenged patent claims”; “Momenta faces the near certainty of an infringement suit when it markets its competing drug”; and “the Board’s patentability determination affects Momenta’s concrete plans now.”

Stay tuned to Big Molecule Watch for further developments in this appeal.