Termination Of Product Development Precludes Standing To Appeal PTAB IPR Decision Upholding Patent

In Momenta Pharmaceuticals, Inc. v. Bristol-Meyers Squibb Co., the Federal Circuit issued another decision analyzing the contours of a petitioner's Article III standing to appeal PTAB decisions upholding a patent. In contrast to Amerigen, where the court found standing for a would-be generic competitor whose ANDA was subject to a Paragraph III certification against the challenged patent, in Momenta the court found that the challenger's termination of product development precluded standing.

The Patent At Issue

The Patent at issue was BMS's U.S. Patent No. 8,476,239, directed to "fluid formulations of the protein molecule CTLA4Ig ... an immunosuppressive agent used in treatment of immune system disorders such as rheumatoid arthritis." As noted in the court decision, the patent pertains to BMS's Orencia® (abatacept) biologic product.

In 2015, Momenta petitioned for Inter Partes Review (IPR) of the '239 patent. The PTAB instituted review, but upheld the patent against Momenta's challenge. When Momenta appealed to the Federal Circuit, BMS challenged Momenta's Article III standing to do so.

Momenta's Product Development

According to the Federal Circuit decision, "Momenta was reportedly attempting to develop a biosimilar counterpart of Orencia®" when it petitioned for IPR of the '239 patent. In its motion to dismiss the Federal Circuit appeal, BMS asserted that "Momenta's proposed product had failed its Phase 1 clinical trials and had been withdrawn." Before the Federal Circuit, "Momenta responded that it had not abandoned its intent to produce a counterpart of the Orencia® product, that the '239 Patent is an obstacle to these activities, and that it is injured by the estoppel provision," of the IPR statute, such that it does have Article III standing to appeal.

Subsequently, Momenta advised the court of "discussions with its collaboration partner, Mylan, to exit its participation in the development of ... M834, a proposed biosimilar to ORENCIA®." According to BMS, that "confirm[ed] Momenta's lack of standing to appeal."

In response to the court's order to show cause, Momenta argued that, "because of BMS's patent and the Board's decision upholding it, Momenta and its partner Mylan still face the same fork in the road about the commercial formulation for their biosimilar productthey must decide whether to proceed with the current formulation or switch to a more expensive and potentially less commercially viable option. That decision and the costs...