Timing the filing of an inter partes review for
companies in the early stage of developing a biosimilar product
should be carefully considered based on the recent Federal Circuit
case, Momenta Pharmaceuticals, Inc. v Bristol-Myers Squibb
Co., Appeal No. 2017-1694 (February 7, 2019). Momenta filed an
IPR before the PTAB to challenge the validity of a BMS patent
covering Orencia® (abatacept) while in its Phase I trials for
its own biosimilar product. The PTAB instituted review, conducted
trial, and sustained the validity of the BMS patent claims. During
this period, however, Momenta's own product failed its Phase I
trials and subsequently decided to terminate its pursuit of the
biosimilar to the abatacept product at that time. As an Article III
court, the Federal Circuit held that Momenta's decision to no
longer pursue its biosimilar product rendered its standing to
appeal the PTAB's decision moot as there was no judiciable
injury. Nevertheless, the question of when to
