Abatacept – USA

On Feb 07, 2019 Federal Circuit held that Momenta Pharmaceuticals challenge to Orencia® patent is moot because Momenta have stopped developing a biosimilar version of product.

Momenta appealed the decision of PTAB which found patentability of all claims 1 to 15 of US 8,476,239  owned by Bristol-Myers Squibb Company (“BMS”). The ’239 Patent, entitled “Stable Protein Formulations,” describes and claims specific fluid formulations of the protein molecule CTLA4Ig, an immunosuppressive agent used in treatment of immune system disorders such as rheumatoid arthritis.

Momenta in July 2015 petitioned for Inter Partes Review (IPR) of the ’239 Patent. At that time Momenta was reportedly attempting to develop a biosimilar counterpart of Orencia®. The PTAB instituted review, conducted trial, and sustained patentability of the ’239 Patent claims. Momenta filed an appeal to the Federal Circuit, as provided by 35 U.S.C. § 319. BMS moved to dismiss the appeal, stating that Momenta does not have standing to invoke federal court jurisdiction, citing the constitutional requirements of Article III. BMS stated that Momenta’s proposed product had failed its Phase 1 clinical trials and had been withdrawn. 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, 35 U.S.C. § 315(e). Momenta stated that this appeal meets the criteria of Article III, citing the “relaxed” standard for Article III compliance when the right of appeal is established by statute.

On Oct 1, 2018, Momenta filed a Letter stating that it is in discussion with Mylan to exit its participation in the development of its other five biosimilar programs including M834, a proposed biosimilar to ORENCIA®.  After shoe cause notice by Court, Momenta responded on Nov 2, 2018, stating that the appeal was not moot because as of today, the companies continue to be jointly responsible under that agreement for product development and for sharing the costs of that development. Momenta included a Declaration of its Chief Business Officer, Young Kwon, who declared that “[t]he parties have not yet reached an understanding about whether or when any termination notice will be delivered,” BMS responded that a third party’s possible future development of this abandoned product does not provide constitutional standing to Momenta. BMS stated that Momenta’s “possible future royalty . . . is too speculative to support standing,” On Dec 10, 2018 BMS filed another Letter and a Form 8-K stating that Momenta has terminated collaboration agreement with Mylan with respect to the development of . . . M834, a proposed biosimilar to ORENCIA® . . . . BMS stated that these documents confirm Momenta’s lack of or loss of standing, and establish that the appeal is moot. Momenta has not responded, and have not withdrawn its appeal.

Federal Circuit said that although the statutory grant of judicial review may “relax” the Article III criteria, judicial review of agency action remains subject to the constitutional foundation of injury-in-fact. On abandoning development of this product, Momenta has no legally protected interest in the validity of the ’239 Patent, and there is no “real need to exercise the power of judicial review.” 

Momenta’s argument that it might at some future time receive a royalty from Mylan, if Mylan should produce an Orencia® biosimilar, has no support in precedent, See Clapper, 568 U.S. at 414 n.5. Even though Momenta may have been working in pursuit of potentially infringing activity, it is established that jurisdiction must exist throughout the judicial review, and an intervening abandonment of the controversy produces loss of jurisdiction. See Arizonans for Official English v. Arizona, 520 U.S. 43, 67 (1997). Standing and mootness may not be coextensive in all cases. However, when the potential for injury has been mooted by events, the federal courts are deprived of jurisdiction. If a case does not “present a ‘case or controversy’ due to developments during litigation, those claims become moot.”

Thus, Federal Circuit held that Momenta does not have standing to invoke federal appellant jurisdiction, and the appeal is mooted by Momenta’s discontinuance of any potentially infringing activity.