February 7, 2019

Abandoning Infringing Conduct Caused Loss of Standing to Appeal IPR

By Bryan K. Wheelock, Principal

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., [2017-1694] (February 7, 2019), the Federal Circuit dismissed the appeal of the PTAB’s Final Written Decision sustaining patentability of claims 1 through 15 (all the claims) of U.S. Patent No. 8,476,239 for lack of standing/jurisdiction and for mootness.

The ‘239 patent covered compounds under the generic name “abatacept” and the Bristol-Myers Squibb (BMS) brand name Orencia® used in treatment of immune system disorders such as rheumatoid arthritis. Momenta’s proposed product failed its Phase 1 clinical trials and had been withdrawn, so BMS moved to dismiss the appeal because Momenta no longer had standing. Momenta responded that it had not abandoned its intent to produce a counterpart and that the ’239 Patent is an obstacle to these activities, and that it is injured by the estoppel provision of 35 U.S.C. § 315(e). Momenta cited the “relaxed” standard for Article III compliance when the right of appeal is established by statute.

The Federal Circuit said that Congress cannot erase Article III’s standing requirements by statute. Noting that Momenta had initially stressed that it had spent millions of dollars in its development of a biosimilar, upon Momenta’s termination of all potentially infringing activity, Momenta has not shown “an invasion of a legally protected interest” that is “actual or imminent, not conjectural or hypothetical.” The Federal Circuit concluded that upon 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.

The Federal Circuit rejected Momenta’s argument that the estoppel effect of the decision created standing, noting that estoppel cannot constitute an injury-in-fact when Momenta “is not engaged in any activity that would give rise to a possible infringement suit.”

The Federal Circuit further found that Momenta’s abandonment of the development of a biosimilar made the appeal moot: the cessation of potential infringement means that Momenta no longer has the potential for injury, thereby mooting the inquiry.