By: Katherine Rubino

On February 7th, 2019 the Court of Appeals for the Federal Circuit (CAFC) affirmed a decision by the Patent Trial and Appeal Board (PTAB) dismissing an inter-partes review (IPR) due to a lack of standing and mootness. This decision centers around IPR 2015-01537, Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co.

Bristol-Myers Squibb Co. (BMS) is owner of ‘239 patent which is directed at formulations for cytotoxic T-lymphocyte associated protein 4 immunoglobulin (CTLA4Ig), commonly known as abatacept and sold by BMS under the brand name Orencia. Orencia is commonly used for conditions associated with immune system over-stimulation such as rheumatoid arthritis and psoriatic arthritis. Orencia works by blocking antigen-presenting cells from delivering stimulatory signals, thus leading to down regulation of T cells, and as such blocking an inflammatory response.

In July of 2015, Momenta filed a petition for IPR review of BMS’s ‘239 patent, as Momenta was developing a biosimilar drug product containing CTLA4Ig in partnership with Mylan. The PTAB initiated the IPR and upheld patentability of BMS’s ‘239 patent. Momenta then appealed the PATB’s decision to the CAFC.

Upon appeal to the CAFC, BMS moved to dismiss the appeal, claiming that Momenta did not have standing to bring the appeal, after Momenta’s phase I trials of its biosimilar product failed testing. In November of 2018, Momenta had terminated its partnership with Mylan to develop the biosimilar drug product containing CTLA4Ig.

In view of these findings, the CAFC dismissed Momenta’s appeal for lack of standing and mootness. Generally, a party cannot bring suit unless he or she can demonstrate that he or she will be imminently harmed. The CAFC reasoned that because Momenta had stopped its development of a biosimilar product it “is not engaged in any activity that would give rise to a possible infringement suit.” Momenta then argued that it may at some future time receive a royalty from Mylan, if Mylan were to ever produce a biosimilar containing CTLA4Ig. The CAFC also dismissed this argument, citing that unknown future events were speculative at most.

During the appeal at the CAFC, BMS brought up a mootness argument, pointing out that Momenta’s decision to abandon pursuit of the biosimilar placed Momenta beyond the reach of the law. Cases that are considered moot are dismissed under Article Three of the Constitution which limits the jurisdiction of the federal courts to actual cases and controversies. The CAFC affirmed BMS’s mootness argument, explaining that “Momenta has not shown an invasion of a legally protected interest that is actual or imminent, not conjectural or hypothetical.” The CAFC concluded by claiming “there is no real need to exercise the power of judicial review.”

The CAFC further explained that even though Momenta may have been working in a potentially infringing space, jurisdiction must exist throughout the entire review. Because Momenta abandoned its plans to pursue the biosimilar partway through the review, the intervening abandonment of the controversy leads to a loss of review. In E.I. DuPont de Nemours & Co. v. Synvina C.v., the CAFC held that an appeal was available, because an actual controversy existed. In that case, both parties were actively engaged in activities that were likely to pose a significant risk of patent infringement.

After reviewing all evidence, the CAFC affirmed the PTAB’s dismissal. Looking ahead, this case demonstrates that activities that occur throughout the appeal process can have a direct impact on a pending appeal. Cases that are brought before the CAFC must be ripe and have an actual concurrently engaged controversy. Proposed and speculative future events will not account for ripeness and may even lead to dismissal as moot.