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From Intellectual Property Law Daily, February 7, 2019

Standing, mootness halt PTAB appeal after Momenta abandons drug development

By Peter Reap, J.D., LL.M.

After terminating development of a competing drug, Momenta Pharmaceuticals no longer had standing to appeal a ruling by the PTAB that sustained a patent for treating rheumatoid arthritis. The appeal was also moot.

In light of Momenta Pharmaceuticals’ cessation of all activity that could potentially infringe on Bristol-Myers Squib’s (BMS’) patent for a drug used to treat rheumatoid arthritis, Momenta no longer possessed standing to invoke federal appellate jurisdiction to appeal a decision by the patent trial and Appeal Board upholding the patentability the patent, the U.S. Court of Appeals for the Federal Circuit has determined. For the same reason, the appeal was moot and was dismissed (Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., February 7, 2019, Newman, P.).

BMS’ United States Patent No. 8,476,239 (the ’239 Patent) describes and claims specific fluid formulations of the protein molecule CTLA4Ig (cytotoxic T-lymphocyte associated protein 4 immunoglobulin), an immunosuppressive agent used in treatment of immune system disorders such as rheumatoid arthritis. The product has the common name "abatacept" and is sold by BMS under the brand name Orencia.

Momenta, attempting to develop a biosimilar counterpart of Orencia, petitioned for Inter Partes Review of the ’239 Patent in 2015. The PTAB instituted review, conducted trial, and sustained patentability of the ’239 Patent claims.

Momenta filed this appeal, 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 BMS stated that Momenta’s proposed product had failed its Phase 1 clinical trials and had been withdrawn. After further communications between the court and the parties, on December 10, 2018 BMS filed another Letter under Rule 28(j), enclosing a Preliminary Prospectus Supplement and a Form 8-K that Momenta had filed with the Securities and Exchange Commission on December 6, 2018. These documents stated: "We have elected to terminate our collaboration agreement with Mylan with respect to the development of ... M834, a proposed biosimilar to ORENCIA® …. On November 19, 2018, we delivered a formal notice of this partial termination to Mylan, as provided in the collaboration agreement."

BMS asserted that these documents confirm Momenta’s lack of or loss of standing, and establish that the appeal is moot. Momenta did not respond, but also did not withdraw its appeal. "No principle is more fundamental to the judiciary’s proper role in our system of government than the constitutional limitation of federal-court jurisdiction to actual cases or controversies," the Federal Circuit noted, citing DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 341–42 (2006). Although Momenta had initially stressed that it had spent millions of dollars in its development of an Orencia® biosimilar, now 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, the court held. 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." Warth v. Seldin, 422 U.S. 490, 508 (1975).

Momenta argued that since the purpose of the America Invents Act is to provide an alternative to district court litigation, appeal should be available from the PTAB as it would be available from a district court decision. Momenta contended that the estoppel provision provides injury-in-fact, and that this sufficed to support constitutional standing. However, estoppel of Momenta was irrelevant now that Momenta has terminated its development of the Orencia® product, the appellate court decided. Further, Momenta’s argument that it might at some future time receive a royalty from Mylan, if Mylan should produce an Orencia® biosimilar, had no support in precedent.

In E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1005 (Fed. Cir. 2018), the court held that appeal was available because the parties were direct competitors and were in commercial dispute, and the petitioners faced a significant risk of patent infringement in their demonstration plant that was entering into operation. The court concrete plans’ for present and ‘future activity that create[] a substantial risk of future infringement or likely cause the patentee to assert a claim of infringement.’" Id. Unlike that case, here Momenta now made clear that no concrete plans are afoot, the court observed.

Momenta also argued that since it was engaged in infringing activity when these proceedings began, it has not lost its standing to complete the review. However, when the potential for injury has been mooted by events, the federal courts are deprived of jurisdiction, the court stated. There are exceptions to mootness, for example when the issue has avoided review and is likely to be repeated, or when the defendant voluntarily ceased the challenged activity and the plaintiff seeks to preserve its win. But here, the cessation of potential infringement means that Momenta no longer has the potential for injury, thereby mooting the inquiry, the court explained.

This case is No. 17-1694.

Attorneys: Deanne Maynard (Morrison & Foerster LLP) for Momenta Pharmaceuticals, Inc. Christopher Neil Sipes (Covington & Burling LLP) for Bristol-Myers Squibb Co.

Companies: Momenta Pharmaceuticals, Inc.; Bristol-Myers Squibb Co.

MainStory: TopStory Patent FedCirNews

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