By Kevin E. Noonan –

In addition to Arbutus Biopharma and Genevant Sciences defending on appeal the District Court’s summary judgment decision in their favor, these plaintiffs filed their complaint against the Federal Government pursuant to 28 U.S.C. § 1498 for recompense before the Court of Federal Claims (No. 26-446 C) resulting from Moderna’s infringing activities relating to patented lipid nanoparticle components of their mRNA anti-COVID-19 vaccine.  Plaintiffs argue that their position is supported by the statute and by Moderna’s (and the Government’s) own assertions and arguments in the prior litigation now on appeal.  Also mentioned is the threat that they may not have access to this remedy due to statute of limitations restrictions in the time it will take the Federal Circuit to rule on Moderna’s appeal, and a detailed recitation of their grounds for asserting infringement for each of the infringed patents (U.S. Patent Nos. 8,058,069; 8,492,359; 8,822,668; 9,364,435; 9,504,651; and 11,141,378).

In response, the Government filed a Motion to Dismiss under the Rules of the U.S. Court of Federal Claims (RCFC) 12(b)(1) and invoked 28 U.S.C. § 1500 asserting that until the matter involving Moderna is finally adjudicated the Court does not have jurisdiction.

As acknowledged in the Motion, “[t]he Government does not dispute that claims against the Government Employee Doses can jurisdictionally be before this Court.”  But Arbutus included the claims to the Disputed Doses (i.e., those that were administered to the public) in their complaint, and the continued pendency of the district court suit and the operative Delaware judgment present a jurisdictional bar to claims against the Disputed Doses in this suit at this time according to the Government’s motion.

The Motion also asserts that any remedy as to the Disputed Doses claims “can only lie with either the district court, pursuant to 28 U.S.C. § 1338, or with this Court, pursuant to § 1498″ (emphasis in motion).  Here, because the District Court has already entered judgment there is a risk duplicative liability and duplicative recovery, contrary to § 1500 and § 1498.

The Government asserts that Plaintiffs’ attempt to include the Disputed Doses in the present dispute for the express purpose of circumventing the applicable statute of limitation finds no basis in law.  The Government explains that, in addition to the inclusion of the FAR clauses providing for express authorization and consent, the C-100 Contract was a direct procurement contract for the allegedly infringing goods between the Government and Moderna—the Government purchased the doses of vaccine from Moderna, meaning that those doses, like any other goods the Government chooses to buy, were for the Government’s benefit and thus recovery is limited to the provisions of § 1493.

The Motion maintains that a party seeking to invoke a court’s subject matter jurisdiction must prove that such jurisdiction exists by a preponderance of the evidence, citing Mars Inc. v. Kabushiki- Kaisha Nippon Conlux, 24 F.3d 1368, 1372 (Fed. Cir. 1994); Rocovich v. United States, 933 F.2d 991, 993 (Fed. Cir. 1991); and Reynolds v. Army & Air Force Exch. Serv., 846 F.2d 746, 748 (Fed. Cir. 1988).  The plain language of the statute, 28 U.S.C. § 1500, provides that the Court of Federal Claims:

[S]hall not have jurisdiction of any claim for or in respect to which the plaintiff . . . has pending in any other court any suit or process against the United States or any person who, at the time when the cause of action alleged in such suit or process arose, was, in respect thereto, acting or professing to act, directly or indirectly under the authority of the United States [emphasis added].

As set forth in the Motion, “[t]he Federal Claims Court’s two-part inquiry into the applicability of § 1500 when the activity allegedly occurred with government authority asks ‘(1) whether there is an earlier-filed suit or process pending in another court and, if so, (2) whether the claims asserted in the earlier-filed case are for or in respect to the same claims asserted in the later-filed Court of Federal Claims action,’” citing Brandt v. United States, 710 F.3d 1369, 1374 (Fed. Cir. 2013); Tecon Eng’rs, Inc. v. United States, 343 F.2d 943, 949 (Ct. Cl. 1965); and Ensign–Bickford Aerospace & Def. Co. v. United States, 118 Fed. Cl. 363, 368 (2014).  The Motion notes that this case “presents unique circumstances” that have not come before the Court in earlier cases, for example by maintaining in the district court case that Section 1498 does not apply to liability for the Disputed Doses and before this Court that it does.  The Government notes that these diametrically different positions are “in contravention with the historical justification of § 1500,” which was to curb duplicative lawsuits and “address the problem that judgments in suits against officers were not preclusive in suits against the United States,” citing United States v. Tohono O’Odham Nation, 563 U.S. 307, 311, 315 (2011).  Also, the circumstances here are distinct from earlier cases where jurisdiction of this Court was not barred, because in the competing district courts there was a lack of jurisdiction, citing Acetris Health, LLC v. United States, 949 F.3d 719 (Fed. Cir. 2020), and Tindall v. United States, No. 2023- 1139, 2023 WL 2881312 (Fed. Cir. Apr. 11, 2023) as examples. And the Government argues that the jurisdictional test set forth above is satisfied, wherein “the district court Disputed Doses claims are substantially the same as the Disputed Doses claims in this case,” and accordingly that the Court does not have jurisdiction as to those claims, citing Tohono O’Odham Nation (wherein the test enunciated by the Supreme Court, is “whether the operative facts are substantially the same between the two cases, regardless of the relief sought and the claims pleaded”).

The Motion further asserts that “Plaintiffs cannot claim that this Court has jurisdiction over the Disputed Doses by virtue of the Government’s Statement of Interest in the district court case while they simultaneously have an operative consent judgment for substantially the same claims from the district court” and argues accordingly that the Court of Federal Claims does not have jurisdiction over the Disputed Doses.

Finally, the Government argues that “there is no textual or judicially created exception to § 1500 for the purposes of avoiding a statute of limitations” and that “[w]hile Plaintiffs may have concerns related to applicable statutes of limitations related to the Disputed Doses claims, it is Plaintiffs who have created any such problem by filing suit in this Court before resolution of their claim against Moderna in the district court.”  In a footnote, the Government “maintains that any later attempts to bring the Disputed Doses into the present matter—whether via amendment or refiling of a complaint—are and will be subject to applicable six-year statute of limitations,” citing Tindall, and in the main text of the motion asserts that “this Court is not—and cannot be—a placeholder.”

The Government’s position sets forth a scenario where the Federal Circuit could limit Arbutus to pursuing its infringement liability claims to the Court of Federal Claims and at the same time that running of the statute of limitations precludes any such recovery from this Court.