What the court decided
In Northwestern University v. Moderna, Inc., No. 1:24-cv-01151 (D. Del.), Northwestern alleges that Moderna's lipid-nanoparticle vaccines infringe three Northwestern patents: method patent 9,216,155 and product patents 10,328,026 and 8,323,686, which the court describes as relating to synthetic nanostructures for delivering mRNA into human cells. The complaint accuses Spikevax and mResvia, and Northwestern's briefing also accuses mNexspike. Northwestern seeks at least a reasonable royalty plus enhanced damages for willful infringement. After an earlier ruling, direct, induced, and contributory infringement and willfulness remain live on all three patents, as does infringement under 35 U.S.C. 271(f) on the two product patents.
The September 30, 2026 opinion and order (D.I. 130) grants Northwestern's motion to dismiss and strike (D.I. 38). It dismisses with prejudice Moderna's counterclaims for a declaratory judgment based on the government's license (Count VII) and for breach of contract (Count IX). It strikes, without leave to amend, Moderna's affirmative defenses of unclean hands, third-party beneficiary, patent exhaustion, and license. The court treated the question as one on the merits, not standing: whether a litigant may invoke a license "goes to the merits, not to the court's power to hear the case."
Why the license did not help Moderna
When a contractor keeps title to a federally funded invention, 35 U.S.C. 202(c)(4) reserves to the government "a nonexclusive, nontransferrable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States" the invention. Moderna, which does not allege that it was a party to the government's license, argued that because the government contracted with it to supply Spikevax, its sales to the government were licensed. The court concluded that the Act "provides no counterclaim or defense for third parties as opposed to the government," agreeing with other district courts, including the Middle District of North Carolina in Madey v. Duke University.
The court read section 202(c)(4) together with 28 U.S.C. 1498(a). Both recognize that the government may have a third party practice an invention on its behalf, but only section 1498 "provides the third party with an affirmative defense," by sending the patentee's claim for work done for the government, with its authorization or consent, to a suit against the United States in the Court of Federal Claims. Reading the Bayh-Dole license to give contractors a parallel defense, the court reasoned, would let them bypass the conditions and remedy of section 1498(a). It also rejected Moderna's reliance on the license's "have practiced" wording, distinguishing cases that construed privately negotiated "have made" clauses, because here the words are "a statutory requirement that every funding agreement must include."
The related defenses fell for the same reasons. Moderna is not a third-party beneficiary, the court held, because the Act's intended beneficiaries are the funded institutions and the government, and the license is nontransferrable. Filing a patent suit against which a disputed, license-based defense exists "is not unconscionable conduct," so the unclean-hands defense was struck. On exhaustion, Moderna, as the maker and initial seller of the doses, was "not a purchaser downstream of any authorized sale," and its alternative theory based on the government's later distribution of doses was "either legally insufficient or redundant" of its section 1498(a) defense. Moderna's noninfringement counterclaims (Counts IV through VI) may proceed only on theories other than the government's license. The court denied leave to amend, writing that "[t]he defects identified above are legal, not factual."
The section 1498 defense is still open
The ruling does not decide Moderna's section 1498(a) defense or its counterclaim on that defense (Count VIII). Northwestern moved (D.I. 80) to strike the defense and for partial judgment on the counterclaim, relying on a District of Delaware decision in a different case that rejected a materially identical defense as to doses distributed to the public. The parties stipulated that any ruling should await Moderna's appeal of that decision, Arbutus Biopharma Corp. v. Moderna, Inc., No. 26-1581 (Fed. Cir.), and the court denied Northwestern's motion without prejudice to refiling after the Federal Circuit decides it. As stipulated, 500,001,540 Spikevax doses were sold under the C0100 contract, 6,244,340 of those doses were administered to U.S. government employees, and Northwestern does not seek damages from Moderna for those 6,244,340 doses.
What to watch next
The parties must file a joint report on how to proceed on the section 1498(a) defense and counterclaim within seven days after the Federal Circuit decides Arbutus, or by April 7, 2027 if no decision has issued by then. Claim construction is under way: notices filed September 28, 2026 report service of Northwestern's opening claim construction brief and Moderna's opening claim construction brief in support of indefiniteness. The case can also end at any time by settlement or dismissal.