Biotech patent lawsuit news in 2026 has been dominated by a record-setting mRNA settlement, a unanimous Supreme Court decision easing pressure on generic drug launches, and a Federal Circuit ruling that steadied patent eligibility for gene-therapy inventions. Biosimilar fights over Regeneron’s Eylea and cross-border mRNA vaccine litigation between Moderna, Pfizer, BioNTech, and GSK are still running in parallel. Here is what has actually moved.
Moderna’s $2.25 Billion LNP Settlement
Genevant Sciences and Arbutus Biopharma announced in March 2026 that Moderna agreed to pay up to $2.25 billion to end all U.S. and international patent enforcement over the lipid nanoparticle technology used in Spikevax.1PR Newswire. Genevant Sciences and Arbutus Biopharma Announce $2.25 Billion Settlement If paid in full, it would be the largest disclosed patent settlement in pharmaceutical history.
The deal has two components. Moderna owes $950 million upfront in July 2026. A further $1.3 billion turns on a Federal Circuit ruling about whether the government-use defense under 28 U.S.C. § 1498 shields Moderna’s vaccine sales. If the appellate court affirms liability, Moderna pays within 90 days; if Moderna wins, the money is refunded with interest.2IPWatchdog. Moderna Settles With Genevant and Arbutus, Ending LNP Patent Dispute
The settlement landed days before a scheduled Delaware jury trial. A February 2026 ruling by Judge Wolson had already stripped out most of Moderna’s defenses, holding that the government-use statute did not cover the vast majority of vaccine sales and barring Moderna’s obviousness and derivation arguments on estoppel grounds. Moderna consented to a judgment of infringement and no invalidity on four Arbutus patents covering the molar ratios and formulation methods for the LNPs in its mRNA vaccines.1PR Newswire. Genevant Sciences and Arbutus Biopharma Announce $2.25 Billion Settlement In return, Genevant granted Moderna a global, non-exclusive license for SM-102-containing mRNA vaccines against infectious diseases.
Supreme Court Rewrites the Skinny-Label Rules in Hikma v. Amarin
On June 4, 2026, the Supreme Court unanimously reversed the Federal Circuit in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. The case asked whether Hikma’s use of a “skinny label” for generic icosapent ethyl, combined with press releases and website language calling the product a “generic equivalent” of Amarin’s Vascepa, could support an induced-infringement claim.3Supreme Court of the United States. Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889
Under the Hatch-Waxman Act, a generic manufacturer can carve a patented indication out of its label and market the drug only for unpatented uses. The Federal Circuit had let Amarin’s suit go forward, reasoning that physicians could plausibly read Hikma’s communications as encouragement to prescribe for the patented cardiovascular indication. Justice Jackson, writing for the Court, rejected that framing. The proper question, she wrote, is whether the generic “actively encouraged” infringing use. Compliance with statutory labeling requirements and ordinary industry practice does not amount to active encouragement.3Supreme Court of the United States. Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889
For generic manufacturers, the practical effect is significant. Launching under a skinny label and describing the product in routine equivalence terms will generally not create inducement exposure without direct evidence of encouragement to prescribe off-label.4Proskauer Rose LLP. Supreme Court Reverses Federal Circuit in Hikma
Federal Circuit Revives Gene-Therapy Patent Claims
In a precedential February 20, 2026 decision, the Federal Circuit reversed a district court’s ruling that REGENXBIO’s gene-therapy patent was ineligible under 35 U.S.C. § 101. The case, REGENXBIO Inc. v. Sarepta Therapeutics, Inc., involves U.S. Patent No. 10,526,617, which covers cultured host cells containing recombinant nucleic acid molecules encoding adeno-associated virus capsid proteins. Sarepta uses a related AAV variant to manufacture SRP-9001, a gene therapy for Duchenne muscular dystrophy.5United States Court of Appeals for the Federal Circuit. REGENXBIO Inc. v. Sarepta Therapeutics, Inc., No. 2024-1408
The District of Delaware had granted summary judgment to Sarepta on the theory that the claim components exist in nature. The Federal Circuit held that the claims must be evaluated as a whole. Because the engineered host cells result from splicing nucleic acid sequences from different biological sources into a cell that does not and cannot exist in nature, they are “markedly different” from any natural product, and the eligibility inquiry ends at step one of the Alice/Mayo framework.5United States Court of Appeals for the Federal Circuit. REGENXBIO Inc. v. Sarepta Therapeutics, Inc., No. 2024-1408 The case returns to Delaware for further proceedings.6IPWatchdog. CAFC Reverses § 101 Ineligibility Ruling: Gene Therapy Claims Not Directed to Natural Phenomenon
CRISPR Priority Stays With the Broad Institute
On March 26, 2026, the Patent Trial and Appeal Board reaffirmed on remand that the Broad Institute holds priority for the use of CRISPR-Cas9 gene editing in eukaryotic cells. The Board concluded that the CVC group (University of California-Berkeley, University of Vienna, and Emmanuelle Charpentier) did not prove its inventors conceived of an operative eukaryotic CRISPR-Cas9 system before the Broad inventors reduced the invention to practice on October 5, 2012.7UC Berkeley News. PTAB Sides With Broad Institute Over University of California on Patent Priority for Use of CRISPR in Eukaryotic Cells
The decision blocks 14 pending CVC applications at the USPTO. It does not affect the more than 60 U.S. and 40 non-U.S. patents already awarded to CVC covering CRISPR-Cas9 use in various cell types. CVC could appeal again to the Federal Circuit, which had remanded the case in May 2025 after finding the Board applied an incorrect legal standard on conception.8IPWatchdog. PTAB Upholds Priority Win for Broad Institute in CRISPR Patent Case
Harbour BioMed Jury Verdict Against Amgen
A Delaware federal jury returned a unanimous verdict of $20,203,704 on June 14, 2026, finding that Amgen Inc. and its Teneobio subsidiary willfully infringed Harbour Antibodies BV’s U.S. Patent No. 10,906,970. The patent describes methods of making heavy-chain-only antibodies using transgenic animals. The trial began June 8 before Judge Maryellen Noreika.9Law360. Jury Tells Amgen to Pay $20.2M in Antibody Patent Trial Because the jury found willfulness, Harbour BioMed can ask the judge to treble damages, which would push the award to roughly $60.6 million.10PR Newswire. Harbour BioMed Secures Landmark Victory in US Patent Infringement Case Against Amgen
mRNA Vaccine Litigation Still Running on Several Fronts
The Moderna–Arbutus settlement did not end mRNA patent litigation. Several parallel cases remain active.
GSK v. Pfizer/BioNTech and GSK v. Moderna
GSK sued Pfizer and BioNTech in April 2024 in the District of Delaware, asserting eight patents on lipid mRNA vaccine formulation technology acquired from Novartis in 2015. A claim construction hearing was scheduled for April 2026, with fact discovery running through July 2026.11United States District Court for the District of Delaware. GSK v. Pfizer Inc. et al., No. 24-cv-512 GSK filed a parallel case against Moderna in October 2024, also in Delaware, seeking royalties on Spikevax, RSV vaccine mResvia, and the next-generation COVID vaccine mNexspike. GSK amended its complaint in September 2025 to add mNexspike; Moderna has said it will fight.12Fierce Pharma. GSK Expands mRNA Patent Litigation to Include Moderna’s Next-Generation COVID Vaccine
Moderna and Pfizer/BioNTech Trade Wins
In April 2026, European appellate officials invalidated one of Moderna’s patents on the grounds that its claims included details absent from the original application, giving Pfizer and BioNTech a win in that jurisdiction.13Law360. Pfizer, BioNTech Defeat Moderna COVID Jab Patent In the UK, the Supreme Court refused Pfizer/BioNTech’s appeal in December 2025, leaving intact a lower court ruling that found one of Moderna’s mRNA patents valid.14Supreme Court of the United Kingdom. Pfizer Limited and Others v. ModernaTX, Inc and Others
Arbutus and Genevant v. Pfizer/BioNTech
Separately from the Moderna deal, Arbutus and Genevant are pursuing LNP patent infringement claims against Pfizer and BioNTech in the District of New Jersey. Four patents are asserted, and the court issued a favorable claim construction ruling for the plaintiffs in September 2025. No trial date has been set.15SEC Filing – Arbutus Biopharma. Arbutus Biopharma Exhibit 99.1
Eylea Biosimilar Fights
Regeneron’s eye drug Eylea (aflibercept), with roughly $4.8 billion in annual U.S. sales, is at the center of the most contested biosimilar litigation of 2026. The Federal Circuit upheld preliminary injunctions in January 2025 blocking biosimilar launches by Mylan, Samsung Bioepis, and Formycon, ruling that Regeneron’s U.S. Patent No. 11,084,865 was likely valid and infringed.16Patently-O. Biologics Enforcement and Biosimilar Litigation
Two competitors have since settled. Biocon settled in April 2025, securing a license to launch Yesafili (aflibercept-jbvf) in the second half of 2026.17BiologicsHQ. Regeneron and Biocon Settle Litigation Over Eylea Biosimilar Yesafili Sandoz settled in September 2025, with permission to launch Enzeevu (aflibercept-abzv) in the fourth quarter of 2026 or earlier under certain conditions.18Sandoz. Sandoz Reaches Agreement With Regeneron Resolving All Patent Litigation Related to Its US Aflibercept Biosimilar Samsung Bioepis, Formycon, and Celltrion remain under active injunctions and have filed inter partes review petitions at the PTAB challenging the ‘865 patent. Amgen launched its biosimilar Pavblu at risk in October 2024 and is still in litigation.
Amgen v. Sanofi Keeps Reshaping Antibody Claims
The Supreme Court’s 2023 decision in Amgen Inc. v. Sanofi continues to drive litigation strategy. That ruling held that patent specifications must enable the full scope of the claimed invention without undue experimentation, which effectively invalidated broad “genus” claims describing antibodies by function rather than structure. The Federal Circuit has said it does not read the decision as disturbing prior enablement case law, but functional genus claims are now widely regarded as invalid as a practical matter.19Penn State Law Review. Redefining Enablement: The Impact of Amgen v. Sanofi on Patent Law and Biotechnology
Accused infringers now routinely raise Amgen in dispositive motions to knock out enablement issues before trial, and patent applicants face pressure to provide detailed molecular-level data and draft narrower claims in a therapeutic antibody market valued at over $160 billion.20UC Irvine Patent and Copyright Law Journal. Redefining Enablement: The Impact of Amgen v. Sanofi on Patent Law and Biotechnology