Vaccine Patent Litigation

Pending U.S. District Court Patent Vaccine Litigations (Organized by filing date, starting with most recently filed)

Acuitas Therapeutics Inc. et al v. Alynylam Pharmaceutical, Inc. et al,
1-24-cv-00816 (D. Del)
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  • Complaint Filed: July 12, 2024
  • Plaintiff(s):  Acuitas Therapeutics Inc.; Michael J. Hope; Steven M. Ansell; Xinyao Du
  • Defendant(s): Alynylam Pharmaceutical Inc.
  • Asserted Patent(s): Plaintiffs seek a declaratory judgment of co-inventorship of U.S. Patents 11,246,933; 11,382,979; 11,590,229; 11,612,657; 11,633,479; and 11,633,480
  • Accused Product(s): N/A
  • Litigation Status: Pending

GlaxoSmithKline Biologics SA et al v. Pfizer Inc. et al,
1-24-cv-00512 (D. Del)
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  • Complaint Filed: April 25, 2024
  • Plaintiff(s): GlaxoSmithKline Biologicals SA; GlaxoSmithKline LLC
  • Defendant(s): Pfizer Inc.; Pharmacia & Upjohn Co., LLC; BioNTech SE; BioNTech Manufacturing GmBH; BioNTech US Inc.
  • Asserted Patent(s): U.S. Patents 11,638,693; 11,638,694; 11,666,534; 11,766,401; 11,786,467
  • Accused Product(s): (1) the original monovalent COMIRNATY® COVID-19 vaccine; (2) the bivalent COMIRNATY® COVID-19 original plus BA.1 variant vaccine; (3) the bivalent COMIRNATY® COVID-19 original plus BA.4/5 variant vaccine; and (4) the monovalent COMIRNATY® COVID-19 XBB.1.5
    variant vaccine.
  • Litigation Status: Pending

Alnylam Pharmaceuticals, Inc. v. Pfizer Inc. et al,
1-23-cv-00578 (D. Del.)
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  • Complaint Filed: May 26, 2023
  • Plaintiff(s): Alnylam Pharmaceuticals, Inc.
  • Defendant(s): Pfizer Inc.; Pharmacia & Upjohn Co., LLC
  • Asserted Patent(s): U.S. Patents 11,633,479; 11,633,480; 11,612,657; 11,590,229
  • Accused Product(s): COVID-19 vaccine
  • Litigation Status: Pending
    • On October 2, 2023, the case was consolidated with C.A. 1:22-cv-00336 and C.A. 22-cv-0092.  The 1:22-cv-00336 (see below) was designated as the lead case.

Alnylam Pharmaceuticals, Inc. v. Moderna, Inc. et al,
1-23-cv-00580 (D. Del.)+

  • Complaint Filed: May 26, 2023
  • Plaintiff(s): Alnylam Pharmaceuticals, Inc.
  • Defendant(s): Moderna, Inc.; ModernaTX, Inc.; Moderna US, Inc.
  • Asserted Patent(s): U.S. Patents 11,590,229; 11,633,479; 11,633,480
  • Accused Product(s): Moderna COVID-19 vaccine
  • Litigation Status: Pending
    • On October 2, 2023, the Court set a schedule for the case.  Fact discovery is to be completed by November 7, 2024.  Trial is scheduled to start on December 15, 2025.
    • On November 8, 2023, the parties submitted a joint stipulation of dismissal of the ʼ229 and ʼ480 patents.  The stipulation was so ordered by the Court on November 13, 2023.

Arbutus BioPharma Corp et al v. Pfizer Inc et al,
3-23-cv-01876 (D. N.J.)+

  • Complaint Filed: April 4, 2023
  • Plaintiff(s): Arbutus Biopharma Corp.; Genevant Sciences GmBH
  • Defendant(s): Pfizer Inc.; BioNTech SE
  • Asserted Patent(s): U.S. Patents 9,504,651; 8,492,359; 11,141,378; 11,298,320
  • Accused Product(s): COVID-19 mRNA LNP vaccine products (including pediatric doses; booster doses; supplemental doses; reformulations; boosters or re-vaccinations; variant-specific formulations; bivalent formulations; and the products known or marketed as Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, COMIRNATY, Tozinameran, BNT162b2, or PF-07302048)
  • Litigation Status: Pending

ModernaTX, Inc. et al v. Pfizer Inc. et al,
1-22-cv-11378 (D. Ma.)+

  • Complaint Filed: August 26, 2022
  • Plaintiff(s): ModernaTX, Inc.; Moderna USA, Inc.
  • Defendant(s): Pfizer Inc.; BioNTech SE; BioNTech Manufacturing GmbH; BioNTech US Inc.
  • Asserted Patent(s): U.S. Patents 10,898,574; 10,702,600; 10,933,127
  • Accused Product(s): COMIRNATY® COVID-19 vaccine
  • Litigation Status: Stayed
    • On January 17, 2023, the Court issued a Scheduling Order.  Fact discovery is to be completed by December 13, 2023.  Expert discovery is to be completed by June 7, 2024.
    • On August 1, 2023, the Court issued a claim construction order.
    • On March 27, 2024, BioNTech filed a motion to stay the case, in view of the PTAB’s final determination of instituted IPRs on the asserted ‘600 and ‘127 patents.  On April 12, 2024, the Court granted the motion, staying the case pending resolution of the IPRs.

BioNTech SE et al v. CureVac SE,
2:23-cv-00222 (E.D. Va.)+

  • Complaint Filed: July 25, 2022 (originally filed in D.Ma., C.A. 1-22-cv-cv-11202; transferred to E.D. Va. on May 15, 2023)
  • Plaintiff(s): BioNTech SE; BioNTech Manufacturing GmbH; Pfizer Inc.
  • Defendant(s): CurVac AG
  • Asserted Patent(s):  U.S. Patents 11,135,312; 11,149,278; 11,241,493; 11,286,492; 11,345,920; 10,760,070; 11,471,525; 11,576,966; 11,596,696
  • Accused Product(s): COMIRNATY® COVID-19 vaccine
  • Litigation Status: Pending
    • On November 14, 2023, third party Acuitas Therapeutics filed a motion to intervene and to sever and stay certain claims, arguing that it had licensed related patents to BioNTech and Pfizer.  On April 12, 2024, the magistrate judge issued a Report and Recommendation, concluding that “intervention is proper” and recommending a “stay of the entire infringement action pending solution of the inventorship questions.”
    • On April 25, 2024, the parties filed a notice of settlement between CureVac and Acuitas.
    • On June 11, 2024, the magistrate judge issued a Revised Report and Recommendation on Severance and Stay, vacating the prior recommendation and recommending denial of Acuitas’s motion to stay and sever.
    • On June 14, 2024, the Court issued a dismissal order, dismissing intervening party Acuitas from the action with prejudice.
    • On June 14, 2024, the Court issued a dismissal order, dismissing CureVac’s causes of action for infringement of the ‘493 patent, the ‘525 patent, the ‘966 patent, and all allegations that “Acuitas, BioNTech, or Pfizer, violated by confidentiality obligations or that Acuitas’s actions, or BioNTech or Pfizer’s actions with respect to Aquitas, support or are the bases for any claim or response to any defense or counterclaim, including willful infringement allegations against BioNTech and/or Pfizer.”
    • On June 14, 2024, the Court granted, with modifications, Plaintiffs’ Motion to Reduce the Number of Asserted Claims.  CureVac is to reduce the number of asserted claims to no more than 50 by June 25, 2024, and to not more than 20 within 14 days after close of expert discovery.

Alnylam Pharmaceuticals, Inc. v. Moderna, Inc. et al,
1-22-cv-00925 (D. Del.)+

  • Complaint Filed: July 12, 2022
  • Plaintiff(s): Alnylam Pharmaceuticals, Inc.
  • Defendant(s): Moderna, Inc.; ModernaTX, Inc.; Moderna US, Inc.
  • Asserted Patent(s): U.S. Patent 11,382,979
  • Accused Product(s): Moderna COVID-19 vaccine
  • Litigation Status: On appeal
    • On July 27, 2022, the case was consolidated with C.A. 1:22-cv-00335 (D. Del.).
    • On August 21, 2023, the Court issued a claim construction order.
    • On August 30, 2023, the Court issued a final judgment of non-infringement and closed the case.  The parties had stipulated to a final judgment of non-infringement.
    • The case is currently on appeal to the Federal Circuit, Case No. 23-235.

Alnylam Pharmaceuticals, Inc. v. Pfizer Inc. et al,
1-22-cv-00924 (D. Del.)+

  • Complaint Filed: July 12, 2022
  • Plaintiff(s): Alnylam Pharmaceuticals, Inc.
  • Defendant(s): Pfizer Inc.; Pharmacia & Upjohn Co. LLC; BioNTech SE; BioNTech Manufacturing GmbH
  • Asserted Patent(s): U.S. Patent 11,382,979
  • Accused Product(s): COMIRNATY® COVID-19 vaccine
  • Litigation Status: Pending
    • On August 10, 2022, the case was consolidated with C.A. 1:22-cv-00336 (D. Del.).  The 1:22-cv-00336 (see below) was designated as the lead case.

Alnylam Pharmaceuticals, Inc. v. Pfizer Inc. et al,
1-22-cv-00336 (D. Del.)+

  • Complaint Filed: March 17, 2022
  • Plaintiff(s): Alnylam Pharmaceuticals, Inc.
  • Defendant(s): Pfizer Inc.; Pharmacia & Upjohn Co. LLC
  • Asserted Patent(s): U.S. Patent 11,246,933
  • Accused Product(s): COMIRNATY® COVID-19 vaccine
  • Litigation Status: Pending
    • On July 27, 2022, the case was consolidated with C.A. 1:22-cv-00924
    • On September 13, 2022, the Court issued a scheduling order.  Fact discovery is to be completed by November 1, 2023, and expert discovery is to be completed by May 15, 2024.  A jury trial is set for November 18, 2024.
    • On August 9, 2023, the Court issued a claim construction order.
    • On October 2, 2023, the case was consolidated with C.A. 1:23-cv-000578.
    • On October 2, 2023, the Court issued a revised scheduling order.  Fact discovery is to be completed by May 22, 2024.  A jury trial is set to begin on July 7, 2025.
    • On April 6, 2024, the Court granted Plaintiffs’ request for leave to amend its infringement contentions.

Alnylam Pharmaceuticals, Inc. v. Moderna, Inc. et al,
1-22-cv-00335 (D. Del.)+

  • Complaint Filed: March 17, 2022
  • Plaintiff(s): Alnylam Pharmaceuticals, Inc.
  • Defendant(s): Moderna, Inc.; ModernaTX, Inc.; Moderna US, Inc.
  • Asserted Patent(s): U.S. Patent 11,246,933
  • Accused Product(s): Moderna COVID-19 vaccine
  • Litigation Status: On appeal
    • On May 23, 2022, Moderna filed a partial motion to dismiss for failure to state a claim, arguing that to the extent Plaintiffs seek royalties on the sale of COVID-19 vaccine, such claim must only proceed in the Court of Federal Claims.  On April 26, 2023, the court denied the motion to dismiss.
    • On July 27, 2022, the case was consolidated with C.A. 1:22-cv-00925 (D. Del.).
    • On September 13, 2022, the Court issued a Scheduling Order.  Fact discovery is to be completed by November 1, 2023.  Trial is scheduled to begin on November 8, 2024.
    • On April 26, 2023, the Court denied Moderna’s motion to amend its invalidity contentions.
    • On August 21, 2023, the Court issued a claim construction order.
    • On August 25, 2023, the parties filed a Stipulation and Joint Motion for Entry of Final Judgment of Non-Infringement, in view of the Court’s claim construction order.  On August 30, 2023, the Court issued a final judgment of non-infringement and closed the case.
    • The case is currently on appeal to the Federal Circuit, Case No. 23-2357.

Arbutus BioPharma Corp. et al v. Moderna, Inc. et al,
1-22-cv-00252 (D. Del.)+

  • Complaint Filed: February 28, 2022
  • Plaintiff(s): Arbutus Biopharma Corp.; Genevant Sciences GmbH
  • Defendant(s): Moderna, Inc.; ModernaTX, Inc.
  • Asserted Patent(s): U.S. Patents 8,058,069; 8,492,359; 8,822,668; 9,364,435; 9,504,651; 11,141,378
  • Accused Product(s): Moderna COVID-19 vaccine
  • Litigation Status: Pending
    • On May 6, 2022, Moderna filed a partial motion to dismiss for failure to state a claim, arguing that to the extent Plaintiffs seek royalties on the sale of COVID-19 vaccine, such claim must only proceed in the Court of Federal Claims.  The Court denied the motion on November 2, 2022.
    • On February 14, 2023, the United States of America filed a Statement of Interest.
    • Moderna renewed its partial motion to dismiss for failure to state a claim, after the United States of America filed a Statement of Interest.  The Court again denied the motion on March 10, 2023.
    • On March 2, 2023, an intervenor-Plaintiff filed a motion to intervene with a class action to “challenge Moderna’s attempt to shift liability” for its COVID-19 to the United States.  The Court denied the motion on March 8, 2023.
    • On March 21, 2023, the Court issued a Scheduling Order.  Fact discovery is to be completed by March 1, 2024.  Expert discovery is to be completed by July 10, 2024.
    • A claim construction hearing was held on February 22, 2024.  The Court issued a claim construction opinion on April 3, 2024.
    • On June 20, 2024, the Court issued an order on various discovery disputes.

Resolved U.S. District Court Patent Vaccine Litigations (Since 2020) (Organized by filing date, starting with most recently filed) 

Acuitas Therapeutics, Inc. et al v. CureVac SE,
2-23-cv-00610 (E.D. Va.)+

  • Complaint Filed: November 13, 2023
  • Plaintiff(s): Acuitas Therapeutics Inc.; Michael Hope; Ying Tam; Paulo Lin; Barbara Mui
  • Defendant(s): CureVac SE
  • Asserted Patent(s): Declaratory Judgment to correct inventorship for U.S. Patents 11,241,493; 11,471,525; 11,576,966; 11,596,686
  • Accused Product(s):
  • Litigation Status: Dismissed in view of a settlement.
    • On April 25, 2024, the parties filed a notice of settlement.  On June 11, 2024, the parties filed a stipulation of dismissal and, on June 24, 2024, the case was dismissed.

Acuitas Therapeutics Inc. et al v. Genevant Sciences GmbH et al,
3-23-cv-04200 (D.N.J.)+

  • Complaint Filed: August 14, 2023
  • Plaintiff(s): Acuitas Therapeutics Inc.
  • Defendant(s): Genevant Sciences GmBH; Arbutus Biopharma Corp.
  • Asserted Patent(s): Declaratory Judgment of non-infringement and invalidity of U.S. Patents 8,058,069; 8,492,359; 8,222,668; 9,006,417; 9,364,435; 9,604,651; 9,518,272; 11,141,378; 11,298,320; 11,318,098
  • Accused Product(s) COMIRNATY® COVID-19 vaccine
  • Litigation Status: Pending
    • On October 13, 2023, Defendants filed a motion to dismiss for lack of subject matter jurisdiction, arguing that there is no actual controversy.  On May 20, 2024, the Court granted the motion and ordered the case dismissed without prejudice.

Promosome LLC v. Moderna, Inc. et al,
3:23-cv-01047 (S.D. Cal.)+

  • Complaint Filed: June 6, 2023
  • Plaintiff(s): Promosome LLC
  • Defendant(s): Moderna, Inc.; Moderna US Inc.; ModernaTX, Inc.
  • Asserted Patent(s): U.S. Patent 8,853,179
  • Accused Product(s): Moderna COVID-19 vaccine
  • Litigation Status: Voluntarily dismissed
    • On September 19, 2023, Plaintiff filed a notice of voluntarily dismissal, without prejudice.

Promosome LLC v. Pfizer et al,
3:23-cv-01048 (S.D. Cal.)+

  • Complaint Filed: June 6, 2023
  • Plaintiff(s): Promosome LLC
  • Defendant(s): Pfizer Inc.; BioNTech SE; BioNTech Manufacturing GmbH
  • Asserted Patent(s): U.S. Patent 8,853,179
  • Accused Product(s): COMIRNATY® COVID-19 vaccine
  • Litigation Status: Voluntarily dismissed
    • On October 4, 2023, Plaintiff filed a notice of voluntarily dismissal, without prejudice.

BioNTech SE et al v. Curevac AG,
1-22-cv-cv-11202 (D. Ma.)+

  • Complaint Filed: July 25, 2022
  • Plaintiff(s): BioNTech SE; BioNTech Manufacturing GmbH; Pfizer Inc.
  • Defendant(s): CureVac AG
  • Asserted Patent(s): Declaratory Judgment of non-infringement of U.S. Patents 11,135,312; 11,149,278; 11,241,493
  • Accused Product(s): COMIRNATY® COVID-19 vaccine
  • Litigation Status: Transferred to E.D. Va.
    • On October 27, 2022, Plaintiffs filed a motion to dismiss for lack of jurisdiction, or to transfer to E.D. Va.  On May 15, 2023, the Court granted the motion, transferring the case to E.D. Va. (C.A. 2:23-cv-00222).

Acuitas Therapeutics, Inc. v. Genevant Sciences GmbH et al,
1:22-cv-02229 (S.D.N.Y.)+

  • Complaint Filed: March 18, 2022
  • Plaintiff(s): Acuitas Therapeutics, Inc.
  • Defendant(s): Genevant Sciences GmbH; Arbutus Biopharma Corp.
  • Asserted Patent(s): Declaratory Judgment of non-infringement of U.S. Patents 8,058,069; 8,492,359; 8,222,668; 9,006,417; 9,364,435; 9,404,127; 9,604,651; 9,518,272; 11,141,378
  • Product(s) at Issue: COMIRNATY® COVID-19 vaccine
  • Litigation Status: Voluntarily dismissed
    • On September 6, 2022, Plaintiffs filed an amended complaint.
    • On October 4, 2022, Defendants filed a motion to dismiss for lack of subject matter jurisdiction, arguing that there is no actual controversy between the parties.
    • On August 4, 2023, Plaintiffs filed a notice of voluntarily dismissal, without prejudice.

Allele Biotechnology & Pharmaceuticals, Inc. v. Pfizer Inc. et al,
3-20-cv-01958 (S.D. Cal.)+

  • Complaint Filed: October 5, 2020
  • Plaintiff(s): Allele Biotechnology & Pharmaceuticals, Inc.
  • Defendant(s): Pfizer, Inc.; BioNTech SE; BioNTech US, Inc.; Does 1-30
  • Asserted Patent(s): U.S. Patent 10,221,221
  • Accused Product(s): BNT162 vaccine
  • Litigation Status: Voluntarily dismissed
    • On February 8, 2021, Defendants filed a motion to dismiss for failure to state a claim, arguing that any use of the patent was covered by the 271(e)(1) safe harbor.  On February 15, 2021, Plaintiffs filed an amended complaint.  On February 21, 2021, the Court denied Defendants’ motion to dismiss as moot.  On March 26, 2021, Defendants again filed a motion to dismiss, again arguing that any use of the patent was covered by the 271(e)(1) safe harbor.  On May 4, 2021, the Court denied the motion.
    • On January 4, 2022, the parties filed a joint Motion to Dismiss.  The Court granted the motion, and dismissed the case with prejudice, on January 5, 2022.

Last Updated: July 16, 2024