Big Molecule Watch

• Complaint Filed:  Jan. 2, 2025
• Plaintiff(s):  Acuitas Therapeutics Inc.
• Defendant(s):  GlaxoSmithKline Biologicals SA, GlaxoSmithKline LLC
• Asserted Patent(s):  Declaratory Judgment of non-infringement and invalidity of U.S. Patent Nos. 11,638,693; 11,638,694; 11,666,534; 11,766,401; 11,786,467
• Accused Product(s): COVID-19 Comirnaty
• Litigation Status: Pending

Northwestern University v. Moderna, Inc. et al,
1-24-cv-01151 (D. Del.)+

• Complaint Filed:  Oct. 16, 2024
• Plaintiff(s):  Northwestern University
• Defendant(s):  Moderna, Inc.; ModernaTX, Inc.; Moderna US, Inc.
• Asserted Patent(s):  U.S. Patent Nos. 9,216,155; 10,328,026; 8,323,686.
• Accused Product(s): Spikevax SARS-CoV-2 S protein mRNA vaccine family
• Litigation Status: Pending
  • On Dec. 23, 2024, Moderna filed a motion to dismiss, asserting that Northwestern’s allegations of infringement failed to state a claim for which relief can be granted.

• Complaint Filed:  Oct. 12, 2024
• Plaintiff(s):  GlaxoSmithKline Biologicals SA; GlaxoSmithKline LLC
• Defendant(s):  Moderna, Inc.; ModernaTX, Inc.; Moderna US, Inc.
• Asserted Patent(s):  U.S. Patent Nos. 11,291,682; 11,324,770; 11,596,645; 11,690,862; 11,707,482; 11,666,534; 11,786,467
• Accused Product(s): Spikevax mRNA vaccines; mRESVIA mRNA vaccines
• Litigation Status: Pending
  • On Jan. 9, 2025, GlaxoSmithKline filed a partial motion to dismiss Defendants’ counterclaims and affirmative defenses of patent misuse and prosecution laches.

• Complaint Filed:  Oct. 12, 2024
• Plaintiff(s):  GlaxoSmithKline Biologicals SA; GlaxoSmithKline LLC
• Defendant(s):  Moderna, Inc.; ModernaTX, Inc.; Moderna US, Inc.
• Asserted Patent(s):  U.S. Patent Nos. 11,324,770; 11,690,861; 11,690,864; 11,717,529; 11,786,467; 11,883,534
• Accused Product(s):  mRESVIA RSV F protein mRNA vaccine product
• Litigation Status: Pending

• Complaint Filed: July 12, 2024
• Plaintiff(s):  Acuitas Therapeutics Inc.; Michael J. Hope; Steven M. Ansell; Xinyao Du
• Defendant(s): Alnylam 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
  • On Sept. 19, 2024, Alnylam filed a motion to dismiss, asserting that Acuitas and the Acuitas scientists have not demonstrated standing to bring suit.

• Complaint Filed: Apr. 25, 2024; amended complaint filed on Aug. 14, 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
  • On Sept. 20, 2024, GlaxoSmithKline filed a motion to dismiss defendants’ counterclaims and affirmative defenses of patent misuse and prosecution laches.  On Oct. 24, 2024, the parties filed a stipulated order to dismiss, without prejudice, defendants’ counterclaims and affirmative defenses of patent misuse and prosecution laches, so ordered by the Court on Oct. 28, 2024.

• 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 Oct. 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.

• 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 Oct. 2, 2023, the Court set a schedule for the case.  Fact discovery is to be completed by Nov. 7, 2024.  Trial is scheduled to start on Dec. 15, 2025.
  • On Nov. 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 Nov. 13, 2023.
  • The Court issued a claim construction order on July 31, 2024, and an additional claim construction order on Sept. 10, 2024.
  • On Oct. 2, 2024, the Court issued a final judgment of non-infringement of all asserted claims of the ʼ479 patent.

• Complaint Filed: Apr. 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
  • On Sept. 7, 2023, the Court issued a Scheduling Order.  No trial date was set.  On Nov. 27, 2023, the Court issued an amended Scheduling Order.  On Sept. 18, 2024, the Court issued another amended Scheduling Order.
  • A claim construction hearing was held on Dec. 12, 2024.

• Complaint Filed: Aug. 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 Jan. 17, 2023, the Court issued a Scheduling Order.  Fact discovery is to be completed by Dec. 13, 2023.  Expert discovery is to be completed by June 7, 2024.
  • On Aug. 1, 2023, the Court issued a claim construction order.
  • On Mar. 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 Apr. 12, 2024, the Court granted the motion, staying the case pending resolution of the IPRs.

• Complaint Filed: July 25, 2022 (originally filed in D.Mass., 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 Nov. 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 Apr. 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 Apr. 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.
  • On July 30, 2024, the Court issued a claim construction order.

• 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 Aug. 21, 2023, the Court issued a claim construction order.
  • On Aug. 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. 23-2357.

• 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 Aug. 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.

• Complaint Filed: Mar. 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 Sept. 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 Nov. 18, 2024.
  • On Aug. 9, 2023, the Court issued a claim construction order.
  • On Oct. 2, 2023, the case was consolidated with C.A. 1:23-cv-000578.
  • On Oct. 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 Apr. 6, 2024, the Court granted Plaintiffs’ request for leave to amend its infringement contentions.
  • On Aug. 12, 2024, the Court issued a claim construction order, revised on Sept. 9, 2024.
  • On Dec. 20, 2024, BioNTech filed motions for summary judgment of literal noninfringement, non-infringement under the doctrine of equivalents, and invalidity under 35 U.S.C. § 112.

• Complaint Filed: Mar. 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 Apr. 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 Sept. 13, 2022, the Court issued a Scheduling Order.  Fact discovery is to be completed by Nov. 1, 2023.  Trial is scheduled to begin on Nov. 8, 2024.
  • On Apr. 26, 2023, the Court denied Moderna’s motion to amend its invalidity contentions.
  • On Aug. 21, 2023, the Court issued a claim construction order.
  • On Aug. 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 Aug. 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.

• Complaint Filed: Feb. 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 Feb. 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 Mar. 10, 2023.
  • On Mar. 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 Mar. 8, 2023.
  • On Mar. 21, 2023, the Court issued a Scheduling Order.  Fact discovery is to be completed by Mar. 1, 2024.  Expert discovery is to be completed by July 10, 2024.
  • A claim construction hearing was held on Feb. 22, 2024.  The Court issued a claim construction opinion on Apr. 3, 2024.
  • On June 20, 2024, the Court issued an order on various discovery disputes.

• Complaint Filed: Nov. 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 Apr. 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.

• Complaint Filed: Aug. 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:  Dismissed.
  • On Oct. 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.

• 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 Sept. 19, 2023, Plaintiff filed a notice of voluntarily dismissal, without prejudice.

• 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 Oct. 4, 2023, Plaintiff filed a notice of voluntarily dismissal, without prejudice.

• 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 Oct. 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).

• Complaint Filed: Mar. 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 Sept. 6, 2022, Plaintiffs filed an amended complaint.
  • On Oct. 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 Aug. 4, 2023, Plaintiffs filed a notice of voluntarily dismissal, without prejudice.

• Complaint Filed: Oct. 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 Feb. 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 Feb. 15, 2021, Plaintiffs filed an amended complaint.  On Feb. 21, 2021, the Court denied Defendants’ motion to dismiss as moot.  On Mar. 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 Jan. 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.