Vaccine Patent PTAB Tracker

(Organized by Patent Owner)

Arbutus Biopharma Corp.+

U.S. Patent 8,058,069
Title: Lipid formulations for nucleic acid delivery

IPR2019-00554, filed by Moderna, Inc. f/k/a Moderna Therapeutics, Inc. (challenging claims 1-22)

U.S. Patent 9,364,435
Title: Lipid formulations for nucleic acid delivery

IPR2018-00739, filed by Moderna, Inc. f/k/a Moderna Therapeutics, Inc. et al (challenging claims 1-20)

  • Filing date: Mar. 5, 2018
  • Status: Instituted on Sept. 12, 2018.  On Sept. 11, 2019, the PTAB issued a Final Written Decision finding claims 1-6, 9, 12, 14, and 15 unpatentable, and finding claims 7, 8, 10, 11, 13, and 16-20 not unpatentable.  On Dec. 1, 2021, the Federal Circuit affirmed.
  • Petition
  • Decision on Institution
  • Final Written Decision

U.S. Patent 9,404,127
Title: Non-liposomal systems for nucleic acid delivery

IPR2018-00680, filed by Moderna, Inc. f/k/a Moderna Therapeutics, Inc. et al (challenging claims 1-22)

Genzyme Corp.+

U.S. Patent 9,051,542
Title: Compositions and methods to prevent AAV vector aggregation

IPR2023-00608, filed by Novartis Gene Therapies, Inc. et al (challenging claims 1, 2, 5, and 6)

IPR2023-00609, filed by Novartis Gene Therapies, Inc. et al (challenging claims 1, 2, 5, and 6)

U.S. Patent 10,429,288
Title: Analytical ultracentrifugation for characterization of recombinant viral particles

IPR2023-01044, filed by Novartis Gene Therapies, Inc. et. al (challenging claims 1, 17-34)

  • Filing date: June 30, 2023
  • Status: Instituted on Jan. 9, 2024.  Terminated on Mar. 4, 2024 (before a FWD) in view of a settlement agreement.
  • Petition
  • Institution Decision

IPR2023-01045, filed by Novartis Gene Therapies, Inc. et. al (challenging claims 4-16)

  • Filing date: June 30, 2023
  • Status: Instituted on Jan. 17, 2024.  Terminated on Mar. 4, 2024 (before a FWD) in view of a settlement agreement.
  • Petition
  • Institution Decision

GlaxoSmithKline Biologicals SA+

U.S. Patent 8,530,171
Title: High level expression of recombinant toxin proteins

IPR2020-00890, filed by Pfenex, Inc. (challenging claims 1-33)

  • Filing date: May 7, 2020
  • Status: Dismissed on Aug. 8, 2020 (before institution decision).
  • Petition

IPR2020-00962, filed by Pfenex, Inc. (challenging claims 1-33)

  • Filing date: May 27, 2020
  • Status:  Terminated on Dec. 23, 2020 in view of a settlement agreement (before institution decision).
  • Petition

U.S. Patent 8,753,645
Title: Conjugation process of bacterial polysaccharides to carrier proteins

IPR2018-01229, filed by Merck Sharp & Dohme Corp. et al (challenging claims 1-11)

IPR2018-01236, filed by Merck Sharp & Dohme Corp. et al (challenging claims 1-11)

U.S. Patent 9,265,839
Title: Conjugation process of bacterial polysaccharides to carrier proteins

IPR2018-01234, filed by Merck Sharp & Dohme Corp. et al (challenging claims 1-10)

IPR2018-01237, filed by Merck Sharp & Dohme Corp. et al (challenging claims 1-10)

U.S. Patent 9,422,345
Title:  Expression system

IPR2019-00230, filed by Merck Sharp & Dohme Corp. et al (challenging claims 1, 2, 4-14, and 16-21)

IPR2019-01028, filed by Pfenex Inc. (challenging claims 1, 2, 4, 6, 8, 12-14, 17-19, and 21)

IPR2019-01027, filed by Pfenex Inc. (challenging claims 1, 2, 4, 6, 8, 12-14, 17-19, and 21)

IPR2019-01478, filed by Pfenex Inc. (challenging claims 1, 2, 4-14, and 16-21)

IPR2019-00241, filed by Merck Sharp & Dohme Corp. et al (challenging claims 1, 2, 4-14, and 16-21)

ModernaTx,Inc.+

U.S. Patent 10,702,600
Title: Betacoronavirus mRNA vaccine

IPR2023-01358, filed by BioNTech SE et al (challenging claims 1, 2, 4-6, 8-12, 16-17, 20-21, and 26)

  • Filing date: Aug. 28, 2023
  • Status: Instituted on Mar. 19, 2024.  Final Written Decision issued on March 5, 2025, finding all challenged claims unpatentable.
  • Petition
  • Institution Decision

U.S. Patent 10,933,127
Title:  Betacoronavirus mRNA vaccine

IPR2023-01359, filed by BioNTech SE et al (challenging claims 1-3, 6-9, 11-13, 17-18, and 20)

  • Filing date: Aug. 28, 2023
  • Status: Instituted on Mar. 19, 2024.  Final Written Decision issued on March 5, 2025, finding all challenged claims unpatentable.
  • Petition
  • Institution Decision

Pfizer, Inc.+

U.S. Patent 9,492,559
Title: Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof

IPR2017-02136, filed by Merck Sharp & Dohme Corp. (challenging claims 11-15 and 20-37)

  • Filing date: Sept. 20, 2017
  • Status: Instituted on Mar. 22, 2018.  On Mar. 13, 2019, the PTAB issued a Final Written Decision finding all challenged claims unpatentable.  On Feb. 4, 2022, the request for director review was denied.  On Mar. 5, 2024, the Federal Circuit affirmed (Case No. 2019-1875).
  • Petition
  • Decision on Institution
  • Final Written Decision

IPR2017-02138, filed by Merck Sharp & Dohme Corp. (challenging claims 11-15 and 20-37)

  • Filing date: Sept. 20, 2017
  • Status: Instituted on Mar. 22, 2018.  On Mar. 13, 2019, the PTAB issued a Final Written Decision finding all challenged claims unpatentable.  A request for rehearing was filed on Apr. 5, 2018, which was denied on May 4, 2018.  On Feb. 4, 2022, the request for director review was denied.  On Mar. 5, 2024, the Federal Circuit affirmed (Case No. 2019-1876).
  • Petition
  • Decision on Institution
  • Final Written Decision

IPR2017-02132, filed by Merck Sharp & Dohme Corp. (challenging claims 1-10, 16-19, and 38-45)

  • Filing date: Sept. 19, 2017
  • Status: Instituted on Mar. 22, 2018.  On Mar. 13, 2019, the PTAB issued Final Written Decision finding all challenged claims unpatentable.  The PTAB also denied the Patent Owner’s motion to amend to replace claims 1-4, 9, 41, and 42 with substitute claims 46-52.  On Feb. 4, 2022, the request for director review was denied.  On Mar. 5, 2024, the Federal Circuit affirmed-in-part, vacated-in-part, and remanded-in-part (Case No. 2019-1873).  The Federal Circuit affirmed the PTAB’s decision with respect to claims 1-45 and proposed substitute claims 46, 47, and 50-52, but vacated and remanded as to proposed substitute claims 48 and 49.
  • Petition
  • Decision on Institution
  • Final Written Decision

IPR2017-02131, filed by Merck Sharp & Dohme Corp. (challenging claims 1-10, 16-19, and 38-45)

  • Filing date: Sept. 19, 2017
  • Status: Instituted on Mar. 22, 2018.  On Mar. 13, 2019, the PTAB issued a Final Written Decision finding all challenged claims unpatentable.  The PTAB also denied the Patent Owner’s motion to amend to replace claims 1-4, 9, 41, and 42 with substitute claims 46-52.  On Feb. 4, 2022, the request for director review was denied.  On Mar. 5, 2024, the Federal Circuit affirmed-in-part, vacated-in-part, and remanded-in-part (Case No. 2019-1871).  The Federal Circuit affirmed the PTAB’s decision with respect to claims 1-45 and proposed substitute claims 46, 47, and 50-52, but vacated and remanded as to proposed substitute claims 48 and 49.
  • Petition
  • Decision on Institution
  • Final Written Decision

IPR2018-00187, filed by Sanofi Pasteur Inc. et al (challenging claims 1-45)

  • Filing date: Nov. 20, 2017
  • Status: Instituted on June 5, 2018.  On June 3, 2019, the PTAB issued a Final Written Decision finding all challenged claims unpatentable.  The PTAB also denied the Patent Owner’s motion to amend to replace claims 1-4, 9, 41, and 42 with substitute claims 46-52.  On Feb. 4, 2022, the request for director review was denied.  On Mar. 5, 2024, the Federal Circuit affirmed-in-part, vacated-in-part, and remanded-in-part (Case No. 2019-2224).  The Federal Circuit affirmed the PTAB’s decision with respect to claims 1-45 and proposed substitute claims 46, 47, and 50-52, but vacated and remanded as to proposed substitute claims 48 and 49.
  • Petition
  • Decision on Institution
  • Final Written Decision

IPR2018–00188, filed by Sanofi Pasteur Inc. et al (challenging claims 1-45)

The Regents of the University of Michigan+

U.S. Patent 10,138,279
Title: Compositions and methods for Bacillus anthracis vaccination

IPR2022-00674, filed by Trutek Corp. (challenging claims 1-14)

Wyeth LLC+

U.S. Patent 8,562,999
Title: Formulations which stabilize and inhibit precipitation of immunogenic compositions

IPR2017-00378, filed by Merck Sharp & Dohme Corp. (challenging claims 1-6, 10, 11, 14, and 17-20)

  • Filing date: Dec. 1, 2016
  • Status: Instituted on June 13, 2017.  On June 8, 2018, the PTAB issued a Final Written Decision finding claims 1-6, 10, 11, 14, 17, 19, and 20 unpatentable, and finding claim 18 not unpatentable.  On Nov. 26, 2019, the Federal Circuit (Case No. 18-2133) vacated and remanded the finding that claim 18 is not unpatentable.  On Nov. 5, 2020, the Board issued a Final Decision on Remand, finding claim 18 not unpatentable.  The Patent Owner appealed and on Sept. 29, 2021, the parties filed a joint agreement to dismiss the appeal (Case No. 21-1453).
  • Petition
  • Decision on Institution
  • Final Written Decision
  • Final Decision on Remand

IPR2017-00380, filed by Merck Sharp & Dohme Corp. (challenging claims 1-6, 10, 11, 14, and 17-20)

  • Filing date: Dec. 1, 2016
  • Status: Instituted on June 30, 2017.  On June 8, 2018, the PTAB issued a Final Written Decision finding claims 1-6, 10, 11, 14, 17, 19, and 20 unpatentable, and finding claim 18 not unpatentable.  On Nov. 26, 2019, the Federal Circuit (Case No. 18-2134) vacated and remanded the finding that claim 18 is not unpatentable.  On Nov. 5, 2020, the Board issued a Final Decision on Remand, finding claim 18 not unpatentable.  The Patent Owner appealed and on Sept. 29, 2021, the parties filed a joint agreement to dismiss the appeal (Case No. 21-1454).
  • Petition
  • Decision on Institution
  • Final Written Decision
  • Final Decision on Remand

IPR2017–00390, filed by Merck Sharp & Dohme Corp. (challenging claims 7-9, 12, 13, 15, 16, 21, and 22)

U.S. Patent 8,895,024
Title: Multivalent pneumococcal polysaccharide-protein conjugate composition

IPR2017–01194, filed by Merck Sharp & Dohme Corp. et al. (challenging claims 1-11)

U.S. Patent 9,399,060
Title: Multivalent pneumococcal polysaccharide-protein conjugate composition

IPR2017-01223, filed by Merck Sharp & Dohme Corp. (challenging claims 1 and 4-13)

IPR2017-01215, filed by Merck Sharp & Dohme Corp. (challenging claims 1-13)

IPR2017–01211, filed by Merck Sharp & Dohme Corp. (challenging claims 1-13)

  • Filing date: Mar. 30, 2017
  • Status: Institution denied on Oct. 20, 2017.  Request for rehearing filed on Nov. 20, 2017 and denied on Jan. 22, 2018.
  • Petition
  • Decision on Institution

PGR2017–00016, filed by Merck Sharp & Dohme Corp. (challenging claims 1-13)

PGR2017–00017, filed by Merck Sharp & Dohme Corp. (challenging claims 1-13)

Last updated on March 10, 2025.