(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)
- Filing date: January 9, 2019
- Status: Instituted on July 24, 2019. On July 23, 2020, the PTAB issued a Final Written Decision finding claims 1-22 not unpatentable. The decision was affirmed by the Federal Circuit on December 1, 2021.
- Petition
- Decision on Institution
- Final Written Decision
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: March 5, 2018
- Status: Instituted on September 12, 2018. On September 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 December 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)
- Filing date: February 21, 2018
- Status: Instituted on September 12, 2018. On September 10, 2019, the PTAB issued a Final Written Decision finding all challenged claims unpatentable. On April 11, 2023, the Federal Circuit affirmed.
- Petition
- Decision on Institution
- Final Written Decision
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)
- Filing date: February 22, 2023
- Status: Institution denied on August 30, 2023.
- Petition
- Decision on Institution
IPR2023-00609, filed by Novartis Gene Therapies, Inc. et al (challenging claims 1, 2, 5, and 6)
- Filing date: February 22, 2023
- Status: Institution denied on August 30, 2023.
- Petition
- Decision on Institution
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 January 9, 2024. Terminated on March 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 January 17, 2024. Terminated on March 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 August 8, 2020 (before institution decision).
- Petition
IPR2020-00962, filed by Pfenex, Inc. (challenging claims 1-33)
- Filing date: May 27, 2020
- Status: Terminated on December 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)
- Filing date: June 11, 2018
- Status: Instituted on December 18, 2018. Terminated after settlement on June 12, 2019.
- Petition
- Decision on Institution
IPR2018-01236, filed by Merck Sharp & Dohme Corp. et al (challenging claims 1-11)
- Filing date: June 11, 2018
- Status: Instituted on December 18, 2018. Terminated after settlement on June 12, 2019.
- Petition
- Decision on Institution
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)
- Filing date: June 11, 2018
- Status: Instituted on December 18, 2018. Terminated after settlement on June 12, 2019.
- Petition
- Decision on Institution
IPR2018-01237, filed by Merck Sharp & Dohme Corp. et al (challenging claims 1-10)
- Filing date: June 11, 2018
- Status: Instituted on December 18, 2018. Terminated after settlement on June 12, 2019.
- Petition
- Decision on Institution
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)
- Filing date: November 7, 2018
- Status: Instituted on May 9, 2019. Terminated after settlement on June 12, 2019.
- Petition
- Decision on Institution
IPR2019-01028, filed by Pfenex Inc. (challenging claims 1, 2, 4, 6, 8, 12-14, 17-19, and 21)
- Filing date: May 6, 2019
- Status: Instituted on November 13, 2019. Terminated after settlement on November 12, 2020.
- Petition
- Decision on Institution
IPR2019-01027, filed by Pfenex Inc. (challenging claims 1, 2, 4, 6, 8, 12-14, 17-19, and 21)
- Filing date: May 6, 2019
- Status: Institution denied on November 13, 2019.
- Petition
- Decision on Institution
IPR2019-01478, filed by Pfenex Inc. (challenging claims 1, 2, 4-14, and 16-21)
- Filing date: August 9, 2019
- Status: Institution denied on February 10, 2020.
- Petition
- Decision on Institution
IPR2019-00241, filed by Merck Sharp & Dohme Corp. et al (challenging claims 1, 2, 4-14, and 16-21)
- Filing date: November 7, 2018
- Status: Instituted on May 9, 2019. Terminated after settlement on June 12, 2019.
- Petition
- Decision on Institution
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: August 28, 2023
- Status: Pending. Instituted on March 19, 2024.
- 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: August 28, 2023
- Status: Pending. Instituted on March 19, 2024.
- 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: September 20, 2017
- Status: Instituted on March 22, 2018. On March 13, 2019, the PTAB issued a Final Written Decision finding all challenged claims unpatentable. On February 4, 2022, the request for director review was denied. On March 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: September 20, 2017
- Status: Instituted on March 22, 2018. On March 13, 2019, the PTAB issued a Final Written Decision finding all challenged claims unpatentable. A request for rehearing was filed on April 5, 2018, which was denied on May 4, 2018. On February 4, 2022, the request for director review was denied. On March 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: September 19, 2017
- Status: Instituted on March 22, 2018. On March 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 February 4, 2022, the request for director review was denied. On March 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: September 19, 2017
- Status: Instituted on March 22, 2018. On March 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 February 4, 2022, the request for director review was denied. On March 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: November 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 February 4, 2022, the request for director review was denied. On March 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)
- Filing date: November 20, 2017
- Status: Institution denied on June 5, 2018.
- Petition
- Decision on Institution
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)
- Filing date: March 29, 2017
- Status: Institution denied on September 28, 2022.
- Petition
- Decision on Institution
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: December 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 November 26, 2019, the Federal Circuit (Case No. 18-2133) vacated and remanded the finding that claim 18 is not unpatentable. On November 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: December 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 November 26, 2019, the Federal Circuit (Case No. 18-2134) vacated and remanded the finding that claim 18 is not unpatentable. On November 5, 2020, the Board issued a Final Decision on Remand, finding claim 18 not unpatentable. The Patent Owner appealed and on September 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)
- Filing date: December 2, 2016
- Status: Instituted on June 13, 2017. On June 8, 2018, the PTAB issued a Final Written Decision finding all challenged claims unpatentable.
- Petition
- Decision on Institution
- Final Written Decision
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)
- Filing date: March 29, 2017
- Status: Institution denied on October 20, 2017. Request for rehearing was filed on November 20, 2017 and denied on January 22, 2018.
- Petition
- Decision on Institution
- Decision Denying Request for Rehearing
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)
- Filing date: March 31, 2017
- Status: Institution denied on October 20, 2017.
- Petition
- Decision on Institution
IPR2017-01215, filed by Merck Sharp & Dohme Corp. (challenging claims 1-13)
- Filing date: March 30, 2017
- Status: Institution denied on October 20, 2017.
- Petition
- Decision on Institution
IPR2017–01211, filed by Merck Sharp & Dohme Corp. (challenging claims 1-13)
- Filing date: March 30, 2017
- Status: Institution denied on October 20, 2017. Request for rehearing filed on November 20, 2017 and denied on January 22, 2018.
- Petition
- Decision on Institution
PGR2017–00016, filed by Merck Sharp & Dohme Corp. (challenging claims 1-13)
- Filing date: March 22, 2017
- Status: Institution denied on October 20, 2017.
- Petition
- Decision on Institution
PGR2017–00017, filed by Merck Sharp & Dohme Corp. (challenging claims 1-13)
- Filing date: March 24, 2017
- Status: Institution denied on October 20, 2017.
- Petition
- Decision on Institution
Last updated on June 25, 2024.