PTAB Tracker

Abatacept (ORENCIA)+

U.S. Patent 8,476,239
Patent Owner: Bristol-Myers Squibb
Title: Stable Protein Formulations

IPR2015-01537, filed by Momenta

Adalimumab (HUMIRA)+

U.S. Patent 8,889,135
Patent Owner: Abbvie Biotechnology, Ltd.
Title: Methods of Administering anti-TNFa-antibodies

IPR2016-00408, filed by Boehringer Ingelheim

IPR2016-00409, filed by Boehringer Ingelheim

IPR2016-00172, filed Coherus BioSciences, Inc.

U.S. Patent 9,017,680
Patent Owner: Abbvie Biotechnology, Ltd.
Title: Methods of Administering anti-TNFa antibodies

IPR2016-00188, filed by Coherus BioSciences

U.S. Patent 9,073,987
Patent Owner: AbbVie Biotechnology, Ltd.
Title: Methods of Administering anti-TNFa antibodies

IPR2016-00189, filed by Coherus BioSciences

U.S. Patent 9,085,619
Patent Owner:  Abbvie Biotechnology
Title: Anti-TNF Antibody Formulations

IPR2017-01009, filed by Coherus BioSciences, Inc.

IPR2017-01008, filed by Coherus

IPR2017-00822, filed by Coherus BioSciences, Inc.

IPR2017-00823, filed by Coherus BioSciences, Inc.

IPR2017-00826, filed by Coherus BioSciences, Inc.

  • Filing date: January 31, 2017
  • Status: Unopposed motion to dismiss petitions without prejudice filed by petitioner on April 7, 2017 and granted on April 11, 2017.
  • Petition

IPR2017-00827, filed by Coherus BioSciences, Inc.

  • Filing date: January 31, 2017
  • Status: Unopposed motion to dismiss petitions without prejudice filed by petitioner on April 7, 2017 and granted on April 11, 2017.
  • Petition

U.S. Patent 8,802,100
Patent Owner:  AbbVie Biotechnology
Title:  Formulation of human antibodies for treating TNF-alpha associated disorders

IPR2017-01823, filed by Sandoz

U.S. Patent 9,512,216
Patent Owner:  AbbVie Biotechnology
Title:  Use of TNFa Inhibitor

IPR2017-01824, filed by Sandoz

IPR2018-00002, filed by Sandoz

U.S. Patent 8,911,737
Patent Owner: AbbVie Biotechnology
Title: Methods of administering anti-TNFa antibodies

IPR2017-01987, filed by Sandoz

U.S. Patent 8,974,790
Patent Owner: AbbVie Biotechnology
Title: Methods of administering anti-TNFa antibodies

IPR2017-01988, filed by Sandoz

U.S. Patent 9,090,689
Patent Owner: AbbVie Biotechnology
Title: Use of TNFa inhibitor for treatment of psoriasis

IPR2017-02105, filed by Sandoz

U.S. Patent 9,067,992
Patent Owner:  AbbVie Biotechnology
Title:  Use of TNFa inhibitor for treatment of psoriatic arthritis

IPR2017-02106, filed by Sandoz

U.S. Patent 8,916,157
Patent Owner:  AbbVie Biotechnology
Title:  Formulation of human antibodies for treating TNF-a associated disorders

IPR2015-01514, filed by Amgen

U.S. Patent 8,916,158
Patent Owner: AbbVie Biotechnology
Title: Formulation of Human Antibodies for Treating RNF-a Associated Disorders

IPR2015-01517, filed by Amgen

U.S. Patent 9,114,166
Patent Owner: AbbVie Biotechnology
Title:  Formulation of Human Antibodies for Treating TNF-a Associated Disorders

IPR2016-01018, filed by Coherus

U.S. Patent 9,187,559
Patent Owner: Abbvie Biotechnology
Title:  Multiple-Variable Dose Regimen for Treating Idiopathic Inflammatory Bowel Disease

IPR2018-00156, filed by Sandoz

U.S. Patent 10,155,039
Patent Owner: Coherus BioSciences, Inc.
Title: Stable Aqueous Formulations of Adalimumab 

PGR2019-00064, filed by Fresenius Kabi USA, LLC and Fresenius Kabi Swissbiosim GmbH

Aflibercept (EYLEA)+

U.S. Patent 9,669,069
Patent Owner:  Regeneron Pharmaceuticals, Inc.
Title: Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders

IPR 2021-00880, filed by Mylan Pharmaceuticals, Inc.

IPR 2022-00257, filed by Celltrion, Inc.

  • Filing date: December 9, 2021
  • Status: Instituted on February 9, 2022; joined with IPR 2021-00880.  Final written decision issued on November 9, 2022, finding claims 1 and 8-12 unpatentable.  Appeal pending (Fed. Circ. Case No. 23-1395).
  • Petition
  • Institution Decision
  • Final Written Decision

IPR 2022-00301, filed by Apotex, Inc.

  • Filing date: December 9, 2021
  • Status: Instituted on February 9, 2022; joined with IPR 2021-00880.  Final written decision issued on November 9, 2022, finding claims 1 and 8-12 unpatentable.  Appeal pending (Fed. Circ. Case No. 23-1395).
  • Petition
  • Institution Decision
  • Final Written Decision

U.S. Patent 9,254,338
Patent Owner:  Regeneron Pharmaceuticals, Inc.
Title: Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders

IPR 2021-00881, filed by Mylan Pharmaceuticals, Inc.

IPR 2021-00258, filed by Celltrion, Inc.

  • Filing date: December 9, 2021
  • Status: Instituted on February 9, 2022; joined with IPR 2021-00881.  Final Written Decision issued on November 9, 2022, finding claims 1, 3-11, 13, 14, 16-24, and 26 unpatentable.  Appeal pending (Fed. Circ. Case No. 23-1396).
  • Petition
  • Institution Decision
  • Final Written Decision

IPR 2022-00298, filed by Apotex, Inc.

  • Filing date: December 9, 2021
  • Status: Instituted on February 9, 2022; joined with IPR 2021-00881.  Final Written Decision issued on November 9, 2022, finding claims 1, 3-11, 13, 14, 16-24, and 26 unpatentable. Appeal pending (Fed. Circ. Case No. 23-1396).
  • Petition
  • Institution Decision
  • Final Written Decision

U.S. Patent 10,857,231
Patent Owner:  Regeneron Pharmaceuticals, Inc.
Title: Formulations of VEG Antagonist Fusion Proteins and Methods of Manufacturing Them

PGR 2021-00117, filed by Celltrion, Inc.

U.S. Patent 10,130,681
Patent Owner:  Regeneron Pharmaceuticals, Inc.
Title: Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders

IPR 2022-01225, filed by Mylan Pharmaceuticals, Inc.

  • Filing date: July 1, 2022
  • Status: Instituted on January 11, 2023.  Final Written Decision issued on Jan. 9, 2024, finding claims 1, 3-11, 13-14, 16-24, and 26 unpatentable.  Notice of appeal to Federal Circuit filed on March 12, 2024.
  • Petition
  • Institution Decision
  • Final Written Decision

IPR 2023-00442, filed by Samsung Bioepis Co., Ltd.

IPR 2023-00532, filed by Celltrion, Inc.

  • Filing date: February 10, 2023
  • Status: Instituted, and joined with IPR 2022-01225, on March 22, 2023.  Final Written Decision issued on Jan. 9, 2024, finding claims 1, 3-11, 13-14, 16-24, and 26 unpatentable.  Notice of appeal to Federal Circuit filed on March 12, 2024.
  • Petition
  • Institution Decision
  • Final Written Decision

U.S. Patent 10,888,601
Patent Owner:  Regeneron Pharmaceuticals, Inc.
Title: Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders

IPR 2022-01226, filed by Mylan Pharmaceuticals, Inc.

  • Filing date: July 1, 2022
  • Status: Instituted on January 11, 2023.  Final Written Decision issued on January 9, 2024, finding claims 1-9, 34-39, 41-43, and 45 unpatentable.  Notice of appeal to Federal Circuit filed on March 12, 2024.
  • Petition
  • Institution Decision
  • Final Written Decision

IPR 2023-00533, filed by Celltrion, Inc.

  • Filing date: February 10, 2023
  • Status: Instituted, and joined with IPR 2022-01226, on March 22, 2023.  Final Written Decision issued on January 9, 2024, finding claims 1-9, 34-39, 41-43, and 45 unpatentable.  Notice of appeal to Federal Circuit filed on March 12, 2024.
  • Petition
  • Institution Decision
  • Final Written Decision

IPR 2023-0566, filed by Samsung Bioepis Co., Ltd. (challenging claims 1-9, 34-39, 41-43, and 45)

  • Filing date: February 10, 2023
  • Status: Instituted, and joined with 2022-01226, on March 22, 2023.  Final Written Decision issued on January 9, 2024, finding claims 1-9, 34-39, 41-43, and 45 unpatentable.  Notice of appeal to Federal Circuit filed on March 12, 2024.
  • Petition
  • Institution Decision
  • Final Written Decision

IPR 2023-00739, filed by Samsung Bioepis Co., Ltd. (challenging claims 10-12, 17-19, 21, 25-28, and 33)

IPR 2024-00201, filed by Biocon Biologics, Inc. (challenging claims 10-12, 17-19, 21, 25-28, and 33)

  • Filing date: November 20, 2023
  • Status:  Pending
  • Petition

U.S. Patent 11,253,572

Patent Owner:  Regeneron Pharmaceuticals, Inc.
Title: Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders

IPR 2022-01524, filed by Apotex, Inc.

IPR 2023-00884, filed by Samsung Bioepis Co., Ltd.

IPR 2024-00260, filed by Celltrion, Inc.

IPR 2024-00298, filed by Biocon Biologics Inc.

U.S. Patent 10,857,205
Patent Owner:  Regeneron Pharmaceuticals, Inc.
Title: Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders

IPR 2023-00099, filed by Mylan Pharmaceuticals, Inc.

  • Filing date: October 28, 2022
  • Status: Institution denied on March 1, 2023, in view of Regeneron’s statutory disclaimer of all claims of the ‘205 patent
  • Petition
  • Decision Denying Institution

U.S. Patent 10,464,992
Patent Owner:  Regeneron Pharmaceuticals, Inc.
Title: VEGF antagonist formulations suitable for intravitreal administration

IPR 2021-00402, filed by Chengdu Kanghong Biotechnology Co., Ltd.

IPR 2023-00462, filed by Celltrion, Inc.

  • Filing date: January 17, 2023
  • Status: Instituted on July 20, 2023.  On January 17, 2023, Regeneron filed a statutory disclaimer disclaiming claims 1-18.  On January 22, 2024, Regeneron filed an Unopposed Motion to Terminate Proceeding in view of the statutory disclaimer.  On February 21, 2024, the PTAB issued an adverse judgment in view of the statutory disclaimer.
  • Petition
  • Institution Decision
  • Adverse Judgment After Institution of Trial

IPR 2023-01312, filed by Samsung Bioepis Co., Ltd.

  • Filing date: August 18, 2023
  • Status: Instituted on Dec. 8, 2023; joined with IPR2023-00462.  On January 17, 2023, Regeneron filed a statutory disclaimer disclaiming claims 1-18.  On January 22, 2024, Regeneron filed an Unopposed Motion to Terminate Proceeding in view of the statutory disclaimer.  On February 21, 2024, the PTAB issued an adverse judgment in view of the statutory disclaimer.
  • Petition
  • Institution Decision
  • Adverse Judgment After Institution of Trial

U.S. Patent 10,406,226
Patent Owner:  Regeneron Pharmaceuticals, Inc.
Title: Method of manufacturing VEGF antagonist fusion proteins

IPR 2023-00620, filed by Celltrion, Inc.

Bevacizumab (AVASTIN)+

U.S. Patent 7,622,115
Patent Owner:  Genentech
Title: Treatment with anti-VEGF antibodies

IPR2016-01771, filed by Hospira

U.S. Patent 9,795,672
Patent Owner: Genentech
Title: Treatment with Anti-VEGF Antibodies

IPR2018-00373, filed by Pfizer

Dupilumab (DUPIXENT)+

U.S. Patent 8,679,487
Patent Owner: Immunex Corp.
Title: Anti-interleukin-4 receptor antibodies

IPR2017-01879, filed by Sanofi-Aventis

IPR2017-01129, filed by Sanofi Aventis

IPR2017-01884, filed by Sanofi Aventis

Eculizumab (SOLIRIS)+

U.S Patent 9,725,504
Patent Owner: Alexion Pharmaceuticals Inc.
Title: Treatment of paroxysmal nocturnal hemoglobinuria patients by an inhibitor of complement

IPR2019-00739, filed by Amgen

IPR2023-00999, filed by Samsung Bioepis Co., Ltd.

U.S. Patent No. 9,718,880
Patent Owner: Alexion Pharmaceuticals Inc
Title: Treatment of paroxysmal nocturnal hemoglobinuria patients by an inhibitor of complement

IPR2019-00740, filed by Amgen

IPR2023-00998, filed by Samsung Bioepis Co., Ltd.

U.S. Patent No. 9,732,149
Patent Owner: Alexion Pharmaceuticals Inc
Title: Treatment of paroxysmal nocturnal hemoglobinuria patients by an inhibitor of complement

IPR2019-00741, filed by Amgen

IPR2023-00933, filed by Samsung Bioepis Co., Ltd.

U.S. Patent No. 10,590,189
Patent Owner: Alexion Pharmaceuticals Inc
Title: Treatment of paroxysmal nocturnal hemoglobinuria patients by an inhibitor of complement

IPR2023-01069, filed by Samsung Bioepis Co., Ltd.

U.S. Patent No. 10,703,809
Patent Owner: Alexion Pharmaceuticals Inc
Title: Treatment of paroxysmal nocturnal hemoglobinuria patients by an inhibitor of complement

IPR2023-01070, filed by Samsung Bioepis Co., Ltd.

Etanercept (ENBREL)+

U.S. Patent 8,163,522
Patent Owner:  Hoffman-Laroche
Title:  Human TNF receptor

IPR2017-01916, filed by Coherus

IPR2015-01792, filed by Coalition for Affordable Drugs

U.S. Patent 8,063,182
Patent Owner: Genentech
Title: Antibodies to PRO7436 polypeptides

IPR2017-02066, filed by Coherus

Insulin Glargine (LANTUS)+

U.S. Patent No. 7,476,652
Patent Owner: Sanofi
Title: Acidic Insulin Preparations having Improved Stability

IPR2017-01526, filed by Mylan

U.S. Patent No. 7,713,930
Patent Owner: Sanofi

Title: Acidic insulin preparations having improved stability

IPR2017-01528, filed by Mylan

U.S. Patent No. 8,603,044
Patent Owner: Sanofi
Title: Pen-type injector

IPR2018-01675, filed by Mylan

  • Filing date: September 10, 2018
  • Status: Instituted on Apr. 2, 2019.  Final Written Decision issued on May 29, 2020, finding claims 11, 14, 15, 18, and 19 unpatentable.  Appeal decision mooted in view of related appeals in IPR 2018-01670, IPR 2018-01676, IPR 2018-01678, and IPR 2019-00979.
  • Petition
  • Decision on Institution
  • Final Written Decision

IPR2018-01676, filed by Mylan

U.S. Patent No. 8,679,069
Patent Owner: Sanofi
Title: Pen-type injector

IPR2018-01670, filed by Mylan

IPR2019-00979, filed by Hospira, Pfizer

U.S. Patent No. 8,992,486

Patent Owner: Sanofi
Title: Pen-type injector

IPR2018-01677, filed by Mylan

  • Filing date: September 10, 2018
  • Status: Petitioner’s unopposed motion to dismiss granted on Dec. 19, 2018.
  • Petition

IPR2018-01678, filed by Mylan

IPR2019-00122, filed by Mylan

IPR2018-01679, filed by Mylan

IPR2019-00980, filed by Hospira, Pfizer

IPR2019-00981, filed by Hospira, Pfizer

IPR2019-00982, filed by Hospira, Pfizer

U.S. Patent No. 9,526,844
Patent Owner: Sanofi
Title: Pen-type injector

IPR2018-01680, filed by Mylan

IPR2018-01682, filed by Mylan

IPR2018-01696, filed by Mylan

IPR2019-01022, filed by Hospira, Pfizer

IPR2019-01023, filed by Hospira, Pfizer

U.S. Patent No. 9,604,008
Patent Owner: Sanofi
Title: Pen-type injector

IPR2018-01684, filed by Mylan

IPR2019-00987, filed by Hospira, Pfizer

Natalizumab (TYSABRI)+

U.S. Patent 8,815,236
Patent Owner: Biogen
Title: Method for Treating Multiple Sclerosis and Crohn’s Disease

IPR2016-00912, filed by Swiss Pharma

U.S. Patent 8,349,321
Patent Owner: Biogen
Title:  Immunoglobin Formulation and Method of Preparation Thereof

IPR2016-00915, filed by Swiss Pharma

U.S. Patent 8,900,577
Patent Owner: Biogen
Title: Immunoglobulin Formulation and Method of Preparation thereof

IPR2016-00916, filed by Swiss Pharma

U.S. Patent 11,292,845
Patent Owner: Biogen
Title: Methods of Treating Inflammatory and Autoimmune Diseases with Natalizumab

PGR 2022-00054, filed by Sandoz, Inc.

Pegfilgrastim (NEULASTA)+

U.S. Patent 8,952,138
Patent Owner: Amgen
Title: Refolding proteins using a chemically controlled redox state

IPR2016-01542, filed by Apotex

U.S. Patent 9,856,287
Patent Owner: Amgen
Title: Refolding proteins using a chemically controlled redox state

PGR2019-00001, filed by Adello Biologics, LLC

IPR2019-00971, filed by Fresenius Kabi USA, LLC and Fresenius Kabi Swissbiosim GmbH

IPR2020-00314, filed by Fresenius Kabi USA, LLC and Fresenius Kabi Swissbiosim GmbH

Pembrolizumab (KEYTRUDA)+

U.S. Patent 10,934,356
Patent Owner: The Johns Hopkins University
Title: Checkpoint blockage and microsatellite instability

IPR2024-00622, filed by Merck Sharp & Dohme LLC

  • Filing date: March 4, 2024
  • Status: Pending
  • Petition

U.S. Patent 11,325,974
Patent Owner: The Johns Hopkins University
Title: Checkpoint blockage and microsatellite instability

IPR2024-00623, filed by Merck Sharp & Dohme LLC

  • Filing date: March 4, 2024
  • Status: Pending.
  • Petition

U.S. Patent 11,325,975
Patent Owner: The Johns Hopkins University
Title: Checkpoint blockage and microsatellite instability

IPR2024-00624, filed by Merck Sharp & Dohme LLC

  • Filing date: March 4, 2024
  • Status: Pending
  • Petition

U.S. Patent 11,339,219
Patent Owner: The Johns Hopkins University
Title: Checkpoint blockage and microsatellite instability

IPR2024-00625, filed by Merck Sharp & Dohme LLC

  • Filing date: March 4, 2024
  • Status: Pending
  • Petition

U.S. Patent 11,591,393
Patent Owner: The Johns Hopkins University
Title: Checkpoint blockage and microsatellite instability

IPR2024-00240, filed by Merck Sharp & Dohme LLC

  • Filing date: Nov. 30, 2023
  • Status: Pending
  • Petition

U.S. Patent 11,629,187
Patent Owner: The Johns Hopkins University
Title: Checkpoint blockage and microsatellite instability

IPR2024-00649, filed by Merck Sharp & Dohme LLC

  • Filing date: March 13, 2024
  • Status: Pending
  • Petition

U.S. Patent 11,643,462
Patent Owner: The Johns Hopkins University
Title: Checkpoint blockage and microsatellite instability

IPR2024-00648, filed by Merck Sharp & Dohme LLC

  • Filing date: March 13, 2024
  • Status: Pending
  • Petition

U.S. Patent 11,643,491
Patent Owner: The Johns Hopkins University
Title: Checkpoint blockage and microsatellite instability

IPR2024-00650, filed by Merck Sharp & Dohme LLC

  • Filing date: March 13, 2024
  • Status: Pending
  • Petition

U.S. Patent 11,649,287
Patent Owner: The Johns Hopkins University
Title: Checkpoint blockage and microsatellite instability

IPR2024-00647, filed by Merck Sharp & Dohme LLC

  • Filing date: March 13, 2024
  • Status: Pending
  • Petition

Risankizumab (SKYRIZI)+

U.S. Patent 11,078,265
Patent Owner: Boehringer Ingelheim International GmgH
Title: Anti-IL-23 antibodies

PGR2022-00037, filed by Sandoz Inc.

Rituximab (RITUXAN)+

U.S. Patent 7,820,161
Patent Owner: Biogen
Title: Treatment of Autoimmune Diseases

IPR2016-01614, filed by Celltrion

IPR2017-01115, filed by Pfizer

IPR2015-00415, filed by Boehringer Ingelheim

IPR2015-01744, filed by Celltrion

  • Filing date: August 17, 2015
  • Status: Terminated prior institution following motion to dismiss by petitioner on October 6, 2015.
  • Petition

U.S. Patent 7,976,838
Patent Owner: Genentech
Title: Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNFa inhibitor

IPR2016-01667, filed by Celltrion

IPR2017-02042, filed by Sandoz

IPR2017-02036, filed by Sandoz

IPR2017-01923, filed by Pfizer

IPR2015-00417, filed by Boehringer Ingelheim

IPR2015-01733, filed by Celltrion

  • Filing date: August 14, 2015
  • Status: Terminated following motion to dismiss by petitioner on October 6, 2015.
  • Petition

IPR2018-01019, filed by Celltrion

  • Filing date: May 4, 2018
  • Status: Instituted on Oct. 30, 2018.  Joined with IPR 2017-01923.   Terminated following settlement on April 2, 2019.
  • Petition
  • Decision on Institution 

U.S. Patent 8,329,172
Patent Owner:  Biogen
Title:  Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody

IPR2017-01093, filed by Celltrion

IPR2017-01166, filed by Pfizer

IPR2015-00418, filed by Boehringer Ingelheim

IPR2018-00285, filed by Pfizer

U.S. Patent 8,557,244
Patent Owner: Biogen
Title:  Treatment of Aggressive Non-Hodgkins Lymphoma with Anti-CD20 Antibody

IPR2017-01094, filed by Celltrion

  • Filing date: March 15, 2017
  • Status: Institution denied on Oct. 2, 2017.  Petitioner’s Request for Rehearing denied on January 2, 2018.
  • Petition
  • Decision on Institution

IPR2017-01167, filed by Pfizer

U.S. Patent 9,296,821
Patent Owner: Biogen
Title: Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibodies

IPR2017-01095, filed by Celltrion

IPR2018-00186, filed by Pfizer

U.S. Patent 7,682,612
Patent Owner:  Genentech
Title:  Treatment of Hematologic Malignancies Associated with Circulating Tumor Cells Using Chimeric Anti-CD20 Antibody

IPR2017-01227, filed by Celltrion

IPR2017-01230, filed by Celltrion

IPR2017-02126, filed by Pfizer

U.S. Patent 8,206,711
Patent Owner: Genentech
Title: Treatment of Chronic Lymphocytic Leukemia Using Anti-CD20 Antibodies

IPR2017-01229, filed by Celltrion

IPR2017-02127, filed by Pfizer

U.S. Patent 8,821,873
Patent Owner: Biogen
Title: Treatment of Diffuse Large-cell Lymphoma with Anti-CD20 Antibody

IPR2017-01168, filed by Pfizer

U.S. Patent 8,545,843
Patent Owner: Biogen
Title: Treatment of Vasculitis

IPR2018-00086, Petitioner: Pfizer

U.S. Patent 9,504,744
Patent Owner: Biogen
Title: Treatment of Diffuse Large-Cell Lymphoma with Anti-CD20 Antibody

IPR2018-00231, filed by Pfizer

Tocilizumab (ACTEMRA)+

U.S. Patent 7,521,052
Patent Owner: Chugai Seiyaku Kabushiki Kaisha
Title: Methods for Treating Interleukin-6 Related Diseases

IPR 2021-01024, filed by Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmBH

U.S. Patent 10,744,201

Patent Owner: Chugai Seiyaku Kabushiki Kaisha
Title: Methods for Treating Rheumatoid Arthritis with a Human IL-6 Receptor Antibody and Methotrexate

IPR 2021-01025, filed by Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmBH

U.S. Patent 8,580,264
Patent Owner: Chugai Seiyaku Kabushiki Kaisha, Genentech, Inc., and Hoffmann-La Roche
Title: Subcutaneously Administered Anti-IL-6 Receptor Antibody

IPR 2021-01288, filed by Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmBH (consolidated with IPR 2021-01542)

IPR 2021-01542, filed by Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmBH (consolidated with IPR 2021-01288)

IPR 2022-00578, filed by Celltrion, Inc.

U.S. Patent 10,874,677
Patent Owner: Chugai Seiyaku Kabushiki Kaishi and Hoffmann-La Roche
Title: Subcutaneously Administered Anti-IL-6 Receptor Antibody

IPR 2021-01336, filed by Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmBH

IPR 2022-00579, filed by Celltrion, Inc.

U.S. Patent 9,750,752
Patent Owner: Chugai Seiyaku Kabushiki Kaishi and Hoffmann-La Roche
Title: Subcutaneously Administered Anti-IL-6 Receptor Antibody

IPR 2022-00201, filed by Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmBH

U.S. Patent 10,231,981
Patent Owner: Chugai Seiyaku Kabushiki Kaishi and Hoffmann-La Roche
Title: Subcutaneously Administered Anti-IL-6 Receptor Antibody for Treatment of Juvenile Idiopathic Arthritis

IPR 2022-01065, filed by Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmBH

  • Filing date:  June 7, 2022
  • Status: Terminated on October 27, 2022 due to settlement (prior to institution decision)
  • Petition
  • Termination decision

Trastuzumab (HERCEPTIN)+

U.S. Patent 7,846,441
Patent Owner: Genentech
Title: Treatment with Anti-ErbB2 Antibodies

IPR2017-01121, filed by Celltrion

IPR2017-00731, filed by Pfizer

IPR2018-00016, filed by Pfizer

IPR2017-02063, filed by Pfizer

IPR2018-00192, filed by Samsung Bioepis

U.S. Patent 7,892,549
Patent Owner: Genentech
Title:  Treatment with Anti-ErbB2 Antibodies

IPR2017-01122, filed by Celltrion

IPR2017-00737, filed by Pfizer

IPR2017-00739, filed by Pfizer

IPR2017-01960, filed by Samsung Bioepis

U.S. Patent 6,627,196
Patent Owner: Genentech
Title: Dosages for Treatment with Anti-ErbB2 Antibodies

IPR2017-01139, filed by Celltrion

IPR2017-00804, filed by Pfizer

IPR2017-01958, filed by Samsung Bioepis

U.S. Patent 7,371,379
Patent Owner: Genentech
Title:  Dosages for Treatment with  Anti-ErbB2 Antibodies

IPR2017-01140, filed by Celltrion

IPR2017-00805, filed by Pfizer

IPR2017-01959, filed by Samsung Bioepis

U.S. Patent 8,591,897
Patent Owner: Genentech
Title:  Anti-ErbB2 Antibody Adjuvant Therapy

IPR2017-01726, filed by Pfizer

IPR2017-01727, filed by Pfizer

IPR2017-00959, filed by Celltrion

  • Filing date: February 21, 2017
  • Status: Terminated following Patent Owner request for adverse judgment on September 11, 2017.
  • Petition

U.S. Patent 6,339,142
Patent Owner: Genentech
Title: Protein Purification

IPR2017-02019, filed by Pfizer

IPR2018-00330, filed by Pfizer

U.S. Patent 9,249,218
Patent Owner:  Genentech
Title: Protein Purification

IPR2017-02020, filed by Pfizer

IPR2018-00331, filed by Pfizer

Ustekinumab (STELARA)+

U.S. Patent 10,961,307
Patent Owner: Janssen Biotech, Inc.
Title: Methods of treating moderately to severely active ulcerative colitis by administering an anti-IL12/IL23 antibody

IPR2023-01103, filed by Samsung Bioepis Co., Ltd.

  • Filing date: June 21, 2023
  • Status: Terminated on August 9, 2023 in view of a settlement agreement
  • Petition

IPR2023-01444, filed by Biocon Biologics, Inc.

  • Filing date: Nov. 22, 2023
  • Status: Pending
  • Petition

General Biologic Patents+

U.S. Patent 6,407,213
Patent Owner: Genentech
Title: Methods for Making humanized antibodies

IPR2017-02139, filed by Samsung Bioepis

IPR2017-02140, filed by Samsung Bioepis

  • Filing date: September 29, 2017
  • Status: Final Written Decision issued on Nov. 29, 2018, finding claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 unpatentable and claims 65, 72, 75–77, and 79 not unpatentable.  No appeal.
  • Petition
  • Decision on Institution
  • Final Written Decision

IPR2017-02031, filed by Boehringer Ingelheim

IPR2017-02032, filed by Boehringer Ingelheim

IPR2017-01488, filed by Pfizer

IPR2017-01489, filed by Pfizer

IPR2017-01373, filed by Celltrion

  • Filing date: May 8, 2017
  • Status: Final Written Decision issued on Nov. 29, 2018, finding claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 unpatentable and claims 65, 72, 75–77, and 79 not unpatentable.  No appeal.
  • Petition
  • Decision on Institution 
  • Final Written Decision

IPR2017-01374, filed by Celltrion

IPR2016-01693, filed by Mylan

IPR2016-01694, filed by Mylan

U.S. Patent 6,716,602
Patent Owner: Genentech
Title:  Metabolic Rate Shifts in Fermentations Expressing Recombinant Proteins

IPR2016-01608, filed by bioeq

U.S. Patent 9,051,556
Patent Owner: Shire
Title: Purification of iduronate-2-sulfatase

IPR2016-00258, filed by Green Cross Corp.

U.S. Patent 6,946,292
Patent Owner: Kyowa Hakko Kirin Co.
Title:  Cells producing compositions with increased antibody dependent cytotoxic activity

IPR2017-01252, filed by Aragen Bioscience

U.S. Patent 8,067,232
Patent Owner: Kyowa Hakko Kirin Co.
Title: Antibody composition-producing cell with inactivated A-1, 6-fusocyltransferase

IPR2017-01254, filed by Aragen Bioscience

U.S. Patent 7,425,446
Patent Owner: Kyowa Hakko Kirin Co.
Title: Antibody composition-producing cell

IPR2017-01262, filed by Aragen Bioscience

U.S. Patent 7,332,289
Patent Owner: Chugai Pharmaceutical Co.
Title: Method of Purifying Protein

IPR2017-01357, filed by Pfizer

U.S. Patent 7,927,815
Patent Owner: Chugai Pharmaceutical Co.
Title: Protein Purification Method

IPR2017-01358, filed by Pfizer

U.S. Patent 6,870,034
Patent Owner: Genentech
Title:  Protein Purification

IPR2017-02029, filed by Boehringer Ingelheim

U.S. Patent 6,331,415
Patent Owner: Genentech
Title: Methods of producing immunoglobulins, vectors and transformed host cells for use therein

IPR2016-01373, filed by Merck Sharp & Dohme Corp.

IPR2016-00710, filed by Mylan

IPR2017-00047, filed by Merck Sharp & Dohme Corp.

IPR2016-00383, filed by Genyzme Corporation

IPR2015-01624, filed by Sanofi-Aventis

IPR2016-00460, filed by Genzyme Corporation

U.S. Patent 7,807,799
Patent Owner:  Genentech
Title:  Reducing Protein A Leaching During Protein A Affinity Chromatography

IPR2016-01837, filed by Pfizer

U.S. Patent 8,940,878
Patent Owner: Amgen
Title: Capture purification processes for proteins expressed in a non-mammalian system

IPR2019-00791, filed by Kashiv Biosciences, LLC

U.S. Patent 9,643,997
Patent Owner: Amgen
Title: Capture purification processes for proteins expressed in a non-mammalian system

IPR2019-00797, filed by Kashiv Biosciences, LLC

IPR2019-01183, filed by Fresenius Kabi USA, LLC and Fresenius Kabi Swissbiosim GmbH

Last updated: March 18, 2024