Big Molecule Watch

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

IPR2015-01537, filed by Momenta

• Filing date: July 2, 2015
• Status: Final Written decision finding all claims patentable. Notice of Appeal filed on February 22, 2017. Federal Circuit dismissed appeal for lack of standing on February 7, 2019.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Final Written Decision

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

IPR2016-00408, filed by Boehringer Ingelheim

• Filing date: December 29, 2015
• Status: Final Written Decision finding claims 1-5 unpatentable. Notice of Appeal filed on July 31, 2017.  Judgment affirmed by Federal Circuit pursuant to Fed. Cir. R. 36 on Jan. 7, 2020.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

IPR2016-00409, filed by Boehringer Ingelheim

• Filing date: December 29, 2015
• Status: Final Written Decision finding claims 1-5 unpatentable.  Notice of Appeal filed on July 31, 2017.  Judgment affirmed by Federal Circuit pursuant to Fed. Cir. R. 36 on Jan. 7, 2020.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

IPR2016-00172, filed Coherus BioSciences, Inc.

• Filing date: November 9, 2015
• Status: Final Written Decision finding claims 1-5 unpatentable. Notice of Appeal filed on July 14, 2017.  Judgment affirmed by Federal Circuit pursuant to Fed. Cir. R. 36 on Jan. 7, 2020.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Petitioner Revised Reply
• Final Written Decision
• Notice of Appeal

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

IPR2016-00188, filed by Coherus BioSciences

• Filing date: December 7, 2015
• Status: Final Written Decision finding claims 1-4 unpatentable. Notice of Appeal filed on July 14, 2017.  Judgment affirmed by Federal Circuit pursuant to Fed. Cir. R. 36 on Jan. 7, 2020.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Petitioner Revised Reply
• Final Written Decision
• Notice of Appeal

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

IPR2016-00189, filed by Coherus BioSciences

• Filing date: December 7, 2015
• Status: Final Written Decision finding claims 1 and 2 unpatentable. Notice of Appeal filed on July 14, 2017.  Judgment affirmed by Federal Circuit pursuant to Fed. Cir. R. 36 on Jan. 7, 2020.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Petitioner Revised Reply
• Final Written Decision
• Notice of Appeal

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

IPR2017-01009, filed by Coherus BioSciences, Inc.

• Filing date: March 2, 2017
• Status: Institution denied on September 7, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

IPR2017-01008, filed by Coherus

• Filing date: March 2, 2017
• Status: Institution denied on September 7, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

IPR2017-00822, filed by Coherus BioSciences, Inc.

• Filing date: January 31, 2017
• Status: Institution denied on September 7, 2017.
• Petition
• Replacement Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

IPR2017-00823, filed by Coherus BioSciences, Inc.

• Filing date: January 31, 2017
• Status: Institution denied on September 7, 2017.
• Petition
• Replacement Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

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

• Filing date: July 20, 2017
• Status: Institution denied on February 9, 2018.
• Petition
• Patent Owner Preliminary Response
• Petitioner Reply
• Decision Denying Institution 

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

IPR2017-01824, filed by Sandoz

• Filing date: July 20, 2017
• Status: Institution denied on Feb. 9, 2018. Notice of Appeal filed on July 5, 2018. On Oct. 18, 2018, the appeal was dismissed after the parties submit a stipulation of voluntary dismissal.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution 
• Request for Rehearing
• Decision Denying Rehearing
• Notice of Appeal

IPR2018-00002, filed by Sandoz

• Filing date: October 2, 2017
• Status: Institution denied on May 3, 2018. Notice of Appeal filed on July 5, 2018.  On Oct. 18, 2018, the appeal was dismissed after the parties submit a stipulation of voluntary dismissal.
• Petition
• Patent Owner Preliminary Response
• Petitioner Reply
• Decision Denying Institution
• Notice of Appeal

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

IPR2017-01987, filed by Sandoz

• Filing date: August 21, 2017
• Status: Institution denied. Request for rehearing filed on April 6, 2018. Terminated after settlement.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution
• Request for Rehearing

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

IPR2017-01988, filed by Sandoz

• Filing date: August 21, 2017
• Status: Institution denied. Request for rehearing filed on April 6, 2018. Terminated after settlement on Nov. 2, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution
• Request for Rehearing

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

IPR2017-02105, filed by Sandoz

• Filing date: September 14, 2017
• Status: Instituted on April 3, 2018.  Terminated after settlement on Nov. 2, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response

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

• Filing date: September 14, 2017
• Status: Instituted on April 3, 2018.  Terminated after settlement on Nov. 2, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response

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

• Filing date: June 26, 2015
• Status: Institution denied on January 14, 2015.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

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

• Filing date: June 26, 2015
• Status: Institution denied on January 14, 2016.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

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

• Filing date: May 9, 2016
• Status: Institution denied. Petitioner’s Request for Rehearing denied on February 2, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution
• Request for Rehearing
• Rehearing Denial

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

• Filing date: November 6, 2017
• Status: Institution denied on June 5, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

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

• Filing date: September 17, 2019
• Status: Institution denied on March 19, 2020.  Request for rehearing filed on April 17, 2020; denied on Jan. 27, 2021.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution
• Request for Rehearing
• Decision Denying Request for Rehearing

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.

• Filing date: May 5, 2021
• Status:  Instituted on November 10, 2021.  Final written decision issued on November 9, 2022, finding claims 1 and 8-12 unpatentable.  Appeal (Fed. Circ. Case No. 23-1395) was voluntarily dismissed on July 9, 2024.
• Petition
• Preliminary Response
• Petitioner’s Reply
• Patent Owner’s Sur-reply
• Institution Decision
• Patent Owner’s Response
• Final Written Decision

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 (Fed. Circ. Case No. 23-1395) was voluntarily dismissed on July 9, 2024.
• 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 (Fed. Circ. Case No. 23-1395) was voluntarily dismissed on July 9, 2024.
• 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.

• Filing date: May 5, 2021
• Status:  Instituted on November 10, 2021.  Final written decision issued on November 9, 2022, finding claims 1, 3-11, 13, 14, 16-24, and 26 unpatentable.  Appeal (Fed. Circ. Case No. 23-1396) was voluntarily dismissed on July 9, 2024.
• Petition
• Petition
• Patent Owner’s Preliminary Response
• Petitioner’s Reply
• Institution Decision
• Patent Owner’s Response
• Final Written Decision

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 (Fed. Circ. Case No. 23-1396) was voluntarily dismissed on July 9, 2024.
• 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 (Fed. Circ. Case No. 23-1396) was voluntarily dismissed on July 9, 2024.
• 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.

• Filing date: September 7, 2021
• Status: Institution denied on March 15, 2022
• Petition
• Institution Decision

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 (Fed. Cir. Case No. 24-1564).
• Petition
• Institution Decision
• Final Written Decision

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

• Filing date: January 6, 2023
• Status:  Instituted on July 19, 2023.  Final Written Decision issued on June 14, 2024, finding claims 1, 3-11, 13, 14, 16-24, and 26 unpatentable.
• Petition
• Institution Decision
• Final Written Decision

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 (Fed. Cir. Case No. 24-1564).
• 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 (Fed. Cir. Case No. 24-1567).
• 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 (Fed. Cir. Case No. 24-1567).
• 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 (Fed. Cir. Case No. 24-1567).
• 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)

• Filing date: March 26, 2023
• Status: Instituted on October 23, 2023.  On July 30, 2024, the PTAB issued an adverse judgment, in view of patent owner’s disclaimer of claims 10-12, 17-19, 21, 25-18, and 33.
• Petition
• Institution Decision
• Adverse Judgment After Institution of Trial

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:  Instituted on Jan. 16, 2024, and joined with IPR2023-00739.  On July 30, 2024, the PTAB issued an adverse judgment, in view of patent owner’s disclaimer of claims 10-12, 17-19, 21, 25-18, and 33.
• Petition
• Institution Decision
• Adverse Judgment After Institution of Trial

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.

• Filing date: Sept. 9, 2022
• Status: Institution denied on March 10, 2023
• Petition
• Institution Decision

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

• Filing date: April 27, 2023
• Status: Instituted on Nov. 17, 2023.  On July 23, 2024, the PTAB entered an adverse judgment, in view of the patent owner’s disclaimer of claims 1-30.
• Petition
• Institution Decision
• Entry of Adverse Judgment

IPR 2024-00260, filed by Celltrion, Inc.

• Filing date: Dec. 14, 2023
• Status: Instituted on Jan. 30, 2024.  Joined with IPR2023-00884.  On July 23, 2024, the PTAB entered an adverse judgment, in view of the patent owner’s disclaimer of claims 1-30.
• Petition
• Institution Decision
• Entry of Adverse Judgment

IPR 2024-00298, filed by Biocon Biologics Inc.

• Filing date: Dec. 18, 2023
• Status: Instituted on Jan. 31, 2024.  Joined with IPR2023-00884.  On July 23, 2024, the PTAB entered an adverse judgment, in view of the patent owner’s disclaimer of claims 1-30.
• Petition
• Institution Decision
• Entry of Adverse Judgment

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.

• Filing date: January 7, 2021
• Status: Voluntarily terminated (before institution decision) on June 25, 2021
• Petition
• Order Granting Motion to Dismiss and Terminate Proceedings

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.

• Filing date: February 28, 2023
• Status: Institution denied on Sept. 1, 2023, in view of Regeneron’s statutory disclaimer of claims 1-4 of the ‘226 patent
• Petition
• Institution Decision

U.S. Patent 11,084,865
Patent Owner:  Regeneron Pharmaceuticals, Inc.
Title: VEGF antagonist formulations suitable for intravitreal administration

IPR 2025-00176, filed by Samsung Bioepis Co., Ltd. (challenging claims 1-12, 14-17, 19-20, 22-36, 39-42, 44-45, and 47-55)

• Filing date:  Nov. 20, 2024
• Status: Pending
• Petition

IPR 2025-00233, filed by Formycon AG (challenging claims 1-12, 14-17, 19-20, 22-36, 39-42, 44-45, and 47-55)

• Filing date:  Nov. 29, 2024
• Status: Pending
• Petition

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

IPR2016-01771, filed by Hospira

• Filing date: September 9, 2016
• Status: Final Written Decision finding all claims unpatentable. Notice of Appeal filed on May 10, 2018.  On July 31, 2019, the Federal Circuit affirmed pursuant to Fed. Cir. R. 36.
• Petition
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision
• Notice of Appeal

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

IPR2018-00373, filed by Pfizer

• Filing date: January 5, 2018
• Status: Institution denied on August 2, 2018.
• Petition
• Decision Denying Institution

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

IPR2017-01879, filed by Sanofi-Aventis

• Filing date: July 28, 2017
• Status: Final Written Decision finding claims 1-14, 16, and 17 unpatentable. Notice of Appeal filed on April 15, 2019.  On Oct. 13, 2020, the Federal Circuit issued an opinion affirming-in-part, and dismissing-in-part.
• Petition
• Patent Owner Preliminary Response
• Petitioner Reply
• Sur Reply in Support of Patent Owner Preliminary Response
• Decision on Institution 
• Final Written Decision
• Notice of Appeal

IPR2017-01129, filed by Sanofi Aventis

• Filing date: March 23, 2017
• Status: Institution denied on October 4, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

IPR2017-01884, filed by Sanofi Aventis

• Filing date: July 31, 2017
• Status: Final Written Decision finding claims 1-17 unpatentable.  Notice of Appeal filed on April 8, 2019.  On Oct. 13, 2020, the Federal Circuit issued an opinion affirming-in-part, and dismissing-in-part.
• Petition
• Patent Owner Preliminary Response
• Petitioner Reply
• Sur Reply in Support of Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Final Written Decision

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

• Filing date: February 28, 2019
• Status: Instituted on August 30, 2019.  Terminated following settlement on June 1, 2020.
• Petition
• Preliminary Response
• Petitioner Reply to Preliminary Response
• Decision on Institution 
• Patent Owner Response
• Petitioner Reply 

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

• Filing date: May 31, 2023
• Status: Instituted on Dec. 8, 2023.  Terminated on Sept. 4, 2024 in view of a settlement.
• Petition
• Institution Decision
• Termination Decision

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

• Filing date: February 28, 2019
• Status: Instituted on August 30, 2019.  Terminated following settlement on June 1, 2020.
• Petition
• Patent Owner Preliminary Response
• Petitioner Reply to Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply 

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

• Filing date: May 31, 2023
• Status: Instituted on Dec. 8, 2023.  Terminated on Sept. 4, 2024 in view of a settlement.
• Petition
• Institution Decision
• Termination Decision

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

• Filing date: February 28, 2019
• Status: Terminated following settlement on June 1, 2020.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution 
• Patent Owner Response 
• Petitioner Reply 

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

• Filing date: May 18, 2023 (challenging claim 1)
• Status: Instituted on Dec. 8, 2023.  Terminated on Sept. 4, 2024 in view of a settlement.
• Petition
• Institution Decision
• Termination Decision

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.

• Filing date: June 16, 2023
• Status: Instituted on Dec. 20, 2023.  Terminated on Sept. 4, 2024 in view of a settlement.
• Petition
• Institution Decision
• Termination Decision

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.

• Filing date: June 16, 2023
• Status: Instituted on Dec. 19, 2023.  Terminated on Sept. 4, 2024 in view of a settlement.
• Petition
• Institution Decision
• Termination Decision

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

IPR2017-01916, filed by Coherus

• Filing date: August 4, 2017
• Status: Institution denied on March 9, 2018. Petitioner’s request for rehearing denied on July 13, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution
• Request for Rehearing
• Request for Rehearing Denied

IPR2015-01792, filed by Coalition for Affordable Drugs

• Filing date: August 22, 2015
• Status: Institution denied on March 11, 2016.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

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

IPR2017-02066, filed by Coherus

• Filing date: September 7, 2017
• Status: Institution denied on March 9, 2018. Petitioner’s request for rehearing denied on July 13, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution
• Request for Rehearing
• Decision Denying Request for Rehearing

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

IPR2017-01526, filed by Mylan

• Filing date: June 5, 2017
• Status: Final Written Decision finding claims 1-25 unpatentable.  On Nov. 12, 2019, the Federal Circuit affirmed.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Patent Owner Sur-Reply
• Final Written Decision

U.S. Patent No. 7,713,930
Patent Owner: Sanofi
Title: Acidic insulin preparations having improved stability

IPR2017-01528, filed by Mylan

• Filing date: June 5, 2017
• Status: Final Written Decision finding claims 1-20 unpatentable.  On Nov. 12, 2019, the Federal Circuit affirmed.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Patent Owner Sur-Reply
• Final Written Decision

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

• Filing date: September 10, 2018
• Status: Final Written Decision issued on May 29, 2020, finding all challenged claims unpatentable.  Affirmed by the Federal Circuit on Dec. 29, 2021.
• Petition
• Patent Owner Preliminary Response 
• Petitioner Reply to Preliminary Response 
• Patent Owner Sur Reply 
• Decision on Institution
• Patent Owner Response 
• Petitioner Reply 
• Final Written Decision 

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

IPR2018-01670, filed by Mylan

• Filing date: September 10, 2018
• Status: Final Written Decision issued on April 2, 2020, finding sole challenged claim unpatentable.  Affirmed by the Federal Circuit on Dec. 29, 2021.
• Petition
• Patent Owner Preliminary Response
• Petitioner Reply to Preliminary Response 
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

IPR2019-00979, filed by Hospira, Pfizer

• Filing date: May 2, 2019
• Status: IPR Instituted on August 15, 2019.  Final Written Decision issued on August 11, 2020, finding claims 1-3 unpatentable.  Affirmed by the Federal Circuit on Dec. 29, 2021.
• Petition
• Decision on Institution
• Patent Owner Response
• Petitioner Reply 
• Patent Owner Sur Reply
• Final Written Decision

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

• Filing date: September 10, 2018
• Status: Final Written Decision issued on May 29, 2020, finding all challenged claims unpatentable.  Affirmed by the Federal Circuit on Dec. 29, 2021.
• Petition
• Decision on Institution
• Patent Owner Response 
• Petitioner Reply 
• Patent Owner Sur Reply
• Final Written Decision 

IPR2019-00122, filed by Mylan

• Filing date: October 29, 2018
• Status: Final Written Decision issued on May 29, 2020, finding all challenged claims 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 
• Patent Owner Response
• Petitioner Reply
• Final Written Decision 

IPR2018-01679, filed by Mylan

• Filing date: September 10, 2018
• Status: Final Written Decision issued on May 29, 2020, finding all challenged claims unpatentable.  Affirmed by the Federal Circuit on Dec. 29, 2021.
• Petition
• Decision on Institution 
• Patent Owner Response
• Petitioner Reply
• Final Written Decision 

IPR2019-00980, filed by Hospira, Pfizer

• Filing date: May 2, 2019
• Status: On August 15, 2019, IPR instituted; joined with IPR2018-01679 and terminated.
• Petition
• Decision on Institution

IPR2019-00981, filed by Hospira, Pfizer

• Filing date: May 2, 2019
• Status: On August 15, 2019, IPR instituted; joined with IPR2018-01679 and terminated.
• Petition
• Decision on Institution 

IPR2019-00982, filed by Hospira, Pfizer

• Filing date: May 2, 2019
• Status: On August 15, 2019, IPR instituted; joined with IPR 2019-00122 and terminated.
• Petition
• Decision on Institution

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

IPR2018-01680, filed by Mylan

• Filing date: September 10, 2018
• Status: Final Written Decision issued on May 29, 2020, finding all challenged claims unpatentable.  Affirmed by the Federal Circuit on Dec. 29, 2021.
• Petition
• Patent Owner Preliminary Response 
• Petitioner Reply to Preliminary Response 
• Decision on Institution
• Patent Owner Response 
• Petitioner Reply
• Final Written Decision 

IPR2018-01682, filed by Mylan

• Filing date: September 10, 2018
• Status: Final Written Decision issued on May 29, 2020, finding all challenged claims unpatentable.  Appeal decision mooted by Federal Circuit on Dec. 29, 2021.
• Petition
• Decision on Institution
• Final Written Decision 

IPR2018-01696, filed by Mylan

• Filing date: September 10, 2018
• Status: Institution denied.
• Petition
• Decision on Institution

IPR2019-01022, filed by Hospira, Pfizer

• Filing date: May 2, 2019
• Status: On Aug. 19, 2019, IPR instituted; joined with IPR 2018-01680 and terminated.
• Petition
• Decision on Institution 

IPR2019-01023, filed by Hospira, Pfizer

• Filing date: May 2, 2019
• Status: On Aug. 20, 2019, IPR instituted; joined with IPR 2018-01682 and terminated.
• Petition
• Decision on Institution 

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

IPR2018-01684, filed by Mylan

• Filing date: September 10, 2018
• Status: Final Written Decision issued on May 29, 2020, finding claims 1, 7, 8 and 17 unpatentable.  Appeal withdrawn on May 4, 2021.
• Petition
• Decision on Institution
• Final Written Decision 

IPR2019-00987, filed by Hospira, Pfizer

• Filing date: May 2, 2019
• Status: IPR Instituted on Aug. 15, 2019.  Joined with IPR 2018-01684.
• Petition
• Decision on Institution

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

• Filing date: April 18, 2016
• Status: Institution denied on October 17, 2016. Request for Rehearing denied on February 3, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

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

IPR2016-00915, filed by Swiss Pharma

• Filing date: April 18, 2016
• Status: Institution denied on October 17, 2016. Request for Rehearing denied on February 3, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

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

IPR2016-00916, filed by Swiss Pharma

• Filing date: April 18, 2016
• Status: Institution denied on October 17, 2016. Request for Rehearing denied on February 3, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

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.

• Filing date: July 29, 2022
• Status: Institution denied on February 2, 2023
• Petition
• Decision Denying Institution

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

IPR2016-01542, filed by Apotex

• Filing date: August 5, 2016
• Status: Final Written Decision issued on Feb. 15, 2019, upholding validity of claim 18 and finding claims 1–17 and 19–24 unpatentable.  Request for rehearing denied on May 20, 2019.  Federal Circuit vacated and remanded on March 24, 2020.  Joint Motion to Terminate Proceedings filed on July 14, 2020.  On Oct. 4, 2021, Patent Owner filed a Request for Director Review; denied on Nov. 22, 2021.  Final Written Decision reversed by the Federal Circuit on April 14, 2022.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision
• Request for Rehearing
• Additional Briefing
• Decision Denying Rehearing

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

• Filing date: October 1, 2018
• Status: Instituted on Apr. 19, 2019.  Terminated following settlement on December 6, 2019.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response

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

• Filing date: April 14, 2019
• Status: Institution denied on October 16, 2019.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

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

• Filing date: December 20, 2019
• Status: Terminated following settlement.
• Petition
• Patent Owner Preliminary Response

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.  Instituted on Sept. 23, 2024
• Petition
• Institution Decision

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.  Instituted on Sept. 23, 2024
• Petition
• Institution Decision

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.  Instituted on Sept. 23, 2024
• Petition
• Institution Decision

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.  Instituted on Sept. 23, 2024
• Petition
• Institution Decision

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.  Instituted on June 13, 2024.
• Petition
• Institution Decision

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.  Instituted on Sept. 27, 2024.
• Petition
• Institution Decision

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.  Instituted on Oct. 3, 2024.
• Petition
• Institution Decision

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.  Instituted on Sept. 27, 2024.
• Petition
• Institution Decision

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.  Instituted on Sept. 27, 2024.
• Petition
• Institution Decision

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

PGR2022-00037, filed by Sandoz Inc.

• Filing date: May 2, 2022
• Status: Institution denied on November 7, 2022
• Petition
• Patent Owner Preliminary Response
• Institution Decision
• Decision Denying Petitioner’s Request on Rehearing (Feb. 23, 2023)

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

IPR2016-01614, filed by Celltrion

• Filing date: August 15, 2016
• Status: Final written decision issued on Feb. 21, 2018, finding claims not unpatentable.  Appeal dismissed on Nov. 6, 2018.
• Petition
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

IPR2017-01115, filed by Pfizer

• Filing date: March 24, 2017
• Status: Final Written Decision issued on Feb. 21, 2018, finding claims 1–3, 5–7, and 9– 11 not unpatentable.  Appeal dismissed on Mar. 20, 2019.
• Petition
• Decision on Institution
• Final Written Decision

IPR2015-00415, filed by Boehringer Ingelheim

• Filing Date: December 15, 2014
• Status: Terminated after institution following request for adverse judgment by petitioner on October 1, 2015.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

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

• Filing date: August 24, 2016
• Status: Institution denied on March 2, 2017. Request for Rehearing denied on August 18, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

IPR2017-02042, filed by Sandoz

• Filing date: August 31, 2017
• Status: Institution denied on March 4, 2018.
• Petition
• Petitioner Reply to Patent Owner Preliminary Response
• Decision on Institution

IPR2017-02036, filed by Sandoz

• Filing date: August 31, 2017
• Status: Institution denied on March 4, 2018.
• Petition
• Patent Owner Preliminary Response
• Petitioner Reply to Patent Owner Preliminary Response
• Decision on Institution

IPR2017-01923, filed by Pfizer

• Filing date: August 29, 2017
• Status: Terminated following settlement on April 2, 2019.
• Petition
• Patent Owner Preliminary Response
• Petitioner Sur Reply to Patent Owner Preliminary Response
• Decision on Institution
• Decision Denying Rehearing

IPR2015-00417, filed by Boehringer Ingelheim

• Filing date: December 15, 2014
• Status: Terminated after institution following request for adverse judgment by petitioner on October 1, 2015.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

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

• Filing date: March 15, 2017
• Status: Institution denied on October 6, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

IPR2017-01166, filed by Pfizer

• Filing date: April 21, 2017
• Status: Institution denied on Nov. 13, 2017. Petitioner filed Request for Rehearing on Dec. 12, 2017. Pfizer withdrew its Request for Rehearing on January 16, 2019.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

IPR2015-00418, filed by Boehringer Ingelheim

• Filing date: December 15, 2014
• Status: Institution denied on July 13, 2015.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

IPR2018-00285, filed by Pfizer

• Filing date: Dec. 14, 2017
• Status: Instituted on July 9, 2018.  Terminated following settlement.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Sur Reply
• Patent Owner Response
• Petitioner Reply

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

• Filing date: April 27, 2017
• Status: Institution denied on Nov. 6, 2017. Request for rehearing denied on March 22, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Request for Rehearing
• Decision on Rehearing

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

• Filing date: March 15, 2017
• Status: Final Written Decision finding claims 1-6 unpatentable.  Appeal voluntarily dismissed on March 26, 2019.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Decision Denying Request for Rehearing
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

IPR2018-00186, filed by Pfizer

• Filing date: December 1, 2017
• Status: IPR instituted on June 14, 2018. Terminated on November 8, 2018.
• Petition
• Decision on Institution
• Motion to Terminate
• Termination Decision

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

• Filing date: March 31, 2017
• Status: Institution denied on October 23, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

IPR2017-01230, filed by Celltrion

• Filing date: March 31, 2017
• Status: Institution denied on October 12, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

IPR2017-02126, filed by Pfizer

• Filing date: October 6, 2017
• Status: Institution Denied on April 30, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

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

IPR2017-01229, filed by Celltrion

• Filing date: March 31, 2017
• Status: Institution denied on October 23, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

IPR2017-02127, filed by Pfizer

• Filing date: October 6, 2017
• Status: Institution denied on April 19, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution 

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

• Filing date: April 28, 2017
• Status: Final Written Decision finding claims 1-5 unpatentable.  Affirmed by Federal Circuit on Dec. 16, 2020 pursuant to Fed. Circuit Rule 36.
• Petition
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

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

IPR2018-00086, Petitioner: Pfizer

• Filing Date: November 2, 2017
• Status: Institution denied on May 31, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

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

• Filing date: December 1, 2017
• Status: Terminated on June 6, 2018 (before institution decision).
• Petition
• Patent Owner Preliminary Response
• Motion to Terminate
• Termination Decision

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

• Filing date: June 28, 2021
• Status: Instituted on January 6, 2022; terminated on October 12, 2022 due to settlement
• Petition
• Institution Decision
• Patent Owner’s Response
• Petitioner’s Reply
• Termination decision

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

• Filing date: June 28, 2021
• Status: Instituted on January 6, 2022; terminated on October 12, 2022 due to settlement
• Petition
• Institution Decision
• Patent Owner’s Response
• Petitioner’s Reply
• Termination decision

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)

• Filing date: August 18, 2021
• Status: Instituted on February 23, 2022; terminated on October 17, 2022 due to settlement
• Petition (claims 1-3 and 6-11)
• Institution Decision
• Patent Owner’s Response
• Termination decision

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

• Filing date: September 24, 2021; terminated on October 17, 2022 due to settlement
• Status: Instituted on March 3, 2022
• Petition (claims 4, 5, and 12)
• Institution Decision
• Termination decision

IPR 2022-00578, filed by Celltrion, Inc.

• Filing date: February 21, 2022
• Status: Instituted on August 31, 2022; Final Written Decision issued on August 29, 2023, finding claims 1-12 unpatentable.
• Petition
• Institution Decision
• Final Written Decision

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

• Filing date: August 18, 2021; terminated on October 17, 2022 due to settlement
• Status: Instituted on February 23, 2022
• Petition
• Institution Decision
• Termination decision

IPR 2022-00579, filed by Celltrion, Inc.

• Filing date: February 21, 2022
• Status: Instituted on August 31, 2022; Final Written Decision issued on August 29, 2023, finding claims 1-8 unpatentable.
• Petition
• Institution Decision
• Final Written Decision

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

• Filing date: November 24, 2021
• Status: Instituted on June 3, 2022.  Terminated on October 17, 2022 due to settlement
• Petition
• Institution Decision
• Termination decision

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

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

IPR2017-01121, filed by Celltrion

• Filing date: March 21, 2017
• Status: Final Written Decision finding claims 1-14 unpatentable.  Affirmed by the Federal Circuit on March 26, 2020.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Motion to Amend
• Petitioner Reply
• Final Written Decision

IPR2017-00731, filed by Pfizer

• Filing date: January 20, 2017
• Status: Final Written Decision finding claims 1-14 unpatentable.  Affirmed by the Federal Circuit on March 26, 2020.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution
• Decision Granting Rehearing and Instituting IPR
• Patent Owner Response
• Motion to Amend
• Petitioner Reply
• Final Written Decision

IPR2018-00016, filed by Pfizer

• Filing date: October 3, 2017
• Status: Institution denied on February 21, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

IPR2017-02063, filed by Pfizer

• Filing date: September 6, 2017
• Status: Final Written Decision issued on Feb. 22, 2018, finding claims 1–14 unpatentable.  Affirmed by the Federal Circuit on March 26, 2020.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Final Written Decision

IPR2018-00192, filed by Samsung Bioepis

• Filing date: November 30, 2017
• Status: Institution denied on June 18, 2018.
• Petition
• Decision Denying Institution

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

IPR2017-01122, filed by Celltrion

• Filing date: March 21, 2017
• Status: Final Written Decision issued on Oct. 3, 2018, finding claims 1–11 and 14–17 unpatentable.  Affirmed by the Federal Circuit on March 26, 2020.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Motion to Amend
• Petitioner Reply
• Final Written Decision

IPR2017-00737, filed by Pfizer

• Filing date: January 20, 2017
• Status: Final Written Decision issued on July 27, 2017, finding claims 1-17 unpatentable.   Affirmed by the Federal Circuit on March 26, 2020.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution 
• Patent Owner Response
• Motion to Amend
• Petitioner Reply
• Final Written Decision

IPR2017-00739, filed by Pfizer

• Filing date: January 20, 2017
• Status: Institution denied on July 27, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

IPR2017-01960, filed by Samsung Bioepis

• Filing Date:
• Status: Final Written Decision issued on Oct. 3, 2018, finding claims 1–17 unpatentable.  Affirmed by the Federal Circuit on March 26, 2020.
• Petition
• Decision on Institution
• Final Written Decision

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

IPR2017-01139, filed by Celltrion

• Filing date: March 24, 2017
• Status: Final Written Decision issued on Oct. 3, 2018, finding claims 1–3, 5, 7, 9–11, 13–15, and 17–33 not unpatentable.   Appeal voluntarily dismissed on Dec. 19, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

IPR2017-00804, filed by Pfizer

• Filing date: May 4, 2017
• Status: Final Written Decision issued on Oct. 3, 2018, finding claims 1–3, 5, 7, 9–11, and 17–33 not unpatentable.  No appeal.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

IPR2017-01958, filed by Samsung Bioepis

• Filing date: August 25, 2017
• Status: Final Written Decision issued on Oct. 3, 2018, finding claims 1–3, 5, 7, 9–11, and 17–33 not unpatentable.  Appeal voluntarily dismissed on Dec. 19, 2018.
• Petition
• Decision on Institution
• Final Written Decision

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

IPR2017-01140, filed by Celltrion

• Filing date: March 24, 2017
• Status: Final Written Decision issued on Oct. 3, 2018, finding claims 1–3, 5, 7, 9–11, 16–28, and 30–40 not unpatentable.  Appeal voluntarily dismissed on Dec. 20, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

IPR2017-00805, filed by Pfizer

• Filing date: January 30, 2017
• Status: Final Written Decision issued on Oct. 3, 2018, finding claims 1–3, 5, 7, 9–11, 16–28, and 30–40 not unpatentable.  Appeal voluntarily dismissed on July 1, 2019.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

IPR2017-01959, filed by Samsung Bioepis

• Filing date: August 25, 2017
• Status: Final Written Decision issued on Oct. 3, 2018, finding claims 1–3, 5, 7, 9–11, 16–28, and 30–40 not unpatentable.  No appeal.
• Petition
• Decision on Institution
• Final Written Decision

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

IPR2017-01726, filed by Pfizer

• Filing date: June 30, 2017
• Status: Institution denied on January 23, 2018.
• Petition
• Decision on Institution

IPR2017-01727, filed by Pfizer

• Filing date: June 30, 2017
• Status: Institution denied on January 23, 2018.
• Petition
• Decision on Institution 

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

• Filing date: August 29, 2017
• Status: Terminated following settlement.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution 
• Patent Owner Response

IPR2018-00330, filed by Pfizer

• Filing date: Dec. 18, 2017
• Status: Institution denied on July 9, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

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

IPR2017-02020, filed by Pfizer

• Filing date: August 29, 2017
• Status: Terminated following settlement.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response

IPR2018-00331, filed by Pfizer

• Filing date: Dec. 19, 2017
• Status: Institution denied on July 9, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision Denying Institution

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: Terminated on March 4, 2024 prior to institution decision, in view of a settlement agreement
• Petition

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

IPR2017-02139, filed by Samsung Bioepis

• Filing date: September 29, 2017
• Status: Final Written Decision issued on Nov. 29, 2018, finding claims 1, 2, 4, 30, 31, 33, 25, 29, 62–64, 66, 67, 69, 72, 78, 80, and 81 unpatentable.  No appeal.
• Petition
• Decision on Institution
• Final Written Decision

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

• Filing date: August 31, 2017
• Status: Instituted on March 29, 2018.  Terminated following settlement on July 31, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Request for Rehearing
• Decision Granting Rehearing
• Decision Denying Rehearing
• Termination Decision

IPR2017-02032, filed by Boehringer Ingelheim

• Filing date: August 31, 2017
• Status: Instituted on March 29, 2018.  Terminated on July 31, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Request for Rehearing
• Decision Denying Rehearing
• Termination Decision

IPR2017-01488, filed by Pfizer

• Filing date: May 25, 2017
• Status: Final Written Decision issued on Nov. 29, 2018, finding claims 1, 2, 4, 30, 31, 33, 25, 29, 62–64, 66, 67, 69, 72, 78, 80, and 81 unpatentable.  No appeal.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution 
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

IPR2017-01489, filed by Pfizer

• Filing date: May 25, 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
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

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

• Filing date: May 8, 2017
• Status: Final Written Decision issued on Nov. 29, 2018, finding claims 1, 2, 4, 25, 29, 30, 31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 unpatentable.  No appeal.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

IPR2016-01693, filed by Mylan

• Filing date: August 30, 2016
• Status: Terminated following settlement on March 3, 2017 (before institution decision).
• Petition
• Patent Owner Preliminary Response
• Termination Decision

IPR2016-01694, filed by Mylan

• Filing date: August 30, 2016
• Status: Terminated following settlement on March 3, 2017 (before institution decision).
• Petition
• Patent Owner Preliminary Response
• Termination Decision

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

IPR2016-01608, filed by bioeq

• Filing date: August 16, 2016
• Status: Institution denied on February 22, 2017.  Request for Rehearing denied on August 30, 2017.
• Petition
• Patent Owner Preliminary Response
• Petitioner Reply to Patent Owner Preliminary Response
• Decision Denying Institution

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

IPR2016-00258, filed by Green Cross Corp.

• Filing date: November 25, 2015
• Status: Final written decision issued on March 22, 2017, finding claims not unpatentable.  Appeal voluntarily dismissed on May 22, 2018.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Petitioner Reply
• Final Written Decision

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

• Filing date: April 6, 2017
• Status: Institution denied on October 23, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

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

• Filing date: April 6, 2017
• Status: Institution denied on October 23, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

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

IPR2017-01262, filed by Aragen Bioscience

• Filing date: April 11, 2017
• Status: Institution denied on October 23, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

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

IPR2017-01357, filed by Pfizer

• Filing date: May 19, 2017
• Status: Final Written Decision issued on Nov. 28, 2018, finding claims 1-8 and 13 not unpatentable.  Appeal dismissed on Apr. 27, 2020 for lack of standing.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

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

IPR2017-01358, filed by Pfizer

• Filing date: May 19, 2017
• Status: Final Written Decision issued on Nov. 28, 2018, finding claims 1-7, 12 and 13 not unpatentable.  Appeal dismissed on Apr. 27, 2020 for lack of standing.
• Petition
• Patent Owner Preliminary Response
• Institution Decision
• Patent Owner Response
• Petitioner Reply
• Final Written Decision

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

IPR2017-02029, filed by Boehringer Ingelheim

• Filing date: August 31, 2017
• Status: Terminated following settlement on November 7, 2018.
• Petition
• Decision on Institution
• Patent Owner Response
• Termination Order

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.

• Filing date: July 7, 2016
• Status: Institution denied on January 3, 2017.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Decision Denying Institution

IPR2016-00710, filed by Mylan

• Filing date: March 3, 2016
• Status: Terminated following settlement on May 10, 2017.
• Petition
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Termination Decision

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

• Filing date: October 11, 2016
• Status: Terminated following settlement on April 4, 2017.
• Petition
• Decision on Institution

IPR2016-00383, filed by Genyzme Corporation

• Filing date: 30, 2015
• Status: Institution denied on June 23, 2016.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution

IPR2015-01624, filed by Sanofi-Aventis

• Filing date: July 27, 2015
• Status: Terminated following settlement on September 2, 2016.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Patent Owner Response
• Termination decision

IPR2016-00460, filed by Genzyme Corporation

• Filing date: January 15, 2016
• Status: Terminated following settlement on September 2, 2016.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution
• Termination Decision

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

IPR2016-01837, filed by Pfizer

• Filing Date: September 16, 2016
• Status: Final written decision issued on Mar. 6, 2018, finding all claims unpatentable.  Affirmed by the Federal Circuit on Jan. 10, 2020.
• Petition
• Decision on Institution
• Patent Owner Response
• Petitioner Reply
• Final Written Decision
• Notice of Appeal

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

• Filing date: March 7, 2019
• Status: Terminated following settlement.
• Petition
• Patent Owner Preliminary Response
• Petitioner Reply to Preliminary Response
• Decision on Institution

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

• Filing date: March 7, 2019
• Status: Terminated following settlement.
• Petition
• Patent Owner Preliminary Response
• Petitioner Reply to Preliminary Response
• Decision on Institution 

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

• Filing date: June 8, 2019
• Status: Terminated following settlement.
• Petition
• Patent Owner Preliminary Response
• Decision on Institution 
• Patent Owner Response