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Item 3. Legal Proceedings

2024-03-14 compared with 2023-03-10 · 51 added, 36 removed, 79 unchanged (52% of the section changed)

Legal Proceedings

Legal Proceedings Relating to Vadadustat

Opposition Proceedings Against Akebia

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287720 in the Indian Patent Office.

Akebia Therapeutics, Inc.

| Form 10-K | Page 106

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On July 26, 2022, Sandoz AG filed an opposition against our issued European Patent No.

3277270 in the European Patent Office.

3277270 in the European Patent Office, or the EPO .

During an oral proceeding held on February 6, 2024, the EPO's Opposition Division rejected the opposition and upheld the patent as granted.

Settled Opposition Proceedings Against Akebia

On February 13, 2023, FibroGen, Inc., or FibroGen, filed an opposition against our issued European Patent No.

3357911 in the European Patent Office.

Proceedings Filed by Akebia Against FibroGen, Inc.

We filed an opposition in the European Patent Office, or the EPO, against FibroGen’s European Patent No.

3357911, or the ’ 911 EP Patent , in the EPO.

On November 21, 2023, we and our collaboration partner in Japan, Mitsubishi Tanabe Pharma Corporation, or MTPC , entered into a Settlement and Cross License Agreement, or the Settlement Agreement , with FibroGen and its collaboration partner in Europe and Japan, Astellas Pharma Inc., or Astellas .

This Settlement Agreement resolves all patent disputes between Akebia, MTPC, FibroGen and Astellas in the EU, the contracting states to the European Patent Convention, the UK , and Japan with no cash payment.

On November 22, 2023, FibroGen withdrew the opposition against the ’911 EP Patent pursuant to the terms of the Settlement Agreement.

Settled Proceedings Filed by Akebia Against FibroGen

We filed an opposition in the EPO against FibroGen’s European Patent No.

1463823, or the ’823 EP Patent on December 5, 2013, and an oral proceeding took place March 8 and 9, 2016.

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On February 27, 2023, FibroGen withdrew its appeal, and the patent remains revoked.

On May 13, 2015, May 20, 2015 and July 6, 2015, we filed oppositions to FibroGen’s European Patent Nos.

2322155, or the ’155 EP Patent, 1633333, or the ’333 EP Patent, and 2322153, or the ’153 EP Patent in the EPO, respectively, requesting the patents be revoked in their entirety.

These method of use patents do not prevent persons from using the compound for other uses, including any previously known use of the compound.

In particular, these patents do not claim methods of using any of our product candidates for purposes of inhibiting HIF-PH for the treatment of anemia due to chronic kidney disease, or CKD.

While we do not believe these patents will prevent us from commercializing vadadustat for the treatment of anemia due to CKD, we filed these oppositions to provide us with maximum flexibility for developing vadadustat and our pipeline of investigational oral hypoxia-inducible factor prolyl hydroxylase, or HIF-PH, inhibitor compounds.

With regard to the opposition that we filed in Europe against the ’333 EP Patent, an oral proceeding took place on December 8 and 9, 2016.

Following the oral proceeding, the Opposition Division of the EPO ruled that the patent as granted did not meet the requirements for patentability under the European Patent Convention and, therefore, revoked the patent in its entirety.

On December 9, 2016, FibroGen filed a notice to appeal the decision to revoke the ’333 EP Patent.

The Board of Appeal held an oral proceeding on this appeal on February 24 and 25, 2022, during which proceeding the '333 EP Patent was maintained in restricted form.

The ‘333 EP patent was originally granted with four independent claims, one of which was found obvious on appeal.

The remaining claims are directed to:

treatment of anemia of chronic disease in subjects having a percent transferrin saturation of less than 20% (claim 1), treatment of anemia that is refractory to treatment with exogenously administered erythropoietin (claim 6), and treatment of iron deficiency (claim 15).

In oral proceedings held on May 29, 2017, regarding the ’155 EP Patent, the European Opposition Division ruled that the ’155 EP Patent as granted did not meet the requirements for patentability under the European Patent Convention and, therefore,

revoked the patent in its entirety.

FibroGen filed a notice to appeal the decision to revoke the ’155 EP Patent on May 29, 2017.

An oral proceeding for the appeal was held on February 22, 2022, during which proceeding the Board of Appeal maintained the revocation of the ‘155 EP Patent in its entirety.

In related oral proceedings held on May 31, 2017 and June 1, 2017 for the ’153 EP Patent, the Opposition Division of the EPO maintained the patent after FibroGen significantly narrowed the claims to an indication for which vadadustat is not intended to be developed.

We and Glaxo separately filed notices to appeal the decision to maintain the ’153 EP Patent on November 9, 2017.

Bayer filed a notice to appeal the decision on November 14, 2017.

Glaxo withdrew its appeal on March 2, 2020 and Bayer withdrew its appeal on June 30, 2021.

An oral proceeding for the appeal was held on February 21, 2022, during which proceeding the Board of Appeal revoked the ‘153 patent in its entirety.

On April 3, 2019, we filed oppositions to FibroGen’s European Patent Nos.

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On July 8, 2022, FibroGen filed notice to appeal the Opposition Division’s decision for the ’301 EP Patent, which it withdrew on August 17, 2022.

These two patents expired in December 2022, and we do not expect the Opposition Division’s decision on the two patents to have any effect on our commercialization of vadadustat in Europe.

In 2018, we and our collaboration partner in Japan, Mitsubishi Tanabe Pharma Corporation, or MTPC, jointly filed a Request for Trial before the JPO to challenge the validity of certain of FibroGen’s HIF-related patents in Japan:

On November 21, 2023, we withdrew our appeal to the Opposition Division’s decision for ’531 EP Patent pursuant to the terms of the Settlement Agreement.

In 2018, we and MTPC jointly filed a Request for Trial before the Japan Patent Office, or JPO to challenge the validity of certain of FibroGen’s HIF-related patents in Japan:

JP4845728, JP5474872 and JP5474741.

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In September 2022, FibroGen filed a revocation lawsuit for JP4845728 in the Intellectual Property High Court requesting cancellation of the JPO’s decision on the claims that were invalidated.

We do not believe the JPO’s decisions will prevent our collaboration partner MTPC from continuing to commercialize vadadustat for the treatment of anemia due to CKD in Japan.

In November 2023, Akebia, MTPC, and FibroGen filed with the Japan Intellectual High Court written consent to withdraw the revocation lawsuits related to JP4845728, JP5474872 and JP5474741 pursuant to the terms of the Settlement Agreement.

United Kingdom

On December 13, 2018, we filed Particulars of Claim in the Patents Court of the United Kingdom to challenge the validity of FibroGen’s six HIF-related patents in the UK:

the ’823 EP Patent (UK), the ’333 EP Patent (UK), the ’153 EP Patent (UK), the ’155 EP Patent (UK), European Patent (UK) No.

the ’823 EP Patent (UK), European Patent (UK) No.

1633333, or the ’333 EP Patent (UK) , European Patent (UK) No.

2322153, or the ’153 EP Patent (UK), European Patent (UK) No.

2322155, or the ’155 EP Patent (UK) , European Patent (UK) No.

2,289,531, or the ’531 EP Patent (UK) , and European Patent (UK) No.

2,298,301, or the ’301 EP Patent (UK) .

In May 2019, Astellas Pharma Inc., or Astellas, the exclusive licensee of FibroGen’s HIF-related patents, sued Akebia for patent infringement in the Patents Court of the UK.

In May 2019, Astellas, the exclusive licensee of FibroGen’s HIF-related patents, sued Akebia for patent infringement in the Patents Court of the UK.

In September 2019, we filed an Amended Particulars of Claim to include FibroGen’s European Patent No.

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this claim was held to be valid but not infringed by vadadustat.

On June 11, 2020, FibroGen and Astellas appealed the Patents Court’s judgment on the invalidity of the ’823 EP Patent (UK), the ’301 EP Patent (UK), the ’333 EP Patent (UK), the ’153 EP Patent (UK), and the ’155 EP Patent (UK) in the Court of Appeal (Civil Division).

On June 11, 2020, FibroGen and Astellas appealed the Patents Court’s judgment on the invalidity of the ’823 EP Patent (UK), the ’301 EP Patent (UK), the ’333 EP

Akebia Therapeutics, Inc.

| Form 10-K | Page 107

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Patent (UK), the ’153 EP Patent (UK), and the ’155 EP Patent (UK) in the Court of Appeal (Civil Division).

On June 8, 2021 - June 10, 2021, the United Kingdom Court of Appeal held a three-day hearing for the appeal.

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Akebia sought permission to appeal to the UK Supreme Court, which was granted on October 3, 2022.

Hearing for the appeal is scheduled for March 5-7, 2024.

We do not expect the UK Court of Appeal’s judgment to have any effect on our commercialization of vadadustat in the UK because the patents expired in December 2022.

On November 28, 2023, we filed an application for withdrawal of the Appeal at the UK Supreme Court pursuant to the terms of the Settlement Agreement.

On December 15, 2023, the UK Supreme Court ordered that the Appeal be withdrawn.

Legal Proceedings Relating to Auryxia

Stockholder Litigation Relating to the Merger

On June 28, 2018, we entered into an Agreement and Plan of Merger with Keryx and Alpha Therapeutics Merger Sub, Inc., or the Merger Sub, pursuant to which the Merger Sub would merge with and into Keryx, with Keryx becoming a wholly owned subsidiary of ours, or the Merger.

On June 28, 2018, we entered into an Agreement and Plan of Merger with Keryx and Alpha Therapeutics Merger Sub, Inc., or the Merger Sub, pursuant to which the Merger Sub merged with and into Keryx, with Keryx becoming a wholly owned subsidiary of ours, or the Merger.

On December 12, 2018, we completed the Merger.

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On January 18, 2023, defendants moved to dismiss the amended consolidated complaint in its entirety, and the plaintiffs filed their opposition on March 6, 2023.

Briefing on defendants’ motion to dismiss is scheduled to be completed by April 5, 2023.

Briefing on defendants’ motion to dismiss the amended consolidated complaint was completed on April 5, 2023.

Oral argument was held on March 13, 2024.

At the conclusion of the hearing, the Court granted our motion to dismiss.

We deny any allegations of wrongdoing and intend to continue vigorously defending against the one active stockholder lawsuit described in this Legal Proceedings section, the Consolidated State Action.

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A resolution of the Consolidated State Action in a manner adverse to us, however, could have a material effect on our financial position and results of operations in the period in which the action is resolved.

Settled ANDA Litigation

In February 2023, we received a Paragraph IV certification notice letter regarding an Abbreviated New Drug Application, or ANDA, submitted to the U.S.

Food and Drug Administration, or FDA, by Zydus Worldwide DMCC requesting approval for a generic version of Auryxia tablets (210 mg ferric iron per tablet).

On March 24, 2023, we and Panion & BF Biotech, Inc., or Panion, filed a complaint for patent infringement against Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc., and Zydus Lifesciences Limited, or collectively Zydus, in the United States District Court for the District of Delaware arising from

Akebia Therapeutics, Inc.

| Form 10-K | Page 108

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Zydus’ ANDA filing with the FDA.

On May 30, 2023, we and Panion entered into a settlement and license agreement with Zydus, which resolved the patent litigation brought by we and Panion.

Such settlement and license agreement, consistent with our prior ANDA settlements, granted Zydus a license to market a generic version of Auryxia in the U.S.

beginning on March 20, 2025 (subject to FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature.

Additionally, in accordance with the settlement and license agreement, the parties terminated all ongoing litigation among us, Panion and Zydus regarding Auryxia patents pending in the Delaware District Court.

The settlement and license agreement is confidential and subject to review by the U.S.

Federal Trade Commission and the U.S.

Department of Justice.

On June 5, 2023, the Delaware District Court entered a stipulation and order of dismissal filed by the parties to terminate the action against Zydus.

Mine Safety Disclosures

Not applicable.

Akebia Therapeutics, Inc.

| Form 10-K | Page 109

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 3. Legal Proceedings