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Item 1. Legal Proceedings

2024-05-09 compared with 2023-11-08 · 4 added, 98 removed, 1 unchanged (99% of the section changed)

Legal Proceedings.

Legal Proceedings Relating to Vadadustat

Opposition Proceedings Against Akebia

In September 2018, Dr.

Reddy’s Laboratories Limited filed an opposition to our issued Indian Patent No.

287720 in the Indian Patent Office.

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

3277270 in the European Patent Office.

An oral hearing is scheduled for February 6, 2024.

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.

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:

JP4845728, JP5474872 and JP5474741.

On September 26, 2019, the JPO conducted an invalidation trial for JP5474872 and JP4845728.

On November 11, 2019, the JPO conducted an invalidation trial for JP5474741.

On April 1, 2022, the JPO issued a final decision for JP4845728, which invalidated all claims except claims directed to the medical use to treat anemia that does not respond to erythropoiesis.

On May 18, 2022, the JPO issued a final decision for JP5474741 and JP5474872, which maintained the claims in amended form.

In May 2022, MTPC filed revocation lawsuits for the three patents in the Intellectual Property High Court requesting cancellation of the JPO’s decisions.

In July 2022, we filed a revocation lawsuit for JP4845728 in the Intellectual Property High Court requesting cancellation of the JPO’s decision.

In August 2022, we filed revocation lawsuits for JP5474741 and JP5474872 in the Intellectual Property High Court requesting cancellation of the JPO’s decisions.

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.

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.

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

1487472, or the ’472 EP Patent (UK) .

On February 28, 2020, the parties agreed to dismiss the ’472 EP Patent (UK) from the trial.

A trial was conducted in March 2020.

On April 20, 2020, the Patents Court of the UK issued a judgment in favor of Akebia, which invalidated all the claims at issue in each of the ’823 EP Patent (UK), the ’333 EP Patent (UK), the ’153 EP Patent (UK), the ’155 EP Patent (UK) and the ’301 EP Patent (UK).

The ’531 EP Patent (UK) was amended to a single claim to recite one specific compound;

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 8, 2021 - June

Akebia Therapeutics, Inc.

| Form 10-Q | Page 36

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

On August 24, 2021, the Court of Appeal issued a judgment, which reversed the Patents Court’s judgment on the invalidity of the ’823 EP Patent (UK) and maintained certain claims of the ’823 EP Patent (UK) and the ’301 EP Patent (UK) in amended form, and which affirmed the Patents Court’s judgment on the invalidity of the ’333 EP Patent (UK), the ’155 EP Patent (UK), and the ’153 EP Patent (UK).

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.

Legal Proceedings Relating to Auryxia

ANDA Litigation

In February 2023, Keryx Biopharmaceuticals, Inc., or Keryx , 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, Keryx 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 Delaware District Court arising from Zydus’ ANDA filing with the FDA.

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

Such settlement and license agreement, consistent with Keryx’s prior ANDA settlements, granted Zydus a license to market a generic version of Auryxia in the United States 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 Keryx, 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.

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 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.

On July 15, 2021, a purported former Keryx stockholder filed a putative class action in the Supreme Court of the State of New York against Akebia, a current officer of Akebia (John P.

Butler), a former officer of Akebia (Jason A.

Amello), former directors of Akebia (Muneer A.

Satter, Scott A.

Canute, Michael D.

Clayman, Maxine Gowen, Duane Nash, Ronald C.

Renaud, Jr., and Michael S.

Wyzga), a current director of Akebia (Cynthia Smith), a former director and officer of Keryx (Jodie P.

Morrison), a former officer of Keryx (Scott A.

Holmes) and former directors of Keryx (Michael Rogers, Kevin J.

Cameron, Steven C.

Gilman, Daniel P.

Regan, Mark J.

Enyedy, and Michael T.

Heffernan, some of whom are current members of our Board of Directors).

The action is captioned Loper v.

Akebia Therapeutics, Inc., et al., or the Loper Action .

The complaint in the Loper Action alleges that the registration statement filed in connection with the Merger contained allegedly false and misleading statements or failed to disclose certain allegedly material information in violation of Section 11, 12(a)(2), and 15 of the Securities Act of 1933, as amended.

It alleges, among other things, that Akebia failed to disclose heightened safety risks that allegedly threatened the prospects of the Phase 3 PRO2TECT clinical trial and the commercial viability of vadadustat.

The complaint in the Loper Action seeks damages including interest thereon, an award of plaintiffs’ and the class’s costs and expenses, including counsel fees and expert fees, and rescission, disgorgement, or such other equitable or injunctive relief that the Court deems appropriate.

On August 16, 2021, another purported former Keryx stockholder filed a putative class action making substantially similar allegations and asserting the same claims as the Loper Action, also in the Supreme Court of the State of New York against Akebia and many of the same individual defendants named in the Loper Action.

The action is captioned Panicho v.

Akebia Therapeutics, Inc., et al., or the Panicho Action .

On September 13, 2021, the parties in the Loper Action and Panicho Action entered into a joint stipulation and proposed order, which provided for the consolidation of the two actions under the caption In re Akebia Therapeutics, Inc.

Securities Litigation, or the Consolidated State Action .

On October 27, 2021, plaintiffs filed a consolidated complaint in the Consolidated State Action.

On January 10, 2022, defendants moved to dismiss the consolidated complaint in its entirety.

Briefing on defendants’ motion to dismiss was completed on April 22, 2022.

Oral argument was held on October 7, 2022, and the Court dismissed the complaint without prejudice on October 17, 2022, giving plaintiffs thirty days to amend their complaint.

On November 16, 2022, plaintiffs filed an amended consolidated complaint, asserting the same claims and seeking the same relief as the consolidated complaint.

On January 18, 2023, defendants moved to dismiss the amended consolidated complaint in its entirety.

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

Oral argument is currently scheduled to be held on January 12, 2024.

Akebia Therapeutics, Inc.

| Form 10-Q | Page 37

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.

There is no assurance, however, that we will be successful in the defense of this action, or any associated appeals, or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs of this action.

Moreover, we are unable to predict the outcome or reasonably estimate a range of possible losses at this time.

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.

From time to time, we may be involved in legal proceedings arising from the normal course of business activities.

Defending such proceedings is costly and can impose a significant burden on management and employees.

The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

We are not presently a party to any litigation the outcome of which, if determined adversely to us, would in our estimation, have a material adverse effect on our business, operating results, cash flows or financial condition.

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-Q

Item 1. Legal Proceedings