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Item 1. Legal Proceedings

2023-05-08 compared with 2022-11-03 · 11 added, 97 removed, 75 unchanged (59% of the section changed)

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3277270 in the European Patent Office.

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, Inc.’s, or 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.

Following the oral proceeding, the Opposition Division of 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.

FibroGen has appealed that decision.

Oral hearing for the appeal is scheduled for February 28 – March 1, 2023.

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.

2289531, or the ’531 EP Patent, and 2298301, or the ’301 EP Patent in the EPO, respectively, requesting the patents be revoked in their entirety.

Oral proceedings for oppositions to the two patents were held on September 7-8 and 10, 2021.

Following oral proceedings, the Opposition Division of the EPO maintained certain claims in amended form in the two patents.

On January 26, 2022, we filed notice to appeal the Opposition Division’s decision for ’531 EP Patent.

On July 8, 2022, FibroGen filed notice to appeal the Opposition Division’s

decision for the ’301 EP Patent.

These two patents will expire 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.

On June 2, 2014, we filed an invalidity proceeding before the Japan Patent Office, or JPO, against certain claims of FibroGen’s Japanese Patent No.

4804131, or the ’131 JP Patent, which is the Japanese counterpart to the ’823 EP Patent, and the JPO issued a preliminary decision finding all of the challenged claims to be invalid.

FibroGen subsequently amended the claims and the JPO accepted the amendments.

The resulting ’131 JP Patent does not cover vadadustat or any pyridine carboxamide compounds.

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:

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

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

United States

On March 29, 2021, we filed a lawsuit against FibroGen and AstraZeneca AB in the United States District Court for the District of Delaware to seek a declaratory judgment of non-infringement and invalidity of FibroGen’s twelve HIF-related patents in the United States:

8,318,703, 8,466,172, 8,614,204, 9,920,011, 8,629,131, 8,604,012, 8,609,646, 8,604,013, 10,626,090, 10,894,774, 10,882,827, and 10,927,081.

On April 5, 2022, we voluntarily dismissed, without prejudice, our declaratory judgment complaint against FibroGen and AstraZeneca under Rule 41(a)(1)(A)(i) of the Federal Rules of Civil Procedure.

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 2018 and 2019, Keryx Biopharmaceuticals, Inc., or Keryx, received Paragraph IV certification notice letters regarding Abbreviated New Drug Applications, or ANDAs, submitted to the U.S.

Food and Drug Administration, or FDA, by third parties requesting approval for generic versions of Auryxia tablets (210 mg ferric iron per tablet).

In response to such ANDA filings, Keryx and its licensors, Panion & BF Biotech, Inc., or Panion, and, as applicable, Chen Hsing Hsu, M.D., filed complaints for patent infringement against such third parties.

Keryx, Panion and, as applicable, Dr.

Hsu have now entered into settlement and license agreements resolving all patent litigation proceedings brought by Keryx, Panion and, as applicable, Dr.

Hsu, in response to ANDAs filed by third parties seeking approval to market generic versions of Auryxia ® (ferric citrate) tablets prior to the expiration of the applicable patents.

Each settlement agreement granted the defendants 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.

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, or Zydus, 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, Zydus Pharmaceuticals (USA) Inc., and Zydus Lifesciences Limited in the Delaware District Court arising from Zydus’ ANDA filing with the FDA.

Stockholder Litigation Relating to the Merger

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On December 12, 2018, we completed the Merger.

In October and November 2018, four purported shareholders of Keryx filed four separate putative class actions, or the Merger Securities Actions, against Keryx, a former officer and director of Keryx (Jodie P.

Morrison), former directors of Keryx (Kevin J.

Cameron, Mark J.

Enyedy, Steven C.

Gilman, Michael T.

Heffernan, Daniel P.

Regan and Michael Rogers, some of whom are current members of our Board of Directors), and, with respect to the Rosenblatt action discussed below, the Merger Sub and Akebia, challenging the disclosures made in connection with the Merger.

Three of the Merger Securities Actions were filed in the Delaware District Court:

Keryx Biopharmaceuticals, Inc., et al.

(filed October 16, 2018);

Keryx Biopharmaceuticals, Inc., et al.

(filed October 24, 2018);

and Andreula v.

Keryx Biopharmaceuticals, Inc., et al.

(filed November 1, 2018).

The fourth Merger Securities Action was filed in the Massachusetts District Court:

Rosenblatt v.

Keryx Biopharmaceuticals, Inc., et al.

(filed October 23, 2018).

On February 19, 2019, the plaintiff in the Rosenblatt action filed a notice of voluntary dismissal of the action without prejudice.

On March 27, 2019, the plaintiff in the Van Hulst action filed a notice of voluntary dismissal of the action without prejudice.

On April 2, 2019, the Delaware District Court granted Abraham Kiswani, a member of the putative class in both the Andreula and Corwin actions, and plaintiff John Andreula’s motion to consolidate the remaining two Merger Securities Actions pending in the Delaware District Court and consolidated the Corwin and Andreula cases under the caption In re Keryx Biopharmaceuticals, Inc., or the Consolidated Federal Action.

The Delaware District Court also appointed Kiswani and plaintiff Andreula as lead plaintiffs for the Consolidated Federal Action.

On June 3, 2019, the lead plaintiffs filed a consolidated amended complaint in the Consolidated Federal Action, or the Consolidated Complaint.

The Consolidated Complaint generally alleged 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 14(a) and 20(a) of the Exchange Act and Rule 14a-9 promulgated thereunder.

The alleged misstatements or omissions related to (i) certain financial projections for Keryx and Akebia and certain financial analyses performed by our advisors and (ii) any alleged negotiations that may have taken place regarding the conversion of certain convertible notes of Keryx in connection with the Merger.

The Consolidated Complaint sought compensatory and/or rescissory damages, a declaration that the defendants violated Sections 14(a) and 20(a) of the Exchange Act and Rule 14a-9 thereunder, and an award of lead plaintiffs’ costs, including reasonable allowance for attorneys’ fees and experts’ fees.

The defendants in the Consolidated Federal Action moved to dismiss the Consolidated Complaint in its entirety and with prejudice on August 2, 2019.

On April 15, 2020, the Delaware District Court granted the defendants’ motion and dismissed the Consolidated Complaint in its entirety.

On July 2, 2020, lead plaintiffs filed a second consolidated amended complaint, or the Second Consolidated Complaint.

The Second Consolidated Complaint (i) asserted the same claims under the Exchange Act as the Consolidated Complaint, (ii) named the same defendants as the Consolidated Complaint, (iii) sought the same relief as the Consolidated Complaint and (iv) as with the Consolidated Complaint, challenged as false or misleading alleged misstatements or omissions related to certain financial projections for Keryx and Akebia and certain financial analyses performed by our advisors.

The defendants in the Consolidated Federal Action moved to dismiss the Second Consolidated Complaint in its entirety with prejudice on August 10, 2020.

Briefing on defendants’ motion to dismiss was completed on September 28, 2020, and on April 1, 2021, the District Court granted Defendants’ motion in its entirety and dismissed the Second Consolidated Complaint with prejudice.

The lead plaintiffs appealed, and briefing on the appeal was completed on October 7, 2021.

The Third Circuit submitted the case on the briefs without oral argument on February 10, 2022.

On July 21, 2022, the Third Circuit affirmed the District Court’s order of dismissal.

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.

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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.

The Court further ordered that, in the event plaintiffs do not file an amended complaint within thirty days of the dismissal, the dismissal shall be deemed to be with prejudice.

On March 14, 2022, a purported stockholder of Akebia filed a putative federal securities class action against Akebia as well as three present and former officers of Akebia in the U.S.

District Court for the Eastern District of New York.

The action was captioned Deputy v.

Akebia Therapeutics, Inc., et al., No.

1:22-cv-01411, or the EDNY Action.

The complaint in the EDNY Action alleged that defendants made materially false and misleading statements in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.

The alleged misstatements or omissions related to 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 EDNY Action sought damages including interest thereon, an award of plaintiffs’ and the class’s costs and expenses, including counsel fees and expert fees, or such other and further relief that the Court deems appropriate.

Plaintiffs Abraham Kiswani and Joseph Gorski were appointed co-lead plaintiffs on June 28, 2022, and on July 22, 2022, a stipulated scheduling order was entered allowing co-lead plaintiffs to file an amended complaint on or before August 29, 2022.

On August 29, 2022, co-lead plaintiffs filed a stipulation of voluntary dismissal, and the Court entered an order dismissing the co-lead plaintiffs from the action on August 30, 2022.

The original named plaintiff filed a stipulation of voluntary dismissal on September 7, 2022, and the court formally terminated the case on September 8, 2022.

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 June 21, 2023.

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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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