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Item 3. Legal Proceedings

2022-03-01 compared with 2021-02-25 · 129 added, 81 removed, 163 unchanged (56% of the section changed)

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Legal Proceedings Relating to Vadadustat

Opposition Proceedings Against Patents Covering Vadadustat

Opposition Proceedings Against Akebia

In July 2011, a third party filed an opposition to our issued European Patent No.

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287720 in the Indian Patent Office.

Opposition and Invalidity Proceedings Against FibroGen, Inc.

Proceedings Filed by Akebia Against FibroGen, Inc.

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

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FibroGen has appealed that decision.

Likewise, we also filed an invalidity proceeding before the Japan Patent Office, or JPO, on June 2, 2014 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.

To date, the U.S.

Patent and Trademark Office has not issued FibroGen a patent covering the same claim scope as it obtained initially in Europe and Japan in the ’823 EP Patent and ’131 JP Patent.

In the event FibroGen were to obtain such a patent in the United States, we may decide to challenge the patent as we have done in Europe and Japan.

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 related patents claim, among other things, various compounds that either stabilize HIFα or inhibit a HIF hydroxylase or a HIF prolyl hydroxylase, or HIF-PH, for treating or preventing various conditions, including, among other things, iron deficiency, microcytosis associated with iron deficiency, anemia of chronic disease, anemia wherein the subject has a transferrin saturation of less than 20%, anemia refractory to treatment with exogenously administered erythropoietin and microcytosis in microcytic anemia.

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

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 and our collaborators with maximum flexibility for developing vadadustat and our pipeline of investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, or HIF-PHI, compounds.

Oppositions to the ’155 EP Patent and the ’153 EP Patent were also filed in the EPO by Glaxo Group Limited, or Glaxo, and by Bayer Intellectual Property GmbH, Bayer Pharma Aktiengesellschaft, and Bayer Animal Health GmbH, or, collectively, Bayer.

Glaxo withdrew its oppositions on March 2, 2020.

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

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.

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

An oral proceeding for the appeal is scheduled for February 2022.

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 is scheduled for February 2022.

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.

Subsequently, 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.

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

An oral proceeding for the appeal is scheduled for February 2022.

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 are scheduled for September 2021.

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.

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 February 10, 2020, we filed an opposition to FibroGen’s European Patent No.

2324834 in the EPO requesting the patent to be revoked in its entirety.

2324834, or the ’834 EP Patent, in the EPO requesting the patent to be revoked in its entirety.

On October 19, 2021, FibroGen submitted a request to the Opposition Division to terminate these opposition proceedings and revoke the '834 patent.

On May 21, 2018, we filed a Statement of Claim in Canadian Federal Court to challenge the validity of three of FibroGen’s HIF-related patents in Canada:

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On February 16, 2021, the parties agreed to dismiss the lawsuit in its entirety.

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.

On June 22, 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 one of FibroGen’s HIF-related patents in Japan, JP4845728.

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On April 2, 2020, the JPO issued a pre-notice of a trial decision for JP5474741, which invalidated all claims except two claims in amended form.

We do not believe these decisions will prevent our collaboration partner MTPC from launching vadadustat for the treatment of anemia due to CKD in Japan.

We expect the JPO to issue a final decision this year.

We do not believe these decisions will prevent our collaboration partner MTPC from commercializing vadadustat for the treatment of anemia due to CKD in Japan.

United Kingdom

On December 13, 2018, we and our collaboration partner, Otsuka Pharmaceutical Co.

Ltd., or Otsuka, filed Particulars of Claim in the Patents Court of the United Kingdom, or the UK, to challenge the validity of FibroGen’s six HIF-related patents in the UK:

Ltd., or Otsuka, 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.

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

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

In September 2019, we and Otsuka filed an Amended Particulars of Claim to

include FibroGen’s European Patent No.

1487472, or the ’472 EP Patent (UK).

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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 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 and Otsuka are seeking permission to appeal to the UK Supreme Court.

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 and our collaboration partner Otsuka America Pharmaceutical, Inc.

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.

The defendants filed a motion to dismiss the lawsuit on June 4, 2021.

We and Otsuka filed an opposition to the defendants’ motion on July 2, 2021, and the defendants filed a reply brief on July 16, 2021.

We are awaiting the Court's decision on the Defendant's motion to dismiss.

Legal Proceedings Relating to Auryxia

ANDA Litigation

On October 31, 2018, November 6, 2018, December 24, 2018 and February 4, 2019, 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 Lupin Atlantis Holdings SA, or Lupin, Teva Pharmaceuticals USA, Inc., or Teva, Chemo Research S.L., or Chemo, and Mylan Pharmaceuticals Inc., or Mylan, respectively, requesting approval for generic versions of Auryxia tablets (210 mg iron per tablet).

On October 31, 2018, November 6, 2018, December 24, 2018 and February 4, 2019, Keryx Biopharmaceuticals, Inc., or Keryx, received Paragraph IV certification notice letters regarding Abbreviated New Drug Applications, or ANDAs, submitted to the U.S.

On December 13, 2018, Keryx and its licensors, Panion & BF Biotech, Inc., or Panion, and Chen Hsing Hsu, M.D., filed a complaint for patent infringement against Lupin and Lupin Ltd., or the Lupin Defendants, in the United States District Court for the District of Delaware, or the Delaware District Court, arising from Lupin’s ANDA filing with the FDA.

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Hsu filed a motion with the Judicial Panel on Multidistrict Litigation seeking to consolidate these four cases in the Delaware District Court for pretrial proceedings.

On March 29, 2019, April 2, 2019, and April 12, 2019, Keryx received Paragraph IV certification notice letters regarding ANDAs submitted to the FDA by Lupin Ltd., Watson Laboratories, Inc., or Watson, a wholly-owned, indirect subsidiary of Teva, and Par Pharmaceutical, Inc., or Par, an Endo International company, or Endo, respectively, requesting approval for generic versions of Auryxia tablets (210 mg iron per tablet).

On May 10, 2019, Keryx, Panion and Dr.

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On June 4, 2019, Keryx and Panion filed a notice of voluntary dismissal to dismiss the suit in the Nevada District Court in view of the Watson Defendants’ consent to venue of the Delaware District Court.

On June 26, 2019, Keryx, Panion and Dr.

On June 26, 2019,

Keryx, Panion and Dr.

Hsu notified the Judicial Panel on Multidistrict Litigation of additional actions in the Delaware District Court against the Lupin Defendants and the Watson Defendants.

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On September 19, 2019, the Delaware District Court set a trial date for February 8, 2021.

The trial has been rescheduled for June 28, 2021.

The trial was rescheduled for June 28, 2021.

On January 13, 2021, the Delaware District Court vacated the deadlines for the case involving Mylan pending resolution of a discovery dispute.

this order had no effect on the action against the Chemo Defendants.

On February 2, 2021, the Delaware District court stayed the case involving the Chemo Defendants until March 4, 2021;

this order had no effect on the action against Mylan.

On July 22, 2019, Keryx received from Teva a supplemental Paragraph IV certification notice letter regarding its ANDA.

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This settlement resolved patent litigation brought by Keryx and Panion in response to Par’s ANDA seeking approval to market a generic version of Auryxia tablets prior to the expiration of the applicable patents.

Pursuant to the terms of the settlement, Keryx and Panion will grant Par 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 agreement, the parties will terminate all ongoing litigation between Keryx and Panion and Par regarding Auryxia patents pending in the Delaware District Court and the Southern New York District Court.

Pursuant to the terms of the settlement, Keryx and Panion granted Par 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 agreement, the parties terminated all ongoing litigation between Keryx and Panion and Par regarding Auryxia patents pending in the Delaware District Court and the Southern New York District Court.

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

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Department of Justice.

On August 5, 2019, the parties filed a request to stay the litigation pending a review of the settlement and license agreement by these

regulatory authorities.

On August 5, 2019, the parties filed a request to stay the litigation pending a review of the settlement and license agreement by these regulatory authorities.

On September 6, 2019 and September 9, 2019, the Southern New York District Court and the Delaware District Court, respectively, entered a stipulation and order of dismissal filed by the parties to terminate the actions against Par.

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This settlement resolved patent litigation brought by Keryx and Panion in response to Teva and Watson’s ANDAs seeking approval to market a generic version of Auryxia tablets prior to the expiration of the applicable patents.

Pursuant to the terms of the settlement, Keryx and Panion will grant Teva and Watson 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.

Pursuant to the terms of the settlement, Keryx and Panion granted Teva and Watson 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 agreement, the parties terminated all ongoing litigation between Keryx and Panion and Watson and Teva regarding Auryxia patents pending in the Delaware District Court.

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This settlement resolved patent litigation brought by Keryx and Panion in response to Lupin and Lupin Ltd.’s ANDAs seeking approval to market a generic version of Auryxia tablets prior to the expiration of the applicable patents.

Pursuant to the terms of the settlement, Keryx and Panion will grant Lupin and Lupin Ltd.

Pursuant to the terms of the settlement, Keryx and Panion granted Lupin and Lupin Ltd.

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.

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On October 5, 2020, the Delaware District Court entered a stipulation and order of dismissal filed by the parties to terminate the action against the Lupin Defendants.

As a result of the timely filing of these lawsuits against the Chemo Defendants and Mylan in accordance with the relevant statute, a 30-month stay of approval was imposed by the FDA on Chemo’s ANDA and Mylan’s ANDA, absent an earlier judgment by the court in each of these lawsuits finding the patents at issue invalid, unenforceable or not infringed.

We and the other plaintiffs in each of these lawsuits are seeking, among other relief, an order that the effective date of FDA approval of the ANDA be a date no earlier than the expiration of each of the patents at issue and equitable relief enjoining the Chemo Defendants and Mylan from infringing these patents.

On January 13, 2021, the Delaware District court vacated the deadlines for the case involving Mylan pending resolution of a discovery dispute;

this order had no effect on the action against the Chemo Defendants.

On February 2, 2021, the Delaware District court stayed the case involving the Chemo Defendants until March 4, 2021;

this order had no effect on the action against Mylan.

On March 25, 2021, Keryx and Panion entered into a settlement and license agreement with the Chemo Defendants.

This settlement resolved patent litigation brought by Keryx and Panion in response to Chemo’s ANDA seeking approval to market a generic version of Auryxia tablets prior to the expiration of the applicable patents.

Pursuant to the terms of the settlement, Keryx and Panion granted Chemo 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 agreement, the parties terminated all ongoing litigation among Keryx, Panion, and the Chemo Defendants 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.

2021, the Delaware District Court entered a stipulation and order of dismissal filed by the parties to terminate the action against the Chemo Defendants.

On September 22, 2021, Keryx, Panion and Dr.

Hsu entered into a settlement and license agreement with Mylan.

This settlement resolved patent litigation brought by Keryx, Panion, and Dr.

Hsu in response to Mylan’s ANDA seeking approval to market a generic version of Auryxia tablets prior to the expiration of the applicable patents.

Pursuant to the terms of the settlement, Keryx, Panion, and Dr.

Hsu granted Mylan 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 agreement, the parties terminated all ongoing litigation among Keryx, Panion, Dr.

Hsu, and Mylan regarding Auryxia patents pending in the Delaware District Court and the North District Court of West Virginia.

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 September 28, 2021, the Delaware District Court entered a stipulation and order of dismissal filed by the parties to terminate the action against Mylan.

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.

CMS Litigation

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Azar II in his official capacity as Secretary of Health and Human Services, and Seema Verma in her official capacity as administrator for CMS challenging CMS’s decision that Auryxia would no longer be covered by Medicare for the treatment of iron deficiency anemia, or IDA, in adult patients with CKD not on dialysis, or the IDA Indication, and imposing a prior authorization requirement for Auryxia in the treatment of adult patients with CKD on dialysis, or the Hyperphosphatemia Indication.

On October 29, 2019, we filed a motion for a preliminary injunction asking the court to provide relief while the lawsuit is pending, specifically, to restore coverage of Auryxia for the IDA Indication, and to remove the prior authorization requirement for Auryxia for the Hyperphosphatemia Indication.

In the alternative, we filed a motion for summary judgment with the court asking it to decide the case on the merits.

On February 4, 2020, the court denied our request for a preliminary injunction.

We filed an expedited appeal with the Court of Appeals for the First Circuit challenging the district court’s denial of our motion for a preliminary injunction.

The First Circuit Court of Appeals held oral argument on August 14, 2020, and affirmed the district court’s denial of our request for a preliminary injunction on September 30, 2020.

The case is now before the district court .

On October 29, 2019, we filed a motion for a preliminary injunction asking the Massachusetts District Court to provide relief while the lawsuit was pending, specifically, to restore coverage of Auryxia for the IDA Indication, and to remove the prior authorization requirement for Auryxia for the Hyperphosphatemia Indication.

In the alternative, we filed a motion for summary judgment with the Massachusetts District Court asking it to decide the case on the merits.

On February 4, 2020, the Massachusetts District Court denied our request for a preliminary injunction.

We filed an expedited appeal with the Court of Appeals for the First Circuit challenging the Massachusetts District Court's denial of our motion for a preliminary injunction.

The First Circuit Court of Appeals held oral argument on August 14, 2020, and affirmed the Massachusetts District Court's denial of our request for a preliminary injunction on September 30, 2020.

We then attempted to reach a settlement with CMS, but we were unsuccessful in these efforts.

On October 22, 2021, the parties agreed to dismiss the litigation.

As a result, Auryxia remains not covered by Medicare for the IDA Indication and the prior authorization requirement for Auryxia for the Hyperphosphatemia Indication also remains in place.

Shareholder Litigation Relating to Auryxia Supply

Four putative class action lawsuits were filed against Keryx Biopharmaceuticals, Inc., or Keryx, and certain of its former officers (Gregory P.

Four putative class action lawsuits were filed against Keryx and certain of its former officers (Gregory P.

Madison, Scott A.

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Plaintiff sought to represent all stockholders who purchased shares of Keryx common stock between May 8, 2013 and August 1, 2016.

The complaint alleges that Keryx and the named individual defendants violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and Rule 10b-5

promulgated thereunder by making allegedly false and/or misleading statements concerning Keryx, its supplier relationships, and future prospects, and that the allegedly misleading statements were not made known to the market until Keryx’s August 1, 2016 announcement of an interruption in its supply of Auryxia.

By order dated July 19, 2018, the Massachusetts District Court granted in part and denied in part the defendants’ motion to dismiss the complaint.

On February 27, 2019, defendants filed a motion for judgment on the pleadings.

On April 30, 2019, plaintiff filed a motion to further amend his complaint, and also moved for class certification.

The Massachusetts District Court heard oral argument on the motions for judgment on the pleadings and class certification on June 19, 2019.

The complaint alleges that Keryx and the named individual defendants violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning Keryx, its supplier relationships, and future prospects, and that the allegedly misleading statements were not made known to the market until Keryx’s August 1, 2016 announcement of an interruption in its supply of Auryxia.

On September 23, 2019, the Massachusetts District Court issued a Memorandum and Order denying plaintiff’s motion for class certification, granting defendants’ motion for judgment on the pleadings, and denying plaintiff’s motion for leave to further amend his Complaint.

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On September 24, 2019, plaintiff filed a notice of appeal.

The First Circuit Court of Appeals held oral argument on September 15, 2020, and a decision has not yet been issued.

On June 21, 2021, the First Circuit affirmed the District Court’s judgment in its entirety.

The time for plaintiff to seek further appellate review has now lapsed, so the judgment in favor of Akebia and the other defendants is now final.

Two stockholder derivative complaints also were filed on December 16, 2016 against Keryx and certain of its former officers (Gregory P.

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Keryx Biopharmaceuticals, Inc., et al., and one captioned James Anderson v.

Keryx Biopharmaceuticals, Inc., et al.

Each of these two complaints generally alleges breach of fiduciary duty, unjust enrichment, abuse of control, mismanagement and corporate waste.

On June 27, 2017, the Superior Court of Massachusetts granted the parties’ motion to consolidate and stay the derivative litigations, and that stay remains in effect.

All of the complaints seek unspecified damages, interest, attorneys’ fees, and other costs.

It is expected that such complaints would be dismissed if the above-mentioned ruling of the Massachusetts District Court entering judgment for the defendants in the case brought under the securities laws stands;

however, as discussed above, we are awaiting the outcome of the appeal of that judgment.

Legal Proceedings Relating to the Merger

Biopharmaceuticals, Inc., et al.

Each of these two complaints generally alleged breach of fiduciary duty, unjust enrichment, abuse of control, mismanagement and corporate waste.

On June 27, 2017, the Superior Court of Massachusetts granted the parties’ motion to consolidate and stay the derivative litigations pending the outcome of the federal securities litigation.

On July 15, 2021, the plaintiffs in these actions filed a Notice of Dismissal, without prejudice, of all claims.

Shareholder 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.

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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 Action.

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

On June 3, 2019, the lead plaintiffs filed a consolidated amended complaint in the Consolidated 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 Securities Exchange Act of 1934, as amended, or the Exchange Act, and Rule 14a-9 promulgated thereunder.

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 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 Action in its entirety.

On July 2, 2020, lead

plaintiffs filed a second consolidated amended complaint, or the Second Consolidated Complaint.

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) asserts the same claims under the Exchange Act as the Consolidated Complaint, (ii) names the same defendants as the Consolidated Complaint, (iii) seeks the same relief as the Consolidated Complaint and (iv) as with the Consolidated Complaint, challenges 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 Action moved to dismiss the Second Consolidated Amended Complaint in its entirety with prejudice on August 10, 2020.

Briefing on defendants’ motion to dismiss was completed on September 28, 2020, and the court has not yet issued a decision.

On December 10, 2018, a stockholder of Keryx, Michael J.

Donnelly, filed a complaint against Keryx pursuant to Section 220 of the Delaware General Corporation Law in the Delaware Court of Chancery, captioned Donnelly v.

Keryx Biopharmaceuticals, Inc., or the Donnelly Action.

The Donnelly Action sought inspection of various Keryx books and records, purportedly to investigate “possible wrongdoing,” in connection with Keryx’s negotiation and approval of the Merger, as well as the independence of former members of Keryx’s Board of Directors, some of whom are current members of our Board of Directors.

In addition to the production of books and records, the Donnelly Action sought costs and expenses incurred in the action, including reasonable attorneys’ fees.

On January 31, 2019, Keryx answered the complaint in the Donnelly Action.

The Delaware Court of Chancery entered a scheduling order to govern the Donnelly Action on March 28, 2019.

The trial for the Donnelly Action took place on July 10, 2019.

On October 24, 2019, the Delaware Chancery Court issued a written decision granting inspection, denying the plaintiff’s request for costs and expenses, and directing the parties to confer on the proper scope of the inspection.

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 October 7, 2021, and the Third Circuit submitted the case on the briefs without oral argument on February 10, 2022.

The decision is currently pending.

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.

The alleged misstatements or omissions relate to the safety, approvability, and 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 the same defendants named in the Loper Action (except for Kevin J.

Cameron, Scott A.

Holmes, and Daniel P.

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 is scheduled to be complete by March 28, 2022.

We deny any allegations of wrongdoing and intend to continue vigorously defending against the shareholder lawsuits described in this Legal Proceedings section.

5 unchanged sentences

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What changed 10-K

Item 3. Legal Proceedings