What changed in this filing

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Item 1. Legal Proceedings

2021-11-04 compared with 2021-08-05 · 61 added, 39 removed, 226 unchanged (31% of the section changed)

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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.

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.

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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 is scheduled for February 2022.

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

Oral proceedings for opposition to the ‘834 EP Patent are currently scheduled for October 2021.

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

We expect the Court of Appeal to issue its judgment in the third quarter of 2021.

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).

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

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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 and Otsuka requested oral

argument on the motion on July 23, 2021.

We and Otsuka requested oral argument on the motion on July 23, 2021.

The Court has discretion whether to hear oral argument on the motion.

The decision on the motion to dismiss may take up to six months.

Legal Proceedings Relating to Auryxia

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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 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.

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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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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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 will grant 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.

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.

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On March 26, 2021, the Delaware District Court entered a stipulation and order of dismissal filed by the parties to terminate the action against the Chemo Defendants.

As a result of the timely filing of the lawsuit against Mylan in accordance with the relevant statute, a 30-month stay of approval expiring August 4, 2021 was imposed by the FDA on Mylan’s ANDA, absent an earlier judgment by the Court in the lawsuit finding the patents at issue invalid, unenforceable or not infringed.

We 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 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.

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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Department of Health and Human Services, Alex M.

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.

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.

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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 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.

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.

The case remains before the District Court, following the District Court's denial of defendants' motion to dismiss on July 9, 2021.

Shareholder Litigation Relating to Auryxia Supply

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The time for plaintiff to seek a rehearing before the First Circuit has now lapsed.

Plaintiff has until September 17, 2021 to file a petition for certiorari to the United States Supreme Court to the extent Plaintiff wishes to seek any further appellate review.

Plaintiff has until November 18, 2021 to file a petition for certiorari to the United States Supreme Court to the extent Plaintiff wishes to seek any further appellate review.

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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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 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 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.

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.

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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.

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

On April 1, 2021, the Delaware District Court granted the defendants’ motion and dismissed the Second Consolidated Complaint in its entirety.

On April 29, 2021, lead plaintiffs filed a notice of appeal in the United States Court of Appeals for the Third Circuit.

Briefing on the appeal is ongoing and is currently scheduled to be complete on September 9, 2021.

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

Briefing on the appeal was completed on October 7, 2021.

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.

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

The State Merger Securities Action is captioned Loper v.

Akebia Therapeutics Inc., et al.

The complaint in the State Merger Securities 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 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 State Merger Securities 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.

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 October 15, 2021, the Supreme Court of the State of New York entered a joint stipulation and order consolidating the Loper Action and Panicho Action under the caption In re Akebia Therapeutics, Inc.

Securities Litigation, or the Consolidated State Action, providing for the filing of a consolidated complaint in the Consolidated State Action by October 27, 2021, and providing for briefing to be completed on any motion to dismiss such consolidated complaint by March 28, 2022.

The consolidated complaint was filed on October 27, 2021.

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

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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