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Item 1. Legal Proceedings

2021-08-05 compared with 2021-05-10 · 53 added, 35 removed, 212 unchanged (29% 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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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 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.

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

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 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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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.

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

United States

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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' response to the complaint is due June 4, 2021.

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 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

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.

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.

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 ferric iron per tablet).

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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.

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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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 and the other plaintiffs in the lawsuit 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.

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.

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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.

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 is now before the district court where the defendants have recently filed a motion to dismiss, which is pending.

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

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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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.

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 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.

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.

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.

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

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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.

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.

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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 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.

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 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.

Keryx conferred with and produced books and records to the plaintiff in the Donnelly Action, and the Donnelly Action was dismissed on May 7, 2021.

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.

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 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 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.

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