What changed in this filing

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Item 1. Legal Proceedings

2022-08-04 compared with 2022-05-09 · 30 added, 43 removed, 135 unchanged (35% of the section changed)

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Opposition Proceedings Against Akebia

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

2044005, or the ’005 EP Patent, in the European Patent Office, or the EPO.

During the oral proceedings, which took place on April 10, 2013, the Opposition Division of the EPO maintained the ’005 EP Patent.

This decision resulted in the maintenance of a claim directed to a compound chosen from a group of eight compounds, including vadadustat, as well as claims to compositions and methods for treating various diseases, including, but not limited to, anemia.

Both parties appealed the decision of the Opposition Division of the EPO.

On February 27, 2018, we withdrew the ’005 EP Patent from appeal and filed a divisional patent application to pursue a focused claim set that includes claims for vadadustat, as well as pharmaceutical compositions and methods of treating anemia.

In September 2018, Dr.

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Proceedings Filed by Akebia Against FibroGen, Inc.

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

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.

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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.

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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, or HIF-PH, inhibitor 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 and Bayer withdrew its oppositions on June 30, 2021.

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.

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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.

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.

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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.

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.

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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.

On July 20, 2018 and August 13, 2018, we and MTPC jointly filed a Request for Trial before the JPO to challenge the validity of two additional FibroGen HIF-related patents in Japan, JP5474872 and JP5474741, respectively.

In 2018, we and our collaboration partner in Japan, Mitsubishi Tanabe Pharma Corporation, or MTPC, jointly filed a Request for Trial before the JPO to challenge the validity of certain of FibroGen’s HIF-related patents in Japan:

JP4845728, JP5474872 and JP5474741.

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

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

On February 10, 2020, the JPO issued a pre-notice of a trial decision for JP4845728, which invalidated all claims except two claims in amended form.

On March 11, 2020, the JPO issued a pre-notice of a trial decision for JP5474872, which invalidated all claims except one claim in amended form.

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

We expect the JPO to issue final decisions for JP5474741 and JP5474872 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.

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

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

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

We do not believe the JPO’s decisions will prevent our collaboration partner MTPC from continuing to commercialize vadadustat for the treatment of anemia due to CKD in Japan.

United Kingdom

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

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:

On December 13, 2018, we filed Particulars of Claim in the Patents Court of the United Kingdom to challenge the validity of FibroGen’s six HIF-related patents in the UK:

the ’823 EP Patent (UK), the ’333 EP Patent (UK), the ’153 EP Patent (UK), the ’155 EP Patent (UK), European Patent (UK) No.

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2,298,301, or the ’301 EP Patent (UK).

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

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

1487472, or the ’472 EP Patent (UK).

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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:

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.

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.

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.

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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 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.

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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 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

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.

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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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.

It alleges, among other things, that Akebia failed to disclose heightened safety risks

that allegedly threatened the prospects of the Phase 3 PRO2TECT clinical trial and the commercial viability of vadadustat.

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

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

Cameron, Scott A.

Holmes, and Daniel P.

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

The action is captioned Panicho v.

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

Oral arguments have not yet been scheduled.

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 (John P.

Butler, David A.

Spellman, and Jason A.

Amello) in the U.S.

Oral argument is currently anticipated to be held before the end of 2022.

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.

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

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

The alleged false and misleading statements relate to the safety, approvability, and commercial viability of vadadustat.

The complaint in the EDNY Action alleges 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 relate 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 seeks 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.

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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