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The resulting ’131 JP Patent does not cover vadadustat or any pyridine carboxamide compounds.
−Removed: To date, FibroGen has been unsuccessful in its attempts to obtain a patent in the United States covering the same claim scope as it obtained initially in Europe and Japan in the ’823 EP Patent and ’131 JP Patent.
−Removed: 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.
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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.
−Removed: 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 HIF-PHI compounds.
+Added: 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.
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On December 9, 2016, FibroGen filed a notice to appeal the decision to revoke the ’333 EP Patent.
−Removed: An oral proceeding for the appeal is scheduled for March 2021.
+Added: An oral proceeding for the appeal is scheduled for February 2022.
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.
−Removed: An oral proceeding for the appeal is scheduled for March 2021.
+Added: An oral proceeding for the appeal is scheduled for February 2022.
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.
−Removed: An oral proceeding for the appeal is scheduled for March 2021.
+Added: An oral proceeding for the appeal is scheduled for February 2022.
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.
+Added: Oral proceedings for oppositions to the two patents are scheduled for September 2021.
On February 10, 2020, we filed an opposition to FibroGen’s European Patent No.
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On June 25, 2020, the parties agreed to dismiss the CA 2467689 patent from the lawsuit.
+Added: On February 16, 2021, the parties agreed to dismiss the lawsuit in its entirety.
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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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.
+Added: United Kingdom
On December 13, 2018, we and our collaboration partner, Otsuka Pharmaceutical Co.
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On February 28, 2020, the parties agreed to dismiss the ’472 EP Patent (UK) from the trial.
−Removed: A trial was conducted on March 2-19, 2020.
+Added: A trial was conducted in March 2020.
On April 20, 2020, the Patents Court of the UK issued a judgment in favor of Akebia, which invalidated all the claims at issue in each of the ’823 EP Patent (UK), the ’333 EP Patent (UK), the ’153 EP Patent (UK), the ’155 EP Patent (UK) and the ’301 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).
+Added: United States
+Added: On March 29, 2021, we and our collaboration partner Otsuka America Pharmaceutical, Inc.
+Added: 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:
+Added: 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.
+Added: The defendants' response to the complaint is due June 4, 2021.
Legal Proceedings Relating to Auryxia
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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.
−Removed: 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).
+Added: 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).
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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On April 18, 2019, Keryx, Panion and Dr.
−Removed: Hsu filed a motion with the Judicial Panel on Multidistrict Litigation seeking to consolidate these four cases in the Delaware
−Removed: District Court for pretrial proceedings.
−Removed: 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).
+Added: 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.
+Added: 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 ferric iron per tablet).
On May 10, 2019, Keryx, Panion and Dr.
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On September 19, 2019, the Delaware District court set a trial date for February 8, 2021.
−Removed: The trial has been rescheduled for June 28, 2021.
+Added: The trial was rescheduled for June 28, 2021.
+Added: On January 13, 2021, the Delaware District court vacated the deadlines for the case involving Mylan pending resolution of a discovery dispute.
On July 22, 2019, Keryx received from Teva a supplemental Paragraph IV certification notice letter regarding its ANDA.
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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.
−Removed: 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.
+Added: 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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Pursuant to the terms of the settlement, Keryx and Panion will grant Lupin and Lupin Ltd.
−Removed: 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
−Removed: agreements of this nature.
+Added: 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, the Lupin Defendants and Dr.
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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.
−Removed: 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.
−Removed: 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.
+Added: On March 25, 2021, Keryx and Panion entered into a settlement and license agreement with the Chemo Defendants.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The settlement and license agreement is confidential and subject to review by the U.S.
+Added: Federal Trade Commission and the U.S.
+Added: Department of Justice.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: On January 13, 2021, the Delaware District court vacated the deadlines for the case involving Mylan pending resolution of a discovery dispute.
CMS Litigation
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Department of Health and Human Services, Alex M.
−Removed: 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 CMS’s related decision that imposed a prior authorization requirement for Auryxia in the treatment of adult patients with CKD on dialysis, or the Hyperphosphatemia Indication.
+Added: 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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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.
+Added: The case is now before the district court where the defendants have recently filed a motion to dismiss, which is pending.
Shareholder Litigation Relating to Auryxia Supply
26 unchanged sentences
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.
−Removed: All of the complaints seek
−Removed: unspecified damages, interest, attorneys’ fees, and other costs.
+Added: 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.
−Removed: Other Matters
+Added: 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 June 3, 2019, the lead plaintiffs filed a consolidated amended complaint in the Consolidated Action, or the Consolidated Complaint.
−Removed: 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.
+Added: 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,
+Added: as amended, or 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.
1 unchanged sentence
The defendants in the Consolidated Action moved to dismiss the Consolidated Complaint in its entirety and with prejudice on August 2, 2019.
−Removed: On April 15, 2020, the Delaware District Court granted the defendants’ motion and dismissed the Consolidated Action in its entirety.
+Added: 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.
1 unchanged sentence
The defendants in the Consolidated Action moved to dismiss the Second Consolidated Amended Complaint in its entirety with prejudice on August 10, 2020.
+Added: Briefing on defendants’ motion to dismiss was completed on September 28, 2020, and the court has not yet issued a decision.
+Added: On April 1, 2021, the Delaware District Court granted the defendants’ motion and dismissed the Second Consolidated Complaint in its entirety.
+Added: 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.
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On January 31, 2019, Keryx answered the complaint in the Donnelly Action.
−Removed: 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.
+Added: 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.
We deny any allegations of wrongdoing and intend to continue vigorously defending against the shareholder lawsuits described in this Legal Proceedings section.
−Removed: There is no assurance, however, that we will be successful in the defense of these lawsuits, or any associated appeals, or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs
−Removed: of these actions.
+Added: There is no assurance, however, that we will be successful in the defense of these lawsuits, or any associated appeals, or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs of these actions.
Moreover, we are unable to predict the outcome or reasonably estimate a range of possible losses at this time.
1 unchanged sentence
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.