5 unchanged sentences
287720 in the Indian Patent Office.
+Added: On July 26, 2022, Sandoz AG filed an opposition against our issued European Patent No.
+Added: 3277270 in the European Patent Office.
Proceedings Filed by Akebia Against FibroGen, Inc.
29 unchanged sentences
On January 26, 2022, we filed notice to appeal the Opposition Division’s decision for ’531 EP Patent.
−Removed: On July 8, 2022, FibroGen filed notice to appeal the Opposition Division’s decision for the ’301 EP Patent.
+Added: On July 8, 2022, FibroGen filed notice to appeal the Opposition Division’s
+Added: 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.
11 unchanged sentences
In July 2022, we filed a revocation lawsuit for JP4845728 in the Intellectual Property High Court requesting cancellation of the JPO’s decision.
+Added: In August 2022, we filed revocation lawsuits for JP5474741 and JP5474872 in the Intellectual Property High Court requesting cancellation of the JPO’s decisions.
+Added: In September 2022, FibroGen filed a revocation lawsuit for JP4845728 in the Intellectual Property High Court requesting cancellation of the JPO’s decision on the claims that were invalidated.
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.
15 unchanged sentences
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).
−Removed: Akebia and Otsuka are seeking permission to appeal to the UK Supreme Court.
+Added: Akebia sought permission to appeal to the UK Supreme Court, which was granted on October 3, 2022.
We do not expect the UK Court of Appeal’s judgment to have any effect on our commercialization of vadadustat in the UK.
9 unchanged sentences
Keryx, Panion and, as applicable, Dr.
−Removed: Hsu have now entered into settlement and
−Removed: license agreements resolving all patent litigation proceedings brought by Keryx, Panion and, as applicable, Dr.
+Added: 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.
57 unchanged sentences
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.
−Removed: It alleges, among other things, that Akebia failed to disclose heightened safety risks
−Removed: that allegedly threatened the prospects of the Phase 3 PRO2TECT clinical trial and the commercial viability of vadadustat.
+Added: 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.
7 unchanged sentences
Briefing on defendants’ motion to dismiss was completed on April 22, 2022.
−Removed: Oral argument is currently anticipated to be held before the end of 2022.
+Added: Oral argument was held on October 7, 2022, and the Court dismissed the complaint without prejudice on October 17, 2022, giving plaintiffs thirty days to amend their complaint.
+Added: The Court further ordered that, in the event plaintiffs do not file an amended complaint within thirty days of the dismissal, the dismissal shall be deemed to be with prejudice.
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.
−Removed: The action is captioned Deputy v.
+Added: The action was captioned Deputy v.
Akebia Therapeutics, Inc., et al., No.
1:22-cv-01411, or the EDNY Action.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: We deny any allegations of wrongdoing and intend to continue vigorously defending against the stockholder 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 of these actions.
+Added: The complaint in the EDNY Action alleged that defendants made materially false and misleading statements in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
+Added: The alleged misstatements or omissions related to heightened safety risks that allegedly threatened the prospects of the Phase 3 PRO2TECT clinical trial and the commercial viability of vadadustat.
+Added: The complaint in the EDNY Action sought 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.
+Added: Plaintiffs Abraham Kiswani and Joseph Gorski were appointed co-lead plaintiffs on June 28, 2022, and on July 22, 2022, a stipulated scheduling order was entered allowing co-lead plaintiffs to file an amended complaint on or before August 29, 2022.
+Added: On August 29, 2022, co-lead plaintiffs filed a stipulation of voluntary dismissal, and the Court entered an order dismissing the co-lead plaintiffs from the action on August 30, 2022.
+Added: The original named plaintiff filed a stipulation of voluntary dismissal on September 7, 2022, and the court formally terminated the case on September 8, 2022.
+Added: We deny any allegations of wrongdoing and intend to continue vigorously defending against the one active stockholder lawsuit described in this Legal Proceedings section, the Consolidated State Action.
+Added: There is no assurance, however, that we will be successful in the defense of this action, or any associated appeals, or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs of this action.
Moreover, we are unable to predict the outcome or reasonably estimate a range of possible losses at this time.
−Removed: A resolution of these lawsuits in a manner adverse to us, however, could have a material effect on our financial position and results of operations in the period in which a particular lawsuit is resolved.
+Added: A resolution of the Consolidated State Action in a manner adverse to us, however, could have a material effect on our financial position and results of operations in the period in which the action is resolved.
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.