40 unchanged sentences
Bayer filed a notice to appeal the decision on November 14, 2017.
−Removed: An oral proceeding for the appeal is scheduled for July 2020.
+Added: An oral proceeding for the appeal is scheduled for March 2021.
On April 3, 2019, we filed oppositions to FibroGen’s European Patent Nos.
54 unchanged sentences
On September 19, 2019, the Delaware District court set a trial date for February 8, 2021.
+Added: The trial has been rescheduled for June 28, 2021.
On July 22, 2019, Keryx received from Teva a supplemental Paragraph IV certification notice letter regarding its ANDA.
7 unchanged sentences
On April 27, 2020, the Delaware District Court conducted a Markman hearing concerning certain claim construction issues with respect to four Orange Book-listed patents, and issued an order in favor of Keryx.
−Removed: On August 2, 2019, Keryx and Panion entered into a settlement and license agreement with Par resolving 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.
+Added: On August 2, 2019, Keryx and Panion entered into a settlement and license agreement with Par.
+Added: 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.
5 unchanged sentences
On September 6, 2019 and September 9, 2019, the Southern New York District Court and the Delaware District Court, respectively, entered a stipulation and order of dismissal filed by the parties to terminate the actions against Par.
−Removed: On April 30, 2020, Keryx and Panion entered into a settlement and license agreement with Teva and Watson resolving 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.
+Added: On April 30, 2020, Keryx and Panion entered into a settlement and license agreement with Teva and Watson.
+Added: 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.
−Removed: Additionally, in accordance with the agreement, the parties will terminate all ongoing litigation between Keryx and Panion and Watson and Teva regarding Auryxia patents pending in the Delaware District Court.
+Added: 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.
The settlement and license agreement is confidential and subject to review by the U.S.
2 unchanged sentences
On May 4, 2020, the Delaware District Court entered a stipulation and order of dismissal filed by the parties to terminate the action against Teva and Watson.
−Removed: As a result of the timely filing of these lawsuits against the Lupin Defendants, the Chemo Defendants and Mylan in accordance with the relevant statute, a 30-month stay of approval was imposed by the FDA on Lupin's ANDA, Lupin Ltd.'s ANDA, 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
−Removed: patents at issue and equitable relief enjoining the Lupin Defendants, the Chemo Defendants and Mylan from infringing these patents.
+Added: On September 24, 2020, Keryx, Panion and Dr.
+Added: Hsu entered into a settlement and license agreement with the Lupin Defendants.
+Added: 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.
+Added: Pursuant to the terms of the settlement, Keryx and Panion will grant Lupin and Lupin Ltd.
+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
+Added: agreements of this nature.
+Added: Additionally, in accordance with the agreement, the parties terminated all ongoing litigation among Keryx, Panion, the Lupin Defendants and Dr.
+Added: Hsu 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 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.
+Added: 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.
+Added: 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.
CMS Litigation
6 unchanged sentences
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.
−Removed: The appeal is currently pending, and oral argument is scheduled for August 14, 2020.
+Added: 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.
+Added: 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.
Shareholder Litigation Relating to Auryxia Supply
13 unchanged sentences
On September 24, 2019, plaintiff filed a notice of appeal.
−Removed: The parties completed appellate briefing on May 19, 2020, and the First Circuit Court of Appeals has set oral argument for September 15, 2020.
+Added: The First Circuit Court of Appeals held oral argument on September 15, 2020, and a decision has not yet been issued.
Two stockholder derivative complaints also were filed on December 16, 2016 against Keryx and certain of its former officers (Gregory P.
10 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 unspecified damages, interest, attorneys’ fees, and other costs.
+Added: All of the complaints seek
+Added: 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;
6 unchanged sentences
Cameron, Mark J.
−Removed: Enyedy, Steven
+Added: Enyedy, Steven C.
Gilman, Michael T.
25 unchanged sentences
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.
+Added: The defendants in the Consolidated Action moved to dismiss the Second Consolidated Amended Complaint in its entirety with prejudice on August 10, 2020.
On December 10, 2018, a stockholder of Keryx, Michael J.
8 unchanged sentences
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 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
+Added: 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.