5 unchanged sentences
1:20-cv-00812.
−Removed: The complaint alleged that prior to our August 10, 2020 receipt of a CRL from the FDA concerning our NDA for PEDMARK™, defendants made materially false or misleading statements and failed to disclose material facts about our third-party PEDMARK™ product manufacturing facility and the impact the facility would have on regulatory approval for PEDMARK™.
+Added: The complaint alleged that prior to our August 10, 2020 receipt of a CRL from the FDA concerning our NDA for PEDMARK ® , defendants made materially false or misleading statements and failed to disclose material facts about
+Added: our third-party PEDMARK ® product manufacturing facility and the impact the facility would have on regulatory approval for PEDMARK ® .
On December 3, 2020, the court appointed a lead plaintiff to represent the putative class.
On February 1, 2021, the lead plaintiff filed an amended complaint.
−Removed: The amended complaint added members of our Board of Directors as defendants, asserted a putative class period from December 20, 2018 through August 10, 2020, made allegations similar
−Removed: to those in the original complaint, claimed the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5, and sought an unspecified amount of compensatory damages and attorneys’ fees and costs.
+Added: The amended complaint added members of our Board of Directors as defendants, asserts a putative class period from December 20, 2018 through August 10, 2020, makes allegations similar to those in the original complaint, claims the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5, and seeks an unspecified amount of compensatory damages and attorneys’ fees and costs.
On March 3, 2021, defendants filed a motion to dismiss the amended complaint.
6 unchanged sentences
In his proposed second amended complaint, lead plaintiff seeks to add allegations stemming from the receipt of a second CRL following our resubmission of our NDA for PEDMARK ® , which we received on November 29, 2021, among other things.
−Removed: On April 20, 2022, defendants filed an opposition to lead plaintiff’s motion for post judgment relief.
+Added: Defendants filed an opposition to plaintiff’s motion for post judgment relief on April 20, 2022.
On May 4, 2022, lead plaintiff submitted a reply in support of his motion.
+Added: On September 27, 2022, defendants filed a request for judicial notice regarding the FDA’s press release announcing that it has approved PEDMARK ® .
+Added: On October 18, 2022, lead plaintiff filed his opposition to request for judicial notice.
+Added: On October 21, 2022, defendants filed a reply in support of the request for judicial notice.
We believe that this lawsuit is without merit and intend to defend it vigorously.
1 unchanged sentence
Failure by us to obtain a favorable resolution of the lawsuit could have a material adverse effect on our business, results of operations, and financial condition.
−Removed: We have not recorded a liability as of June 30, 2022, because we believe a potential loss is not probable or reasonably estimable given the nature of the proceedings and our success so far by obtaining a dismissal with prejudice of the amended complaint.
+Added: We have not recorded a liability as of September 30, 2022, because we believe a potential loss is not probable or reasonably estimable given the nature of the proceedings and our success so far by obtaining a dismissal with prejudice of the amended complaint.
Fennec Pharmaceuticals Inc.
2 unchanged sentences
Fennec Pharmaceuticals Inc.
−Removed: et al., Case No.
1:22-cv-00115.
−Removed: The complaint asserts a putative class period from May 28, 2021 through November 28, 2021, and alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 by making materially false and misleading statements or omissions regarding the status of our third-party PEDMARK™ product manufacturing facility, including the facility’s compliance with cGMP and remediation of deficiencies outlined in the August 10, 2020 CRL, and the impact its status and compliance would have on regulatory approval for PEDMARK™ in the period leading up to the Company’s November 29, 2021 receipt of a CRL for a subsequent NDA for PEDMARK™.
+Added: The complaint asserts a putative class period from May 28, 2021 through November 28, 2021, and alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 by making materially false and misleading statements or omissions regarding the status of our third-party PEDMARK ® product manufacturing facility, the facility’s compliance with cGMP, and the impact its status and compliance would have on regulatory approval for PEDMARK ® in the period leading up to the Company’s November 29, 2021 receipt of a CRL for a subsequent NDA for PEDMARK ® .
The complaint seeks an unspecified amount of damages and attorneys’ fees and costs.
1 unchanged sentence
Fisher filed a motion to be appointed lead plaintiff and represent the putative class and on May 9, 2022, the court appointed him as lead plaintiff.
−Removed: On June 23, 2022, the lead plaintiff filed an amended complaint.
−Removed: The amended complaint asserts the same putative class period from May 28, 2021 through November 28, 2021, is brought against the same defendants, makes allegations similar to those in the original complaint.
+Added: On June 23, 2022, lead plaintiff filed an amended complaint.
+Added: The amended complaint asserts the same putative class period from May 28, 2021 through November 28, 2021, is brought against the same defendants and makes allegations similar to those in the original complaint.
On August 5, 2022, defendants filed a motion to dismiss the amended complaint.
−Removed: We believe that this lawsuit is without merit and intend to defend it vigorously.
+Added: On August 26, 2022, lead plaintiff filed an opposition to the motion to dismiss.
+Added: On September 9, 2022, defendants filed a reply in support of the motion to dismiss.
+Added: On September 27, 2022, defendants filed a request for judicial notice regarding the FDA’s press release announcing that it approved PEDMARK ® On September 30, 2022, lead plaintiff filed an opposition to the request for judicial notice.
+Added: On October 6, 2022, defendants filed a reply in support of the request for judicial notice.
+Added: On October 12, 2022, the U.S.
+Added: District Court Judge issued a memorandum opinion and order dismissing the amended complaint in its entirety and with
+Added: prejudice, and on October 14, 2022, entered judgment.
+Added: Lead plaintiff has until November 14, 2022 to file a notice of appeal.
+Added: We believe that the lawsuit is without merit and intend to defend it vigorously.
We cannot predict the outcome of this lawsuit.
Failure by us to obtain a favorable resolution of the lawsuit could have a material adverse effect on our business, results of operations, and financial condition.
+Added: We have not recorded a liability as of September 30, 2022, because we believe a potential loss is not probable or reasonably estimable given the nature of the proceedings and our success so far by obtaining a dismissal with prejudice of the amended complaint.
Hope Medical Enterprises, Inc.
2 unchanged sentences
In its petitions, Hope seeks to invalidate our U.S.
−Removed: 10,596,190 (“US ‘190”), which is exclusively in-licensed from Oregon Health & Science University (“OHSU”) and relates to a method of using our PEDMARK™ product, and our U.S.
−Removed: 10,792,363 (“US ’363”),
−Removed: which relates to an anhydrous form of STS, which is the active pharmaceutical ingredient in our PEDMARK™ product.
+Added: 10,596,190 (“US ‘190”), which is exclusively in-licensed from OHSU and relates to a method of using our PEDMARK ® product, and our U.S.
+Added: 10,792,363 (“US ’363”), which relates to an anhydrous form of STS, which is the active pharmaceutical ingredient in our PEDMARK ® product.
US ‘190 was issued on March 24, 2020.
US ‘363 was issued on October 6, 2020.
−Removed: On January 11, 2022, our licensor OHSU filed a Request for Supplemental Examination of US ‘190 requesting the consideration by the Central Re-examination Unit (“CRU”) of the USPTO of certain prior art references, including references cited by Hope in its Petition for IPR that are relevant to the granted claim of the patent.
−Removed: On January 28, 2022, the CRU found that the cited references constitute a substantial new question of patentability and ordered an ex parte reexamination of the single US ‘190 claim of pursuant to 35 U.S.C.
−Removed: On March 11, 2022, the CRU issued a substantive Office Action.
−Removed: We filed a preliminary response to Hope’s Request for IPR of the ‘190 Patent in February 2022, requesting that the ‘190 IPR be denied on the basis that the CRU is already reviewing the relevant issues in the Supplemental Examination Proceeding and is further advanced than PTAB in its consideration.
+Added: On January 11, 2022, OHSU filed a Request for Supplemental Examination of US ‘190 requesting the consideration by the Central Re-examination Unit (“CRU”) of the USPTO of certain prior art references, including references cited by Hope in its Petition for IPR that are relevant to the granted claim of the patent.
On May 9, the PTAB granted Hope Medical’s Petition to Institute the IPR against the ‘190 patent and a stayed the Supplemental Examination pending the result of the ‘190 IPR.
+Added: On August 12, 2022, we filed a Motion to Amend the single claim of the ‘190 Patent in the IPR to focus on the treatment of medulloblastoma.
+Added: We expect a decision in the ‘190 IPR in May 2023, which can be appealed by the losing party.
Further, in May 2022, the PTAB granted Hope Medical’s Petition to Institute the IPR against the ‘363 patent.
+Added: During the ‘363 IPR, we disclaimed the patent claims directed to the anhydrous morphic form of STS and continued with claims directed to its method of manufacture.
We expect a decision in the ‘363 IPR in May 2023, which can be appealed by the losing party.
−Removed: In February and April 2022, the USPTO issued Notices of Allowance to Fennec for two additional patents that cover the PEDMARK TM pharmaceutical formulation.
+Added: On April 5, 2022, the USPTO issued U.S.
+Added: 11,291,728 (‘728) that covers the PEDMARK pharmaceutical formulation.
+Added: On September 14, 2022, the USPTO issued Notices of Allowance to us for two additional patent applications that cover the PEDMARK pharmaceutical formulation.
We expect these two additional U.S.
−Removed: patents to issue in the second half of 2022 and will be listed in the FDA’s Orange Book on approval of PEDMARK TM .
−Removed: These patents will expire in 2039, unless held invalid or unenforceable by a court or final jurisdiction.
−Removed: We plan to vigorously defend our intellectual property rights related to PEDMARK™.
−Removed: However, we are unable to predict the outcome of Hope’s IPR petitions, or the Supplemental Examination, and an invalidation of one or both of the ‘190 and ‘363 patents may have a material adverse effect on our ability to protect our rights in PEDMARK™ beyond periods of marketing exclusivity for PEDMARK TM possible in the United States under Orphan Drug Designation and in Europe under European Market Exclusivity for Pediatric Use (“PUMA”).
+Added: patents to issue in Q4 of 2022 or Q1 of 2023.
+Added: These patents will expire in 2039, unless held invalid or unenforceable by a court of final jurisdiction.
+Added: On approval of PEDMARK, we listed the ‘728 and the ‘190 patents in the FDA Orange Book.
+Added: We plan to update the Orange Book with additional patents granted by the USPTO on issuance.
We obtained U.S.
−Removed: Orphan Drug Designation for the use of PEDMARK TM in the prevention of platinum-induced ototoxicity in pediatric patients in 2004.
+Added: Orphan Drug Designation for the use of PEDMARK in the prevention of platinum-induced ototoxicity in pediatric patients in 2004.
We plan to pursue PUMA upon approval of the MAA, which would allow for 10 years of market exclusivity upon PUMA approval.
+Added: We plan to vigorously defend our intellectual property rights related to PEDMARK.
+Added: However, we are unable to predict the outcome of Hope’s IPR petitions, or the Supplemental Examination.
+Added: While we now have, or will shortly receive, additional U.S.
+Added: patents that cover PEDMARK™ over the IPR challenged patents, an invalidation of our patents covering PEDMARK could have a material adverse effect on our ability to protect our rights in PEDMARK beyond periods of marketing exclusivity for PEDMARK possible in the United States under Orphan Drug Designation and in Europe under European Market Exclusivity for Pediatric Use (“PUMA”).
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.