22 unchanged sentences
The Company appealed this ruling to the North Carolina Court of Appeals.
+Added: On September 3, 2025, the Court of Appeals reversed the dismissal of the Company’s claim for legal malpractice and remanded the case to the Superior Court for further proceedings.
+Added: The defendants filed a petition for discretionary review of this decision by the North Carolina Supreme Court on October 8, 2025.
+Added: The Supreme Court has not decided whether to accept the case for review.
Patent-Related Proceedings
27 unchanged sentences
The Court found that AstraZeneca had not proved its claim that Wyeth’s asserted patents were invalid as indefinite, or that Wyeth had committed acts that would give rise to findings of unclean hands, implied waiver, or patent misuse.
−Removed: AstraZeneca has filed a motion challenging the jury’s verdict and requesting a new trial.
−Removed: Wyeth has filed a motion requesting supplemental damages for past infringement from January 1, 2024, through the date of judgment;
+Added: AstraZeneca filed a motion challenging the jury’s verdict and requesting a new trial.
+Added: Wyeth filed a motion requesting supplemental damages for past infringement from January 1, 2024, through the date of judgment;
pre-and-post judgment interest, and ongoing royalties through the remaining term of the patents.
7 unchanged sentences
Wyeth filed a notice of appeal on September 12, 2024, appealing the District Court’s judgment as a matter of law, as well as other rulings and opinions of the Court adverse to Wyeth.
−Removed: Wyeth filed its opening brief on appeal to the Federal Circuit on December 18, 2024.
+Added: On December 18, 2024, Wyeth filed its opening brief.
+Added: On March 13, 2025, AstraZeneca filed its response brief.
+Added: On March 20, 2025, non-parties Regeneron Pharmaceuticals, Inc.
+Added: and Sanofi-Aventis U.S.
+Added: LLC filed a motion for leave to file an amicus curiae brief in the Federal Circuit.
+Added: The motion was granted on May 16, 2025.
+Added: On June 6, 2025, Wyeth filed its reply brief.
+Added: Briefing on the appeal is now complete, and the parties await further order from the Court.
Acebright China Litigation
34 unchanged sentences
On January 10, 2025, the Court conducted a hearing of party experts on the evaluation of evidence.
+Added: On July 14, 2025, the Court conducted a hearing to examine evidence and debate merits of party arguments.
+Added: On September 28, 2025, the Court issued a first-instance decision, deciding that Acebright’s product does not fall within the scope of the patent-in-suit, and Acebright did not infringe the NERLYNX® Patents;
+Added: the Court also decided that the Company’s enforcement efforts were not malicious and did not amount to unfair competition.
Aosaikang China Litigation
49 unchanged sentences
On September 25, 2023, the CNIPA accepted the Company’s withdrawal request.
+Added: On September 9, 2025, the NMPA approved Kelun’s ANDA to market a generic version of the Company’s NERLYNX® in China with the approval number of GuoYaoZhunZi H20255337.
Demai Litigation
6 unchanged sentences
ZL201410082103.7.
+Added: On February 13, 2025, the Company withdrew the lawsuits from BJIPC, filed an Article 76 petition with the CNIPA against the Demai ANDA and requested administrative determination that Demai’s generic neratinib maleate tablet falls within the scope of the claims of Nerlynx Patent No.
+Added: ZL201080060546.6.
+Added: On February 21, 2025, the CNIPA accepted the Company’s petition and started examination.
+Added: On March 18, 2025, the Company filed a request with the NMPA to set up a nine-month stay on Demai’s ANDA.
+Added: Hexal European Patent Opposition
+Added: An opposition was filed by Hexal AG (“Hexal”) on August 3, 2016 against European Patent No.
+Added: EP2416774 which was licensed from Pfizer in 2011, and which claims neratinib for use in a method for treating HER-2/neu overexpressed/amplified cancer and improving IDFS, wherein the method comprises delivering neratinib therapy to HER-2/neu overexpressed/amplified cancer patients following the completion of at least one year of trastuzumab adjuvant therapy, and wherein the neratinib therapy comprises treating the cancer patients with neratinib for at least twelve months.
+Added: An oral hearing was held on December 8, 2017, wherein the patent was maintained as granted.
+Added: Following an appeal filed by Hexal, the Board of Appeal of the European Patent Office rejected the claims as granted and all pending auxiliary requests during the oral hearing of September 2, 2021.
+Added: Before issuance of a decision, we withdrew approval of the text in which the patent was granted and all pending auxiliary requests, thereby revoking the patent and concluding the appeal.
+Added: One European divisional application, namely EP15188350.1, was granted with the European patent number EP3000467 on March 1, 2023.
+Added: Oppositions against EP3000467 were filed by Hexal on November 3, 2023, by Alfred E.
+Added: Tiefenbacher (GmbH & Co.
+Added: KG) on November 28, 2023 and by Generics (UK) Limited (“Generics”) on December 1, 2023.
+Added: EP3000467 is used as the basic patent for Supplementary Protection Certificate applications for the EMA-approved NERLYNX® product, 17 of which have been granted, three proceedings have been stayed, and 11 are in active prosecution.
+Added: The patentee response to the notice of opposition was filed on April 15, 2024, following which, all three opponents filed additional arguments in reply to the patentee’s submission.
+Added: On February 6, 2025, the Company filed its response to the summons to attend oral proceedings, including six auxiliary requests.
+Added: Tiefenbacher and Hexal filed their responses to the summons to oral proceedings on February 6 and 7, 2025, respectively.
+Added: Hexal filed a further brief on March 19, 2025.
+Added: Oral proceedings took place on April 9 and 10, 2025.
+Added: EP3000467 was upheld as amended after the first instance hearing based on Auxiliary Request 1, which covers the EMA approved indication for NERLYNX® as an extended adjuvant therapy for treating early stage hormone receptor-positive HER-2-overexpressed/amplified breast cancer.
+Added: The first instance decision may be appealed.
+Added: Hexal filed an appeal on June 6, 2025, Generics filed an appeal on June 20, 2025 and Wyeth filed an appeal on June 30, 2025.
+Added: On September 5, 2025, Wyeth filed its grounds of appeal, including nine auxiliary requests.
+Added: On the same day, Hexal filed its grounds of appeal.
+Added: Generics filed its grounds of appeal on September 4, 2025, and Alfred E.
+Added: Tiefenbacher filed its grounds of appeal on September 1, 2025.
+Added: On December 16, 2025, Alfred E.
+Added: Tiefenbacher withdrew its appeal.
+Added: Wyeth responded to the opponents’ grounds of appeal on January 12, 2026.
+Added: One European divisional application is pending in the same family, namely EP 23157078.8.
+Added: A response to the European Search Opinion (ESO) for this application was filed February 14, 2024.
+Added: The first office action was issued on January 28, 2025 with a response to the first office action filed on July 22, 2025.
MINE SAFETY DISCLOSURE
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.