38 unchanged sentences
Fact discovery closed on May 19, 2023, and expert discovery closed on November 17, 2023.
−Removed: The Court recently denied the parties’ respective motions for summary judgment and Daubert motions, other than to clarify that Plaintiffs’ damages cannot extend to any time period before the asserted patents were issued.
+Added: The Court denied the parties’ respective motions for summary judgment and Daubert motions, other than to clarify that Plaintiffs’ damages cannot extend to any time period before the asserted patents were issued.
The Court granted AstraZeneca’s motion to dismiss the Company as a Plaintiff on constitutional standing grounds but denied the motion to dismiss Wyeth as a Plaintiff on constitutional standing grounds.
On April 29, 2024, the Court granted AstraZeneca’s motion to dismiss AstraZeneca’s counterclaims against Puma which removed Puma from the case.
−Removed: Wyeth remains in the case as a Plaintiff and counterclaim-defendant.
+Added: Wyeth remained in the case as a Plaintiff and counterclaim-defendant.
Under Puma’s worldwide exclusive license agreement with Pfizer, Inc.
(the parent of Wyeth) as amended, the Company also maintains contractual rights to recover monetary damages in the AstraZeneca litigation, and those contractual rights are unaffected by the court’s March 18, 2024 and April 29, 2024 orders.
−Removed: A jury trial is scheduled to begin on May 13, 2024.
+Added: A jury trial was held May 13-17, 2024.
+Added: The jury found in favor of Wyeth and against AstraZeneca.
+Added: In particular, the jury found that use of Tagrisso® according to each of the three FDA-approved indications infringes the asserted claims of the ‘314 and ‘162 patents, and that AstraZeneca induces that infringement.
+Added: The jury further rejected AstraZeneca’s challenges to the validity of the patents, finding that they are not invalid.
+Added: The jury awarded damages to Wyeth for past acts of infringement through December 31, 2023, in the amount of $107,500,000.
+Added: A separate bench trial related to certain equitable claims and defenses raised by AstraZeneca was held before Judge Kennelly on June 20 and 25, 2024, and the Court has taken those issues under advisement.
+Added: AstraZeneca has filed a motion challenging the jury’s verdict and requesting a new trial.
+Added: Wyeth has filed a motion requesting supplemental damages for past infringement from January 1, 2024 through the date of judgment;
+Added: pre-and-post judgment interest, and ongoing royalties through the remaining term of the patents.
+Added: Briefing on these motions from both sides was completed on July 16, 2024, and the Company awaits the Court's ruling.
Acebright China Litigation
On January 18, 2022, Shanghai Acebright Pharmaceuticals Group Co., Ltd.
−Removed: (“Acebright”) filed an ANDA with the National Medical Products Administration in China (“NMPA”) seeking approval to market a generic version of the Company’s NERLYNX® (neratinib) tablet, 40mg in China.
+Added: (“Acebright”) filed an abbreviated new drug application (“ANDA”) with the National Medical Products Administration in China (“NMPA”) seeking approval to market a generic version of the Company’s NERLYNX® (neratinib) tablet, 40mg in China.
Acebright seeks approval prior to the expiration of three patents listed on the China Patent Information Registration Platform for Marketed Drugs (“Chinese Orange Book”), namely, Chinese Patent Nos.
23 unchanged sentences
The Company seeks a judgment that Acebright’s product infringes the ’789 patent and Acebright’s act of offer for sale shall be enjoined.
−Removed: On January 2, 2024, Jiangsu Nanjing Intermediate People’s Court accepted the civil complaint and has recently set an oral hearing for June 20, 2024.
+Added: On January 2, 2024, Jiangsu Nanjing Intermediate People’s Court accepted the civil complaint.
+Added: An oral hearing was held on June 19, 2024, during which the Company amended its complaint to allege that Acebright making, selling and offering to sell the generic version of NERLYNX® infringes the ’789 patent.
+Added: A decision has not yet been issued.
Aosaikang China Litigation
67 unchanged sentences
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.