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Item 3. Legal Proceedings

2025-02-27 compared with 2024-02-29 · 54 added, 20 removed, 107 unchanged (41% of the section changed)

18 unchanged sentences

in the Superior Court of Mecklenburg County, North Carolina.

On August 22, 2023, the defendants filed motions to dismiss the cas e.

These motions were presented at a hearing on February 20, 2024, but there has yet to be a ruling.

Mfolozi Dlamini, individually and on behalf of all others similarly situated v.

Puma Biotechnology, Inc.

On May 26, 2023, Mfolozi Dlamini filed a Class Action Complaint against the Company in the United States District Court for the Central District of California, alleging injuries as a result of unauthorized disclosure of certain individuals’ personally identifiable information in connection with a data security incident discovered by the Company in June 2022.

On September 21, 2023, the plaintiff and the Company agreed to dismiss the action with prejudice.

On August 22, 2023, the defendants filed motions to dismiss the case.

These motions were presented at a hearing on February 20, 2024.

The Superior Court Judge granted the motions to dismiss on March 20, 2024.

The Company appealed this ruling to the North Carolina Court of Appeals.

Patent-Related Proceedings

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10,603,314 (“the ‘314 patent”) and 10,596,162 (“the ‘162 patent”) ( Puma Biotechnology, Inc.

AstraZeneca Pharmaceuticals LP et al.

, 1:21CV01338 (D.

AstraZeneca Pharmaceuticals LP et al ., 1:21CV01338 (D.

The Company’s complaint alleges that AstraZeneca’s commercial manufacture, use, offer for sale, sale, distribution, and/or importation of Tagrisso® (osimertinib) products for the treatment of gefitinib and/or erlotinib-resistant non-small cell lung cancer infringes the ‘314 and ‘162 patents.

8 unchanged sentences

Fact discovery closed on May 19, 2023, and expert discovery closed on November 17, 2023.

The parties recently exchanged motions for summary judgment on certain issues and also Daubert challenges to certain expert opinions.

A jury trial is scheduled to begin on May 13, 2024.

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 the Company, which removed the Company from the case.

Wyeth remained in the case as a Plaintiff and counterclaim-defendant.

Under the Company’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.

A jury trial was held May 13-17, 2024.

The jury found in favor of Wyeth and against AstraZeneca.

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.

The jury further rejected AstraZeneca’s challenges to the validity of the patents, finding that they are not invalid.

The jury awarded damages to Wyeth for past acts of infringement through December 31, 2023, in the amount of $107,500,000.

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.

On August 6, 2024, Judge Kennelly issued his ruling on the issues that were tried in the bench trial, finding for Wyeth and against AstraZeneca on all claims and defenses.

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.

AstraZeneca has filed a motion challenging the jury’s verdict and requesting a new trial.

Wyeth has 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.

Briefing on these motions from both sides was completed on July 16, 2024.

On August 14, 2024, Judge Kennelly ruled on AstraZeneca’s motion challenging the jury’s verdict, granting it in part and denying it in part.

The Court granted AstraZeneca’s motion for judgment as a matter of law that the '314 and '162 patents are invalid under 35 U.S.C.

§ 112 for lacking enablement and adequate written description as to a particular claim limitation.

In all other respects, the Court denied AstraZeneca’s motion.

The Court entered its final and appealable judgment accordingly.

The Company respectfully disagrees with the Court’s ruling regarding invalidity with respect to the particular claim limitation.

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.

Wyeth filed its opening brief on appeal to the Federal Circuit on December 18, 2024.

Acebright China Litigation

On January 18, 2022, Shanghai Acebright Pharmaceuticals Group Co., Ltd.

(“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.

(“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.

5 unchanged sentences

On July 11, 2022, CNIPA decided that claims 5 and 6 of Patent No.

ZL200880118789.3 are not eligible for registration in the Chinese Orange Book on the ground that these two pharmaceutical method-of-use claims fall in the scope of “patents of crystalline forms,” which are not eligible for listing in the Chinese Orange Book.

ZL200880118789.3 are not eligible for registration in the Chinese Orange Book on the ground that these two pharmaceutical method-of-use claims fall within the scope of “patents of crystalline forms,” which are not eligible for listing in the Chinese Orange Book.

On September 9, 2022, CNIPA decided that the generic drug in Acebright’s ANDA does not fall within the protection scope of claims 1, 3, 5 and 6 of Patent No.

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On May 24, 2023, the BJIPC accepted the Company’s withdrawal request.

On July 24, 2023, the Company withdrew the remaining one civil lawsuit and one appeal in relation to Chinese Patent No.

On July 24, 2023, the Company withdrew the one remaining civil lawsuit and one appeal in relation to Chinese Patent No.

ZL200880118789.3 at the BJIPC.

5 unchanged sentences

On January 2, 2024, Jiangsu Nanjing Intermediate People’s Court accepted the civil complaint.

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.

On July 24, 2024, the Company submitted a request to withdraw the lawsuit.

On August 8, 2024, Jiangsu Nanjing Intermediate People’s Court accepted the withdrawal request.

On September 27, 2024, the Company filed an additional patent infringement claim against Acebright at Jiangsu Nanjing Intermediate People’s Court.

On October 14, 2024, the Court accepted the complaint and designated case number (2024) Su 01 Min Chu 2192 to this case.

On December 16, 2024, the Court conducted an evidence exchange hearing.

On January 10, 2025, the Court conducted a hearing of party experts on the evaluation of evidence.

Aosaikang China Litigation

9 unchanged sentences

Also on January 6, 2023, the CNIPA declined to accept the Company’s request for administrative determination in relation to Patent Nos.

ZL200880118789.3 and ZL201710057547.9, alleging that the listed claims are not eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall in the scope of “patents of crystalline forms,” which are not eligible for listing in the Chinese Orange Book.

ZL200880118789.3 and ZL201710057547.9, alleging that the listed claims are not eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of “patents of crystalline forms,” which are not eligible for listing in the Chinese Orange Book.

On January 28, 2023, the Company requested the NMPA to institute a nine-month stay against Aosaikang ANDA starting from the CNIPA’s acceptance of the Company’s request for administrative determination.

3 unchanged sentences

The two CNIPA administrative decisions on NERLYNX® Patents have lifted the stay of Aosaikang’s ANDA by NMPA.

The Company has the right to appeal each CNIPA administrative decision within six months of receiving the decision.

The Company also has the right to enforce the four Orange Book patents in civil litigation before the Chinese court.

On October 22, 2024, the NMPA approved Aosaikang’s ANDA to market a generic version of the Company’s NERLYNX® in China with the approval number of GuoYaoZhunZi H20249180.

Convalife China Litigation

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Also on February 3, 2023, the CNIPA declined to accept the Company’s request for administrative determination in relation to Patent Nos.

ZL200880118789.3 and ZL201710057547.9, alleging that the listed claims are not eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of “patents of crystalline forms,” which are not eligible for listing in the Chinese Orange Book.

On February 24, 2023, the Company requested the NMPA to institute a nine-month stay against Convalife ANDA starting from the CNIPA’s acceptance of the Company’s request for administrative determination.

3 unchanged sentences

The two CNIPA administrative decisions on NERLYNX® Patents have lifted the stay of Convalife’s ANDA by NMPA.

The Company has the right to appeal each CNIPA administrative decision within six months of receiving the decision.

The Company also has the right to enforce the four Orange Book patents in civil litigation before the Chinese court.

On June 28, 2024, the NMPA approved Convalife’s ANDA to market a generic version of the Company’s NERLYNX® in China with the approval number of GuoYaoZhunZi H20244222.

Kelun China Litigation

7 unchanged sentences

On March 21, 2023, the CNIPA declined to accept the Company’s request for administrative determination in relation to Patent Nos.

ZL200880118789.3 and ZL201710057547.9, alleging that the listed claims are not eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of “patents of crystalline forms,” which are not eligible for listing in the Chinese Orange Book.

On March 24, 2023, the CNIPA accepted the Company’s request for administrative determination in relation to Patent Nos.

4 unchanged sentences

On September 25, 2023, the CNIPA accepted the Company’s withdrawal request.

Demai Litigation

Zhengzhou Demai Pharmaceutical Co., Ltd (“Demai”) filed an ANDA with NMPA in China seeking approval to market a generic version of the Company’s NERLYNX®.

The ANDA application No.

is CYHS2402776.

On August 26, 2024, Demai made a Type 4.2 declaration against Orange Book Patent ZL201410082103.7, alleging that its generic version of NERLYNX does not fall within the scope of the claims of this Orange Book patent.

On September 30, 2024, the Company filed a lawsuit against Demai at the BJIPC based on Nerlynx Patent No.

ZL201080060546.6 and on October 8, 2024, the Company filed a lawsuit against Demai at the BJIPC based on Nerlynx Patent No.

ZL201410082103.7.

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.

What changed 10-K

Item 3. Legal Proceedings