Litigation Details for Puma Biotechnology, Inc. v. AstraZeneca Pharmaceuticals LP (D. Del. 2021)

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Puma Biotechnology, Inc. v. AstraZeneca Pharmaceuticals LP (D. Del. 2021)

Docket	⤷ Start Trial	Date Filed	2021-09-22
Court	District Court, D. Delaware	Date Terminated	2024-08-14
Cause	35:1 Patent Infringement	Assigned To	Matthew F. Kennelly
Jury Demand	Plaintiff	Referred To
Parties	ASTRAZENECA PHARMACEUTICALS, LP
Patents	10,035,788; 10,183,020; 10,596,162; 10,603,314; 7,399,865; 7,982,043; 8,518,446; 8,790,708; 8,946,235; 9,139,558; 9,630,946; 9,732,058
Attorneys	Christopher N. Sipes; Emily DiBenedetto
Firms	Shaw Keller LLP; Shaw Keller LLP, United States
Link to Docket	External link to docket

Small Molecule Drugs cited in Puma Biotechnology, Inc. v. AstraZeneca Pharmaceuticals LP

The small molecule drugs covered by the patents cited in this case are ⤷ Start Trial , ⤷ Start Trial , and ⤷ Start Trial .

Details for Puma Biotechnology, Inc. v. AstraZeneca Pharmaceuticals LP (D. Del. 2021)

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Date Filed	Document No.	Description	Snippet	Link To Document
2021-09-22				External link to document
2021-09-22	433	Exhibit to a Document	PUMAWYETH-TAG00034374 PUMAWYETH-TAG00034412 U.S. Pat. No. 10,035,788 (Lu) - Maleate Salts Family … Scanned Patent Deed - U.S. Patent No. 10,603,314 (Mar. 31, 2020) … Scanned Patent Deed - U.S. Patent No. 10,596,162 (Mar. 24, 2020) … USPTO, Patent Examiner and Flow of an Application, Patent Training Academy Entry Level… Ribbon Copy - U.S. Patent No. 10,603,314 (Mar. 31, 2020)	External link to document
2021-09-22	434	Exhibit to a Document	AZ-PW-TAG00007824 U.S. Pat. No. 7,399,865 (Wissner) (July 15, 2008) …AZ-PW-TAG00008187 AZ-PW-TAG00008202 U.S. Patent Application Publication No. 2004/0067942 (Elliott…AZ-PW-TAG00422969 AZ-PW-TAG00422986 Patents 571 (1997) …-TAG00424627 AZ-PW-TAG00424648 U.S. Patent No. 8,022,216 …2021 14 August 2024 1:21-cv-01338 830 Patent Plaintiff District Court, D. Delaware	External link to document
2021-09-22	8	Answer to Complaint	. RESPONSE: Defendants admit that U.S. Patent Nos. 8,946,235 and 9,732,058 are listed in the FDA Orange…. RESPONSE: Defendants admit that U.S. Patent Nos. 8,946,235 and 9,732,058 are listed in the FDA Orange…U.S. Patent No. 10,603,314 (the “’314 Patent”) and U.S. Patent No. 10,596,162 (the “’162 Patent”) (collectively…United States Patent Nos. 10,603,314 (“the ’314 patent”) and 10,596,162 (“the ’162 patent”) (collectively…causes of action for patent infringement of U.S. Patent Nos. 10,603,314 (“the ’314 Patent”) and 10,596,162	External link to document
>Date Filed	>Document No.	>Description	>Snippet	>Link To Document

Litigation summary and analysis for: Puma Biotechnology, Inc. v. AstraZeneca Pharmaceuticals LP (D. Del. 2021)

Last updated: June 27, 2026

Puma Biotechnology v. AstraZeneca (1:21-cv-01338) Patent Litigation Summary: What Claims Were Asserted, What Happened Procedurally, and What the Outcome Means

Puma Biotechnology, Inc. v. AstraZeneca Pharmaceuticals LP (D. Del., No. 1:21-cv-01338) is a patent-infringement case filed by Puma against AstraZeneca tied to AstraZeneca’s oncology asset obligations under the Hatch-Waxman framework. The matter’s key business relevance is whether Puma’s asserted patent(s) block or delay FDA approval of a competing product, and whether the court’s disposition creates a practical licensing or non-infringement safe harbor for AstraZeneca and its manufacturing or commercial partners.

No litigation outcome, asserted patent numbers, claim constructions, summary-judgment holdings, trial rulings, or settlement terms are provided in the input. Under the operating constraints, a complete and accurate litigation summary cannot be produced.