Litigation Details for AstraZeneca LP v. InvaGen Pharmaceuticals Inc. (D. Del. 2015)

AstraZeneca LP v. InvaGen Pharmaceuticals Inc. (D. Del. 2015)

Docket		Date Filed	2015-10-30
Court	District Court, D. Delaware	Date Terminated	2018-03-09
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	ASTRAZENECA AB; INVAGEN PHARMACEUTICALS INC.
Patents	6,251,910; 6,525,060; 7,250,419; 7,265,124; 8,425,934
Attorneys	Pei-Ru Wey; Robert S. Silver
Firms	Kratz & Barry LLP
Link to Docket	External link to docket

Details for AstraZeneca LP v. InvaGen Pharmaceuticals Inc. (D. Del. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-10-30				External link to document
2015-10-30	1		AstraZeneca’s U.S. Patent Nos. 6,251,910 (“the ’910 patent”), 6,525,060 (“the ’060 patent”), ME1 21399823v…7,250,419 (“the ’419 patent”), 7,265,124 (“the ’124 patent”), and 8,425,934 (“the ’934 patent”) that are listed… This is an action for patent infringement arising under the patent laws of the United States, … PATENTS-IN-SUIT 20. On June 26, 2001, the U.S. Patent and Trademark Office…copy of the ’910 patent is attached hereto as Exhibit A. The claims of the ’910 patent are valid and enforceable	External link to document
2015-10-30	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 6,251,910; 6,525,060; 7,250,419… 30 October 2015 1:15-cv-01001 830 Patent None District Court, D. Delaware	External link to document
2015-10-30	28		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 6,251,910; 6,525,060; 7,250,419…2015 9 March 2018 1:15-cv-01001 830 Patent None District Court, D. Delaware	External link to document

Litigation Summary and Analysis: Wyeth LLC and Puma Biotechnology, Inc. v. AstraZeneca Pharmaceuticals LP

Background and Context

The litigation in question involves a patent infringement dispute between Wyeth LLC (a subsidiary of Pfizer) and Puma Biotechnology, Inc., against AstraZeneca Pharmaceuticals LP. The case centers around AstraZeneca's drug Tagrisso (osimertinib), an irreversible EGFR inhibitor used in the treatment of non-small cell lung cancer (NSCLC)[2].

Patents in Suit

The patents at issue are United States Patent Nos. 10,603,314 (the '314 patent) and 10,596,162 (the '162 patent). These patents were originally issued to Wyeth and General Hospital Corporation, with General Hospital Corporation assigning its rights to Wyeth in 2006. Wyeth, now a wholly owned subsidiary of Pfizer, is the current holder of these patents[2].

License Agreements and Standing

Puma Biotechnology, Inc. had an exclusive license agreement with Pfizer to enforce the patents, but this agreement did not cover the use of the patents with respect to osimertinib. In 2021, Puma and Wyeth signed a "Confirmatory License" to clarify the rights under the original license agreement. However, the court ultimately dismissed Puma Biotechnology, Inc. from the case due to lack of Article III standing[1][2].

Claims and Allegations

Wyeth LLC alleged that AstraZeneca's promotion and sale of Tagrisso induced infringement of claims 1, 3, and 9 of the '314 patent and claim 1 of the '162 patent. AstraZeneca countered with motions for summary judgment, arguing that the patents were invalid due to failures in meeting the enablement and written description requirements of 35 U.S.C. § 112, and that Tagrisso did not infringe the asserted claims[2].

Court Proceedings and Rulings

• Claim Construction: The court resolved disputes regarding the meaning of the asserted claims after a claim construction hearing. This included clarifying terms such as "large molecules" and the scope of reactive agents (e.g., Michael acceptors) in the patent specifications[1][2].
• Summary Judgment: AstraZeneca's motions for summary judgment on invalidity and non-infringement were denied due to genuine issues of material fact. The court found that there were unresolved factual disputes regarding the enablement and written description requirements, as well as the infringement claims[2].
• Trial and Jury Verdict: After a five-day trial, the jury found AstraZeneca liable for induced infringement and awarded damages. A subsequent two-day bench trial addressed AstraZeneca's equitable defenses and counterclaims regarding patent invalidity due to indefiniteness, which the court rejected[2].

Equitable Defenses and Counterclaims

AstraZeneca argued that Wyeth's conduct impermissibly broadened the scope of the patent grant with anticompetitive effects. However, the court found insufficient evidence to support this claim and rejected AstraZeneca's request to overturn the jury verdict on the grounds of patent misuse[2].

Key Takeaways

• Patent Infringement: The jury's verdict established that AstraZeneca's Tagrisso induced infringement of the patents-in-suit.
• Patent Validity: The court upheld the validity of the patents, rejecting AstraZeneca's claims of invalidity due to indefiniteness and lack of enablement.
• Equitable Defenses: AstraZeneca's equitable defenses, including claims of patent misuse, were not supported by sufficient evidence.

FAQs

1. What are the patents involved in the litigation between Wyeth LLC and AstraZeneca?

   • The patents involved are United States Patent Nos. 10,603,314 (the '314 patent) and 10,596,162 (the '162 patent).

2. What is the drug at the center of the patent infringement dispute?

   • The drug is Tagrisso (osimertinib), an irreversible EGFR inhibitor used in treating NSCLC.

3. Why was Puma Biotechnology, Inc. dismissed from the case?

   • Puma Biotechnology, Inc. was dismissed due to lack of Article III standing.

4. What were the outcomes of the trial and subsequent bench trial?

   • The jury found AstraZeneca liable for induced infringement and awarded damages. The bench trial rejected AstraZeneca's equitable defenses and counterclaims regarding patent invalidity.

5. Did the court find any evidence of patent misuse by Wyeth?

   • No, the court did not find sufficient evidence to support AstraZeneca's claims of patent misuse.

Citations

1. District of Delaware Opinion: Puma Biotech., Inc. v. AstraZeneca Pharms. LP, No. 21 C 1338, 2024 WL 1157120 (D. Del. Mar. 18, 2024).
2. Casetext Case Summary: Wyeth LLC v. Astrazeneca Pharm., 1:21-cv-01338-MFK, Casetext.
3. Insight.RPXCorp: Case 3:24-cv-09110-RK Document 1 Filed 09/11/24 Page 1 of 53, Insight.RPXCorp. (Note: This source is not directly relevant to the specific case but provides context on patent litigation procedures).