Puma Biotechnology, Inc. v. Astrazeneca Pharmaceuticals LP Et Al

Parties Involved

  • Plaintiff: Puma Biotechnology, Inc. | Wyeth LLC
    • Counsel for Plaintiff: Jack B. Blumenfeld | Megan Elizabeth Dellinger | Rodger Dallery Smith , II | Alexis Adian Smith | Bethany K. Biesenthal | Jennifer L. Swize | John M. Michalik | Michelle B. Smit | Shehla Wynne
  • Defendant: AstraZeneca Pharmaceuticals, LP | AstraZeneca AB | AstraZeneca PLC | Astrazeneca Pharmaceuticals LP
    • Counsel for Defendant: Alexander Trzeciak | Ashley Winkler | Christopher N. Sipes | Einar Stole | Elaine H. Nguyen | Eric R. Sonnenschein | Jason Reinecke | Kaveh V. Saba | Megan P. Keane | Melissa Keech | Priscilla G. Dodson | Robert T. McMullen | Tobias Ma | Andrew Russell | Emily DiBenedetto | Karen Elizabeth Keller

Verdict Information

  • Verdict date: May 17, 2024
  • Total damages awarded to the Plaintiff: $107, 500,000

About the Case

Cause

Plaintiffs Puma Biotechnology, Inc. (“Puma”) and Wyeth LLC filed a complaint against Defendants AstraZeneca Pharmaceuticals LP, AstraZeneca AB, and AstraZeneca PLC, alleging patent infringement under U.S. patent laws, specifically U.S. Patent Nos. 10,603,314 (“the ’314 patent”) and 10,596,162 (“the ’162 patent”) for treating non-small cell lung cancer (NSCLC), the leading cause of cancer death in the U.S., Japan, and Western Europe, comprising about 75% of lung cancer cases.

In 2003, the FDA approved gefitinib (IRESSA®) for treating EGFR-mediated NSCLC in the U.S. Soon after, erlotinib (TARCEVA®) gained FDA approval for the same condition. However, some NSCLC patients became resistant to these treatments. The inventors of the patents-in-suit discovered that small molecule inhibitors binding irreversibly to the EGFR tyrosine kinase domain could treat NSCLC resistant to gefitinib and/or erlotinib, as claimed in the ’314 and ’162 patents.

Puma, a biopharmaceutical company, licensed these patent rights from Pfizer and Wyeth in 2011, aiming to develop and market approved therapies. They invested millions in this endeavor, holding NDA 208051 for NERLYNX® (neratinib), approved by the FDA on July 17, 2017, for treating HER2-positive breast cancer, and conducting phase 2 clinical trials for using neratinib to treat EGFR-mutant mediated lung cancers.

The ’314 patent, titled “Method For Treating Gefitinib Resistant Cancer,” was issued on March 31, 2020, and Wyeth and Puma held exclusive rights to enforce it. AstraZeneca Pharmaceuticals LP held NDA No. 208065 for Tagrisso® (osimertinib), approved by the FDA on November 13, 2015, as an irreversible EGFR inhibitor. Plaintiffs alleged that using Tagrisso® Products according to the Tagrisso® Product Label infringed the ’314 and ’162 patents, with AstraZeneca’s commercial activities directly infringing, contributing to, and actively inducing infringement by others, including end users, knowingly encouraged by AstraZeneca. Plaintiffs sought damages, reasonable royalty, and enhanced damages.

Injury

AstraZeneca’s actions directly infringed and induced others to infringe the ‘162 patent, contributing to infringement under 35 U.S.C. Sections  271(a)–(c). Plaintiffs had suffered and would continue to suffer damages from AstraZeneca’s infringement of the ‘162 patent. Plaintiffs deserved compensation from AstraZeneca, including reasonable royalties. AstraZeneca infringed the ‘162 patent with full knowledge and without a good faith belief of its invalidity or non-infringement. Plaintiffs had been and would continue to be substantially and irreparably damaged by this infringement. Without an injunction against AstraZeneca’s active inducement and contribution to infringement, Plaintiffs would suffer irreparable injury.

Damages

Plaintiffs requested a trial by jury on all triable issues. They prayed for judgment against AstraZeneca, asserting that AstraZeneca had induced and contributed to the infringement of the ’314 patent and continued to do so. They claimed that AstraZeneca’s infringement of the ’314 patent had been and continued to be willful. Additionally, they asserted that AstraZeneca had induced and contributed to the infringement of the ’162 patent and continued to do so.

They also claimed that AstraZeneca’s infringement of the ’162 patent had been and continued to be willful. Plaintiffs sought a permanent injunction against AstraZeneca’s infringing activities. They requested an accounting of all damages sustained due to AstraZeneca’s infringement, along with actual damages and prejudgment interest. Plaintiffs sought increased or enhanced damages under 35 U.S.C. Section 284 and an award of attorneys’ fees and costs under 35 U.S.C. Section 285. Lastly, they sought any other relief the Court deemed just and proper.

Jury Verdict

On May 17, 2024, a Delaware jury found the verdict to be in favour of the Plaintiff. The jury found that the Defendant had infringed the subject patents and was directed to pay $107,500,000 to the Plaintiff as compensation for the past infringement through December 31, 2023.

Court Documents:

Available upon request