Puma Biotechnology says court denied AstraZeneca’s motion for invalidity

In a regulatory filing, Puma Biotechnology (PBYI) noted that on September 22, 2021, the company and Wyeth, as co-plaintiffs, filed suit against AstraZeneca (AZN) for infringement of United States Patent Nos. 10,603,314 and 10,596,162. The company’s complaint alleges that AstraZeneca’s commercial manufacture, use, offer for sale, sale, distribution, and/or importation of Tagrisso products for the treatment of gefitinib and/or erlotinib-resistant non-small cell lung cancer infringes the ‘314 and ‘162 patents. The company is an exclusive licensee of the ‘314 and ‘162 patents under the Pfizer (PFE) Agreement. Plaintiffs seek a judgment that AstraZeneca’s product infringes the asserted patents and an award of monetary damages in an amount to be proven at trial. AstraZeneca filed an answer and counterclaims on November 5, 2021, including claims challenging the asserted patents as not infringed and/or invalid, and accusing plaintiffs of unclean hands and patent misuse. On March 18, 2024, the court denied AstraZeneca’s motion for invalidity, denied AstraZeneca’s motion for summary judgment of non-infringement, except as to pre-issuance damages, and denied plaintiffs’ motion for summary judgment on AstraZeneca’s advice of counsel defense. The court denied the plaintiffs’ and defendants’ motions to exclude certain expert testimony. AstraZeneca also moved to dismiss both the company and Wyeth as plaintiffs for lack of constitutional standing. The court denied the motion to dismiss with respect to Wyeth and granted the motion with respect to the company. The company was dismissed as a plaintiff in the matter, but remains a counterclaim-defendant in the action. “Under the company’s worldwide exclusive license agreement with Pfizer, 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 order on the standing motion. The case remains ongoing with a jury trial scheduled to begin on May 13, 2024,” Puma stated.