LOS ANGELES, CA - Puma Biotechnology, Inc. (NASDAQ:PBYI) has experienced a series of legal developments in its patent infringement suit against AstraZeneca (NASDAQ:AZN), according to a recent SEC filing. The case, which involves claims that AstraZeneca's Tagrisso® infringes on two Puma patents, has seen a mixed verdict, with a jury ruling in favor of Puma's licensing partner Wyeth on infringement but the court later finding certain patent claims invalid.
The legal battle began on September 22, 2021, when Puma and co-plaintiff Wyeth filed suit against AstraZeneca alleging that the commercial activities surrounding Tagrisso®, a treatment for certain types of non-small cell lung cancer, infringed on U.S. Patent Nos. 10,603,314 and 10,596,162. Puma holds exclusive rights to these patents under an agreement with Pfizer (NYSE:PFE), Inc., the parent company of Wyeth.
Following a series of legal proceedings, including a Markman hearing and the closure of fact and expert discovery, the Court denied motions for summary judgment and Daubert motions from both parties. However, the Court clarified that damages could not be awarded for any period before the patents were issued. Puma was dismissed from the case on constitutional standing grounds, leaving Wyeth to continue the litigation.
In a jury trial held from May 13-17, 2024, Wyeth prevailed, with the jury finding that Tagrisso® infringed on the asserted patent claims and rejecting AstraZeneca's invalidity challenges. The jury awarded Wyeth damages amounting to $107.5 million for past infringement up to December 31, 2023.
Subsequently, a bench trial led to a ruling in favor of Wyeth on August 6, 2024, dismissing AstraZeneca's claims of patent invalidity and other defenses. However, the court partially granted AstraZeneca's motion for judgment as a matter of law on August 14, 2024, finding the patents invalid due to lack of enablement and adequate written description for a specific claim limitation. All other aspects of AstraZeneca's motion were denied.
Wyeth, maintaining its stance on the validity of the patents, filed a notice of appeal on September 12, 2024, challenging the court's judgment and other adverse rulings. The SEC filing stated that Puma maintains contractual rights to recover monetary damages from the AstraZeneca litigation, unaffected by the court's recent orders.
This complex legal matter continues to unfold, with both parties having completed briefing on post-trial motions as of July 16, 2024. The case is based on information disclosed in a press release statement.
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