IP Law Daily, PATENT—D. Del.: Biotechnology company dismissed from lawsuit over lung cancer drug Tagrisso, (Mar 18, 2024)

By Brian Craig, J.D.

A biotechnology company’s license does not cover use of the compound in AstraZeneca’s Tagrisso drug, but Wyeth remains a plaintiff.

In a patent infringement case against AstraZeneca Pharmaceuticals involving the drug Tagrisso used for treating lung cancer, the federal district court in Delaware has dismissed plaintiff Puma Biotechnology, Inc. from the lawsuit, but Wyeth remains a plaintiff and the case must be decided by a jury. The court concluded that the biotechnology company lacks standing because its license does not cover use of the compound in the drug for Tagrisso. But the court held a jury must decide questions over invalidity of the patents and whether AstraZeneca infringed the patents owned by Wyeth, a subsidiary of Pfizer (Puma Biotechnology, Inc. v. AstraZeneca Pharmaceuticals LP , March 18, 2024, Kennelly, M.).

Puma Biotechnology, Inc., and Wyeth LLC sued AstraZeneca Pharmaceuticals LP and AstraZeneca AB (collectively AstraZeneca) for infringement of two patents that claim a method of treating a certain form of non-small cell lung cancer. The patents were originally issued to Wyeth and General Hospital Corporation. In 2006, General Hospital Corporation assigned its rights in the patents to Wyeth. Wyeth was acquired by Pfizer in 2009 and is wholly owned subsidiary of Pfizer. In 2011, Puma signed an agreement with Pfizer to exclusively license the patents-in-suit with respect to a compound known as neratinib and certain other compounds. AstraZeneca moved to dismiss both Puma and Wyeth for lack of standing. In the alternative, AstraZeneca moved for summary judgment based on the defense of invalidity, non-infringement, and over pre-issuance damages. Puma and Wyeth moved for partial summary judgment on AstraZeneca’s advice-of-counsel defense. The parties also filed motions to exclude certain expert testimony related to damages.

Standing. The court held that Puma lacks standing, but Wyeth has suffered an injury to establish standing. The Federal Circuit has held that parties holding exclusionary rights and interests created by the patent statutes, but not all substantial rights to the patent have Article III standing. It is undisputed that Puma’s exclusive license to the patents-in-suit is “compound-specific.” Puma holds rights to practice the patents only with respect to certain compounds. Puma’s exclusive license does not permit it to practice the patents-in-suit with respect to osimertinib, the compound in Tagrisso. This means that AstraZeneca’s allegedly infringing activity falls outside of the scope of Puma’s license. Because Puma has no right to use or exclude others from practicing the patents-in-suit with respect to osimertinib, it has no standing to sue AstraZeneca for infringement.

While the court dismissed Puma as a plaintiff based on lack of standing, the court denied the motion to dismiss Wyeth as a plaintiff. AstraZeneca argued that Wyeth lacks standing because it has given its patent rights to its parent company Pfizer. The Federal Circuit has held that those who possess exclusionary rights in a patent suffer an injury when their rights are infringed.

Even if Wyeth has given Pfizer veto power over settlements in litigation related to the patents, Wyeth, as patentee, maintains the right to grant or refuse a license to AstraZeneca for the alleged infringing conduct. Thus, Wyeth has suffered an injury-in-fact for Article III standing purposes.

Invalidity. The court concluded that the case must go to trial and that AstraZeneca is not entitled to summary judgment on its invalidity defense. AstraZeneca argued that all of the Wyeth’s claims fail because the patents fail to meet the enablement and written description requirements. The specification discloses information sufficient to meet the written description requirement for negative claim limitations. AstraZeneca may argue that the exclusion of an inhibitor casts doubt on whether the specification enables a person of ordinary skill in the art to identify the compounds with which the claimed method of treatment can be practiced without undue experimentation at trial. But genuine disputes of material fact preclude summary judgment on the invalidity defenses based on enablement and lack of a written description and must be decided by a jury.

Non-infringement. Next, the court denied AstraZeneca’s motion for summary judgment on non-infringement. The court concluded that factual questions regarding whether Tagrisso infringes the asserted claims of the patents must be resolved by the jury.

Pre-issuance damages. The court granted AstraZeneca’s motion for summary judgment on pre-issuance damages. As a general rule, patent owners may only collect damages for patent infringement that takes place during the term of the patent. Because AstraZeneca is only accused of induced infringement, it cannot be liable for pre-issuance damages.

Advice of counsel. The court concluded that can AstraZeneca can present evidence in support of the advice-of-counsel defense at trial and denied Wyeth’s motion for summary judgment on AstraZeneca’s advice-of-counsel defense. The court rejected Wyeth’s contention that only AstraZeneca’s Board of Directors can be considered the relevant decisionmaker that must rely directly on the opinions of outside counsel for purposes of the advice-of-counsel defense.

Expert testimony. Finally, the court denied Wyeth’s motions to exclude the testimony of AstraZeneca’s expert witnesses on damages. The court found the testimony of AstraZeneca’s expert witness using data analysis is sufficiently reliable and that any late disclosure was harmless.

The Case is No. 21 C 1338.

Attorneys: Jack B. Blumenfeld (Morris, Nichols, Arsht & Tunnell LLP) for Puma Biotechnology, Inc., and Wyeth LLC. Andrew Russell (Shaw Keller LLP) for AstraZeneca Pharmaceuticals, LP, AstraZeneca AB, and AstraZeneca AB.

Companies: Puma Biotechnology, Inc.; Wyeth LLC; AstraZeneca Pharmaceuticals, LP; AstraZeneca AB; AstraZeneca AB; General Hospital Corp.; Pfizer Inc.

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