IP Law Daily, PATENT—D. Del.: Jury’s $107.5 million verdict against AstraZeneca vacated in lung cancer treatment litigation, (Aug 15, 2024)

By Brian Craig, J.D.

The patents asserted by Pfizer subsidiary Wyeth LLC are invalid for failure to meet the enablement requirement and for lack of a written description.

Concluding that two patents owned by pharmaceutical giant Wyeth for treating lung cancer are invalid for failure to meet the enablement requirement and for lack of a written description, the federal district court in Delaware has vacated a $107.5 million jury verdict award against AstraZeneca Pharmaceuticals. In granting AstraZeneca’s motion for judgment as a matter of law, the court found that AstraZeneca presented clear and convincing evidence for patent invalidity based on lack of enablement. The court concluded that no reasonable jury could find that the patents enabled a person skilled in the art to administer a unit dosage covered by the claims to a patient without undue experimentation (Wyeth LLC v. AstraZeneca Pharmaceuticals LP, No. 1:21-cv-01338 (D. Del. Aug. 14, 2024)).

Wyeth, LLC owns U.S. Patents Nos. 10,603,314 (the ’314 patent) and 10,596,162 (the ’162 patent), both of which claim a method of treating a form of non-small cell lung cancer. Wyeth brought suit for infringement against AstraZeneca alleging that its drug Tagrisso (osimertinib) induced infringement of several claims of both patents. After a five-day trial, a jury found AstraZeneca liable and awarded $107.5 million in damages. The court then held a bench trial on AstraZeneca’s affirmative defenses and counterclaim of invalidity issuing its ruling. AstraZeneca then moved for judgment of a matter of law, arguing that no reasonable jury could have found that (1) AstraZeneca induced infringement of the patents-in-suit; (2) the patents were valid; or (3) that Wyeth suffered damages. Specifically, AstraZeneca argued that the patents are invalid due to anticipation, obviousness, lack of enablement, and lack of written description.

Infringement. The court first concluded that Wyeth presented sufficient evidence at trial to support both direct infringement and induced infringement. Wyeth presented evidence that second-line prescriptions continued to generate sales for AstraZeneca after the patents issued. The jury was permitted to conclude from these facts that AstraZeneca possessed specific intent to encourage another’s infringement.

Invalidity. The court held, however, that the patents are invalid based on lack of enablement and lack of written description. While the court rejected AstraZeneca’s argument that the patents are invalid due to anticipation and obviousness, the court found that both the ’314 patent and the ’162 patent are invalid back on lack of enablement. The enablement requirement is satisfied if the specification contains sufficient information to permit a person of skill in the art to make and use the claimed invention. AstraZeneca presented clear and convincing evidence that the patents are not enabled because an extraordinary and undue amount of experimentation would be required to identify the unit dosage for each of the myriad irreversible epidermal growth factor receptor (EGFR) inhibitors encompassed within the scope of the asserted claims.

The patent claims here are also invalid based on a lack of written description, the court found. A patent specification must contain a written description that clearly allows persons of ordinary skill in the art to recognize that the inventor invented what is claimed. The court concluded that nothing in the specification suggests that the inventors in fact had identified a unit dosage of the specified compounds that could be administered daily to a patient at levels high enough to show the desired therapeutic effect of interfering with the EGFR pathway and killing cancer cells. In other words, the specification describes an “unfinished project, not a completed invention.”

Damages. While the court agreed with AstraZeneca on patent invalidity, the court denied AstraZeneca’s motion for judgment as a matter of law that Wyeth did not suffer any damages. Experts at trial testified of a reasonable royalty rate. In fact, AstraZeneca’s own expert testified that a reasonable royalty rate would be three percent. The jury award of $107.5 million in damages is quite close to the implied royalty rate of 3.5 percent that would result in the $107.5 million in damages awarded by the jury.

Accordingly, the court granted AstraZeneca’s motion for judgment as a matter of law that the patents are invalid due to lack of enablement and lack of written description of the claimed invention, but otherwise denied AstraZeneca’s post-trial motion.

The Case is No. 1:21-cv-01338.

Judge: Kennelly, M.

Attorneys: Jack B. Blumenfeld (Morris, Nichols, Arsht & Tunnell LLP) for Wyeth LLC. Alexander Trzeciak (Covington & Burling LLP) for AstraZeneca Pharmaceuticals LP And AstraZeneca AB.

Companies: Wyeth LLC; AstraZeneca Pharmaceuticals LP; AstraZeneca AB

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