On March 18, 2024, the U.S. District Court for the District of Delaware issued an opinion in Puma Biotechnology, Inc v. AstraZeneca Pharmaceuticals LP et al, 1:21-cv-1338-MFK granting AstraZeneca's motion for pre-issuance damages.
The parties are pharmaceutical companies that commercialize drugs to treat cancer and other illnesses. The suit is trying to block sales of AstraZeneca's drug Tagrisso (osimertinib) to treat lung cancer, which AstraZeneca has been selling since 2015. Wyeth has an exclusive license with Puma for developing and commercializing Wyeth's drug Nerlynx (neratinib) for treating breast cancer and is currently in clinical trials for treating lung cancer. The patents-in-suit (10,603,314 and 10,596,162) claim a method of treating a certain form of non-small cell lung cancer.
AstraZeneca moved for summary judgement on a variety of issues, including standing, invalidity, non-infringement, and pre-issuance damages, which the court denied with the exception of the pre-issuance damages.
Wyeth argued that a narrow exception exists to the general rule that patent owners can only collect damages for patent infringement that occurs during a patent term. The proposed exception comes from the "provisional rights" codified at 35 U.S.C. § 154(d), where a patent owner has the right to obtain a reasonable royalty from:
any person who, during the period beginning on the date of publication of the application for such patent . . . and ending on the date the patent is issued:
(A)(i) makes, uses, offers for sale, or sells in the United States the invention as claimed in the published patent application or imports such an invention into the United States; or
(ii) if the invention as claimed in the published patent application is a process, uses, offers for sale, or sells in the United States or imports into the United States products made by that process as claimed in the published patent application.
35 U.S.C. § 154(d)(1) (emphasis added).
The parties recognized and agreed that § 154(d) does not explicitly include a provision incorporating the induced infringement language of § 271(b); however, Wyeth argued that section 154(d) does not need to expressly mention induced infringement. The court disagreed based on the plain text of § 271(b) being directed to induced infringement of a patent while § 154(d) only extends rights to certain conduct specifically enumerated and not to all post-issuance patent rights. Therefore, the statute does not authorize pre-issuance damages for induced infringement.