Claim construction:

Sanofi-Aventis U.S. LLC et al v. Actavis LLC et al

Court: District of Delaware

Case: 20-804

Date: Jan. 05, 2021

Judge: Richard J Andrews

 

This is a claim construction dispute concerning U.S. Patent No. 10,583,110 and U.S. Patent No. 10,716,777. The patents-in-suit disclose methods of treating metastatic castration-resistant prostate cancer with cabazitaxel. At the hearing, the parties agreed to a construction that resolved two of the three disputed terms: “a method of increasing survival” and “to a patient in need thereof.” All that remains is to construe “increasing survival.”

 

Disputed term: “Increasing Survival”

a. Plaintiff’s proposed construction: prolonging life as compared to no treatment or palliative treatment

b. Defendants’ proposed construction: Increasing any of:

– overall survival

– tumor progression-free survival

– pain progression-free survival, or

– prostate-specific antigen (PSA) progression-free survival

c. Court’s construction: Increasing any of:

– overall survival

– tumor progression-free survival

– pain progression-free survival, or

– prostate-specific antigen (PSA) progression-free survival

 

Plaintiffs argued that the term “increasing survival” would be readily understood by a POSA as “prolonging life.” Plaintiff asserted that they successfully disclaimed Defendants’ construction (or any construction broader than the one they propose) during the prosecution of the related US 8,927,592 patent. Defendants argued that the specification, which should be given dispositive weight, is clear – it defined above four measures of survival. Defendants argued that “prolonging life” includes progression free survival so the statements cannot disclaim the inclusion of progression free survival. Second, Defendants argued that to the extent Plaintiff has disavowed anything, what it has disavowed is the inclusion of non-time-based measurements (tumor-shrinkage, pain reduction, etc.) rather than the other, time-based survival measures discussed in the specification.

 

Court agreed with Defendants’ construction & said that the specification discusses two forms of survival: “overall survival” and “progression free survival.” The only instance Plaintiffs point to where “survival” is used to refer exclusively to “overall survival” is a citation to a review article in the specification. Therefore, the disavowals cited by Plaintiffs do not meet the standard necessary to rewrite the definitions offered in the specification.