In Andrulis Pharmaceuticals Corp. v. Celgene Corp., C.A. No. 13-1644-RGA (D. Del. June 26, 2015), Judge Richard G. Andrews construed terms in claim 2 of U.S. Patent No. 6,140,346, finding three sets of related terms to be indefinite. The patent relates to a “novel method for treating cancers with thalidomide alone or in combination with other antiangiogenic and anti-cancer agents.” Id. at 1 (citation and internal quotation marks omitted).
The terms found indefinite were: “enhanced” and “enhanced combination”; “enhanced therapeutically-effective amounts of thalidomide”; and “said neoplastic diseases are sensitive to said enhanced combination.” Defendant argued that “enhanced” required degrees that the patent never articulated. Id. at 7. The Court found the “central issue” to be whether “enhanced means greater than additive,” as Plaintiff claimed the addition of “enhanced” was needed for the claim to overcome prior art, “or whether it renders the claim indefinite.” Id.
The Court concluded that the term was indeed indefinite. There was no evidence narrowing its meaning, id. at 8, and the patent provided very little guidance as to the meaning, id. at 8-9. The Court also found that the prosecution history did not support Plaintiffs’ contention that “enhanced” necessarily meant “greater than additive” in light of the prosecution history. Id. at 9. In fact, “[t]he prosecution history demonstrates that the applicant did not simply adopt the examiner’s position that the claims require a greater than additive effect.” Id. at 10. “It cannot be the case that ‘enhanced’ is merely a synonym for ‘greater than additive’ when read within the context of the examiner’s rejection, and the applicant’s amendment and response.” Id. The inventor’s own testimony supported the interpretation that “enhanced” was not synonymous with “additive effect,” id. at 12, although the Court did not find the inventors’, or proffered experts’, testimony on this subject particularly probative. See id. at 12, 13. It concluded that “[b]ecause ‘enhanced’ can mean less than additive, additive, or greater than additive, the term is indefinite because it does not inform a person skilled in art of the invention with reasonable certainty of its meaning in the patent-in-suit.” Id. at 13.
As to “enhanced therapeutically-effective amounts of thalidomide,” the Court concluded that its “grammatical structure adds a second reason for a finding of indefiniteness.” Id. at 14. Plaintiffs attempted to argue “enhanced” did not modify “therapeutically-effective amounts of thalidomide,” but the Court found this would result in “grammatical gymnastics.” Id. at 15. The larger term was indefinite because it was “unclear what an ‘enhanced’ amount of thalidomide . . . would be.” Id. The Court also found the third term “said neoplastic diseases are sensitive to said enhanced combination” indefinite “[f]or the reasons offered int eh analysis of the [other two] terms.” Id. at 17.
The Court also construed the terms “administering” and “neoplastic diseases.”