In Bayer Intellectual Property GMBH et al. v. Warner Chilcott Co., LLC, C.A. No. 12-1032-GMS (D. Del. Apr. 21, 2015), Judge Gregory M. Sleet considered defendants’ motion for summary judgment, and found U.S. Patent No. 5,980,940 (“the ’940 Patent”) to be indefinite and therefore invalid. The ’940 Patent claims “an oral contraception regimen in which two hormones are taken at set time points throughout the dosing schedule.” Id. at 1. As Judge Sleet explained, the court found in its October 9, 2014 Claim Construction Order that it was unable to construe the phrase “high contraceptive reliability, low incidence of follicular development, and satisfactory cycle control, with reliable avoidance of intracyclic menstrual bleeding and undesirable side-effects.” Id. at 2. Specifically, the court found that the “words of degree” – i.e., “high,” “low,” “satisfactory,” and “reliable”–“had no standards against which to draw comparisons, and the patent offered no suggestions for how to measure these criteria.” Id. The court therefore indicated that “summary judgment would be the proper avenue to address an indefiniteness challenge.” Id.
Judge Sleet noted that “[t]he court has already explained in its Claim Construction Order that the intrinsic record fails to assign meaning to the words of degree in the disputed term” and that plaintiffs “did not seek reconsideration of this ruling, and the court need not revisit its reasoning.” Id. at 3. Rather, plaintiffs contended that the disputed term is not indefinite “because one skilled in the art would understand–with reasonable certainty–its meaning, as demonstrated by extrinsic evidence.” Id. As Judge Sleet explained, plaintiff provided “dozens of pieces of extrinsic evidence, as well as a supplemental declaration . . . , in support of a new argument that the disputed term and the words of degree simply indicate that the claimed invention performs comparably to other oral contraceptives on the market.” Id. at 3-4.
As an initial matter, Judge Sleet took issue with plaintiffs’ “procedure in making [their] arguments,” as the court provided counsel “an opportunity during the Markman hearing to explain why extrinsic evidence was necessary to construe terms,” at which time plaintiffs conceded the evidence was merely for “context.” Id. at 4. Nevertheless, plaintiffs “flooded the court with never-before-seen evidence and expert testimony, supporting a new, ‘clearly established’ meaning of the disputed term.” Id. at. 5. Judge Sleet thus found plaintiffs’ “efforts to reargue claim construction with entirely new evidence at this time . . . improper.” Id.
Judge Sleet went on to explain that even if the court accepted the newly presented extrinsic evidence, it would reach the same result and find the term indefinite. First, as Judge Sleet noted, “the proposed construction (and the underlying extrinsic evidence) conflicts with the intrinsic record of the ’940 Patent, violating a basic tenet of claim construction.” Id. at 5. Further, “the conflicting interpretations of the disputed term offered . . . in [the] two declarations underscore the fact that the patent ‘fails to inform, with reasonable certainty, those skilled in the art about the scope of the invention.’” Id. at 6. Lastly, Judge Sleet found that even if the court accepted plaintiffs’ new construction (“comparable to other marketed oral contraceptives”), the court would still find the ’940 to be indefinite, as the intrinsic record failed to provide objective boundaries as to the term “comparable.” Id.