Bayer Intellectual Property GmbH v. Warner Chilcott Co.

Case Name: Bayer Intellectual Property GmbH v. Warner Chilcott Co., LLC, 12-1032-GMS, 2015 U.S. Dist. LEXIS 52061 (D. Del. Apr. 21, 2015) (Sleet, J.) 

Drug Product and Patent(s)-in-Suit: Lo Loestrin^® Fe (norethindrone acetate / ethinyl estradiol / ferrous fumarate); U.S. Pat. No. 5,980,940 ("the '940 patent")

Nature of the Case and Issue(s) Presented: The '940 patent claims an oral contraception regimen in which two hormones are taken at set time points throughout the dosing schedule. The parties sought construction of the claim term, “high contraceptive reliability, low incidence of follicular development, and satisfactory cycle control, with reliable avoidance of intracyclic menstrual bleeding and undesirable side-effects.” In its claim construction order, the court found that it was unable to construe the disputed phrase because 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. Thus, Warner Chilcott, following the court’s guidance, moved for summary judgment of indefiniteness. The court granted the motion and found the asserted claims invalid as indefinite.

Why Defendant Prevailed: The intrinsic record failed to assign meaning to the words of degree in the disputed term. Moreover, Bayer did not seek reconsideration of the court’s claim construction ruling. Nevertheless, Bayer argued that the disputed term was not indefinite because one skilled in the art would understand—with reasonable certainty—its meaning, as demonstrated by extrinsic evidence. Bayer relied on dozens of pieces of extrinsic evidence, as well as a supplemental declaration from its expert, Dr. Lee Shulman, showing that the words of degree in the disputed claim term simply indicate that the claimed invention performs comparably to other oral contraceptives on the market.

The court rejected this evidence on various grounds. Firstly, it had given counsel for Bayer an opportunity during the Markman hearing to explain why extrinsic evidence was necessary to construe the terms, whereas Bayer conceded that the evidence was merely for “context.” Secondly, during a subsequent teleconference, the court explained that additional extrinsic evidence would not be considered. “Bayer has flooded the court with never-before-seen evidence and expert testimony, supporting a new, ‘clearly established’ meaning of the disputed term. Bayer’s efforts to reargue claim construction with entirely new evidence at this time is improper.” Finally, the court found that the proposed construction would conflict with the intrinsic record of the ’940 patent. “Whereas Bayer pushes for a construction that essentially replaces all of the words of degree in the disputed term with ‘comparable,’ the specification and prosecution history state repeatedly that the patented invention performed superior to prior art products on the market.” Bayer’s proposed construction also cannot stand on its own because the word “comparable” requires a frame of reference.