Judge Gregory M. Sleet recently issued an opinion construing the disputed terms of U.S. Patent No. 5,980,940 (“the ’940 Patent”), entitled “Pharmaceutical Combination Preparation for Hormonal Contraception.” Bayer Intellectual Property GmbH et al. v. Warner Chilcott Co., LLC et al., C.A. No. 12-1032-GMS (D. Del. Oct. 9, 2014). As to the phrase “effective estrogen content,” defendants’ construction was founded on “the lowest level disclosed in a preferred embodiment, and requires ethinyl estradiol in an amount of at least 15 [micrograms] in the combined pill and at least 2 [micrograms] in the unopposed pill.” Id. at 2. Defendants argued that “given the patent’s objective to provide a daily estrogen content that was ‘as low as possible in each individual dosage unit,’ the inventors would have preferred and described lower respective doses if they believed that such estrogen content would be ‘effective.’” Id. Judge Sleet found, however, that “the subjective intent of the inventor when he used a particular term is of little or no probative weight in determining the scope of a claim,” and that “when a claim term is expressed in general descriptive words, [the court] will not ordinarily limit the term to a numerical range that may appear in the written description or in other claims.” Id. at 2. The Court thus found that the term “effective estrogen content” captures “pharmaceutical combinations with ethinyl estradiol levels below 15 [micrograms] in the combined pill and below 21 [micrograms] in the unopposed pill.” Id.
As to the disputed phrase “high contraceptive reliability, low incidence of follicular development, and satisfactory cycle control, with reliable avoidance of intracyclic menstrual bleeding and undesirable side-effects,” Judge Sleet found that the “disputed phrase should not be construed as a single term because it includes five distinct requirements that cover different oral contraceptive concepts/characteristics.” Id. at 3. However, Judge Sleet was ultimately unable to construe this disputed phrase. After rejecting both parties’ proposed constructions, Judge Sleet provided the following explanation:
The plain meaning of the claim language leaves the court with numerous questions, the answers to which are necessary to complete an infringement analysis regarding when the claim limitations are met. For example, how high must the contraceptive reliability be? What incidence of follicular development would be considered low? What constitutes satisfactory cycle control? And even more problematic are the reliable terms. What level of avoidance is necessary for intracyclic menstrual bleeding, and is it evaluated after the first 28 day administration cycle or after prolonged use? The uncertainty is compounded for side effects. The specification discusses various side effects ranging from headaches to cardiovascular disease. What constitutes an unacceptable avoidance of headaches is a thoroughly different question than what would constitute unacceptable avoidance of cardiovascular disease, yet the two are linked together in a single characteristic in the disputed phrase. Finally, even if the court did have individual standards against which the limitations are measured, the intrinsic record does not indicate what analytical tools or processes should be used to make the measurements.
Id. at 7-8. Judge Sleet went on to further explain that “[t]he Supreme Court has recently held that the proper test for whether a patent is indefinite is ‘if its claims, read in light of the patent’s specification and prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.’” (citing Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, *6 (2014)). Judge Sleet concluded that “[t]he difficulty the court has encountered in construing the terms may unavoidably present an indefinite issue that will need to be addressed at summary judgment.” Id. at 8.