Ortho-McNeil Pharm. v. Caraco Pharm. (Fed. Cir. 2006).
Ortho’s patent covers a pain-relief combo of tramadol and acetaminophen with a ratio of “about 1:5.” Caraco’s drug has a ratio of 1:8.67. The lower court construed the claims and found no infringement.
Claim Construction: On appeal, the Federal Circuit construed the term “about 1:5” by first looking at the intrinsic evidence. In the patent and claims, Ortho had used the term “about” repeatedly: disclosed ratios included about 1:1, about 1:5, about 1:19 to about 1:5, and about 1:1600.
The court reasoned that the term must have a narrow meaning in this patent because a broad meaning would leave other claimed ratios meaningless. The court also noted that the literal meaning of the term should be narrowly construed because Ortho “could have easily claimed a [broader] range of ratios”
An expert testified that the statistical range should be 1:3.6 to 1:7.1 based on a confidence interval constructed from the data in the patent, and the Federal Circuit agreed. (The patent discussed the importance of 95% CI).
Literal Infringement: The Federal Circuit found that there could be no literal infringement because the upper claimed bound for the ratio was 1:7.1 while Caraco’s ratio was 1:8.67.
Doctrine of Equivalents: No DOE because Ortho cancelled claims with broader range during reissue. Interestingly, the Court made this ruling based on vitiation rather than prosecution history estoppel:
[I]t cancelled the broader "comprising" claims, except for claim 6. In sum, having so distinctly claimed the "about 1:5" ratio, Ortho cannot now argue that the parameter is broad enough to encompass, through the doctrine of equivalents, ratios outside of the confidence intervals expressly identified in the patent. We agree with the district court that to do so would eviscerate the limitation.
Summary judgment of noninfringement affirmed