Ortho-McNeil Pharmaceutical, Inc. v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2007)

    By Donald Zuhn --

In an appeal from a District Court decision granting summary judgment in favor of Defendant-Appellee Caraco Pharmaceutical Laboratories, Ltd. (Caraco), the Federal Circuit concluded that the District Court did not err in construing the term "about 1:5" or in finding no literal infringement or infringement under the doctrine of equivalents, and thus, affirmed the District Court's grant of summary judgment of non-infringement.

Plaintiff-Appellant Ortho-McNeil Pharmaceutical, Inc. (Ortho) owns U.S. Patent No. 5,336,691 (the '691 patent), which relates to a pharmaceutical composition comprising certain weight ratios of the analgesics tramadol and acetaminophen (Ortho sells this composition under the trademark Ultracet®).  The '691 patent discloses that "[c]ertain ratios [of tramadol and acetaminophen] result in a composition which exhibits synergistic analgesic effects," and that "[t]he most preferred ratios are from about 1:19 to 1:50."  The '691 patent also discloses that ratios of "about 1:1 and about 1:5 are encompassed by the present invention."

Seeking approval to market a pharmaceutical composition containing tramadol and acetaminophen having a weight ratio of no less than 1:7.5 and an average weight ratio of 1:8.67, Caraco filed an Abbreviated New Drug Application (ANDA) with the FDA.  In response, Ortho filed suit against Caraco, alleging that the filing of the ANDA infringed claim 6 of the '691 patent.  The asserted claim recites a pharmaceutical composition comprising tramadol and acetaminophen in a weight ratio of "about 1:5."  Caraco then moved for summary judgment of non-infringement.

The threshold issue in this case involves the proper construction of the term "about 1:5."  Before the District Court, Ortho argued that "about 1:5" means "approximately 1:5, and . . . encompasses a range of ratios of at least 1:3.6 to 1:7.1," and Caraco countered that the term means "approximately 1:5, subject perhaps to minor measuring errors of, say, 5 or 10%."  Relying on Ortho's experts, who testified that those of ordinary skill in the art would understand that the term "about 1:5" encompasses a range of ratios between 1:3.6 and 1:7.1, the District Court construed the term "about 1:5" to mean "approximately 1:5, encompassing a range of ratios no greater than 1:3.6 to 1:7.1."

Based on its construction of the term "about 1:5," the District Court concluded that the composition described in Caraco's ANDA did not literally infringe the '691 patent.  In addition, the District Court determined that Caraco's composition - having an average weight ratio of 1:8.67 - did not infringe the '691 patent under the doctrine of equivalents, since such a finding would render the "about 1:5" limitation meaningless.

With regard to the District Court's construction of the term "about 1:5," the Federal Circuit considered the intrinsic and extrinsic evidence in the case, and determined that the District Court had not erred in construing the term "about 1:5" to mean "approximately 1:5, encompassing a range of ratios no greater than 1:3.6 to 1:7.1."  In reaching this determination, the Federal Circuit noted that "[t]he intrinsic evidence points to a meaning for the term 'about 1:5' that is narrow because the 1:5 weight ratio, along with the 1:1 weight ratio, is distinctly claimed and distinguished from other broader weight ratios in the patent."  In particular, the Court noted that because some of the claims in the '691 patent recite a single weight ratio and some claims recite ranges of weight ratios, "one of ordinary skill in the art would understand the inventors intended a range when they claimed one and something more precise when they did not."  The Court also noted that while the inventors tested ratios of 1:1, 1:3, 1:5, 1:5.7, and 1:15, "the patentees chose to specifically claim ratios of 1:1 and 1:5" rather than "claim[] a ratio range of 'about 1:1 to about 1:5,' or even a ratio range of 'about 1:3 to about 1:5.'"

With regard to the District Court's decision to grant summary judgment of non-infringement, the Federal Circuit first determined that under the District Court's claim construction, "there can be no literal infringement because Caraco's formulation must have a weight ratio of tramadol to acetaminophen of no less than 1:7.5."  Turning to the issue of infringement under the doctrine of equivalents, the Federal Circuit agreed with the District Court that to expand the weight ratio of "about 1:5" to encompass a composition having an average weight ratio of 1:8.76 "would eviscerate the limitation."  The Federal Circuit, therefore, concluded that the District Court properly granted summary judgment of non-infringement in favor of Caraco.

Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Lab., Ltd. (Fed. Cir. 2007)
Panel: Circuit Judges Schall and Gajarsa and Chief Judge McKinney
Opinion by Chief Judge McKinney

Comments

[Paul Martin NoPrescription]

If they got a patent how can they use the word about? We are talking medicines here and an aproximate is not an option, they should stick to an exact amount period.