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What is the meaning of the word “of” when used in a patent? The Federal Circuit Court of Appeals that deal elusive question in a recent dispute between two pharmaceutical manufacturers and expert testimony of great help to find the answer.

But while the court has accepted the advice of experts on the meaning of “approximately” used in the patent, it appeared an about-face and rejected their testimony as to the ultimate question of infringement.

Ortho-McNeil Pharmaceutical brought the lawsuit against the manufacturer of generic drugs-Caraco Pharmaceutical Laboratories, alleging infringement of its U.S. Patent No. 5,336,691. Ortho patent covered a painkiller composed of two well-known analgesics, tramadol and acetaminophen.

The patent has shown that when combined in certain ratios the effects of both drugs were increased. Involved in this case was the claim of the patent No. 6, which involved a composition where the ratio of the material to acetaminophen is tramadol   a weight of about 1:5. “

Ortho continued after Caraco filed an application for abbreviated new drug to disclose its plan to manufacture and sell his own composition containing tramadol and acetaminophen. Caraco said the medicine had an average ratio of tramadol to acetaminophen of 1:8.67 and no less than 1:7.5. Ortho Caraco argued that the drug would infringe its patent.

The district court granted the summary trial and Ortho appealed to the Federal Circuit. Both the district court and on appeal, the case focused on the construction of the term “about 1:5.” Ortho argued that covered a radius of at least 1:3.6 to 1:7.1, and that, under the doctrine of equivalents, the wording of Caraco infringed. Caraco argued for a restrictive interpretation.

The district court adopted the construction asserted by Ortho, the “about 1:5″ means “approximately 1:5, encompassing a range of ratios of no more than 1:3.6 to 1:7.1.” He came to this conclusion relying in part on the intrinsic evidence of the application and the specification and in part to the extrinsic evidence of Ortho experts, Dr. Donald R. Stanski and Dr. Eric Smith. The two experts gave the Notice that one of ordinary skill in the art to conclude that “about 1:5″ limitation include a series of reports that would extend to include and 1:7.1.

The Federal Circuit upheld that construction. As the district court, he found support for this construction as in the claim itself and the testimony of the expert Ortho, Dr. Stanski. “Dr. Stanski has estimated that” about 1:5 “means” about 1:5, which includes up to and including 1:7.1 “, noted the court.

Caraco Accepting this construction means that the product did not literally infringe Ortho patent. Ortho patent covered a maximum ratio of 1:7.1, while Caraco started 1:7.5. The question, therefore, became Caraco if the drug under the violation of the doctrine of equivalents.

Building on its experts, Ortho said it did. One expert, Dr. Stanski, said that the weight of 1:8.76 is substantially similar to a weight ratio of 1:5. Another expert, Dr. Smith said in its report that the “degree of synergy of a composition with a weight of tramadol to acetaminophen of 1:5 is identical to the measure of the synergy of a composition with a weight of tramadol to acetaminophen of 1:8.67.

But the district court agreed. It concluded that a finding of infringement by a formulation with an average weight of 1:8.67 would render meaningless “about 1:5″ limitation.

The Federal Circuit affirmed, finding that the 1:5 critical parameter for the invention. Stretching the limits of this parameter Caraco to cover the drug would be in direct conflict with the patent for the express both the claim of 1:1 and 1:5 ratios, the court said.

“In this case, if the ratio of 1:5 of the analgesic response is statistically different from that of other ratios any time,” the court said. “The intrinsic evidence points to the desirability and thus the criticality of the ratio of 1:5 compared to other ratios.”

“Ortho can not now claim that the parameter is sufficiently broad to encompass, through the doctrine of equivalents, the rate outside the confidence interval expressly identified in the patent,” continued the court. “We agree with the district court that eviscerate the limitation.”

For these reasons, the court said, he concluded that the drug Caraco does not infringe Ortho’s patent and that the district court properly granted a summary of non-infringement.

Ortho-McNeil Pharmaceutical, Inc. v. Caraco Pharmaceutical Laboratories, Ltd., Case No. 06-1102 (Fed. Cir. January 19, 2007).

Written by Robert Ambrogi for Bullseye, IMS Expert Services Publication

Robert Ambrogi is the editor of Bullseye, a monthly newsletter distributed by IMS Expert Services. IMS Expert Services is the first expert witness consulting and litigation research firm in the legal industry, focused exclusively on providing custom expert witness in search of lawyers.



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