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Patent Specification Defines Claim Term Despite Alleged Ordinary Meaning

March 20, 2003

Decision icon Decision

Last Month at the Federal Circuit - April 2003

Judges: Lourie (author), Michel, and Bryson

In Abbott Laboratories v. Novopharm Ltd., No. 02-1387 (Fed. Cir. Mar. 20, 2003), the Federal Circuit affirmed the lower court’s grant of SJ of noninfringement.

U.S. Patent No. 4,895,726 (“the ‘726 patent”) claims a composition and methods relating to therapeutic fenofibrate, which can be used to treat hyperlipidemia or hypercholesterolemia. After Novopharm Ltd. (“Novopharm”) filed an ANDA seeking approval to market a generic fenofibrate, the assignee of the ’726 patent and its exclusive licensee, Abbott Laboratories (“Abbott”), filed suit under the provisions of the Hatch-Waxman Act. Abbott holds the approved New Drug Application for fenofibrate and markets fenofibrate as TRICOR®.

Whether Novopharm’s generic fenofibrate would infringe if approved by the FDA hinged on the construction of the term “co-micronization,” which appeared in both of the asserted independent claims and was added during prosecution. Abbott argued that the plain meaning of the disputed claim term should control, but the Federal Circuit disagreed.

In particular, the Court explained that claim terms are generally accorded their ordinary and accustomed meaning, except where the patentee clearly defines a term in the specification. Here, the ’726 patent explicitly defines “co-micronization” as an “intimate mixture of fenofibrate and a solid surfactant,” and, thus, the claim term excluded mixtures including ingredients, such as excipients and water, in addition to the intimate mixture of fenofibrate and a surfactant. Because Novopharm’s process will not ”co-micronize” fenofibrate and a solid surfactant, there will be no literal infringement. The Court further ruled that Novopharm’s process will not infringe under the DOE, as that would vitiate the step of “co-micronization” in contravention of the all-elements rule.