The patentee, evoking a go-for-broke strategy, stipulated that its patents would be invalid and not infringed unless the district court claim construction was reversed or modified. The patentee lost all as the U.S. Court of Appeals for the Federal Circuit brushed aside the argument that claims are to be construed to preserve their validity and affirmed the district court’s claim construction. Housey Pharmaceuticals, Inc. v. Astrazeneca UK Ltd., Case Nos. 03-1193, -1210 (Fed. Cir. May 7, 2004) (Clevenger, J.) (Newman, J., dissenting).
Housey sued Astrazeneca and 11 other pharmaceutical entities alleging infringement of four patents. The issue focused a claim 1 of U.S. Pat. No. 4,980,281 (the `281 patent), directed to a method of determining whether a substance is an inhibitor or activator of a protein whose production by a cell evokes a responsive change in a phenotypic characteristic, is representative
of the claims in suit. The method requires treatment of a test cell containing the protein of interest and a control cell with a substance and comparing the phenotypic response between the treated cells.
The district court construed the term "inhibitor or activator of a protein" to mean a substance that has a greater effect on the phenotype of the test cell compared to the control cell, expressly rejecting Housey’s argument that an inhibitor or activator of a protein required direct binding to the protein of interest. The court’s construction included substances that affect a phenotypic change through direct or indirect interactions with the protein of interest.
Applying a "heavy presumption" that the claim language carries its ordinary meaning, even where to do so would render the claim invalid, the Federal Circuit analyzed the claim language, dictionary definitions and intrinsic evidence to construe the meaning of the term "inhibitor or activator of a protein." Affirming that an inhibitor or activator of a protein is not limited to substances that directly bind to the protein of interest, the majority held that the claim language clearly supports the broader construction. The claim recites steps that identify an inhibitor or activator by determining the effect of a substance on the occurrence of a phenotypic response. The specification expressly defines the term without reference to binding and Housey’s reliance on dictionary definitions failed to support the narrow construction because they included a general definition requiring an effect on the biological activity. The Court also concluded that the specification failed to clearly disavow the broad plain meaning, holding that the specification and prosecution affirmatively demonstrated that Housey intended that the claim not be limited to direct binding.
In dissent, Judge Newman characterized recent panel decisions regarding the plain meaning rule as "confusing" and argued that without due consideration to the context of the invention, the Court’s "heavy presumption" may lead to absurd results because it disregards the fact that technical terms take their meaning from the document in which they are used and not the general meaning from general usages of the term. In Judge Newman’s view "[i]t is time to restore the law of claim construction to a more apt wisdom and more usable simplicity."
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