Prosecution History Informs Claim Meaning Even Without Unmistakable Disclaimer

Author:Ms Courtenay Brinckerhoff
Profession:Foley & Lardner

Although non-precedential, the Federal Circuit decision in Aptalis Pharmatech, Inc. v. Apotex Inc. is worth a read to see how the court "tiptoes" the "fine line between reading a claim in light of the specification, and reading a limitation into the claim from the specification." Here, the court also notes that the prosecution history can inform claim meaning even without clear and unmistakable disclaimer of claim scope.

The Patents At Issue

The patents at issue were U.S. Patent Nos. 7,790,199 and 7,829,121, which are listed in the Orange Book for Aptalis's AMRIX® product. The court cited claim 1 of the '199 patent as representative:

A pharmaceutical dosage form comprising a population of extended release beads, wherein said extended release beads comprise: an active-containing core particle comprising cyclobenzaprine hydrochloride as the active; and an extended release coating comprising a water insoluble polymer membrane surrounding said core, wherein said water insoluble polymer mem- brane comprises a polymer selected from the group consisting of ...

wherein the total amount of cyclobenzaprine hydrochloride in the pharmaceutical dosage form is 30 mg;

wherein following a single oral administration of the pharmaceutical dosage form, the pharma- ceutical dosage form provides a maximum blood plasma concentration (Cmax) of 19.851±5.8765 ng/mL of cyclobenzaprine HCl and an AUC0-168 of 736.60±259.414 ng"hr/mL.

The highlighted claim language was in dispute. In particular, Apotex argued that its ANDA product did not infringe because it used a matrix-type formulation to achieve extended release, not an extended release coating.

The Federal Circuit Decision

The non-precedential decision was authored by Judge Stoll and joined by Judges Reyna and Wallace.

The district court had construed the claims broadly enough to encompass the Apotex product. On appeal, Apotex argued that the intrinsic evidence showed that "an 'extended release coating' is limited to a continuous outer film, not simply '[a] layer of any substance that is applied onto the surface of another.'" The Federal Circuit agreed.

First, the court considered the "coating" and "surrounding" language of the claims:

A coating that surrounds the core or encloses it on all sides connotes a continuous coating, i.e., one that covers the entire surface of the core. And, because the extended release coating must surround the core, the plain claim language suggests that the coating must be located outside of the...

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