Thursday, July 07, 2011

File history disclaimer dooms RECKITT BENCKISER INC. at CAFC

The CAFC noted:

In the context of the ’252 patent’s disclosure, which clearly distinguishes between SR formulation tablets and two-portion modified release products, the district court properly considered the prosecution history, including the amendments and remarks made by the applicants during prosecution of the application leading to the ’252 patent. Reckitt, slip op. at 22-26. The court correctly concluded that the prosecution history demonstrated a disclaimer of single-formulation SR guaifenesin tablets, even if those tablets release some guaifenesin immediately upon ingestion. Id. at 45 (characterizing the prosecution history as a “disclaimer of products with merely immediate release and sustained release properties,” as opposed to products with discrete IR and SR portions). The applicants dis- avowed claim coverage of sustained release tablets by cancelling original claims 1-11 and remarking to the examiner that “[o]riginal claims 1-11 were directed to a sustained release formulation . . . . [T]he sustained release claims have been cancelled to facilitate prosecu- tion.” Id. at 23. The unmistakable effect of that dis- avowal, evident from the applicants’ remarks distinguishing the prior art, was to limit the remaining claims to two-portion guaifenesin products. For instance, the applicants distinguished one reference by arguing that it “does not disclose a composition having both an immediate release portion that is fully bioavailable in the subject’s stomach and a sustained release portion that provides therapeutically effective bioavailability for at least 12 hours.” Id. at 24. The file history thus demonstrates a “clear and unambiguous” prosecution disclaimer. Seachange, 413 F.3d at 1373.


The district court’s claim construction, therefore, properly accounted for the patent’s disclosure and the applicants’ clear and unmistakable prosecution history disclaimer. See N. Am. Container, Inc. v. Plasti- pak Packaging, Inc., 415 F.3d 1335, 1345 (Fed. Cir. 2005) (concluding that the applicant, through arguments during prosecution, met “the high standard required in order to show a prosecution disclaimer”).

The doctrine of claim differentiation arose:

Under the doctrine of claim differentiation, “the presence of a dependent claim that adds a particular limitation raises a presumption that the limita- tion in question is not found in the independent claim[,] [a]lthough that presumption can be overcome if the cir- cumstances suggest a different explanation, or if the evidence favoring a different claim construction is strong . . . .” Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910 (Fed. Cir. 2004) (citations omitted).

Of bioequivalence:

Reckitt asserts, in essence, that bioequivalence necessitates infringement by equivalence. We have clarified, however, that “bioequivalency and equivalent infringement are different inquiries.” Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1298 (Fed. Cir. 2009). Indeed, on the facts of this case, prosecution history estoppel bars Reckitt from recapturing single-formulation SR guaifenesin tablets like those it disclaimed in obtaining the ’252 patent.


However, “when a patent applicant surrendered claim scope during prosecution before the PTO, the ordinary and customary meaning of a claim term may not apply.” Elbex Video, Ltd. v. Sensormatic Elecs. Corp., 508 F.3d 1366, 1371 (Fed. Cir. 2007). To narrow the scope of claim language, a prosecution history disclaimer must be “clear and unambiguous.” Seachange Int’l, Inc. v. C-COR Inc., 413 F.3d 1361, 1373 (Fed. Cir. 2005).

Fitzpatrick, Cella represented Reckitt in the losing cause.


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