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Actual Reduction to Practice Is Not Required for Inherent Anticipation of a Therapeutic Method

May 08, 2012

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Last Month at the Federal Circuit - June 2012

Judges: Lourie (dissenting), Dyk (author), Prost

[Appealed from: Board]

In In re Montgomery, No. 11-1376 (Fed. Cir. May 8, 2012), the Federal Circuit affirmed the Board’s decision that certain claims of U.S. Patent Application Serial No. 11/118,824 (“the ’824 application”) are invalid for anticipation.

The claims at issue are directed to methods of treating or preventing stroke with known renin-angiotensin system (“RAS”) inhibitors. The examiner rejected these claims as anticipated by four prior art references, and Montgomery appealed to the Board.

The Board construed the independent claim as having two elements: (1) to administer an RAS inhibitor, and (2) “the patient population receiving the inhibitor . . . encompasses patients diagnosed as required stroke treatment or prevention.” Slip op. at 6 (alteration in original) (citation omitted). The Board concluded that all four references taught administration of ramipril to stroke-prone patients, and that the claims were anticipated. The Board rejected Montgomery’s argument that none of the references demonstrated actually treating or preventing stroke, finding that ramipril inherently treats or prevents stroke regardless of whether the authors recognized this inherent characteristic. Montgomery appealed to the Federal Circuit.

On appeal, the Federal Circuit focused on the HOPE reference (“HOPE”), noting that because it disclosed both elements, it need not address the other three references. The Court found no error in the Board’s uncontested conclusion that HOPE disclosed the administration of ramipril to patients diagnosed as in need of stroke treatment or prevention.

The Court then turned to the requirement that the method be “for the treatment or prevention of stroke or its recurrence.” The Court stated that it need not resolve whether the claim required efficacy, because it agreed with the Board that even if the claim had such a requirement, it was inherent in carrying out the claim steps. The Court found that HOPE inherently anticipated the claims, because it disclosed a protocol for administering ramipril to stroke-prone patients, and further disclosed that doing so inevitably treats or prevents stroke. The Court stated that it “agree[d] with the dissent that a result is only inherent if it inevitably flows from the prior art disclosure, but there is no question here that treating stroke-prone patients with ramipril does in fact inevitably treat or prevent stroke.” Id. at 11. The Court stated that it has “repeatedly held that ‘[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent,’” even if “those of ordinary skill heretofore may not have recognized the[] inherent characteristics of the [prior art].” Id. (alterations in original) (citations omitted).

Montgomery argued that inherent anticipation requires an actual reduction to practice, and that HOPE did not disclose actual performance of the method. The Federal Circuit disagreed, noting that while “[a]n invitation to investigate is not an inherent disclosure,” “HOPE’s protocol for the administration of ramipril is far from an abstract theory . . . .” Id. at 14 (alteration in original) (quoting Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004)). The Court found that HOPE was identical to the ’824 application in all relevant respects, as neither disclosed actual results from the administration of ramipril, and noted that Montgomery conceded that HOPE’s authors could have obtained the patent claims based on the HOPE reference. The Court concluded that HOPE anticipated the claims, and affirmed the rejection.

Judge Lourie dissented, stating that the Court’s precedent has been steadfast in holding that inherent anticipation requires inevitability, and that a mere proposal for further experimentation is not enough. Judge Lourie found that the results of the study proposed in HOPE were not predictable or inevitable, and disagreed with the majority’s finding to the contrary. Judge Lourie further disagreed with the majority’s finding that HOPE would anticipate even if it merely proposed administering ramipril for treatment or prevention of stroke without actually doing so. Judge Lourie stated that “a mere description of a process that, if it had been carried out, might yield a particular undisclosed result is not an inherent anticipation of that result.” Lourie Dissent at 5.

Summary authored by Kimberly D. Braslow, Ph.D., student associate at Finnegan.