In re Montgomery, App no. 2011-1376 (Fed. Cir. May 8, 2012) (a copy is available at the end of this post), a divided panel affirmed the Board’s decision that a claim to a “new use for an old compound” was inherently anticipated by a reference disclosed in a proposed clinical trial that had not been carried out as of the effective filing date of the application. The claim in question was:
“A method for the treatment or prevention of stroke or its recurrence, wherein said method comprises administering, to a patient diagnosed as in need of such treatment or prevention, an inhibitor of the rennin-angiotensin system, said inhibitor having a Clog P greater than about 1.”
Claim 45 recited that the inhibitor comprises ramipril. Although the Examiner had found inherent anticipation based on four references, the panel only relied on a paper describing the planned “HOPE study,” which was to be a large scale trial of ramipril and Vitamin E “which describe[s] the administration ramipril to subjects at risk of stroke.” The two judge majority (Prost, Dyk) noted that the results of the trial indicated that the risk of stroke was, in fact, reduced, but that the results were published after the effective filing date of Montgomery’s application and so were “irrelevant to an anticipated analysis.” Slip op. at 5.
In interpreting the claims, the majority wrote that “[w]e are skeptical that a proper interpretation of the claims would require an efficacy requirement,” citing Bristol-Myers Squibb Co. v. Ben-Venue Labs., Inc. 246 Fed. 1371 (Fed. Cir. 2001). In the main claim in Bristol-Myers, the result (“a method for…”) was also only recited in the preamble, and so was held to “merely express a purpose [to be achieved].” But if a method of treatment claim, properly construed, does not meet the efficacy requirement, has it been construed so as to preserve its validity under s. 101? The panel left this as dicta, but it underscores the importance of reciting the result achieved by a claim to a medical treatment in the body of the claim.
The majority went on to affirm the inherency rejection, stating that “[w]e have repeatedly held the ‘[n]ewly discovered results of known processes directed to the same purpose [Ed. Note: see Perricone v. Medicis] are not patentable because such results are inherent.…As we stated in Cruciferous Sprout, 301 F.3d at 1350, ‘[i]t matters not that those of ordinary skill heretofore may not have recognized the inherent characteristics of the [prior art].’ [Ed. Note: Cruciferous Sprout was wrongly decided, at least with respect to the medical uses of the sprouts.]…HOPE discloses a protocol for the administration to stroke-prone patients, and administering ramipril to stroke-prone patients inevitably treats or prevents stroke….Thus HOPE inherently anticipates the claims at issue.”
The majority rejected Montgomery’s position that inherent anticipation requires that the claimed method have been actually performed, and that HOPE does not disclose actual performance of the method: “We stated [in Schering, 339 F.3d at 1381] that anticipation ‘requires only an enabling disclosure,’ not ‘actual creation or reduction to practice,’…the prior art patent inherently anticipated as long as it ‘disclose[d] in an enabling manner the administration of loratadine to patients.’ Id. At 1380; see also SmithKline Beecham Corp. v. Apotex, 403 F.3d 1331, 1343-1344 (Fed. Cir. 2005).”
In my opinion, these statements set up, if not set off, Judge Lourie’s dissent, which could be a textbook chapter on inherent anticipation. Judge Lourie dissented from the denying of rehearing en banc in Schering Corp. v Geneva Pharm., Inc., which he cites early in the dissent, and argues: “An unbounded concept of inherency, as Schering illustrates, threatens to stymie innovation by withdrawing from the realm of patentability that which has not before been known, used or benefited from. Properly understood, anticipation by inherency is far more limited…I believe that the majority has found inherency where it does not exist.” Slip op. dissent at page 2.
The legal hair that Judge Lourie asserts must be split in determining whether or not a prior art document supports inherent anticipation is the inevitability of the outcome of the prior art considered, as it must be, before the outcome is known. “For anticipation by inherency, a later-claimed invention must have necessarily resulted from the practice of a prior art reference…Were inevitability not required for inherency, a mere proposal for further experimentation could anticipate a claimed invention….’An invitation to investigate is not an inherent disclosure’ [citing Metabolite Labs., 370 F.3d at 1367]…. Inherency follows from the carrying out of an activity that inherently produces what is claimed; inherency does not arise from a plan whose description does not indicate its realization.”
This is a fine point, because the majority made it clear that a description of a method need not be carried out in fact, but only enable, the claimed result, in order to anticipate it. I think what Judge Lourie is saying – and he says it more than once—is that “[i]n the unpredictable arts, rarely, if ever will an untested [not actually carried out ] proposal necessitating further study and optimization [like a clinical trial protocol] meet the stringent standard of inherent anticipation.” Slip op. at 3, dissent. In other words, he is finding enough unpredictability in the HOPE trial to rule that it fails the standard that “inherency must be certain,” even though one of the goals of the trial was to investigate the effects of the drug on stroke and, in fact, the eventual conclusion was that it did lessen the chance of stroke.
Lourie’s reasoning makes sense in cases in which the prior art process (a) had not yet been carried out and (b) where the results which form the basis of the claim would not occur with absolute certainty, were the process to have been carried out. The level of uncertainty, e.g., in the results of a clinical trial, destroys the required predictability of the outcome which must be more than “reasonably predictable,” e.g. a la Wands, but must be inevitable.