By Kevin E. Noonan --
In an otherwise unremarkable case of a PTO rejection based on anticipation, Judges Dyk and Lourie engaged in an interesting colloquy on the proper interpretation of what constitutes inherent anticipation, in In re Montgomery. The case involved claims to methods for "treating or preventing" stroke, using "renin-angiotensin system (RAS)" inhibitors, specifically ramipril. The claims at issue included the following:
42. 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 ClogP of greater than about 1.
43. The method as claimed in claim 42, wherein the inhibitor of the rennin-angiotensin system comprises at least one inhibitor of angiotensin-converting enzyme.
45. The method as claimed in claim 43, wherein the inhibitor of angiotensin-converting enzyme comprises ramipril.
(Emphasis in original)
The claims were rejected based on any of four prior art references:
• AIRE (The Acute Infarction Ramipril Efficacy (AIRE) Study Investigators, Effect of Ramipril on Mortality and Morbidity of Survivors of Acute Myocardial Infarction with Clinical Evidence of Heart Failure, 342 Lancet 821 (1993));
• Frampton (James E. Frampton & David H. Peters, Ramipril: An Updated Review of Its Therapeutic Use in Essential Hypertension and Heart Failure, 49 Drugs 440 (1995) (abstract));
• HOPE (The HOPE Study Investigators, The HOPE (Heart Outcomes Prevention Evaluation) Study: The Design of a Large, Simple Randomized Trial of an Angiotensin- Converting Enzyme Inhibitor (Ramipril) and Vitamin E in Patients at High Risk of Cardiovascular Events, 12 Can. J. Cardiology 127 (1996)); or
• Gohlke (Peter Gohlke et al., Angiotensin-Converting Enzyme Inhibition Improves Cardiac Function, 23 Hypertension 411 (1994)) as evidenced by Richer (C. Richer et al., Antihypertensive Drugs in the Stroke-Prone Spontaneously Hypertensive Rat, 19 Clinical & Experimental Hypertension 925 (1997) (abstract), available here.
The Examiner, and the Board, found that each of these references taught administration of ramipril to individuals at risk for stroke (the Court's opinion noting that the limitation that the RAS inhibitor had "a ClogP of greater than about 1" was inherently a property of ramipril).
Specifically, the Board made the factual determinations that "[h]ypertension is a known risk for stroke" and that the cited references described studies showing treatment of patients with hypertension with ramipril (although at least in the AIRE study the results were not statistically significant). The HOPE study was described as involving the combination of ramipril and Vitamin E "in the prevention of myocardial infarction, stroke, or cardiovascular death." (The HOPE study showed statistically significant reduction in stroke risk, but not until after Montgomery's priority date.) The Gohlke reference showed "the effects of . . . ramipril on functional and biochemical cardiac parameters in stroke-prone spontaneously hypertensive rats," which found that the treatment "improves cardiac function even at low doses," where Richer established that "[t]he stroke-prone spontaneously hypertensive rat . . . is an experimental model that has been widely used to investigate the potential preventive effects vs stroke and mortality of numerous antihypertensive agents." The Board construed the claims as having two elements: "(1) 'to administer an inhibitor of the rennin-angiotensin system,' and (2) 'the patient population receiving the inhibitor . . . encompasses patients diagnosed as required stroke treatment or prevention.'" The Board held that each reference provided these elements and hence anticipated the claims.
The Federal Circuit opinion noted that the Board did not rule "directly" on the question of whether the claims contained a requirement that the method be effective at treating or preventing stroke, but said it "appeared to assume that they did include such a requirement." In rejecting Montgomery's argument that the references did not demonstrate efficacy for using ramipril to treat stroke, the Board found that efficacy was "inherent" and need not be demonstrated, citing In re Cruciferous Sprout Litig., 301 F.3d 1343, 1350 (Fed. Cir. 2002).
The Federal Circuit upheld the Board's decision, in an opinion by Judge Dyk joined by Judge Prost; Judge Lourie dissented. In the majority opinion, Judge Dyk set forth the analytical framework: first the claims are construed giving claim terms their "broadest reasonable interpretation consistent with the specification," citing In re Bond, 910 F.2d 831, 833 (Fed. Cir. 1990). Then, the claims are compared to the prior art, and anticipation found if every limitation is contained in a single reference. In re Aoyama, 656 F.3d 1293, 1296 (Fed. Cir. 2011). Regarding inherent anticipation, an unrecited limitation is present so long as it is "necessarily present, or inherent, in the single anticipating reference," citing Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003); but the opinion emphasized the word "necessarily" in this context, finding authority for this proposition in In re Oelrich, 666 F.2d 578, 581 (CCPA 1981).
The opinion focused on claim 45, with expressly recited ramipril, saying that the other two claims, being broader in scope would also be anticipated. The Federal Circuit relied on the HOPE reference, finding that its determination that this reference anticipates eliminates any reason to address Montgomery's arguments on the other references. The HOPE reference satisfied the limitation that ramipril be administered to "a patient diagnosed as in need of [stroke] treatment or prevention" according to the Court, and the opinion states that Montgomery did not dispute this Board finding.
Turning to the preamble ("for the treatment or prevention of stroke or its recurrence") (which the Board and the Court construed as an affirmative limitation), the opinion noted that while the Board "appeared to assume that the patent included an efficacy requirement," the majority was "skeptical that a proper interpretation of the claims would include an efficacy requirement." The opinion bases its skepticism on its opinion in Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1371, 1375 (Fed. Cir. 2001), which it characterized as concerning a "similar "method of treatment" claim; in that case, the Court held that a method "for reducing hematologic toxicity" "merely express[ed] a purpose  rather than requiring a particular result." That construction "is even more appropriate here," says the majority, because the Board and the Court applies the "broadest reasonable interpretation" standard.
After this semantic sojourn, however, the majority finds that its resolution is not necessary, because it agrees with the Board that "even if the claim includes an efficacy requirement, efficacy is inherent in carrying out the claim steps." "[T]here is no question here that treating stroke-prone patients with ramipril does in fact inevitably treat or prevent stroke," according to the majority, and of course Montgomery does not (and cannot) disagree, since the efficacy of ramipril to treat or prevent stroke is "the entire premise of [Montgomery's] patent." Relying on Bristol-Myers Squibb, Cruciferous Sprout, and King Pharmaceuticals, Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1270 (Fed. Cir. 2010), the majority held that the HOPE reference disclosed administration of ramipril to "stroke-prone" patients, which "inevitably treats or prevents stroke." Nor does the law require that ramipril had ever been administered to treat or prevent stroke, provided that the treatment was at least "merely proposed," citing for support the outcome in Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003), and SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44 (Fed. Cir. 2005).
Judge Lourie dissented, calling inherency "a very tricky concept in patent law." Judge Lourie uses Schering Corp. v. Geneva Pharm., Inc. as an example, contrasting the "salutary goal" of the principle in "prevent[ing] subject matter that is effectively in the public's possession from being retrieved by a patent and withdrawn from the public domain" with the risk of "withholding patent protection from that which the public knew nothing about until a later inventor found it." Sounding like an antipode to Justice Breyer, the dissent states that an "unbounded concept of inherency  threatens to stymie innovation by withdrawing from the realm of patentability that which has not before been known, used, or benefited from." This is not Judge Lourie's conception of inherent anticipation, which requires "inevitability," which the Court's cases have been "steadfast" in requiring, citing Bettcher Indus., Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639 (Fed. Cir. 2011); Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939); and Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 1047 (Fed. Cir. 1995), the latter case illustrating that "even a very high likelihood" is not enough.
The alternative, according to Judge Lourie, would be that "a mere proposal for further experimentation could anticipate a claimed invention"; "[a]n invitation to investigate is not an inherent disclosure." Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004). "[I]nnovation should not be impeded by mere speculation." Turning to the majority's interpretation of the HOPE reference, Judge Lourie states that "[a] description of a process, even if not carried out, is an anticipation of that process. But 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"; Judge Lourie considers the HOPE reference to be better characterized as the latter of these two situations and thus not to anticipate the claims.
While perhaps not invoking the establishment of a trend, the dissent does make a case that the current members of the Court have become more likely to find inherent anticipation under a broader set of circumstances than have been applied heretofore. Whether this is another example of the turn of this Court, under persistent influence by the Supreme Court, to be less "patent friendly" than it was previously (at least as some have perceived) will depend on whether and to what extent this trend continues.
In re Montgomery (Fed. Cir. 2012)
Panel: Ciercuit Judges Lourie, Dyk, and Prost
Opinion for the court by Circuit Judge Dyk; dissenting opinion by Circuit Judge Lourie