Court Opinion

ID: 8411416
Source: CourtListenerOpinion
Date Created: 2022-11-02 18:55:20.888596+00
Date Added: 2024-06-11T16:47:51.340869
License: Public Domain

GAJARSA, Circuit Judge,
dissenting.
I respectfully dissent from the majority’s affirmance because the district court did not undertake the required legal analysis to determine whether an ordinarily skilled artisan reading the patent would understand it to reveal a credible utility for the invention. In addition, the district court failed to make the factual findings necessary to support the ultimate legal conclusion regarding enablement. See Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1149 (Fed.Cir.2004) (“Enablement is a matter of law that we review without deference; however, this Court reviews the factual underpinnings of enablement for substantial evidence.”). Thus, I would vacate the judgment of non-enablement and remand for the district court to make the required factual findings and to perform the necessary legal analysis in the first instance.
The parties do not dispute that Dr. Davis’s insight regarding galantamine’s utility for treating Alzheimer’s Disease (AD) was correct; later animal studies and human clinical trials proved and confirmed galantamine’s effectiveness. The relevant question here is whether, at the time Dr. Davis filed her application, the patent’s written description would have credibly revealed to an ordinarily skilled artisan galantamine’s utility for AD treatment. See In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir.1999) (noting that the patent’s written description must “illuminate a credible utility” to meet the enablement requirement). The district court failed to answer that question. Instead, the district court reasoned:
Dr. Davis did not receive any confirming data until after the '318 patent was allowed. In view of the prior art disclosures regarding the flaws of physostigmine [a compound chemically similar to galantamine] in AD treatment, discussed previously in the context of obviousness, it does not follow that a person of ordinary skill in the art, reading the '318 patent, would have recognized that galanthamine would be effective in treating AD in the absence of any experimental proof. Put another way, since plaintiffs rely exclusively on the prior art to establish enablement, the court agrees with defendants that the '318 patent cannot both be non-obvious and enabled.
In re '818 Patent Infringement Litig., 578 F.Supp.2d 711, 736 (D.Del.2008) (citation and footnote omitted) (“District Court Decision”).
The district court’s reasoning is flawed. In general terms, an inventor may look at the prior art differently than those before her, arrive at a novel and nonobvious in*1329sight, and submit a patent application that compiles the prior art findings that led her to the insight in such a way as to render obvious in hindsight what was wholly non-obvious at the time she filed her application. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007) (“The question is not whether the combination was obvious to the patentee but whether the combination was obvious to a person with ordinary skill in the art.”); Grain Processing Corp. v. Am. Maize-Products Co., 840 F.2d 902, 907 (Fed.Cir.1988) (In considering obviousness, “[c]are must be taken to avoid hindsight reconstruction by using ‘the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.’ ” (quoting Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1012 (Fed.Cir.1983))). As a result, the proper focus when assessing enablement is on what is disclosed in the patent, not what is taught in the prior art. See In re Ziegler, 992 F.2d 1197, 1201 (Fed.Cir.1993) (“The how to use prong of section 112 incorporates as a matter of law the requirement of 35 U.S.C. § 101 that the specification disclose as a matter of fact a practical utility for the invention.” (emphases added)). In terms of the present case, if Dr. Davis used her unique neuroendocrine perspective to examine the prior art and arrive at a novel insight about galantamine based on selected prior art findings, then the invention may be nonobvious; and if her patent disclosed those selected findings in such a manner that a person of ordinary skill would credit her insight regarding galantamine’s utility, then the invention is enabled.
Unfortunately, the district court committed error here by focusing generally on what the prior art does or does not teach — the primary factual consideration underlying obviousness — while neglecting to consider what the patent text discloses to an ordinarily skilled artisan — the primary factual consideration underlying enablement. Specifically, although the '381 patent describes particular findings from six prior art publications, the district court noted only one such publication, see District Court Decision, 578 F.Supp.2d at 722, and did not determine how one of ordinary skill would understand those cited findings, either independently or in combination with one another. Thus, it is clear that the district court failed to focus on the necessary underlying factual findings required to ascertain how an ordinarily skilled artisan would understand the text of the patent for the purpose of establishing utility and thus enablement. Under the district court’s erroneous approach, a court can invalidate for lack of enablement a patent claim to a nonobvious combination of prior art elements without ever considering what the patent actually discloses to one of ordinary skill in the art. That is contrary to law.
Nor was the district court’s error harmless. See Majority Op. at at 1327-28 n. 12. Because the district court failed to make the required fact-findings, which stemmed from its erroneous legal analysis, the majority must engage in extensive appellate fact-finding in order to affirm the district court’s judgment. It is improper for an appellate court to become the fact-finder. This court cannot presume to have the skills of the ordinary artisan and cannot substitute its weighing of the evidence and factual conclusions for those of the fact-finder. According to the majority, even though the district court failed to make the appropriate findings or conduct the proper legal analysis, we need not vacate here because “the record would not support a finding of utility.” Id. I respectfully disagree. The record clearly includes evidence that may support a finding of utility, which the majority discounts in order to reach its *1330erroneous conclusion.1 For example, Janssen provided evidence indicating that the specific findings recited in the patent, as understood by one of ordinary skill in the art, disclose the following: (1) galantamine administration increases blood cortisol levels and plasma acetylcholine when muscarinic function is blocked, an indication that galantamine increases the function of central nicotinic receptors, J.A. 8906-07; J.A. 9296-97; J.A. 9302-03; (2) galantamine can cross into the brain and affect brain function, J.A. 9298; J.A. 9303; (3) galantamine also has muscarinic effects in the brain, as indicated by its ability to improve memory in animals that have been administered scopolamine (a muscarinic receptor blocker) to induce amnesia, J.A. 8250; J.A. 8963; J.A. 9298-99; and (4) the patent discloses the importance of nicotinic receptors in AD by describing an animal model for AD that includes muscarinic and nicotinic receptors, J.A. 9302. Thus, one of ordinary skill — having the relevant background knowledge and reading the patent text at the time the application was filed— may have understood the patent to disclose the importance of nicotinic receptors in AD intervention and galantamine’s promising effects on nicotinic function and memory, such that she would recognize in the patent text galantamine’s credible utility as an AD treatment. Moreover, the defendants’ expert agreed that “[a] person in 1986 reading the patent would believe that galanthamine would be a treatment for Alzheimer’s Disease.” J.A. 8327. Although the defendants’ expert gave that testimony in support of his assertion that the claims are obvious, see Majority Op. at 1327 n. 11, the testimony is nonetheless evidence that may support a finding for the patentee on enablement. Because there is evidence of record that supports a conclusion that the '318 patent claims are not invalid, it is inappropriate for this *1331court to weigh the evidence and make contrary factual findings, especially in the absence of any consideration by the district court of numerous prior art references that were specifically discussed in the patent. Thus, in my judgment the district court’s failure to make the necessary findings and conduct the proper legal analysis is reversible error. We should remand to the district court for it to make the appropriate factual findings instead of weighing the evidence ourselves.
Finally, I disagree with the majority opinion’s emphasis on the sufficiency of the evidence presented by Janssen. As both parties correctly note, the question before us is “whether the defendants have shown, by clear and convincing evidence, that the patent’s marshalling of evidence from the technical literature of galantamine’s effects, combined with its model for Alzheimer’s therapy, is not sufficient for a skilled artisan to believe the invention’s utility.” Appellant’s Br. at 27; Appellee’s Br. at 29. That is a correct articulation of the question presented on appeal because, unlike many of the cases upon which the majority and district court rely, the claims in dispute here are issued patent claims, and are thus. presumed valid. Yet, the majority fails to establish the defendants’ burden and instead focuses almost exclusively on the sufficiency of Janssen’s showing and the merit of Janssen’s arguments. See, e.g., Majority Op. at 1327 (“Similarly, [the testimony of Janssen’s expert witness, Dr. Raskind] falls far short of demonstrating that a person of ordinary skill in the art would have recognized that the specification conveyed the required showing of utility.”). That focus is improper. Because the district court erred as a matter of law and failed to make certain required factual findings, we cannot defer to the district court’s legal conclusion or fact-findings, and thus, it is particularly problematic for the majority to require Janssen to demonstrate on appeal that its patent is valid.
For the foregoing reasons, I respectfully dissent from the majority’s decision.

. In particular, the majority discounts both the disclosures made in the '318 patent specification and the value of the post-filing test results offered to support a finding of credible utility. In so doing, the majority attempts to distinguish this court’s decision in In re Brana, 51 F.3d 1560 (Fed.Cir.1995). See Majority Op. at 1325 n. 8. I do not believe a distinction may so readily be made. Rather, as here, evidence of post-filing test results was presented to support a finding of utility. That evidence, the court found, "alone should have been sufficient to satisfy applicants' burden [even assuming the PTO had met its initial burden, thereby shifting the burden to applicants]." Brana, 51 F.3d at 1567. The majority’s claim that "unlike the present case, the testing [in Brana] was submitted to the PTO during prosecution” is misleading. The appeal in Brana was taken from the Board of Patent Appeals to this court during prosecution of a patent application. And thus the Brana panel could not possibly have intended to provide for a distinction between test results offered to support the credible utility of an otherwise enabling disclosure pre- and post-patent issuance.
Moreover, the majority’s relentless focus on the need for timely test results as evidence of utility appears to conflate credible utility in the context of enablement, at issue here, with the notion of reduction to practice, which is not at issue. See, e.g., Majority Op. at 1326 (”[N]o case has been called to our attention where utility was established simply by analytic reasoning [without testing].”). Such a conflation risks the introduction of an actual reduction-to-practice requirement into patent law, contrary to more than a century of settled precedent. See The Telephone Cases, 126 U.S. 1, 536, 8 S.Ct. 778, 31 L.Ed. 863 (1888) ("The law does not require that a discoverer or inventor, in order to get a patent for a process, must have succeeded in bringing his art to the highest degree of perfection; it is enough if he describes his method with sufficient clearness and precision to enable those skilled in the matter to understand what the process is, and if he points out some practicable way of putting it into operation.”). To reiterate: the question here is whether the written description of the '318 patent would have illuminated to a person of ordinary skill in the art a credible utility, not whether actual utility was in fact demonstrated.