The Role of Objective Indicia of Nonobviousness When Evaluating Whether a Patent Claim Is Obvious

For patent claims, the obviousness question under 35 U.S.C. § 103 has been the most common invalidity issue litigated in both district court and post-grant proceedings before the PTO. Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1074 (Fed. Cir. 2016) (en banc) (Dyk, J., dissenting). When conducting an obviousness analysis, the Supreme Court in Graham v. John Deere Co., 383 U.S. 1 (1966), instructs courts to consider: (1) “the scope and content of the prior art”; (2) “differences between the prior art and the claims at issue”; (3) “the level of ordinary skill in the pertinent art”; and (4) “secondary considerations,” which are also known as objective indicia of nonobviousness. Id. at 17–18. A critical inquiry en route to making a determination on obviousness is how objective indicia may “give light to the circumstances surrounding the origin of the subject matter sought to be patented.” Id. Such objective indicia may include commercial success, long felt but unresolved needs, failure of others, industry praise, and unexpected results. See id.; Apple, 839 F.3d at 1052; In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1075 (Fed. Cir. 2012).   

Amarin’s certiorari petition raises the question of “[w]hether a court must consider objective indicia of nonobviousness together with the other factors bearing on an obviousness challenge before making any obviousness determination.” Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., petition for cert., Case No. 20-1119 (U.S. Feb. 11, 2021) (hereinafter “Amarin Petition”), at i, Question Presented. Amarin argues in the affirmative—that is, the Supreme Court has instructed courts to use a “totality of the evidence” approach when conducting an obviousness analysis, where all Graham factors are given “full and fair consideration” prior to making any obviousness conclusion. Amarin Petition at 2–4, 27. As discussed below, federal circuit panels have decided that this is the correct approach. Nonetheless, according to Amarin, the federal circuit has also authorized the use of a prima facie framework when considering objective evidence. Id. at 3. In the prima facie framework, objective indicia are considered as rebuttal evidence after a prima facie determination of obviousness has been made by the court. Id. at 2–3. This, Amarin asserts, departs from the instructions set forth in Graham and erroneously shifts a burden of proof to the patent owner when defending against obviousness allegations. Id. at 3–4. Amarin contends that the prima facie framework ultimately leads to over-invalidation of patents and suppression of innovation. Id. at i. While at the time of this writing it is unknown whether the Supreme Court will grant the petition, this article in the meantime explores case law setting forth the potentially different treatments given to objective indicia of nonobviousness in courts today.

The Totality of the Evidence Approach

Graham does not appear to use the language “totality of the evidence,” per se. But Graham explains the importance of objective indicia of nonobviousness in a manner that is consistent with the totality of the evidence approach. Graham reasons that objective indicia “lend a helping hand to the judiciary which ... is most ill-fitted to discharge technological duties cast upon it by patent legislation.” Id. at 36. Objective indicia serve to “guard against slipping into use of hindsight” and to “resist the temptation to read into the prior art the teachings of the invention in issue.” Id. The Supreme Court reiterated the importance of guarding against hindsight in its more recent KSR decision, in which the Court explained that “[a] factfinder should be aware ... of the distortion caused by hindsight bias and must be cautious of arguments reliant upon ex post reasoning.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). The KSR decision also described Graham as setting forth a “flexible” and “broad” obviousness inquiry where “the sequence of the[] questions might be reordered in any particular case.” Id. at 415, 406–07.

Consistent with this, the federal circuit has employed a “totality of the evidence” approach where “all evidence relevant to obviousness or nonobviousness [has been] considered, and [] considered collectively.” Cyclobenzaprine, 676 F.3d at 1077–78. For example, in Cyclobenzaprine, the federal circuit explained that “the most relevant objective considerations, when considered as a part of the totality of the evidence, support a nonobviousness finding.” Id. at 1083. There, the panel instructed that courts “may not defer examination of the objective considerations until after the fact finder makes an obviousness finding.” Id. at 1075 (citing Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538–39 (Fed. Cir. 1983)). Further, the federal circuit panel emphasized that Graham “did not characterize the objective factors as after-the-fact considerations or relegate them to secondary status.” Id. at 1078. Similarly, in Stratoflex, the federal circuit recognized that objective indicia “may often be the most probative and cogent evidence in the record,” emphasizing that they are “to be considered as part of all the evidence, not just when the decisionmaker remains in doubt after reviewing the art.” Stratoflex, 713 F.2d at 1538–39.

The Prima Facie Obviousness Framework

Despite its precedent requiring that the totality of evidence approach be used when evaluating objective indicia of nonobviousness, some federal circuit panels have appeared to at times embrace a prime facie obviousness framework. For instance, in Intercontinental, a federal fircuit panel found nothing wrong with “the court’s not-uncommon choice of words when conducting the ultimate weighing, namely, that the objective indicia ‘do not overcome Kellogg’s extremely strong prima facie showing.’” Intercontinental Great Brands LLC v. Kellogg N. Am. Co., 869 F.3d 1336, 1345–46 (Fed. Cir. 2017). Rather, that panel stated that as long as objective indicia was considered “merely before drawing the ultimate obviousness conclusion,” this would be sufficient. Id. Similarly, the federal circuit panel in Merck affirmed a district court decision that first reached a prima facie obviousness conclusion and then appeared to put a burden on the patent owner to “overcome [that] ‘strong prima facie case of obviousness’” with objective indicia. See Merck Sharp & Dohme Corp. v. Hospira, Inc., 874 F.3d 724, 728, 731 (Fed. Cir. 2017). Other federal circuit cases have similarly employed this framework. See, e.g., Cubist Pharm., Inc. v. Hospira, Inc., 805 F.3d 1112, 1130 (Fed. Cir. 2015) (“We sustain the district court’s determination that the secondary consideration evidence did not overcome the showing of obviousness based on the prior art.”); Novo Nordisk A/S v. Caraco Pharm. Lab., Ltd., 719 F.3d 1346, 1353 (Fed. Cir. 2013) (“In this case, the court found that Caraco’s prima facie evidence, if unrebutted, would be sufficient to establish that the repaglinide/metformin combination was obvious to try .... Having so found, it was entirely appropriate for the court to next consider whether Novo’s countervailing secondary consideration evidence ... was sufficient to ‘overcome’ Caraco’s prima facie case.”).

The concern with the prima facie framework expressed by Amarin and some courts is that it “erroneously shifts the burden of proof to the patentee to show nonobviousness—all in contravention of [the Supreme] Court’s precedent.” Amarin Petition at 3–4. Judge Newman, dissenting in Merck, elaborated on the consequences of using a prima facie framework, explaining that it “convert[s] three of the four Graham factors into a self-standing ‘prima facie’ case,” while requiring objective indicia to “achieve rebuttal weight.” Merck, 874 F.3d at 732 (Newman, J., dissenting). Consequently, the prima facie framework can distort the burden of proof and in turn render objective indicia ineffective as “independent evidence of nonobviousness.” Id. at 733 (Newman, J., dissenting). For similar reasons, the burden-shifting framework used in the prima facie framework was rejected by the federal circuit panel in Cyclobenzaprine. 676 F.3d at 1079–80. The panel in that case found error in the district court’s decision to assume that “it was [the patent owner’s] burden to disprove the court’s initial obviousness finding.” Id. at 1080.

The Potential Inconsistency in the Approaches Used by Courts When Evaluating Objective Indicia May Warrant Clarification by the Supreme Court

As Amarin’s petition suggests, a tension does appear to exist between the Supreme Court’s acknowledgement that the Graham factors may be “reordered in any particular case,” with the suggestion that the Federal Circuit may have allowed a prima facie framework in which objective indicia would be considered only after a prima facie case of obviousness is made. See, e.g., ZUP, LLC v. Nash Mfg., Inc., 896 F.3d 1365, 1380-1381 (Fed. Cir. 2018) (Newman, J., dissenting) (“It is incorrect to convert the fourth Graham factor into ‘rebuttal,’ requiring it to outweigh the other three factors” because objective indicia are “‘not just a cumulative or confirmatory part of the obviousness calculus, but constitute[] independent evidence of nonobviousness.’”), cert. denied, 139 S. Ct. 1211 (2019); Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1370-1371 (Fed. Cir. 2012) (Newman, J., concurring in part, dissenting in part) (“The district court erred in its application of the Graham factors by asking whether the evidence of secondary considerations were sufficient to overcome its ‘final conclusion’ that the patent is obvious.”).

Comparisons of decisions including Graham, KSR, Cyclobenzaprine, and Stratoflex, which employ a totality of evidence approach, and other decisions such as Intercontinental and Merck, which appear to employ a prima facie framework, reflect a tension in the approaches that courts sometimes use when conducting an obviousness analysis. Taking into consideration the Federal Circuit’s precedent in Cyclobenzaprine and Stratoflex, the court’s apparent endorsements of a prima facie obviousness framework have potentially created confusion in the law that may need to be reconciled. As Judge Reyna explained when dissenting-in-part in Intercontinental, seminal decisions on the subject have “made no ‘prima facie’ finding of obviousness, did not relegate objective indicia into an afterthought, and reserved its legal conclusion for after discussion of all relevant factual inquiries.” Intercontinental, 869 F.3d at 1358 (Reyna, J., dissenting-in-part) (citing Graham, KSR, Cyclobenzaprine, Stratoflex). Despite this, the Federal Circuit has recognized that “it has inconsistently articulated the burden of proof applicable to an obviousness defense in district court litigation.” Cyclobenzaprine, 676 F.3d at 1075; see also Intercontinental, 869 F.3d at 1356 (“In light of mixed messages coming from our court—endorsement of a prima facie framework on one hand but insistence to view the evidence as a whole on the other—trial courts have continued to find a prima facie case of obviousness before turning to objective indicia as rebuttal evidence.” (Reyna, J., dissenting-in-part)).

As Amarin argues in its certiorari petition, a clarification of how objective indicia of nonobviousness should be evaluated may be needed to reconcile past inconsistencies in case law and to properly guide future decisions of the courts. At the time of this article, the Supreme Court has not distributed the petition for conference. However, whether in this or a future case, further clarification from the court about how to address objective indicia of nonobviousness when considering obviousness challenges may be beneficial for patent owners and litigants.