Objective Indicia in Obviousness: Part of Entirety Evidence or Rubuttal for Prima Facie Obviousness?
Determining Obviousness for an Invention
As presented in 35 U.S.C. §103, a patent for a claimed invention may not be obtained “if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious” to one of ordinary skill in the art. The Supreme Court, in Graham v. John Deere Co., 383 U.S. 1 (1966), first laid out the factors by which legal determinations of obviousness may be made: the scope and content of the prior art; the differences between the prior art and the claims at issue; and the level of ordinary skill in the pertinent art. Also relevant, the Graham court said, was any objective indicia of non-obviousness, such as commercial success, long-felt but unsolved need, failure of others, industry praise and unexpected results. The framework of obviousness was one of the means of balancing the public policy aspects of the patent system, as noted by the Graham court:
“the underlying policy of the patent system that ‘the things which are worth to the public the embarrassment of an exclusive patent,” as Jefferson put it, must outweigh the restrictive effect of the limited patent monopoly” and that the “inherent problem was to develop some means of weeding out those inventions which would not be disclosed or devised but for the inducement of a patent.”
Id. at 10-11.
Mixed Messages from the Federal Circuit
Despite being part of the framework of obviousness for many years, applying objective indicia to the question of obviousness has been challenging, given that the objective indicia of non-obviousness do not relate directly to the cited prior art but relate to obviousness in a more general sense. Moreover, the Federal Circuit has given “mixed messages” (to use the words of Judge Reyna in Intercontinental Great Brands LLC v. Kellogg North America Co., dissent slip op. at 8) on the role of such objective evidence of non-obviousness. In some cases, the Federal Circuit has employed a prima facie framework where the objective indicia come into play as a rebuttal after a prima facie showing of obviousness has been made. For example, in Cubist Pharm., Inc. v. Hospira, Inc., 805 F.3d 1112, 1130 (Fed. Cir. 2015), the Federal Circuit stated, “we sustain the district court’s determination that the secondary consideration evidence did not overcome the showing of obviousness based on the prior art” (emphasis added).
In other cases, the Federal Circuit has rejected a formal burden-shifting framework, directing the district court to consider all evidence, including objective indicia of non-obviousness, before making an ultimate conclusion of obviousness. For example, in In re Cyclobenzprine, 676 F.3d 1063, 1080 (Fed. Cir. 2012), the Court held, “secondary considerations, where present, are to be considered along with the other Graham factors in determining obviousness, and not merely as a “secondary” inquiry after a finding of obviousness is made.”
Intercontinental Court – Objective Indicia Is Rebuttal After Prima Facie Determination
Two fairly recent cases have highlighted this split within the members of the Federal Circuit. On September 7, 2017, in Intercontinental Great Brands LLC v. Kellogg North America Co. (Nos. 2015-2082, 2015-2084), a three member panel of the Federal Circuit affirmed a district court’s summary judgment of obviousness of a patent owned by Intercontinental Great Brands (previously Kraft Foods Global Brands LLC). Kraft argued that objective indicia must be evaluated before drawing a conclusion about whether a person skilled in the art had a motivation to combine the prior art, not merely before drawing the ultimate obviousness conclusion, slip op. at 16. The majority rejected this argument, finding that there was no precedent for this. Id. Judge Taranto, writing for the majority, stated that the district court’s “structuring [of] the analysis fulfills the requirement that the approach to determining obviousness be ‘expansive’ and ‘flexible,’” Id. at 18.
Not everyone on the panel agreed. A dissenting opinion was filed by Judge Reyna, who stated:
“For too long, this court has turned a blind eye to what I consider to be a grave concern: the application of a prima facie test that necessarily achieves a legal determination of obviousness prior to full and fair consideration of evidence of objective indicia of non-obviousness.”
Intercontinental, dissent slip op. at 1-2. According to Judge Reyna, the “burden of persuasion should not shift from the challenger to the patent holder after a legal determination of obviousness has already been made,” Id. at 2. Thus, Judge Reyna recommended that the district court be instructed to “abandon the prima facie framework and instead proceed in two steps: (1) consider all factual evidence, both favoring and disfavoring a finding of obviousness; and (2) make a legal conclusion of obviousness.” Id. at 11.
Merck Court – Objective Indicia Should Be Part of The Entirety Of Evidence
Fast forwarding about a month and a half, on October 26, 2017, a separate three member panel of the Federal Circuit issued an opinion in Merck Sharp & Dohme Corp. v. Hospira Inc. (No. 2017-1115). Merck argued that the lower court had “improperly discounted Merck’s objective evidence, which it found to be persuasive, when weighing the obviousness factors,” id. at 9. The majority, composed of Circuit Judges Lourie and Hughes, disagreed and affirmed the lower court’s finding that the Merck patent at issue was obvious.
A dissenting opinion was filed by Circuit Judge Newman, who found that the court did not give the proper weight to Merck’s evidence that the drug at issue was not obvious because it was commercially successful and copied by competitors. According to Judge Newman:
“[s]ome Federal Circuit decisions appear to have sought a shortcut, and converted three of the four Graham factors into a self-standing ‘prima facie’ case, whereby the objective considerations must achieve rebuttal weight.”
Merck, dissent slip op. at 4. Judge Newman stated that “it is time to remedy our inconsistent treatment of the procedures and burdens in applying the evidentiary factors of obviousness,” Id. at 1.
In December 2017, the Federal Circuit rejected a request for en banc review for the Intercontinental Great Brands case. Similarly, a request for en banc review in the Merck Sharp case was denied in January 2018. Hence the varying opinions regarding treatment of objective indicia evidence will remain for now. Regardless of the way that objective evidence is structured in an obviousness analysis, it must be considered by a court as it forms an essential part of the framework of obviousness analysis and should be presented by practitioners whenever possible.
Written By Nayyer Siddiqi