This excerpt from the Cyclobenzaprine decision is illuminating as it relates to concerns here about panel composition:
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“After the district court found that Mylan and Par proved the asserted claims obvious, it considered Cephalon's proof of objective considerations of nonobviousness to determine whether Cephalon's proofs were sufficient to “rebut” that obviousness determination. Specifically, the district court considered Cephalon's evidence of the failure of others to make the patented invention; ?longfelt but unsolved needs fulfilled by the patented invention; ?commercial success of the patented invention; ?and unexpected results produced by the patented invention. See Graham, 383 U.S. at 17–18, 86 S.Ct. 684; ?Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1369 (Fed.Cir.2007). The district court found Cephalon's evidence insufficient to rebut Mylan's and Par's showing. The district court erred, however, by making its finding that the patents in suit were obvious before it considered the objective considerations and by shifting the burden of persuasion to Cephalon. In doing so, the district court contravened this court's precedent requiring that a fact finder consider all evidence relating to obviousness before finding a patent invalid on those grounds, and the court imposed a burden-shifting framework in a context in which none exists.
1.
The premature nature of the court's obviousness finding is apparent. Before it reached the objective considerations, the district court stated that the claimed PK profile “would have been obvious to one of skill in the art at the time of the invention” and that “a person of ordinary skill in the art would have been motivated to take a group of known elements to create an extended release version of cyclobenzaprine, and [would have had] a reasonable expectation of success in doing so.” It was not until after the district court found the asserted claims obvious that it proceeded to analyze the objective considerations, or what it called the “secondary considerations.”
2.
The district court's error is understandable because this court has inconsistently articulated the burden of proof applicable to an obviousness defense in district court litigation. It was error nonetheless.
In Stratoflex, Inc. v. Aeroquip Corp., we held that a fact finder in district court litigation may not defer examination of the objective considerations until after the fact finder makes an obviousness finding:
It is jurisprudentially inappropriate to disregard any relevant evidence on any issue in any case, patent cases included. Thus evidence rising out of the so-called “secondary considerations” must always when present be considered en route to a determination of obviousness· Indeed, evidence of secondary considerations may often be the most probative and cogent evidence in the record. It may often establish that an invention appearing to have been obvious in light of the prior art was not. It is to be considered as part of all the evidence, not just when the decisionmaker remains in doubt after reviewing the art.
713 F.2d 1530, 1538–39 (Fed.Cir.1983) (citations omitted). Many subsequent cases have expressly followed Stratoflex's directive that courts consider all objective evidence before reaching an obviousness conclusion. See Ruiz v. A.B. Chance Co., 234 F.3d 654, 663 (Fed.Cir.2000) (“Our precedent clearly establishes that the district court must make Graham findings before invalidating a patent for obviousness.”); ?Cable Elec. Prods. v. Genmark, Inc., 770 F.2d 1015, 1026 (Fed.Cir.1985) (quoting Stratoflex, 713 F.2d at 1539) (“The opinions of this court have suggested that evidence on these secondary considerations is to be taken into account always, ‘not just when the decisionmaker remains in doubt after reviewing the art.’?”); ?Simmons Fastener Corp. v. Illinois Tool Works, Inc., 739 F.2d 1573, 1575 (Fed.Cir.1984); ?(“The section 103 test of nonobviousness set forth in Graham is a four part inquiry comprising, not only the three familiar elements (scope and content of the prior art, differences between the prior art and the claims at issue, and level of ordinary skill in the pertinent art), but also evidence of secondary considerations when such evidence is, of course, present”); ?Richardson–Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 1483 (Fed.Cir.1997) (holding that “we must consider all of the evidence under the Graham factors before reaching our decision”); ?Rockwell Int'l Corp. v. United States, 147 F.3d 1358, 1366 (Fed.Cir.1998) (following Richardson–Vicks?); ?and Kan. Jack, Inc. v. Kuhn, 719 F.2d 1144, 1150–51 (Fed.Cir.1983) (finding that a district court's consideration of commercial success complied with “the basic requirement that all evidence touching the obvious-nonobvious issue be fully considered before a conclusion is reached on that issue” (citing In re Sernaker, 702 F.2d 989, 996 (Fed.Cir.1983))).
While many panels of this court have adhered to Stratoflex's directive, some instead have spoken of the obviousness analysis in terms of a “prima facie” case which must then be “rebutted” by the patentee. Under that framework, a court inquires whether the party challenging validity has proven a “prima facie” case of obviousness, based only on reference to the patent and the proffered prior art, and only then considers objective evidence, asking whether such evidence is sufficient to overcome the prima facie case.3
Despite this language, however, those cases should not be interpreted as establishing a formal burden-shifting framework. This is so for a number of reasons. First, a review of those cases indicates that in none was the placement of the burden with respect to evidence of objective considerations, or the timing of the fact finder's consideration of that evidence, determinative. See supra n. 3.
Second, even panels that have used the “prima facie” and “rebuttal” language generally have made clear that a fact finder must consider all evidence of obviousness and nonobviousness before reaching a determination. For example, in Iron Grip Barbell Co. v. USA Sports, Inc., while the panel did hold that “there is no objective evidence to rebut the strong showing of obviousness based on the prior art,” 392 F.3d 1317, 1325 (Fed.Cir.2004), it also cautioned that, in “determining the question of obviousness, inquiry should always be made into whatever objective evidence of nonobviousness there may be.” Id. at 1323 (quoting Vandenberg v. Dairy Equip. Co., 740 F.2d 1560, 1567 (Fed.Cir.1984)). In Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., while the panel observed that, “f all of the factual disputes regarding the objective evidence resolve in favor of [plaintiff], it has presented a strong basis for rebutting the prima facie case [of obviousness],” the panel stated, “[t]o be clear, a district court must always consider any objective evidence of nonobviousness presented in a case.” 617 F.3d 1296, 1305 (Fed.Cir.2010). And in WMS Gaming Inc. v. International Game Technology, while the panel stated that “[t]he objective evidence of nonobviousness may be used to rebut a prima facie case of obviousness based on prior art references,” it also stated that “[t]he consideration of the objective evidence presented by the patentee is a necessary part of the obviousness determination.” 184 F.3d 1339, 1359 (Fed.Cir.1999). Thus, a reading of these cases that permits a fact finder to reach a conclusion of obviousness before considering all relevant evidence, including evidence of objective considerations, would not only conflict with Stratoflex's directive that objective considerations are “to be considered as part of all the evidence, not just when the decisionmaker remains in doubt after reviewing the art,” 713 F.2d at 1538, but would ignore their actual holdings.
Next, the Supreme Court has never imposed nor even contemplated a formal burden-shifting framework in the patent litigation context. It has, instead, required that all evidence relevant to obviousness or nonobviousness be considered, and be considered collectively. In Graham, the Court stated that “[s]uch secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented,” along with 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. 383 U.S. at 17–18, 86 S.Ct. 684. Notably, the Court did not characterize the objective factors as after-the-fact considerations or relegate them to “secondary status.” The Court, rather, indicated that the objective considerations have broader applicability, noting that, “[a]s indicia of obviousness or nonobviousness, these inquiries may have relevancy.” Id. The Court recently reaffirmed this approach to objective considerations when it described the obviousness inquiry as “expansive and flexible” and noted that Graham “invite[s] the courts, where appropriate, to look at any secondary considerations that would prove instructive.” KSR, 550 U.S. at 415, 127 S.Ct. 1727. And, in i4i, the Court reaffirmed both the scope and placement of the burden of proof in these circumstances. 131 S.Ct. at 2245 n. 4.”
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