A claim of patent infringement in U.S. litigation is more often than not met by a defense of patent invalidity by “obviousness.” But litigants and district courts struggled with seemingly contradictory precedents on the structure of the obviousness analysis. The Court of Appeals for the Federal Circuit recently clarified obviousness analysis in patent litigation by explaining the role of the objective indicia of nonobviousness and the burden of proof (the burdens of production and persuasion) in In re Cyclobenzaprine Hydrochloride Extended—Release Capsule Patent Litigation (In re Cyclobenzaprine) , 676 F.3d 1063 (Fed. Cir. 2012).This article analyzes the doctrinal aspects of the case and what they mean to practitioners.

Obviousness is the U.S. legal concept analogous to the European concept of the inventive step. It considers the circumstances under which an invention is considered sufficiently inventive and different from the prior art to warrant patent protection. By statute, the obviousness analysis considers whether “the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” 35 U.S.C. § 103(a). Under controlling Supreme Court law, four factors must be considered in the analysis:

(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 resolved”; and

(4) “Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc.”

Graham v. John Deere Co., 383 U.S. 1, 18 (1966). See also KSR Int’l Co. v. Teleflex Inc. (Graham) , 550 U.S. 398, 406 (2007). The fourth factor, called varyingly “secondary considerations” or “objective indicia” has been described as “the most probative and cogent evidence in the record.” Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538–39 (Fed. Cir. 1983). The objective indicia can only demonstrate non-obviousness—their absence is irrelevant to obviousness, so as such they are raised by the patentee. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1478 (Fed. Cir. 1998) (absence of objective indicia is a “neutral factor” and their presence “can only further support nonobviousness”).

In re Cyclobenzaprine considered the role of the objective indicia in the obviousness analysis. Some confusion had developed as to the burden of proof concerning the objective indicia in patent litigation, largely from cases that had tried to analogize to procedures used in the U.S. Patent Office during patent prosecution. During patent prosecution, the examiner bears the initial burden of presenting grounds for obviousness—so-called “prima facie obviousness.” If the examiner meets the initial burden, the burden of coming forward with rebuttal evidence or argument shifts to the applicant. The applicant may attempt to rebut the Examiner’s rejection (e.g. logical flaws in the rejection) or introduce additional evidence. However, this procedure does not alter the obviousness analysis itself. “The examiner’s prima facie case and an applicant’s rebuttal evidence ... are purely procedural devices. The concept of prima facie obviousness in ex parte patent examination is but a procedural mechanism to allocate in an orderly way the burdens of going forward and of persuasion as between the examiner and the applicant.” In re Piasecki, 745 F.2d 1468, 1471-72 (Fed. Cir. 1984).

Relying on these Patent Office procedures by analogy, some litigants argued that the proper way to conduct the obviousness analysis in litigation was that once the party challenging the patent had come forward with sufficient evidence— established “prima facie obviousness”— then obviousness is presumed and the burden shifts to the patentee to rebut or disprove obviousness, including through the objective indicia of non-obviousness. But, this ignores that the issued patent involved in litigation is presumed valid by statute 35 U.S.C. § 282, while the patent application involved in prosecution in the Patent Office, of course, does not.

Under the correct analysis, as explained in In re Cyclobenzaprine, a party challenging a patent always bears the ultimate burden of proving invalidity and that burden (the burden of persuasion) never switches to the patentee. Although the burden of producing evidence (the burden of production) can shift between the parties, there is never a presumption of obviousness. All of the facts relevant to obviousness—including the objective indicia—must be considered as whole before reaching a conclusion of obviousness.

Cyclobenzaprine did not make new law. One of the Federal Circuit’s foundational obviousness cases, Stratoflex v. Aeroquip, held that “evidence rising out of the so-called ‘secondary considerations’ must always when present be considered en route to a determination of obviousness” and objective indicia evidence “is to be considered as part of all of the evidence, not just when the decision maker remains in doubt after reviewing the art.” Stratoflex, 713 F.2d at 1538–39.

It should be noted that, because the objective indicia only go to proof of non-obviousness, a court is not required to consider the objective indicia before reaching a conclusion of nonobviousness. The party challenging the patent can fail to meet its burdens of persuasion or production in ways related to the first three Graham factors that do not implicate the objective indicia. Among other things, the challenger must present evidence sufficient to establish some articulated, rational reason to select and combine the teachings of the prior art to produce the claimed invention with a reasonable expectation of success. If these critical facts are not established, a court may rule in favor of the patentee without considering the objective indicia evidence. Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1363 (Fed. Cir. 2007).

 

The correct understanding and application of the burdens is not trivial. It can be the difference between the validity and invalidity of a patent as, indeed, it was in In re Cyclobenzaprine.

The secondary considerations—more properly called the objective indicia of nonobviousness—play a critical role in the obviousness analysis. They have two major functions. First, they bridge the gap from the often highly technical world of the prior art to the real world impact of the invention. As explained by the Supreme Court, the objective indicia “focus attention on economic and motivational rather than technical issues and are, therefore, more susceptible of judicial treatment than are the highly technical facts often present in patent litigation…” Graham, 363 U.S. 1, 36 (U.S. 1964). Second, they “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. Although obviousness must be considered from the perspective of a hypothetical person of ordinary skill in the art with no knowledge of the invention, it is very easy to slip into a forbidden hindsight analysis. “[K]nowing that the inventor succeeded in making the patented invention, a fact finder might develop a hunch that the claimed invention was obvious, and then construct a selective version of the facts that confirms that hunch.” Cyclobenzaprine, 676 F.3d at 1079.

Ultimately, the objective indicia create inferences of nonobviousness based on what happened in the “real world.” For example, the fact that a problem remained unsolved for a period of time, despite attempts to solve it, suggests that the patentee’s solution was not obvious. Similarly, if an invention is commercially successful, it suggests that it was not obvious because there is always an implicit incentive to make commercially valuable inventions.

In Cyclobenzaprine the proper application of the burdens and consideration of the objective indicia demonstrated that the claimed invention was not obvious, while under the improper analysis the opposite conclusion was reached. The case involved two patents covering aspects of a once-daily extended release formulation of the muscle relaxant cyclobenzaprine hydrochloride marketed as Amrix® The prior art disclosed immediate-release formulations of cyclobenzaprine that required multiple daily doses to be effective. At trial, Cephalon (the patentee) presented evidence: (1) of long-felt but unmet need for an extended release formulation of cyclobenzaprine, (2) that others tried and failed to develop such formulation, and (3) that the claimed formulation improved patient compliance. Specifically, Cephalon established that a “long felt need existed for a therapeutically effective, extendedrelease cyclobenzaprine formulation. The immediate-release formulation existed for decades, but that formulation’s regimen of multiple daily doses led to poor patient compliance.” Similarly, “others tried but failed to develop an extended-release version.” Finally, Cephalon’s medical expert “testified that patient compliance with a medical regimen is important and that he began prescribing Amrix, in part, because of the prospect of more convenient dosing for his patients.” Cyclobenzaprine , 676 F.3d at 1083.

Despite this significant objective evidence of nonobviousness, the district court held that the asserted claims were invalid for obviousness. Using the erroneous prima facie obviousness concept , i t presumed obviousness based on the prior art and then required Cephalon to disprove obviousness through objective indicia.

The Federal Circuit reversed. It explained that, under the proper analysis, the objective indica evidence supported the inferences “that skilled artisans would not have reasonably expected to succeed in developing the claimed formulation [and] … it was difficult for researchers to create a therapeutically effective, extended-release product. Because a desire existed for such a product, researchers, presumably, would have created one if they were able to do so.” Id . As a result, the claims were not obvious.

Following Cyclobenzaprine, patent litigators on both sides must remember that, in patent infringement litigation, there is no “prima facie obviousness,” but rather the “burden of persuasion” and the “burden of production.” Cyclobenzaprine erased any artificial lines between objective indicia and the other facts related to obviousness that may have arisen through a misunderstanding of the applicability of patent office procedure. Obviousness should be considered as a whole—and no considerations are “secondary” in importance.