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Jul 1, 2007 (Vol. 27, No. 13)

KSR: A Bump in the Road for Biotech?

Changes in Assessing Obviousness of Patents Shouldn't Affect the Industry

  • The Supreme Court’s recent decision in KSR International Co. v. Teleflex Inc. is likely to impact how biotechnology patents are obtained and may even threaten the validity of some existing patents but it is not cause for alarm in the biotech industry. The Court rejected the Federal Circuit’s rigid application of its obviousness test and adopted a more flexible approach that permits the consideration of a broader range of factors when assessing obviousness. While the Patent Office’s initial reaction to KSR appears to be conservative, it is not hard to imagine rejections based on language from the Supreme Court opinion. The opinion, however, also provides guidance for supporting patents and ultimately may prove to be little more than a bump in the road for biotechnology patents.

  • The Dispute

    KSR arose from a dispute between two competing manufacturers of gas pedal systems for the automotive industry. Teleflex charged that KSR had infringed its patents for gas pedals that combined features of electronic sensor pedals and adjustable accelerator pedals. At issue was whether the Teleflex patent stood up to the requirement that an invention not be obvious.

    In lay terms, obviousness in patent law means that someone versed in the technology could be expected to arrive at the invention—in this case, an adjustable pedal with an electronic sensor—given the information that was publicly available at the time. While gas pedals with each feature of the KSR pedal were known, because there was no evidence of a prior teaching, suggestion, or motivation (TSM) to make KSR’s combination, the Federal Circuit found that the invention was non-obvious. The Supreme Court rejected that “rigid” application of the TSM test, and held the invention obvious under a more flexible standard.

  • Traditional Oviousness Analysis

    Since the Supreme Court’s 1966 decision in Graham v. John Deere Co., obviousness has been evaluated under a framework that requires considering “the scope and content of the prior art,...[the] difference between the prior art and the claimed invention...and the level of ordinary skill in the...art.” Additionally, “secondary considerations” such as “commercial success, long felt but unsolved needs, [and] failure of others” can be used to show non-obviousness.

    To provide uniformity and consistency in the application of Graham, the Federal Circuit adopted the TSM test, requiring that some teaching, suggestion, or motivation to combine the prior art be found either in the prior art, the nature of the problem, or the knowledge of a person having ordinary skill in the art. The TSM test also was thought to guard against the insipid effects of hindsight, by placing objective limits on assertions of obviousness.

  • The Decision

    KSR reaffirms the Graham v. John Deere Co. framework. However, where the Federal Circuit had used its TSM test to apply Graham, KSR states that there must only be “an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR explains that a reason might be found in “interrelated teachings of multiple patents; the effects of [design or marketplace] demands...and the background knowledge possessed by a person having ordinary skill in the art.”

    KSR also redefines the “person of ordinary skill in the art” by adding the quality of “ordinary creativity.” Thus, KSR notes that obviousness can be determined with reference to “the inferences and creative steps that a person of ordinary skill in the art would employ.”

    The Patent Office’s initial interpretation of KSR concludes that “it remains necessary to identify the reason why a person of ordinary skill in the art would have combined the prior art elements in the manner claimed.” Thus, examiners may view KSR as a matter of semantics, requiring them to replace their teaching, suggestion, or motivation analysis with an identification of the required “reason” to combine.

    Still, KSR outlines general circumstances that may invite obviousness rejections. For example, if the claims are directed to “the combination of familiar elements according to known methods [that] does no more than yield predictable results” or if there was “a known problem for which there was an obvious solution encompassed by the patent’s claims.” Additionally, KSR provides that “any need or problem known in the field...and addressed by the patent can provide a reason for combining the [prior art].”

  • Impact on Biotech

    Of particular concern to the biotechnology industry may be KSR’s resurrection of the “obvious to try” standard, which the Federal Circuit has consistently rejected, particularly in biotech cases. KSR states that “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.”

    Under those circumstances “the fact that a combination was obvious to try might show that it was obvious.” However, it should be possible to defeat an obvious-to-try issue by showing, for example, that there were too many possible avenues to pursue to render the particular claimed solution obvious; that the possible solutions were not predictable; that the claimed solution was expected to be disadvantageous; or that the claimed solution required technical advances beyond the person of ordinary skill in the art. Indeed, several Federal Circuit judges writing after KSR have questioned the applicability of obvious-to-try in the pharmaceutical context.

    Overall, KSR’s emphasis on predictability and technical ability could prove important to biotechnology inventions. KSR repeatedly notes that combination inventions that achieve predictable results are likely to be obvious. However, most biotechnology inventions involve some level of unpredictability such as in how different elements interact and in the results they achieve.

    KSR also recognizes that a combination may not be obvious if its implementation was beyond the level of ordinary skill in the art. This is often the case with biotechnology inventions, where even moving a known solution from one application to another may require innovation. KSR also acknowledges that a prior art teaching away from the claimed invention will support a finding of non-obvious such as where an invention combines elements that the prior art suggested should not or could not be combined successfully.

    Another reason that KSR might not prove to be problematic for biotechnology inventions is that the TSM test has rarely arisen in appeals of biotechnology patents. Of 60 pre-KSR Federal Circuit decisions that applied the TSM test, only three are related to chemical or biotechnology patents. Even in these cases, the outcome might not be different under KSR.

    In one case, the Federal Circuit denied a preliminary injunction where there was a “substantial argument” that the patent was obvious in view of a prior publication and evidence of similarities between the disclosed drug and the claimed drug. In another case, the Federal Circuit upheld the patent where there were significant teachings away from the claimed invention. In the third case, the Federal Circuit found the claim at issue to be obvious where “express teachings in the art provide the motivation and suggestion to modify [a prior disclosure] such that the recombinant cells described therein should be used with compounds not previously known to interact with them for purposes of drug screening.”

    Although obviousness may become a more important issue for biotechnology patents as the industry matures, for now it often takes a back seat to other issues, such as enablement. Thus, KSR may not have as much of an impact on the biotech industry as it will on other fields.

    KSR refines the current obviousness analysis but leaves in place important limitations on obviousness, including the requirement for a reason to combine the prior art in the manner claimed and the predictability and technical feasibility of the claimed subject matter at the time of the invention.

    Biotechnology innovators aware of KSR’s principles should be able to support and defend their patents by emphasizing the innovation required to bring their inventions to fruition.



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