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.