Key Patent Ruling No Biotech Killer

16 May 2007 Publication
Authors: Courtenay C. Brinckerhoff

U.S. Supreme Court refines what "obvious" means for patents, but doesn't scrap protection for innovators.

A key patent decision from the U.S. Supreme Court last month raised concerns among biotechnology companies that the ruling would weaken patent claims and make it tougher to secure needed protection. The decision in KSR International Co. v. Teleflex Inc. is far from a death-knell for the industry. But it may require more up-front investment in patents if more evidence is required to support patent claims.

The case involved two competing makers of 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. Although the dispute centered on car parts, its implications extend to all industries, and have particular resonance among biotech companies.

At issue was whether the Teleflex patent stood up to the requirements that an invention be both new and "non-obvious." In lay terms, obviousness within the realm of patents 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 the Federal Circuit found the Teleflex patent was not obvious, the Supreme Court disagreed.

The top court's decision reaffirmed the framework for evaluating obviousness that has been used since the 1966 case of Graham v. John Deere Co. In that case, the Supreme Court spelled out how to approach the question of obviousness. This includes considering precisely what information was publicly available ("prior art"), the differences between that information and the invention, and the level of skill—including education and work experience—of the ordinary person working in the field of the invention ("the person of ordinary skill in the art").

The Supreme Court disapproved of how the Federal Circuit applied this framework, and announced a more liberal approach. The Federal Circuit would not find an invention to be obvious unless there was evidence of some "teaching, suggestion or motivation" to combine the prior art in a way that would result in the invention.

In contrast, the Supreme Court held that there must only be "an apparent reason to combine the known elements in the fashion claimed by the patent at issue," and endorsed the consideration of a broader range of factors to identify such a reason.

Although innovators are never comfortable when the Supreme Court issues a patent ruling, the latest decision includes guidance for supporting patents, which should prove particularly useful for biotechnology inventions. For example, while the decision emphasized that combination inventions that achieve predictable results are likely to be considered obvious, most biotechnology inventions involve some level of unpredictability, such as in how different elements interact and in the results they achieve.

The Justices also recognized that a combination invention 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.

Importantly, the decision also upholds the principle that non-obviousness can be found where existing information discouraged the approach adopted by invention. This will be helpful where an invention combines elements that the prior art—publicly available information—suggested should not or could not be combined successfully.

Just how the decision will affect future patent applications is not yet clear. The court plainly adopted a more flexible approach to obviousness. But the US Patent Office's initial reaction to KSR was conservative. The office concluded "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." As a result, patent examiners may view the decision as a matter of semantics, merely requiring them to replace their "teaching, suggestion, or motivation" analysis with an identification of the required "reason" to combine.

Still, the biotech industry should expect the ruling to affect the costs, if not the final outcome, of patent prosecution. While many inventions that would have been non-obvious before the decision will remain non-obvious under the new standard, innovators may have to make more up-front investments in their patents to convince the Patent Office.

For example, the decision may lead to increased reliance on inventor or expert declarations discussing factors such as the unpredictability of the invention or the technical advances required to implement it. Or, if an invention is attacked as an obvious solution to a known problem under the "obvious to try" standard resurrected by the decision, the innovator may decide to respond with evidence. One option might be to show there were too many possible avenues to pursue to render the particular, claimed solution obvious, or that the claimed solution was expected to be disadvantageous. Of course, gathering such evidence will increase up-front patent costs. But the return on investment should be high if a stronger patent results.

The decision refines the current analysis of obviousness, but leaves in place important limitations on the standard, 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 the ruling's principles and willing to make up-front investments in their patents should be able to support and defend their patents by emphasizing the innovation required to bring their inventions to fruition.

This article first appeared on The Journal Life Sciences Web site.