At The Razor's Edge: Prosecuting And Defending Against Patent Infringement Claims Post-KSR

KSR Overview

While commentators might disagree over the magnitude of change, there is little dispute that the U.S. Supreme Court's KSR Int'l Co. v. Teleflex, Inc., 127 S. Ct. 1727 (2007) (KSR) decision last year has impacted the manner in which plaintiffs and defendants have approached patent infringement claims. For years, practitioners largely relied on the case law driven "teaching-suggestion-motivation" (TSM) test in determining whether it was obvious to put together known elements in the art to meet the asserted claim. The Federal Circuit had likewise long-rejected any "obvious to try" standard. In KSR, the Supreme Court held that because the Federal Circuit applied its own TSM test too rigidly, the claim "must be found obvious." The Court further noted that TSM is a "helpful insight," but "when a court transforms the general principle into a rigid rule that limits the obviousness inquiry, as the Court of Appeals did here, it errs."

This decision has and will continue to impact the ability to procure and defend patents on medical devices. The medical device arena necessarily involves the use of common elements and components ? such as needles, pumps, and valves. Thus, KSR's directive to exercise common sense and to afford the person of ordinary skill to art areas outside the medical field opens up potential new obviousness challenges that may not have existed before.

In particular, had the KSR court merely commented on the proper application of the TSM test, there may have been little fanfare. Instead, the Court expounded on several aspects of the obviousness inquiry: (i) Flexibility: The obviousness inquiry is an "expansive and flexible approach"; (ii) Ordinary Creativity: "A person of ordinary skill is also a person of ordinary creativity, not an automaton," who will not limit herself to art with the same problem, nor can she be confined to the problem patentee was trying to solve; (iii) Obvious to Try: "[T]hat a combination was obvious to try might show that it was obvious under 103"; (iv) Predictability: The patent must be more than "the predictable use of prior art elements according to their established functions"; and (v) Design Need/Market Pressure: Products driven by design needs or market pressures ? when there are finite number of identified predictable solutions ? are likely the result from ordinary skill, not innovation. In applying KSR, subsequent courts have quoted these tenets in their findings.

Post-KSR Patentee Win Rates

Post-KSR Medical Industry Cases

Nonetheless, recent cases in the medical...