Don't make it harder to get patents, biotech firms and drugmakers told the U.S. Supreme Court yesterday. The case, which concerns a dispute between rival gas-pedal manufacturers over the definition of obviousness in a patent application, is being billed as the biggest patent issue in years to come before the Supreme Court, which has faced a string of recent high profile intellectual property cases.
KSR International Co. vs. Teleflex Inc. didn't begin as a fundamental challenge to a pillar of U.S. intellectual property law. Rather, it started as a garden-variety infringement case focusing on whether Teleflex's invention of an automobile pedal, which combines known electric and adjustable pedals' technologies, was obvious and therefore didn't deserve a patent. But as the case worked its way to the Supreme Court, it became a lightning rod for charges that the U.S. Patent and Trademark Office (PTO) allows obvious ideas or inventions to win patent protection.
The issue is important to scientists because biotech inventions, among other technical innovations, usually rest upon novel combinations of existing elements, such as a known antibody and a known protein target. PTO examiners make the first call on the obviousness of such technologies, followed by courts. Both groups must examine the science and technology at the time of a patent. Decades of court rulings have instructed the PTO to look in the public record for a clear indication of whether a particular invention might have been suggested. If the office can't find such an example, the invention is ruled sufficiently nonobvious.
In briefs filed in June, software companies and some consumer activist groups said that the current standard sets too low a bar to obtain a patent. "The overpatenting that results," wrote a group of patent professors, "creates an unnecessary drag on innovation through higher prices to consumers." More appropriate, critics say, is a strict reading of a congressional law requiring the PTO to judge whether a "person having ordinary skill in the art" would have found a proposed invention obvious.
The biotechnology industry disagrees. A lower bar for obviousness would "deter investment within the biotechnology industry ... [and] negatively affect public health," argued the Washington, D.C.-based Biotechnology Industry Organization in a friend-of-the-court brief filed yesterday. The existing framework is "useful and objective" and discourages examiners from assuming that an invention is obvious, according to the brief. In addition, says an attorney for the group, many innovative biotech inventions "look fairly unremarkable" in retrospect.
Oral arguments are set for 28 November. Patent attorney Harold Wegner of Foley & Lardner in Washington, D.C., predicts the high court will embrace the call for a lower bar for determining obviousness. The court returned mixed verdicts on patent issues last year, including a move that many say weakened the enforcement power of patents last summer.