Supreme Court Rules On Patents

THE U.S. SUPREME COURT issued a ruling on April 30 that may make patenting new inventions and defending existing patents more difficult in all fields, including chemistry-related areas. The unanimous decision relaxes the standard used by the Patent & Trademark Office (PTO) and the courts to determine whether an invention is obvious and therefore not patentable.

"For the chemical, pharmaceutical, and biotechnology industries, the ruling is a step backward," patent attorney Charles E. Miller, a partner at the law firm of Dickstein Shapiro, tells C&EN.

For example, he says, a researcher may patent a racemic mixture with some desirable activity and later purify the active isomer. Patenting that single compound under the latest Supreme Court standard will become more difficult because isolation of the single isomer could now be considered an obvious next step.

The case before the court, KSR International Co. v. Teleflex Inc., centered on whether the U.S. Court of Appeals for the Federal Circuit—the court that hears all patent appeals—applied the correct standard to determine whether a patented invention was valid. The case involved a patent held by Teleflex for an adjustable gas pedal with an electronic sensor. KSR challenged the patent on the grounds that the work covered was obvious in that it simply combined elements from existing patents.

Although a lower court agreed with KSR and found the patent to be invalid, the Federal Circuit reversed the decision on appeal because it did not find any evidence that the prior references taught, suggested, or motivated such a combination of elements. This teaching, suggestion, or motivation (TSM) test for obviousness has been used by the Federal Circuit for more than two decades.

In the KSR case, "the Supreme Court held that the Federal Circuit had been too strict with its application of the TSM test," explains Ben M. Davidson, a partner at the Howrey law firm. According to the ruling, he says, the high court found that the Federal Circuit had turned a helpful insight that is the TSM test into a "rigid and mandatory formula."

Under the ruling, courts must now consider factors such as market forces and design incentives when assessing whether work is obvious, in addition to the TSM test. The ruling also instructs courts to consider whether the work would be obvious for someone skilled in the field to try on the basis of prior references.

"Although the technology in the KSR case was relatively straightforward and predictable," Davidson says, the ruling "may have far-reaching implications for companies in all fields, including pharmaceutical and biotechnology fields." He explains that the ruling may increase the likelihood that PTO examiners will reject patent applications as obvious on the basis of "a combination of chemicals, biologicals, and techniques known to those skilled in the art."

Concern about how this decision will affect PTO is shared by Robert M. Abrahamsen, a shareholder at the law firm of Wolf Greenfield. "The decision may embolden patent examiners at the patent office to make rejections that they might not have otherwise made," he says.

In the long run, however, Abrahamsen isn't worried about the impacts of this ruling. "The opinion seemed to focus predominantly on predictable situations where you have combinations of known elements with expected results," he notes, adding that for areas like chemistry and drug development, which are considered unpredictable arts, the likelihood of this ruling having a significant impact is even more remote.