KSR v. Teleflex — Are Medical Device Patents at Risk?

05 October 2007 Publication

The Pulse

The Supreme Court Rejects the Federal Circuit’s Rigid Approach to Obviousness Determinations
In patent law it is not always obvious, or easy, to determine what is an “obvious” invention. Lawyers, judges, inventors, and business executives continue to struggle with this seemingly simple issue.

On April 30, 2007, the U.S. Supreme Court gave us its current guidance on the subject when it unanimously reversed the U.S. Court of Appeals for the Federal Circuit in KSR International Co. v. Teleflex Inc. The Supreme Court’s opinion fundamentally changes the law regarding obviousness in a manner that is likely to make patents on medical devices harder to obtain and enforce.

The KSR case concerns a basic issue of whether or not a claimed invention is patentable. The invention in this case was a mechanism that combined an electronic sensor with an adjustable automobile pedal so that the pedal’s position can be transmitted to a computer that controls the throttle in the vehicle’s engine. However, the principles of the KSR case would apply equally as well to an electronic sensor that controls a pump drive used, for example, in a heart-lung machine.

Obvious Inventions Are Not Patentable
An applicant is not entitled to a patent if the differences between the invention sought to be patented and prior patents, prior publications, or other prior information are such that the invention as a whole “would have been obvious” at the time the invention was made to a person having ordinary skill in the technology to which the invention pertains. In applying this standard, the Federal Circuit has held that even if all of the elements of an invention can be found somewhere in prior patents, publications, or other available information, the invention still is not obvious unless there is a “teaching, suggestion, or motivation” to combine the prior information to create the claimed invention, with the “teaching, suggestion, or motivation” found in some place other than the inventors’ disclosure.

The Supreme Court opinion reversed the Federal Circuit’s “rigid approach” in analyzing the question of obviousness. In so doing, the Supreme Court’s opinion re-emphasized that an obviousness determination required a “broad inquiry.”

Are Medical Device Patents at Risk?
In the KSR opinion, the Supreme Court re-emphasized some old principles that likely will make medical device patents harder to obtain and easier to invalidate. Many medical device inventions, like almost all inventions, are combinations of elements and components — for example, pumps, filters, needles, prostheses, or electrical components — that are well-known and commonly used. In the KSR case, the Supreme Court stated a need for caution in granting a patent based upon a combination of elements found in the prior art, particularly when the invention only unites old elements with no change in their respective functions. The Supreme Court stated that a combination of familiar elements “is obvious,” and thus not patentable, if the combination does no more than “simply arranges old elements with each performing the same function it had been known to perform” and yields no more than one would expect from such an arrangement.” Those seeking to obtain or enforce medical device patents can expect to face some form of this logic applied to conclude their invention is “obvious.”

Yet, as a practical matter, most inventions in most technologies are made of old or familiar elements. As Judge Learned Hand observed almost 50 years ago, “substantially every invention” is a “combination of old elements.” Reiner v. I. Leon Co., 285 F.2d 501 (2d Cir. 1960) More recently, the Court of Appeals for the Federal Circuit wisely noted that in making inventions “Men [and women] must work with old elements.” Fromson v. Advance Offset Plate, 755 F.2d 1549, 1556 n.3 (Fed. Cir. 1985). Nobel laureate Albert Szent-Gyorgyi observed, “Discovery consists of seeing what everybody has seen and thinking what nobody has thought.” However, if what everybody has seen are old or familiar elements, this may be “discovery,” but the Supreme Court may have some doubts as to whether it is a patentable invention.

The Supreme Court’s opinion states that the obviousness inquiry “must ask whether the improvement [represented in the claimed invention] is more than the predictable use of prior art elements according to their established functions.” If it is, the invention likely will be found to be not “obvious.”

Aircraft or Heart Valves — What’s the Problem?
The Supreme Court identified three errors in the Federal Circuit’s obviousness analysis. First, the Supreme Court held that “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” This is in contrast to the Federal Circuit’s rule that only problems addressed by the patentee could be considered as the source of a motivation to combine references. Thus, for example, under the logic of KSR, a prior patent seeking to solve a problem involving turbulent flow of air over the wing of an aircraft may be used against a medical device invention seeking to solve a problem involving turbulent flow of blood over a heart valve, since both arguably relate to the same problem — turbulence — and the same field of endeavor — fluid flow.

A Person of Ordinary Skill Is Not an Automaton
Second, the Supreme Court held that the Federal Circuit had adopted too constricted a view of the person of ordinary skill in the art. Because “[a] person of ordinary skill also is a person of ordinary creativity, not an automaton,” the fact that an invention is obvious to try may suffice to establish unpatentability.

Common Sense and the “Obvious to Try” Standard
When 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. If this leads to the anticipated success, it is likely the product is not one of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious.

Third, the Supreme Court explained that the Federal Circuit had overemphasized the risk that patent examiners and courts would fall prey to hindsight bias.

The Supreme Court’s opinion revised the tests for obviousness and did so in a manner that is likely to make medical device patents harder to obtain and easier to invalidate. Indeed, recent cases following KSR have indicated this is what is happening. In making decisions about obtaining or enforcing medical device patents, inventors and business executives need to thoroughly understand the new “obviousness” analysis.

This article is a part of the October 2007 edition of The Pulse, a newsletter for leaders in the Medical Device Industry.