Medical Device Link.

NEWS TRENDS

Steven Yu says the decision raises the hurdle for patents.

A U.S. Supreme Court decision in late April could make it tougher for medical device manufacturers to obtain patents and to use them as legal weapons against competitors.

“This Supreme Court decision raises the hurdle for patenting an invention,” says Steven Yu, MD, an associate in the Washington, DC, office of Kenyon & Kenyon LLP. “For those involved in medical device design and development, this decision means that it will be more difficult to obtain patents from the U.S. Patent [and Trademark] Office.”

The decision, stemming from the case KSR v. Teleflex, may end up causing device companies to rethink their strategies on intellectual property (IP) and product development. Medical device patent and IP attorneys believe there will be an effect on the industry but disagree as to its extent. Much will depend on how stringently the U.S. Patent and Trademark Office and lower courts apply the findings from the KSR decision.

In order to be valid, potential patents must pass the test of “obviousness.” That is, a patent claim is not legitimate unless its content is not obvious to the average person who has knowledge of the field. In the KSR decision, the Supreme Court struck down the test the Federal Circuit had used since 1983 to determine obviousness and replaced it with a more stringent standard. That standard has its basis in patent legislation and a 1966 court case.

Of particular significance is that patents based on new combinations of elements or components already known in a technical field might fail the new test. And in the medical device industry, most inventions are new combinations and uses of things that already exist.

“According to the Supreme Court, an invention that simply addresses a design need or market pressure to solve a problem does not make it patentable,” says Yu. “The invention would be considered obvious if there are a finite number of predictable solutions to the problem and a skilled technician would be expected to try those solutions. Thus, obtaining a patent will require a stronger showing of why the invention is not obvious. For instance, the inventor may have to demonstrate that the particular solution has unexpected results or show that others have previously tried the same approach and failed.”

Marginal inventions may not be patented owing to this decision, says Wheeler.

Manufacturers whose inventions are a combination of known elements will have to “be careful,” says George Wheeler, an attorney at McAndrews, Held & Malloy (Chicago). “If there’s no new result, patentability could be in doubt. However, every invention is a combination in some way of known elements. So you may need to prove that it was not obvious to make the combination to a greater extent than before.”

The decision may prompt medical device manufacturers to rethink what is worth the effort to patent, Wheeler adds. “People will always patent their best inventions, but this decision might mean that marginal inventions will not be patented,” he says. “You may need to produce more evidence to patent those. So some may be a bit more conservative in what they try to patent.”

Device makers often combine known elements, notes Mayer.

Chances are, device companies will not change strategies until they see how the decision plays out in the lower courts. The potential to put a serious crimp on valid patents is there, says Mika Mayer, an associate in the Palo Alto, CA, office of Morrison Foerster. “I am troubled by the language the Supreme Court uses with regard to combining known elements in particular ways,” she says. “Combining known elements is what medical device companies do.”

Ciotti says it will be difficult to go back to a stricter approach.

However, Mayer’s colleague Tom Ciotti, a partner at Morrison Foerster, says there is a chance the lower courts will be mindful of history and will not be too extreme in invalidating patents. Before a special circuit was created to hear patent cases, the Ninth Circuit had a reputation for holding patents to a very strict standard, leading those who wanted to invalidate them to try to get cases heard there. The test the Supreme Court struck down was a response to the Ninth Circuit’s approach. “Philosophically, it will be difficult to go back to the Ninth Circuit approach,” says Ciotti. “That didn’t work very well because it was too strict.”

Including patient data in a patent application is key, Wrigley says.

Regardless of how strictly the lower courts interpret the KSR decision, says Barbara Wrigley, “it will be important to include data in your [patent] application that demonstrate that the results are not predictable, or at least to have those data available in case you are asked to produce them.” Wrigley is an attorney with Oppenheimer Wolff & Donnelly LLP (Minneapolis).

It will also be helpful to show that conventional wisdom in the field was that the invention was not possible, she says. That is, “if the prior art includes A, B, and C, and makes reference to D, it would be obvious to combine two references to get A, B, C, and D. But if a prior patent with A, B, and C said ‘you can’t use D with A, B, and C because it won’t work,’ to be able to come up with A, B, C, and D in light of that would be a powerful argument.”

Another potent argument, says Ciotti, will be to demonstrate that there has been “a long-felt need for a solution to this problem.”