Medical Device Daily Senior Staff Report

The Advanced Wound Management division of Smith & Nephew (S&N; St. Petersburg, Florida) has been in a state of limbo since March, Tom Dugan, president of the division's North American business, told Medical Device Daily.

But that uncertainty ends this week as the company celebrates its victory in the long lasting patent litigation brought by Kinetic Concepts (KCI; San Antonio) relating to the Smith & Nephew Renasys-F (foam) dressing kit.

The company reported Tuesday that the U.S. District Court for the Western District of Texas has ruled that U.S. patents 5,645,081 and 7,216,651, licensed to KCI from Wake Forest University (Winston-Salem, North Carolina), are invalid due to “obviousness.“ As a result of this ruling, the Renasys-F dressing kit will continue to be sold in the U.S. The judgment overturns a previous jury verdict from March (Medical Device Daily, March 11, 2010).

KCI first filed suit against S&N in 2007 shortly after that company acquired Blue Sky Medical Group (Carlsbad, California) (MDD, May 17, 2007). Blue Sky had been involved in litigation over its negative pressure wound therapy products with KCI for several years prior to its acquisition by S&N.

KCI lost a 2006 trial against Blue Sky regarding these gauze-based products, a different version of the system.

KCI said it will continue to analyze the court's ruling and assess its next steps including, among other options, a request for reconsideration or an appeal to the Court of Appeals for the Federal Circuit. This ruling does not affect any other patents in KCI's extensive negative pressure intellectual property portfolio, the company noted.

“We strongly disagree with the court's decision, which effectively sets aside the jury verdict from March 2010,“ said Cathy Burzik, president/CEO of KCI. “We have successfully competed for years against other NPWT products. This decision will not change the fact that we offer the most proven and innovative NPWT solutions in the marketplace, backed by the vast majority of clinical evidence and the broadest clinical expertise and field service in the industry.“

Dugan said the company knew going into the litigation that it would not be resolved quickly, as patent suits tend to drag on for quite some time. “We always looked at it as not a single event, but that it was going to be a long journey,“ he said.

Obviously, S&N is happy with the court's ruling.

“We're very pleased with the ruling, we think it validates our position, which we had all along that there was prior art here that was important,“ Dugan said. “We're pleased it has gone in our favor and we're looking forward to being able to access the market on a broader basis and make sure that all this concern and overhang around the March jury verdict goes away.“

While S&N's product was never pulled from the market and there were never any restrictions imposed by the courts on the company's wound management business, the company has been impacted by customers who were leery of converting to S&N devices because of the ongoing legal battle.

Dugan's hope is that now all of that uncertainty will go away and the company will be able to reach those customers who were cautious before. He added that this ruling will give customers more of a choice about which wound therapy products to use and who to buy them from.

“KCI controlled the market prior to this, so therefore customers really didn't have a choice . . . the power has shifted back into the hands of the customers,“ Dugan said. “That's good for the system both in terms of clinically and economically so we're pretty pleased about that . . . the broader picture is now there will be [many] more options in the market.“

This judgment is consistent with court decisions invalidating KCI's related patents in the UK and Germany, S&N noted.

Amanda Pedersen, 309-351-7774;

amanda.pedersen@ahcmedia.com

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