A Medical Device Daily

Kinetic Concepts, (KCI; San Antonio) reported that the German Federal Patent Court has ruled that a German patent licensed to KCI from Wake Forest University (Winston-Salem, North Carolina) related to KCI's V.A.C. technology is invalid.

The validity of the German patent (EP 0620720 (DE 69224847)) is being challenged by Medela (McHenry, Illinois) M lnlycke Health Care (Goteborg, Sweden) and Smith & Nephew (S&N; London). The decision is not final and KCI and Wake Forest said they intend to appeal the decision to the German Federal Supreme Court.

The patent remains valid in Germany until a final ruling from the appellate court. While the patent decision may result in new devices being marketed in Germany, should KCI prevail on appeal, it would be entitled to damages.

"While we are disappointed with this ruling of the German Federal Patent Court, KCI remains confident in the validity of this patent," said Catherine Burzik, KCI president/CEO. "As the global leader in advanced wound care, we remain committed to partnering with our customers while leveraging proven competencies and established infrastructure to effectively commercialize innovative systems and therapies in this market."

"We will continue to vigorously defend and enforce our intellectual property rights," said Stephen Seidel, executive VP/general counsel of KCI. "This ruling is limited to the German patent at issue, and does not directly impact the other patents in KCI's portfolio, including the two U.S. patents which were upheld as valid by the U.S. Court of Appeals in February."

S&N and KCI have been engaged in litigation in the U.S. in connection with KCI's NPWT patents. KCI first filed suit against S&N in May of 2007 shortly after that company acquired Blue Sky Medical Group (Carlsbad, California) (Medical Device Daily, May 17, 2008). As part of the U.S. legal process, three of KCI's U.S. patents relating to NPWT stand rejected as unpatentable by the U.S. Patent and Trademark Office.

In other legalities:

• A federal jury in Miami convicted two physicians and two medical assistants in connection with a $5.3 million Medicare fraud scheme, according to Acting Assistant Atty. Gen. Rita Glavin of the Criminal Division and U.S. Attorney R. Alexander Acosta of the Southern District of Florida.

After a two-week trial in federal court in Miami, a jury found David Rothman, MD; Keith Russell, MD; Eda Marietta Milanes; and Jorge Luis Pacheco; guilty on all charged counts, including conspiracy to commit healthcare fraud and multiple counts of healthcare fraud for submitting claims to Medicare for unnecessary medications.

According to evidence presented at trial, the defendants worked as doctors and medical assistants at two Miami clinics, Medcore Group and M&P Group of South Florida, that purported to specialize in the treatment of human immunodeficiency virus (HIV).

Evidence at trial established that Rothman was the medical director for both Medcore and M&P Group between May 2004 and January 2006. Russell took over as medical director at M&P Group after January 2006. Pacheco and Milanes worked as medical assistants for Russell at M&P Group.

One of the owners of the clinics, Tony Marrero, testified at trial that the clinics were established for the sole purpose of defrauding Medicare. Marrero testified that the scheme was to submit claims for medically unnecessary HIV infusion and injection treatments. Evidence at trial showed that Medcore and M&P Group billed Medicare for $5,300,186 and were paid $2,511,387 during two years of operations.

• Wolters Kluwer Health (Amsterdam, the Netherlands), a provider of information for healthcare professionals, reported that the U.S. District Court for the District of Massachusetts has granted final approval to the amended settlement between the company's Medi-Span (Indianapolis) subsidiary and the plaintiffs who filed a class-action lawsuit against it in May 2007.

The plaintiffs alleged that Wolters Kluwer Health's Medi-Span negligently published Average Wholesale Price (AWP) information that had been wrongfully inflated by First DataBank (San Francisco) a prior owner of Medi-Span.

Wolters Kluwer Health continues to deny the plaintiffs' allegations and any liability based on those allegations. In addition to other provisions, Wolters Kluwer Health has agreed to adjustments in the AWP as a part of the amended settlement.