A Medical Device Daily

Kinetic Concepts (KCI; San Antonio), a med-tech company developing wound care and therapeutic surfaces, reported that Wake Forest University (Winston-Salem, North Carolina) has been awarded a continuation patent relating to KCI's V.A.C. technology, U.S. Patent No. 7,216,651. The patent, exclusively licensed to KCI, further broadens its intellectual property around negative-pressure wound therapy, the company said.

KCI also reported that it has filed a patent infringement suit against Smith & Nephew (S&N; London) and BlueSky Medical (Carlsbad, California) concerning the manufacture, use and sale of negative pressure devices, which KCI says infringe its newly-issued patent.

Separately, KCI also filed an infringement suit against Medela (Baar, Switzerland) for infringement of the same patent. Both cases have been filed in the Federal District Court for the Eastern District of Texas.

BlueSky and Medela are also defendants in a previous patent infringement suit brought against them by KCI, now on appeal before the Federal Circuit Court of Appeals.

"We are very pleased with the issuance of this patent as it further strengthens our intellectual property around V.A.C. Therapy," said Catherine Burzik, president/CEO of KCI. "Our advanced wound care IP portfolio covers a wide range of therapy methods and systems, including our foam-based V.A.C. System, as well as gauze-based systems marketed by BlueSky and Medela for use in negative pressure wound therapy. We will continue to enforce and protect our intellectual property rights around the world while further investing in R&D and core competencies aimed at advancing the quality and effectiveness of care for patients with complex, hard-to-heal wounds."

S&N just this week reported that its Advanced Wound Management business agreed to buy BlueSky for an initial payment of $15 million, with potential milestone payments of up to $95 million (Medical Device Daily, May 14, 2007).

Blue Sky has developed products for treating chronic wounds using negative pressure wound therapy and makes a range of negative pressure pumps and wound dressing kits to serve its global customer base. The company has been engaged in litigation with KCI and was recently successful in its defense of a patent infringement suit (MDD, Aug. 31, 2006). Although the decision is the subject of an appeal, S&N said it believes that BlueSky's products do not infringe KCI patents.

Earlier this month KCI and Medela both filed appeals with the U.S. District Court for the Western District of Texas in patent infringement litigation KCI brought against Medela and BlueSky.

The patents at issue are licensed by KCI from Wake Forest University and relate to KCI's V.A.C. technology, used for the treatment of patients with serious, complex wounds. The trial court found the patents to be valid and enforceable, but not infringed, the companies reported (MDD, May 3, 2007).

KCI is appealing the portion of the decision that found the patents were not infringed, while Medela is appealing the portion of the decision that found the KCI patents valid and enforceable.

KCI said the U.S. Federal Circuit Court in Washington would hear its appeal but no schedule for the appeal process has been established.

In other patent news: Rosetta Genomics (Rehovot, Israel), a microRNA company, reported that the U.S. patent office issued it Patent No. 7,217,807. The company said this is the first microRNA composition of matter patent ever issued relating to a human or viral microRNA gene, and it believes the issuance sets an important precedent for the company's entire patent portfolio.

The patent covers composition of matter directed at a specific microRNA gene found in the Human Immunodeficiency Virus (HIV).

Ranit Aharonov, PhD, executive VP, intellectual property and computational biology at Rosetta, said, "Rosetta Genomics is the first commercial entity to receive a patent on a microRNA gene. Given we have another patent which has been allowed, and many others in active examination, we feel confident that we will continue to see issuances of our patents for both human and viral microRNA gene sequences as well as patents covering microRNA biomarkers and our cutting-edge enabling technologies."

MicroRNAs are a naturally occurring form of RNAi that act as protein regulators and have the potential to form the basis for a new class of diagnostics and therapeutics, the company said.

• HistoRx (New Haven, Connecticut) reported receiving a U.S. patent for its AQUA technology, an automated quantitative immunohistochemical (IHC) technology that enables in situ biomarker analysis for pathology.

U.S. Patent No. 7,219,016, "Systems and Methods for Automated Analysis of Cells and Tissues," is issued to Yale University (New Haven) and exclusively licensed to HistoRx. It claims that the AQUA technology process, particularly the PLACE method (Pixel Locale Assignment for Compartmentalization of Expression), whereby biomarker expression is quantified in specific compartments of cells in tissue sections such as biopsies.

The invention is the result of work pioneered by David Rimm, MD, PhD, and Robert Camp, MD, PhD, both of Yale University School of Medicine.

HistoRx is developing quantitative histopathology technology for measurement and localization of protein biomarkers in their natural context within tissue.

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