A Medical Device Daily

After a three-week trial in the U.S. District Court for the District of Massachusetts, CytoLogix (Cambridge, Massachusetts), received a jury verdict of $10.7 million in damages in patent infringement claims against Ventana Medical Systems (Tucson, Arizona). CytoLogix technologies contain unique slide-staining methods used by pathologists in the diagnosis of cancer and other diseases, the company said.

CytoLogix was founded by Steven Bogen, MD, PhD, a pathologist affiliated with the Boston University School of Medicine. Jack Pirozzolo and Vickie Henry of Foley Hoag led the CytoLogix trial team. Litigation on the CytoLogix family of patents covering this diagnostic technology is expected to continue.

CytoLogix’ last legal victory against Ventana was in the spring of 2004 when Judge Rya Zobel of the U.S. Federal Court in Boston issued a permanent injunction against Ventana (Medical Device Daily, May 21, 2004).

That injunction covered Ventana’s Benchmark and Discovery systems and any variation of those products that infringed CytoLogix U.S. patent nos. 6,180,061 (‘061) or 6,183,693 (‘693).

In other patent activity:

• Occlutech (Jena, Germany) a European manufacturer of cardiac occlusion devices such as atrial septal defect (ASD), patent foramen ovale (PFO) and left atrial appendage (LAA) occluders, said it has initiated invalidation proceedings against AGA Medical’s (Plymouth, Minnesota) European patent in the UK Occlutech claims that most of the broader claims interpreted into this patent by AGA Medical were not accepted by the examiners of the European Patent Office in the original patent approval process due to the existence of prior art. This creates a “significant and justified basis” for Occlutech to file for invalidation, the company said.

In addition, Occlutech is asking the UK court to rule that their devices are outside the claims of AGA’s patent, on the grounds of substantial differences between the patent and the configuration of the Occlutech devices. No date has yet been set for the hearing, but Occlutech said it would be seeking an early ruling on these issues.

“We see a substantial chance that AGA’s European patent will be invalidated by this and as a result of AGA’s own actions and argumentation with the European Patent Office,” said Robert Moszner, CEO of Occlutech. “Occlutech’s technology base is very different from AGA’s where we do an individual braiding of each device. Our unique technology and methods are superior and very different from anything else on the market and we are eager to have the non-infringement confirmed in court in the UK as early as possible.”

Occlusion devices are used to treat structural heart disease, including structural heart defects and abnormalities, such ASDs and PFOs, in a minimally invasive, non-surgical way. The market for these devices, and the PFO occluders in particular, are expected to expand significantly over the next few years.

• NeoStem (New York), a company that specializes in the collection, processing and storage of stem cells from healthy adults for personal use in times of critical medical need, said that it has filed a far-reaching patent application that initiates the process of safeguarding the company’s procedures for collecting, storing and developing potential biotherapies from adult stem cells derived from a patient’s own body. The application encompasses several concepts that include next generation biomedical services such as bio-insurance and the formulation of designer stem cell-related therapies for healthy individuals interested in mitigating potential health conditions in the future.

NeoStem’s technology positions the company at the forefront of a bold new shift in the medical industry where the patient’s own body would provide the materials, such as adult stem cells, necessary to formulate therapies that have, until recently, been provided by pharmaceutical companies in the form of synthetic, chemically engineered drugs.

“We believe NeoStem is positioned to take a leadership role in the emerging stem cell therapeutic market by fractionating the cells for the treatment of different diseases in what many medical doctors and scientists believe to be the next great revolution in medicine,” said Robin Smith, MD, CEO/chairman of NeoStem. “We believe we are at the threshold of stem cells being a mainstream therapeutic that will dramatically change how medicine is practiced in the future. NeoStem is firmly committed to protect and continue to build a robust portfolio of pending patents as a means to securing long-term value for our shareholders.”

NeoStem’s first-to-market competitive advantage uniquely positions it to capitalize on the hundreds of adult stem cell-based clinical therapy trials currently underway, the company said. As these stem cell-based therapies become available, NeoStem said its clients will be among the first to benefit from the life saving progress that has already been made for such debilitating conditions as cancer, heart disease, multiple sclerosis, lupus, and many others.

“It is important for investors to understand that we believe that our proprietary technology positions us above and beyond the processes currently being employed by cord blood banks, which simply inject the entire spectrum of stem cells without regard to the specific disease target,” said Denis Rodgerson, PhD, director of Stem Cell Science of NeoStem. “We believe that the NeoStem service offering will prove to be heads and shoulders above any other stem cell services company.”

NeoStem is a biotechnology services company enhancing the delivery of adult stem cell therapeutics to health-conscious consumers.

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