A Medical Device Daily

Occlutech (Jena, Germany), a manufacturer of coronary occlusion devices said it has obtained approval for its IP position in relation to patents held by AGA Medical (Minneapolis) from the European International Association for the Protection of Intellectual Property (AIPPI).

AGA claims it is the owner of a European patent (EP 0 808 138) registered in Germany for intravascular occlusion devices and the method of forming or manufacturing these medical devices. The patent was granted in October 2005.

AGA’s original action against Occlutech, filed in Dusseldorf in August 2006, requested damages against Occlutech, Drabo Medizintechnik (Cologne, Germany) and their CEOs and further requested a permanent injunction prohibiting them from manufacturing and marketing the infringing “Figulla Occluder” line of products (Medical Device Daily, Aug. 29, 2006). AGA said the three-judge panel held that Occlutech and Drabo infringed AGA’s patent and granted AGA the right to enforce an order prohibiting the defendants from any manufacture, possession or sale of its infringing products.

During the original grant procedure, however, the Examiners of the European Patent Office did not accept the broad scope of the claims. This created significant reason for Occlutech to appeal the first instance district court’s decision that Occlutech literally infringe the AGA patent in Germany and to initiate non-infringement proceedings in several other European countries (MDD Aug. 7, 2007).

Occlutech asked AIPPI for an independent, clarifying opinion which now further supports Occlutech’s position. In a statement Robert Moszner, CEO of Occlutech, said: “We are very pleased with the opinion of AIPPI. In addition to several expert opinions, it strongly supports our view that we are not infringing the patent brought forward by AGA Medical. We have developed a unique technology that is surrounded by its own strong intellectual property and we look forward to having our position confirmed in European and U.S. National courts.”

Occlusion devices are used to treat structural heart disease, including structural heart defects and abnormalities such as Atrial Septal Defects, (ASD), and Patent Foramen Ovale (PFO) — an undesired channel between the hearts two atria that is present in up to 25% of the population — in a minimally invasive, non-surgical way. The market for PFO occluders in particular is expected to expand significantly as the link between PFO and strokes, as well as severe migraine, becomes increasingly well-documented.

AIPPI is the world’s leading non-government organization for research into and protection of intellectual property, and is a respected source for opinions and arbitration on IP matters such as patent interpretation and the use of IP in unfair competition.

In other patent news: Axela (Toronto) reported that it has been issued patent number 7,314,749, “Method and apparatus for assay based on light diffraction” by the U.S. Patent and Trademark Office. This core patent augments more than 150 other patents and applications, which define the company as the leading provider of novel protein research and diagnostic tools based on diffractive optic measurements.

Additionally the company said it has changed its name from Axela Biosensors to Axela to reflect the broad range of applications and markets served by its technology beyond traditional biosensing. The company has established operations in a GMP/GLP facility in Foster City, California to accelerate the development of real time multiplex immunoassay kits for the dotLab System.

“The issuance of this patent further reinforces the strong intellectual property position Axela has established in the use of diffractive optics to significantly improve the performance of immunoassays in research and diagnostic applications,” said Rocky Ganske, Axela CEO. “Initial product offerings available through our partner VWR International are focused on accelerating the study of biomolecular interactions, optimizing protein expression and the rapid development of quantitative immunoassays for the research markets. Axela and its collaborators have already demonstrated the benefits of real-time measurements that extend the dynamic range of multiplex analysis and access unique diagnostic targets. This is reflected in our recent name change and the expansion of U.S. operations to commercialize proprietary content and panels.”

Axela develops real-time protein detection, characterization and monitoring directly in biological samples.