A Medical Device Daily

W.L. Gore & Associates (Flagstaff, Arizona) reported that it has been sued by NMT Medical (Boston) and Lloyd Marks, MD, in the U.S. District Court for the District of Delaware for allegedly infringing U.S. patent No. 5,108,420 (the '420 patent) through the manufacture and sale of its Gore Helex Septal Occluder devices.

Gore's technology is approved by the FDA to treat atrial septal defect (ASD) in the heart and has been used to treat thousands of children and adults worldwide since first entering clinical trials in 1999. Additionally, Gore has received FDA approval to begin clinical studies to assess the effectiveness of the Gore Helex Device to close patent foramen ovale (PFO) in the heart.

Gore said it first learned of the claim of patent infringement only after NMT Medical and Marks filed their complaint on Oct. 23. The company said the Gore Helex devices do not infringe any valid patent rights in the '420 patent.

The company said it would have welcomed the opportunity to explain its to the plaintiffs if they had been willing to enter into a dialogue prior to initiating the lawsuit.

Gore said it would "vigorously defend its valid patent rights against these baseless claims of infringement," so that it can continue to provide its technology to patients with serious heart defects.

In another occlusion device patent case, Occlutech (Jena, Germany), a manufacturer of cardiac occlusion devices, said that it has won its litigation case against AGA Medical (Plymouth, Minnesota) regarding non-infringement of the Dutch version of the European patent; EP 0808138.

The patent court in The Hague stated that the disputed Occlutech products do not infringe the Dutch part of EP 0808138 (equivalent of German patent DE 695 34 505.2) held by AGA Medical.

In reaching its decision, the Dutch court had full access to the now-appealed 2007 German District Court ruling resulting from litigation initiated by AGA Medical in 2006.

Occlutech said that in its view, AGA Medical argued for an "extraordinarily broad interpretation" of its granted patent claims, contributing to Occlutech's defeat in the first district court ruling. However, it said the broad scope of the claim, interpreted before the German court in 2007, was not accepted by the European Patent Office's examiners during the original patent granting procedure.

This and several other factors created what Occlutech said were "justified reasons" for appealing the district court ruling in Germany and to initiate non-infringement proceedings internationally and, in particular, before the patent court in The Hague.

AGA Medical said it will appeal the ruling to the Dutch appellate court.

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