February, 2007 - AmniSure® International, LLC wins its litigation against Oy Medix Biochemica (
Finland
) in the Federal Patent Court of Germany in
Munich
. As the result of this legal victory, the Medix patent (German part of EP 0 565 541 - DE 691 28 428) was completely invalidated. The invalidation of the Medix patent also led to staying the infringement action that Medix previously initiated against AmniSure and that is presently pending at the
Appeal Court
in Düsseldorf after being decided in first instance against AmniSure. While Medix may have the right to appeal the
Federal Patent Court
decision, our opinion is that this latest court decision marks the end of any meaningful legal opposition from Medix to our AmniSure® ROM Test. This is particularly true given that the Medix patent covering the ROM diagnostic method (German part of EP 0 565 541 - DE 691 28 428) has only few more years left before its expiration. AmniSure® International LLC reserves the right to replicate its successful legal action against Medix in other markets outside
Germany
.
English translation of the German verdict can be viewed here.
August 2005: American Journal of Perinatology (peer-reviewed) magazine publishes an article entitled “AmniSure® Placental Alpha Microglobulin-1: Rapid Immunoassay versus Standard Diagnostic Methods for Detection of Rupture of Membranes” by Larry M. Cousins, M.D. et al. According to the study discussed in the article, “AmniSure® is highly accurate [>99%] in diagnosing fetal membrane rupture.” The article can be found here.
Philadelphia, May 3-5, 2004. N-Dia, Inc. (developer of AmniSure®) officially launches its AmniSure® test in the US.
New York, February 2004. N-Dia, Inc. (developer of AmniSure®) secured FDA clearance for marketing its flagship AmniSure® test in the US.
