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Good News, Bad News for Hologic on the Financial, Legal Front

by Astrid Fiano, DOTmed News Writer | November 13, 2009

According to the legal documents filed in the case, Conceptus, Inc. sells the Essure system, a transcervically introduced birth-control product. Essure is different from tubal ligation in that it does not involve incisions and can be performed in a doctor's office without general anesthesia. The fallopian-tube occlusion results from tissue growth into and around a transcervically implanted metal coil device. Essure received approval from the FDA in 2002. The Adiana system transcervically implants a silicone device, called as a matrix, and uses radiofrequency energy to obstruct the fallopian tubes.

Among other reasons for denying the preliminary junction, Judge William Alsup said that Conceptus did not meet its burden on the likelihood of success on the merits with respect to the patent's validity, enforceability, and infringement as required by law. That the Adiana system uses an intrafallopian device made out of silicone, not resilient metal was itself dispositive of not meeting the burden, Jusge Alsup stated. In addition, while Conceptus claimed that the Adiana method infringed on Conceptus' 904 patent, which has a scar formation element, the Adiana method description stated that no scar tissue would be formed in the procedure.

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"While we realized from the start that preliminary injunctions are rarely granted, we nonetheless are disappointed with the court's decision on this matter. We continue to believe that at trial we will win on the merits of our case and prove conclusively that the Adiana system infringes our patents," Mark Sieczkarek, president and chief executive officer of Conceptus, said in a prepared statement. "Our patents are the foundation of our work in developing one of the most effective forms of permanent contraception ever available and we intend to vigorously enforce all of our intellectual property rights against infringement or misappropriation."

Hologic's financial news: http://www.hologic.com/fin-results/view/173-year.2009_173-id.234881579.html

Conceptus' comments: http://investor.conceptus.com/releasedetail.cfm?ReleaseID=423001

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