A jury trial is under way in a lawsuit filed last year by Hologic Inc. (NSDQ:HOLX) against SenoRx (NSDQ:SENO), alleging that SenoRx infringed patents covering Hologic’s MammoSite breast cancer radiation therapy system with its Contura device.
The lawsuit, filed in the U.S. District Court for Northern California, accuses Aliso Viejo, Calif.-based SenoRx of violating a trio of patents for its MammoSite brachytherapy balloon catheter device. The system delivers radiation to the cavity left from the removal of cancerous breast tissue during lumpectomy. Bedford, Mass.-based Hologic acquired the technology in its $6.2 billion buyout of Cytyc Corp. in 2007.
The case is based in part on SenoRx’s application for 510(k) clearance from the Food & Drug Administration for its SenoRad device. That type of clearance relies on a so-called “predicate device,” already FDA-approved, as a “substantial equivalent” of the new product. SenoRx used the MammoSite as its predicate device in the application, which the FDA approved in May, 2007, deeming the SenoRad (later branded as the Contura) to be substantially equivalent to the MammoSite device.
“The SenoRad applicator has the following similarities to the previously cleared predicate devices: same indications for use; same intended use; same intended treatment site; same operating principle; same technological characteristics; equivalent dosimetric characteristics; and same sterilization method,” according to court documents [emphasis from original documents].
In its answer to the complaint, SenoRx denies that Contura infringes MammoSite and claims that the Hologic patents named in the suit are invalid, according to court documents.