UPDATE: Hologic loses patent fight to SenoRx, plans appeal

December 21, 2009 By MassDevice staff Leave a Comment

Hologic Inc. (NSDQ:HOLX) lost a patent battle with SenoRx Inc. (NSDQ:SENO), after a California jury ruled a pair of Hologic patents invalid.

In a lawsuit filed late last year, Bedford, Mass.-based Hologic accused SenoRx of infringing two patents covering Hologic’s MammoSite breast cancer radiation therapy system with its Contura device. But a jury in the U.S. District Court for Northern California decided that both patents were invalid and that, in any case, Aliso Viejo, Calif.-based SenoRx didn’t violate one of them.

Hologic said it plans to appeal the decision to the Court of Appeals for the Federal Circuit.

The lawsuit alleged that SenoRx violated Hologic’s 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. Hologic acquired the technology in its $6.2 billion buyout of Cytyc Corp. in 2007.

Hologic’s case in part relied 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].

Both companies posted gains Dec. 18, with SenoRx stock closing at $6.77, up about 4 percent, and Hologic up about 1.4 percent, to $13.66.

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