Hologic Inc. (NSDQ:HOLX) is getting a late boost, with shares now up nearly 3.5 percent after the women’s health firm said a federal appeals court reversed an earlier decision siding with SenoRx Inc., now part of C.R. Bard (NYSE:BCR), in a patent infringement dispute.
Citing an incorrect claim construction, the U.S. Court of Appeals for the Federal Circuit tossed a California district court summary judgment ruling Hologic’s patent claim was invalid and that sales of the SenoRx Contura breast brachytherapy product should be allowed to continue.
The original 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.
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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].
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The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
