Hologic, maker of the Selenia Dimensions digital breast tomosynthesis system, is taking on Fujifilm Medical Systems in a patent-infringement lawsuit over its Aspire Cristalle System.
The Selenia received patents from the U.S. Patent and Trademark Office in 2010 and FDA approval in 2011.
At issue is the appearance of the Aspire Cristalle at Las Vegas and Los Angeles conferences recently – and the promotion of uses that are allegedly in patent violation, according to the Connecticut Law Tribune
On January 23, 2017, “FujiFilm USA announced that it had received pre-market approval from the U.S. Food and Drug Administration for its “Digital Breast Tomosynthesis (DBT),” as an optional software upgrade for the FujiFilm ASPIRE Cristalle system, and that “[t]he optional DBT upgrade for the ASPIRE Cristalle system is now available in the United States,” the lawsuit stated
It went on to state that FujiFilm is “directly infringing” on one of the patents “by making, using, offering for sale, and/or selling within the United States, and/or importing into the United States, X-ray breast imaging devices, including at least their ASPIRE Cristalle product.”
The suit alleged that five patents in total are infringed on, including 7,831,296; 8,452,379; 7,688,940; 7,986,765 and 7,123,684, according to Life Sciences Intellectual Property Review
The suit was filed in Connecticut, which is home to FujiFilm's U.S. headquarters.
When FujiFilm announced pre-market FDA approval for ASPIRE Cristalle in January, it stated
that there was an optional DBT upgrade for the device, “known as AMULET Innovality outside of the United States,” adding that “the ASPIRE Cristalle FFDM system with DBT combines FujiFilm’s state-of-the-art hexagonal close pattern (HCP) detector design, advanced image processing and image acquisition workflow to optimize patient dose while maximizing image quality.”
The suit stated that as a result “defendants have encouraged customers and end users to use at least the ASPIRE Cristalle product in an infringing manner, provided operating manuals instructing customers and end users to use at least that product in an infringing manner, provided training and/or technical support to customers and end users instructing how to use at least that product in an infringing manner, and advertised, marketed, and promoted the use of at least that product in an infringing manner.”
With the DBT option, HCB News reported at the time
, the X-ray tube on the ASPIRE Cristalle FFDM system moves through an arc around the breast to acquire a series of low-dose image slices at different angles. That generates a 3-D view of the breast, which allows the radiologist to see through the tissue without any obstruction.
The images are reconstructed into high-resolution one-millimeter slices that are displayed individually or dynamically in a cine mode. That makes it easier for radiology to spot lesions that may be hard to see on 2-D mammography images because of overlapping breast structures.
GE Healthcare, Siemens Healthineers and Hologic Inc. are currently the top three players in the global DBT market. They collectively account for almost 90 percent revenue share of the market, according to a Future Market Insights report from 2016.
Hologic's suit asks that the infringement stop, that monetary damages are awarded, including costs.
Two of Hologic's lawyers, Calvin P. Griffith and John M. Michalik, who are partners with the firm of Jones Day, were part of the group that won a $2.54 billion patent infringement case in favor of Idenix Pharmaceuticals against Gilead Sciences, according to the Tribune.