par Thomas Dworetzky
, Contributing Reporter | July 03, 2017
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.”