US International Trade Commission Judge Finds Fujifilm Infringes on Hologic Patents

Hologic, Inc. announced that an Administrative Law Judge of the U.S. International Trade Commission (ITC) has issued a favorable initial ruling in the investigation of the patent infringement complaint filed by Hologic, Inc. against Fujifilm.

The asserted patents pertain to x-ray mammography with tomosynthesis and other related mammography technologies found in Hologic’s market-leading Selenia® Dimensions® and 3Dimensions™ systems, which are manufactured in the United States.  These technologies contribute to Hologic’s innovative 2D and 3D™ combination exam which is FDA approved as superior to 2D mammography alone, has been found to detect 20-65% more invasive breast cancers*,[1], and reduces callbacks by up to 40%*,1,[2]

As part of the initial ruling, the Judge ruled that Fujifilm infringed all of the patents brought to trial and rejected Fujifilm's defenses against these patents. As a result of this ruling, the Judge recommended an exclusion order that prevents the importation of infringing Fujifilm products into the United States, as well as a cease-and-desist order preventing the further sale and marketing of infringing Fujifilm products in the United States. A final ruling by the ITC is scheduled to issue by November 26, 2018.

"We are pleased that the Administrative Law Judge has upheld the integrity of our intellectual property against Fujifilm," said Pete Valenti, President of Breast and Skeletal Health at Hologic. "We are confident that the Commission will uphold the decision to issue both an exclusion order and a cease-and-desist order covering Fujifilm's infringing products.  As the world leader and innovator in mammography, we will continue to vigorously protect our intellectual property, which drives innovation for our customers and patients."

*Compared to 2D mammography alone

[1] Results from Friedewald, SM, et al. "Breast cancer screening using tomosynthesis in combination with digital mammography." JAMA 311.24 (2014): 2499-2507; a multi-site (13), non-randomized, historical control study of 454,000 screening mammograms investigating the initial impact the introduction of the Hologic Selenia Dimensions on screening outcomes. Individual results may vary. The study found an average 41% (95% CI: 20-65%) increase and that 1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1000 screening exams were found in women receiving combined 2D FFDM and 3D™ mammograms acquired with the Hologic 3D Mammography™ System versus women receiving 2D FFDM mammograms only

[2] Bernard D, Macaskill P, Pellegrini M, et. Al. Breast cancer screening with tomosynthesis (3D mammography) with acquired or synthetic 2D mammography compared with 2D mammography alone (STOMR-2); a population based prospective study. Lancet Oncol. 2016 Aug; 17(8):1105-13

SOURCE Hologic, Inc.