Patent-challenged developer stirs up Lanham Act claims

Brave New World

Guardant Health, Inc., a developer of non-invasive cancer diagnostics, claims to have invented a breakthrough product to identify the genetic progeny of cancerous cells.

Its Guardant 360 product tests the blood of the patient, picking up stray DNA strands from cancerous cells in the body without invasively gathering tissue. This method is more sensitive and accurate than a traditional tissue biopsy, as the genetic makeup of various cancers may differ within one patient or even within one tumor. Tissue-based biopsies are more limited by the particular cancer profiles drawn from the specific area tested.

Guardant 360 also identifies the distinct strains of the cancer throughout the patient and allows doctors to target those strains with appropriate drugs–an approach preferable to a broad treatment of chemotherapy.

Bad Blood

Guardant sued Foundation Medicine, Incorporated (FMI), a rival biopsy developer, for making misrepresentations about Guardant 360 in its advertising. Guardant claims that FMI’s advertising falsely claimed that Guardant 360 is inaccurate, with high rates of false negatives and positives. The complaint also calls out FMI for touting its own product’s accuracy as superior to that of Guardant 360. Most concerning to Guardant was FMI’s purported insinuation that Guardant’s product is dangerous to a patient’s health.

The suit is the latest round of an ongoing slugfest between the two companies; FMI sued Guardant last year in the Eastern District of Texas, claiming that Guardant 360 violated the patent of its own biopsy diagnostic technology. The suit was recently transferred to the District of Delaware.

The Takeaway

This latest salvo was filed by Guardant in June in the Northern District of California, and it includes allegations that FMI’s advertising violates Section 43(a)(1) of the Lanham Act as well as the California Business and Professional Code’s provisions concerning misleading statements and unfair business competition. The diagnostics industry awaits the next iteration of this feud.