Natera accuses CareDx of infringing DNA testing patents
Natera has accused rival medical company CareDx of infringing two patents covering its “cell-free” DNA (cfNDA) testing technology, Prospera.
The Texas-based company filed two separate lawsuits at the US District Court for the District of Delaware on Friday, May 13, alleging that CareDx manufactures several products related to organ transplantation.
The patents-in-suit are US patents 10,655,180 and 11,111,544, which cover a “system and method for cleaning noisy genetic data and determining chromosome copy number” and “methods for Simultaneous Amplification of Target Loci” respectively.
The patents are tied to Natera’s 2019 Prospera platform, a diagnostic test for evaluating organ transplant health to determine the likelihood of rejection.
Medicare issued a draft Local Coverage Determination (LCD) for Prospera. This is a decision by a Medicare administrative contractor on whether a particular service or item is “reasonable or necessary” and covered by medicare.
Companies specialising in the field can submit comments supporting or deriding a treatment’s classification for LCD.
Natera claims that it received only three letters which did not support Prospera’s LCD designation, and they were from CareDc or “self-identified paid advocates of CareDx” in an attempt to “interfere with Natera’s commercialization efforts”.
The two complaints identify CareDx’s AlloSure, AlloSeq, KidneyCare, and HeartCare products as infringing its two patents.
Natera seeks judgments that CareDx infringes the ‘180 and ‘544 patents and has asked the court for preliminary and permanent orders preventing CareDx from further infringements.
It also has requested that the Delaware court deem the case exceptional and so be awarded attorney fees as well as prejudgment and post-judgment interest.
Last year, Invitae accused Natera’s cancer detection technology which it markets as Signatera of infringing its DNA-sequencing patents at the same Delaware court.
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