Sunday, April 19, 2020

Diagnostic DNA Dispute

Natera, a California biotechnology company involved in molecular oncology diagnostics, filed a patent infringement suit against ArcherDx on January 27, 2020, alleging infringement of claims of United States Patent No. 10,538,814 (the "'814 patent").  GenomeWeb reported on April 15, 2020, that Natera had amended its complaint to include alleged infringement of claims of U.S. Patent Nos. 10,557,172, 10,597,708, and 10,590,482.

The abstract of the '814 patent describes the inventive subject matter as follows:
The invention provides methods for simultaneously amplifying multiple nucleic acid regions of interest in one reaction volume as well as methods for selecting a library of primers for use in such amplification methods. The invention also provides library of primers with desirable characteristics, such as minimal formation of amplified primer dimers or other non-target amplicons.
Claim 1 of the '814 patent reads as follows:
A method for amplifying and sequencing DNA, comprising: 
ligating adaptors to cell-free DNA isolated from a biological sample, wherein the adaptors each comprises a universal priming site; 
performing a first PCR to simultaneously amplify at least 10 target loci using a universal primer and at least 10 target-specific primers in a single reaction volume; 
performing a second, nested PCR to simultaneously amplify the at least 10 target loci using the universal primer and at least 10 inner target-specific primers in a single reaction volume, wherein at least one of the primers comprises a sequencing tag; 
performing high-throughput sequencing to sequence the amplified DNA comprising the target loci.
It would not a bridge too far to predict that ArcherDx will robustly attempt to raise invalidity defenses against this and other patents claims, invoking both patentable subject matter (that is, 35 U.S.C. §101) and obviousness (that is, 35 U.S.C. §103).