It looks like the genetic testing service companies have concluded that the best defense is a good offense when it comes to Myriads claimed patent suite protecting its BRCA1 and BRCA2 franchise. Quest has also asked California courts to declare that it is free to pursue BRCA1 and BRCA2 testing by endorsing that it is either not infringing Myriad's claims (under a slew of patents) or the patents are invalid. Though it makes no specific arguments as to how this is the case.
Rather its brief seems to concentrate its efforts on establishing that it has every reason to believe that Myriad will send a cease and desist letter and/or sue if Quest should offer this type of genetic testing. It bolsters its assertion by citing instances where Myriad has sent letters and or sued competitors entering the space -- plus another instance when a competitor delayed entry when it felt threatened by a suit. OK.
Quest asserts that it has developed a commercial offering for BRCA gene testing, "[a]fter years of research and development, and a financial commitment of millions of dollars." Further, [t]he types of hereditary alterations detected by Quest's BRCA Assay include alterations in DNA copy number, deletions, duplications or rearrangements in BRCA1 and BRCA" and none of its methods "make or use cloned DNA, replicative cloning vectors, expression systems or host cells comprising BRCA1 or BRCA2 DNA" or BRCA polypeptides or primers. Despite these distinctions, Quest asserts that it is at risk of suit from Myriad, thus justifying its complaint for declaratory judgment. See Patent Docs blog for above and more.
Quest is hoping for that "get out of jail card free" but it is hard to determine whether it has earned it.
Posted by Bruce Lehr Oct 14th 2013.