Myriad Genetics...is suing 2 companies that offer less expensive testing for the BRCA1 and BRCA2 genes....The genes are associated with an increased risk of developing breast, ovarian, and other cancers. The suit alleges that the competitors — Ambry Genetics ...and Gene by Gene, Ltd. ...— are infringing on specific Myriad patents that are distinct from those invalidated by the US Supreme Court in June. DNATraits, a division of Gene By Gene, offers testing for the BRCA1 and BRCA2 genes in the United States for $995, according to the company. Ambry's testing reportedly costs $2280. Both prices compare favorably to Myriad's testing, which costs $4000. According to documents filed ... in US District Court in Utah, Myriad is not contesting the Supreme Court's rejection of their patents on naturally occurring DNA for the BRCA genes. In fact, the company's lawyers state that their new lawsuit "involves none of those 5 rejected claims."Instead, the suit relates to patent claims on "synthetic DNA," which Myriad asserts "were not affected by the Court's decision and remain valid and enforceable." Synthetic DNA, also known as cDNA, is patentable, according to Myriad's interpretation of the Supreme Court's ruling in June, because it involves "physical, transformative steps" in the laboratory. A number of the patent claims in the new lawsuit involve gene-specific probes, primers, and arrays that are part of the Myriad BRCA testing process and employ cDNA synthesized in a laboratory, according to the documents. Even after the Supreme Court decision, Myriad reports having 24 patents and 515 patent claims that involve BRCA1 and BRCA2 testing. Ambry, in turn, announced ...that it intends to "vigorously defend itself" against the patent infringement suit....When the Supreme Court invalidated 5 Myriad patents in June, patient advocates hailed the ruling as opening the door to less expensive testing. However, at the same time, Myriad immediately set the stage for more legal action.
It's only a matter of time before Myriad Genetics' stranglehold on BRCA1/BRCA2 testing is loosened. However, the legal battles will continue for some time with much at stake for the genetic testing industry. As I understand the article quoted above, the legal battle now turns to a discussion of patent claims and synthetic DNA (cDNA), This involves the extent to which Ambry and Gene by Gene infringe on the Myriad intellectual property relating to the role of cDNA in testing for BRCA1/BRCA2. I am sure that another bone of contention at some point will be the clinical information that Myriad has collected over the years about the various DNA missense mutations that can occur at the BRCA1/BRCA2 loci and the clinical significance of them (see: BRCA2 ). Of course, researchers working in the area of breast cancer genetics have been accumulating their own data over the years about BRCA mutations and much of this data is publicly available rather than proprietary for Myriad.