InVitae Corporation announced on November 26th that it plans to defend its right to provide naturally occurring genetic diagnostic testing and services including BRCA.
https://www.invitae.com/en/press/invitae-responds-myriad-genetics-lawsuit/
In a complaint filed in Utah federal court, Myriad claims that InVitae is infringing on 11 patents for products that assess a patient’s risk for breast and other cancers. University of Utah Research Foundation et al v Invitae
Myriad has filed multiple lawsuits against multiple companies who have recently launched BRCA1 and BRCA2 tests. Defendants include Ambry Genetics, Gene by Gene, Quest Diagnostics (DGX), BioReference Laboratories(BRLI), and most recently LabCorp (LH).
A US Supreme Court ruling in June http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf found that human genes can not be patented and the court invalidated key Myriad claims. The court concluded that “DNA, which is merely isolated from nature, is not patentable subject matter, including mutations existing in nature (such as BRCA1 and BRCA2)”
With this ruling the court removed a key barrier that was preventing laboratories from offering comprehensive cancer testing that included the BRCA related genes — at a potentially lower cost.
However, Myriad alleges laboratories still infringe on several of its remaining patents and correctly states it still has more than 500 other patent claims, including composition of matter, method and system claims.
InVitae and others such as the Genetic Alliance are strongly in support of building a free and open database containing diagnosis information and clinical interpretation of genetic information. They support the “Free the Genes” initiative and are committed to making genetic testing information more available.
On November 26, InVitae filed a counter-suit against Myriad in California Northern District Court Invitae-v-Myriad-Genetics to declare the Myriad patents invalid and not infringed by InVitae.
The InVitae press release announcing their counter-suit against Myriad is on their website: https://www.invitae.com/en/press/invitae-files-suit-against-myriad-genetics/
