This is an important case for biotechnology, discussed in an earlier post, but the implications are hard to assess until the Federal Circuit reviews the case on appeal.
Although the lawsuit was brought to address perceived impediments to innovation and access to genetic diagnostic testing, the decision could potentially implicate the validity of a host of other biotechnology patents, including patents used to protect biologic drugs.
I mean, they owned a part of me that I could never recover. My genetic essence is held captive." --John Moore, the subject of US Patent No.
Thus, this protein plays a role in transcription, DNA repair of double-strand breaks Myriad's business model of offering the diagnostic test exclusively led from Myriad being a startup in 1994 to being a publicly traded company with 1200 employees and about $500M in annual revenue in 2012; it also led to controversy over high prices and the inability to obtain second opinions from other diagnostic labs, which in turn led to the landmark Association for Molecular Pathology v. The human BRCA1 protein consists of four major protein domains; the Znf C3HC4- RING domain, the BRCA1 serine domain and two BRCT domains.
These domains encode approximately 27% of BRCA1 protein.
Orthologs, styled Brca1 and Brca1, are common in other mammal species.
BRCA1 and BRCA2 are normally expressed in the cells of breast and other tissue, where they help repair damaged DNA, or destroy cells if DNA cannot be repaired.
Sweet's ruling will resound far beyond the BRCA genes.
Biogen Corporation controls your kidney's essential KIM gene; the University of California holds patents on the TCP-1, -2 and -3 genes that enable your tongue to sense taste; and patents have been granted for genes that control the functions human bones, heart, teeth, tongue, colon, skin, brain, bone, ear, lung, liver, kidney, sperm, blood and immune system.They are involved in the repair of chromosomal damage with an important role in the error-free repair of DNA double-strand breaks.BRCA1 and BRCA2 have been described as "breast cancer susceptibility genes" and "breast cancer susceptibility proteins".This stands in contrast to the semantic mayhem triggered by the original ruling "Pigs fly!" a headline of the described as "jaw-dropping," "radical," and "astonishing," Judge Sweet of the United States District Court invalidated the patents on the breast- and ovarian-cancer genes, declaring that they are not made by man and thus patent-ineligible.BRCA1 and BRCA2 are normal; it is their mutation that is abnormal.