Managers and the Legal Environment 7th Edition by David Madsen, Constance Bagley

Exercise 7

Myriad Genetics, Inc. has patents for isolated DNA sequences associated with a predisposition to breast and ovarian cancers (the BRCA1 and BCRA2 genes) and for diagnostic methods of identifying mutations in those DNA sequences. A group of plaintiffs challenged the validity of the patents in court. The challenged patents include (1) a patent over the composition of isolated DNA sequences related to breast and ovarian cancers; (2) a patent for the method of comparing/analyzing isolated DNA sequences (which can be accomplished by mere inspection); and (3) a patent for the method of screening potential cancer therapeutics through changes in cell growth rates, which involves growing cells, determining cell growth rates, and comparing growth rates. Are the isolated DNA sequences a product of nature and thus patent ineligible? Are these methods of comparing DNA sequences too abstract to patent? Is the method for screening potential cancer therapeutics too abstract to be a patent-ineligible scientific principle, or does it include transformative steps that are patent eligible? Would making a correlation between the presence of the BRCA1 and BRCA2 genes and a heightened risk of breast and ovarian cancer be patentable? [Ass'n for Molecular Pathology v. U.S. Patent Trademark Office, 2011 WL 3211513 (Fed. Cir. 2011).]