At least for now, isolated human genes are patentable, although this issue seems destined for the Supreme Court.
Background / Facts: The claims at issue on remand (in light of Prometheus) cover two “isolated” human genes, BRCA1 and BRCA2 (collectively, “BRCA1/2” or “BRCA”), and certain alterations, or mutations, in these genes associated with a predisposition to breast and ovarian cancers. Relying on a large set of DNA samples from families with inherited breast and ovarian cancers, the inventors correlated the occurrence of cancer in individual family members with the inheritance of certain marker DNA sequences. This allowed the inventors to identify, or “map,” the physical location of the BRCA genes within the human genome and to isolate the BRCA genes and determine their exact nucleotide sequences. This in turn allowed Myriad to provide BRCA diagnostic testing services to women.
Issue(s): Whether isolated human genes are patent-eligible under 35 U.S.C. § 101.
Holding(s): Yes. The main point of contention between the majority and the dissent is whether isolated human genes are merely a product of nature. The majority hung their hat on the idea that the isolation provides sufficient transformation: “The isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials. For example, virtually every medicine utilized by today’s medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials. But, as such, they are different from natural materials, even if they are ultimately derived from them. The same is true of isolated DNA molecules.” (In my view, this line of reasoning is hard to swallow and the dissent makes the more compelling argument that the minor differences caused by isolation – a couple dangling covalent bonds at the end – are inconsequential; the majority’s opinion frankly seems to be predicated more on judicial activism in which they recognize and attempt to foster, using patent protection, the development of gene therapy / screening technologies that seem to be beneficial.)