In March this year, the US Court of Appeals was ordered by the US Supreme Court to reconsider its decision in Association for Molecular Pathology v Myriad Genetics (see our previous post). Last Thursday, the Court of Appeals handed down its decision, which held by a 2-1 majority that Myriad Genetics had the right to patent two BRCA genes, which are used for the screening of inheritable breast and ovarian cancer.
The central issue in the proceedings was whether the BRCA genes were eligible for patent protection. The US Supreme Court has consistently held that while patent-eligibility under 35 U.S.C. § 101 should be interpreted broadly, “laws of nature, natural phenomena, and abstract ideas” are not patentable. The Plaintiffs argued that Myriad Genetics should not be allowed to patent the isolated BRCA genes because they are a “product of nature”. Judge Lourie (with whom Judge Moore agreed) held otherwise:
“The isolated DNA molecules before us are not found in nature. They are found 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.”
In contrast, dissenting Judge Bryson held that the change in chemical structure in the isolated gene sequence was “necessarily incidental to the extraction of the genes from the environment in which they are found in nature” and while the process of extraction might be patentable, “the isolated genes are not materially different from the native genes”. He drew an analogy to the extraction of minerals, the extracted minerals being not patentable.
The judges were careful to distinguish the legal question in the case from the moral and ethical concerns which arise. Judge Moore stated:
“…the patents in question raise substantial moral and ethical issues related to awarding a property right to isolated portions of human DNA – the very thing that makes us humans”.
However, the majority held that such concerns are the domain of policy makers and for Congress, not a matter for judicial activism. Whether the Plaintiffs will launch a second appeal to the US Supreme Court is not yet known, but they have 90 days to do so – watch this space.