On November 30, 2012, the United States Supreme Court granted certiorari in Association for Molecular Pathology v. Myriad Genetics (No. 12-398) to decide whether human genes are patentable. The case arises out of a declaratory judgment action brought by various researchers and institutions that certain claims in patents held by Myriad Genetics relating to isolated genes associated with a predisposition to breast and ovarian cancer are invalid because the subject matter of the patents is not eligible to be patented under 35 U.S.C. § 101.
The Patent Act provides that “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor . . . .” 35 U.S.C. § 101.
While this statement and scope is broad, it is not unlimited. The Supreme Court has held, most recently in Mayo Collaborative Services v. Prometheus, Inc., 132 S. Ct. 1289 (2012), that laws of nature, natural phenomena, and abstract ideas are not eligible to be patented, as are mental processes and products of nature.
The question in this case is whether human genes fall within the scope of Section 101, or whether they are natural phenomena that are ineligible to be patented.
Split Decision at the Federal Circuit
In deciding this issue, the Federal Circuit panel (comprised of Circuit Judges Lourie, Moore, and Bryson) each wrote separate opinions endorsing different rules to decide this issue. Judge Lourie (writing for the majority) found that human genes are patentable, reasoning that the isolated DNA molecules at issue in the claims of the patents are not found in that form in nature. Because they are different from natural materials and isolated through the product of human ingenuity, they are eligible to be patented.
Judge Moore agreed that the claims are patent eligible, but for a different reason. She noted that human genes have been patented for years and are specifically allowed by the US Patent Office. She also noted that if she was writing on a blank slate, she might reach a different conclusion.
Finally, Judge Bryson dissented, finding the claims were not patent eligible. He found that the isolated genes performed the same function as they do inside the full DNA sequence. Thus, there was no transformation, and the genes are nothing more than an extraction of a naturally-occurring phenomena.
The researchers and institutions petitioned the Supreme Court for a writ of certorari, which the Supreme Court granted on the limited question of “Are human genes patentable?”
Numerous Amici Have Weighed in
Given the importance of this issue, both to researchers and pharmaceutical companies, a number of parties have weighed in with the Supreme Court, urging that the standard for patent eligibility for human genes be clarified. Their briefs can be read here.
It will be interesting to follow this case and its briefing in the coming months to see how the Supreme Court decides this issue or whether it leaves it to Congress to decide.