On appeal, the Supreme Court vacated and remanded the case back to the Federal Circuit to reconsider the issues in light of Mayo v. Prometheus.

On remand, the Federal Circuit held that Mayo v. Prometheus did not affect the outcome of the case, so the American Civil Liberties Union and the Public Patent Foundation filed a petition for certiorari.

The Supreme Court held that merely isolating genes (even with introns removed), which are found in nature, does not make them patentable.

However, the SCOTUS agreed with the “friend of the court brief” submitted by the USPTO, that complementary DNA should be patent eligible, because it does not exist in Nature but rather was “engineered by man,” even though this decision lacks scientific consistency.

A prominent US biotech patent lawyer commented on the SCOTUS decision: "It is inconsistent to conclude that isolated DNA and naturally occurring DNA are not markedly different because their information content is the same, and at the same time find that cDNA is patent eligible despite having virtually identical information content to naturally occurring mRNA.

In 1990, at a meeting of the American Society of Human Genetics, a team of scientists led by Mary-Claire King, from the University of California, Berkeley announced the localization through linkage analysis of a gene associated with increased risk for breast cancer (BRCA1) to the long arm of chromosome 17.

Myriad Genetics was founded in 1994 as a startup company out of the University of Utah, by scientists involved in the hunt for the BRCA genes.

[7] In that same year, the first BRCA1 U.S. patent was filed by the University of Utah, National Institute of Environmental Health Sciences (NIEHS), and Myriad.

[14][15] Gene patents have generated a great deal of controversy, especially when their owners or licensees have aggressively enforced them to create exclusivity.

[16] For example, in 1998, the University of Pennsylvania's Genetic Diagnostic Laboratory received cease and desist letters on the basis of patent infringement from Myriad, which requested clinical pathologists to stop testing patient samples for BRCA.

[11] Because of these kinds of legal threats to its members' medical practices, the Association for Molecular Pathology has actively lobbied against the existence of, and exclusive licensing of, gene patents and was the lead plaintiff in this litigation.

Seed Co. v. Kalo Inoculant Co.), US courts thought that "purified and isolated" doctrine still applied to molecules, and that Funk Bros. affected only living things.

The 1980 US Supreme Court decision in Diamond v. Chakrabarty opened a floodgate in patenting isolated genes, purified proteins, and cell lines.

Eventually, the practice of patenting "purified and isolated" products of nature came to an end in 2013, when the SCOTUS announced its decision in Association for Molecular Pathology v. Myriad Genetics.

[11] The American Civil Liberties Union (ACLU) and Public Patent Foundation represented the plaintiffs, with attorney Chris Hansen arguing the case.

If the invention falls under one of several excluding categories, however, including a "naturally occurring article" (a defined term in the law), then it is not patent eligible.

Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable under 35 U.S.C.

[33][34] The Department of Justice provided a surprising and unsolicited brief that in part supported the appellants but also suggested that claims covering isolated naturally occurring human genetic sequences are not properly patentable.

Judge Alan Lourie, who wrote the majority ruling, reasoned that isolated DNA is chemically distinct from the natural state of a gene in the body.

[39] After the Federal Circuit ruling, the Association for Molecular Pathology petitioned for a writ of certiorari to the Supreme Court, asking it to review this case.

And again—now reinforced by the Mayo decision—the Federal Circuit affirmed the lower court's decision, that method claims directed to "comparing" or "analyzing" DNA sequences are patent ineligible.

Judge William Bryson wrote a dissent with respect to the non-patentability of isolated DNA sequences, applying the reasoning of the Supreme Court in the Mayo case, with respect to methods involving "natural laws", to products of nature:In Mayo, which involved method claims…the [Supreme] Court found that the method was not directed to patent-eligible subject matter because it contributed nothing "inventive" to the law of nature that lay at the heart of the claimed invention…In concluding that the claims did not add "enough" to the natural laws, the Court was particularly persuaded by the fact that "the steps of the claimed processes…involve well-understood, routine, conventional activity previously engaged in by researchers in the field."

[46]On September 25, 2012, the American Civil Liberties Union and the Public Patent Foundation filed another petition for certiorari with the Supreme Court with respect to the second Federal Circuit Decision.

We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.

The District Court's decision was received as an unexpected ruling, because it contradicted the generally accepted practice of gene patents.

[56][57] Jim Dwyer, a reporter for The New York Times, wrote: "But for many people, it is impossible to understand how genes—the traits we inherit from our parents and pass along to our children—could become a company's intellectual property.

[64] In a unanimous decision in October 2015, the High Court of Australia, Australia's final court of appeal, concluded that an isolated nucleic acid, coding for a BRCA1 protein, with specific variations from the norm that are indicative of susceptibility to breast cancer and ovarian cancer was not a "patentable invention".