Australian court: Sorry, but you can’t patent genes

An Australian high court has struck down a pharmaceutical company’s claims that it held patents to the BRCA-1 and BRCA-2 cancer genes, siding with a patient who had argued that because the genes existed in nature, they could not be considered an invention.

According to BBC News, US-based Myriad Genetics had been awarded a patent for the genes—which if present, significantly increase a woman’s risk of developing breast and ovarian cancers—in the 1990s after finding and isolating them. However, 69-year-old Yvonne D’Arcy, a two-time cancer survivor, challenged the company’s right to claim ownership of the genes.

Myriad, whose ownership of BRCA-1 and BRCA-2 had previously been overturned by the US Supreme Court, successfully won the case twice in Australian Federal Courts. However, earlier this week, the High Court overturned those decisions, ruling unanimously that the biotech group had only discovered the genes, not invented them, and thus could not obtain a patent.

While detecting the genes “might be, in a formal sense, a product of human action,” the court ruled that “it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed.” As such, it was not officially an invention.

Research failed to pass the “manufacture test”

Myriad argued that the patents were to make sure that they could make their work commercially available to everybody, according to ABC News Australia, and would thus encourage additional analysis of the genes. D’Arcy and cancer campaigners believed that doing away with the patents would make testing for these genes more accessible, BBC News added.

In their 2013 ruing, the US Supreme Court determined that DNA was a product of nature, and as such was not patentable. However, the justices did determine that synthetic, lab-made DNA was not a product of nature, meaning someone could claim ownership of it. Attorneys for Myriad had said that the US ruling did not reflect regulations in Australia, where a different standard is used.

As ABC News explained, Australian inventions are subject to something called the “manufacture test”, in which the differences in structure and function of genetic substances is emphasized, not the similarities as is the case in the States. The company argued that the US decision had actually strengthened their case by determining the materials they used were isolated from the genes and represented a “non-naturally occurring molecule.”

On Wednesday, the High Court determined that Myriad’s work did not fall within the concept of “manufacture.” D’Arcy called that ruling “a win” for patients that “have the genetic footprint for breast cancer or any cancer basically.” She added that the decision would make testing cheaper and more available, and that she hoped “other countries will see sense and follow us.”

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