ACLU files Supreme Court brief in Myriad case
The American Civil Liberties Union (ACLU) has urged the US Supreme Court to invalidate Myriad Genetics’ patent claims over two human genes linked to breast and ovarian cancer.
In the latest development in the controversial dispute, the ACLU filed a brief on January 23 seeking to overturn an appeals court ruling that said isolated DNA molecules were patentable.
Biotech company Myriad owns patents allowing it to isolate and detect two genes, BRCA1 and BRCA2. The US Court of Appeals for the Federal Circuit said in August 2012 that Myriad’s claims to isolated DNA molecules were patentable because they protected a man-made composition that was different from naturally-occurring DNA.
In November last year, the Supreme Court limited the ACLU’s subsequent appeal to the patentability of human genes – not the way Myriad removes the genes from the body or tests them for mutations, which the appeals court had backed the company to do.
In its response in January, the ACLU, which is leading 19 other parties including physicians and geneticists, says Myriad defends its claims on the grounds that a gene becomes a human invention when removed from the human body:
“Under this rationale, a kidney ‘isolated’ from the body would be patentable, gold ‘isolated’ from a stream would be patentable, and leaves ‘isolated’ from trees would be patentable. This defence defies common sense and elevates the draftsman’s art over the long-standing prohibition on patenting of products and laws of nature,” the brief says.
The brief alleges that Myriad’s claims over the genes have stifled scientific research, adding: “Myriad has given women false negative results, while also barring other laboratories from testing genes to verify the accuracy of Myriad’s results.”
Myriad was not immediately available for comment. But in an interview with WIPR last year, senior director of legal affairs Ben Jackson said isolated DNA molecules were markedly different from what exists in nature, having a distinct name, character and use.
The Supreme Court will now deliver the final ruling on the patentability of human genes, but not necessarily other contentious areas in the life sciences field.
“It is unlikely to close the book on many correlated questions in biotechnology, particularly here where the decision will likely be limited to the facts on hand and where the claims at issue do not go beyond ‘isolated DNA’,” said Jennifer Camacho, shareholder at Greenberg Traurig.
She said the Myriad case has divided the life sciences industry, particularly “early-stage” drug and diagnostic companies relying on the earliest-discovered genes, and life sciences companies that believe broad gene patents hinder the development of improved or alternative drugs or diagnostics.
If the Supreme Court overturns the August 2012 ruling, Camacho said it would have wide-ranging implications in the life sciences industry.
“Those companies that previously held a strong patent position based on broad coverage of a gene may no longer enjoy a strong position unless they have diversified their portfolio. On the other hand, those companies that were constrained in their patent portfolios and freedom to operate by broad third party gene patents may have an opportunity to compete on a level playing field.”
Myriad is set to file its brief to the Supreme Court on March 7. The case is expected to be heard in October this year.
