Court Reaffirms Right of Myriad Genetics to Patent Genes

By REUTERS

Published: August 16, 2012

A federal appeals court reaffirmed on Thursday the right of Myriad Genetics to patent two genes linked to breast and ovarian cancer, after the Supreme Court told it to take another look at the hotly contested case.

A panel of the United States Court of Appeals for the Federal Circuit upheld Myriad’s right to patent “isolated” genes known as BRCA1 and BRCA2, which account for most inherited forms of breast and ovarian cancer.

But the court denied the biotechnology company’s effort to patent methods of “comparing” or “analyzing” DNA sequences.

Women who test positive using Myriad’s gene test, called BRACAnalysis, have an 82 percent higher risk of breast cancer and a 44 percent higher risk of ovarian cancer in their lifetimes.

The lawsuit against Myriad and the University of Utah Research Foundation, which hold the patents on the genes, argued that the patents were illegal and restricted scientific research and patients’ access to medical care.

The American Civil Liberties Union, which brought the case, argued that patents on human genes violated the First Amendment and patent law because genes are “products of nature.”

But Judge Alan Lourie, writing for a majority in the ruling, said: “Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.”

Thursday’s decision in the ethically charged litigation was made five months after the Supreme Court, in a case involving a blood test developed by Prometheus Laboratories, unanimously ruled that companies were not permitted to patent observations about natural phenomena.

A week later, the Supreme Court set aside the federal appeals court’s July 2011 decision favoring Myriad, which is based in Salt Lake City, and directed that court to review the case in light of the Prometheus ruling.

Myriad’s patenting effort has drawn opposition from groups including the American Medical Association, the March of Dimes, the American Society for Human Genetics and the Association for Molecular Pathology.

In a brief arguing against patenting genes, Dr. James Watson, one of the discoverers of the double helix structure of DNA, said he feared the court had failed to appreciate the fundamentally unique nature of the human gene, which stores information necessary to create and propagate life.

“It is a chemical entity, but DNA’s importance flows from its ability to encode and transmit the instructions for creating humans. Life’s instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts.”

Nevertheless, the appeals court accepted the argument of Myriad’s supporters that denying patent protection could stifle innovation by the company and others.

“Patents encourage innovation and even encourage inventing around; we must be careful not to rope off far-reaching areas of patent eligibility,” Judge Lourie wrote.

This article has been revised to reflect the following correction:
Correction: August 20, 2012
Because of an editing error, an earlier version of this article misstated the court that affirmed Myriad’s patent as the United States Court of Appeals for the District of Columbia Circuit.