Firms May Patent Genes, Not Comparative Means

(CN) - Companies may patent human genes associated with hereditary cancer, but cannot patent methods of comparing those genes, the appellate court for the Federal Circuit ruled.

Medical organizations, researchers and cancer patients filed a federal lawsuit in 2009, alleging that the U.S. Patent and Trademark Office should not have allowed Utah-based Myriad Genetics to patent two human genes associated with hereditary breast and ovarian cancer.

According to the lawsuit, mutations in the human genes BRCA1 and BRCA2 are responsible for most cases of hereditary breast and ovarian cancer. Researchers can predict the risk of getting the disease in women with a history of breast and ovarian cancer in their families by analyzing and comparing those genes.

Diagnostic testing may help women who are predisposed to BRCA gene mutations decide on a plan of treatment or prevention, including increased surveillance or preventive mastectomies or ovary removal.

Myriad and the University of Utah Research Foundation, who own the patents to the BRCA1 and BRCA2 genes, have the exclusive right to perform diagnostic tests on the genes in the United States.

The plaintiffs argued that the patents were illegal, because they restricted scientific research and patients' access to medical care. Myriad could set arbitrary prices and rules for genetic testing, because other researchers could not even look at gene samples without Myriad's permission, the complaint alleged. The patient plaintiffs stated that they had been unable to obtain genetic testing at a price they could afford or covered by their insurance because of Myriad's patent protection.

A federal judge in 2010 found that Myriad's patents were invalid, because human DNA molecules were "products of nature" and could not be patented. The court also ruled that Myriad's methods of analyzing and comparing DNA sequences were patent-ineligible mental processes.

An appeals court reversed the decision, but the U.S. Supreme Court last year ordered it to re-hear the case after ruling in a similar case that natural processes cannot be patented.

After hearing the controversial case for the second time, the appeals court Thursday reached the same conclusion, reversing the lower court's decision that Myriad's genes and methods were patent-ineligible.

The appeals judges agreed that one of the plaintiffs, Dr. Ostrer, formerly a researcher at New York University School of Medicine, had standing to challenge Myriad's patents. Ostrer had sufficiently alleged that he was willing and able to perform clinical BRCA testing, but was deterred by Myriad's enforcement of its patent rights, according to the 106-page ruling.

The court rejected Myriad's contention that time had made the dispute hypothetical, because Myriad hadn't actively enforced its patent rights in more than 10 years.

"In many cases a controversy made manifest by a patentee's affirmative assertion of its patent rights will dissipate as market players and products change", Judge Lourie wrote for the court. "In this case, however, the relevant circumstances surrounding Myriad's assertion of its patent rights have not changed despite the passage of time."

But the court again found that Myriad's claims to isolated BRCA genes and to a process for screening potential cancer therapeutics were patent-eligible.

Isolated DNA molecules are man-made products, and while they may retain part of the information in the native DNA, they have a distinctive chemical structure and identity from those found in nature, the ruling states.

In response to Judge Bryson's partially dissenting opinion, which pointed out that BRCA genes are found in nature and Myriad merely extracts them from their environment, causing only "incidental changes", Lourie noted that the isolation of DNA molecules meant they were converted to new entities.

"It is also important to dispute the dissent's analogy to snapping a leaf from a tree," Lourie wrote. "With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, easily done by anyone. Creating a new chemical entity is the work of human transformation, requiring skill, knowledge, and effort."

The Patent and Trademark Office and the courts have long agreed that DNA molecules are patent-eligible, and changes to longstanding practices should come from Congress, not the courts, the ruling states.

What's more, Lourie noted, holding DNA molecules patent-ineligible may discourage innovation.

Myriad may also patent a method for screening potential cancer therapeutics via changes in cell growth rates of transformed cells, which are altered in laboratories and therefore not naturally-occurring. But the judges agreed that Myriad's methods of analyzing and comparing certain DNA sequences are abstract mental processes which cannot be patented.

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