The U.S. Court of Appeals for the Federal Circuit issued a ruling July 29 in a case that raised fundamental questions about the patentability of human genes.

In Association for Molecular Pathology, et. al. v. U.S. Patent and Trademark Office, et. al., No. 10-1406, the American Civil Liberties Union and plaintiffs challenged patents on two breast cancer genes, collectively known as BRCA1/2. A judge in the U.S. District Court, Southern District of New York, ruled last year that the defendants – Myriad Genetics and the University of Utah Research Foundation – were not entitled to patent protection for the genes. In July, the federal appeals court reversed that decision.

Appeals court Judge Alan Lourie wrote that Myriad’s composition claims to isolated DNA molecules are patent-eligible, as the isolated molecules are not found in nature in that state. The appeals court also reversed the District Court’s decision that Myriad’s method claims to screening potential cancer therapeutics via changes in cell growth rates is a patent-ineligible scientific principle. But the court affirmed the District Court’s decision that Myriad’s claim to comparing or analyzing DNA sequences are patent ineligible, as the process requires no transformative steps and only abstract mental steps.

While the three judges were able to reach a majority opinion in the case, two judges wrote individual opinions that shed light on the difficulties in determining the boundaries of patent-eligibility.

Judge Kimberly Moore concurred in part, writing, “The patents in this case might well deserve to be excluded from the patent system, but that is a debate for Congress to resolve. I therefore decline to extend the ‘laws of nature’ exception to include isolated DNA sequences.”

Judge William Bryson concurred in part, and dissented in part. “…We are therefore required to decide whether the process of isolating genetic material from a human DNA molecule makes the isolated genetic material a patentable invention,” he wrote. “The court concludes that it does; I conclude that it does not.”•

Rehearing "The merits of medical patents" IL July 6-19, 2011