Appeals Court Upholds U. of Utah's Controversial Breast-Cancer Gene Patents

August 16, 2012

A federal appeals court on Thursday again upheld the legality of gene patents developed at the University of Utah and used by Myriad Genetics Inc. for a controversial test it sells exclusively to help predict the hereditary risk of breast and ovarian cancer.

The Public Patent Foundation and the American Civil Liberties Union, backed by many disease foundations and organizations representing academic researchers, have sought to challenge the legality of the patents. The opponents say that it is illegal to patent forms of nature and that the patents restrict scientific research and patients' access to medical care.

But in its 2-to-1 decision, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit said the claims in the patents for isolating DNA molecules on the genes covered "non-naturally occurring" matter and were therefore eligible for patents, as were some of the related gene-screening techniques.

A federal district court initially sided with the challengers to those patents, which involve genes known as BRCA 1 and BRCA 2. The appeals court later reversed that decision, and early this year the case was pending before the U.S. Supreme Court.

But in March, after the Supreme Court ruled in a different case that an invention that merely describes natural processes could not be patented, the justices ordered the U.S. Court of Appeals for the Federal Circuit to reconsider its prior rulings on the Myriad Genetics patents. (The Federal Circuit is the appeals court with national jurisdiction for appeals in patent-law cases.)

'Snapping a Leaf From a Tree'

In light of the Supreme Court's decision, the appeals-court panel, in its latest ruling, did reject some of Myriad's patent claims related to comparisons and analysis of the genes, saying they were just "mental processes."

But the majority rejected arguments by the patent challengers that the isolated DNA molecules were legally undeserving of patents, saying that would upend "the settled expectation of the inventing and investing communities." Such a decision, the majority wrote, "must come, not from the courts, but from Congress."

In his dissent, Judge William C. Bryson said the patents were undeserved because the isolating of the DNA molecules was ultimately "akin to snapping a leaf from a tree."

But the judges in the majority, Alan D. Lourie and Kimberly A. Moore, disagreed. "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," they wrote. "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."

In a written statement, Chris Hansen, a staff lawyer with the ACLU's Speech, Privacy, and Technology Project, said the ruling "prevents doctors and scientists from exchanging their ideas and research freely."

Myriad, in a news release praising the ruling, said that the gene patents had not hindered research on BRCA 1 and BRCA 2, "and Myriad has never denied, opposed, or impeded any research studies on these, or any other, genes." The company said "more than 18,000 scientists have researched the BRCA genes, publishing more than 9,000 research papers."

The case drew supporting briefs from dozens of industry and academic groups, including one, jointly submitted by the Biotechnology Industry Organziation and the Association of University Technology Managers, that supported the patents.

Daniel B. Ravicher, executive director of the patent foundation at the Benjamin N. Cardozo School of Law, said the plaintiffs, who include several university professors, have not yet decided what to do next. They could request a rehearing by the full appeals court or seek an appeal to the Supreme Court.