Human genes can be patented in U.S. - Court overrules previous ruling

By Dr. Ananya Mandal, MDJul 31 2011

A lower court in the U.S. had earlier ruled that human genes cannot be patented by biotech companies who use them for diagnostic purposes. Now a federal appeals court ruled on Friday that genes can be patented. The Court of Appeals for the Federal Circuit, which specializes in patent cases, said that Myriad Genetics was entitled to patents on two human genes used to predict if women have an increased risk of getting breast and ovarian cancer.

The court said that DNA isolated from the body was eligible for patents because it was “markedly different” in its chemical structure from DNA that exists inside the chromosomes in the body. As a result, the isolated DNA is not simply a product of nature, which would not be eligible for a patent. The 2-to-1 decision on the gene patenting issue was also a rejection of arguments made by the Obama administration, which had filed a friend of the court brief arguing that isolated DNA should not be patented. That brief went against the long-standing policy of the United States Patent and Trademark Office to grant such patents.

The appeals court ruled against Myriad in another part of the case, however. The court said that Myriad’s patent claims on the process of analyzing whether a patient’s genes had mutations that raised the risk of cancer was not patentable because it involved only “patent-ineligible abstract mental steps.” The case may eventually reach the Supreme Court.

This ruling has been welcomed by the biotechnology industry. Thousands of human genes have been patented, and some biotechnology executives say such patents are essential for encouraging innovation. Gerald J. Flattmann Jr., a patent lawyer at Paul Hastings in New York, who represents pharmaceutical companies but was not involved in this case said, “It basically adhered to the policy the Patent Office has pursued since the early ’80s, when the biotech industry was born… Isolated gene patents are the cornerstone of the biotechnology industry.”

However some experts say it is unethical to patent something that is part of the human body or the natural world. Some also say that the cost of testing might be reduced if companies did not hold testing monopolies because of their patents. Myriad, which holds the patents on the genes called BRCA1 and BRCA2 with the University of Utah Research Foundation, charges more than $3,000 for its breast cancer risk test.

A lawsuit challenging the patents on the breast cancer risk genes was filed in 2009 by the American Civil Liberties Union and the Public Patent Foundation, acting as the lawyers for various cancer patients, medical researchers and medical societies. In an opinion issued in March 2010, United States District Judge Robert W. Sweet in Manhattan ruled the patents were invalid.

“The claims cover molecules that are markedly different — have a distinctive chemical identity and nature — from molecules that exist in nature,” Judge Alan D. Lourie wrote for the court. While Judge Lourie’s opinion spoke for the court, the other two judges wrote their own opinions. Judge Kimberly A. Moore agreed that genes were patentable but cited somewhat different reasoning, including that only Congress should change Patent Office policy to grant such patents. “Judicial restraint is particularly important here because an entire industry developed in the decades since the Patent Office first granted patents to isolated DNA,” Judge Moore wrote. “Disturbing the biotechnology industry’s settled expectations now risks impeding, not promoting, innovation.” But the third judge on the panel, William C. Bryson, dissented, saying that the genes should not be patented just because they were isolated from the body. In some respects, he wrote, “extracting a gene is akin to snapping a leaf from a tree.”

Peter D. Meldrum, chief executive of Myriad, said Friday that he was “absolutely delighted with the ruling.” He said the patent claims that the court ruled invalid were not important and that patent protection for the company’s test was as strong as before the lawsuit was filed. Daniel B. Ravicher, executive director of the Public Patent Foundation, which helped file the suit, called the decision a partial victory for the plaintiffs. Noting that one judge dissented on the gene patents, he said, “They can’t agree among themselves.” Mr. Ravicher said the plaintiffs were considering either asking the entire appellate court to rehear the gene patenting aspects of the case or appealing to the Supreme Court.

Lisa A. Haile, a patent lawyer at DLA Piper in San Diego who is not involved in the Myriad case, said the appeals court on Friday suggested Myriad’s claims would have been upheld if there was another step, such as sequencing the genes, in addition to just mental steps. “You can’t say diagnostic claims aren’t patentable,” Ms. Haile said. “It’s just the way these claims were written.”