March 5, 2021

Gene Patent in Cancer Test Upheld by Appeals Panel

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 ruled that DNA isolated from the body was eligible for patents because it was “markedly different” in its chemical structure from DNA that exists 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 come before the Supreme Court, which has already agreed to hear another case related to the patentability of diagnostics based on chemical changes in the human body.

The decision on the patentability of genes and DNA cheered much, though not all, of the biotechnology industry. Thousands of human genes have been patented, and biotechnology executives say such patents are essential for encouraging innovation, particularly development of diagnostic tests.

Critics have said it is unethical to patent something that is part of the human body or the natural world. Some critics have also said that the patents can impede patient care. Myriad’s full test for breast cancer risk costs more than $3,000 since the gene patents give the company a monopoly on such testing.

A lawsuit challenging the patents on the breast cancer risk genes was filed 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 importance of DNA, he said, was the information content it carried in terms of how proteins should be made. In that aspect, he said, the isolated DNA was not really different from the DNA in the body. The claim that isolating the DNA made it different, he said, was just “a lawyer’s trick.”

But the appellate decision rejected that argument, saying that since DNA is a chemical, the chemical structure is what matters and that “informational content is irrelevant to that fact.”

“We conclude that the challenged claims are drawn to patentable subject matter because 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.

He said that isolating DNA was not simply a matter of purifying it, like extracting a mineral from the earth.

Judge Kimberly A. Moore wrote a separate opinion, agreeing that the breast cancer risk genes were patentable but citing 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 expectation 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.”

Judge Bryson argued that upholding the patents could impede the movement in diagnostics toward whole-genome sequencing. In a few years, experts say, it should be possible for a person to have his or her entire DNA sequenced for less than Myriad charges for just two genes. But separate patents held on many individual genes could make that cumbersome.

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