Santé bien être nutrition environnement / Health

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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 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.

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 some biotechnology executives say such patents
are essential for encouraging innovation.

“It basically adhered to the policy the Patent Office has pursued
since the early ’80s, when the biotech industry was born,” said Gerald
J. Flattmann Jr., a patent lawyer at Paul Hastings in New York, who
represents pharmaceutical companies but was not involved in this case.
“Isolated gene patents are the cornerstone of the biotechnology
industry.”

Critics 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
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
argument that isolating the DNA made it different, he said, was just “a
lawyer’s trick.”

But the appellate decision Friday rejected Judge Sweet’s reasoning,
saying that since DNA is a chemical, the chemical structure is what
matters and that “informational content is irrelevant to that fact.”

“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.

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.

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.”

Judge Lourie, in the prevailing opinion, rejected that analogy,
saying that isolating DNA created a new chemical entity. It was not
simply a matter of separating or purifying the DNA, he said, and not
like snapping off a leaf or extracting a mineral from the earth.

The patent claims that the appellate court ruled invalid involved
analyzing a patient’s genes to see if they had deleterious mutations.
Many diagnostic tests involve analyzing some gene or chemical in the
body, and whether such tests can be patented is an issue that the
Supreme Court has agreed to consider in another case.

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.”

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