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Federal Court Upholds Patenting on Human Genes

By Pharmaceutical Processing | August 1, 2011

 

NEW YORK (AP) — A federal court said Friday that human genes
can be patented, reversing a lower court’s ruling that involved a test for
breast cancer but which could have had big implications for biotechnology and pharmaceutical
companies.

Judge Alan Lourie’s ruling says the genes can be patented
because the isolated DNA has a “markedly different chemical
structure” from DNA within the body. The U.S. Patent and Trademark Office
has been awarding patents on genes for almost 30 years.

“The ability to visualize a DNA molecule through a
microscope, or by any other means, when it is bonded to other genetic material,
is worlds apart from possessing an isolated DNA molecule that is in hand and usable,”
Lourie wrote for a 2-to-1 majority. “It is the difference between
knowledge of nature and reducing a portion of nature to concrete form, the
latter activity being what the patent laws seek to encourage and protect.”

The lawsuit concerned two patents held by Myriad Genetics
Inc. of Salt Lake City.
Myriad’s BRACAnalysis test looks at gene sequences linked to increased risk of
breast and ovarian cancer. The American Civil Liberties Union argued that genes
couldn’t be patented, and in March 2010, a New York district court agreed.

“Today’s ruling is a blow to the idea that patent law
cannot impede the free flow of ideas in scientific research,” said Chris
Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project.

ACLU Attorney Sandra Park said the ACLU will consult with
its clients in deciding whether to appeal or seek another remedy. The
plaintiffs include geneticists who said they were not able to continue their
work because of Myriad’s patents, along with breast cancer and women’s health
groups, patients, and groups of researchers, pathologists, and laboratory
professionals.

Myriad was able to continue selling the BRACAnalysis test
despite the previous ruling from Judge Robert Sweet of the U.S. District Court
for the Southern District of New York.

Lourie ruled against Myriad on five claims, saying the
company cannot patent comparisons and analysis of DNA sequences. The company
said it still holds 237 claims that are not affected by the decision. The company’s
shares rose 2.3 percent in aftermarket trading.

 

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