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Validity of human gene patents upheld by Federal Appeals Court

Validity of human gene patents upheld by Federal Appeals Court


The US Court of Appeals upheld an earlier ruling that isolated human genes can be patented. The case involves Myriad Genetics and its patents on the genes BRCA1 and BRCA2, which are used to screen for breast and ovarian cancer.

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The US Court of Appeals for the Federal Circuit upheld an earlier ruling that isolated human genes can, in fact, be patented. The case involves Myriad Genetics, Inc. and its patents on two genes (BRCA1 and BRCA2), mutations in which are highly correlated with hereditary breast and ovarian cancers. The ruling leaves Myriad as the "exclusive US commercial provider of genetic screenings for the diseases," reports The Wall Street Journal. The ACLU, who represented the plaintiffs in the case including the Association for Molecular Pathology and College of American Pathologists, noted that Myriad’s monopoly allows it to set the cost of tests (which range from $300 to $3,000, depending on the test) and eliminates the possibility of alternate tests using the same genes.

In the 2–1 ruling, Judge Alan Lourie wrote that:

"The isolated DNA molecules before us are not found in nature. They are obtained in he laboratory and are man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter… For example, virtually every medicine utilized by today’s medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials. But, as such, they are different from natural materials, even if they are ultimately derived from them. The same is true of isolated DNA molecules."

In Judge William Bryson’s dissenting opinion he maintained that DNA, even when isolated, is not a man-made invention:

"The only difference between the naturally occurring BRCA genes during transcription and the claimed isolated DNA is that the claimed genes have been isolated according to nature’s predefined boundaries, i.e., at points that preserve the ability of the gene to express the protein for which it is coded. In that respect, extracting a gene is akin to snapping a leaf from a tree."

An ACLU spokeswoman told The Wall Street Journal that it is considering its legal options, which could include asking the appeals court to reconsider or appealing directly to the Supreme Court.