Human Gene Patent

August 8, 2011
Biotechnological Patents, Inventions, Patents

Image source: desktopdna.org

Patented Human Genes

The United States Court of Appeals ruled that human genes can be patented. It has reversed a federal district court’s ruling on the lawsuit.

Myriad Genetics is a molecular diagnostic company and they have successfully obtained patents for two human genes (BRCA1 / BRCA2).

These genes are used to predict a women’s risk in developing breast and ovarian cancer.

The plaintiffs claimed that human genes are a product of nature and that Myriad Genetics only isolates DNA from the body rather than creating something new.

The Lawyers of Myriad Genetics argued, using a baseball bat as an example:
“One could say that it is extracted from a tree, but in that case the process of extracting the baseball bat necessarily changes the nature, form and use of the tree and thus results in a manmade manufacture, not a naturally occurring product.”

The Lawyers of Myriad Genetics continued saying the isolated gene (BRCA1 / BRCA2) cannot be found in nature and therefore it is patentable.

The court agreed with Myriad Genetics
Judge Alan Lourie said “an isolated DNA has a markedly different chemical nature from the native DNA. In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. They have to be chemically cleaved from their chemical
combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.”

On 29 July 2011 the United States Court of Appeals for the Federal Circuit made their decision and ruled that Myriad Genetics patents are valid.

BRCA1 & BRCA2

BRCA1 is a human caretaker gene that produces a protein called breast cancer type 1 susceptibility protein, responsible for repairing DNA. BRCA1 is expressed in the cells of breast where it helps repair damaged DNA.

BRCA2 belongs to the tumor suppressor gene family and is involved in the repair of chromosomal damage with an important role in the repair of DNA double strand breaks.

Although the structures of the BRCA1 and BRCA2 genes are very different, the proteins made by both genes are essential for repairing damaged DNA.

Research suggests that both the BRCA1 and BRCA2 proteins regulate the activity of other genes and play a critical role in embryo development.

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