16th jun, 2013

Setback for Myriad – Good news for gene research and the patent system

For some years now the human genome has been a battlefield in intellectual property. Companies have tried to patent the use of genes in therapy, drugs and other uses.

Now there is a landmark decision in the US Supreme Court setting out the framework for patents and genetics.

Myraid Genetics discovered the precise location and sequence of two human genes, mutations of which can substantially increase the risks of breast and ovarian cancer. The subsequently patented the use of these sequences.

Myriad was sued by the Association for Molecular Pathology claiming that the patents were  invalid.

The Supreme Court ahs decided in favor of the Association for Molecular Pathology invalidating the patents.

The court gives the following reason:

·         Myriad’s DNA claim falls within the law of nature exception. Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes

·         Myriad did not create or alter either the genetic information encoded in the BCRA1 andBCRA2 genes or the genetic structure of the DNA. It found an im­portant and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.

·         Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together.

This is a very good ruling which means that no one can monopolize the human genes and their use in treating people that are ill.

The case was put in perspective by the news that Angelia Jolie was treated for the illness that the patents cover. That gave the case a human face.

Director of the Danish Patent And Trademark Office, Jesper Kongstad, is quoted for saying that this decision is strengthening the patent system as a whole. The reason is that in Europe it has long been impossible to patent genes as those patented in the Myriad case. A similar legal position in both the US and Europe will make the patent system more robust.

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