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Who Owns Your Genes?

Thursday, April 15, 2010 8:56 am

Who owns your genes? It seems like a pretty simple question – it has to be you. However, the Patent Office had a different answer.

As background, genes are part of the 3 billion human DeoxyriboNucleic Acid (DNA) bases. The bases are arranged in a two strand spiral called a double helix which is held together by two molecules, one sugar and the other phosphate. Heredity passes the DNA from the chromosomes of one generation to the chromosomes of the next. There are many genes within each chromosome with different genes determining different traits. To recap, genes reside in our chromosomes which are part of our DNA.

Because everyone’s DNA is unique unto themselves, then logically, we must certainly own our DNA. The United States Patent and Trademark Office (USPTO) didn’t see it that way and awarded patent rights to different parts of everyone’s DNA to a number of biotech companies. This changed, however, on March 29, 2010 with Judge Sweet’s ruling in Association for Molecular Pathology and ACLU v. USPTO and Myriad Genetics which invalidated seven Myriad Genetics' patents for two genes known to be linked to breast and ovarian cancers.

Taking the lead for the Plaintiffs, the ACLU argued persuasively that genes are products of nature and are hence not patentable subject matter. Further, they asserted that patents on human genes restrict research to only one company that could charge whatever amount they wanted. Myriad Genetics’ counter argument claimed that the process of isolating DNA from the human body transforms it into patentable subject matter because the genes were previously unknown, were clearly useful and certainly not obvious. Therefore, the new, useful and non-obvious patent standard was met resulting in a patent granted by the Patent Office.

The Court’s decision in the Myriad Genetics’ case also brings into question the validity of other patents based on human DNA. So far approximately 20% of the human genes have been patented by companies who have invested billions of dollars in research in the hopes of recovering their costs and making a profit. Without a profit incentive, medical breakthroughs could be significantly slowed. Thus with so much at stake, Judge Sweet’s ruling will certainly be appealed.

So, who owns your genes? For right now it’s you, but stay tuned.

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