US federal judge invalidates gene patents

In a case that has major ramifications for the health care industry and for personalized medicine, a federal judge in New York yesterday invalidated the patents on BRAC1 and BRAC2 genes held by Myriad Genetics and the University of Utah.

In his 182-page ruling, Judge Sweet stated that the patents “are directed to a law of nature and were therefore improperly granted.”

This case is clearly headed for the U.S. Supreme Court, and there may be several twists and turns along the road. The question of exactly what can and cannot be patented with respect to the identification of specific genes and the commercial application of tests for such genes is extraordinarily complicated. The “New” Prostate Cancer InfoLink is certainly not sufficiently knowledgeable to predict where this will all end up.

At issue, at the end of the day, on the one hand, is whether commercial companies will be willing to develop commercially viable genetic tests if they cannot secure patents on the underlying technology. On the other hand we are facing the question of whether it is reasonable to patent the properties of “a law of nature” and to profit from such a patent.

There are already several media stories covering this issue for those who have a particular interest in this topic (which most certainly will have ramifications for the management of prostate cancer overtime). Here is a brief list of the more detailed media reports:

As just one prostate cancer-specific example of the potential impact of this ruling, it calls into question the right of any one company to own patents to the PCA3 gene and tests developed to identify the presence of this gene.

One Response

  1. In my OPINION, it is quite different to “own” the rights to a gene that naturally exists in in the human genome, as compared to having patentable rights to a test that has been developed to detect its presence at levels of confirmed diagnostic significance.

    One is a “discovery” of something that already exists which should NOT be patentable, while the other is a “developed” product for a specific purpose, which should be patentable. – (aka) az4peaks

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