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Federal Judge Invalidates A Gene Patent To The Surprise Of Many

A recent 3 part series discussed the pros/cons of the current medical patent system (Are Patents Impeding Medical Care and Innovation? Part 1, 2, 3). In Part 1, the practice of patenting natural cellular processes were called into question and whether this meant that the patent holder (i.e., often a company) then owned parts of your body. Seems like a silly and even ridiculous question, but these outcomes represent real implications of these patent practices. The USA Today recently published a story that U.S. District Court Judge Robert Sweet ruled against several genetic patents owned by Myriad Genetics of Salt Lake City

This all began when a women with aggressive breast cancer needed to be tested for a mutated BRCA gene, which Myriad owned the patent. The presence of the mutated gene would predict whether she was at risk for ovarian cancer and if her doctor needed to remove her ovaries as a preventative measure. However, Myriad Genetics did not have an agreement with her insurance company to pay for the cost of this test due to a low reimbursement rate.

It was only 1.5 years later when Myriad donated 200 of these tests to the women’s home state that this badly needed genetic testing was conducted, and it turns out that she tested positive for the mutated gene. In Myriad’s defense, they note that hundreds of millions of dollars were invested to research these specific genetic processes, which significantly increased the cost of this test.

Nonetheless, the judge stated that patents are specifically issued for an original invention and that Myriad Genetics did not design or create this gene. I agree. How can one patent a natural process? This is analogous to me patenting the sun or oxygen, and then to charge anyone who benefits from sunlight or breathing.

In the end, this is a ground breaking ruling that will shake the genetic patent industry. Of course, an appeal is expected and this will likely end up at the Supreme Court.

Visit USA Today for the full story.

CFisher

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