Not only that, but a federal court has now ruled that FDA can regulate your cells as drugs.
We reported in January that the US Food and Drug Administration wants to treat your body’s stem cells as drugs—cells taken from our own bodies and then re-implanted with the purpose of treating medical problems, usually to renew damaged body parts.
And now, as reported by the Wall Street Journal, a DC district court has ruled that these adult stem cells are in fact “drugs” (and therefore fall under FDA jurisdiction), even when the cells are taken from a patient and then re-inserted into him or her. In other words, the court ruled that you don’t have the right to stem cell treatment even when you’re using your own stem cells to treat your own injury!
The court’s ruling extends FDA oversight, at least in principle, into things as common as in-vitro fertilization. In other words, reproductive cells would also become “drugs” under the law.
Now a private company, Myriad Genetics, is arguing that they own the patent for two genes, BRAC1 and BRAC2, which account for most inherited forms of breast and ovarian cancer.
Women who are at high risk for inheriting breast cancer can test for mutations in these two genes. Under the Myriad gene test, called the BRACAnalysis, women who test positive have 82% higher risk of breast cancer and 44% higher risk of ovarian cancer. The results of the test are instrumental in determining a woman’s treatment options.
If Myriad’s patent claims are upheld, it means they have ownership over particular genes in the human body. They can charge whatever dollar amount they dream up to access those genes via the test—which is currently $4,000. Women concerned about their risk of breast or ovarian cancer wouldn’t be able to have anyone but Myriad look at their genes. And such a high price means a woman who might need the test the most might not be able to afford it.
The patents would keep competitors from offering tests, which restricts market competition to decrease prices, increase access, and improve the tests themselves. It would also cut off scientific research: scientists outside Myriad couldn’t study these genes without Myriad’s permission. Think of that: no new breast cancer therapies could be developed using these genes, because someone holds a patent on them and won’t give others access to them.
The American Civil Liberties Union and the Public Patent Foundation filed lawsuit against Myriad, the University of Utah Research Foundation, and the US Patent and Trademark Office. They said the patent restricts scientific research and patient access to medical care, and violates the First Amendment and patent law because genes are part of nature and therefore cannot be patented.
ACLU and PPF won in the lower court, but lost on appeal in federal court. Two of the judges said genes can be patented because testing looks for distinctive chemical forms of the genes and not as they appear naturally in the body. The dissenting judge argued that “plucking a leaf from a tree does not turn it into a human-made invention.”
However, in March the Supreme Court vacated the decision. They instructed the appeals court revisit the case, and arguments will begin on July 20. ACLU will be arguing that genes are natural and therefore cannot be patented.
Dietary supplements have long been denied patent protection because they are considered natural. The same standards should apply to the pharmaceutical industry. The system shouldn’t create loopholes to allow them patent protections on our own bodies just to increase their profits and deny consumer access.