NEW YORK (Reuters) – A lawsuit challenging patents on two human genes associated with hereditary breast and ovarian cancer can move forward, a U.S. federal judge ruled on Monday.
This is where health and business clash. Myriad holds the important patents that permit a test to be done. hey do not license the test to anyone else, doing it themselves. They can charge whatever they want, as there is no possible competition, on a test that is absolutely critical for the prognosis of many women.
The ACLU filed suit. The basis is that the patents are based on natural products, that already occur in the world:
The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes – in fact, about 20 percent of our genes are patented. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents.
As a result of the PTO granting patents on the BRCA genes to Myriad Genetics, Myriad’s lab is the only place in the country where diagnostic testing can be performed. Because only Myriad can test for the BRCA gene mutations, others are prevented from testing these genes or developing alternative tests. Myriad’s monopoly on the BRCA genes makes it impossible for women to access other tests or get a second opinion about their results, and allows Myriad to charge a high rate for their tests – over $3,000, which is too expensive for some women to afford.
That’s right. Since no other test is allowed, there is no way to get a second opinion. You just have to hope that Myriad does the tests rights and has the right process. And no one can look for a different or better test because myriad holds the patent on the genes themselves, and on anything those genes could be used for.
I am all for the use of IP to provide funds to recoup development costs. BUt the ability to patent the gene sequences themselves is actually hampering the progress of research. Patents are part of a contract between innovators and society. But some cases, such as this one, show the imbalance that has occurred with these sorts of patents.
The only pricing pressure on Myriad is… well nothing. They could charge $10,000 for the test. No one could stop them. In some cases, the monopoly of a patent hurts society, particularly something that is of critical need but which can be obtained elsewhere.
Most other companies who hold similar patents license their technology to multiple companies, each who do their own test. So only a fraction of the money from each test goes to the patent holder. Myriad, on the other hand, can grab ALL the revenue from the tests. Their greed is what brought this lawsuit. The fact that it can proceed is hopeful.
I don’t expect this case to be the one that changes things but it can be one of the stepping stones. IP provides important benefits, both to the innovators and to society. But it gets out of whack every so often, usually because the IP holders over reach (Simply look at how long copyrights are for now compared to the previous century.)
We fill figure this all out eventually. Perhaps creating monopolies from some health products is not the best approach.