In an article titled Patently Unjust in the June 2010 issue of The Progressive (not available online), Kari Lydersen describes a similar issue to the one involving Henrietta Lacks, where private companies are making a bundle out of publicly funded research. In this case, the publicly funded Human Genome Project has made freely available the full human genome but some private companies have obtained patents over individual genes.

The particular case that Lydersen deals with involves the genes known as BRCA1 and BRCA2. Certain mutations in these genes are predictors of breast and ovarian cancer, since women with such mutations are five times more likely to develop breast cancer and ten to thirty times more likely to develop ovarian cancer. We are now able to test if a woman has these mutations in which case they have to make difficult decisions about whether to preemptively remove their breasts and ovaries. These genes were discovered as part of the genome project.

It turns out that a single company named Myriad Genetics holds several patents on the genes and as a result claims exclusive rights to the tests they developed to detect the mutations. They charge about $3,000 for the test, which prices many women out of the market. They claim that if companies could not make money, they would not have the incentive to develop the tests. There is some truth in this but it is also true that a huge amount of federal (i.e. public) research funding went into the research that provided the basis for the company’s work, which should also be a factor. If the public funds something, the public should also benefit.

The reasons given by the company’s founder for the high price they charge for the tests is revealing about the why medical costs are so high in the US. He says, “In the U.S. what you charge for a test is a complex equation of what it costs you to do it and what people will pay” (my italics). This is part of the problem in a system with employer-based private health insurance coupled with monopoly providers. Well-to-do groups with power can pressure their insurance companies to cover the costs of tests which enables the testing companies to charge higher prices than they need to merely cover costs and provide a reasonable profit. The price then becomes prohibitive for those without insurance and drives up the cost of health care. I have written about this before.

As Lydersen writes, this is a widespread problem.

Myriad is far from the only patent holder on human genes; about 20 percent of the human genome is patented. This basically means that only the patent holder can offer testing and other services related to a specific gene. Patents currently cover genes related to other diseases, including Alzheimer’s, asthma, colon cancer, muscular dystrophy, and spinal muscular atrophy, a hereditary disease that kills children at a young age.

What is worse, because the company claims exclusive rights to the genes, women cannot get a second opinion on such a major question. At a minimum, what is needed is at least for more than one company to be able to provide services so that they can compete with each other. Giving private companies monopoly power over the use of research results that were largely publicly funded seems wrong.

The intricacies of patent law are too subtle for me to get into but on the surface the U. S. Patent Office seems to have been too generous in allowing companies to patent genes. It is illegal to patent a product of nature but the US Patent Office has granted Myriad and similar outfits patents on the genes on the basis that they were able to isolate them from their natural state and purify them. But others argue that this is far too expansive a view. After all, just because you develop a technique to highly purify gold (say) should not enable you to claim the patent to gold. I can understand patents being awarded to the purifying process because that is something the company did develop. That would reward their intellectual contribution while yet preserving the right of other companies to invent alternative methods of purification of the same gene and thus develop competing tests.

The right of private companies to patent genes was litigated and Lydersen writes that in March of 2010 US District Judge judge Robert W. Sweet ruled that Myriad’s claims did not meet the test of what makes something derived from nature patentable and invalidated the patents, saying in his ruling:

“The patents issued by the USPTO are directed to a law of nature and therefore were improperly granted,” Sweet wrote. “DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature…. DNAs existence in an ‘isolated’ form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to ‘isolated DNA containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter.”

Patents are valuable things and protect the rights of inventors and other creative people but the Patent Office should be wary of taking the claims of private companies too much at face value, especially when it comes to patenting things in nature like bits of DNA.

Myriad has appealed the ruling to the US Court of Appeals and much hangs in the balance.