Biology in the News Explained

Myriad Genetics did not create the BRCA gene. Evolution did.

A federal judge has recently denied the defense’s motion to dismiss the the class action suit against biotech company Myriad Genetics and the University of Utah. Thus, one small hurdle on the hopeful road to repealing disastrous patent rules, allowing gene sequences to be locked away from scientific research for decades, has been overcome.

Others have pointed out that you are not allowed to study 20 percent of your own genome (even if you have the skills to do so). At this rate, eventually no one will even be able to do a cheek swab on themselves without having to pay royalties to a corporation.

Is this really what patent law was supposed to achieve?

The case most often cited as the landmark in biological patent law is Diamond v. Chakrabarty (1980). While it might be a reasonable argument that a human-designed organism was created, and thus constitutes a patentable invention, it is unclear why this precedent led to patents for genes, which are existing natural products. The isolation and sequencing of a gene is a completely different act from the creation of a new biological organism, and these should never have been lumped simply because they are both biological.

Most people do not realize that there are hundreds of mutations to the BRCA genes patented by Myriad that make people more susceptible not only to breast cancer, but any cancer involving hormone targets, including ovarian and prostate cancer. But no one is allowed to study any of these sequences without paying Myriad Genetics royalties or getting their express permission (which comes with a lot of restrictions about reporting research results). Thus, most of the data languishes in a cybervault, unstudied by Myriad Genetics or anyone else, even though these mutations could potentially tell us a lot about the genetics of cancer susceptibility.

Most of the outrage against Myriad is because their patent allows them to charge thousands of dollars and take a week or more to do an analysis that could be done in any molecular lab in the country (including the one at my small regional liberal arts campus) in less than a day for around a hundred dollars, if the genetic code were freely available to work with. Myriad’s argument that no one would do this test if they could not charge thousands of dollars to do it is absurd. This is just the sort of thing that public health labs do all the time.

Or think of it this way: in the normal world of patents, people use their knowledge of nature to build a machine. Someone else has access to the same knowledge, to build a better machine, if possible. If genetic data were freely available, anyone could develop a patentable test for it. In fact, different people or companies could compete to produce the best test possible. This is the kind of world that all the Rand disciples, so common in the business world, should be supporting. When the natural phenomenon itself has been patented, we are left with one company doing a test, and we have to just take their word for it that it is the best test to do. Any competition to produce a better product has been eliminated. Not very free-market.

From an academic perspective, the most important issue is of patents that tie up genes so that research cannot be done by other scientists, and thus scientific progress is retarded. Genetic data from most organisms goes into GenBank, a public sequence database that is invaluable to researchers who want to build on the work of others.

Building slightly on previous work is all that Myriad did. Their discovery of the exact sequence of nucleotides making up the BRCA gene was made possible by taxpayer-funded groundwork laid by other scientists, particularly Mary-Claire King, who identified the region on chromosome 17 where BRCA turned out to be located. One of the founders of Myriad himself, Mark Skolnick, was the recipient of more than $5,000,000 in National Institutes of Health grants given specifically to look for BRCA1 (one of two genes he later patented through his company) (Williams-Jones, 2002). Myriad simply won a race to sequence the genes, because they spent more money to run more sequencing machines than anyone else.

Of course it is not necessarily wrong for taxpayer money be spent in a way that will create jobs and growth in certain sectors of business. This is the point of many government programs, not least the current stimulus package. And certainly anyone who creates something of value, even when the work that led to the creation was publicly funded, should be able to profit from it. Many patents developed in this way benefit society and the economy.

But patents are supposed to be there to protect people who actually did the work to create something. Leaving aside the argument that Myriad (and for that matter, any scientist who worked on any step of the process) created nothing in the first place, all the dozens of other people who worked hard to lay the scientific foundation for Myriad’s patent claim had no say in the decision to allow Myraid to have complete rights over that genetic data that they had a significant role in revealing. Most biological researchers and scientific organziations (including the American College of Medical Geneticists) believe that genetic data should be open source, because they themselves never would have been able to do their own research without “standing on the shoulders of giants.”

Imagine if each small step of the long process that has now led to the fairly trivial final step of gene sequencing and patenting was itself patented along the way. The result would be a completely prohibitive cost and complication of doing basic research, because of the royalties needed to pay out along the way. It is this belief of thousands of government and academic scientists, that the pursuit of knowledge for the benefit of society is more important than profit, that has led to companies like Myraid even having the opportunity in the first place to make their big bucks.

For a University to be one of the codefendents in the lawsuit is a sad state of affairs indeed for the pursuit of scientific progress. The argument that without the patenting of genes all scientific progress will grind to a halt is mythological. If scientists cared only about making a lot of money for what they do, why would any of them work for a university? In acutality, as put by Williams-Jones (2002):

If the BRCA patents stand, hundreds of other gene patents are likely to follow, exacerbating the current rush to patent genes – what former [Canadian] Premier Harris described as the ‘Wild West’ situation. This will have a direct impact on the manner in which scientific knowledge and discoveries are commercialized and transformed into clinical practice. Unrestrained DNA patenting could lead to a situation where all genes are patented and new research becomes prohibitively expensive, what Heller and Eisenberg have described as a ‘tragedy of the anticommons.’ Unrestrained gene patenting would also have a significant impact on the provision of genetic services through the public health care system, potentially making genetic tests and therapeutics unaffordable, and thereby raising serious issues of justice in access to medical services.

Of course, we don’t have a public health care system, at least not yet. But really, what difference does it make? Most of us pay large health premiums, so we are indeed paying these outrageous royalties to companies who performed the now-trivial act of running a sequencer – or a whole bunch of them. (If companies chose not to pay for the tests, it just would not do, because that would be rationing!) So, if you could benefit from a genetic test, you will be happy to realize now that you have paid for the test twice – first as a taxpayer, for the research that led to the test, and now as an insurance holder.

Isn’t capitalism great?

Update: As of March 29, 2010, the court has ruled against Myriad Genetics in this case. Appeals to follow…

Reference

B. Williams-Jones, 2002. History of a gene patent: Tracing the development and application of commercial BRCA testing. Health Law Journal 10: 124-146.

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