It has been a dramatic few weeks for genetics and cancer. First, national sex symbol Angelina Jolie took the courageous step of publicly revealing her bilateral preventative mastectomy that she undertook after finding out that she had certain genetic mutations that predisposed her to breast cancer. Then, last week, the Supreme Court struck down the patent for the very test that Jolie had deployed to make her medical decision.
The justices unanimously ruled that Myriad’s patent for the genetic tests for the so-called breast cancer genes, BRCA1 and BRCA2, was not valid because the innovation on which it was based failed the “product of nature” test. That is, discovering an exact sequence of DNA — specifically, the mutations in the two genes that predisposes an individual to greater cancer risk — does not constitute a new creation in and of itself.
The Jolie case, however, demonstrates yet a different reason that human genetic sequences should not be patented: the effects of genes are fluid and subject to change thanks to social evolution.
Currently, as stated in the Justice Clarence Thomas’ decision,
The average American woman has a 12- to 13-percent risk of developing breast cancer, but for women with certain genetic mutations, the risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer.
But what if more and more women follow Angelina’s lead and undergo preventative mastectomies or ovariectomies? For a moment, imagine all women with the BRCA mutations did so. Then having the “bad” DNA sequences would predict lower risk of cancer but higher risk of undergoing preventative surgery.
It is this very process of social response to information and the resultant changing risk pattern that undermine the intellectual property claim. Namely, the patent language filed by Myriad states,
It is a discovery of the present invention that the BRCA1 locus which predisposes individuals to breast cancer and ovarian cancer, is a gene encoding a BRCA1 protein… mutations in the BRCA1 locus are also associated with breast cancer, ovarian cancer and other cancers, which represents an indicator of these cancers or of the prognosis of these cancers.
Thus, the patent is for a genetic marker that predicts cancer. What happens when it no longer predicts?
This phenomenon of changing “facts” is not unique to genetics, but rather to all science that deals with humans. Effects come and go as they are absorbed by the adaptive system we call society. My favorite example of this comes from a paper by an economist, Edward Saunders, who found that, everything else equal, there was a slight uptick in the price of stocks on the New York Stock Exchange when it was sunny in Manhattan (where the trading floor is located), with a corresponding negative effect when it was cloudy or rainy in the Big Apple.
Now what did this intrepid young social scientist do? Instead of forming a new private equity fund called “Helios Capital” or “Apollo Investments” to arbitrage the finding and get filthy rich, he published a paper about the phenomenon in the American Economic Review. The moment Wall Street found out about it, every analyst worth her salt put New York City weather into her statistical model and — POOF! — the effect was gone thanks to the wonders of data and the free market. I hope Saunders at least got tenure.
In a similar manner, before long the gene for breast cancer may be associated with lower odds of contracting the disease thanks to the steps women with the now-dangerous alleles take to mitigate their risk. In the not-so-distant future, BRCA1 mutations may predict mastectomies, not breast cancer.
Like the analysts on Wall Street that incorporated Manhattan weather into their mathematical models, once we know about our “innate” tendencies, we can do something about them. And that even includes biological associations like cancer risk. So before the United States Patent and Trademark Office grants any more intellectual property rights that rely on humans not changing their behavior in response to the “invention,” they better think twice — because Americans certainly will.