BESHAR: How much for those genes?

In May, Angelina Jolie announced that she had elected for a preventative double mastectomy. She had tested positive for BRCA1 and BRCA2, inherited genes that indicate an increased risk for breast cancer by up to 80 percent.

One month later, the Supreme Court negated the patentability of these BRCA1 and BRCA2 genes, declaring that because genes “exist as natural phenomena,” pharmacological companies could not claim ownership to their use in genetic testing.

This news felt good. Jolie inspired me, revealing a composure and maturity I had not perceived in “Mr. and Mrs. Smith.” The Supreme Court’s decision made me feel safe, because it was me — not some sprawling, commercialized pharmacological company — who had control of my own body.

But the Supreme Court’s decision has a little-known, under-publicized caveat. And its implications may be huge for pharmacological companies, the advent of personalized medicine and our own quests for good health. Indeed, the decision may not have impacted Hollywood millionaire Angelina Jolie, but it will impact the scores of American women and men who seek similar, expensive genetic testing. And a study from Yale’s Cancer Center Genetic Counseling Program shows that testing increasingly leads to preventative mastectomies — with over a 25 percent increase in interest among participants over the past 15 years.

In their ruling, the Supreme Court made a distinction between DNA — the pieces of cellular information that dictate who we are — and cDNA — or, complementary DNA, a type of synthetic, man-made DNA used in drug development. According to the Justices, the artificiality of cDNA qualifies it as patentable. This means that Myriad Genetics, the pharmacological company that identified and uses the cDNA forms of BRCA1 and BRCA2 to quantify a patient’s breast cancer risk, can file lawsuits against companies seeking to replicate its test.

First, a bit of background for those of you who have not suffered through MCDB’s “Genetics.” To carry out an action, our cells copy our cellular information, DNA, into messenger RNA (mRNA), which is then translated into cellular soldiers (proteins). When researchers need DNA to manipulate, they reverse copy this messenger mRNA back into DNA, now called complementary DNA (cDNA). cDNA and DNA are almost identical, minus those bits of DNA that serve no purpose.

According to the Supreme Court, this cDNA is “an invention.” While it is true that the cDNA would not have existed without the technician’s intervention, the cDNA, a true second-hand copy, is functionally identical to what was already there. Does this make it a legitimate creation?

The ruling may also conflict with the rules that restrict the patenting of obvious or predictable inventions. If a technician can combine mRNA and a “reverse-copy” enzyme and predict with almost exact certainty the cDNA product, is the “invention” really original enough for patentability? What’s more, the decision seems to forget that cDNA occurs naturally when viruses attack the cell. In fact, the study of HIV has contributed to artificial cDNA methodology in the first place.

But moving past the issues of constitutionality, the ruling will have considerable impact for average Americans. First, it may allow Myriad to maintain the lofty price of genetic testing. Currently, the company charges about $3,000 for BRCA1 and BRCA2 testing — an unrealistic price tag for a cancer common among low and middle-income women and men. By allowing Myriad Genetics to maintain legal protection over the BRCA1 and BRCA2 cDNA, the Supreme Court has shut out competitors. Competition would lower costs and increase quality.

Second, the ruling limits access to information and possibilities for scientific advancement. What happens when a laboratory discovers that another company claims ownership of the cDNA they are working with? Will they have to shut down years of research?

Patent-protection is important. It gives monetary incentive to pharmacological companies, stimulating their investment in not only the big-name cancers, but also the rarer genetic diseases. As companies like Myriad Genetics identify more and more genes like BRCA1 and BRCA2, medicine will grow more personalized and effective. Doctors will be able to use genomic information to recommend specific dosages, types and mechanisms of drug therapy. Ideally, such approaches will improve treatment responses and limit growing healthcare costs.

But by over-commoditizing “the cDNA invention,” the Supreme Court has narrowed the scientific playing field and choked the emergence of genomic breakthroughs. The ruling may seem insignificant — judicial jargon based on the input of a “c” before DNA — but it will unequivocally impact the way our generation confronts a disease familiar to so many of our own mothers and grandmothers.

Isabel Beshar is a senior in Saybrook College. Contact her at isabel.beshar@yale.edu.

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