In the most recent term of the Supreme Court, which ended June 26, decisions were made on gay rights, voting rights and affirmative action. But lost in that list of big-ticket cases was a case that may very well be a landmark decision in a coming era of biotechnology. That case, Assoc. for Molecular Pathology et al. v. USPTO and Myriad Genetics, Inc. et al., centered on the debate over whether human genes were patent eligible and will have lasting effects on biological science research across the nation.
In 1995 and 1996, Myriad Genetics filed for, and was later granted, a number of patents on two human breast cancer awareness genes, known as BRCA1 and BRCA2. The DNA sequences of these genes can be used to help predict breast cancer. Prior to the June 13 ruling, Myriad, as the owner of the BRCA1 and BRCA2 patents, held exclusive rights to any commercial process, including medical tests, which used these genes – allowing Myriad to charge artificially inflated rates for its breast cancer screens, sometimes at prices pushing $3,000.
On June 13, in a rare unanimous decision, the court struck down some of those patents, ruling that human DNA, as a naturally occurring form of matter, is not patentable. The decision was heralded by many, including Francis Collins, head of the National Institutes of Health, as “a victory for all those eagerly awaiting more individualized, gene-based approaches to medical care.”
But although the court’s decision in the case represents a step forward, it is not the giant leap many in the scientific community hoped for. Because while the court ruled DNA is not eligible for patent, it ruled that another form of DNA, known as cDNA, is patentable.
What difference does the “c” make? DNA in a cell is filled with sequences that get removed in the process of “translating” it into the proteins that make up an organism. cDNA is simply DNA without those “intervening sequences.”
In its opinion, the Court reasoned that cDNA “is distinct from the DNA from which it was derived” because it has been so edited, and is therefore “not a ‘product of nature’ and is patent eligible.”
But cDNA is very much a product of nature. Retroviruses like HIV make cDNA as a part of their life cycle, as do bits of self-replicating DNA called “retrotransposons.” In fact, a 2011 paper by Sanchez et al. suggests that not only is cDNA a naturally occurring substance, but that BRCA1 cDNA, the cDNA of the gene patented by Myriad, is itself present in nature in certain individuals.
But the court in its opinion dismissed the presence of naturally occurring cDNA and did not address the 2011 study. In doing so, the justices seem to be ignoring their own reasoning in the decision. All the information in the BRCA1/2 cDNA was already present in an organism’s DNA. And by the court’s own admission, the reason DNA isn’t patentable is precisely because its information content is naturally occurring – a contradiction tantamount to stating that one could take a published book, remove some of the chapters, and then publish it again under a different author’s name simply because the text had been edited.
When a Supreme Court justice feels it necessary to reinforce that he was “unable to affirm [some aspects of the biology] by my own knowledge or even own belief,” as Justice Scalia did in this case, we should take note.
Undoubtedly, the confusing nature of this Supreme Court ruling is the result of a difficult task undertaken in good faith by the justices. Biology and genetics are phenomenally complicated subjects, and only growing more so. But correspondingly, they are phenomenally powerful, phenomenally deep and phenomenal sources of innovation for the betterment of mankind. We as citizens need to ask if “in good faith” alone is still enough.
McBee is a Plan II and biology senior from Austin.