Sidney R. Kushner: Supreme Court's confusing take on gene patents

In this June 4, 2013, file photo, actress Angelina Jolie arrives for the film premiere of the film "World War Z," in Berlin, Germany. The Supreme Court ruled June 13 that companies cannot patent parts of naturally occurring human genes, a decision with the potential to profoundly affect the emerging and lucrative medical and biotechnology industries. It throws out patents held by Utah-based Myriad Genetics Inc. on an increasingly popular breast cancer test brought into the public eye recently by actress Angelina Jolie's revelation that she had a double mastectomy because of one of the genes involved in this case. ASSOCIATED PRESS FILE PHOTO


"By the Supreme Court's failure to understand the science of living cells, its decision will continue to permit the patenting of genes because the sequences of cDNAs, which are only copies of mRNAs that exist in the cell, delineate what is essential for a functional gene."

In the unanimous decision handed down June 13, the Supreme Court correctly ruled that "a naturally occurring DNA segment is a product of nature and not patent eligible." In contrast, the court demonstrated a lack of understanding regarding how human cells function when it ruled that a complementary DNA copy (cDNA) of a human gene is not a "product of nature" and therefore is patent eligible. The Supreme Court upheld Myriad Genetics' patent claims on cDNA but ruled that isolated DNA are not eligible for patents.

First, it is necessary to understand the basic structure of human genes. They are composed of two types of segments, those that contain useful information (exons) and those that contain junk (introns). Each gene is composed of multiple copies of both types of segments. A simple analogy is a sentence written on a blackboard that has extra letters randomly interspersed among the words. Unless the extra letters are removed, the sentence does not make sense.

For the information in a human gene to be converted into a product, it first is copied into an RNA molecule that is nonfunctional because it contains the information from both types of segments. Remarkably, the RNA molecule contains signals that help the cell's processing machinery to remove the extraneous information yielding a messenger RNA (mRNA) in which all the information makes sense, as in the sentence on the blackboard. Subsequently, the information in the mRNA is converted into proteins that carry out biological reactions necessary for cell survival.

In the court's opinion addressing the patentability of cDNAs, the justices held that "the laboratory technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA." Based on my over 40 years of research in the field of molecular genetics, I can unequivocally state that this is not the case. Rather, the technician only makes an exact copy of the mRNA that was isolated from the cell. In the blackboard analogy, this is equivalent to a writer copying the sentence onto a clean piece of paper. Furthermore, the copying of the mRNA into a cDNA utilizes a naturally occurring enzyme. There is nothing innovative or creative about making cDNAs. Yes, the cDNA has been synthesized in the laboratory, but it is an exact copy of existing mRNAs. Thus, the making of a cDNA does not represent the invention of "... any new and useful ... composition of matter ...."

Sidney R. Kushner is a research professor in the Department of Genetics at the University of Georgia. His son Aaron Kushner is CEO of Freedom Communications Inc. and publisher of the Orange County Register.


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