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Gene patents [ClearOnMoney]
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Commentary

Gene patents

13 Jun 2013 by Jim Fickett.

The US Supreme Court made a ruling today on gene patents which might affect investments in biotechs. Most newspaper reporters really did not understand the ruling (see Nature for a decent report), so I thought I'd try to summarize concisely.

Just a little bit of background on the biology of genes is helpful. Your genetic makeup is encoded in DNA which, from the point of view of the information encoded, can be thought of as 42 long string of letters (or 23 pairs of chromosomes). Each letter is A, C, G, or T (representing four related but distinct “nucleotides”). The strings/chromosomes are each on the order of 100 million letters/nucleotides long. A gene is, more or less, the instruction set for making a protein. The first step in making the protein from a gene is to copy a segment of the DNA into the chemically similar RNA, and splice out some sub-segments, to give a so-called “messenger RNA”, or mRNA. In many experimental procedures DNA is more convenient to handle than RNA, so biologists often make a DNA copy of an mRNA, called a cDNA. For what follows, it is important to emphasize that a cDNA is essentially a xerox copy of some stretches of the original DNA comprising a gene. It is not central for what follows, but may help clarify, that in each pair of chromosomes you get two copies of each gene, one from each parent, and these may be the same or slightly different.

A patent normally requires the creation of something new; you cannot patent a new mountain that you discover. A gene “sequence”, essentially the portion of the above-described strings corresponding to a particular gene, is simply the description of a naturally occurring object. So it is odd that the patent office has been approving patents on genes, based on gene sequences, for years. And it is not very surprising that today the Supreme Court ruled patents on genes invalid.

What is a little odd from a scientific point of view is that the court upheld patents on cDNAs. It is true that a cDNA is an artificial construct, an “invention” of a sort. But the information content of a cDNA is neither more nor less than the information content of a naturally occurring mRNA. While the early patents on cDNAs were today upheld, probably today a cDNA would be regarded as too obvious to be a patentable invention, so the treatment of cDNAs will probably not be of long-term importance.

The essential point of pragmatic interest from today's ruling is that the gene itself cannot be patented, but methods of determining which variant of a gene one person has or, in other words, methods of interpreting the medical import of each person's genetic heritage, can indeed be patented. This is a very sensible ruling. No one can claim a right to the naturally occurring gene, but anyone who invents a test to produce useful information can profit from that invention.

The particular tests under scrutiny by the court were tests for ovarian and breast cancer developed by Myriad Genetics. The ruling means that Myriad continues to have exclusive rights to their own particular tests, but cannot stop another company from inventing a competing test that produces comparable information from the sames genes, but by a different readout technology. There are many ways to probe the genes of an individual and, though I don't know the details of Myriad's patent, I suspect that Myriad will have competition.