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severalog

Time to BRCA the habit

J. Harry Caufield

The US Supreme Court has ruled that human genes cannot be patented. That's great news until we stop to consider what a human gene includes. The ruling bars patents on original human DNA, presumably in any variation of its sequence. That is, I couldn't file a patent for the sequence of my favorite human gene or of any of its alleles. The ruling does specifically permit any implementation or subsequent product made using that sequence, up to and including synthesis of cDNA. By means of awkward simile, that's like prohibiting patents on maple trees (or, at least, the concept and structure of a maple tree) but permitting patents on maples grown in a tree farm. There's still plenty of room for perfectly legitimate patents to be granted and for new products to be protected. I'm just concerned that this ruling stops well short of actually resolving the issue of what kinds of biological material can or can't be patented.

We've reached the point at which the whole "natural" vs. "artificial" dichotomy just doesn't pass muster anymore. Advancements in synthetic biology promise to blur a line that wasn't especially crisp to begin with, especially when discussing raw DNA sequences. The SCOTUS ruling states "cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments...creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring." The issue here really shouldn't be whether cDNA of a patented sequence could be found in a human (that is, without influence by outside factors like viruses), but rather that the cDNA still bears exactly the same protein-coding message as the RNA transcript does, just in an edited format.

We can, of course, get more philosophical about the issue and debate what constitutes a "human" gene. At least eight percent of the sequenced human genome is made up of retroviral sequences. Some of them even code for things in active use. There have also been suspected instances of bacterial sequences jumping into the genome of their human host. I suppose each of these issues will create their own legal issues when the time comes, i.e. the next time a biomedical company gets overzealous about their intellectual property. In the meantime, this new ruling will have to suffice.

Update: I like the 2010 district court ruling. It went farther than today's SCOTUS ruling.