Frog-
Your style of argument is both endearing (as when a child insists that the moon is made of cheese), and frustrating (as when that same child refuses to take “no” for an answer). Your inability to understand the specific circumstances and requirements surrounding the patenting of genes (and related gene fragments –ESTs and SNPs) stems from your misappropriation of the idea of “controversy” (although I suspect your failure to understand stems from a deeper lack of fundamental knowledge regarding DNA and genes). Your uncontested BELIEF that genes fail to meet the necessary criteria for patenting is DIFFERENT from the reality that genes have been, and continue to be patented. (I say “uncontested” because I too believe the criterion is too lax).
Should you be able to patent a “discovery”? Clearly, no.
Are genes “discovered”? Well, technically yes, (sort of).
When genes (and their relatives) are isolated and purified, are the sufficiently different from their form in “nature” to constitute an “invention”? Hmmm, probably, but the decision is not up to me (or you). The USPTO (and the Supreme Court) have already said “YES” (about 25,000 times as of the year 2000).
So where does that leave SNPs? Well, you have to understand what they are. (I’ll give you the benefit of the doubt and assume you understand the basic structure and function of genes and their relationship to proteins and protein activity, and move forward from here). By analogy, let’s call the following sentence a gene (BOX1, for short); “PUT THE RED BALL IN THE BLUE BOX”. This gene is ubiquitous in humans and results in lots of boxed red balls (which is part of normal metabolic activity). Imagine the gene is already public domain (or patented). Let’s further imagine that a company determines that 80% of individuals with “boxes disease” (a failure to put red balls in the blue box) have a single-letter misspelling in this gene so now it reads; “PUT THE RED BALL IN THE BLUE FOX”. This gene has a SNP at position 30 (from B to F).
Is this difference novel? Yes
Is it non-obvious? Yes
Is it useful? Does it have a “utility” Yes. A simple utility could be as a genetic marker for “boxes disease”. The polymorphism could be used as part of a diagnostic test (a gene-chip perhaps).
Is it patentable? YES. The new gene could be patented, even if only different by a SNP from public domain or prior patent. Although you are patenting a gene, you have just, in effect, patented a SNP. (At this point, feel free to fall on the floor and throw a temper tantrum).
You may continue to argue the difference between SNP’s and genes if you wish (if you truly know them), but you will need to take your arguments to the USPTO, not me.
But what about the public domain of SNP’s created by the SNP Consortium? Well, that database consists of approximately 3 million (I think?) mapped SNP’s (the numerical position and the letter change). Whether or not a particular SNP is in a gene depends on its location (it could be in a “non-coding” region). Are the public SNP’s protected from future patents? Not necessarily, but it does make it harder, not impossible) to demonstrate novelty. But perhaps the most important aspect of the public SNP database is that it consists of SNP’s from about 24 individuals. This database provides a baseline analysis of SNP’s across ethic groups, but is does not provide enough information to create diagnostic tools or markers for specific disease (since diseases are not represented in the database, unless they are correlated with ethnicity). Still with me Frog?
What does that MEAN? It means that the vein of SNP “discoveries” as markers for specific disease has not yet been tapped and remains at full potential and patentability. Any company that discovered a gene variant (SNP) that correlates with a specific disease, which is also not part of the 24-person SNP database, would be able to patent the gene variant (based on the position of the SNP’s) as novel, non-obvious and useful.
Keep whining Frog. Eventually your parents will stop arguing with you just to keep you quiet.
Good Luck!
AI
