Well the timing on finishing up the intro to genetics series couldn’t have been better if I do say so myself.  Just a couple days ago a Judge in New York, by the name of Robert Sweet threw out Myriad Genetics claims to patents on two genes, BRCA1 and BRCA2 (Sweet!).  See, Gene Ruling Could Have Broad Reach.  These two genes are associated with breast cancer and potential disease progression and so a diagnostic test for their presence or absence is used in putting together a treatment plan for breast cancer patients.

As we mentioned in the last post, co-discover of DNA and former head of NIH’s human genome project, James Watson realized patenting of human genes was, to make a bad pun, patently absurd from the start.  Now, any government regulatory body worth its salt, however, clearly realizes the number one priority on its mission statement is to kiss industry’s butt, as no industry means no industry to regulate.  Therefore if there was even a remote chance that gene patents would be commercially valuable government regulators would defend the idea to their dying breath.

In 1992, when Dr. Watson was over-ruled by NIH director Bernadette Healy on the issue of gene patents, he retired, or was driven out depending on your perspective.  As an avid sailor, Dr. Craig Venter, who we also introduced in the last post, knew which way the wind was blowing.  When he founded Celera Genomics to sequence the human genome, he began patenting and selling patents from the human genome.  By the time he cashed out he was a multi-millionaire many times over, while shortly thereafter, stock holders and investors in Celera began to realize that just because they held a patent on a gene didn’t mean they had any idea how to leverage that patent into money, and like the initial dot.com craze, the rug was pulled out from under Celera, while Dr. Venter sailed off to the Galapagos islands.

As we move forward we find that by the present nearly 20% of the known human genome has a patent claim on it.  One company alone, Incyte, a drug company in Palo Alto, California, holds patents on some 2,000 human genes, or somewhat less than 10% of the entire human genome! Don’t it make your brown eyes blue?

We talked in parts one through three of the intro to genetic series about what exactly a gene is and how it is a portion of DNA where information is encoded in the sequences of nucleotide bases.  How that information is read in groupings of three which correspond to amino acids which are linked together to make a specific protein.  So, and this is just a WAG but is at least in the ball park, an average gene is about on the order of 1,000 – 10 or 20,000 bases long.  So a company receives a patent which covers the specific nucleotide sequence which makes up a specific gene.

The idiocy and offensiveness of this approach to patents may be seen from a number of different angles.  First, there is no intellectual creation involved!  There is no intellectual property, as the judge rightly notes, genes are products of nature they are not products of invention.  What’s more, the ease, rapidity and cost of genetic sequencing has improved at an astonishing rate, so that it is no longer even a great effort to sequence large segments of DNA.

While a very rough analogy might be made between proprietary and open-source computer code, the analogy breaks down in several respects.  For one, no one wrote the code, it just existed in nature, a more appropriate analogy might be if 100 years ago, it was declared that anything new and unique related to life seen under a microscope could be patented, if I became the first to see a mitochondrion, I would declare a patent on it.  In the same way those who first sequence a specific gene can declare a patent on it, a little like the explorer setting foot on new land and claiming it for king and country, I saw it first so it’s mine.  Another way genetic sequences are quite distinct from computer code, is that computer code doesn’t exist in self-replicating organisms that may kill you.  If someone obtains a patent on Ebola virus and heaven forbid there were an outbreak, the patent holder is in the position of holding up research and indeed has even a-priori held up research by not sharing his discovery with the broader community.

This is not the way any science works or advances and it is not the way medical science advances, indeed it is the whole point of the medical literature to share important advances with the broader community.  Patents on things that exist in nature have no validity while there is something especially morally repugnant in considering that some company 1/2 way around the world lays claim to patents on nearly 1/10th of the genes in yourself and your heritage, one tenth of those in your parents, grandparents, children etc.  I don’t care what law is passed there is no valid authority for such a claim, it’s about like saying I see a rainbow so I have a patent on it.  Or saying we will tax you on the very air you exhale!! (Oh, wait, errr … scratch that one).

Myraid Genetics did figure out how to make money off gene patents.  As the presence or absence of the BRCA 1 and 2 genes are important in devising a breast cancer treatment plan they have a motivated and captive audience and as no other company in the US can test for the presence of these genes because of the patent they have a monopoly on the market.  If someone wanted a second opinion, they would have to send a sample outside the United States in order to have a company other than Myraid confirm the results.  So along with being bad for research, gene patents also don’t make sense clinically either from a quality of care or cost standpoint.  Oh and they charge $3,000 dollars for the test, of which I would guess around some $2,970 would be profit.

Another way to realize the absurdity of gene patents is to consider what is known as single nucleotide polymorphisms (SNPs).  Put simply a gene corresponds to a single protein, but there is a lot of variability in any single gene, I mean just look around your community.  Looked at on the genetic level one can even characterize more variability down to a minor change in a single nucleotide base.  There are millions of SNPs.  Are all of these SNPs patentable?  If you send in a tissue sample for genetic sequencing are you going to later find out that some aspect of your genome has been patented?  “Why that trait of excessive back hair growth has been in our family for generations, how dare you patent it!”  But really, all kidding aside, one can see how offensive the idea of patenting human physical traits actually is, there is no intellectual property involved here, there is only characterization at the molecular level of variations in human physical expression.  To pretend to a right to patent such traits is, dare I say it, racist in the extreme, as it pretends to claims and privileges over hereditary physical expressions that one can never have a right to.

Already, I have been reading that this ruling will be challenged and may eventually end up as a supreme court case.  When I skimmed some of the legal beagle sites they did seem to make it clear, from what I could follow, that this was a resounding rejection of all claims by the plaintiff regarding patenting of human genes and that it would likely have very broad implications.  Amen.