mood: genetic
music: Jonathan Coulton – That Spells DNA
The mistake was tiny, microscopic, invisible to the naked eye, yet none the less lethal for its size. A mistake repeated billions upon billions of times during the months prior, marring the codex of the developing life within. The genome of the father and the genome of the mother both carried the mistake – and this mistake was, in them, benign. But then the long chains of information tangled and combined, the two copies of the error becoming a fully-formed gene expressing a particular protein. A minuscule modification that elsewhere might have done nothing, occurring in just the right sequence. A mistake called ΔF5081. A three base-pair deletion at location 7Q on the 7th human chromosome. Through a series of complex chemical interactions, it effected the sodium transport across every cell in the child’s body. This condition is called cystic fibrosis.
This is just one example out of a thousand possible genetic-related conditions – to sample from just the “A”s: Acrodysostosis, Aarskog-Scott syndrome, Acytosiosis. Genetic abnormalities are a cause of many cancers as well – and breast cancer, which accounts for around 10% of all cancer incidence in women, is among them. It is also somewhat unique in that the two genes (BRCA1 and BRCA2) responsible for many breast and ovarian cancers are patented.
Gene patents have only been around since the 1990’s, and since that time the US Patent Office has granted more than three million genome-related patents to various entities. For us to understand the arguments for gene patents, it’s important to understand how patents work in the United States.
Gene patents in the United States
The patentability of stuff is determined by the Patent and Trademark Office, part of the Department of Commerce. Patents are judged on four criteria: the invention must be “useful” in a practical sense (an inventor must describe some useful purpose for it.), “novel” (not known or used before the time of filing), “nonobvious” (not an improvement easily made by someone trained in the relevant field of expertise) and described in enough detail to allow someone in the relevant field to use it for the stated purpose. (Sometimes called the “enablement” criteria.)
An important note is that raw products of nature are not patentable. You can usually only patent a DNA or genomic product after the sequences have been isolated, purified, or modified to produce a unique form not found in nature. Another important note is that once filed, patents are valid for twenty years from the filing date.
Something else that we need to remember is that many times companies are not patenting genes themselves, but processes using the genes. Methods for detecting faulty genes, or some other novel use for the sequences. It can also cover the material copies of the genes made during whatever process the inventor puts them through. That’s important, because it’s deeply flawed.
Two Sides
There are several things to consider in the case of gene patents. On the one hand, patents allow a company or inventor to protect his or her intellectual property, which encourages and drives innovation. 3M has made some amazing advances in the world of sticky things due in part to its ability to patent its works. (Tegaderm, a nifty medical adhesive, comes to mind.) A patent provides a financial incentive for an entity to work to commercialize a given product. But here we come to an important distinction: the human genome is a naturally-occurring substance, present in every human being, and not patentable.
There are both legal and ethical reasons for this.
The ethical reasons should be obvious – enforcing patents on a gene prevents scientists and clinicians from unrestricted access in studying them, which impedes research and causes the prolonged suffering of people with genetic disorders. Unrestricted access to the entirety of the human genome has immense benefits for society, and contributes far more to the elimination of human suffering than granting access to only an elite few. The potential benefits to humankind by many working on a gene or genes far outweighs the utility to any one company or entity being allowed exclusive access to it.
Consider a company that finds a “SIDS gene”2, and proceeds to patent it. They could legally enforce their patent by preventing anybody else from working on the gene, and charge $50,000 for a test that could only be performed on Tuesdays in Bolivia – for a test to know if a baby would die suddenly. No person in their right mind could view this as ethical by any stretch, but if we allow patents on genes, it’s not a scenario outside the realm of reality.
We run into some other obvious legal problems introduced by gene patents. The very idea is a non-sequitor: genes are naturally-occurring, and patents are a way to protect something you’ve invented; something you thought up yourself. Patent law has long held that products and laws of nature are not patentable subject matter. Some companies make the argument that “DNA compounds having naturally occurring sequences are eligible for patenting when isolated from their natural state and purified.” Yet, “isolated and purified” simply means that the gene has been excised from the natural chromosome; it otherwise has not been engineered or transformed.
“Isolated and purified” isn’t really a limitation at all. It merely means marking the beginning and end point of the gene, and maybe cutting out some introns (meaningless junk DNA that doesn’t do anything). That’s about as inventive as making a map of the night sky, with the positions of planets and stars. It gives the maker no “right” to the night sky, or preclude others from depicting it. Indeed, we often speak of “mapping” the human genome. It already exists in the public domain. As the ACLU says:
“The Patent Clause in Article 1, Section 8 of the U.S. Constitution gives Congress the power to award patents “to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” Human genes are not inventions, and awarding patents on them does not promote the progress of science. Instead, gene patents slow scientific advancement, because there is no way to invent around a gene — the gene is the basis for all subsequent research.”
A Myriad of Poor Decisions
One particular company seems to come up anytime there’s a discussion of gene patents – Myriad Genetics – they’re the company that holds the patents on the BRCA1 and BRCA2. I read over the patent description online, which is an unbelievably dense chunk of text. From what I gathered, Myriad not only hold a patent on a method of screening and detection (along with various others) but also holds a patent on an isolated portion of the gene. And this is the part that I have a problem with – the patent is overly-broad, as well as ethically and legally wrong.
A further issue is that Myriad Genetics is infamous for its misanthropic behavior – the method of detection that it holds a patent on is one that it charges $3,400 to perform, the company will only do the test at its headquarters in Utah – and it refuses to license the test to anybody else.
This is often not the case – most patents of this sort don’t impede research. Thousands of BRCA papers have been published, and in surveys few scientists say that the patents impede research. But few isn’t none. The survey reflects the fact that many patents are cheap and easy to license and are unrestrictive- the patentholder allows anyone to work on the gene for only nominal payment. Because Myriad doesn’t, and has such a fierce reputation for enforcing its BRCA rights, these patents are different.
Conclusions
Is the fact that one company is acting badly reason enough to invalidate all gene patents? I believe it is, not only for that reason but also because of the ethical and legal issues raised. The justification for patents is that they encourage innovation: make a discovery, reap the financial rewards. But I have real doubts that this applies in genetics – and real doubts that any sort of moral case could be made for allowing anyone to “own” genetic information. We already have evidence that gene patents harm patients3, and patenting a gene is a very different thing from patenting a particular way of screening for it – there are many ways of detecting a particular gene, and not allowing patents on the genes themselves would allow other, hopefully less greedy types to find other ways around a restrictive patent. As an obvious aside, it’s also worth noting that we might not even be having this discussion if Myriad Genetics wasn’t being run by a bunch of dicks.
Gene patents don’t encourage progress and innovation, they restrict it by putting too much power into the hands of one entity information that belongs to all. The human genome cannot be owned – nor should it be.
This is really an argument about patenting too far “upstream”. There’s plenty of room for innovation by making sure the natural thing you’re working on remains free and open to all, but making sure you’re allowed to keep a monopoly on the fascinating new things you do with it. That’s exactly the sort of thing that’s needed – research on the genetic disorders that affect people like Emily (who has CF) or my friend who suffered from cancer.
As a society, we should not tolerate patents on human genes that act as a brake on the discovery of information that will ultimately benefit the entirety of humanity. Am I wrong? Have I overlooked something critical?
Sock it to me.
Exit, stage left.
Sparks
1: This was going to be a different footnote that I ended up not using, and I didn’t want to go through and change the rest. So now I’m going to call attention to my technically improper use of the <acronym> tag. Sorry, Pixel.
2: For those of you with any knowledge of genetics, I realize this scenario is hopelessly ridiculous. It’s only a thought exercise.
3: Sick babies denied treatment in DNA row, The Sydney Morning Herald. (Of course, using a phrase like “Sick babies denied treatment” in your headline is kind of like saying “Politician Bob likes to kick puppies”)