In a monumental step towards bringing sanity to biotech patents, a court ruled that a patent granted for the sequence of a gene associated with breast cancer was invalid. Basically, Myriad Genetics held a patent on the use of the sequence of BRCA1 and BRCA2, genes with alleles associated with high risk of breast cancer. Thanks to its patent, Myriad was the only company able to make tests for these alleles, and medical societies like the Association for Molecular Pathology, the American College of Medical Genetics, the American Society for Clinical Pathology, and the College of American Pathologists filed suit to gain their members access to a competitive marketplace for effective and accurate tests. They were joined by individual doctors and medical advisors who sought to develop new tests for dangerous BRCA variants and were blocked, as well as Breast Cancer Action â a breast cancer patients' group â and the Boston Women's Health Book Collective â publishers of Our Bodies, Our Selves â and individual cancer patients and patients with a history of breast cancer who could not afford Myriad's test. They were represented by the ACLU, which has concerns for the privacy implications of gene patents, and by the Public Patent Foundation at Cardozo Law School, which focuses on blocking undeserved patents and unsound patent policies.
After considering the relevant biology and underlying law, the judge concluded that patenting the sequence of a gene, a longstanding practice, violates the principle that naturally occurring objects cannot be patented. Patent attorneys have gotten around that by technically patenting the mechanism for isolating the sequence, a dodge which the judge recognized as "a lawyer's trick" and not a meaningful distinction. The isolated genes are still products of nature, not a unique invention.
This does not invalidate patents on organisms with modified genes or genomes, nor does it invalidate the act of modifying a gene in order to insert it into an organism. This does not, by my reading, set up Monsanto's genetically modified Roundup Ready crops to lose patent protection, though it may free up competitors to develop similar genes, and may give farmers an easier way to protect themselves against a claim when Monsanto asserts patent violations because of crosspollination.
The court was asked to consider the chilling effect on research produced by patents for naturally occurring genes. Fortunately, the decision seems to have avoided that line of argument, as it opens a massive can of worms. In general, I'm inclined to oppose patents and copyright laws that restrict research, artistic development, medical care, or other humanitarian services. On the other hand, I don't think that's a call judges ought to be making. I'd rather see the laws themselves fixed when such chilling effects are seen. This judge's ruling fired a shot across the bow of lawmakers about the abuses of genetic patents, and one hopes lawmakers will listen.
Given the sweeping victory on a summary judgment motion, the ACLU is understandably elated. "We are extremely gratified by this groundbreaking decision," said Sandra Park, staff attorney with the ACLU Women's Rights Project. "This is the beginning of the end to patents that restrict women's access to their own genetic information and interfere with their medical care." We can hope so. The appeals are inevitable, and are headed toward a notably pro-corporate and anti-woman Supreme Court, so there's no guarantee that this ruling will hold up, but it's a good first step.
As John Ball, executive vice president of the American Society for Clinical Pathology put it: âItâs good for patients and patient care, itâs good for science and scientists. It really opens up things.â
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How does the law rule on naturally-occurring pharmaceutical chemicals? (i.e. can you only patent the synthetic route to Compound X if compound X is found naturally?)
Additionally, if a gene produced synthetically is found later to occur in nature, does this invalidate the patent?
I think that the key is novelty at the time of the invention, but I'm not a lawyer. One can certainly patent a method for synthesizing a naturally occurring molecule or chemical compound.
"How does the law rule on naturally-occurring pharmaceutical chemicals? (i.e. can you only patent the synthetic route to Compound X if compound X is found naturally?)"
You generally can't patent a substance. You can patent a _treatment_ which uses this substance or a method to synthesize it.
So you can still patent treatments based on genomic data. For example, a "method to treat disease by using this sequence of DNA incorporated into adenoviruses" will be patentable.
For better or worse this decision will probably be overturned on appeal. There is a precedent that isolated forms of naturally occurring substances are patentable.
"In general, I'm inclined to oppose patents and copyright laws that restrict research, artistic development, medical care, or other humanitarian services."
If the underlying developments aren't made in the first place then the restrictions will be irrelevant; people are better off if only one company can offer a treatment then if zero companies can offer it (not to say that this would necessarily be the case without the patents, however). This isn't to say that we couldn't do without patents but another system to pay for the research would be necessary. For example, having the government fund medical research in these areas directly, which probably would have some advantages but is unlikely to happen any time in the near future. (Of course I'm assuming that this patent was actually for a nonobvious invention but if it was actually anticipated by previous research that is another issue and the solution doesn't necessarily require reducing the patentable subject matter.
I think in the case of DNA sequences people object mainly due to a visceral reaction to the idea that someone somehow owns their body but this isn't really how these patents work and I think it would be unwise to make a policy decision based on this anyway. Rather than fearing the idea that someone can patent the isolated form of a DNA sequence for a short period of time we should ensure that as much research is done as possible (whether this means patents or no patents).
people object mainly due to a visceral reaction to the idea that someone somehow owns their body
My objection (as a non-lawyer) has always been that you shouldn't be able to patent what amounts to an observation, no matter how sophisticated the means of acquiring that observation.
Here's a deal for these folks at Myriad: if you can patent a natural, human allele which is linked to breast cancer you can also be financially liable for the deaths it causes. After all, you own it. Oops. No likey?
That's great news. As the law is, patents should not apply to genes anyway - but a few silly court cases here and there suggest otherwise and there has been expensive lobbying in other countries to allow the patenting of genes.
@Alex: In the USA you can indeed patent a specific substance and there are many synthetic chemicals which were patented (and quite a few drugs currently available which are patented). Until recently no one would dare patent a process either, and process patents remain among the most dubious patents ever. Things discovered in nature were not considered patentable, and unless there have been laws to amend that position, then gene patents are not legitimate. So I can't patent sea salt but I can patent some previously unpublished synthetic chemical which has no exact counterpart in nature.
I drove by Myriad genetics a few times in research park when the lawsuit began, and most of the time people with signs were outside protesting. Not because of the gene patent thing, it was because they had an icky labor dispute going on. The place kind of looks evil, too.
To the first commenter- from what I understand, the patents for things like that used to be on the process. A company would patent the way that they derived the drug from the naturally occuring substance. This also meant that if some other company found a cheaper or better way to make a drug, they could do so and sell it for less. In the 80's patents were allowed to be on the chemicals themselves instead of the process used to manufacture them. The drawbacks for this (for the public) are obvious, but it is good for the companies who dominated the market place when it happened. I have only done some preliminary research on this so I very well could be wrong. Your criticism is valid and makes sense, and the law should reflect it consistently.
Also, the patent office is notorious for letting silly things through- remember when those magnetic healing bracelets got a patent? The patent text restated "the magnets help blood flow faster" in every possible way, and that was all there really was to it.
ya truly said
There's a fascinating take on this at the Skeptic's Health Journal, sort of provides some of the background to the debate, if interested you can read on it here, http://healthjournalclub.blogspot.com/
On what impact this may have on ag-biotech and patents held by monsanto etc:-
I'm not sure this is entirely the same thing, although it is at least in the same ballpark - Monsanto, as far as I understand it, has a patent on the use of a naturally occuring gene, transformed into soy/corn etc etc, with a particular promoter (or maybe promoter strategy, not sure) and a particular terminator sequence - as such it isn't a patent on a naturally occuring stretch of DNA, but on a combination of sets of naturally occuring stretches of DNA, utilized for a specific purpose (herbicide tolerance in plants) - with my vastly insufficient knowledge of the workings of patent law I think this would retain a status of patentable whereas (qutie rightly in my opinion) patents relating to stretches of naturally occuring DNA without any innovative steps to make them do anything in particular are apparently now invalid (depending on how the appeal goes)
Whether or not this would open up the use of the RR gene by other companies driven by a different promoter, or with a different terminator, or whether the use of this gene (and I would imagine homologues with a certain degree of similarity) specifically to resist glyphosate in crop plants is the patentable aspect remains to be seen - there would be a pretty strong arguement (if the BRCA1/2 decision is upheld) that use of the RR gene may be more open than it was.
On whether or not farmers can be sued for cross pollination of their crops - this really isn't here or there, farmers aren't sued for accidental gene presence, but for presence which could not be accidental. (ie actual patent infringement rather than being subject to the whims of pollen flow or accidental spillage from a passing truck full o' grain tm)
Ewan, IIRC from Food, Inc., there are cases of farmers sued for accidental spillage and cross-fertilization. Also for saving seeds, which seeds were produced through a natural process which can't be patented and seems to stretch the notion of patent infringement: e.g. http://www.organicconsumers.org/Monsanto/farmerssued.cfm
Thanks for the post! Very interesting, I'm glad they didn't get the patent.