Breast Cancer Gene Lawsuit Argues Patents Invalid 294
bkuhn writes "The ACLU and the Public Patent Foundation have filed a lawsuit
charging that patents on two human genes associated with breast and
ovarian cancer are unconstitutional and invalid. The
lawsuit (PDF) was filed
on behalf of four scientific organizations representing more than
150,000 geneticists, pathologists, and laboratory professionals, as well
as individual researchers, breast cancer and women's health groups, and
individual women. Individuals with certain mutations along these two
genes, known as BRCA1 and BRCA2, are at a significantly higher risk for
developing hereditary breast and ovarian cancers."
Re:I don't understand it. (Score:5, Informative)
Re:I don't understand it. (Score:4, Informative)
These patents do not cover only the gene sequence. These patents often are related to the methods by which the gene sequence was identified within the particular culture of cells from which it was taken. The patent may also cover the methods by which those cells were cultured or the methods by which those cells were derived from other cell lines. The patents also may cover the methods by which this particular sequence may be used to identify other tissues containing cells which, by matching this sequence, will match the cell line from which the sequence is derived--thereby solidifying the position of the inventors if a diagnostic test were to ever be developed. For example, in a question of a patient population with multiple cancers, or with multiple different forms of the cancer in question (breast cancer), are those patients viable candidates for treatment with a pharmaceutical which was developed specifically to target the cancer which is characterized by the DNA sequence given in this particular patent? We wouldn't want to develop a pharmaceutical to treat cancers characterized by sequence ABC and then give that pharmaceutical to patients with a similar cancer displaying sequence CBD.
These are all very logical reasons why these patents exist. If you know how the industry works, though, none of them really hold any water in true practice. Patents are nothing but resume boosters for scientists and the patents rarely, if ever, actually monetarily benefit any of the named inventors except for the lead investigator(s). If you are socially and financially well-connected to begin with then your patent may help you. If not then the patent is the legal paperwork by which the company or group you worked for can use to cut you out of all profits. In most companies a large number of patents will translate into a significant salary increase or a promotion for the lead investigators but translates into little more than a token fee (usually around a dollar, or a single option of stock, or something similar) in exchange for which the employee signs away all rights to claim ownership of their own work.
It's still in the gene databases (Score:3, Informative)
Can anybody explain what patenting the genes actually means? The articles aren't too clear. They're still in the public databases: BRCA1 [ensembl.org] and BRCA2 [ensembl.org]. This includes the sequence, SNPs, transcript information and all the other goodies. In fact, the Ensembl home page [ensembl.org] still lists BRCA2 as an example for its search box...
I can understand they might patent technology they have developed that is associated with those genes, which seems fair. But if all this information is still available, they haven't really patented the gene itself.
Re:It's still in the gene databases (Score:2, Informative)
Patents don't mean the information is not available. Indeed, the whole point of patents is to make the information available, in exchange to a limited-time monopoly on its use.
For example, if someone holds a patent on a time machine, then you don't violate the patent by describing, in arbitrary detail, how the time machine works. You do violate the patent by building it yourself (provided you don't have a license to do so).
Re:New Business Model (Score:5, Informative)
Re:I don't understand it. (Score:5, Informative)
One of the patents cited was 5,747,282.
Claim 1 states:
1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2
I'm not any genetic engineer, but it seems they are receiving a patent on the specific DNA coding. So did they "discover" the code or is this code used to locate BRCA1? Seems pretty broad.
I actually RTFA (Score:2, Informative)
I know, I know. We don't do that here. But it's a shame because it actually does help in this case.
Basically, a company found that if a gene exists, the patient has increased risk of cancer. And so they made a test to determine if that gene exists. And then they patented their invention, because they want to be the ones to profit from their work.
Other than "cancer" being important in the story, it's like any other patent case. A company made a unique discovery that they want to profit from. Other people don't like that a patent restricts them.
Same old story.
Re:It's still in the gene databases (Score:4, Informative)
A bunch of folks have said in this discussion that patenting the gene doesn't patent the gene itself, but only the method of finding it, the method of using it, and other methods having to do with the gene.
It is true that methods for doing all those things are patentable subject matter, but an inventor can also get a patent on the gene itself if the inventor is the first to purify that gene from its surrounding environment. The landmark case for this proposition (that chemicals found in nature are patentable in their isolated and purified form) is called Parke-Davis v. H.K. Mulford 189 F. 95 (S.D.N.Y. 1911). I tried to find a link to the case online, but couldn't find anything for free. The case concerns purified adrenaline, which before the invention at issue could only be used in conjunction with the rest of the junk in whatever gland produces adrenaline. The court held that purified adrenaline was different enough from the adrenaline found in nature that the substance itself could be patented. This is the basis for gene patents and also pharmaceutical patents (most of the drugs you take can be found in nature, just not in purified form).
Re:It's still in the gene databases (Score:3, Informative)
IANAL and IANAG (I am not a geneticist). However my wife works for Genbank (http://www.ncbi.nlm.nih.gov/Genbank/). She is a geneticist and we've discussed this issue. When a company patents a gene they have the rights to information and usage of that gene. This essentially halts research on the gene, because anything you discover is owned by the company with the patent unless you work out some type of licensing agreement. This is bad for medical research because a company won't study a disease if the gene is owned by another company. Any cure or medication they came up would not be usable without licensing. Considering the high cost of medical research, it's just not worth it do research unless you own the patent. Companies are in the process of patenting every gene they can find in hopes that one of them will be important for instance the genes described in this article that relate to breast cancer.
Re:I don't understand it. (Score:4, Informative)
I have a sneaking suspicion that you are right - this isn't about the gene itself, but how to isolate/observe, etc. That process could very well be an invention
Everything I read says the patent is on the gene.
http://www.wipo.int/wipo_magazine/en/2006/04/article_0003.html [wipo.int]
"Myriad holds U.S. patents 5747282 and 5710001 on the isolated DNA coding for a BRCA-1 polypeptide and on a screening method."
Ah, AND on a screening method. Patents on human genes (isolated DNA coding) make me confused; wary.
Re:I don't understand it. (Score:5, Informative)
I think this is what you were getting to, but I just wanted to clarify. The constitution actually doesn't grant us any rights. By default you have the freedom to do whatever the hell you want, and the only thing the government can do is decide which of your innate rights it wants to take away. The founders understood this and argued about whether a bill of rights was necessary, because all it does is state rights that we already have. The first ten amendments don't actually grant us any new rights, they only list rights that the government is not allowed to take away.
It's too bad that most people don't understand this and believe that they only have the rights that they are given by the government. It should be the other way round, meaning you have all rights except for those that the government explicitly takes away.
Re:I don't understand it. (Score:3, Informative)
I have a sneaking suspicion that you are right - this isn't about the gene itself, but how to isolate/observe, etc. That process could very well be an invention and it certainly cost R&D money to the original developer.
You are both wrong. In the US genes can be patented and then any future therapy based on targeting that particular gene falls under the patent.
This is not the same as patenting a process or a particular therapy, which most people (myself included) would argue is reasonable use of a patent.
Comment removed (Score:5, Informative)
Comment removed (Score:3, Informative)
Re:I don't understand it. (Score:3, Informative)
it's just that without Myriad, *no one* would know that having the BRCA1 gene was a precursor to breast cancer.
Really? Then why is there research on the topic that predates the company? Here's a paper from 1994 that includes at least one co-founder of Myriad: http://www.sciencemag.org/content/vol266/issue5182/index.dtl [sciencemag.org]. Of course, 1994 is after the founding of Myriad in 1991-1992, but you already pointed out that the research takes 5-6 years. Additionally, that paper cites work from http://www.sciencemag.org/cgi/content/abstract/250/4988/1684 [sciencemag.org], which was published in 1990 (before Myriad). The title of that article is "Linkage of early-onset familial breast cancer to chromosome 17q21."
My understanding of the history of Myriad is that they are an example of university research commercialization. That is, the company was founded to establish and protect intellectual property based on work that was done by researchers at the University of Utah. A lot of universities are doing this now, where start-up companies are formed to expand on and profit from research. If the start-ups do well, the universities get a share of the profits.
Just one problem... As this was university research, it was almost certainly publically funded through grants from NIH, NSF, etc. Hence, we US taxpayers funded the research, not Myriad. Yes, Myriad continues to do research to further develop their products, but Myriad's flagship is still BRACAnalysis, which is the product of university research.
Furthermore, Myriad aggressively pursues their IP rights. In 2001, they sent cease-and-desist letters to the Canadian government, claiming that ANY BRCA1 or BRCA2 testing method other than BRACAnalysis violates their patents. So, yes, they are claiming ownership of ALL information relating to the genes, and not just the process. Many provinces are fighting back, and the outcome of those legal battles is unclear.
Re:I don't understand it. (Score:5, Informative)
Re:I don't understand it. (Score:3, Informative)
In Europe the patent was revoked, because Myriad's screening test was found to be inaccurate and the patent prevented making improved tests.
So, no. Myriad did not add any knowledge, and the patent did prevent others adding too...
Re:I don't understand it. (Score:3, Informative)
Nope you are both wrong. This *IS* about the gene itself. The patent is extremely broad and covers such things as:
1) the "normal" sequence of the BRCA1 and BRCA2 genes
2) the fact that various mutations in those genes are associated with breast cancer
Researchers/doctors are unable to offer alternative tests because offering a test requires being able to compare a patient's sequence with the (patented) "normal" sequence. But Myriad refuses to allow this, so even scientists doing basic research can't sequence their subject's BRCA1/2 genes!!!
Since Myriad Genetics even owns a patent on the "fact" that certain mutations are associated with disease, researchers/doctors aren't even allowed to interpret the results for their patients because doing so would utilized the patented fact that the patient's mutation is associated with breast cancer.
Read the article and/or complaint filed. This lawsuit has been a LONG time coming.
YEs it IS that ridiculous. The patent office was dumb/ignorant when they awarded the patents and it's about time this mistake was challenged.
Re:I don't understand it. (Score:3, Informative)
farming is like owning a vineyard
Arguably, growing grapes IS FARMING.
Re:I don't understand it. (Score:5, Informative)
Are you ^!&%! kidding? Are people so bamboozled by the FUD of pharmaceutical companies that anyone who doesn't know the truth assumes that the big, nice company must have sunk a ton of time and money into finding this gene from scratch, and without them the gene would never have been found? The truth is very, very different, and this is why Myriad is so hated in the scientific community.
BRCA1 was discovered by Mary-Claire King [nature.com], now a geneticist at the University of Washington, following over a decade of government-funded basic science work that started when she was a graduate student and then junior faculty at UC Berkeley. Back then genetics was hard work - not hard like today, *really* hard. When she started no one really believed that one could even find a gene for a trait that wasn't expressed 100%, it just seemed too complicated to pick one mutation out of a huge haystack when you had to allow for some people having the bad mutation yet having a normal phenotype. Remember this is before the human genome project, before automated sequencing; she even started before PCR. Just pinning the candidate gene down to one small region of one chromosome took over a decade of work by dozens of people.
As the process came towards fruition, they first narrowed the field to a small part of chromosome 17 (paper [nih.gov]), then made a laborious map of the region of interest (paper [nih.gov]), and then together with a group at the NIH, they identified the actual single gene we now know as BRCA1, sequenced it, and spelled out the mutations in it that caused breast cancer in the affected families (paper1 [nih.gov], paper2 [nih.gov]). Notice that all of this was done completely in the public eye, with all of her lab's results published immediately so as to help other researchers advance the field with her. It was good science.
But wait, where's Myriad genetics so far? What's left to do? Didn't we already "discover" BRCA1? How could anyone patent it now? All good questions. The next thing to do was to make a copy of this gene, by itself, in a test tube. This would be preliminary work for all sorts of biochemical analysis. The act of copying a gene off of a chromosome onto a separate loop of DNA in a test tube is called "cloning". Cloning is still pretty hard even today, especially for long genes like BRCA1. It can take months, especially since you usually need to copy it in bits and then glue those bits together.
What Myriad understood, and perhaps Dr. King did not, is that a cloned gene (that loop in a test tube) is patentable because it's considered "artificial", even if it's a perfect copy of a natural sequence of DNA. Myriad jumped in at this point, threw their whole company into cloning the gene and then patenting it, and did it before Dr. King or anyone else realized they were in a race. Ironically, Dr. King's lab had probably already cloned it in pieces (usually a prerequisite to sequencing) but hadn't made a complete intact copy yet, and certainly hadn't filed any patents. Myriad did none of the prior work on BRCA1. They did not come up with the idea of hereditary breast cancer. They did not do the laborious work of mapping where BRCA1 might be. They did not pinpoint the gene that was BRCA1. They did not sequence