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Breast Cancer Gene Lawsuit Argues Patents Invalid
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."
Monsanto would be the one to ask about that.
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.
the NPG electrode was replaced with carbon blac
You poke fun, but this happens with genetically modified corn
"When life gives you lemons, don't make lemonade. Make life take the lemons back!" -- Cave Johnson
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.
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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.
Comment removed based on user account deletion
Just to add a little clarity, you cannot patent anything that occurs in nature. But these folks managed to convince the courts that these genes are not naturally occuring because they don't occur alone in nature. They always occur in some kind of gene sequence. It's somewhat analogous to if gold only occurred naturally in ore, and you were therefore granted a patent on pure gold once you figured out how to extract it. I'm not saying this is good (in fact, I think it's ridiculous), but that's the theory.
Today's Sesame Street was brought to you by the number e.
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, 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), then made a laborious map of the region of interest (paper), 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, paper2). 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