Numerous defenders of Myriad often claim that the patents do not cover naturally-occurring genes, but rather only "methods" created by humans, or "isolated and purified" genes, which they allege can only be created by man. After all, they claim, isolated genes do not appear in nature, and it takes the work of humans to create them. This is, of course, hogwash. Isolating a gene is accomplished in nature in the process of cellular metabolism. Protein synthesis is accomplished without human intervention, much less, human invention, because various forms of RNA read the beginnings and ends of genes, omit the introns, and construct proteins from the remaining (exon) codons. So, merely finding the beginning and end of a gene is, as I have analogized in my book and elsewhere, equivalent to reading a map, and noting a geographical feature therein. Nature made the feature, and defined its borders, and we simply find it and model it. So that's the "isolation" and it doesn't warrant patent.
The "purification" part is part of nature's bag of tricks too, as mRNA skips the introns (the non-protein coding regions), and in fact some laboratory methods for creating cDNA (thus "purifying" DNA) use mRNA to accomplish this. Again, nothing at all inventive.
Finally, the Myriad patents on BRCA1 and 2 claim un-modified genes -- mutations in the BRCA1 and 2 gene that occur naturally. Their sole inventive claim is "isolation." See the patent yourself, and look at the claims (pp. 153-156). Look specifically at this:
"1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2."
Now, note: these are not method claims, they are not claims for cDNA, but rather over naturally-occurring mutations to naturally-occurring genes. As I discuss above, and in my book, and elsewhere in this blog, this is not inventive at all. Rewarding for discovery of laws of nature goes beyond the scope of patent, and it inhibits research, and access to the "commons by necessity" that is the human genome and laws of nature in general.
It is like saying that since detached bird wings do not exist in nature, one ought to be able to patent detached bird wings. It's madness, and everyone except patent lawyers and others getting wealthy off this insanity can see that.
12 comments:
David-
While you think it is hogwash, it most certainly is not. What you fail to understand about patent law is that a man made process for accomplishing something is patentable even if the man made process mimics a process that occurs in nature.
You can say it as many times as you like, but it will always be untrue. A process that is initiated by man does not happen in nature. This shouldn't be very difficult to understand and I for the life of me cannot understand why you or anyone beliefs that a process initiated by man is something that happens naturally. The method is on demand and in nature it is not on demand. End of story.
-Gene
The process could well be, but not the product. Imagine I create a
new process for combining oxygen and hydrogen to make water, then fine, the process ought to be patentable, but not the water itself. This is how the courts have screwed up badly in the past, as well as the PTO, in thinking that somehow the product could be patentable if it is identical to the naturally-occurring product. There is literally no logic to that reasoning, and so yes, it's hogwash.
Hi David:
I agree with you! One of the worst parts of these patents, in my mind, is that they only detect an increased incidence of breast cancer, unlike the sickle cell anemia analogy I posted earlier on IPwatchdog. This admits that there are other factors that determine penetrance of these mutations. Some may be genetically encoded, while others are definitely environmental. The end result is that they clearly are part of a naturally occuring and functioning gene.
Karl
Hi Karl,
Thanks for the comment. What Gene just defended above shows how a lack of understanding of the science, or in some cases, obfuscation, is what leads some to believe patenting genes is somehow appropriate, or even logical. Gene's comment doesn't address the issue of the claims that assert exclusive rights to the naturally-occurringsequences, he is merely defending the process of creating cDNA (which isn't even an issue in the BRCA1 and 2 patents). He cannot defend the patent on the sequences themselves, and I have yet to see any logical defense of that practice.
Hi David:
There clearly is no defenable position. My thesis advisor invented the first phage cloning vector in 1975. I helped create my first cDNA library in 1978, after learning how to Southern Blot and clone DNA fragments. I sequenced my first DNA in 1979. I did my first Northern Blot in 1982. I made my first gene expression library in 1984. This is all very old news and all supported by public research. I do not understand Gene's position. The only novelty is a kit for diagnosing a propensity for breast cancer. There is still a lot of research left to be done. There are many other genes to sequence, mutations to identify, and information to be coordinated in order to get a true picture of breast cancer induction. What is genetic propensity or environmental induction has not been clarified. Research needs to proceed. Tests need to be performed in order to create the database necessary for everyone to go forward. In this recession, they must be cost effective. A propensity does not insure detectability and only pushes everyone towards mastectomies, whether they need them or not.
David, the mistake you and your defenders are making is looking at each element of the invention separately. Your “logic is the fallacious logic which leads to the conclusion that since each of the words in Lincoln’s ‘Gettysburg Address’ were individually old and well known at the time he used them, it would have been obvious for anyone of ordinary skill with a dictionary before him, to have written it.” In re Dailey and Eilers, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). If you look at each element of a claim in isolation, I can show you that nothing has ever been invented. See Did Edison Invent the Light Bulb http://hallingblog.com/2009/07/20/did-edison-invent-the-light-bulb/.
Every invention is a combination of known/old items, since you cannot create something from nothing (Conservation of matter and energy).
The Myriad patent is not on the gene itself, it is not on the detection, isolation or refining technique itself, it is on the combination of the gene, method of detecting, isolation or refining technique and the knowledge that the gene is linked with breast cancer.
Your isolated in nature argument fails. Gold can be found in isolation in nature also, this does not stop someone from obtaining a patent on a method of detecting, isolation or refining gold.
Dale:
You try to weave a nice tidy argument, yet you fail to understand these genetic mutations are not directly "linked to breast cancer"; they are linked to an increased incidence of breast cancer. This is unlike sickle cell anemia, where the gentic mutaations are directly linked to the incidence of the disease. The issue is penetrance of the genetic markers and in breast cancer, some at best define a 60% linkage with the disease. This clearly admits that there are other considerations to be taken into account. Clearly some are environmental and difficult to evaluate; some are also definitely genetic and have yet to be defined. This clearly limits the value and impact to a diagnostic test only. Obviousness should disqualify the rest of the claims. The only true value of these patents will be understood when the rest of the genetic mutations that define disease progression are defined. This can only happen with further research on defined human population subsets and further gene sequencing efforts. Clearly, there is a misinterprettation of the value of this diagnostic test and more often it leads to double mastectomies, which may not limit disease penetrance or manifistation of the disease in other organs or through cancer cell development from residual tissue and matastasization to new sites. Thus, these genetic mutations still qualify as normal genes found in the human population.
Dale,
Claims in a patent are severable, as you know, and the broadest claims are first. In the patent at issue, the first and broadest claim covers the naturally-occurring mutations of a gene. Myriad has consistently used this patent to stop others who were replicating the gene itself (for scientific research on BRCA1 and 2, not merely for testing purposes), and so Myriad reaches a different conclusion about the scope of the patent than you apparently do.
So why don't Myriad and all the other "gene" patent holders go after DTC genomics companies or those sequencing the genes? And why are there numerous research papers published on BRCA1 and BRCA2 in the years since the patents were issued?
Nature does NOT isolate and purify genes or other DNA sequences. Ironic that your title begins with "Stop Lying."
Allison,
Your comment is nearly incomprehensible, but let me try to make sense of it...
Myriad has gone after those who have, since their patent was issued, sought to replicate the genes. You should go to the following site and read many declarations by those who have been sent cease and desist letters by Myriad for their research on the genes. Publishing papers did not violate the patents, but replicating the genes in the lab for clinical research has, and Myriad has strictly enforced its perceived rights: http://www.aclu.org/free-speech_womens-rights/aclu-challenges-patents-breast-cancer-genes
The only irony I can see is that none of what you claim contradicts my post at all. My claim is that the act of "isolation" by man, based as it is on borders defined by nature, is trivial. Moreover, please pay attention, there was no "purification" involved in this patent. The patent is on a naturally-occurring mutation to a naturally-occurring gene.
Allison,
"So why don't Myriad and all the other "gene" patent holders go after DTC genomics companies or those sequencing the genes?"
Sequencing and/or identifying new genes is beyond the scope of the patents.
"And why are there numerous research papers published on BRCA1 and BRCA2 in the years since the patents were issued?"
Academic researchers and nonprofit institutions are beyond the reach of the patent holder.
"Nature does NOT isolate and purify genes or other DNA sequences."
Nature did create the gene sequences represented in Table 12, as silent or nonlethal gene mutations in a naturally occuring or normal gene, through evolution.
Karl
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