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In Defense of Patenting DNA: A Pragmatic Libertarian Perspective
Although biotechnology patents existed prior to the 1980s as the biotechnology era officially began, they soon became a divisive public policy issue. Perhaps a culture war issue is more appropriate as the free market approach of using DNA patents in biomedical research is under fire from strange bedfellows, a bioconservative-technoprogressive axis. The bioconservative criticisms are on moral grounds and the technoprogressive criticisms for economic reasons based on values.
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COMMENTS
Posted by Athena Andreadis on 07/26 at 08:31 PM
1. Your description of zinc finger transcription factors is incorrect.
2. What you do not say about the Venter/NIH patent attempt is that it proposed to patent not only the ESTs, but also the genes and proteins they represented. This is the equivalent of someone saying "I invented an oil drill -- so all oil drills, oil wells and subterranean oil 'are belong to us'." The NIH saw reason only when the rest of the world threatened to shut down their public databases to US researchers.
Given these two points, I wonder what else might be inaccurate in your account. On a more general note, as a working scientist, I find that patenting exerts a chilling effect and drives the price of research up, resulting in a negative feeback loop. And I'm not alone by far in this conclusion.
Posted by David Koepsell on 07/27 at 01:11 AM
I'm going to craft a lengthy response to the many disagreements I have with this text, but to point out quickly two important points:
1) Athena is right, and it's not just her feelings... Fiona Murray of MIT has demonstrated an actual chilling effect from these patents on basic science.
2) any so-called "libertarian" who supports patenting is experiencing cognitive dissonance because a) there is no natural right to IP, and b) patents are a government-sponsored monopoly, which a libertarian would oppose if he were being honest about his ideological stance.
much more to come shortly... Thanks, Randall, for putting the effort and time into these arguments, I'll do the same in picking them apart. 
best,
David
Posted by Randall Mayes on 07/27 at 04:23 PM
Athena- The ESTs are used as an example to show that government failures occured on the utility clause. There exists no requirement that I include proteins or genes in that minor point to support my majot thesis of why your side is losing a legal battle My understanding of zinc fingers is from talks by Fiona Murray and Drew Endy at Duke. Altough it is possible my desription may contain an error (which you hopefully will elaborate on at some point), it does not take away from the major thesis of why your side is losing a legal battle.
Your seem to be using tactics similar to the Discovery Institute with evolution which have gone no where and is probably why you are frustrated and are defensive.
Daivid- Thanks for your response. It's possible you are confusing libertarians with civil libertarians. For example using a case study of genomics and health insurance discrimination, civil libertatians support ELSI, whereas libertarians support free markets and are not in support of subsidizing others.
A natural right for patenting DNA is obviouslly not in the constitution. So, the branches of our government have decided that patenting DNA is legal and have set up an infrastructure allowing companies to have a temporary monopoly so that society will benefi from the invention.
Thanks for pointing Fiona'a article. I will read it . Based on her talk at Duke though, in my opinion she is not objective, and more credibility will be given to the objective NAS studies which have opposite conclusions. If in fact Fiona is correct, perhaps she is pointing out the obvious and the scientists that are effected will have to be more creative and get around the patents. Patents are meant to excude others i.e. with certain academic exceptions.
I wish there was a paradigm so both sides could be happy. Unfortunately, ad hoc reform seem to be the answer.
Posted by Athena Andreadis on 07/28 at 08:25 PM
Equating a practicing scientist who is also a publicly avowed atheist with someone from the Discovery Institute is an obvious attempt to silence by threat of tainting. Telling only part of the story to torture facts into fitting your preconceived conclusions is a well-known tactic of desperate sophists.
I'm under no obligation to spend time educating you over basics that you should have researched before writing the article. Besides, I'm really busy filing a patent for the periodic table and all its elements.
Posted by Cmon now on 07/28 at 09:54 PM
"an obvious attempt to silence"
How does one silence another on a blog??
Posted by Randall Mayes on 07/29 at 03:12 PM
My reference to the Discovery Institute is pointing out that you are using ad hominem arguments as a tactic to advance your side of the debate. This piece conveys my perspective through six points on why your side has failed on the DNA patenting issue.
I was invited to an MIT-Duke conference held here in Durham, NC. on pateneting and synthetic biology, and Drew Endy discussed
zinc fingers. What ever problems you have about this technical point are not going to sway the courts or leigislature in your favor.
Your side has a number of huge obstacles and you have not helped your case at all.
Thanks for mentioning Fiona's article.
This is her first paragraph.
In the early 1980s, Professor Philip Leder, recently recruited to head the new Genetics department at the Harvard Medical School, developed the first genetically engineered mouse with cancer, dubbed the Oncomouse. Leder and his post-doc Tim Stewart had used novel transgenic techniques to insert an oncogene into a mouse embryo; the result was a mouse that was highly susceptible to cancer. In his pursuit of a deeper understanding of cancer, Leder came to recognize that "it could serve a variety of different purposes, some purely scientific others highly practical" (Kelves, 2002, p. 83). This research was published in Cell in 1984, and in 1988 a broad patent for the Oncomouse was granted by the US Patent Office (USPTO). The Oncomouse patent was more controversial than most; not only was the Oncomouse the first living mammal to be patented, but Du Pont, as the patent's exclusive licensee, aggressively enforced the property rights. Du Pont's strategy included demands for "reach-through" rights and review of publications that used the Oncomouse in further scientific research (Murray, 2006). Ideas that are simultaneously of value as a scientific discovery and inventive construct, such as the Oncomouse, are frequently generated in the disciplines that underpin modern biotechnology (Stokes, 1997).
Here is an e-mail from Dr. Leder himself.
Good to hear from you.. All of ours used the mutant gene injection. Best wishes, Phil
Dr. Leder
Would you be kind enough to clarify an aspect of your work with the OncoMouse?
Numerous articles indicate you used genetic engineering, but from what I understand you used microinjection of mutated gene(s) which is not the classical sense of ge using reverse transcriptase. Did you create more than one OncoMouse and they were created by different procedures?
Phil Benfey is a graet teacher by the way.
Randy Mayes
randy.mayes@duke.edu
Philip Leder, MD
77 Avenue Louis Pasteur
Boston, MA 02115
Note: Dr. Benfey was Leder's doctoral student and taught the first genomics class at Duke which has molded my knowledge of this topic.
On p.4 of David Koepsell's article Individual Collective Rights in Genomic Data in JET, he correctlty refers to Chakarabarty's patent as genetic engineering. I have an e-mail from Daniel Kevles of Yale acknowledging David is wrong. X-rays were used
In the Ethics of Genetic Engineering, which is a position paper for the Center for Inquiry, David incorrectly discusses the OncoMouse and the Chakrabarty patent as genetic engineering (see pp. 11-12).
I have been a guest speaker in several classes at Duke and used David's articles pointing out the incorrect use of genetic engineering in the media. Now, I have another article to use.
These are more examples of technical points. Is this what you want to discuss or do you want to discuss the six points in my article which, in my opinion and not IEETs explain why to date your side has failed?
After reviewing Fiona's article, I conclude, if this is your ace up your sleeve, you guys are hurting
Posted by Randall Mayes on 07/29 at 03:23 PM
On p.4 of David Koepsell's article Individual Collective Rights in Genomic Data in JET, he [substitute incorrectly in the previous post] correctlty refers to Chakarabarty's patent as genetic engineering. I have an e-mail from Daniel Kevles of Yale acknowledging David is wrong. X-rays were used
Posted by David Koepsell on 07/29 at 04:17 PM
Yes, it was directed mutation... this was crude engineering, in the sense that the bacteria were exposed to a mutagen, and ones that were suitable were selected and bred. I am not wrong, this was the product of human direction and creation, although crude. This is why the SCOTUS approved the patent.
Posted by Randall Mayes on 07/29 at 05:32 PM
David
My response was not directed at you. Don't worry about it. It's a compicated concept, and I would like to have a civilized discussion with you, not her.
If you were a molecular biologist it would be an issue, but as an attorney and philosopher you are forgiven for not understanding the distinction. My background is developmental biology and science policy analysis. However, this is not a discussion about who knows the most about biology, rather two different perspectives on the future of biotechnology public policy, and I consider you an expert in this field or I would,t waste my time with this discussion.
Posted by David Koepsell on 07/30 at 01:13 AM
Randall,
I contend that for the purposes of patent, Chakrabarty involved an engineering process in the sense that man altered nature purposefully to achieve a particular result. That result was a product of man, not of nature. In all my descriptions and discussions of the case, as far as I know, I do say he "bred" the bacterium, and never do I claim he spliced genes as in traditional genetic engineering. I don't really require "forgiveness" as the legal and philosophical issue at hand is the alteration of nature (which creates something patentable).
I look forward to a civilized discussion. I am crafting a lengthy response now to point out your many errors, both legal and philosophical.
best,
David
Posted by David Koepsell on 07/30 at 09:01 AM
Randall,
Scientific American confirms that the bacterium in Chakrabarthy was "genetically modified," which I claim is legally speaking the same thing as "engineered" for the purposes of the patent law: http://www.scientificamerican.com/article.cfm?id=gene-patents-breast-cancer-lawsuit-myriad
Now, if you wish to distinguish for some other reasons between engineering and modification, that's fine, but for patent purposes, there is no relevant difference. So kindly point this out while you are telling people I am wrong, I use the terms interchangeably because, for the purposes of patent, there is no distinction. Anything altered by man, which is useful, non-obvious, and novel, is patentable. If you simply wish to make me look foolish, then go right ahead and try. My meaning is clear in context.
best,
David
Posted by Randall Mayes on 07/30 at 04:28 PM
David
In the class where I discussed this topic there was a mixture of philosophy, law, and, med students. Part of the problem is semantics and thus the need for protocols in interdisciplinary studies. So, I began to ask the students for their definition of genetic engineering. Most people had no answer and the few that did were not even close to each other.
What genetic engineering means in molecular biology is using reverse transriptase to recombine DNA from two organisms. Cohen and Boyer received the process patent for this procedure.
So, when pharma used the process to make EPO, HGH, interferon etc. they paid royalties to Cohen and Boyer and received product patents for their drugs.
Leder injected mutated genes and did not pay royalties.
Chakrabarty used X-rays and received a process patent and eventually product patents as well.
Unless you payed royalties to Cohen and Boyer, yiou were not using genetic engineering. I beleive their patent has now expired.
In the social sciences, there are different versions of reality to what genertic engineering means. I think at our level of discussion we should use the scientific meaning and not some popular notion which varies depending on the conversation.
Is it possible we can agree on that?
Posted by David Koepsell on 07/31 at 02:24 AM
Randall,
Law and philosophy are all semantics, which is the connection between words and meanings. It's not trivial to misunderstand or misrepresent one's meanings when they pertain to particular contexts.
While the CFI paper says Chakrabarthy involved "genetic engineering" (as a result of editing by the review committee to simplify my original wording) my recent book Who Owns You?is quite explicit and correct in saying throughout that Chakrabarthy involved "genetic modification." I do say correctly in that book that the case stood for the legal principle that made genetically engineered life forms patentable, but never do I claim in my book (I hope you'll read it) that Chakrabarthy involved genetic engineering.
The important legal issue is modification by humans of natural products. I make a number of analogies in the book to types of modifications that would not amount to patentable inventions (like drawing lines around natural features on maps), and argue at length (bits that you seem to have missed or at least misunderstood) that patenting genes is the same ontologically speaking, and never arises to patentability under the current US patent law.
Still working on my response, should be done next week. Stay tuned.
-David
Posted by Randall Mayes on 07/31 at 03:48 PM
I read your book soon after James posted it on the IEET website. The Duke Law Library purchased a copy of it. I find your book very similar to your JET article.
This topic is huge at Duke. Arti Rai and James Boyle in the Duke Law School are involved with the Science Commons and Wes Cohen of the Fuqua Business School was involved in the NAS studies. Robert Cook-Deegan in Genomics and Public Policy is also very involved. Each school has held numerous conferences.
I'm suprised I haven't seen you here.
Posted by James Street on 12/30 at 02:23 AM
I can't see how your position can be construed as libertarian or anarchist.
If you define libertarian/anarchist activity as individual and group activity with minimal government intervention, you are on shaky ground, obviously, and you don't have to be a lawyer, political theorist or expert in any field to understand why.
I hardly know where to begin but I might as well begin with the concept of The Corporation which is defined by the law and defended by the government. Patents that protect corporations from competition from other corporations and individuals are also defended by the government.
As I said, I don't know where to begin except IN MEDIA RES and using common sense.
The lines are already drawn, of course, and the enemies know each other quite well, but the corporations and their lawyers have all the cards. The trouble is, they have little logic and less reason.
Expertise in the field is irrelevant. The battle is going on in computer science too and you don't need to be an expert in computer science to see that monopoly patent rights over hundreds of thousands of subroutines which produce popular interfaces and other platforms used by the monopoly operating systems of Microsoft, have left their creators spinning in the winds of Linux and open software, or as millionaires living off their royalties.
Bill Gates has more wealth (money) than the bottom 40% of Americans, as a result. The inventor of the Internet, let's see, what's his name?, lives a relatively modest life --- but with the respect of the computer science community.
To cite an extreme example to prove a point, what would have happened to scientific progress if Einstein had formed a corporation by patenting Relativity Theory for making atomic bombs?
The question answers itself.
Only a totalitarian government could have the means to hunt down all the pirates using Relativity Theory and the experimental results needed to make atomic bombs. The United States hasn't been able to do it and neither has China or Russia.
It was impossible. Why because - so far - liberty triumphed over totalitarianism.
Governments rarely get smaller or give up influence and they show no signs of shrinking in the United States. The same is true about corporations. But both can go bankrupt, as history shows.
The only hope for continued scientific progress we Americans have is that we continue to have the liberty to use all scientific and mathematical knowledge freely to make new discoveries and theorems
Finally, science and mathematics do not form a belief system, or the cogs in the wheels of an ideology or faith, but a body of knowledge each part of which can be verified by anyone using logic and experiment.
When the path to verification is mostly closed by secrecy and law, scientific inquiry will be stifled and America will cross a threshold into a scientific and technological dark age.
Access to knowledge will be under the control of corporations and their government servants.
Americans can then safely forget about science and technology and dedicate themselves to making movies, music and sports for the entertainment of the rest of the world.
We can hope that the torch of science will be passed to another, younger and wiser civilization.
Posted by James Street on 12/30 at 03:42 AM
Just a quick personal note, and I don't mean this to be emotional: It's pretty clear (and was clear before I wrote my post) that you will neither allow my previous post on your site or respond to it.
Why? Because you don't consider ME to be a valid member of your discourse space.
It's not unusual. After all, scientific journals have similar bars called judges or experts who determine whether a paper should be allowed into their journal.
But in this case, I am part of the American universe of discourse which the Internet embodies. I am an American citizen without any degree, university position, credentials or employment (that you are aware of.)
And I have not presented any unusual or novel facts, perspectives or ideas.
But the kind of control that your policy exemplifies is exactly the kind of control that stifles scientific inquiry.
Only free, random, friendly and honest thought can produce dialogue (and science) worthy of the name.
Monopoly capitalism stifles that. I sincerely hope that we don't have a civil war to decide this question, but I believe it would be preferable to a descent into irreversible cultural and intellectual decline.
Please don't answer this post. I'll be much happier if you answer another one like it in the future.
Posted by DUI Lawyer Los Angeles on 02/10 at 09:42 PM
If anyone develops a drug, procedure, treatment or anything having to do with that specific gene, whoever owns the patent to it will make money from it. I guess companies are thinking ahead if they are doing research on the gene, they don't want someone else beating them to their intended outcome.
Posted by James Street on 02/11 at 01:02 AM
Should Human Genes Be Patented? US Federal Court Hearing
05 Feb 2010
This week a US federal court heard a case that may decide whether it is legal to patent human genes.
On Tuesday 2nd February, a Manhattan court presided by Judge Robert Sweet heard attorneys argue for and against a federal lawsuit filed by American Civil Liberties Union (ACLU) and the Public Patent Foundation against the Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation.
The lawsuit challenges the government's granting of control of patents on BRCA1 and BRCA2 to Myriad Genetics. The BRCA1 and BRCA2 genes are implicated in inherited breast and ovarian cancers. Myriad Genetics have developed a genetic test where for a fee, a person can have their blood tested to see if they carry mutations of those genes that put them at higher risk of developing those cancers.
The ACLU is representing 20 plaintiffs, including the American College of Medical Genetics, the Association for Molecular Pathology, and various individuals, including Lisbeth Ceriani, a 43-year-old woman from Massachusetts whose doctors last year suggested she have a genetic test for BRCA1 and BRCA2 mutations following a breast cancer diagnosis.
When they submitted her blood to Myriad Genetics, they refused to do the test because they didn't accept her insurance. Ceriani couldn't afford to pay for the test herself (according to a report in Discover magazine it costs in the region of $4,000), so in the end she didn't have one. Since Myriad hold all the relevant patents, there is only one test for the BRCA mutations, and the company also holds power over who can and can't research the genes.
The essence of the lawsuit is that the plaintiffs contest the right of companies to be able to patent "products of nature" and "laws of nature".
Both sides agree on a number of points: researchers should be free to patent new drugs, new treatments, devices, and even specific DNA sequencing methods. And both sides agree that patent law forbids the patenting of natural phenomenal and laws of nature since these weren't invented by humans and patent law does not allow the patenting of something that occurs in nature.
According to an ACLU press statement, both sides also agree that DNA in the body is also a product of nature and therefore should not be patented. However, at this point they part company: the defendants claim that "isolation" of the BRCA genes from the rest of the DNA (they have to be separated from the rest of the DNA to study and test them), makes them patentable.
The plaintiffs refute this claim and say that patents on human genes should never have been granted because "genes are identified, not invented". They argue that no matter how ingenious the isolation process is, it does not alter the structure of the DNA itself and so the genes essentially remain "products of nature".
They also refute Myriad's patent claims over the correlations between mutations and cancer because mutations are a "law of nature": Einstein discovered that e=mc2 but he would not have been allowed to patent it.
Also involved in this case are issues around the First Amendment and the constitution, where by granting patents on the genes themselves, the government has essentially given Myriad exclusive control of all knowledge about the gene, which the plaintiffs argue is a clear violation of the First Amendment.
It is not like a patent for a carburettor, where someone else can invent another kind of carburettor; other researchers cannot "invent around" a gene that has been patented, said the ACLU, which argues that this goes against Article I of the Constitution since gene patents do not "promote the progress of science and useful arts". Instead, they hamper research, testing and development, they said.
Myriad argues that patents are a necessary incentive for researchers to discover the BRCA genes and develop commercial tests. Also, to disallow them would wreck the basis on which the entire biotech industry is based. According to a CNN report the company is also pushing the point that court precedent is on its side.
The plaintiffs refute these claims. For instance, on the incentive angle, they pointed out that researchers were doing BRCA testing before the patents were granted and Myriad stopped anyone else doing research once it got the patents.
Today, said ACLU, thousands of researchers and clinicians who could be doing BRCA testing and give women the results they want can't do it because of the patents. Six of the plaintiffs are individual women who say they have been pre-empted from knowing about their gene status because of the patents.
At the end of the 2-hour hearing, after hearing the arguments for both sides, Judge Robert Sweet thanked the attorneys for their clarity and skill, acknowledged the sharp difference of opinion, and touched on the fact this case is of great concern to science and industry and anyone concerned about breast cancer, pointing out that nearly everyone has been affected by the disease in one way or another either directly or because they know people who have, or they care for them.
A ruling is expected in the next few months, according to a statement on the ACLU website.
As we get to know more and more about breast cancer, a disease that affects one woman out of every eight, we are learning that it is not one disease but many, and perhaps even specific to individuals. The chances are that we will need to know more and more about the genetic basis of the disease so treatments can be tailored to suit individual patients.
Should ACLU and the plaintiffs they represent win the case, it could mean a huge change in the field of genetic research, where the race is on daily to patent more and more genes.
About 20 per cent of human genes are now covered by patent claims (including genes linked to Alzheimer's disease, muscular dystrophy, colon cancer, asthma and many other conditions).
Sources: ACLU, CNN, Discover Magazine.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Article URL: http://www.medicalnewstoday.com/articles/178399.php
Main News Category: Genetics
Also Appears In: Breast Cancer, Litigation / Medical Malpractice, Regulatory Affairs / Drug Approvals,
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