The Case Against Gene Patents
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Written by David Koepsell Posted: June 13, 2009 @ 5:35 pm Page viewed 4,939 times |
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Professor David Koepsell
I favor innovation, and am interested in ensuring that science and technology work hand in hand to both better our standard of living, and enrich those who create new and useful works. But it is not necessarily true that current intellectual property laws always accomplish this. Nor is it so that everything under the sun is subject to intellectual property protection. When Jonas Salk developed his vaccine for polio, he was asked by Edward R. Murrow who owned the patent on the vaccine. His famous reply was “well, the people, I would say. There is no patent. Could you patent the sun?”
Since the mid 1990s, patents have been granted for human genes. Although now they are supposedly limited only to “isolated and purified” genes, this is a limitation of no consequence at all. It merely means marking the beginning and end point of the gene, and perhaps leaving out a few introns (which are meaningless junk that doesn’t do anything to the functioning of the genes, and that remains as a byproduct of evolution.” I argue that this is as “”inventive” as marking the boudaries of natural features, like mountains, on a map. It gives the mapmaker no right to the mountain, nor to preclude others from depicting that mountain.
The practice of patenting genes began during the progress of the Human Genome Project, which was a world-wide publicly funded scientific endeavor to map the human genome. While the HGP released the data it found into the public domain, it left open the option of “downstream” patents for new, inventive innovations, treatments, etc., that might come from the research. Meanwhile, Celera began to patent an unspecified number of sequences it found in its private attempt to map the genome. It’s “shotgun” approach to sequencing remains a vital, patentable innovation that has changed the way gene sequencing is done. It was new, inventive, useful, and non-obvious. But this is not true of human genes that are being patented.
The first public altercations over gene patents came from groups representing those who suffer from genetic diseases. Canavan’s Disease is a monogenic disease (it is carried by one gene only) that strikes a disproportionately among people of Ashkenazi Jewish heritage. When Miami Children’s Hospital acquired a patent for the gene, a group representing families suffering from Canavan’s Disease sued under tort law. They claimed that based on the patent, he Miami Children’s Hospital was unjustly enriched when they not only collected royalties but restricted the number of labs that could offer testing for the disease and charged a fee beyond the cost of the test. Because of the restrictive licensing, many labs stopped offering the test. The case settled, and the legality of gene patenting remains unchallenged in court. It has so far been based only upon the PTO’s interpretation of regulations it has promulgated. Recently, the ACLU’s suit against Myriad over its tests for the “breast cancer genes” has brought this issue back to the spotlight.
I argue in my book – Who Owns You? - that gene patents violate the patent law because what they claim as patentable is a part of nature, and thus neither new nor non-obvious. Awarding patents to non-new discoveries does not encourage innovation, and sitting on what are essentially laws of nature, so far upstream, actually stifles downstream innovation. Moreover, There are certain things that we have regarded both culturally and legally as belonging to a commons, and thus not subject to private ownership. I argue that unmodified genes are exactly this sort of thing.
In Gottschalk v. Benson, the Supreme Court stated: “the patent would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself.” That would amount to patenting an abstract idea, contrary to long established precedent. Laws of nature are inherent in nature. We do not invent them, they are part of the fabric of everything. Gravity is an example, the laws of evolution are another, as are the laws of relativity. Scientists devise explanations for these lawsn that we call “theories”, and attempt to confirm or falsify them through experiment. As we acquire a better understanding of natural processes and products, we become better equipped to manipulate our world, create new things that nature never made, and bring our inventiveness to bear on nature to make our lives better. This is, in sum, the purpose of intellectual property law: to further the progress of the useful arts and sciences. But if we try to do so by allowing governmentally-sponsored monopolies (as intellectual property ultimately is not a free-market device) we must be careful to not stifle innovation by granting monopolistic rights over laws of nature. Instead, we should grant rights only to those things that are the products of human thought and creativity. The application, for instance, of the laws of gravity to some specific way of moving people up and down between floors. The splicing of a genetic segment into a creature in such a way that nature never devised to make an entirely new creature that might, for instance, eat oil, is inventive. Finding a gene that has evolved over millenia is not.
Finally, I argue that the genome is a commons. There are parts of the world that cannot be owned in any practical sense. Radio spectra are my favorite example. There’s no way to exert ownership over a particular band. I can exert my ownership over my possessions and my land, but the only means of trying to control a band on the radio spectrum is to broadcast over it. But along comes my neighbor who does the same thing, and cranks up the wattage. There is no winner. It is the classic tragedy of the commons. I argue that genes, which are, after all, parts of what Richard Dawkins calls “the river of life flowing out of Eden” are simply unencloseable. Parents all over the world are reproducing patented genes, technically violating the patents on those genes because they haven’t sought permission and aren’t paying royalties. The idea is absurd, of course. This is why the practice is absurd. Unmodified genes simply cannot be owned, nor should they be.
But there’s plenty of room for innovation. As I mentioned, Celera deserves the fruits of its invention in developing new, useful, non-obvious technologies for rapidly sequencing genes. When new methods of testing are developed, they ought to be rewarded. A number of corporations agree with the thesis that patenting too far upstream actually stifles innovation, and the SNP (single nucleotide polymorphisms) Consortium is a prime example. The Consortium itself is a not-for-profit organization made up of the Wellcome Trust, a number of leading academic centers, and thirteen pharmaceutical and technological companies. These members have joined efforts to discover the roughly 300,000 SNPs thought to exist in the human genome, and to release this information into the public domain, while securing for each member IP rights over real innovations developed both along the way, and as a result of the effort. The same is true of the HapMap project which includes private companies, academic centers, and public and private research institutes. These efforts underscore the role of public science in profitable enterprise, and the recognition by corporations of the role of each in spurring innovation. None of the private corporations involved in these efforts could be accused of being wild-eyed anarchists seeking to undo private property rights. They simply realize that not everything should be patented, and that upstream patents can stifle downstream innovation, slowing the progress of the useful arts and sciences, and undermining the purposes for which patents were invented in the first place.
My book is certain to cause disagreements, as there is room for reasonable people to debate my assumptions about the role of intellectual property in innovation, as well as the nature of genes and genomes. But this is an issue that requires public debate, and legal challenge. Whether the courts or legislators ultimately change the way that genes are now being patented remains up in the air, which is why now is a perfect time to decide for yourself, and make your arguments, and be heard on this vital issue.
About the Author
David Koepsell is an author, philosopher, and attorney whose recent research focuses on the nexus of science, technology, ethics and public policy. He is an Assistant Professor at the Delft University of Technology, Faculty of Technology, Policy, and Management, Philosophy Section, and he blogs at Who Owns You?
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UCLA postdoc Debra Greenfield, JD, has also recently written about the non-patentability of DNA and DNA sequences in Santa Clara Computer & High Technology Law Journal, Vol. 25, No. 3, March 2009 p.467-538. See http://www.chtlj.org/volumes/v25#v025.i3.Greenfield.pdf Her entire article is downloadable.
Greenfield looks at DNA and DNA sequences not through the lens of molecular chemistry but through the lens of information theory, signalling, computational processing and potential mental steps with citations to recent CAFC decisions in Nuijten, Comiskey and Bilski, plus an extensive review of older cases. Greenfield urges the expansion of non-statutory claimed subject matter under 35 USC 101 to include DNA and DNA sequences because what is actually being claimed in terms of molecular media is akin to printed matter, i.e. information written in the book of life.
Yes, hers is interesting work. The important issue is who is that author, then? If it’s an human-engineered gene, I say ok, let the engineer patent it. If the author is God (or evolution), then, well, I’d say that’s prior art.
It would seem to me that one should be able to patent a test for the presence of a gene, or a method of isolating or modifying or replacing the gene, or as another commenter has said, an engineered gene.
When the human genome was mapped in 2000 both Clinton and Blair stated the raw data should be free, yet patents are placing control on the raw data, data that should be free to realise the promise of this research in advancing the knowledge of human disease. It is a fiction that once you remove the gene from it’s natural environment, the body, you have an invention. There are 3 Australian BRCA1 patents, 686004, 691331 and 691958, and one BRCA2 patent, 773601, registered with IP Australia. Two BRCA1 and BRCA2 patents define the primary invention to be an isolated nucleic acid, (the DNA which has been removed from the body). The BRCA1 patent 691331 defines the primary invention to be any method of detecting in a human the DNA or a biological derivative of the human gene that codes for the mutant protein BRCA1. No Australian court has ruled as to whether an isolated biological material that is identical or substantially identical to a naturally occurring substance or material such as a human gene is eligible patent subject matter. Genetic information is not something that anyone conceived, created or invented. The debate has been hijacked by Patent Attornies using legal semantics to argue that isolated genes are not natural genes
Adele-
Why does it always have to come back to patent attorneys being evil? You are certainly entitled to your opinion, but the constant blaming of patent attorneys does get very old after a while.
In the US the law is really clear on this point. If there is human intervention there is patentable subject matter. Changes to that core law cannot and should not happen in the courts. If there is a decision to be made then it needs to be made by Congress. The same goes for business method patents, and by extension software patents. The Federal Circuit simply ignored that Congress has recognized business method patents.
According to the US Supreme Court and the US Congress, anything made by man under the sun is patentable subject matter.
-Gene
Tom: Yes, if the test were a new, non-obvious, and useful combination of prior art then they could get a patent on the work as a whole. Not on the gene sequences themselves.
Adele: I quite agree, when the HGP concluded, it was announced that the genome was “the common heritage of mankind,” and in my book I take the argument one step further and say it is, in fact, an un-encloseable “commons.”
“anything made by man under the sun” is patentable, yes… but the “isolated” genes were not made by man, they were simply isolated, as in my example of “isolating” a geographic feature from the surrounding geography. Also, it has to be “new, non-obvious, and useful” so, if someone invents a way to synthesize water (H2o) then they could patent the new process of synthesis, but not the molecule H2O.
To Ms. Greenfield, and the people analogizing DNA patenting to information technology, please be reassured that the information is not what is patented. The information is freely available for database searching, sequencing, genetic analysis, etc.
I echo Kevin’s comments. While we might want to have a policy debate on whether this should be happening, it really serves no purpose to mislead the masses and claim that someone else owns a patent on your genetic code. This is why I so disagree with the ACLU. They can grandstand and make giant claims in their complaint against Myriad Technologies, but the reality is the claims they are challenging are diagnostic methods and altered genes, both of which are clearly patentable subject matter and neither of which are naturally occurring.
-Gene
Ack, but Gene, the patent on a human gene limits its scientific use (in the US, not in Europe where all researchers may replicate a patented object for scientific purposes — a mandatory license). The patents on the raw sequences actually have been used to prohibit researchers from doing their science without paying royalties, since studying a gene requires replicating it using PCR (polymerase chain reaction), which is a reproduction of the patented sequence. Ask the researchers who have ACTUALLY been told to stop their research unless they pay for the right to replicate genes that occur in each of us whether this is a good way to spur innovation or whether it hinders it.
They are worried about practical consequences that actually have already happened. They know it’s hindering research, alas.
The ACLU suit and the arguments presented in this op-ed piece are bald populist fear-mongering. They prey on the visceral reaction of: “What?! An evil corporation owns a piece of me?”
The problem with these arguments and the Big Brother paranoia they incite is that Myriad’s patents deny the average person nothing that they possessed before the patents issued. No one infringes by having a BRCA gene in their body. People infringe by isolating or synthesizing nucleic acids encoding BRCA (such as from a body sample), an act which had never been done before Myriad and which was only enabled by Myriad. Far from grabbing something that belonged to world for eons, Myriad’s patents enrich the world by providing it something it never had before. The world possessed the BRCA genes before Myriad no more than it possessed the telephone before Bell. And the only thing Myriad asked in return for years of toil and a huge capital investment was a few years of exclusivity (another point the Chicken Littles conveniently omit from their discussions).
The truth is that, in their heart of hearts, opponents of these patents are usually opposed to patents (and probably private property) in general. They always give a nominal nod to patents (“I favor innovation, and am interested in ensuring that science and technology work hand in hand to both better our standard of living, and enrich those who create new and useful works”), but I’m pretty sure this only so as to not appear too radical.
David-
I disagree with the premise that patents prohibit research. The trouble is that there is very little research for the sake of research at universities any more. Since Bayh-Dole passed and gave rights to universities to exploit and get licensing revenue in return universities have been in business, not purely researching. That is the problem with this argument. The law clearly allows pure scientific research, but scientific research that is leading to the development of commercial viable innovations that will themselves be patented and licensed can only be done with permission. This is as it should be. Universities cannot claim the benefits of Bayh-Dole and then wrap themselves in scientific research as a means to circumvent paying royalties.
-Gene
I have worked in genetic research in industry and now in academia, and have ongoing financial interests in these matters (disclaimer). That said, my best understanding is that the intent of IP on genes is to protect a discovered relationship between specific genes or gene sequences and biological processes for commercial purposes. If a researcher has identified a cause/effect relationship between a particular gene and say a disease, then protecting that information for the purposes of money-making does not automatically seem so farfetched. In theory anyone can still do research on the patented gene, just not try to make money from that research. The intent is to protect companies that need to invest in long-term development programs, especially for therapeutics that take years to bring to market. One problem is that we in universities are also under a lot of pressure to do translational as well as “basic” research, so the lines between academia and industry are completely blurred. Also, since there are only so many genes and so many commercially important medical conditions, in principle eventually someone or other will hold all possible useful patents, which will paralyze the whole field. I would argue that gene patents themselves should probably be annulled not necessarily on any solid theoretical legal ground, but simply on grounds of practicality. The whole thing just wastes way too much time and resources, better spent on getting to actual products such as diagnostic or therapeutic reagents that are certainly patentable by anyone’s definition. I suspect that a real part of the problem is that many patent filings try to go way beyond this, patenting any use of a gene by anyone and threatening academia to to boot. I myself don’t think one can make any reasonable case for patenting the sequences of naturally occurring genes or genetic variants in general – that was in fact shot down by the US patent office when the NIH tried to patent the sequences of EST clones with no associated biological information.
Joe, I am really intrigued by the outlandish notion that telephones were somehow inherent in nature, or a product of natural evolution, just like genes. It seems an insane notion and I am trying to figure out if this is a metaphor or meant as an amnalogy. It cuts to the heart of the role of human intention and invention. telephones required the admixture of human intention with something in nature. The principles (the natural laws) that make telephones work are part of nature, and thus not patentable, but the telephone is. Genes existed long before human thoughts about genes, and so I argue they are the unpatentable “principles,” whereas a specific use for them in a test is an invention. Like using gravity to make an elevator go is a patentable use for an unpatentable principle.
Mark, thanks for the support, at least on the practical side. Good to see researchers generally agree on this (as I have noted through other scientists’ opinions on the practice of gene patenting.
Gene: don’t get me started on Bayh-Dole!
6istheman posted the following in another thread, and it bears some repeating here, which is a comment on Gottschalk that responds well to Joe’s assertion about telephones and genes being somehow analogous:
“The underlying notion is that a scientific principle, such as that expressed in respondent’s algorithm, reveals a relationship that has always existed.
“An example of such a discovery [of a scientific principle] was Newton’s formulation of the law of universal gravitation, relating the force of attraction between two bodies, F, to their masses, m and m’, and the square of the distance, d, between their centers, according to the equation F=mm’/d^2. But this relationship always existed — even before Newton announced his celebrated law. Such ‘mere’ recognition of a theretofore existing phenomenon or relationship carries with it no rights to exclude others from its enjoyment. . . . Patentable subject matter must be new (novel), not merely heretofore unknown. There is a very compelling reason for this rule. The reason is founded upon the proposition that, in granting patent rights, the public must not be deprived of any rights that it theretofore freely enjoyed.”
P. Rosenberg, Patent Law Fundamentals, § 4, p. 13 (1975).”
And by the way, I strongly favor private property (which is a natural right) even while I am sometimes suspicious of broad IP rights (which Gene rightly describes in another thread as being pragmatic creations of the law, and not natural rights). Don’t tar your opponents with too wide a brush, Joe.
here’s an interesting bit from two starkly different, famous geneticists who agree that gene patents hinder research:
http://www.forbes.com/2002/06/26/0626targets.html
David,
This link, while in opposition, may be of interest, particularly in regards to mere “isolation”:
http://www.patentdocs.org/2009/06/falsehoods-distortions-and-outright-lies-in-the-gene-patenting-debate.html
Thanks, breadcrumbs, I have seen that post and note their arguments. I replied to the isolation bit, as I still think my geography analogy is strong.
best,
David
David-
In part the article says: “Venter and Lander agree, gene patents are essential.” They go on to say that in some situations it harms innovation, in their opinion, but even then would not outlaw gene patents completely.
Also, the tendency in the anti-patent community to rely on scientists to tell you whether patents harm research and innovation is a little like relying on a lifeguard for a weather report. Sure, lifeguards are outside all the time and can read signs of distant but oncoming thunderstorms, but they don’t know what causes a thunderstorm, for example. Scientists always claim that patents harm innovation, and their opinions are completely uninformed. Not because they are ignorant, but because they are not familiar. So many scientists (and computer scientists) tell me that a particular patent is in the way because it describes something in the specification. Of course, the specification plays no realistic role in defining the exclusivity. Exclusivity is all about the claims. It is also impossible to know what exclusivity is provided to the patent owner without doing a thorough and complete analysis of the entire file history. So scientists are just wrong, misinformed or lazy. Disregard for the truth and reality is not a problem with the patent system, it is a problem for those who think they know everything and choose not to educate themselves. These people should see road blocks. It is not at all likely that anyone with such narrow view of the world would ever come up with any kind of noteworthy invention, innovation or discovery.
-Gene
Gene,
Interesting points, but in the case of Myriad, the cease and desist letters from Myriad telling scientists at Yale and at U Penn to stop their research went too far, wouldn’t you say? No wonder Venter and other scientists are jumpy. In Europe, there’s a blanket license for scientific research to proceed without any fear of infringement. That would be a nice step in the right direction for gene patents.
Once again, thanks for the reasoned and civil discussion. It’s a hell of a lot more fruitful than the abuse at patentdocs
best,
david
It is hard to take anything you say about genes seriously when you say the following, ” It merely means marking the beginning and end point of the gene, and perhaps leaving out a few introns (which are meaningless junk that doesn’t do anything to the functioning of the genes, and that remains as a byproduct of evolution.”
Introns are more than meaningless junk, they define the boundaries for splice variants of genes. Splice variants as you may or may not know can have very different functions from one another. Introns also impact how a gene is expressed as a protein. It is an old view that introns are meaningless junk. When you are talking about a particular field it is good to know what you are talking about.
Shhh Dan,
Knowledge is a dangerous thing – especially if it ruins one’s argument.
Thanks, Dan, I appreciate your point, but the idea of making cDNA, which is the stuff over which many patents on genes are filed as “isolated and purified,” is that by using mRNA to copy the functional part and then reproducing the cDNA rather than the “unpurified gene” we intentionally leave out introns because they aren;t coding proteins. Thus, the process of creating the supposedly patentable cDNA treats the poor introns as meaningless junk.
I am aware, actually, that current scientific opinion is that not only are the introns doing important signaling, and that even odd artifacts like copy number variation are storing and utilizing important information. I didn’t go into that detail here. Nonetheless, I go in greater depth into all of these various processes in the book, rest assured.
So pardon the unfair characterization of introns, I didn’t mean to upset anyone. And my argument seems intact, despite the correction, because even if introns are doing important work, leaving them out by creating cDNA isn’t inventive, doesn’t make anything new, and fails to be patentable regardless.
best,
David
Dan, please forgive the hyperbole, introns do important things but we intentionally forget that when creating cDNA which uses mRNA to make genes that leave out the parts that don’t code for proteins. So the process of creating the supposedly patentable cDNA treats the introns as “meaningless junk.” I would be less harsh to the poor things, they are artifacts of billions of years of evolution of life, so we should respect the poor buggers.
The argument stands, however. You haven’t shown why, by your pointing out this bit, cDNA should somehow be patentable, or was it a total non-sequitor intended only to somehow impugn my scientific knowledge?
Rest assured, the science is treated in greater depth, and I acknowledge as part of my argument about the non-patentability of DNA, that there are plenty of ways that DNA stores important information aside from coding for proteins.
best,
David
Dan,
Forgive the hyperbole. I am aware that introns do important things, and they are remnants of billions of years of evolution entitled to our respect. But creating the supposedly patentable cDNA involves a process which treats the introns as “meaningless junk” given that it specifically excludes them by using mRNA to copy only the protein-coding parts of genes.
As for my argument, it remains intact. If you want to disregard it for my lack of depth here on the subject of introns, feel free to read the book in which I provide greater depth, and if unsatisfied, let me know, or let the world know. Please.
best,
David
The problem with the argument is that if companies did not have the incentives who would pay for the trials to determine what genes are correlated with specific diseases. NIH has a limited budget and more recently they approval of grants is very low. Who will do the research and pay for it if they can’t profit. Myriad does not prevent people from studying BRCA they prevented competing diagnostic tests. It is in Myriad’s interest to show a greater link and that only comes from academic research. Much of the research by companies is also likely exempt under 271 (see merck v. Integra). Although that case left a lot to be desired it made clear that the exemption is quite large.
As far as the hyperbole over introns your argument is severely weakend when the facts you present are wrong. As far as easily defining the boundaries you overstate how easy it is. People miss splice variants all the time that turn out to be the key.
Dan,
When Myriad sends cease & desist letters to scientists at university labs (as they did) they are interfering with basic science. This has happened with other scientists doing research on patented monogenic diseases as well.
The fix is exactly what is happening: increased funding to NIH to fund the basic science. There’s plenty of researchers lined up to do these studies if they can get the money, so there is elation over the increase in funding this coming year. That’s a step in the right direction.
As for my argument, people can see that this isn’t a science debate, it’s a policy debate, and my statement about introns isn’t that far off when you consider the process of making cDNA, it was a bit of hyperbole, though. My wife has the PhD in genomics, I’m a lawyer and philosopher, so she corrects me when I go too far astray in the science. Thank you, Dan, for doing her job today.
-David
It again comes to people oversimplifying the patent claim and scope.
NO ONE HAS EVER PATENTED OR RESTRICTED THE PRESENCE OF A GENE IN A HUMAN BODY, EVER!!! You cannot patent a human gene as is, or own the genome, period. That has never been done or claimed.
The debate is not claiming “GOD’S GENE” the debate is whether there has been innovation and development of a patentable invention. When gene patenting began, it was novel to identify the “coding region” as a purified sequence, the purified protein, and antibodies directed to the purified protein. These inventor’s invested a lot of time and money to identify the gene and protein and they overcame many obstacles. Ask someone who did sequencing in the 80’s about the obstacles and uncertainty in sequencing.
Today, a simple coding region is NOT PATENTABLE without a function and method of use. Simply identifying a coding region does not require experimentation because the genome is sequenced and used freely. No one has limited the use of the sequenced genome. Go to http://www.ncbi.nlm.nih.gov/ where the genome is available FREE for your review.
The crux of the issue is what rises to the level of novel and what scope does that garner from the patent office. Matching the appropriate level of innovation to patent scope is addressed DAILY before the BPAI, weekly before the CAFC and approximately once a year by the Supreme Court, give or take a case or two. Some companies have invested a lot of money to identify genes that lead to cancer and develop tests for those genes. To allow someone to simply replace the inside of a pregnancy strip with information they developed to produce a better test would deprive them of the ability to get a return on their investment.
By the way, the title “Who Owns You?” is inflammatory and your position in the above article demonstrates that you did not research or understand gene patenting when you wrote the article. Recent opinions and court cases indicate that your thesis is WRONG!
If you’d like a more detailed analysis I can provide cites and FACT based analysis to the statements provided above.
All the best,
Mike
Dear Mike,
I really should have tried USING CAPITAL LETTERS TO MAKE MY POINT! That’s where I seemed to have gone wrong.
If you see my various comments, my own blog, the book, and elsewhere, you see that my objection centers largely around the lack of novelty. cDNA isn’t really “new” and fails to meet the requirement for patentability.
In the Myriad claims, the sequences are patented, under the guise of a “method,” but the effect is a patent on the BRCA1 and 2 sequences.
BUT I’VE SAID ALL THIS BEFORE (ah, yes, that does feel good).
There’s plenty of cites from reputable scientists, theorists, practitioners, etc., and I’ve spent years reading them and comparing their arguments, thank you. They are many and varied, and come down on both sides of this debate. But if you want to send me your cites, who am I to say no?
best,
David
Please let me rephrase the following for clarity:
“Some companies have invested a lot of money to identify genes that lead to cancer and develop tests for those genes. To allow a competitor to simply replace the inside of a pregnancy strip with information the company developed to produce a better test would deprive the company of the ability to get a return on their investment.”
By the way, look at the number of genes that Myriad has investigated, the number of patents filed and the allowed patents. They do not get every patent allowed, they have a tremendous cash burn rate, and may not have gotten a return on their investment to date (even at $2000.00 a test). The policy decision should not be are gene patents viable, but does a privatized system of medical treatment work OR should medical treatment be managed by the government in it’s entirety (from conception to patient treatment). IF you want a privatized medical system patents are required to fund the type of research and development required to continue the many advances we have seen to date.
There are currently patents to medications (Viagra, levoflaxin, etc.), radiation therapy, 4D-ultrasound, plastic surgery, cancer treatments, AIDS treatments, heart surgery, patient records, sterilization, and on and on. No medical procedure, or other procedure, is free from some new innovation that improves upon the existing technology. Each of which could be distributed faster and cheaper if there were no patents. That would in turn save more lives in the short term. But, without patents and with the ease of copying in biotechnology, would the field advance as rapidly if there were no reward for innovation? Would we continue to develop new antibiotics stronger than MRSA bacteria?
Vaccines are a great example where innovation is limited not by patents, but by a low market cap. People do not get vaccines if they cost over a certain price (+/-$30.00 per vaccine). Insurance companies won’t cover “new” vaccines when old ones exist and parents won’t pay for vaccines that aren’t covered by insurance. Companies have developed inhalable and patch vaccines, yet they falter and do poorly because they are not covered by insurance. Thus the methods of administering vaccines has not changed in years even though some practices may contribute to bad vaccine side effects. Use of thimerisol (mercury) for sterilization was just recently stopped, use of egg whites continues, multiple vaccine administration continues, simply because there is no financial incentive to improve.
I argue that without patents, without financial incentive to improve, innovation would be stifled. Companies are not in business to produce the next great medicine, they’re in the business to provide the next financial opportunity. It only works when the cure and the financial opportunity are tied.
Without corporate support, scientific innovations would likely stagnate in university labs and never make it to treatment. How many university research scientists have handed their great innovations to corporations? How many university research scientists have been able to produce a treatment from a scientific theory in a lab?
I will work on the analysis another day and see where we end up.
Mike
Then your problem is solved.
Please review In re Kubin where the Court has stated, “Kubin and Goodwin’s disclosure represents some minor advance in the art. But “[g]ranting patent protection to advances that would occur in the ordinary course without real innovation retards progress.” KSR, 550 U.S. at 419.”
Please do not attempt to enact hasty legislation where a system that has developed over years seems to have the situation well under control.
Thus, although you’ve said it all before, YOU DID NOT READ RECENT CASE LAW . (Ah yes, that does feel good).
In re Kubin: http://www.cafc.uscourts.gov/opinions/08-1184.pdf
Thus the claims by Myriad are one case. If you feel the claims as written are anticipated or obvious, to use the BRCA 1 & 2 genes to detect cancer, then request re-examination before the patent office providing references that state or make obvious the elements of their claims. The patents will be found invalid.
Simply because someone is helped and can have their life saved by an invention does not mean it should be invalidated. Inversely, there is more of an incentive to invest money and expect a return when the disease is critical. As it stands in the eyes of the patent office, Myriad provided a valuable test for identifying the tendency to develop cancer. They had a very good person draft the claims, and although some of the claims are very broad, they appear to have fall-back positions in the claims that should leave them with allowable claims under most circumstances.
Here are many questions to ask yourself:
Would the BRCA tests have existed without Myriad’s investment?
What is Myriad’s cash burn rate for research?
Have they made their return on the BRCA test?
Have they made their return considering the number of genes that did not make a good cancer test?
Would the government do a better job of financing this research and developing a commercial test?
How many university scientists hand-off their inventions to corporations?
How many university scientists have developed a commercial product from conception to treatment?
Do these university scientists have a patent? (Should they have a patent?)
Mike,
If you follow my arguments and voluminous discussions (or read my book), you’ll see that I disagree with the case law. The point of my book is to see a policy change that would invalidate that case law. I do not argue against patents, I argue that by freeing up the upstream science (as well as investing federal moneys heavily in that science) there will be greater innovation downstream AND MORE PATENTS. I do not argue that Myriad should hold no patents on new, useful, non-obvious elements of their tests.
But anyway, frame it how you’d like, simplify and turn it into black or white. This us v. them stuff is quite tiring by now.
or, here’s an idea, examine closely what I have actually argued for, instead of reframing it into the sort of Manichaen battle that seems so popular now-a-days.
best,
David
My apologies David.
I had typed the first text and it was lost when your response posted.
My second post assumed the first post was lost.
There is some redundancy in the two arguments, although I am glad the vaccine example returned.
Have a great day!
Mike
Your arguments are defeated by the fact that your problem does not exist.
Please explain how In re Kubin does not address all of your arguments.
“Kubin and Goodwin’s disclosure represents some minor advance in the art. But “[g]ranting patent protection to advances that would occur in the ordinary course without real innovation retards progress.” KSR, 550 U.S. at 419.”
Simply put: “No one can patent your genome.”
A mother has never given birth to an isolated gene sequence.
Simple human genome sequences are no longer patentable (in re Kubin).
As innovation evolves, patent scope evolves. As in all technologies, as biotechnology matures patent scope becomes narrower.
There is no reason to place special limits on just biotechnology innovations that will cause undue burdens and unforeseen consequences in the field. Government funding is fickle and fluctuates over time without regard for market, public demand or need. Scientific funding covers everything from oceanography to human metabolism and cannot be mandated from above in any logical way. The market is demand driven and will provide solutions for the greatest number of people where required. Eventually todays innovations will become tomorrows public domain and that is the purpose of patents.
The system is not broken, please don’t try to fix it. Those of us who work in the field will tinker with it to ensure it is on track and claims are appropriate.
Thanks for your time,
Mike
Mike,
If the system weren’t broken, then thousands of researchers would not be trying to fix it. I am not a lone voice in the wilderness.
If you are convinced it works so well and nothing is problematic, then chime in on behalf of Myriad in the lawsuit, I am sure their attorneys will be thrilled to have you as an expert witness, explaining how their patents never interfered with their research, and how Nobel Laureates like John Sulston, or other prominent scientists like Francis Collins and others are just paranoid, delusional, or mistaken when they argue against the current, though diminishing, practice of gene patenting. I’m sure they’ll be relieved to hear nothing’s wrong.
I have to bow out now, I’ve made my points many times over and have plenty to do in my day job. I’ll be back to stir the pot another time.
Best
David
I think they are entitled to patent the isolation process, a process resulting in the gene being extracted or demonstrating it’s function, but you can’t patent the gene itself. That is just knowledge, it’s the discovery.
Putting gene sequences into databases accessible only to researchers through licensing fees shows that there are powerful commercial restraints on researchers. The database proposals introduced by Carlos Moorhead have foundered over a period of more than a decade in the US. There is probably a good reason for this.
I am not calling patent attornies evil….and as for the Diehr ruling ‘anything under the sun being patentable’ my understanding was that the US Supreme Court wanted the Federal Circuit to review the law.
My objection is that it is stifling research and it is depriving patients of life saving medical treatments.
There are a lot of practical problems with genes and evidentiary problems. Even if not legally, at least the practical impact is that it is as if the gene itself has been patented rather than the process of isolation.
Consider the whole Monsanto debacle around gene modification in crops and cross pollination, claims that this was an actionable nuisance with compensation being demanded from neighbouring farmers. I recall reading about a patent granted to make cows grow faster or produce beef more efficiently. Action was brought against cattle owners who owned cattle that they alleged had these genes which were naturally occurring within them.
David,
If your only purpose is to stir the pot,… well then you really aren’t listening to what is being said and no argument will make a difference to you.
This appears to be the case, especially since you take comments directed to your lack of understanding of the legal ramifications of your sloppy logic in the intellectual property world as personal attacks (they are not, nor are they “cheap swipes”). Wearing “thin skin” as a shield to deflect actually answering the points and rebutting arguments may be a clever lawyer’s tactic, but upon review, it only shows that you have not fully answered the questions put to you.
Granted, you are dealing with people who have both technical understanding and very specific legal understanding – having feet in Both worlds is what drew me to this particular profession. The questioning may indeed appear brutal, and this is what I alluded to with the public perception battle, as just as the questions are being put to you, “sound bytes” are also being put ot the audiances at large. If you want to lesson the sting of the soundbytes, focus on the legal logic. But then again, your particular legal logic in this arena is weak.
There is more to this exchange than merely “making your points” and running away. As several have pointed out, your points are found wanting and you have not answered the deficiencies.
To borrow from “breadcrumbs”, you are dancing with clown feet, and the camel is refusing to drink at the oasis.
“My objection is that it is stifling research and it is depriving patients of life saving medical treatments.”
The problem with this state is that it is completely false. This is what is said in media and academic circles, as if it were true, but there is never proof. The truth is that patents do not stifle research. The experimental use exception allows for research. What is stifled is research aimed at commercialization. For better or worse, Universities really don’t do much pure research any more. They research to create commercial opportunities that allows them to license and return money to the University. Why should commercial research be allowed at the expense of the patent owner? When Universities become businesses they need to play by the same rules as everyone else.
-Gene
My intent isn’t only to stir the pot, I am trying to defend and promote science.
as for evidence of chilling on science from over-broad patent extension, there’s an excellent article, with empirical evidence, suggesting that this is exactly what is occurring : http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6V8F-4MV0M6X-9&_user=499885&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000024500&_version=1&_urlVersion=0&_userid=499885&md5=b7f45063211f2da98648f47f29eb3574
best,
David
Again, disclaimer that I have financial interests in biotechnology related to human genetics. On a somewhat technical point, multiple academic research groups were in close competition for identification of the specific genes for the chromosomal loci then called (anonymously) BRCA1 and 2. The partial revision of the european patent, or at least part of the challenge, was based on such competitive activities. No one can know what ‘might have been’, but in my experience no single research group has ever really been irreplaceable for finding a human disease gene of major medical significance. In the case of high penetrance recurrent mutations, families harboring such mutations arise by chance all over the world and are ascertained by clinicial geneticists regularly. Conditions that are super rare and of no obvious commercial interest are often studied by only one group, although most genetic discoveries are quickly replicated by other researchers. In the case of low penetrance Hapmap type association studies, there are indeed large well-funded academic consortia studying many of the same diseases that some companies are exploring, and at least in some cases are seeing similar results (for example TCF7L2 for diabetes). I would say that the argument that commercial genetics research finds things that can’t or won’t be found by academia has little empirical evidence to support it. Putting lots of commercial dollars behind research certainly does allow the research to go faster than academia usually does. In the case of diagnostic tests, the key question is whether companies should be allowed to pre-emptively patent gene/disease assocations, or only their particular ‘kit’ or ‘assay’. In the case of the BRCA genes for example, protein truncation tests are easier and cheaper than whole gene resequencing, but certainly miss more mutations. Exon resequencing can miss heterozygous deletions, etc etc. No one anywhere has a kit that detects all possible mutations, the genome is simply too fluid for that. In the case of patents to protect genes for therapeutic development, the timeline of drug programs is so long that such patents are probably not of very much value in general as they will expire not that long after a drug comes to market. So the patenting company itself gets a few years of protection, enough for a small biotech but probably not for a large pharma company. More than one pharma scientists has suggested to me that they don’t think much of gene patents for therapeutic development as a result. The current debate clearly has more to do with patents for molecular diagnostics, being the most direct to market.
I’m not arguing one way or the other here, whatever my personal opinions, just offering some hopefully useful technical info.
“My objection is that it is stifling research and it is depriving patients of life saving medical treatments.”
“The problem with this state is that it is completely false”".
…….I can tell you it HAPPENED IN AUSTRALIA. They denied tests to women suspected of carrying the gene for breast cancer because it was too expensive to pay for the privilege of being tested. A lot of these databases carrying valuable information such as genetic information, a whole host of information, has been FUNDED BY GOVERNMENT, the public purse, and being locked up it “manacles science”.
I don’t understand how a tangible substance (i.e., an isolated nucleic acid) can be a fundamental principle. Objects and substances, and more often their behavior and properties, can EMBODY fundamental principles. But it seems a substance by its very nature cannot be a principle.