When I teach the patent law material in my Introductory Intellectual Property class, we discuss the (very fundamental) principle that “naturally-occurring” things are not patentable subject matter – that patents only cover creations springing from the human mind. “But wait a second,” someone often asks, “what about all those ‘gene patents’ I read about in the newspaper? How can someone have a patent on a human gene if naturally-occurring things aren’t patentable?”
It’s a very good question. The answer, in a nutshell, is that the PTO, and the courts, have developed a doctrine under which the “purified” and “isolated” form of the gene is deemed to be a patentable composition of matter (because it does not, in fact, occur in nature in that form), as opposed to the gene as it actually sits on your chromosome. This allows all of us, thankfully, to do things like beget children without obtaining the authorization of the patent holder (even though the process of begetting children constitutes a “use” of the gene in question . . .).
I’ve always thought it dubious law and even-more-dubious policy (though I’m no expert in the matter), and a federal judge, for the first time, seems to agree. In a very important decision (though it will undoubtedly be subject to review, and quite possibly may be reversed), Judge Sweet (SD NY) invalidated the patent held by Myriad Genetics, Inc. on a gene thought to be associated with breast and ovarian cancer. [The full text of the opinion is here] The language is strong, and calls into question pretty much all 2000 or so of the patents issued in recent years to parts of the human genome (and the many other animal/plant gene patents as well). Noting that many people regard the notion of patenting the isolated form of the gene (but not the gene itself) as nothing more than a “lawyer’s trick,” the court wrote:
“DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA’s existence in an isolated form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable . . .”
I think the judge got it right. There’s a little bit of an “emperor’s new clothes” feel to the opinion — why has it taken everybody so long to realize the obvious? [Kudos to the ACLU, and the Cardozo law School clinic, which managed the litigation on behalf or the Association of Molecular Pathology, and thanks to Tom Bednar for the pointer]
Phillip J. Fry says:
Michael Crichton would like this development.
March 30, 2010, 10:33 amElliot says:
If the isolated gene does not exist in nature, then how can the isolated gene be treated in nature?
March 30, 2010, 10:36 amHoustonSelgin says:
As the husband of a woman with breast cancer, I was shocked when, in my research, I discovered that Myriad Genetics had patented the gene, thus securing a monopoly on all testing for the BRCA1/BRCA2 genes. According to breastcancer.org:
Many women choose prophylactic mastectomies and oophorectomies when tested positive for this gene abnormality.
Testing for this mutation costs 3000.00 or more, and is rarely covered by insurance. We did NOT get the test done, although we may do so later for my daughter.
Hopefully this will result in other companies being able to develop a test, and bring about a cost decrease through market competition. My thanks to Eugene for bringing this to the Conspiracy’s attention.
March 30, 2010, 10:48 ampete says:
I was hoping someone on this website would post about this decision and my reaction is similar to your students.
March 30, 2010, 10:52 amDjDiverDan says:
The kind of clarity of thought demonstrated by this opinion pretty much disqualifies this particular judge from any higher post – what lawyer wants a judge, especially on the Court of Appeals or the Supreme Court, who is able to declare with clarity and precision why these kinds of “angels on the head of a pin” arguments should be rejected?
March 30, 2010, 11:07 amMartinned says:
I can do you one subtler. There’s a case currently before the European Court of Justice on gene patents (Monsanto v. Cefetra). The prejudicial questions asked are the following:
The link above is to the opinion of the Advocate General, who proposed the following answers:
In normal English: he argued for a functional test, where the presence dormant genes, which no longer carry out the function that was described in the patent, are not protected, meaning that the patent holder cannot interfere with the trade in products containing the genetic material in question.
March 30, 2010, 11:30 amChris Travers says:
This is a great day.
If we want to allow “isolated dna” gene patents I think the legislative branches, not the USPTO and the courts, should properly scope out exactly what the protections are. This has been done in the past with regard to plant patents and the protections granted there are reasonable. For example, if I buy two patented roses and I hybridize them, offspring of those roses are not subject to patent infringement claims of the original plant patent holders, but propagation from cuttings would be. Since the rose bush, properly cared for, will outlive the patent, this is fine.
However, “isolated gene” patents are quite different and pose fundamental questions of scope which the USPTO and the courts should not decide on their own.
Hence these should be invalidated. Then if Congress really thinks this is incorrect, they can re-instate them.
March 30, 2010, 11:45 amChris Travers says:
Would functional genes though be protected? Could Myriad sue breast cancer patients for infringing on their patented genes?
March 30, 2010, 11:48 amMartinned says:
I had to quickly google what you were talking about, but if I understand it correctly that puts us back to the question of what is patentable in the first place, i.e. the distinction between a discovery and an invention. In the ECJ case there’s no question that Monsanto invented a way to improve wheat, and that that invention was patentable since it does not occur in nature, etc. The question was simply whether Monsanto could forbid the defendant from importing the wheat in question from Argentina. GMOs cannot be grown here, but they may be imported from other countries. In this case, the problem was that Monsanto could not get a patent in Argentina, since Argentina does not have patent legislation that allows this. So Monsanto tried to get around their problem by suing in Europe instead, where they did have a patent and where the wheat was going to end up.
March 30, 2010, 11:58 amCWuestefeld says:
I’ve always thought that gene patents were nonsense, but for a slightly different reason.
It seems to me that all such patents are based on the extraction of the gene from an actual, living host. As such, every one of these genes necessarily has prior art: the actual, natural example from which it was copied.
The rationalization of patenting the purified form is nonsense, because the purification is an obvious process that is completely formulaic, obvious, and so does not involving any creative process at all.
March 30, 2010, 12:11 pmAdam J says:
Looking at this pragmatically, are there still plenty of incentives for people to invest in isolating and identifing genes without gaining an ownership interest in the use of the gene? While I generally think its good for the expansive scope of patent law to be questioned, I’m concerned that folks won’t be adequately compensated for the hard work of identifying these genes.
March 30, 2010, 12:24 pmalkali says:
@HoustonSelgin: Testing for this mutation [the BRCA mutation] costs 3000.00 or more, and is rarely covered by insurance.
Without disputing HS’s more general point, my own family’s experience with this was different:
About 5 years ago, we learned that my wife’s cousin had one of the BRCA mutations. On that basis our insurer would have paid for testing for my wife, even though she was not currently being treated for any illness. We chose to pay out of pocket for the testing out of an almost certainly misguided intuition that paying cash would better protect our privacy in the event of an adverse result. The test cost us around $500-$600. (Fortunately the result was favorable.) I suspect insurers would pay a cheaper rate.
March 30, 2010, 12:38 pmCurt F. says:
My understanding of the legal theory on which “gene patents” rest was slightly different. I thought that in many cases, the method by which artisans obtain purified and isolated gene sequences was what was patented. In other words, that most gene patents were really patents on PCR primers. Am I wrong on this?
If I’m right, I would favor the same outcome as the judge but for a different reason. Designing PCR primers for a particular gene is definitely obvious to ones skilled in the arts.
March 30, 2010, 12:38 pmHalftrack says:
Don’t you read your own blog?
I insist that you change your title to “Eugene Patent(s?) Invalidated:”
March 30, 2010, 12:39 pmSigivald says:
Adam J: Given that isolating the genes should help in developing genetic treatments for diseases relating to the genes, I imagine so.
And as alkali points out, if isolating them lets us identify, say, a likelihood of cancer in advance of it developing, there’s a huge incentive for large insurers to pay for research to save themselves money over time.
It’s a lot cheaper for them to pay out for a test and early-stage cancer treatment than it is to pay for late-stage treatment… and part of that price differential becomes incentive to pay for research to make it possible, now that we know such things are likely to work.
March 30, 2010, 12:43 pmrandom commenter says:
Bravo.
Adam J: yes, some people staked business plans on the patentability of genes. They will lose money. On the other hand, it was clear from the start that the theory underlying this form of patent was counterintuitive and would be challenged. As for incentives: this decision potentially lowers the cost of conducting research implicating a patented gene for everyone other than the patent holder.
March 30, 2010, 12:45 pmBrett Bellmore says:
“Everybody”? I thought this was the biggest objection to patenting existing genes from the beginning.
March 30, 2010, 12:59 pmDirk D says:
This is not correct. Though most gene patents are written to cover segments amenable to use as PCR primers, they also cover the entire sequence as well.
March 30, 2010, 1:02 pmDana White says:
Amgen’s erythropoetin is also “naturally occurring”. It’s a billion dollar blockbuster drug. It took them years to develop. Hundreds of millions of dollars were spent on clinical trials. It’s saved the lives of thousands of anemia patients. But I guess Amgen shouldn’t get a patent because it’s naturally occurring. The fact of the matter is that the drug erythropoetin is not naturally occurring. It’s produced in tiny amounts in certain cells in the body.
Judge Sweet is an idiot and the case will be reversed on a number of grounds by the Federal Circuit.
March 30, 2010, 1:03 pmDon Miller says:
If I were able to wave a magic wand and change the law to what made sense to me, it would be something like this:
Naturally occurring genes should not be patentable
Methods for isolating a gene, could be patentable
Specific tests for the presence of a gene could be patentable
Artificial genes could be patentable. For example, if someone invented a gene and a method for combining it with Human DNA to produce people with green skin, that used photosynthesis for part of their energy requirements, I would judge that gene, or genes, to be a patentable product. (props to John Scalzi for the example)
My understanding is that there are already artificial genes being used in plants. Round-up ready seeds come to mind.
March 30, 2010, 1:20 pmChris Travers says:
Except that “Eugene” would be “good genes” right?
Technically the title should be Blasgene patents invalidated….
March 30, 2010, 1:24 pmAdam J says:
Sigivald- I’m certain you are right that the genes can help develop treatments (among a myriad of other possible applications), my concern is that they don’t help gene finder develop treatments, because the gene becomes public information which free riders can then use to develop treatments more cheaply. And if the genefinder doesn’t have an upside, why find the gene at all? Also I don’t think insurers invest in researching genes & whatnot, it’s not exactly their line of business.
random commenter – I don’t know what you mean by “staked business plans on the patentability of genes”. If you mean they invested huge sums of money in identifying a gene with the hopes of getting a favorable return on their investment, then sure. I don’t know what their business plan is, but we all better hope that there is a profitable business plan for identifying genes after this decision.
My concern is that identification of genes stagnates because now investors won’t be compensated. If the identification of the gene enters the public domain, then free riders will be able to develop uses for this knowledge at lesser costs then the developer. If this happens, it’s quite possible the genes would never be identified because of insufficient incentives.
March 30, 2010, 1:38 pmrandom commenter says:
“I don’t know what their business plan is, but we all better hope that there is a profitable business plan for identifying genes after this decision.”
Well, I think there is: it’s developing treatments for disease. Identifying genes was never an end in itself.
March 30, 2010, 1:50 pmZathras says:
Because the Federal Circuit is a prime example of agency capture–in this case, by the companies and patent lawyers that make money by patenting everything under the sun.
March 30, 2010, 2:04 pmHoustonSelgin says:
Actually, I believe our insurer would have done the same, but someone has to have already tested positive, or a close family tie already diagnosed w/ breast cancer (mother, sister, etc).
March 30, 2010, 2:07 pmAdam J says:
random commenter- “Well, I think there is: it’s developing treatments for disease. Identifying genes was never an end in itself.” But that’s not a profitable business plan if others can develop the treatments for less money by freeriding on your hard work.
March 30, 2010, 2:11 pmChris Travers says:
So? Have the legislative branch determine exactly what the scope of protections should be.
Also I don’t mind patenting under current law a method for isolating a gene. However, patenting the gene itself raises scope-of-patent issues that the courts shouldn’t delve into without the legislative branches FIRST providing appropriate scope, like they did with plant patents.
These patents should not be valid under current patent law. I am happy to discuss options for hypothetical patent laws that would cover them, but “they should be compensated” is a policy issue which belongs in the hands of Congress, not the courts.
March 30, 2010, 2:13 pmCWuestefeld says:
It was, for the Humane Genome project, and for J. Craig Venter. The former, of course, doesn’t have any business plan at all. And if I recall correctly, Venter’s plan was to profit from access to the gene database.
March 30, 2010, 2:15 pmDeanS says:
To address Dana White’s comments
I have a cousin for which this drug was a literal lifesaver. However, IIRC, the method for synthesizing Erythropoetin was what was patented. There was also a big controversy around the fact that most of the research was done with public funds through the NIH, yet Amgen reaped the majority of the profit.
Dean
March 30, 2010, 2:19 pmPand Raul says:
I haven’t looked at the patent or the opinion, but 101 should not be the standard for invalidating a patent claim on the grounds that it occurs in nature. If it acually does occur in nature, the claim is invalid under 102. If it was obvious to isolate the gene, then the patent claim would be invalid under 103. If it was not obvious to isolate the gene, then the patent owner discovered something that actually helps people. The patent owner was likely motivated to do the research by the patent system, at least in part. If you do not reward that type of discovery with a patent, then people will not have the same amount of incentive to make those types of discoveries. We can debate whether the cost of the patent system is worth the additional discoveries, but don’t bitch about a company charging a high price for its test that can be used to save lives. Without the reward of those high prices, companies will not invest the same amount of money in R&D and that test might not have ever been developed.
Bottom line, Free riders should STFU.
March 30, 2010, 2:21 pmsubpatre says:
Streptomycins, penicillins, and aureomycins are all ‘naturally occurring”, are billion dollar (one would hope ‘billion dollar’ is not the criteria) blockbuster drugs; took years to develop, long trials, saved billions of lives, etcetera ad nauseum. More importantly to this case, all were made by specific gene actions. The same is true of most vaccines.
Yet all of those were protected without resorting to claims on genetic materials. Our patent system —flawed though it may be— is more than robust enough to protect drugs without patenting the genetic source.
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
March 30, 2010, 2:22 pmNothing like a disgruntled investor to call a Judge ‘stupid’ when the facts are against them. There weren’t ‘hundreds of millions’ spent on trials. The only ‘billion dollar’ amount is in athletic performance doping, or to be more precise, doped-athlete performances. And there are currently four other methods of producing the hormone.
Pand Raul says:
DeanS — that is why we should not support NIH. Their involvement amounts to corporate welfare. Regardless, it is irrelevant to the instant case.
March 30, 2010, 2:25 pmChris Travers says:
That’s a concern to take up with your congressmen, not the courts.
March 30, 2010, 2:26 pmTweets that mention The Volokh Conspiracy » Blog Archive » Gene Patent(s?) Invalidated: -- Topsy.com says:
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March 30, 2010, 2:33 pmBioLaw says:
Of course the legislative branch wrote the law which (see 35 U.S.C. 101) allows for the patenting of compositions of matter (which isolated gene sequences are)so I am not sure what your complaint is. If you want to make a special case that this particular composition of matter should not be patentable, then go to the legislature and make it so. As it is, there is no sound legal argument, in my opinion, that genes, in an isolated form, do not satisfy the limitations of 35 U.S.C. 101 regardless of what Judge Sweet ruled (which will be overturned by the CAFC in my opinion).
March 30, 2010, 2:33 pmWhat is interesting as a result of this decision is the sphere of the law of unintended consequences which I would like Professor Post to respond to. Does Professor Post believe that drugs such as Taxol are not patentable? Are metal alloys such as tungsten alloys not patentable? A conservative reading of this case would suggest that all of the aforementioned would be impermissible under Judge Sweet’s analysis.
Dirk D says:
Congress already gave us the broad language of section 101. The limits on patentable subject matter concerning natural products et. al are judge made.
March 30, 2010, 2:40 pmTactful says:
I’m in Adam J’s camp on this for a variety of reasons:
1. The opinion is squarely contrary to 30 years of established case law. Judge Sweet needed a huge recitation of the (rather atypical and unfortunate) facts to create a defensible logic. As the old saying goes, “bad facts make for bad law.”
2. Sigvald, et al — the courts aren’t the ones issuing these patents. The USPTO is, and that’s an entity beholden to the executive branch and at all times responsive to the legislative. In 30 years, neither conservative nor liberal administrations have gone after these patents, and with good reason. You can wheel out the ghost of “agency capture” to explain the PTO’s behavior, but not the Congress’…at least any more than usual.
3. Remember that one goal of the Constitutional patent clause is to move technological secrets out of the private and into the public. One option for hese gene research companies is to develop a proprietary test that tells you whether you are likely to get breast cancer and NOT tell anyone else about the specifics. Even during the “monopoly” years of patent protection, the information is out in the public to be used and built upon, just like in research journals for academics. We have a societal interest in speedy dissemination of research findings, and gene research is cutting edge stuff where we want to keep up. A policy that encourages companies to keep their secrets internally — e.g. from gene discovery through test creation through therapy — slows down the entire process.
4. At a more abstract level — what’s the difference between gene patents and mineral rights? In order to get a gene patent, one has to identify the property, prepare it, and define its boundaries. Ah, but it’s a found object so we can’t patent the thing, right? To get mineral rights, I have to identify the vein, do the preparation work, and define its extent. The ore is absolutely a common good, which we protect for the prospector via real estate rights in the form of a “claim.” (just ask any Oklahoman about their state history with homesteading). Why not permit gene companies to “mine” a totally different type of material? The only real difference is that the patent applies to one type of thing, wherever it may be refined; whereas the ore rights are for everything in a specific parcel.
March 30, 2010, 2:54 pmAdam J says:
Chris Travers- “That’s a concern to take up with your congressmen, not the courts.” I’m a bit confused, what would you suggest that the congressmen do if the Courts decide that no patent can be granted? My problem with congressmen run in the other direction, that they have created & perpetuated a patent system that overcompensates most patent holders & keeps inventions out of the public domain for far to long.
March 30, 2010, 3:01 pmDon Miller says:
Genes should be like elements.
They rarely exist in nature in their pure form. We allow patents on how to extract them, but we don’t allow patents on the elements themselves.
March 30, 2010, 3:13 pmKenneth M. Alfano says:
If a shameless plug isn’t too inappropriate, in this brief recent article I’ve argued that a combination of non-obviousness (in light of various observable phenomena) plus the product-of-nature doctrine (which may admittedly need some revision from its precedent) should invalidate any patents on naturally-occurring genes (unlike tools or methods for isolating or using them, or modified forms of them, which are indeed fine to patent):
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1537690
I should be fair to note, however, that the precedent of allowing “isolated and purified” versions of otherwise-natural substances has a long history (e.g. adrenaline, vitamin B12) which I’m forced to acknowledge and confront head-on. NOTE: It’s NOT just processes/methods involving these things that have been deemed patentable for ~100 years now (since Learned Hand, actually), but the natural substances themselves! That said, I’m all for correcting this now, as I regard it to be unwarranted on multiple levels.
March 30, 2010, 3:18 pmmikeyes says:
Tactful: At a more abstract level — what’s the difference between gene patents and mineral rights? In order to get a gene patent, one has to identify the property, prepare it, and define its boundaries. Ah, but it’s a found object so we can’t patent the thing, right? To get mineral rights, I have to identify the vein, do the preparation work, and define its extent. The ore is absolutely a common good, which we protect for the prospector via real estate rights in the form of a “claim.” (just ask any Oklahoman about their state history with homesteading). Why not permit gene companies to “mine” a totally different type of material? The only real difference is that the patent applies to one type of thing, wherever it may be refined; whereas the ore rights are for everything in a specific parcel.
I suspect that most of us don’t want some biotech company mining our genes because they have laid claim to them without our knowledge. Mineral rights are often separate from real estate ownership and the mineral rights owners can literally knock down your your house in order to get to the minerals if they want. Would this mean that your parents could sell your gene rights even before you are born? Sounds like a good SF novel.
Besides, it would hurt.
March 30, 2010, 3:43 pmKenneth M. Alfano says:
[To clarify my last post, I meant to say that the respective doctrines of nonobviousness (which existed even before it was codified, BTW...) and product-of-nature could both apply to invalidate gene patents simultaneously, but also, that either could potentially stand alone apart from the other as well (especially the former), IMO.]
March 30, 2010, 3:48 pmDan Weber says:
Tactful raises another question: barring the expectation of patent protection, would this company have published what gene they found? Would it have been technically possible for them to keep it a secret? These are honest questions because I don’t know the details.
March 30, 2010, 5:10 pmTactful says:
Mikeyes — I should clarify. I’m not talking about biotech companies getting physical property rights over your (and my) genes that are objects in your (and my) body. I’m just trying to draw an analogy to test the assumption that a so-called “naturally occurring” good can be patented. A patent is a form of temporary property right, hence the term “intellectual property.” The property rights are bundled in a different way from those for real property, sure. But why are we hung up on the idea that a patent (property right) only applies to an idea or non-natural thing?
To make a gene useful — whether originally occurring in nature or only occurring artificially — one must do fairly complicated chemistry and other research. To purify a homogenous quantity of that gene, one must do non-trivial work. I think most everyone on this blog would agree that there’s nothing unfair about giving exclusive control over a parcel’s oil (or surface) to a person. What is the objection to giving ownership over a similarly natrually occurring substance (the gene) that is discovered and developed by a person? It’s not control of *your* genes in *your* body…just of the chemical formula that was found and reproduced.
After all, nobody worries that ingestion of a patented drug somehow gives Pfizer a property interest in components of your body — or even of the chemical molecules itself — after you have eaten the pill and before it’s metaboloized.
March 30, 2010, 5:20 pmjcm says:
Judge Sweet is an idiot and the case will be reversed on a number of grounds by the Federal Circuit ”
March 30, 2010, 6:58 pmdo you work for Am… Name calling is not an argument
And he was right
skyywise says:
I can’t imagine that J. Sweet won’t be overturned on appeal at the Fed. Cir. “Everything under the sun made by man” is pretty broad, and gene patents, including claims directed towards the method of isolation/purification or the method of using the genes in a test do seem to fall under that scope. And I’m honestly too jaded to think that business interests won’t guide the decision.
Substantively, I have my doubts as to whether tests based on genetic markers are non-obvious. The method of developing such a testing is pretty well known. The effort in figuring out which gene to test for might be relatively hard, but the recent Fed. Cir. Ariad decision expressly states that patents are not granted for basic research breakthroughs, no matter how important or necessary they are to later patents. Patents are to be granted for inventing a solved problem / completed product. In my mind, patents on genes seem to be “basic research” subject matter, while the method of purification/isolation is more of an application that is patent-eligible. I think a test based on genetic code could be patent-eligible too, but that obviousness ought to defeat such patent applications.
For those with more interest, I would recommend reading the Ariad decision itself (skip over the debate about commas to get to the policy arguments):
http://www.cafc.uscourts.gov/opinions/08-1248.pdf
as well as these two Patently-O posts on the case:
http://www.patentlyo.com/patent/2010/03/federal-circuit-confirms-that-patents-must-meet-both-the-written-description-and-enablement-requirements-of-section-112.html
http://www.patentlyo.com/patent/2010/03/guest-post-ariad-v-lily-choosing-to-not-disrupt-the-settled-expectations-of-the-patent-community.html
March 30, 2010, 6:59 pmskyywise says:
EPO is a wonderful example of a purification method worthy of a patent. The scientists involved spent years collecting urine and searching for the protein, because they knew it should be there in minuscule amounts. They succeeded, and they got their patents on the method of isolating, purifying, manufacturing for drug scale-up, and producing EPO as a drug; all that good stuff. (I’m writing flippantly, I don’t know Amgen’s patent portfolio details, but the point should remain accurate.)
This does not mean that the protein EPO itself is patent-eligible subject matter. Nor should it be, it is naturally occurring, and everyone pretty much agrees on that.
The genetic marker testing in Myriad is different than the drug form of EPO. Isolating and amplifying an individual’s genetic sequence isn’t novel. Running a gel to determine an individual’s genetic sequence isn’t novel. Getting the reference sequence doesn’t require that each time one apply a method of purification/isolation. Similarly to EPO, once they found the sequence, they had it; done. Comparing an individual’s sequence to a reference sequence is pretty obvious. I don’t see what is left in the invention to claim as new & non-obvious.
(I have to apologize for the gross simplification of the actual science above, but in broad strokes, this is what is going on. The details of the test and methods may indeed be worthy of patent protection, but on first blush they do not seem so to me. They certainly did not seem to be worthy to J. Sweet.)
Also, calling J. Sweet an idiot just because you don’t like the policy being supported is an immature and weak argument.
March 30, 2010, 7:18 pmskyywise says:
Last post on this, promise. And again I have to apologize for running off of memory and not sourcing my assertions.
I believe in Myriad (or a very similar case) the individuals from whom Myriad acquired the genetic code wanted their genetic information to be in the public domain. So it was their genes from their body that Myriad leveraged ownership over. It’s more debatable, but there is an argument that if they people who are the source of the information expressly want their genetic information to be free, then the company should respect their property interests. (Let the debate about the tort of conversion and Helen Lachs begin.)
On the second point, try convincing Monsanto that when their GM crops naturally fertilize the farm next to theirs that the neighboring farmer isn’t infringing on their patents. Given their litigation trend, I would worry that natural processes applied to patented products might eventually lead to individual liability based on metabolism.
March 30, 2010, 7:34 pmDirk D says:
Let’s not divorce that dicta from the context of the WD requirement. Ariad is not even remotely on point here.
This isn’t the full story. A naturally occurring protein in its natural state (i.e. in a cell, blood, or urine etc) is not patent eligible. However, a purified version of the same protein is, under current law, patent-eligible. Note that this allows patenting of the product itself and not just the method of isolation/purification. By the same token a recombinant version of the same protein is also currently patent eligible.
March 30, 2010, 8:07 pmskyywise says:
Respectfully, I completely disagree and think that the policy underlying Ariad is completely on point here.
I agree with the isolation/purification clarification; I was trying to draw the distinction by writing about the drug form of EPO.
March 30, 2010, 8:25 pmChris Travers says:
Probably the same thing they did in 1930 when Congress passed the Plant Patent Act. They can draft a law providing certain exclusive rights, spelled out in statute, to those who discover certain functions associated with certain genes.
Note that the Plant Patent act provides a fairly limited set of exclusive rights concerning specific discovered or bred plants compared to other patents. For example “use” of the patented plant to breed other plants is not restricted by statute. Gene patents are more like plant patents than like industrial process patents. Exactly what is restricted should be a legislative, and not a court, matter.
March 31, 2010, 12:17 amDavid Schwartz says:
If you do something nobody has done before, why should you not be entitled to what is newly made possible by doing that? Yes, the gene previously existed and everything that you could previously do, you can still do. But if you isolate a gene, and this isolated gene has new applications that the non-isolated gene does not, why shouldn’t you be entitled to protect the isolated gene and its new applications?
To give an analogy in a non-gene context, suppose people had discovered that moldy bread fought infection and had been giving people moldy bread for years. If you figured out that penicillin was the active ingredient in the moldy bread and worked out ways to purify and isolate it, why should you not be entitled to patent protection on the isolated penicillin and its new applications? People can, of course, continue to use moldy bread as they did in the past.
Otherwise, what incentive is there to isolate penicillin from moldy bread? And what is the harm if all previous applications of moldy bread are still permissible?
March 31, 2010, 12:26 amBruce Hayden says:
Here is a list of the patents and claims at issue:
March 31, 2010, 12:30 am5,747,282: Claims 1, 2, 5, 6, 7, 20
5,837,492: Claims 1, 6, 7
5,693,473: Claim 1
5,709,999: Claim 1
5,710,001: Claim 1
5,753,441: Claim 1
6,033,857: Claims 1, 2
Mark E. Horning says:
To answer the question posed by David Schwartz,
The incentive to isolate penicillin from moldy bread is that one may patent the method. Note: the method, not the chemical itself. You build your business case on the prospect that you know how to isolate it, and have the patent on HOW.
Besides first mover advantage, the patent on the process protects you from someone else isolating it the same way. If someone finds a better method, that’s what competition is supposed to be about.
You can’t patent “gold”. You can patent a “novel method of separating gold from gold bearing ore”.
March 31, 2010, 1:33 amDavid Schwartz says:
Mark E. Horning: True, you can’t patent gold itself. But if you’re the very first person to find *any* way of separating gold from gold-bearing ore, why shouldn’t you be permitted to protect separating gold from gold-bearing ore?
The will make patent protection effectively worthless for something that can be done a very large number of ways where the trick is figuring out that it’s something worth doing.
Penicillin is a good example — suppose that once you figure out what substance needs isolating, finding many different ways to isolate it is trivial. The only patent protection worth having is on the isolation itself. And failing any patent protection for that, there’s no reason to go to the trouble of figuring out what substance needs isolation.
But fundamentally, this is what patents are supposed to do. The person who first figures out how to do something owns that thing, for a limited time. Otherwise, there is no incentive to figure out useful things to do.
If you are the first person to find a way to travel backwards in time, you can patent a delivery company that uses a time machine. That would cover even people who use completely different mechanisms to travel back in time — as well it should.
March 31, 2010, 3:29 amJustin Levine says:
David Schwartz: But fundamentally, this is what patents are supposed to do. The person who first figures out how to do something owns that thing, for a limited time. Otherwise, there is no incentive to figure out useful things to do.
If you are the first person to find a way to travel backwards in time, you can patent a delivery company that uses a time machine. That would cover even people who use completely different mechanisms to travel back in time — as well it should.
Sorry David, but you are wrong. At least, you should be wrong, though I admit there are many judges who seem to adopt your views and prove themselves to be equally wrong.
You are confusing the concept of INVENTION with that of DISCOVERY. Patents should only cover the former. If you INVENT a process for traveling through time, your patent should cover the process only. If you are merely the first to DISCOVER the general fact that you can travel through time through your process, you should not be allowed a monopoly on that vast field of science if others are able to come up with different processes which achieve the same result.
If I invent a new laser with the intention of using it to cut bagels in half without fear of harming you fingers, would you really think I deserved a monopoly over ALL other methods for hands-free bagel cutting?
When you state: “The person who first figures out how to do something owns that thing, for a limited time.” That statement makes no sense. Figuring out how to do something is not a “thing”. Just as “time travel” is not a “thing”. It is a RESULT. The specific machine you invent in order to travel back in time is a “thing”. That is what you patent. That is only “thing” that patent law should cover. People should then be free to invent different (and perhaps more efficient) “things” in order to achieve the same RESULT of time travel.
(Of course, with today’s completely dysfunctional patent system, you would be sued by a dozen different entities, all claiming that your time machine incorporated several technological components which had separate patents attached to them. Thus you would be hit with restraining orders right away. But I digress.)
How you broadly or narrowly you define the invention is crucial here. Your hypo about time travel seems completely off the mark and is breathtaking in how broadly you would construe patents in order to enrich a select elite few at the expense of science and human progress.
Hopefully the Supreme Court will finally get us started back on the right track by tossing out business method patents (which I presume you are in favor of?) in the Bilksi case.
March 31, 2010, 6:15 amJustin Levine says:
David Schwartz:
Let me offer another hypothetical to illustrate why I feel your views on patents are untenable.
Let’s say we lived in a parallel universe where methods of flight haven’t been discovered yet.
Mr. A invents a hot-air balloon system which allows you travel the skies from point 1 to point 2. He then patents his balloon invention.
The following week, Mr. B invents a Wright Brothers-style single propeller airplane which allows even faster flight. Should Mr. A be able to prevent Mr. B from using his invention since he (A) was the first to invent a “flying machine”? Sure, they are completely different methods to achieve flight. But by your argument as indicated in your “time travel” example, Mr. A should have a monopoly over all forms of flying machines, not just his specific hot-air balloon method.
What if Mr. C then invents the jet engine airplane after B’s invention? Should either Mr. A or B be able to stop him from utilizing it?
What if Mr. D, then invents the helicopter?
I hope my point has come across.
March 31, 2010, 6:30 amDavid Schwartz says:
Justin Levine: My answer to all your questions is “yes”.
Morally and practically: All of these breakthroughs are likely due to A proving the possibility of flight (and then others seeing the value of improving it). If they’re not, B and C can wait a few years, no big loss. It’s obviously super-important to incentivize such “dam breaking” discoveries that lead to huge, rapid progress.
Legally: A’s invention is a system that includes flight. Provided he describes the system properly such that it includes nothing done before him and B’s and C’s developments, then yes — they’re simply repeating his invention with a different middle step but one that provides the same operation.
A could patent, say boarding passengers or loading freight, traveling through the air to a desired destination, then deboarding the passengers or removing the freight — *that* is his invention. If he made it possible, he is entitled to own it.
Of course, B and C could still patent their middle steps, and A could not use them. Or they could use their middle steps to achieve different objects. Or they could license them to A. But they can’t just replace one small piece of A’s invention with a better piece and get around A’s patent. A did the flight transport system first, and he owns it.
March 31, 2010, 7:00 amKen Arromdee says:
Because when the application is “detect the presence of this particular gene”, your application isn’t “new” in any meaningful sense. It’s exactly the same application as you or someone else did last year; all that’s different is what you’re using the application on.
March 31, 2010, 12:01 pmJustin says:
Of course the elephant in the room is this decision will likely be affected by the Bilski decision about to come down from the Supreme Court in the next few weeks, in addition to the 10 other Section 101 cases in all areas (Biotech, Software, Business Methods, etc.) pending before the Supreme Court and Federal Circuit to handle post-Bilski.
It’s an interesting decision, but I’m looking to the upcoming cases to be the ones that really decide what is patentable. The entire patentability question is likely going to be turned on its head in the next year, but I don’t think this particular case will matter.
March 31, 2010, 2:14 pmDavid Schwartz says:
Fine, so everyone else can just continue to do the exact same things they were doing last year and leave this one small area to you. If it’s “one tiny drop in an ocean”, then let the patent holder have his drop. If that prevents other people from doing valuable and important things, it would only be because of the tremendous value of the patent holder’s breakthrough in figuring out *which* drop in the ocean was the valuable one.
March 31, 2010, 2:50 pmKen Arromdee says:
There’s nothing to prevent the patent holder from taking a million drops and leaving everyone dry. He need not figure out which drop is important to do this; he just needs to patent doing it to drop 1, then patent exactly the same thing for drop 2, then exactly the same thing for drop 3, and so on, then when it turns out a drop is useful he looks through his filees and says “Oh, that’s drop 667341. Now pay up.”
March 31, 2010, 3:39 pmDavid Schwartz says:
Ken Arromdee: A patent that doesn’t explain how to do something useful better than it could have been done before — something that would not be obvious given all knowledge prior to the patent — is invalid.
If he patented 667,341 “drops”, it could only be because he found 667,341 distinct useful things to do with each drop. A person cannot synthesize or isolate random compounds or gene sequences and patent them all, even if they had unlimited funds, as they would not be “inventions” since they don’t explain how to do something useful and non-obvious.
The patent wouldn’t teach how to make the invention, since we’re assuming the process used is already known. The patent wouldn’t teach how to use the invention, since we’re assuming no application is known for these compounds when the invention is filed.
To cover a gene, you have to teach how to use it for some new purpose. Essentially, the first person to find a use for a gene owns that gene for a limited time. This creates a valuable incentive to find uses for genes. Obvious, valuable genes will quickly be found, patented, and expire into the public domain. If valuable genes remain patented for long periods of time, it could only be because an extended and valuable process of finding valuable genes is needed — which this patentability encourages.
March 31, 2010, 3:48 pmAdam J says:
Chris, your comparison to the PPA is certainly generally useful as it basically was the first statute involves gene patents, however its not entirely relevant here as patents covered plants that didn’t occur in nature. The legislature can’t do anything once the Courts determine that a gene is naturally occurring. “Naturally occurring” is not a statutory limitation on the patent, but rather a Constitutional limitation of the Article 8 grant of power to Congress.
March 31, 2010, 4:59 pmDavid Schwartz says:
Adam J: The text reads: “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries[.]” It seems that “discoveries” should include the discovery of something naturally-occurring. If the word “invention” was used, one could make an argument that something naturally-occurring, even if one discovers a new use for it, is not an invention.
I haven’t read the actual cases fleshing out what a “discovery” is for purposes of Article 8, but the summaries I’ve read suggest that all that is required is that it be new (not previously done) and useful (does something better than it could be previously done).
In any event, I don’t see any reason Congress couldn’t accomplish the same thing under the Commerce Clause, as I believe it does for Trademarks.
March 31, 2010, 6:07 pmKen Arromdee says:
Um, if they’re gene sequences, of course they can. They just use the dodge “This is an invention which lets you detect gene 1″. “This is an invention which lets you detect gene 2″, etc. The fact that you are basically doing the same thing to detect gene 1, gene 2, and gene 40000 doesn’t make the later ones obvious, in a legal sense.
April 1, 2010, 1:01 amDavid Schwartz says:
Ken Arromdee: Such detection wouldn’t be useful. You’d have to assume some generic use for detecting arbitrary genes such that it’s not obvious to use it to detect any particular gene. I think that’s a direct contradiction in terms and could never happen. (If it works the same for every gene and is only claimed to provide a predictable benefit, then it is obvious to use it against any particular gene to get that predictable benefit. Hence there would be no invention)
But even assuming it did somehow, it wouldn’t matter. Your hypothetical person could only do this once, it would cost him a fortune, and in two decades the problem would solve itself. (And, in fact, nobody is doing this for just the practical reasons mentioned.)
April 1, 2010, 1:37 amAdam J says:
David- I’m not sure if the commerce clause can be used to grant a company a monopoly… that’s a scary thought.
April 1, 2010, 9:05 amSlow says:
I would think only the process for creating the artificial gene should be patentable, no?
What if someone is able to create the same artificial gene but in a different and more efficient way, why shouldn’t he be able to.
April 1, 2010, 10:36 amDavid Schwartz says:
Slow: Because you can’t optimize someone else’s invention and then use it without paying them during the term of the patent. Otherwise, the second someone found the slightest improvement on an invention, the original patent would become almost worthless. Sometimes the invention is figuring out what to do to get the benefit. That is just as much a legitimate invention as figuring out a way to do it. (Though, of course, you must do both to have an invention at all.)
April 1, 2010, 4:45 pmDavid Koepsell says:
Glad to see a concurring opinion. I’m having an Alice in Wonderland debate with the folks at IPWatchdog regarding the issue, with some interesting give and take. I think they’ve backed themselves into an indefensible corner, where if they wish to maintain their position, they must say that Priestley could have patented O2, and if they don’t defend this, then genes are not patent-eligible. In answer to the question above, in which “isolated” genes are allegedly somehow different from genes in “their natural state,” I will simply recount the court’s reasoning, and my own in my book “Who Owns You” and on my blog: the promoter and stop codons isolate the gene from the rest of the genome, telling RNA when to begin and end proteins synthesis, and omitting the introns in the process.
Keep up the good work.
April 3, 2010, 4:24 amDK
Justin Levine says:
David Schwartz:
Re – your reply from March 31st, 2010 at 7AM,
I appreciate your honest and straightforward answer. Though I admit that I remained stunned at the breadth of IP monopolies that you are willing to grant – monopolies that would certainly hinder technological progress far more than it would help it.
I only pray that the courts will follow a different path.
April 3, 2010, 8:17 am