Court Rejects Gene Patent

| 28 Comments

You may not patent a “product of nature.” You may not, for example, search high and low in the rainforest, find a valuable plant, and patent it. Why then may you patent a gene?

The answer could turn out to be that you may not. Last week, according to a report in The New York Times, a Federal district judge invalidated patents on human genes BRCA1 and BRCA2, on the grounds that they are products of nature. Both genes are related to breast cancer and are often used to decide who may be at risk for breast cancer. The judge, Robert W. Sweet, ruled that merely isolating a gene does not make it patentable and indeed called arguments to the contrary “a cheap lawyer’s trick.”

Supporters of the patent note that thousands of genes have been patented and fear that private funding for the development of new medical techniques may be at risk if the decision is upheld. On the other hand, according to an earlier article in Science, the patent owner, Myriad Genetics, has been accused of interfering with other people’s research into breast cancer and the BRCA genes. Indeed, according to Science, Myriad Genetics has been charged with using “its monopoly to impede rival research, restrict clinical practice, and deny people access to medical information.” I have not read the judge’s (lengthy) decision and do not know how he ruled on this accusation.

From my point of view, the decision is at least consistent: if you may not patent a product of nature, then you may not patent a product of nature. I have never understood why the Patent Office permitted genes to be patented in the first place. Neither, evidently, did Judge Sweet.

28 Comments

Good for the judge. My genes are mine even more than my jeans are.

its good to know that at least our judicial system works properly

misha said:

its good to know that at least our judicial system works properly

Sometimes.

Not to sound too naive but, what does this do for recombinant DNA? If both genes are products of nature but their combination is not … ?

IANAL, but my understanding of the overall justification was that you can’t patent a gene, since it’s a product of nature, but you can patent an isolated DNA or RNA copy of the gene, which is a product of human manufacture. Even that is a highly debatable position, but Myriad’s position went much farther. Some of their patents essentially claimed the process of looking at the sequence of BRCA to see if it contained a mutation. Here is the first claim from US #6,033,857:

A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

Pretty ridiculous, IMO - on par with Ariad’s attempt to patent anything that had an effect on NFkB.

For certain kinds of nerd – like me – this decision present both a conundrum and a “well, duuuuuuh.”

The conundrum is that, whenever Bilski comes down from the Supreme Court (99% by the end of June), the briefing on the inevitable appeal will spend half of its time and effort on applying Bilski, and only then worry about the substance. Then, once that is done, the Federal Circuit will probably reverse, and it’ll end up at the Supreme Court.

The “well, duuuuh,” comes from a copyright decision… because that copyright decision (Feist, 1991) interpreted the enabling constitutional clause in a way that essentially requires the result the District Court reached in this matter. In Feist, the Supreme Court held that “originality” is a constitutional component of copyright… and since the constitutional authority for the Patent Act comes from the same clause in the Constitution, the reasoning in Feist will also control then. Feist rejected the older “sweat of the brow” theory of copyright law… which is exactly the economic theory that supposedly justifies the kind of patent rejected in Myriad.

And the nerd in me hopes that maybe between Bilski and Myriad we can get the idiot language in the State Street Bank cases rolled back.

“Supporters of the patent note that thousands of genes have been patented and fear that private funding for the development of new medical techniques may be at risk if the decision is upheld. “

See, this is exactly what the judge was talking about as a “cheap lawyer’s trick”. If you’ve got a new medical technique you want to protect, patent the technique, not the gene.

It is common practice to patent a plant variety, such as a new peach. All the patent holder has to do is make a cross and pick out the best segregant and propagate it asexually and they can patent. They could do this long before a mouse was ever patented.

Good call! In any case US patent protection in the life sciences may mean nothing in a few years’ time. The likes of Brazil, India, and China are not willing to let companies like Myriad build rent generating machines. Brazilian and Indian courts give the short shrift to tendentious arguments, and China gives two hoots. I am fed up with all this attention and money being poured into creating patentable new molecules/markers etc. This does v.little to advance or fund basic science suffering from long years of neglect. Iy also sucks venture money out of applied physical sciences and engineering - green chem, energy, devices and systems etc., Good riddance. Although I must say it came as quite a surprise that the world’s most corporate friendly court system made this decision. But don’t count on this decision surviving an appeal, before the Scotus Fab Four

qetzal said:

IANAL, but my understanding of the overall justification was that you can’t patent a gene, since it’s a product of nature, but you can patent an isolated DNA or RNA copy of the gene, which is a product of human manufacture.

IANAL either, but this argument would also seem to me to be a legal dead end. Myriad isolated a copy of some gene of some person (call him Bob Smith). If its only the isolate they own, then they don’t own any future copy of eric’s gene, or qetzal’s gene, etc… particularly since my isolate and your isolate is likely to have vary slightly from Bob Smith’s in terms of base pairs.

AFAIK patent law also has a ‘newness’ clause (you can’t patent something really old). Most genes have existed for a long long time…longer than patent law, in fact :)

I concur as I wrote the Seattle Times to that effect. But don’t forget what’s already been done. Monsanto has the rights to GE soy and corn (and other?) seed and they ruthlessly pursue anyone who uses their seeds without paying them for the rights to use them. Even if your non-GE seed field becomes accidently contaminated with their seed, you can no longer market your seed since it’s now become GE seed. $$$$$

Ron Okimoto said:

It is common practice to patent a plant variety, such as a new peach.

Ron, these are plant patents. They have restrictions and special rules that normal (“utility”) patents do not have. Genes are covered by utility patents.

The usual rule is that you can’t patent a “product of nature”—that is, a compound that you discover, rather than invent. Long ago, chemical and drug companies protested that they spend very large sums developing and testing some of these discovered compounds. So a—dare I say it—lawyers’ trick was developed. Cases were decided that the compound could be claimed as “a pure substance” or as “an isolated molecule.” That is, the isolation was the invention, not the compound.

This economic compromise has worked, although not without incident, for a long time. Genes, however, exacerbate the problem. The Patent Office early on questioned the patentability of isolated genes. When NIH filed 3,000 gene patent applications all at once, the Patent Office imposed an additional restriction—that the patent describe the function of the gene. You can’t just run DNA through an analyzer and patent everything that comes out.

That was pretty much the law until the Molecular Pathology decision, although pressure has been building steadily. Now the pot has boiled over. This case will undoubtedly go to the Court of Appeals for the Federal Circuit, which handles patent appeals from all District Courts. And then likely to the Supreme Court. The main thing to keep in mind, however, is that legal concepts such as “product of nature” and philosophical categories such as “DNA information” will not be the deciding factors. The problem, as usual, is economic. To what extent should we allow private property rights in this kind of material? What are the other legal consequences of a decision either way? The legal concepts will then be adjusted to fit.

The best answer would probably be a new or modified form of protection that would respect the public’s rights while allowing biotech companies an adequate return on their investments. This has not happened yet, and will never happen. Instead, a bunch of judges who do not understand the technology will cobble together a few narrow tweaks that will solve no-one’s problems, and will fail to apply to many real-world situations.

Please pardon the cynicism from a retired patent attorney who worked mostly in computers, but has spent a couple years in bioinformatics as well.

Olorin said:

Please pardon the cynicism from a retired patent attorney who worked mostly in computers, but has spent a couple years in bioinformatics as well.

You will get no pardons for your cynicism from me because I think that it is healthy. I share it myself. It is possible that you may be pleasantly surprised by the courts, but then again, maybe not. I personally cringe at the thought of patenting genes like this, but I also understand that for R&D to continue, companies need to be able to recoup the costs.

Olorin said: The best answer would probably be a new or modified form of protection that would respect the public’s rights while allowing biotech companies an adequate return on their investments.

Call me naive, but what is wrong with a system where government and/or nonprofit R&D is used to identify “which gene does what,” (because that’s an important social benefit) while biotechs make a lucrative living on developing cheap ways of producing useful genes (or eliminating harmful ones)?

If we take a step back here, no one is forcing private industry to spend $$ figuring out which gene does what. To abuse some latin, “caveat investor” as it were: don’t go into some line of research which isn’t expected to turn a profit unless you’re willing not to turn a profit.

Forcing your way into a market and then complaining to the government that you need extra bonus laws to boost your ROI in that market seems a bit…childish.

The wilting market for physical science related engineering inventions in the US (thanks to the suits who shipped out all manufacturing) has made the life science inventors the focus of venture capital. There is this belief - heroic assumption - that phys-sci invention is easy/low-tech and that life science invention is the new engine of our economy. 1000s of molecules are being developed to cater to the wishes of Peter Pans and Wendys who never want to grow up, and a ramshackle health care delivery system ensures that drug companies and device makers can reap billions from a rigged and gamed health market in the US.

My question is where does it end? If patents can be made on genes that are naturally occurring why not DNA strands that are naturally occurring? Would we then need to pay just to exist? I agree with the decision to not allow the patent.

eric said:

Olorin said: The best answer would probably be a new or modified form of protection that would respect the public’s rights while allowing biotech companies an adequate return on their investments.

Call me naive, but what is wrong with a system where government and/or nonprofit R&D is used to identify “which gene does what,” (because that’s an important social benefit) while biotechs make a lucrative living on developing cheap ways of producing useful genes (or eliminating harmful ones)?

If we take a step back here, no one is forcing private industry to spend $$ figuring out which gene does what. To abuse some latin, “caveat investor” as it were: don’t go into some line of research which isn’t expected to turn a profit unless you’re willing not to turn a profit.

Forcing your way into a market and then complaining to the government that you need extra bonus laws to boost your ROI in that market seems a bit…childish.

Eric,

I think you have it precisely backwards - Myriad Genetics and others invested $$$ in identifying and characterizing the genes that pre-dispose to breast and ovarian cancer. As part of a deal with the government, they disclosed this information, and received in return a limited-time, government-enforced monopoly on the use of this information. That is what a patent is.

There will always be arguments over “what is the appropriate scope of the monopoly, given the utility of the information disclosed?”

But completely changing the rules after the fact (invalidating all gene patents, for instance) is unfair, and would be catastrophic for future investment. Olorin is absolutely correct : it’s about the economics…

DJock said: Eric,

I think you have it precisely backwards - Myriad Genetics and others invested $$$ in identifying and characterizing the genes that pre-dispose to breast and ovarian cancer. As part of a deal with the government, they disclosed this information, and received in return a limited-time, government-enforced monopoly on the use of this information. That is what a patent is.

Why should anyone receive a government monopoly on information as to which gene(s) contribute to breast cancer? Because it takes work to figure out? It took work to figure out exactly how energy was quantized; I don’t see anyone suggesting we should stop all QM R&D unless Heisenberg’s decendents permit us to work on it.

The goal of patents is to promote science. Allowing basic information about how nature works to be patented prevents science. It is also unnecessary, because even if basic information about how nature works is unpatentable, this information helps inventors figure out techniques to manipulate nature, which are patentable. Basic scientific information does not need to be patentable in order for private citizens to have a reason for investigating it, and if its not patentable, they won’t stop investigating it.

People aren’t going to stop caring about breast cancer genes merely the information must be shared. Novel lab procedures for manipulating those genes are certainly patentable, and provide a reason for discovering which genes need to be manipulated.

****

One last argument: 35 U.S.C. 101: “Inventions patentable. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” (My bold.)

Those genes are not a new composition of matter. They’ve been around for thousands of years. Longer than patent law, in fact.

Why should anyone receive a government monopoly on information as to which gene(s) contribute to breast cancer? Because it takes work to figure out?

No, because the developers revealed the information.

Please, if you’re going to rant, rant over the issue, not over something irrelevant.

Patent law and theory is a kludge that overall strikes a reasonable balance between private and public interests. It often fails. Unfortunately, it takes decades to patch it up to a better kludge, since there is always a lot of money at stake.

eric,

Gene patents typically claim something like “an isolated DNA having the sequence described in SEQ ID #1.…” They don’t claim only a single copy (e.g. the one they got from Bob Smith). They claim any isolated DNA having the described sequence.

As I understand it, there is also a bit of leeway in the sequence specification. Sequences with only a small number of variations from the specified sequence may still be covered under the claim. This may depend in part on whether those variations change the utility of the gene. (E.g., if the utility is to express some protein, a few silent mutations that don’t change the protein sequence may be OK, where a mutation that dramatically alters protein activity might not. I’m not too sure on these points, though).

As for newness, you’re still confusing the gene as it exists in nature, which is often millions of years old, with the isolated gene, which would be new.

Again, I’m not necessarily defending gene patents on these terms. But I do think they’re at least a bit more defensible than some of Myriad’s most outrageous claims (such as the one I quoted above).

qetzal said:

eric,

Gene patents typically claim something like “an isolated DNA having the sequence described in SEQ ID #1.…” They don’t claim only a single copy (e.g. the one they got from Bob Smith). They claim any isolated DNA having the described sequence.

As I understand it, there is also a bit of leeway in the sequence specification. Sequences with only a small number of variations from the specified sequence may still be covered under the claim. This may depend in part on whether those variations change the utility of the gene. (E.g., if the utility is to express some protein, a few silent mutations that don’t change the protein sequence may be OK, where a mutation that dramatically alters protein activity might not. I’m not too sure on these points, though).

As for newness, you’re still confusing the gene as it exists in nature, which is often millions of years old, with the isolated gene, which would be new.

Again, I’m not necessarily defending gene patents on these terms. But I do think they’re at least a bit more defensible than some of Myriad’s most outrageous claims (such as the one I quoted above).

I cannot see how patenting genes is defensible. Patenting a methodology for isolating genes or relationships between genes and traits, sure. Patenting some treatment that was derived from the knowledge gained by isolating some genes, go ahead. Those lead to products or services that a company can sell and do not create overly monopolistic conditions. They require some novel synthesis of ideas. They do not prevent me from coming up with a new and different treatment or method for isolating genes either. But the genes themselves are parts of people’s bodies. If body parts such as kidneys do not have monetary value (i.e. I cannot legally sell one of mine to buy a car) then neither should genes. Allowing patents on genes is implying that they do, in fact, have monetary value.

Judge Sweet doesn’t have the authority to overrule existing law which is quite clear: isolated chemical compositions are patentable subject matter. His decision will be overturned, at least in part, to the extent he got that part of the law wrong.

An isolated gene is no different from any other isolated chemical. According to the judge’s logic, an isolated polymerase with extremely desirable and previously unexpected properties obtained from a previously uncharacterized hyperthermophile in the bottom of the ocean would also be unpatentable. It’s ridiculous.

As others have noted upthread, not all of Myriad’s claims are isolated gene composition claims. They raise other issues. But folks here should be especially careful about wading into a complicated field such as patent law and spouting off on “how things should be”. We all know what happens when people ignorant of science start criticizing science because of its perceived “bad effects” on society …

the genes themselves are parts of people’s bodies.

Yes, but the claims do not cover genes that are in people’s bodies. Your BRCA1 genes do not infringe the patent unless you isolate them from your cells. And even if they did: how will Myriad stop you from doing that if you really wanted to?

If body parts such as kidneys do not have monetary value (i.e. I cannot legally sell one of mine to buy a car) then neither should genes.

Like heroin and LSD, kidneys certainly do have monetary value and you can offer them for sale. In both instances you would be violating the law (which is partly responsible for the high values of these articles).

Allowing patents on genes is implying that they do, in fact, have monetary value.

Again, at least some of the claims we are discussing are claims to isolated genes. Such genes do have monetary value. For instance, if I wanted one of my own genes to be copied and presented to me in isolated form, I’d have to pay someone to do it or invest in some supplies and equipment which the average person does not own.

Jesse replied

I cannot see how patenting genes is defensible. Patenting a methodology for isolating genes or relationships between genes and traits, sure.

There are three significant reasons for desiring to patent the gene itself, rather than relying on claims to isolation or treatment methods.

First, once you have figured out the function, the treatment is often straightforward enough that a claim to a method of using the gene would be unpatentable as “obvious” under 35USC103. Isolation of any gene may require a lot of effort, but also can be done by well-known techniques; thus isolation may well be obvious as well.

Second, a person infringes a patent by making, using, or selling the claimed invention. Suppose a large US company markets a patented gene to Chinese, Indian, and Korean medical providers. Your US claim to the treatment method will not reach these foreign providers. If you have a claim to the gene itself, you can nab the US manufacturer when it sells the gene to the foreign providers. Other situations also make it advantageous to have product claims to the gene itself.

Finally, treatment (or isolation) claims may be too narrow to give adequate protection. Once the sequence is known, there may be a very large number of ways to treat patients with it—too many to claim individually, even if you could think of all of them. Claims to one or a few methods woiuld then be easily avoided by infringers. In addition, having only treatment-method claims would not cover other uses of the gene, such as use in research, use in an industrial process to fabricate a material, and so on.

Registered User said:

Judge Sweet doesn’t have the authority to overrule existing law which is quite clear: isolated chemical compositions are patentable subject matter. His decision will be overturned, at least in part, to the extent he got that part of the law wrong.

An isolated gene is no different from any other isolated chemical. According to the judge’s logic, an isolated polymerase with extremely desirable and previously unexpected properties obtained from a previously uncharacterized hyperthermophile in the bottom of the ocean would also be unpatentable. It’s ridiculous.[snip]

Judge Sweet may well be reversed, but not for this reason… because Judge Sweet got the law correct. Registered User’s comment conflates two different parts of the inquiry:

* Is an isolated chemical compound patentable subject matter? Yes… if and only if the isolated chemical is either (a) itself “novel” (a term of art in patent law that is parallel to “original” in copyright law), in which case the patent goes to the chemical itself, or (b) used in a “novel” fashion, in which case the patent goes to the novel usage and not the chemical compound per se. Myriad did not concern whether genes (as Registered User would have them, mere chemical compounds… although both lawyers and chemists would disagree at the boundaries, it’s close enough for government work here) are patentable subject matter. Instead, Judge Sweet’s opinion proceeded to the second question:

* Is the particular composition of matter at issue “novel” within the meaning of the Patent Act? Here, the answer was no, because the gene in question was a naturally existing compound that required no human activity to exist; in constitutional terms, its existence does not advance the useful arts (U.S. Const. Art. I § 8 cl. 8). If the patents at issue in Myriad had concerned only the novel use of specific techniques to discern the presence/absence of the relevant genes in vivo, that might have constituted a “novel” situation that then gets to go through the rest of the inquiry. However, the patents at issue were for naturally existing genes without regard to any “novel” use. (There’s a long, convoluted, and stultifyingly boring line of cases — and it’s even more stultifyingly boring in Europe, if only because they’re mostly in German, and badly written pseudoacademic German at that! — indicating that merely obtaining information from nature in an obvious way is not, itself, novel.)

I’m afraid that Registered User has jumped immediately to the economic justification for protecting this particular item and backfilled into making it therefore patentable. Unfortunately, patent law ain’t that simple, because there are constitutional dimensions to patent law, too. That’s what I was discussing above in my references to Feist… which will control the outcome of this matter, or at least require a Supreme Court — and not merely Federal Circuit — appellate decision to reconcile.

What this ultimately comes down to is this, as I read Registered User’s comments (and some others above):

Postulate: Patents must issue to protect “sweat of the brow” by technologists and economic support by investors

The Supreme Court soundly rejected the corresponding postulate in copyright matters in Feist… on constitutional grounds. Thus, whether Registered User (and others) think it a good idea on policy grounds (and I’m not denying it has a certain attraction), the postulate is unconstitutional and thus cannot stand as a justification for patent protection. It may well justify some other kind of incentives, such as research-encouraging tax credits, or direct subsidies from the government, or profits earned through making a better genetrap; it’s just not within the proper scope of patent law under the US Constitution.

Olorin said:

Jesse replied

I cannot see how patenting genes is defensible. Patenting a methodology for isolating genes or relationships between genes and traits, sure.

There are three significant reasons for desiring to patent the gene itself, rather than relying on claims to isolation or treatment methods.

First, once you have figured out the function, the treatment is often straightforward enough that a claim to a method of using the gene would be unpatentable as “obvious” under 35USC103. Isolation of any gene may require a lot of effort, but also can be done by well-known techniques; thus isolation may well be obvious as well.

Second, a person infringes a patent by making, using, or selling the claimed invention. Suppose a large US company markets a patented gene to Chinese, Indian, and Korean medical providers. Your US claim to the treatment method will not reach these foreign providers. If you have a claim to the gene itself, you can nab the US manufacturer when it sells the gene to the foreign providers. Other situations also make it advantageous to have product claims to the gene itself.

Finally, treatment (or isolation) claims may be too narrow to give adequate protection. Once the sequence is known, there may be a very large number of ways to treat patients with it—too many to claim individually, even if you could think of all of them. Claims to one or a few methods woiuld then be easily avoided by infringers. In addition, having only treatment-method claims would not cover other uses of the gene, such as use in research, use in an industrial process to fabricate a material, and so on.

Certainly there are a lot of reasons to desire such patents. That does not mean that patenting genes is sensible unless you are the particular company that stands to profit from it. This is coming from a staunch capitalist, mind you. I’m not anti corporation, anti business or anti profit. I do feel that patenting genes steps over a line that will hamper the free market in the long run. Patents are supposed to help the free market. The law may disagree with me, but I’m not bashful about making it known when I think that a law is stupid, useless or detrimental to some faucet of our society.

The pharmaceutical companies have been patenting parts of the human genome for years, effectively cutting off research by anyone but themselves in certain areas. These self-serving corporations don’t want any cures or remedies - except their own.

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