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"You Can't Patent Nature"
March 31, 2010 12:53 PM   Subscribe

Followup to this post: A US District Court has ruled that Myriad Genetic's patents on breast cancer genes BRCA1 and BRCA2, which allow them to hold exclusive rights to a widely used genetic test for inherited breast and ovarian cancer susceptibility, are invalid. Genomics Law Report analyzes the ruling in two posts. The decision is likely to be challenged in a legal appeal — but if upheld, it could have huge implications for the biotechnology industry.

Biotech stocks tumbled after the announcement.

Fortune's Daily Brainstorm blog asks, "Is the DNA Patent Dead?

GenomeBoy: After the Gold Rush

Discover:
Tuesday’s decision, if upheld, could have wide repercussions for the multi-billion dollar biotech industry, which is built on more than 40,000 gene patents. Already, about 20 percent of the human genes have been patented. The decision, however, is not binding on other federal courts and other judges may or may not abide by it. But it does the set the stage for years of litigation over other gene patents. Myriad Genetics plans to appeal the judgment.

AOL Daily Finance: "After a U.S. District Court ruling yesterday, women in America may soon be able to get the same access to inexpensive, verifiable gene-testing for breast cancer that women in Europe currently enjoy."
posted by zarq (51 comments total) 8 users marked this as a favorite

 
PDF of the ruling.
posted by zarq at 12:54 PM on March 31, 2010


Good. That's the right decision.
posted by mattdidthat at 12:56 PM on March 31, 2010 [2 favorites]


if upheld, it could have huge implications for the biotechnology industry.

The broad consensus is that will almost certainly be overturned no various grounds at the Federal Circuit level. At the Supreme Court level, should the Court take up the case, things are less certain but not too much less.

women in America may soon be able to get the same access to inexpensive, verifiable gene-testing for breast cancer that women in Europe currently enjoy.

The test costs about $300-$3000 depending on how extensive a test is ordered. Many insurance companies cover the test and the 2008 Genetic Information Nondiscrimination Act prohibits insurance companies from acting on the results. I don't know how expensive genetic tests are in Europe, but that doesn't sound all that unreasonable for a medical test in the US. For example, an MRI in the ER costs in the neighborhood of $3000.
posted by jedicus at 1:02 PM on March 31, 2010


Biotech stocks tumbled after the announcement.

I hate it when people say that stocks are going down and present it as a catch-all, infallible judgment on whatever it was that caused them to fall. If stocks fall after something obviously good and right happens, then they shouldn't have been so high to begin with.

Not that I'm saying that the FPP is doing this. Although to some eyes, it could seem that it might.
posted by JHarris at 1:03 PM on March 31, 2010 [6 favorites]


If you can patent genes, can you patent the things that genes make? This makes literally no sense to me.
posted by amethysts at 1:08 PM on March 31, 2010


Awesome.

I can understand the reasoning for allowing patents for discovered Genes. Even though the genes are already there, it can take a lot of work to actually isolate it, so allowing a limited time patent makes some sense.

On the other hand patenting human genes is just kind of creepy. And it's not all that clear that allowing these patents actually makes science actually happen any faster. There are all kinds of costs and complications associated with working with genes that are patented that it may be doing more to inhibit research. And of course a ton of research is government funded anyway. Obviously, that's going to stop.
posted by delmoi at 1:09 PM on March 31, 2010


If you can patent genes, can you patent the things that genes make? This makes literally no sense to me.

So-called gene patents aren't patents on the genes per se. The patents are on things like an isolated, purified version of the DNA corresponding to the gene (the DNA in your body is neither isolated nor purified) or a method for diagnosing a disease by testing for the presence of the particular version of the gene.

Anyway, yes, you can patent things that genes make, namely proteins. In particular you can patent isolated, purified versions, which, again, don't exist in the body, or you can patent treating a disease by administering the protein as a biologic drug (e.g. infliximab).
posted by jedicus at 1:11 PM on March 31, 2010 [3 favorites]


From the geneomeboy:
3) But even without appeals, this is hardly an “all clear” from a practical standpoint. If you had $50 million bucks lying around, would you enter the breast cancer genetic testing market in the US? I wouldn’t. Myriad’s been at this for well over a decade and it’s had the market all to itself. The legal hurdles may have been dealt with and barriers to entry may be pretty low at this point, but so what? Even if you could undercut its price by more than half, would you want to compete with the iPod?
Seriously? Does anyone care what brand of genetic test they get? And would it really cost $50 million to test for this? Couldn't a company like 23 and me easily add this test to their test battery of 144 tests they already do to your DNA? If they're already licensing the genes, they could just stop making payments.

I think anyone already setup to do DNA tests could just add a test for this gene pretty easily.
posted by delmoi at 1:15 PM on March 31, 2010 [1 favorite]


The broad consensus is that will almost certainly be overturned no various grounds at the Federal Circuit level. At the Supreme Court level, should the Court take up the case, things are less certain but not too much less.

Cites, please. Genome Law Report disagrees with you, and they're pretty educated on these matters.
posted by zarq at 1:15 PM on March 31, 2010


The test costs about $300-$3000 depending on how extensive a test is ordered. Many insurance companies cover the test
Right, but now the testing for all types of things can be done in one pass. 23 and me does 144 tests for $429
posted by delmoi at 1:18 PM on March 31, 2010


Basically all they are saying is that you can't patent a gene that's already there. It took them this long to figure that out? What, before this ruling, I could have patented photosynthesis? Seriously, people, can we please get some biochemists with law degrees involved in whatever regulating bodies are in charge of this?

It shouldn't be that difficult: If a new gene is invented, it can be patented. DNA is just like a programming language for living things. If someone can write something in C and patent it, they can do the same in DNA. That sort of thing right now though, to my knowledge, isn't possible. Has anyone created their own novel, not otherwise naturally occurring enzymes yet? Or even useful proteins? If so, good on them! They deserve a patent.

If a gene is discovered (i.e. it already exists in some organism or another) or is just a combination of existing functional genes, it does not deserve a patent. Why? Because nothing was invented. That's just taking something that already exists and claiming it for yourself. Like if I were to say, "alright everybody, no one else owns mucus yet, so I'm going to go ahead and patent it."

Hey U.S. Patent and Trademark Office: My contact information is in my profile!
posted by battlebison at 1:21 PM on March 31, 2010


Elseworld Onion headline: Genesoft patents As, Cs, Gs, Ts, and Us.
posted by kmz at 1:24 PM on March 31, 2010 [2 favorites]


Cites, please. Genome Law Report disagrees with you, and they're pretty educated on these matters.

GLR didn't really talk much about their chances on appeal, but here's a few reasons why they're not very good.

For starters GLR makes a big deal about how the plaintiffs won on summary judgment. In fact that makes for a weak appeal as the summary judgment determination will be reviewed by the Federal Circuit de novo, giving no deference to the trial judge.

Second, if Myriad was smart they preserved the standing issue on appeal. It's entirely possible that the case will be thrown out on appeal for lack of standing. GLR didn't really talk about the standing issue but it's significant.

Third, GLR even acknowledges that the result flies in the face of established Federal Circuit precedent. "Because genes are chemically different in isolation, at least in a literal sense, they can’t be considered products of nature. The USPTO and the courts, including the Federal Circuit (the patent court of appeals), have uniformly acquiesced."

Fourth, the reasoning behind the policy-heavy decision calls into question the patentability of things like metal alloys, which is a pretty significant side effect.

I could go on, but I neither want to write giant walls of text nor get sucked into a debate about the merits of the case. I'm trying to stick to an objective discussion of the facts and realistic expectations regarding the outcome of the case, for good or ill.
posted by jedicus at 1:25 PM on March 31, 2010 [3 favorites]


What, before this ruling, I could have patented photosynthesis?

No, but if you were the first to do so you could've patented an isolated, purified version of the gene responsible for, say, the production of chlorophyll. You'll note that such a patent wouldn't give you any power of growers or sellers of plants because they don't use an isolated, purified version of the gene but rather the naturally occurring version, which cannot be patented.
posted by jedicus at 1:26 PM on March 31, 2010 [3 favorites]


"You Can't Patent Nature"

So, that applies for biology but not for math or physics... I bet you can still patent formulas or algorithms that any half-assed mathematician would say are a just discovered property of nature, and not an "invention".
posted by qvantamon at 1:29 PM on March 31, 2010


"are just a discovered property".
posted by qvantamon at 1:30 PM on March 31, 2010


I bet you can still patent formulas or algorithms that any half-assed mathematician would say are a just discovered property of nature

No, you can't patent a formula or algorithm. You can patent a useful invention of which a formula or algorithm is a part. Equations in the abstract are useless. You can think about an equation all day and it won't accomplish anything useful, from the point of view of the patent law.

Right, but now the testing for all types of things can be done in one pass. 23 and me does 144 tests for $429

Fair enough, there is a significant premium for the BRCA1/2 tests. But I'm not sure it rises to the point of justifying eliminating patent protection on a whole class of inventions. Because that's basically making the argument that if the test were cheaper then it would be okay but because Myriad got greedy the patent must be invalidated. Obviously the judge didn't entirely base his opinion on that argument, but that's an argument that the plaintiffs advanced.
posted by jedicus at 1:37 PM on March 31, 2010 [1 favorite]


jedicus: Ok. So I can't patent "binary search", but I could (if it weren't for prior art) patent "a method to find names in a sorted catalog by dividing the search space in half at each step".

Tomahto, Tomayto...
posted by qvantamon at 1:54 PM on March 31, 2010


So-called gene patents aren't patents on the genes per se. The patents are on things like an isolated, purified version of the DNA corresponding to the gene (the DNA in your body is neither isolated nor purified) or a method for diagnosing a disease by testing for the presence of the particular version of the gene.

Or on markers for that gene, which can roughly thought of as a combination of signposts pointing in the right direction.

I think patents are a good thing for biotech, as they push progress forward faster. They don't last forever, and they give investors incentive to throw money at very hard and resource-intensive biological research. I admit some concern at this ruling, even if Myriad got greedy.
posted by Blazecock Pileon at 2:09 PM on March 31, 2010 [1 favorite]


I'd also note that most biotech research patents aren't obvious like, say, Amazon's one-click patent. Most biotech companies will throw millions of dollars at a difficult problem, only to hit a dead-end. Eliminating legal avenues for protecting an investment takes away pretty much the only motivation an investor has to put money into this technology.

I guess we could lobby the government to take on the risk of developing tomorrow's therapies, but it seems like the US will only increase science funding where it has some connection to (bio-)terrorism. Capitalism sucks, but in the case of biotech it works more often than it fails.
posted by Blazecock Pileon at 2:25 PM on March 31, 2010


For example, an MRI in the ER costs in the neighborhood of $3000.

An MRI scanner also costs several million dollars, and has an operating expense of almost $1M a year (because of its coolant needs, mostly). Imaging is typically one of the most heavily marked-up ancillary services that a hospital will offer. For a blood test to cost that much is not really evidence that the test is reasonably priced unless it's incredibly labor-intensive or requires expensive specialized equipment of its own.
posted by strangely stunted trees at 2:39 PM on March 31, 2010


es, but it seems like the US will only increase science funding where it has some connection to (bio-)terrorism

What? The U.S. government spends a ton of money on medical research. As far as Increases:
WASHINGTON — For years, Senator Arlen Specter of Pennsylvania has been the National Institutes of Health’s most ardent champion on Capitol Hill. Having survived two bouts with cancer, open-heart surgery and even a faulty diagnosis of Lou Gehrig’s disease, he has long insisted that research that results in medical cures is the best service that government can provide.

But even lobbyists are stunned by the coup Mr. Specter pulled off this week. In return for providing one of only three Republican votes in the Senate for the Obama administration’s $787 billion economic stimulus package, he was able to secure a 34 percent increase in the health agency’s budget — to $39 billion from $29 billion.
posted by delmoi at 2:41 PM on March 31, 2010


Obviously the right decision. Doesn't matter if this hurts businesses, if stocks fall, blah blah blah. You can not patent a product of nature. You didn't invent it, and isolating a gene from the human genome and then saying that thus you can patent the gene is a ridiculous argument and I'm glad the judge pointed it out.

I don't buy the thought that suddenly no one will work on it, because there's no money there. Even if that's true, that doesn't make patenting a gene any more allowable. The patent prevented anyone else from isolating it in order to study it. The human genome should be open-source.
posted by Solon and Thanks at 3:03 PM on March 31, 2010 [1 favorite]


BTW I think important work on this sort of thing belongs in universities - sure, private corporations can do it too, but not if they're only going to take the ball and go home (aka make a patent on a gene linked to breast cancer and prevent anyone else from doing anything with it.)
posted by Solon and Thanks at 3:05 PM on March 31, 2010


Delmoi, I don't have the cite in front of me, but NIH funding actually decreased over inflation, once bioterror research budget items were removed, over the course of the Bush administration. If that has changed under Obama, then that would be a welcome change; however, my point remains that I still don't think the US gov't is in any position or has any motivation to do the kind of research that biotech companies do. There is a place for private companies to do the work that public-funded basic research cannot and will not do.

Jedicus hints at the problem when mentioning metal alloy patents - if I sampled the earth, I'd likely have a non-zero probability of encountering Nature having made a crystal or two or more of a patented, man-made alloy. This doesn't (yet) invalidate those patents. Nor should it, I think.
posted by Blazecock Pileon at 3:16 PM on March 31, 2010


For example, an MRI in the ER costs in the neighborhood of $3000.

And an MRI in Japan costs $150. That illustrates the problem with patent rents and the U.S. medical system.
posted by JackFlash at 4:27 PM on March 31, 2010 [5 favorites]


What exactly did Myriad accomplish here? It wasn't clear from the articles.

Did they:
- discover the BCRA1 and BRCA2 gene sequences in the first place?
- figure out that these existing sequences lead to?
- develop a simple test to see if these sequences are present?

If it was #3, then the patent makes sense to me. But #1 & #2 are BS.
posted by msalt at 4:35 PM on March 31, 2010


I want to live in a world where I can say "this thing costs $300-$3000, and that isn't unreasonable" and truly believe it, but I cannot -- it may seem reasonable when compared to other medical procedures, but compare the median cost ($1650) to the cost of rent for someone who doesn't have medical insurance and it doesn't seem particularly reasonable.
posted by davejay at 4:47 PM on March 31, 2010


Targeted isolation of DNA sequences is not novel, not an invention, and the technique is dog-standard. Patenting BRCA1/2 isolation not anything like patenting an MRI machine, it's like patenting the idea of pointing an MRI machine at your knee. It's like discovering that people had things called right-pinkies, and declaring "nobody else is allowed to put a right-pinky in an MRI machine!"

And actually, a pinky-MRI patent is more defensible than patenting the isolation of a DNA sequence. The novel contribution in a gene-isolation patent is *only* the DNA sequence of interest. There's more invention and intelligence in a process that identifies a right-pinky; it's not like right-pinkies are automatically attracted to other right-pinkies. As the judge rightly identifies, gene isolation patents are not about the chemical nature of DNA, it's about the informational nature of DNA, and moreover the patents are on naturally occurring information.

In the end, these patents on trivialities are holding back true innovation, holding back the inventions that may rise to the level of patentability. It's no surprise that biotech stocks fell, as much of the field consists of rent-seekers, and all those rent-seekers were preventing others from creating something new that's actually of value. Additionally, invalidation of gene patents will make industry attractive to more scientists. I know several that couldn't stomach the bullshit of working for a company that has gene patents; it takes either a certain level of ignorance or money-grubbing to enter the field when the system is set up with rules like that.
posted by Llama-Lime at 4:55 PM on March 31, 2010 [1 favorite]


Maybe I'm out of touch, but shouldn't they be patenting the process for obtaining the purified version of the gene? The gene already exists - saying "but this is a huge, isolated collection of that gene, and that doesn't happen in nature!" is pretty weak.

Instead, they should be patenting "We took the original DNA strand, split the helix, digested it, ran it through a series of centrifuges," etc? It seems that they didn't want to reveal the process, and therefore filed for a patent that was too far-reaching: they patented a product of nature.

So this ruling is a good thing: it will make future biotech companies patent processes. If another company wants to create an isolated version of the same gene, and pours millions into research to come up with a simpler, cheaper way of doing this, they should be allowed to do so and patent the process. Myriad doesn't own the gene, including its isolated form.
posted by Tehhund at 4:58 PM on March 31, 2010 [1 favorite]


it takes either a certain level of ignorance or money-grubbing to enter the field when the system is set up with rules like that.

Ok, I got a little carried away and don't really mean this. There are plenty of excellent reasons to enter an imperfect system when you can end up helping people. Hope I didn't offend anyone.
posted by Llama-Lime at 5:05 PM on March 31, 2010


Patents for medical treatments are putting a block in front of people and saying, "give me whatever I demand, or I will let you die." We have other names for that.
posted by Michael Roberts at 5:06 PM on March 31, 2010 [2 favorites]


But Micheal, the other side of the argument is that without the protection of patents, the financial incentive for developing the cure/treatment is taken away. So while you might phrase it as "give me whatever I demand, or I will let you die" the alternative, without patents, might just be "Sorry, we don't have a cure for that."

Given those choices, I'd begrudgingly side for the first one.

There is a third choice though— public/government funding. If we raise taxes and get the government to fund more developments in the industry, then we'd all win. Of course, then you're left with the tricky problem of staying in power while you attempt to raise those taxes.

It's never easy.
posted by Static Vagabond at 5:39 PM on March 31, 2010 [1 favorite]


A couple of things to know about the Myriad test:

-This is a one-time test. You don't need to get it again if you've ever had it.

-It's not a simple yes-no answer. The results have a lot of gray area. Myriad has followed patients after ambiguous results over several years, and they've added mutations of previously unclear importance to the "bad" list. This database is really expensive to collect and maintain, and something that no other company will have out of the gate.

-The test is substantially less expensive for family members of someone who has tested positive, because a less extensive analysis can be performed. In short, you only have to look for the mutation that you know runs in this family.
posted by Mister_A at 6:10 PM on March 31, 2010 [2 favorites]


The patents are on things like an isolated, purified version of the DNA corresponding to the gene (the DNA in your body is neither isolated nor purified) or a method for diagnosing a disease by testing for the presence of the particular version of the gene.

I think the key mistake we've made is allowing patents to cover the gene itself, rather than a method for isolating and purifying the DNA corresponding to the gene. The latter sounds pretty classically patentable to me, especially if it takes the form of some device, or a novel way of using scientific equipment, etc. But patenting the isolated gene itself? That doesn't seem defensible.

To put it in a 19th century context, we never let people patent machine-made pins, but we did let people patent various machines for making pins. And in doing so, it encouraged quite the diversity of pin-making machines as various manufacturers worked around each others' patents and worked to increase yields. Pretty good all around.

What we've allowed to happen is for the end product to become patented, rather than a device used to produce that product. That was never, at least in my opinion, what the patent system was supposed to be for.

Myriad should be free to patent any novel devices or purification methods that they used to isolate particular genes, but other companies should be free to attempt to work around their patents to achieve the same ends. Allowing patents to cover the end-product rather than a machine or specific implementation of a method is one of the gravest mistakes we have made in modern IP law.
posted by Kadin2048 at 6:14 PM on March 31, 2010 [2 favorites]


Static, a lot of the original research is already publicly funded through the NIH. And I'm not saying anything is ever easy.

A roadblock is still a roadblock, though. And highway robbery is a crime when it's done by the enterprising individual or small informal group; I see no reason it should be lauded just because they have a Board of Directors. Patents have no place in medical tests, or conversely, conservatives should STFU about "death panels". Or - preferably - both.
posted by Michael Roberts at 6:35 PM on March 31, 2010


I really think that if we want to encourage private investment in genetic research, foundations should be establishing X-prize style bounties. Patenting genes that are clearly discovered, not invented, is absurd - and so is U.S. medical pricing.
posted by ransom_k_fern at 8:06 PM on March 31, 2010


If the Old World patented new discoveries like these douchebags patent genes, we'd all be paying a dollar a day to The Columbus Foundation America Exploratory Adventures, Incorporated.
posted by five fresh fish at 8:10 PM on March 31, 2010


And an MRI in Japan costs $150.

I strongly doubt that's the real cost, though it may be the cost that's billed to the patient. MRI machines, as mentioned above, are extremely expensive to buy and operate, and even if radiologists and MRI techs are not paid very much in Japan, there's still a fair bit of labor in running the machine and reading the results. The US cost is terribly inflated for various reasons, but I'd be really surprised if Japan's health care system was so efficient with its MRIs that it was able to amortize the cost down to $150 per use.

Patenting BRCA1/2 isolation not anything like patenting an MRI machine

I'm not sure who claimed the patents here were equivalent to patenting an MRI machine. I sure didn't. I was just pointing out that the cost of the Myriad test is not out of line with other medical tests. I used an MRI at an ER because it's a test that I know costs about $3k. Now, obviously neither the test nor the MRI should really cost that much, but to my mind that has more to do with the broken US healthcare system than with patents.
posted by jedicus at 8:33 PM on March 31, 2010


I never thought anyone claimed MRI machines are equivalent, but I do think they contrast nicely with these invalidated patents as an example of something that should be patentable.

In a year and half, it's likely that $3000 will buy the sequence of an entire genome, without having to isolate anything. In which case, it may not matter much if these ridiculous patents get reinstated by a less-informed appeals court (honestly, this decision is a wonderful intro to some molecular biology, if a court overturns this decision it's certainly because the justices didn't bother to consider the fundamental facts.) Even in that hypothetical future with gene patents reinstated and cheap sequencing getting around them, Myriad's analysis of mutations is probably of value. The BRCA1/2 patents do little to help Myriad, and potentially a lot to hurt medicine.
posted by Llama-Lime at 9:16 PM on March 31, 2010


the other side of the argument is that without the protection of patents, the financial incentive for developing the cure/treatment is taken away.

Have we really gotten to the point where doctors and researchers refuse to find cures unless there's a lot of money in it for them? That's horrible.

It's a shame that researchers have to fight (and pay) for medical school slots that lead others to $400,000/year jobs as specialists. Maybe we could set aside a certain number of seats in medical school for researchers, who would make less money (only $100K?) but get free education and know they will have well-funded government labs and studies, the results of which are free and public goods.
posted by msalt at 10:15 PM on March 31, 2010


Have we really gotten to the point where doctors and researchers refuse to find cures unless there's a lot of money in it for them?

There isn't a lot of money in it, researchers, even in industry are not paid exorbitant salaries. The trick is that it takes a multidisciplinary team years to develop a workable diagnostic test, and that costs money. Not only that, but the investors that put the money in are looking for a large return on their investment to cover the money that went into failed biotech ventures (i.e. most of them.
Arguments about natural justice and about whether it is "fair" to allow these types of patents are absurd. All intellectual property is a legal construct that we collectively have come up with to spur innovation, the only question that matters is whether these patents do that. If they do then they're good, if not then they're bad.
posted by atrazine at 11:08 PM on March 31, 2010


they will have well-funded government labs and studies, the results of which are free and public goods.

This will never happen in any Metafilter vistor's lifetime, but, that aside, governments do a good job funding basic research. Medical research of this variety, on the other hand, is simply too risky, economically and politically, which is why there is a private sector.
posted by Blazecock Pileon at 12:14 AM on April 1, 2010


Jedicus hints at the problem when mentioning metal alloy patents - if I sampled the earth, I'd likely have a non-zero probability of encountering Nature having made a crystal or two or more of a patented, man-made alloy. This doesn't (yet) invalidate those patents. Nor should it, I think.
I don't really think that's relevant to DNA that exists in millions of actual people, quadrillions of human cells -- not with 'non-zero' probability but with near-one probability (near one probability of finding it someone who carried this gene, that is)
3- develop a simple test to see if these sequences are present? If it was #3, then the patent makes sense to me.
The problem is the 'test' might just involve a PCR or sequence test that is already being done on other genes (and today, you can get your entire genome sequenced, which would obviously detect this gene as well)
But Micheal, the other side of the argument is that without the protection of patents, the financial incentive for developing the cure/treatment is taken away. So while you might phrase it as "give me whatever I demand, or I will let you die" the alternative, without patents, might just be "Sorry, we don't have a cure for that."
An alternative might be "Okay, if you discover a gene's function, you get a %royalty/number of genes scanned of any test done, regardless how much is charged."

Part of the problem, I think, is that the cost of doing genetic screening has just dropped incredibly. Compare the human genome project, which took years and billions of dollars to sequence a sample of human's DNA to the fact that now you can sequence an entire person's DNA for a reasonable cost, you can even look up Craig Venter's DNA. Presumably, anyone could look at that file and determine if he carried the defect, but they'd be violating the patent.

And that's why holding a patent on a single gene today makes much less sense then it did back in the day.
posted by delmoi at 1:17 AM on April 1, 2010


I think it's a good point that the purpose of patents is to encourage innovation, and the concept of fair is not terribly useful in terms of furthering that goal.

The comparison to metal alloys is interesting, but there seems to be a clear distinction which hinges on what part of the process is actually useful. With an alloy, the actual created product is what is useful, and deserving of patent protection. In this case, it is not the purified gene which is useful, but rather the discovery that these genes have a correlation with breast cancer. That type of discovery is historically not patentable, and biotech companies get around this by patenting the purified gene itself and claiming that all tests for it are covered by the patent.

That, to my mind, does represent a problem, because it seems to limit, rather than encourage, innovation. When you patent a invention, you are essentially claiming ownership of a useful solution to a problem. Other people may have better solutions, and will patent them. But if you are allowed to patent the problem itself, no one can try to develop a better solution.

To go back to the analogy of metals and alloys, due to its reactivity with oxygen, aluminum essentially does not exist in its elemental state in the earth's crust. A roll of aluminum foil represents a purity of aluminum not found in nature, much like purified genes. However, it would be absurd to allow someone to patent the element.
posted by Nothing at 4:25 AM on April 1, 2010


An MRI scanner also costs several million dollars, and has an operating expense of almost $1M a year (because of its coolant needs, mostly).

Two things:

The US controls the world Helium supply. Liquid Helium (the coolant used in MRI machines) costs considerably more in the rest of the world.

Last time I worked in the MRI field, refilling the machines with LH2 had been enormously reduced due to the use of cryocooler recondensers. That was 10 years ago, and the recondensers I encountered were producing in excess of 10 Watts of cooling at 4K. I'd be surprised if there hasn't been a lot of progress in cryocoolers since then.
posted by Kirth Gerson at 4:35 AM on April 1, 2010


...determine if he carried the defect..

delmoi, as I mentioned above, it is less simple than that. It's not a case where you can see a "T" where there should be a "G" and you're done. There are many variants of these two genes, most of which are indifferent, a few are known to be deleterious, and others are indeterminate. There's a bit more to it than a simple yes/no answer, which is actually a reason for Myriad to move on and not sweat the patent, because I doubt any other company is prepared to execute the analysis at this time.
posted by Mister_A at 5:34 AM on April 1, 2010


The US controls the world Helium supply.

Amarillo, TX Represent!
posted by zarq at 7:51 AM on April 1, 2010


It's not a case where you can see a "T" where there should be a "G" and you're done. There are many variants of these two genes, most of which are indifferent, a few are known to be deleterious, and others are indeterminate. There's a bit more to it than a simple yes/no answer,

So, please correct me if I'm wrong, but their unique contribution appears to be their database of variations, not the purified DNA of the genes, correct? I thought it was established that data and databases per se could not be patented or even copyrighted (though the format and arrangement of a set of data can be copyrighted cf the phone book listings case.)
posted by msalt at 9:51 AM on April 1, 2010


End of Gene Patents Will Help Patients, Force Companies to Change
posted by homunculus at 11:43 AM on April 1, 2010


60 Minutes: Should companies be able to own human genes? Morley Safer examines the idea of biotech firms patenting genes for profit.
posted by homunculus at 6:18 PM on April 4, 2010


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