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Gene genie, let yourself go
April 12, 2013 1:20 PM   Subscribe

After a decade or so of legal back-and-forth between Utah-based Myriad Genetics and medical researchers, the ACLU, and the Public Patent Forum, the US Supreme Court will hear a case next week which attempts to address whether genes — isolated (derivative) or original — can be patented. The stakes are high on both sides: opponents use Myriad's actions to argue that giving short-term monopoly control over humanity's genetic constituency is not in the public interest, while proponents defend the use of patents to spur private research in biotech, alternative energy and other nascent industries.
posted by Blazecock Pileon (58 comments total) 19 users marked this as a favorite

 
You'd think that the existence of the gene itself would be implicit proof of prior art.
posted by mullingitover at 1:27 PM on April 12, 2013 [8 favorites]


I'm torn on this because, at least with patenting, you have to publish enough of what you are doing so that other people can follow your lead mumble mumble years later. With trade secret things might never appear on the radar depending upon how careful you are and how viciously you defend your non-disclosure agreements.
posted by Kid Charlemagne at 1:35 PM on April 12, 2013 [1 favorite]


Bloomberg.
Nature.
LA Times op-ed.

SCOTUSBlog coverage.
I don't know enough to have an opinion on the legal side.
posted by Lemurrhea at 1:37 PM on April 12, 2013 [1 favorite]


You'd think that the existence of the gene itself would be implicit proof of prior art.

First, this case is not about prior art. It is about patentable subject matter. It is about what kinds of things can be patented in the first place, not whether that thing is novel or nonobvious over the prior art.

Whether these patents claim new, useful, and nonobvious inventions and comply with the written description and enablement requirements are entirely different questions that are not at issue here. Even if Myriad won this case on the issue of patentable subject matter, these patents and other "gene patents" could still be invalidated for a host of other reasons, just like any other patent.

But even so: There are several kinds of claims at issue in the Myriad case. One type reads like this:
An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
In other words, the claim is to a particular isolated DNA molecule having a particular sequence. Such molecules do not exist in nature in an isolated form.

And even if they did, "exists in nature" is not how prior art is defined, nor are discoveries (as opposed to inventions) excluded from patentability. In fact, both are explicitly included under 35 U.S.C. § 100(a).
posted by jedicus at 1:46 PM on April 12, 2013 [3 favorites]


You'd think that the existence of the gene itself would be implicit proof of prior art.

You might want to read the second link. It goes into the difference between isolated and original gene products, and how the legal issues have shaped around that distinction (even though Myriad is claiming ownership over both as they relate to breast cancer genes BRCA1 and BRCA2).
posted by Blazecock Pileon at 2:01 PM on April 12, 2013 [1 favorite]


It is fall 2008, I am sitting in a 9AM Patent Law class in an overheated auditorium with a narrow window view of a wet granite building and a lawn, and Guest Professor jedicus has just succeeded in rousing at least half the class from sleeping/reading Achewood, setting a class record in the process.
posted by Inspector.Gadget at 2:03 PM on April 12, 2013 [2 favorites]


: "I'm torn on this because, at least with patenting, you have to publish enough of what you are doing so that other people can follow your lead mumble mumble years later. With trade secret things might never appear on the radar depending upon how careful you are and how viciously you defend your non-disclosure agreements."

At this point, with the extensive abuse of the patent system, I actually think we might be be better off with people trying to keep things secret. Patents assume that only valuable findings are patented, but then the bad patents get issued and defended with the full force of the law.

Let people invent things, let them try to keep it secret, and let other people figure out how they did it. I have a feeling the threat that people won't be able to figure out how they did it is wildly overblown.
posted by mullingitover at 2:04 PM on April 12, 2013 [1 favorite]


The court limited its grant of appeal to the first question - Are human genes patentable?
posted by Kale Slayer at 2:06 PM on April 12, 2013 [2 favorites]


No one can stop my patented genetic fighting technique.
posted by Lipstick Thespian at 2:17 PM on April 12, 2013 [1 favorite]


It goes into the difference between isolated and original gene products

The two primary DNA claims are both to isolated DNAs. One is to a DNA and the other is to a cDNA, but they both claim isolated DNA molecules. Myriad does not claim anything like "a BRCA1 gene as part of a chromosome in a human cell" or the like; it's all isolated molecules.

The court limited its grant of appeal to the first question - Are human genes patentable?

Which is just a terrible phrasing. What does "human gene" even mean in this context? In my view, nobody is patenting a human gene. Genes are parts of chromosomes used by cells. Myriad and other companies have patents on isolated molecules. They may be large, complicated molecules, but they're just molecules. They aren't a part of a human cell, and no one infringes just by existing.

It's like if someone just now discovered insulin and a method for manufacturing it. It would be entirely legally valid to patent isolated, purified insulin. It's just a composition of matter, entirely within the literal scope of the Patent Act. Patents on DNA molecules that are useful for diagnosis and therapy are no different.
posted by jedicus at 2:18 PM on April 12, 2013 [1 favorite]


But you didn't create insulin, you just discovered it. Ergo, you might be able to patent your specific method of producing it, but you can't patent insulin itself. It's the ultimate in prior art; it was made either by evolution or, depending on your worldview, by God.
posted by Malor at 2:23 PM on April 12, 2013 [6 favorites]


I mean, if you can patent insulin or a strand of human DNA, suddenly the world has six billion people infringing on 'your' product.

I angrily reject the idea that you own any part of me.
posted by Malor at 2:25 PM on April 12, 2013 [8 favorites]


Myriad does not claim anything like "a BRCA1 gene as part of a chromosome in a human cell" or the like; it's all isolated molecules.

To be clear, the cDNA in this case is complementary DNA, a "mirror-image" transcript made from the original gene. While legally that specific molecule may not exist in nature, the portion that is functionally complementary to the gene when the gene itself is transcribed into mRNA and subsequently translated does indeed exist in nature.

I think one issue of concern with Myriad is that they are claiming ownership of diagnostic methods for detecting mutations in this natural product by claiming ownership of the cDNA, which is effectively, chemically, claiming ownership of the natural mRNA. In other words, I can't use, say, radioactively-labeled cDNA made in my own lab to label and measure alterations in this mRNA, even though the mRNA is a natural gene product, because some other party claims ownership of all the sequences I would use to detect that natural product.

From a scientific perspective, I can see this as having a fairly chilling effect on research. Cancer research, specifically, of a type for which there is significant public interest.
posted by Blazecock Pileon at 2:33 PM on April 12, 2013 [12 favorites]


Deliberately terrible phrasing opens the door to an equally terrible ruling.
posted by Kale Slayer at 2:34 PM on April 12, 2013


Anyway, within about 15-25 years it'll mostly be a non-issue. Essentially all of these patents were filed after the move to a patent term of 20 years after filing, so there are no "submarine gene patents" being held up in the Patent Office, waiting to surface decades later. And almost all of them were filed within a relatively short period of time during and after the Human Genome Project.

Furthermore, commercializing that research is turning out to be harder than some expected—you may have noticed the dearth of personalized medicine and gene therapies—so except for a few companies like Myriad, the huge number of patents related to discovered human genes hasn't led to a lot of commercial monopolies.

And let's not forget the real motivation behind this case. It's not actually about people owning their bodies or personal liberty because of course the patents don't cover the genes in people's bodies, and the complaint that the patents lead to higher costs could be leveled at all patented tests and therapies. The real motivation is that some doctors and hospitals want a cut of the action. Instead of sending samples to Myriad for testing, they want to perform (and charge for!) the test themselves. That's not a reason to root for or against Myriad, but I think it's worth being clear about the actual nature of the case.
posted by jedicus at 2:36 PM on April 12, 2013 [1 favorite]


But you didn't create insulin, you just discovered it.

"The term “invention” means invention or discovery." 35 U.S.C. § 100(a) (emphasis added). The fact that something exists in nature does not make it patent ineligible (with certain narrow judicially created exceptions for things like chemical elements). You're free to make normative arguments about what the law should be, but I am describing the law as it is.

I mean, if you can patent insulin or a strand of human DNA, suddenly the world has six billion people infringing on 'your' product.

I angrily reject the idea that you own any part of me.


I said "isolated, purified insulin." And Myriad claims isolated DNA molecules having a particular sequence (in other words, relatively short snippets of DNA). Neither you nor anyone else on earth infringes such claims. Your anger is misplaced and unjustified.
posted by jedicus at 2:39 PM on April 12, 2013


It's not actually about people owning their bodies or personal liberty because of course the patents don't cover the genes in people's bodies

If one company has a monopoly on the protocols used to detect and describe that gene, perhaps one could reasonably say that said company owns that gene in all people, for the purposes of doing something — anything — useful with that knowledge, like, say, diagnosing a disease.
posted by Blazecock Pileon at 2:41 PM on April 12, 2013 [8 favorites]


Gee, I wonder which way the court will rule?
posted by telstar at 2:50 PM on April 12, 2013 [2 favorites]


I'm really torn on this one, particularly as genetics startups are on my job radar right now.

One of the more prevalent startup models right now is: Genetic researcher gains prominence in academia, venture capitalists offer researcher own lab. That collapses if the lab can't sell its output.

And frankly a lot of the other startups are people providing tools to the labs.

On the other hand established companies like GE are able to fund the research and use the results themselves internally. So it's not like disbarring patents in going to destroy private genetics research completely or anything.

On the gripping hand we're going to be centuries figuring out how this whole thing works, so what's 20 years up front?
posted by Tell Me No Lies at 2:55 PM on April 12, 2013


One of the more prevalent startup models right now is: Genetic researcher gains prominence in academia, venture capitalists offer researcher own lab. That collapses if the lab can't sell its output.

Sorry, but there is not a prevalent startup model where the output of the lab is patenting human gene sequences. That is what Myriad is defending.
posted by grouse at 3:05 PM on April 12, 2013 [2 favorites]


cDNA can already be trivially produced for an arbitrary sequence through well known processes. Practically speaking, it's a commodity now. If you want a particular cDNA sequence you order it from a supplier and they send it to you. You could make it yourself if you're macho, have the equipment, and value money more than your own time.

Myriad isn't driving technology here, they're rent-seeking in a market that's already passed them by because any number of other companies can do this work faster and more cheaply. Patent law seems pretty broken to me (an admitted outsider). In any case, if the law says Myriad gets the patent, then the law is violating its supposed purpose of spurring and rewarding innovation.

The reason this matters now is that people want to do the research now, and people are dying from cancer now. 20 years doesn't matter to human civilization, but it matters a lot to many individual people.
posted by Humanzee at 3:06 PM on April 12, 2013 [8 favorites]


Sorry, but there is not a prevalent startup model where the output of the lab is patenting human gene sequences.

Perhaps we are talking to different startups and different venture capitalists.
posted by Tell Me No Lies at 3:09 PM on April 12, 2013


If one company has a monopoly on the protocols used to detect and describe that gene, perhaps one could reasonably say that said company owns that gene in all people, for the purposes of doing something — anything — useful with that knowledge, like, say, diagnosing a disease.

I think one could reasonably say that the company owns the temporary right to exclude others from making, using, selling, offering to sell, or importing into the United States that particular isolated DNA molecule. Because that's what the patent means.

It absolutely does not mean that the company "owns the gene in all people for any useful purpose." Such patents do not (and indeed by law and PTO policy cannot) extend any property right whatsoever to the genes that exist in human beings.

For example, it seems trivial to say "'gene patents' don't prevent people from reproducing and passing on those genes to their children," but it proves the point that those patents do not give the company "ownership of the gene in all people for all useful purposes." While these particular patents cover sequences that most would just as soon not pass on to their children, that is not true of many other genes for which the corresponding sequence has been patented. And of course many people with BRCA1 and BRCA2 will still choose to have children.
posted by jedicus at 3:12 PM on April 12, 2013


On the gripping hand we're going to be centuries figuring out how this whole thing works, so what's 20 years up front?

On the gripping hand

Oh, you beautiful bastard.
posted by Ryvar at 3:12 PM on April 12, 2013


So would my parents be able to patent me as the creator? This seems strikingly close to land claim by flag, regardless of who is occupying the area.

Discovery of new species does not lead to ownership of rights to that species, so why should discovery of a protein sequence do that?
posted by Phalene at 3:13 PM on April 12, 2013 [1 favorite]


One of the major specific frustrations I have with the Myriad patents is that they purport to extend to every 15-base (A/T/C/G) subsequence of both BRCA1 and BRCA2. BRCA1 and BRCA2 are each thousands of bases long. Some of these subsequences, then, actually exist in other genes and other regions of the genome. A paper that scanned Chromosome I for these 15mers found, indeed, more than 340,000 hits.
posted by en forme de poire at 3:15 PM on April 12, 2013 [10 favorites]


cDNA can already be trivially produced for an arbitrary sequence through well known processes.

The patents in this case were filed a long time ago. The main DNA patent, 5747282, has a priority date of August 12, 1994. cDNA could not be trivially produced in mid-1994.

Myriad isn't driving technology here, they're rent-seeking in a market that's already passed them by because any number of other companies can do this work faster and more cheaply.

It's not about driving technology. It's about recouping investments made decades ago when these were new, unproven, expensive technologies in a nascent field.

if the law says Myriad gets the patent, then the law is violating its supposed purpose of spurring and rewarding innovation.

Myriad already got the patent. This is about whether Myriad keeps it. And it seems to me that the law spurred and rewarded the innovation that was going on in the mid-1990s at a time when these were very new technologies and very new discoveries.

The reason this matters now is that people want to do the research now, and people are dying from cancer now.

Myriad offers the test today and has offered the test for years. Relative to the cost of cancer treatment, the marginal cost of Myriad doing the test versus even the cheapest possible competitor is an absolute pittance. Further, Myriad has not prevented non-commercial cancer research in this area, just doctors and hospitals trying to offer competing tests.
posted by jedicus at 3:19 PM on April 12, 2013


cDNA can already be trivially produced for an arbitrary sequence through well known processes. Practically speaking, it's a commodity now. If you want a particular cDNA sequence you order it from a supplier and they send it to you. You could make it yourself if you're macho, have the equipment, and value money more than your own time.

That's right. It seems like a researcher can't easily use standard biochemical protocols (like using a generically synthesized batch of labeled cDNA) to detect a gene, because any method that permits detection must use material that someone else owns the rights for.

I'm trying to think of a world where patent law supersedes all other interests. Would a researcher have to look at the periphery outside the boundaries of a gene or else risk landing in a courtroom? Would researchers have to develop novel methods based on looking anywhere but the gene itself, in order to figure out how the gene is damaged? As en forme de poire notes, what about genetic regions that do not have any connection with disease phenotype, yet their study would still require licensing agreements as the derivative products are privately owned (however indirectly) by sheer happenstance?

To the extent that such a world is tenable, is this a good use of the legal system or good for society at large? Given what has played out with Myriad, these seem like reasonable questions to ask.
posted by Blazecock Pileon at 3:23 PM on April 12, 2013 [4 favorites]


One of the major specific frustrations I have with the Myriad patents is that they purport to extend to every 15-base (A/T/C/G) subsequence of both BRCA1 and BRCA2. BRCA1 and BRCA2 are each thousands of bases long. Some of these subsequences, then, actually exist in other genes and other regions of the genome. A paper that scanned Chromosome I for these 15mers found, indeed, more than 340,000 hits.

That is not a patentable subject matter issue. That is a written description and enablement issue. In any case, not all of the claims are so broad. There are also much narrower claims that cover only the precise sequences described in the patent. If those broad claims were invalidated, the narrower ones would remain.
posted by jedicus at 3:27 PM on April 12, 2013


Was the mapping of the human genome intended to be for the public good? The patents that have risen out of this seem to suggest that the good of the free market is what we are protecting. Is innovation is stymied if a quarter of the genes are patented? Alternately, how do we reward the companies like Myriad, (or the one next door where I work) for the real work they do. This is complicated and my brain is in knots thinking about it. Myriad shut down their database to protect their intellectual property, however the results are out there and are being pieced together by Dr. Rehm, Dr. Nussbaum, Dr. Bale and others. How do you reconcile genes and profits when people's lives (both figuratively and literally) hang in the balance? Is the question whether human genes are patentable or are we touching the immediate and nearby question of whether research of the patented gene can be protected from infringement action?
posted by Kale Slayer at 3:36 PM on April 12, 2013 [1 favorite]


It seems like a researcher can't easily use standard biochemical protocols (like using a generically synthesized batch of labeled cDNA) to detect a gene, because any method that permits detection must use material that someone else owns the rights for.

Again, to be clear: there has been no claim in this case that Myriad has impeded or threatened genetic research in this area. This is about clinical genetic testing, not research. There is very little empirical support for a patent thicket or patent anti-commons problem in biotech research. See, e.g., John P. Walsh, Charlene Cho, and Wesley M. Cohen, Patents, Material Transfers and Access to Research Inputs in Biomedical Research [pdf], Final Report to the National Academy of Sciences’ Committee Intellectual Property Rights in Genomic and Protein-Related Inventions (2005) ("our results suggest that commercial activity is widespread among academic researchers. However, patenting does not seem to limit research activity significantly, particularly among those doing basic research.") (emphasis added).
posted by jedicus at 3:39 PM on April 12, 2013


I think one could reasonably say that the company owns the temporary right to exclude others from making, using, selling, offering to sell, or importing into the United States that particular isolated DNA molecule.

Myriad claims not only "isolated molecules" but also analysis of the gene, whether it is isolated or not. If you sequence someone's genome and look to at whether a patient's BRCA1 sequence differs from the reference human genome assembly. So it's not correct to say they are just claiming isolated molecules. They are claiming any useful examination of BRCA1 genes.

Myriad has not prevented non-commercial cancer research in this area

Myriad has, for some reason, chosen not to promise that it will not sue those doing non-commercial research, so those doing so have to do so under the cloud of potential litigation. Off a victory in the Supreme Court, Myriad could easily turn around and sue researchers the next day.

Perhaps we are talking to different startups and different venture capitalists.

Perhaps. More likely is that you have been misinformed. But if you believe this is a prevalent model, perhaps you could name a few startups that are engaging in it.

Was the mapping of the human genome intended to be for the public good?

One of the reasons the public consortium to sequence the human genome sped up their efforts was so they could publish the sequence before people could patent more parts of it.
posted by grouse at 3:41 PM on April 12, 2013 [13 favorites]


That is not a patentable subject matter issue.

I didn't claim that it was.

cDNA could not be trivially produced in mid-1994.

Certainly, it is much easier today, but my understanding is that researchers have been preparing cDNA libraries from mRNA since at least the early 80s.
posted by en forme de poire at 3:41 PM on April 12, 2013


The real motivation is that some doctors and hospitals want a cut of the action. Instead of sending samples to Myriad for testing, they want to perform (and charge for!) the test themselves.

Whoa whoa whoa, you're telling me my local private-practice doctor wants to be able to test if I'm at risk for cancer based on published, open scientific data and charge me for that service, rather than shipping my samples off to a multi-billion dollar company that claims to own the knowledge for checking cancer-risk in humans? That sounds like a major scandal.
posted by crayz at 3:42 PM on April 12, 2013 [5 favorites]


Yeah, jedicus is arguing that monopolies are better.

We all know how well that works in practice.
posted by Malor at 3:45 PM on April 12, 2013 [1 favorite]


So it's not correct to say they are just claiming isolated molecules. They are claiming any useful examination of BRCA1 genes.

I'm aware that there are several other patents at issue, but given the focus of the grant of certiorari ("are human genes patentable") and the discussion here, I have limited by comments to the DNA claims. Anyway, so what? People don't infringe those patents just by existing, either, and it's no more represents ownership over people's bodies than a patent on a method of treating a disease by administering a certain drug is ("you're telling me what I can and can't do to my own body, therefore you're claiming to own my body!").

Off a victory in the Supreme Court, Myriad could easily turn around and sue researchers the next day.

It hasn't done so in the past decade-plus. Without getting too far into the legal weeds, the researchers in this hypothetical could raises defenses such as laches and waiver.

But moreover: what on Earth would be the point? It would be expensive, a colossal PR disaster for Myriad and the University of Utah, it likely wouldn't generate more revenue than it cost, and like hell any genetic researcher would ever commercialize their work with Myriad after that. They'd be shooting themselves in the foot just as the patents on their main product are expiring.
posted by jedicus at 3:49 PM on April 12, 2013


Wow. Don't even get started on insulin. As a Type 1 diabetic, I think it's pathetic that after almost a century there's no such thing as generic insulin. My insulin is derived from some modified super-e coli, I understand, but jeez. I can't help but see the whole situation as rent-seeking writ large.

(Not only can I not get generic insulin - and the lower co-pay that that entails - my insurance considers it a PREMIUM brand name drug.)
posted by Benny Andajetz at 3:49 PM on April 12, 2013 [1 favorite]


Whoa whoa whoa, you're telling me my local private-practice doctor wants to be able to test if I'm at risk for cancer based on published, open scientific data and charge me for that service, rather than shipping my samples off to a multi-billion dollar company that claims to own the knowledge for checking cancer-risk in humans? That sounds like a major scandal.

No, it isn't a scandal. It's only semi-scandalous when you compare it to how the case was originally publicized by the ACLU and the other organizations that sponsored it. Originally the case was about personal liberty, bodily autonomy, and especially about bodily autonomy and access to healthcare for women.

And it's true: if these patents were invalidated today, these tests would be available more cheaply from more providers. But I think that's (1) a short-term solution that would ultimately lead to worse results in the future, (2) not the real motivation for many of the parties involved, and (3) not actually complaints that are unique to gene patents and are sham arguments designed to elicit an emotional response to sympathetic plaintiffs (most of whom have since been dismissed for lack of standing).

Now bear in mind: I think we should have universal healthcare in this country. I'd prefer the whole issue of cost and provider were a moot point. It wouldn't matter whether Myriad had a patent and how many providers there were because the government would be the universal insurer and would negotiate the price anyway. But within the system we have, and on the narrow issue of patentable subject matter, I side with Myriad.
posted by jedicus at 3:56 PM on April 12, 2013 [1 favorite]


Again, to be clear: there has been no claim in this case that Myriad has impeded or threatened genetic research in this area.

I don't want to threadsit; this is a topic I'm just interested in. To that point, I think there may are larger issues here than just Myriad and what it might or might not do. Its patent was granted in 1996, which means that there are only a few years left to maximize return for its investors, barring legal shenanigans. So whether this case comes out good or bad for them, it is probably not going to affect the overall profits they have already accrued.

But what is the big picture for life sciences, depending on how the ruling falls? What could change for basic researchers? How do the various implementations of short-term monopolies affect regular people in the backdrop of rising healthcare costs? If this ruling is limited to humans, what will the status quo do for genetic research focused on algae and plant life, potentially affecting access to future alternative energy and food sources?
posted by Blazecock Pileon at 3:56 PM on April 12, 2013 [1 favorite]


People don't infringe those patents just by existing, either, and it's no more represents ownership over people's bodies than a patent on a method of treating a disease by administering a certain drug is ("you're telling me what I can and can't do to my own body, therefore you're claiming to own my body!").

That's your opinion. I think that barring people from examining their own genome sequence without a license is abhorrent.

But moreover: what on Earth would be the point? It would be expensive, a colossal PR disaster for Myriad and the University of Utah, it likely wouldn't generate more revenue than it cost, and like hell any genetic researcher would ever commercialize their work with Myriad after that.

If Myriad truly has no intention of ever suing breast cancer researchers, then it would be easy enough for them to promise to never do this. That would make that issue go away immediately. What on Earth is the point of not doing so? The only point I can see is that they hope to continue to extract money from researchers who think that they might be sued otherwise.
posted by grouse at 4:01 PM on April 12, 2013 [2 favorites]


But what is the big picture for life sciences, depending on how the ruling falls?

Pro-Myriad ruling: status quo maintained; US remains dominant in biotech, where strong patent protection greatly increased investment and innovation in that field compared to Europe. See Opinion of European Union Economic and Social Committee, COM (1995) 661 final (July 11, 1996), (recognizing that "Europe is lagging further and further behind the USA," as evidenced by the stark contrast in number of biotech patents, firms, and products; proposing strong patent protection as in the United States to solve "Europe's backwardness"); Council Directive 98/44, 1998 O.J. (L 213) (EC) (finally providing some protection for biotech inventions to counter the trend of companies preferring to patent in the United States).

Anti-Myriad ruling: investment in biotech dries up; government-funded basic research continues, but without patent protection commercialization withers. Science marches on, but the rate of new diagnostics and therapies decreases. There is some evidence that the markets and investors have already priced this in. Jonathan D. Rockoff & Pui-Wing Tam, Biotech Funding Gets Harder to Find, Wall St. J., Mar. 19, 2012.

How does the various implementations of short-term monopolies affect regular people in the backdrop of rising healthcare costs?

That's a really complicated question, and it's far beyond the scope of this case. At least right now and for the foreseeable future, gene patents play a very limited role in medicine and thus the cost of healthcare. Myriad's test costs about $300-$3000, depending on how many areas of the gene are tested (and is covered by many insurance plans). Compared to the cost of breast cancer treatment, that's trivial.
posted by jedicus at 4:11 PM on April 12, 2013


I think that barring people from examining their own genome sequence without a license is abhorrent.

What's special about a person's genome sequence? What's different about that from barring a person from performing any other diagnostic method on themselves without a patent license? Or from administering a therapeutic drug on themselves without a patent license?

If Myriad truly has no intention of ever suing breast cancer researchers, then it would be easy enough for them to promise to never do this. ... What on Earth is the point of not doing so?

Hmm...easy enough to make a unilateral covenant not to sue (that nobody is particularly clamoring for, by the way) that would have to be carefully (and thus expensively) drafted so that it didn't allow any researchers who also did clinical testing to claim that their clinical practice was covered, just to name one major pitfall. And it'll need to somehow precisely define "breast cancer researchers" in a way that is easily understandable by everyone, neither underinclusive nor overinclusive, and cannot be gamed. Oh, and I imagine you'd want every company, university, etc that holds a gene patent to make a similar promise?

While I'm sure their lawyers would thank you for the billables, given the essentially complete absence of patent infringement suits against researchers over the past couple of decades, it really seems like a complete waste of time and money that would better be spent on, you know, research.
posted by jedicus at 4:20 PM on April 12, 2013


Anti-Myriad ruling: investment in biotech dries up; government-funded basic research continues, but without patent protection commercialization withers.

This is really far-fetched. As you are fond of pointing out, the question presented in this case is whether genes are patentable. Since patents on human genes are not a major product of current biotech investment, preventing the patenting of human genes shouldn't have major effects on who continues to invest. In fact, it would allow the investment in new enterprises that use modern whole-genome technologies that would otherwise be stopped by human gene patents.

What's special about a person's genome sequence?

It is a product of nature that defines the whole of a person's genetic program. Preventing a person from examining their own genome sequence prevents them from knowing their true self.

Oh, and I imagine you'd want every company, university, etc that holds a gene patent to make a similar promise?

No, I'd rather just see the Supreme Court strike down human genes as patentable subject matter. That would save even more time and money that would be better spent on, you know, research.
posted by grouse at 4:36 PM on April 12, 2013 [9 favorites]


In fact, it would allow the investment in new enterprises that use modern whole-genome technologies that would otherwise be stopped by human gene patents.

That's a really major problem here, I think. To give one example, if you have to outsource analysis of BRCA1/2 to a third party even though you're getting information about the patient's entire genome, you are blind to any potentially important interactions between, say, BRCA1/2 and other tumor suppressors. It is not just a question of having an alternative to the exact service that Myriad provides.
posted by en forme de poire at 4:50 PM on April 12, 2013 [2 favorites]


Preventing a person from examining their own genome sequence prevents them from knowing their true self.

Or maybe it tells us our true selves are just commodities, bought and sold like everything else.
posted by Blazecock Pileon at 4:57 PM on April 12, 2013 [2 favorites]


"It’s as if somebody had a patent on the X-ray images of the pelvic region of a human being," says Weaver. "You could administer the test, but you wouldn’t be able to inform the patient about that region. It’s crazy."
This is basically the crux of it all. The line of patentability needs to be drawn somewhere. Saying "gene patents" is such a broad thing that it's hard to know what exactly is being patented. Using the X-ray analogy, here's one way to portray the gradient, where the "pelvic region" is analagous to a particular gene, such as BRCA1:
  1. Nothing about the X-ray or anatomic region or reporting is patentable
  2. A particular design of X-ray machine, is patentable, but you can't patent it's specific use in specific ways
  3. A particular machine and particular way of choose to point it at the pelvic region is patentable
  4. Any X-ray machine, pointed at the pelvic region, where the doctor reports answers back to the patient
  5. Any device that collects information about the pelvic region by any means and reporting to the patient
  6. Any device that reports anything about the pelvic region
Obviously, there many many more fine gradations here. But with these current patents, we're at 5. One could imagine being at 6, and it sounds like the only reason we're not at 6 is that Myriad has decided it's not worth pursuing academic research on "the pelvic region."

So why is the line drawn at 4/5? It shouldn't be arbitrary. The reason that we draw the line at anywhere except 1 is to promote economic and inventive activity. There is no inherent property in intellectual inventions or discoveries, it's a legal invention. The reason is to provide enough of a carrot without the stick of monopoly crushing too much activity.

IMHO, viewed from that angle, drawing it at 4/5 seems completely insane. It prevents far more discovery than it promotes. Myriad has been doing some amount of discovery on BRCA1 as they develop their test, but their variant database for germline (your normal genome) variants is only 50% of the story. Mutations in BRCA1 and BRCA2 in your tumor are a whole other ball of wax, and Myriad isn't even doing anything with that. And getting that answer right is essential for an entire class of cancer drugs, PARP inhibitors.

If this patent is overruled tomorrow, it will have basically no effect on Myriad's profits or revenues, because nobody will be able to do what Myriad is currently doing. Myriad's true value isn't "we know where the pelvis is and can give you an image of it" their true value is "oh, I see your pelvis is broken here." The true value is in the data that they've collected over the years: the list of all the variants of BRCA1&2 in the human population, and which of these variants put you at higher hereditary risk of cancer. It's worth noting that this extremely valuable database is protected by trade secret, rather than by patent. And if this database of information were out in the public, it would be greatly beneficial for all sorts of scientific discovery regarding basic biology (i.e. if the database contents were patentable and out in the open, it would enable more scientific discovery both in the basic biology of the BRCA1 and BRCA2 genes, as well as larger stories about the implications of particular variants).

The reason that drawing the gene patentability line here is so pernicious to economic activity is that it prevents an entire new class of business that has been opened up. I should say that I have an intense economic interest (and academic interest, but nobody cares about disclosing those interests) in this patent being overturned. I'm at a startup that has been operating as though Myriad's patents would be overturned. We're not trying to do what Myriad is doing. We're not competitors. But their extremely broad and extremely vague patents would stymie an entire new industry, all the while providing no benefit to Myriad. And such is the case with all the "don't look here" patents. At least Myriad is doing something with their patent.

To the scientists and jedicus, I greatly appreciate your comments here, they have made this a far more productive discussion that the typical PATENTZ BAD GRAH GRAH that one encounters on the web
posted by Llama-Lime at 5:04 PM on April 12, 2013 [17 favorites]


I'm not even sure where to start...something like 20% of the human genome is under patent and to imply gene patents have not impacted clinical genetic testing is disingenuous and disregards government studies confirming patents affect access and innovation. Athena holds patents on numerous genes and some of those genes are only available through panels costing thousands of dollars often with no reduction in price if the familial mutation is already known and full sequencing is not needed. Even if access to the patented gene is granted, use may be restricted.

Also, advances in methodologies cannot be disregarded. Genome wide testing is here and not going away whether by aCGH studies or by exome studies. The American College of Medical Genetics and Genomics just announced a list of mutations for which all patients undergoing whole exome studies should be studied for and BRCA1/2 is on that list.

All in all, I think most labs are hoping that sheer force of numbers will prevent Myriad and Athena from being able to continue their miserly holds.
posted by beaning at 5:52 PM on April 12, 2013 [6 favorites]


crazy: Whoa whoa whoa, you're telling me my local private-practice doctor wants to be able to test if I'm at risk for cancer based on published, open scientific data and charge me for that service, rather than shipping my samples off to a multi-billion dollar company that claims to own the knowledge for checking cancer-risk in humans? That sounds like a major scandal.

From the Time article Bitter Pill, Why Medical Bills are Killing Us [prev]:
The country's largest lab tester is Quest Diagnostics, which reported revenues in 2012 of $7.4 billion. Quest's operating income in 2012 was $1.2 billion, about 16.2% of sales.

But that's hardly the spectacular profit margin we have seen in other sectors of the medical marketplace. The reason is that the outside companies like Quest, which mostly pick up specimens from doctors and clinics and deliver test results back to them, are not where the big profits are. The real money is in health care settings that cut out the middleman - the in-house venues, like the hospital testing lab run by Southwestern Medical that billed Scott and Rebecca $132,000. In-house labs account for about 60% of all testing revenue. Which means that for hospitals, they are vital profit centers. Labs are also increasingly being maintained by doctors who, as they form group practices with other doctors in their field, finance their own testing and diagnostic clinics. These labs account for a rapidly growing share of the testing revenue, and their share is growing rapidly. These in-house labs have no selling costs, and as pricing surveys repeatedly find, they can charge more because they have a captive consumer base in the hospitals or group practices. They also have an incentive to order more tests because they're the ones profiting from the tests. The Wall Street Journal reported last April that a study in the medical journal Health Affairs had found that doctors' urology groups with their own labs "bill the federal Medicare program for analyzing 72% more prostate tissue samples per biopsy while detecting fewer cases of cancer than counterparts who send specimens to outside labs."
posted by peeedro at 6:58 PM on April 12, 2013 [1 favorite]


The country's largest lab tester is Quest Diagnostics, which reported revenues in 2012 of $7.4 billion. Quest's operating income in 2012 was $1.2 billion, about 16.2% of sales.

Myriad is quite a bit smaller, with revenues in 2012 over only $496 million. But since they have a monopoly on their product and are legally protected from competition, unlike Quest, they can set the high prices that allow them an operating income of $180 million, 36.4% of sales, or more than double what Quest gets.
posted by grouse at 7:14 PM on April 12, 2013


Sure, but the assumption that testing will automatically be cheaper when unencumbered by patents isn't a given when we know that in-house testing labs routinely over-charge and over-test captive patients because the doctors and hospitals have financial incentive to order these tests.
posted by peeedro at 7:22 PM on April 12, 2013


Sure, but the assumption that testing will automatically be cheaper when unencumbered by patents isn't a given when we know that in-house testing labs routinely over-charge and over-test captive patients because the doctors and hospitals have financial incentive to order these tests.

The assumption that competition will lower prices isn't a given, so let's not allow competition. Got it.
posted by crayz at 7:30 PM on April 12, 2013 [4 favorites]


Further, the implication seems to be that nobody will be interested in doing research to improve people's health unless they can make millions doing so.

I don't think it works that way.
posted by Malor at 9:13 PM on April 12, 2013 [1 favorite]


I'm torn on this because, at least with patenting, you have to publish enough of what you are doing so that other people can follow your lead mumble mumble years later. With trade secret things might never appear on the radar depending upon how careful you are and how viciously you defend your non-disclosure agreements.
The difference is that in the past finding a gene and sequencing it, and developing a test for it was expensive and difficult. Now it's super easy and cheap, and you can sequence entire genomes and then just 'grep' for it.

Imagine if people could patent genes that predict how well certain people respond to specific medicine. There would be now way to both know that information an use that information without telling people about it.
Which is just a terrible phrasing. What does "human gene" even mean in this context? In my view, nobody is patenting a human gene.
Completely disingenuous. They are obviously patenting a gene. If they were only claiming their patents applied to 'isolated' sequences it wouldn't have any effect on whole-genome sequencing.

Secondly, genes are isolated in cells all the time as a part of the DNA->RNA->Protein process. Claiming that genes only exist in chromosomes is totally false.
Wow. Don't even get started on insulin. As a Type 1 diabetic, I think it's pathetic that after almost a century there's no such thing as generic insulin.
There is, it's just that the non-generic type is cheaper to produce.
posted by delmoi at 10:11 PM on April 12, 2013


Further, the implication seems to be that nobody will be interested in doing research to improve people's health unless they can make millions doing so.

I don't think it works that way.


Altruism is fickle. Trust in greed.
posted by Tell Me No Lies at 1:08 AM on April 13, 2013


Jedicus: Why is there a judicially-created exception for the chemical elements?

It seems like discovery of elements is a good analogy for discovery of genes. They're both natural phenomena, and some don't occur by themselves in nature. Americium is a synthetic element, not found in nature, yet useful for household objects (smoke detectors).

Genes are not naturally found in isolated form. Calcium is not naturally found in its elemental state. So why are elements unpatentable but genes are patentable?

(Honest question. I don't see how the analogy doesn't hold, but I'm sure it must have been brought to the attention of the courts.)
posted by Sleeper at 2:49 AM on April 13, 2013 [1 favorite]


Furthermore, commercializing that research is turning out to be harder than some expected—you may have noticed the dearth of personalized medicine and gene therapies...
posted by ennui.bz at 6:01 AM on April 13, 2013


Can We Patent Life?
posted by homunculus at 10:05 AM on April 13, 2013


Jedicus: Why is there a judicially-created exception for the chemical elements?

Let's run with that a bit. One may not patent chemical elements as they are naturally occurring substances - nothing was added by the would-be patentor. However, one may patent specific uses of elements, or processes they are involved in, or combinations of elements with other elements (known as "compounds.")

Myriad is patenting two variations of a gene that are naturally occurring. However, they are patenting their use as prognostics for people who are "at risk" of developing cancer. Also note, the diagnosis is not a perfect correlation - it is not a 100% certainty, though with both genetic variations, the likelihood gets to be ~80% IIRC. They are also patenting a method of detecting the variation and, as has been alluded to above, they continue to spend quite a bit of time and money trying to refine and make clearer, specific variants and their relationship to cancer (ie, which are more exact for what types of cancer, where "type" doesn't necessarily just mean the organ where the cancer occurs.)

In re: Quest's revenues, Pfizer had $59B of revenue's last year. Quest is small stuff in that regards. But neither the pharma or diagnostics companies are the biggest drivers of healthcare costs, it's for-profit hospitals. Which does not excuse what may be seen as excessive profits, I just don't think we're focused on the right problem. But seeing big prices for "just a few pills" or 1/2 a day's work in testing, doesn't track where the growth of costs is primarily coming from.
posted by BillW at 7:37 PM on April 13, 2013 [1 favorite]


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