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An important breast cancer test is now unavailable in British Columbia
October 21, 2002 10:02 AM   Subscribe

An important breast cancer test is now unavailable in British Columbia because of the American company which holds the relevant patent. The B.C. Cancer Agency has been forced to stop the tests after legal threats by Utah-based Myriad Genetics Inc., which has a patent on two genes that can signal whether a woman may develop hereditary breast cancer. I think this is a perfect example of why patenting genes is a terrible idea. Via Slashdot.
posted by homunculus (39 comments total)

 
I guess I don't understand the patent process. I thought you could only patent something you *invented*. If we can start patenting body parts, I'm filing a patent for toenails.

I'd file a patent for brains, but considering how little used they are these days, I don't think I could sue people for much.
posted by GhostintheMachine at 10:14 AM on October 21, 2002


I think you are correct. That is godawful.
posted by Fabulon7 at 10:14 AM on October 21, 2002


Interesting issue, although i'm not sure it's so black and white. Without the expectation of a patent and the resulting revenue, the Utah company probably wouldn't have invested in the research to discover the gene in the first place. So then you have no test at all rather than an expensive one.

One might imagine an alternative world where the research on genes is left primary to government-funded labs and research institutions. It might work just as well as private enterprise, or possibly even better because the research agenda would be driven by public health concerns rather than profit. But since that system is not currently in place, it's hard to see how eliminating the patent system for genes would ultimately help people who are at risk of hereditary illnesses.

Also, I'm curious why the Canadian health system doesn't pay for these tests if they are medically indicated?
posted by boltman at 10:16 AM on October 21, 2002


Because the Canadian health system can't afford $3,500US tests. I support the other provinces who are ignoring the patent. I understand the argument that companies might not pay for the research without expected revenue, but these guys are putting profit before the health of people and that's wrong. Governments need to do more to protect people's rights to accesible health care. At least they should here in Canada, where universal health care should still mean something.
posted by Salmonberry at 10:26 AM on October 21, 2002


Warning--this is speculation:
If the test is used to determine if you may develop hereditary breast cancer, then it is probably given to women who are not necessarily suspected of actually currently having breast cancer.
In that case, the test would not meet the criteria of medically necessary, and the gov't wouldn't pay for it.
Like I said, I'm just speculating.
posted by Fabulon7 at 10:27 AM on October 21, 2002


Some health insurance companies will pay for a portion of the test. I live in the US and went through my HMO when I took one of the BRCA gene mutation tests, because I couldn't afford the premium.

The problem with allowing insurance to pay is that if you test positive for the gene mutation, will the insurance use that as a reason not to insure you, or to charge you a higher premium? So far this hasn't happened, but it doesn't seem unlikely in the future.

I think it is important to note that the test is still available to people in B.C., they simply have to send the sample to Utah. This is what I had to do. I would be surprised if Canadian health care did not pay for a portion of the cost.
posted by birgitte at 10:31 AM on October 21, 2002


Can someone more familiar with this line of patenting answer a question: what did Myriad actually patent, the gene or the test for the gene? It would appear from the linked article that they patented the gene itself (not that I understand how a human body part could be patented in the first place), so on what grounds would they be denying BC the right to determine if the gene is present in patients? I could understand if they had a patent on the test - they could just say, Hey, you can't use our test, only we can use our test! - but on the gene itself?
posted by JollyWanker at 10:36 AM on October 21, 2002


I thought you could only patent something you *invented*.

Myriad doesn't hold a patent on the genes themselves, they hold a patent on the "purified gene isolated from its natural state" (language from the U.S. Patent and Trademark Office). The process of isolation is necessary to perform the test. Right now, to get a patent "on a gene", one must isolate the gene and identify its function or medical implications. Here's a short article describing the guidelines. Note that genes aren't the first naturally occurring products to be patented: there have been patents issued for things like germ-free yeast and purified biochemicals. So "patenting a gene" isn't as ridiculous as it sounds.

That said, I still think that there are problems with the process. Primarily, the existing rules have encouraged companies to begin patenting their discoveries at the earliest possible stage, leading to broad, overly general patents. A solution would be to require patent applicants to describe a specific application for the gene: a test or treatment (better still if they had to demonstrate this application, but that's never going to happen in the current intellectual property environment).
posted by mr_roboto at 10:41 AM on October 21, 2002


JollyWankter - From the Myriad patent:

The present invention relates generally to the field of human genetics. Specifically, the present invention relates to methods and materials used to isolate and detect a human breast and ovarian cancer predisposing gene (BRCA1), some mutant alleles of which cause susceptibility to cancer, in particular breast and ovarian cancer. More specifically, the invention relates to germline mutations in the BRCA1 gene and their use in the diagnosis of predisposition to breast and ovarian cancer. The present invention further relates to somatic mutations in the BRCA1 gene in human breast and ovarian cancer and their use in the diagnosis and prognosis of human breast and ovarian cancer. Additionally, the invention relates to somatic mutations in the BRCA1 gene in other human cancers and their use in the diagnosis and prognosis of human cancers. The invention also relates to the therapy of human cancers which have a mutation in the BRCA1 gene, including gene therapy, protein replacement therapy and protein mimetics. The invention further relates to the screening of drugs for cancer therapy. Finally, the invention relates to the screening of the BRCA1 gene for mutations, which are useful for diagnosing the predisposition to breast and ovarian cancer.

It is interesting to note that the patent relates to gene therapy for the BRCA1 mutation, which from what I've read hasn't happened yet. Can you patent 'gene therapy' if you haven't actually performed it?
posted by birgitte at 10:49 AM on October 21, 2002


"Without the expectation of a patent and the resulting revenue, the Utah company probably wouldn't have invested in the research to discover the gene in the first place "

I'm not sure this is true. Research mapping the human gnome sequence, by the "Human Gnome Project" was released patent free via the internet in 2000 after the publicly funded research programme became a race between the Private/commercial and Public/Academic sphere's. The UK project leader John Sulston (recently awarded the Nobel Prize for in Medicine) was the main advocate for 'donating' the research to 'public community' early to prevent the patenting of the human gnome by a private organisation - therefore preventing the commercial sphere from restricting further research for commercial gain.
posted by keno at 11:02 AM on October 21, 2002


Gnomes are funny.
posted by Robot Johnny at 11:06 AM on October 21, 2002


Can you patent 'gene therapy' if you haven't actually performed it?

Their patent does cover gene therapy (or any type of therapy) for breast or ovarian cancer which involves brca1. Outside of these 2 types of cancer, the patent probably wouldn't hold up. Let's hope the challenges to the patent have some success.

There are ongoing clinical trials of gene therapy for breast and ovarian cancer utilizing brca1, but they started long after the patent was issued and, as far as I can tell, don't involve Myriad people. I'm sure, however, Myriad would love to see them succeed.
posted by shoos at 11:18 AM on October 21, 2002


Unbelievable, it's bad enough that Western medical science is straying from preventative methods and siding with the "let's blast those diseases to kingdom come" approach to wellbeing in general. Now they're patenting genes?

Considering health has a lot to do with one's state of mind, I'm sure many people could do without the knowledge that they may be at risk of developing a certain disease because it's in their genes...
posted by Resonance at 11:20 AM on October 21, 2002


keno: I don't think the patent office (at least the US or European ones) would award a patent on a mere gene sequence (which was what the genome project was about). Myriad was allowed the brca1 patent because they had a clear diagnostic (and likely therapeutic) application for the gene.
posted by shoos at 11:25 AM on October 21, 2002


shoos - thanks for the information regarding gene therapy

Resonance - Those people who could do without the knowledge probably wouldn't the take the test in the first place. No one is forced to do it. Also, Myriad has strict guidelines regarding counseling before the test, and information and counseling available after the results are known. Results are only given by doctors to individual patients. It isn't like you get a letter in the mail saying 'congratulations you have a hereditary likelihood for a disease'.

I'm not saying I support Myriad's patent, but speaking as someone who has actually dealt with them, I do support the way the genetic testing is handled.
posted by birgitte at 11:38 AM on October 21, 2002


Shoos: no, the HGP wasn't about just a single sequence it quickly changed its target from mapping 6% of the gnome to the entire genome once the commercial organisation 'Celera Genomics' (founded by Craig Venter, whom had left the public project) was established. By the time of the 6/2000 release 90% of the whole gnome had been sequenced:

from HGP website "People have to take democratic responsibility for the human genome," says Dr Sulston. "It’s not something that can be left to the commercial manufacturers, like making motor cars." This principled stand was vindicated in March 2000 when US President Bill Clinton and UK Prime Minister Tony Blair issued a joint statement endorsing the public release of genomic data."

Also US Patents have been released to Incyte and Human Genome Sciences for single sequences.
posted by keno at 11:46 AM on October 21, 2002


Slightly off topic but if you go to the Cigna web site and click on the pink ribbon, Cigna will donate $1.00 to fight breast cancer.


Click on the pink ribbon at www.cignafoundation.org
posted by ahimsakid at 12:03 PM on October 21, 2002


Patent wording or not, I think the point here is that a company has made a potentially breast saving technique out of reach to those in British Columbia who cannot pay the copious amounts of cash to said company. That's capitalism for you.
posted by dazed_one at 12:41 PM on October 21, 2002


Patent wording or not, I think the point here is that a company has made a potentially breast saving technique out of reach to those in British Columbia who cannot pay the copious amounts of cash to said company. That's capitalism for you.

Isn't it great? Without that incentive, that gene might not have been discovered at all, and no test would exist. Then no one would have access to it. It's pretty clear to me which is the better result. (Note that patent protection implies that the test will go out of patent eventually and then anyone can use it.)

I'm in favor of government-sponsored research that results in freely-available non-patented genetic tests and drugs and medical equipment. But if a private company takes the risk involved to discover this, how can we justify taking away their rights to make money off of it? Without that reward, the risk would never have been taken. If we make exceptions and allow patent infringement to go on for certain critical tests like this, then I guarantee you no company will be willing to take the risk to develop more such critical tests in the future.

Which is better? Progress that costs something or no progress? There may be better ways to make progress that cost less, but those methods aren't being used. At least this company is doing something to fill in the gap.
posted by daveadams at 1:26 PM on October 21, 2002


You know, there are other ways of reducing the cost of these tests without messing with the patent system. Governments can subsidize the costs for lower income people, or impose price controls within their jurisdictions, or use their bargaining power as major purchasers of health care serives to force them to lower prices in order to get the government's business.

While all of these alternatives have their own set of issues, any of them would be better then making breakthroughs in genetic technology unpatentable, IMO.
posted by boltman at 1:39 PM on October 21, 2002


Daveadams: You say no company would try to find cancer-causing genes if they couldn't patent the genes, but wouldn't there still be money to made on the test for the gene, even if the gene itself were unpatentable? The choice isn't between "Myriad gets nothing" and "Myriad gets whatever it wants." (If it is, maybe we should make patents permanent to increase the incentive for researchers.) France's Curie Institute believes it cannot even improve on the test to find other mutations, because their improved test also finds Myriad's gene. This isn't the best way to promote research.
posted by Yogurt at 2:02 PM on October 21, 2002


As for whether the gene would have been discovered without Myriad, according to this page, Myriad used information from a European group of researchers called Breast Cancer Linkage Consortium. The BCLC was also researching the BRCA1 gene. Myriad reached it first and patented it. It doesn't sound like it would have been undiscovered for long. The BCLC started using in camera meetings to keep information from Myriad. A charity group found BRCA2. Myriad is trying to use its patent to get the patent on BRCA2. The argument that we need to bathe Myriad in money to promote breast cancer research seems to be a philosophical position, one that's not supported by the facts.
posted by Yogurt at 2:15 PM on October 21, 2002


Keno: I know. My point was that the aim of the project was mere sequencing, and a sequence (for a single gene or an entire genome) is not enough in the eyes of the patent offices to merit patenting. Even if they had wanted to, the people behind the HGP couldn't have gotten a single patent from their work without including a practical use for any given sequence they may have wanted to patent.

And the Incyte and Human Genome Sciences patents are as well not for the mere sequences. These companies provided specific applications for the sequences.

There's a good discussion of what's needed to get "gene patent" here.
posted by shoos at 4:48 PM on October 21, 2002


Yogurt: Myriad already has patents covering brca2. The 'charity' group also filed applications around the same time, but I don't know if they were awarded.
posted by shoos at 5:00 PM on October 21, 2002


I feel about this the same way I feel about Internet music pirating. People who advocate the more liberal, and in many cases more sensible position against absolute control of intellectual property by its inventor/artist/discoverer, need to approach the issue from a standpoint of basic respect for intellectual property and for payment for those who risk / invest to develop and exploit it.

This situation is even worse. Although Kazaa can argue with some credibility that privately-pirated MP3s won't ever destroy the economics of the music industry, it is simply impossible to argue that government-led and directed theft of intellectual property in the health sphere won't, if allowed to flourish, have a devestating affect upon health innovations. Bioscience requires massive long-term venture capital and private equity investments, and the capital markets will not hesitate for one second to pull the plug on funding research if it seems likely that the fruit of a successful multi-year discovery and exploitation process will be expropriation by governments.

Useful bioscience patents last only a relatively few years beyond the point where an invention is clinically proven and widely available. The worst case scenario is that a few people too poor to get a treatment or test suffer for a few years, and then, after the invention enters the public domain, everyone benefits from the now cheap test or treatment. The other option is that no one, ever benefits, because the investment won't have occurred in the first place.
posted by MattD at 5:11 PM on October 21, 2002


Isn't it great? Without that incentive, that gene might not have been discovered at all, and no test would exist.

Bullshit. The European Consortium, already mentioned, was already well on its way to sequencing the gene; and if not them, Canada makes significant advances in cancer research every year: if the Europeans hadn't discovered it, a Canadian would have.

...will not hesitate for one second to pull the plug on funding research...

Uh-huh. And the slack will be taken up by (publicly funded) Universities, (publicly funded) research institutes, and (partially publically funded) charities.

Just as has been the case for eversomany advances in health sciences.
posted by five fresh fish at 6:53 PM on October 21, 2002


Five Fresh Fish: I have great respect for what academic bioscientists accomplish, but they cannot replace the role of the private sector, or remedy the destruction of the private sector bioscience caused by systematic theft of intellectual property.

The triple imperatives of academic research are basic/conceptual advances (the Nobel Prize motives), highly likelihood of positive, publishable results (the get tenure / keep your job motives), and, of course developing opportunities to get into the commercial world one's self.

Contemporay genomic and bioinformatic clinical-level discovery involves shotgunning many different approaches at a health problem and hoping for a result, and then hoping that the result will pass through three phases of FDA scrutiny. In the genomics world, there's the further hurdle of hoping that the discovery will have a useful path to a therapy. Academic labs are spectacularly ill-suited, from a structural, organizationa, and institutional incentive standpoint, to make up for the loss of private sector discovery research.

This is to say nothing of your apparent comfort with replacing the private capital markets with increased taxation...
posted by MattD at 7:08 PM on October 21, 2002


Shoos: The charity group is the Imperial Cancer Research Fund and it is now part of Cancer Research UK, which is also a charity. A UK patent and an Australian patent were awarded to its commercial arm. You're right that Myriad now has the US patent to BCRA2 and they're fighting the other two patents. Perhaps they've won, although I couldn't track that down.

The fact that such races between private and public groups exist convinces me that we don't need to give monopolies on gene sequences to convince people to find them. Even if no one in the world wanted cancer cured as a goal in itself, there's plenty of money to be made with tests and treatments based on unpatented sequences.

MattD: In this situation, the public sector very clearly could replace Myriad's work. Indeed, Myriad piggybacked on public medical work and is instead doing some of its best work in the courts. Are there any examples to support your view? Can you think of a company whose valuable gene sequences might not have been found if left to public researchers?
posted by Yogurt at 7:46 PM on October 21, 2002


Hello, everyone... I've lurked on MetaFilter for almost a year now, and this topic is one I think I can contribute to.

I'm a graduate student in genetics, and spent some of my graduate studies working across the hall from a diagnostics lab (ie, the people who actually perform the 'test' Myriad has patented). Hopefully I can provide a little insight.

For starters, Myriad did not discover BRCA1 or BRCA2. The complete sequences for these genes existed in the public domain. The patent holders have a patent stating that they can sequence BRCA1 for the purposes of detecting possibly cancerous mutations in relatives of breast cancer patients.

Myriad did not develop a 'test'. A complete sequencing of this gene is required because any number of mutations in BRCA1 may (or may not be) conducive to tumour formation. Unlike diseases like cystic fibrosis (where a handful of mutations of a chloride ion channel gene represent >70% of CF-causing mutations), familial breast cancer has no common tell-tale mutations. Essentially the 'test' is a complete sequence of BRCA1. Myriad has not provided any special technology that facilitates this process, and it isn't as though complete gene sequencing is a novel idea. Moreover, even if someone does have a mutation in BRCA1, it is not necessarily conducive to cancer. The results obtained by sequencing BRCA1 are by no means black and white, and there is a high potential for false positives, where individuals carry harmless variants of the gene. To further complicate this issue, there are many, many genes which when mutated, may be conducive to familial breast cancer. Knowing an individual's sequence for BRCA1 does completely determine a hereditary predisposition to breast cancer.

The diagnostics lab I mentioned earlier charged roughly 600 Canadian dollars per test. This covered material costs and salaries for the technicians performing the test. The people who work in this lab were essentially heartbroken to hear that Myriad was attempting to enforce their patent. By demanding almost six times the cost of the basic test, this company is essentially holding family members of breast cancer patients hostage.

If Myriad had provided a rapid, accurate, and novel means of detecting BRCA1 mutations, then I would have no argument. But successfully obtaining a patent for the process of sequencing a single gene is simply unreasonable.
posted by vesper at 7:51 PM on October 21, 2002


Thanks for an excellent post vesper. I think the real issue in this case is, as you suggest, whether what Myriad patented can really be classified as property from the perspective of patent law. Maybe it can't/shouldn't--I'm not really sure based on the somewhat contradictory statements that have been posted so far in this thread. I initially thought that this gene patent was more analagous to a patent on a pharmaceutical or a technological device rather than a surgical technique, but now I'm not so sure. If it's like a drug, patent protections should clearly apply. If it's like a surgical techinque, I have grave doubts.

Like I said in the beginning, it is a facinating issue and one that I'm sure will be litigated extensively over the next decade.
posted by boltman at 8:40 PM on October 21, 2002


boltman: I would agree with you in comparing BRCA1 sequencing to a surgical technique, as opposed to a tangible product. I'm not sure if patenting techniques is appropriate or not, but I'm pretty confident that it isn't appropriate when the technique in question is just an amalgamation of existing, public domain knowledge.

(Apologies for the lengthy intro post... I'll work on my pithy quips.) ;-)?
posted by vesper at 9:03 PM on October 21, 2002


Vesper: Welcome to the club. We need more biologists like you around here.

Myriad did in fact first identify (positionally cloned and completely sequenced) BRCA1, with little help from publically available sequence. They were also the first to compile a complete sequence for BRCA2, although they did use a significant portion of publicly available partial sequences. The English group was first to publish a (partial - about two-thirds of the coding) sequence of BRCA2.
posted by shoos at 9:50 PM on October 21, 2002


Yogurt: I did find out about the English group's US patent. They did get one, but they licensed it to a US company, Oncormed, which went down the tubes and then sold it to Myriad.
posted by shoos at 9:56 PM on October 21, 2002


shoos: I looked up the UniGene entry for BRCA1 Hs.194143, and the oldest complete mRNA sequence, U14680. There are two citations there, a paper by Miki et al. (1994), and below that, a comment that Skolnick himself, the senior author on Miki's paper, had submitted the sequence to GenBank two weeks before the Science paper came out. I stand corrected.

So, the senior author of that paper was in fact involved in Myriad. Generally when things are published in a scientific journal they are public data, and when things are submitted to a public database (like NCBI) they also become public knowledge. Did the Myriad patent come out before 14 September 1994 (the date of the GenBank submission)?
posted by vesper at 10:24 PM on October 21, 2002


Actually, the USPTO gives applicants a year between publically disclosing an invention and the deadline for filing. If a over year passes between disclosure and filing, then you're out of luck.

You can check www.uspto.gov to look at myriad's patents. The earliest BRCA1 patent I found was apparently submitted June 7, 1995, but they may have submitted a 'provisional' application before this. The patent was awarded in '98.
posted by shoos at 11:48 PM on October 21, 2002


IP laws do two things: they promote innovation economically, and they restrict the actual process of innovation temporarily. That is why it is necessary to make sure the terms of ownership are the shortest possible while still allowing sufficient economic incentive. It is also necessary to examine in each category of proposed protection whether the incentive will provide stimulation enough to overcome the handicap. Based on the number of public and charitable institutions concurrently working on similar research, this case is an argument that gene sequences do not need IP protection to stimulate research. Other cases would have to be evaluated to determine whether this is true for a significant portion of sequencing research. If it is, then IP protection should be revoked for gene sequences, as the benefits do not outweigh the costs.
posted by Nothing at 4:04 AM on October 22, 2002


European Parliament resolution on the patenting of BRCA1 and BRCA2 ('breast cancer') genes.
A WSJ article on this issue.
An article outlining the Institute Curie's/France's reactions
Excerpt:
European patent attorney Jacques Warcoin says the patent will thus
stifle innovation in France. He also notes that identification of the
BRCA1 gene was made possible by the work of many research teams, as well
as with the collaboration of women from at-risk families. What’s more,
that groundwork helped geneticist Mary-Claire King of the University of
California, Berkeley, accomplish the key step of assessing 183 possible
genetic markers for breast cancer and narrowing the list to one on
chromosome 17. King published her team’s work in late 1990; on the
strength of her findings, Myriad isolated the BRCA1 gene some four years
later.
A collection of articles on various Gene Patents including BRCA-1/2.
Is it just my impression, or is it that gene patents rarely involve important original research and are simply races to patent already existing knowledge?
posted by talos at 4:58 AM on October 22, 2002


vesper & shoos: Wow, thanks for your enlightening posts. For a complete outsider to the gen-tech business, it's a little mystifying how all this can be legal (although obviously, as the opinions in this thread demonstrate, there's still some room for debating whether "legal" = "ethical"), but your explanations and links really helped a lot.
posted by JollyWanker at 6:36 AM on October 22, 2002


The "legal" = "ethical" question I think is central here. The Myriad patents may in the future be pared down if they are challenged in court, but until that happens, in the eyes of the law, Myriad merited those patents.

Is it just my impression, or is it that gene patents rarely involve important original research and are simply races to patent already existing knowledge?

No, it's not just your impression, talos. Sometimes people patent stuff they didn't genuinely think up or develop themselves. This is against patent law, which says that only "whoever invents or discovers" something can patent it. But the USPTO is way overwhelmed with applications to be able to effectively determine inventorship for every case. So they rely on subsequent legal challenges by the 'true' inventors to sort things out.

In the case of Myriad, they themselves did identify BRCA1 and 2 as breast cancer-linked genes and were more or less the first to do so. As you suggested, however, they did also rely on tons of previous work by other groups (including Mary-Claire King's) who didn't get any credit, patent-wise, for helping to identify those genes. It's really like giving the medal just to the anchor on a relay team, but that's the way the patent system works.
posted by shoos at 7:24 PM on October 22, 2002


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