Breast Cancer Gene Lawsuit Argues Patents Invalid

bkuhn writes "The ACLU and the Public Patent Foundation have filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. The lawsuit (PDF) was filed on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, breast cancer and women's health groups, and individual women. Individuals with certain mutations along these two genes, known as BRCA1 and BRCA2, are at a significantly higher risk for developing hereditary breast and ovarian cancers."

Comments

I don't understand it.

[FlyingSquidStudios]

Can someone explain to me why it's legal to patent genes in the first place? I thought patents were supposed to be for new and unique inventions.

Re:I don't understand it.

[Duradin]

Monsanto would be the one to ask about that.

Re:I don't understand it.

[click2005]

IANAwhatever but I thought what was patented was the way these genes are found/isolated. Any drug/treatment that affects these genes will use that method.

Re:I don't understand it.

[ByOhTek]

It depends. If it is a gene you yourself designed, then it is a reasonable target for a patent (or, more likely, copyright). However, if it's a gene that occurs in nature, then it makes no more sense to patent that gene than a species of plant or animal, a rock you found walking into work in the morning, an ocean or a star (stellar, not media - actually, maybe both would make sense, thought the latter isn't natural).

Re:I don't understand it.

[HomelessInLaJolla]

These patents do not cover only the gene sequence. These patents often are related to the methods by which the gene sequence was identified within the particular culture of cells from which it was taken. The patent may also cover the methods by which those cells were cultured or the methods by which those cells were derived from other cell lines. The patents also may cover the methods by which this particular sequence may be used to identify other tissues containing cells which, by matching this sequence, will match the cell line from which the sequence is derived--thereby solidifying the position of the inventors if a diagnostic test were to ever be developed. For example, in a question of a patient population with multiple cancers, or with multiple different forms of the cancer in question (breast cancer), are those patients viable candidates for treatment with a pharmaceutical which was developed specifically to target the cancer which is characterized by the DNA sequence given in this particular patent? We wouldn't want to develop a pharmaceutical to treat cancers characterized by sequence ABC and then give that pharmaceutical to patients with a similar cancer displaying sequence CBD.

These are all very logical reasons why these patents exist. If you know how the industry works, though, none of them really hold any water in true practice. Patents are nothing but resume boosters for scientists and the patents rarely, if ever, actually monetarily benefit any of the named inventors except for the lead investigator(s). If you are socially and financially well-connected to begin with then your patent may help you. If not then the patent is the legal paperwork by which the company or group you worked for can use to cut you out of all profits. In most companies a large number of patents will translate into a significant salary increase or a promotion for the lead investigators but translates into little more than a token fee (usually around a dollar, or a single option of stock, or something similar) in exchange for which the employee signs away all rights to claim ownership of their own work.

Re:I don't understand it.

[drinkypoo]

I don't remember electing Monsanto. Perhaps we should be asking our elected officials why Monsanto is permitted to continue to exist after their numerous offenses against not just the citizens of the USA, but actually humanity. Even Wikipedia seems to have forgotten the contaminated agent orange thing :P

Re:I don't understand it.

[starfire-1]

I have a sneaking suspicion that you are right - this isn't about the gene itself, but how to isolate/observe, etc. That process could very well be an invention and it certainly cost R&D money to the original developer.

I guess the question comes down to whether patent protection for health related concerns should be exempted as some (not myself) consider health care a right (I consider it a need and responsibility to procure, but not a right that I expect others to provide for me.)

The plaintiffs are clearly attempting to use this case to overturn all health related patents (in the article) and in my opinion pull health related research from the private sector to the public sector. This would bolster the advocates of national health care and create another (unwritten) constitutional right.

Re:I don't understand it.

[Organic Brain Damage]

"Your" elected official? Did you give "your" elected official more money than Monstanto gave "your" elected official? I didn't think so. So she is not really "your" elected official. Is she? Of course not.

Re:I don't understand it.

[nomadic]

I don't remember electing Monsanto. Perhaps we should be asking our elected officials why Monsanto is permitted to continue to exist after their numerous offenses against not just the citizens of the USA, but actually humanity. Even Wikipedia seems to have forgotten the contaminated agent orange thing :P

Because the elected official then turns around, quotes the Bible, and promises to lower your taxes, and you vote for him or her.

Anyone willing to limit corporate power is typically not elected, and not because Monsanto gave them money but because of tax-cut and deregulation fanaticism.

Re:I don't understand it.

[giminy]

Can someone explain to me why it's legal to patent genes in the first place? I thought patents were supposed to be for new and unique inventions.

You don't patent the gene, you patent the process of identifying and using knowledge about the gene.

The reason that it's legal to 'patent genes' is that is very, very, very (did I mention very?) expensive to discover which gene(s) control an aspect of a plant or animal. My girlfriend is a molecular scientist, so I get to hear about her research woes all of the time. Without some protection of a genetic discovery, it makes no financial sense for a company to actually do the research and discover which genes control an aspect of a plant or animal's composition. A discovery takes at least 5-6 years of research from several researchers, associated support staff, and requires some fairly expensive equipment.

There seems to be a lot of people calling Myriad a big, evil, genetic patent holding corporation. All that I can say is, look at their financials. They spend hundreds of millions of dollars per year doing genetic research, and they make very little money in return for their investment. When I last examined their financials (beginning of 2008 I think), they had been operating at a loss since they went public. They are advancing human knowledge quite a bit, and they will probably go out of business for it within a few years. I posted their financials to slashdot some time ago (feel free to look up their tax forms, they're a publicly traded company). In 2007, they reported a huge operating loss and came out and said in their disclosure that they are in business because of continued shareholder investment.

I, for one, see genetic patents as a necessary evil. If someone or some company is going to take the time and money to make a genetic discovery, they ought to be given some time to try and profit from that discovery. Genetic sequencing is not a quick nor an easy task -- there's a lot more to it than just throwing some genes in the PCR machine and pushing the 'sequence' button. For what it's worth, my girlfriend is also a likely candidate of the BRCA1 gene, as every female in her family that has been tested for it, has it. She is still okay with genetic patents. And no, we're not cold, heartless capitalists...we shop at the co-op, have a garden, brew our own beer, make our own biodiesel, and do all the things that good hippies should do...it's just that without Myriad, *no one* would know that having the BRCA1 gene was a precursor to breast cancer.

Reid

Re:I don't understand it.

[RawJoe]

One of the patents cited was 5,747,282.

Claim 1 states:

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2

I'm not any genetic engineer, but it seems they are receiving a patent on the specific DNA coding. So did they "discover" the code or is this code used to locate BRCA1? Seems pretty broad.

Re:I don't understand it.

[Duradin]

And this is where someone should point out that this would be an excellent reason to support government funded general scientific research.

It's expensive, offers little return on investment monetarily but could greatly benefit the populace.

Corps aren't shelling out the cash like they used to on research that wasn't going profit the shareholders within a couple of years.

Re:I don't understand it.

[osgeek]

Or your elected official promises to tax the rich and give you free health care, and you vote for him or her... then turns around and behaves in exactly the same corrupt way that you expected "the other team" to behave.

Despite that identical outcome, you'll pat yourself on the back that you elected the team that says the right things with Olberman cheerleading you the whole way - while Sean Hannity and his players are gnashing their teeth and decrying the corruption that was okay when it was their guys.

Montasano gets rich, the Politicians get rich, freedoms and quality of life issues suffer... but at least you get to hate those other guys.

We are so fucked.

Re:I don't understand it.

[osgeek]

Dude, don't come to Slashdot and make some logical argument about the good side of gene patenting and how this might be a complex issue where the knee-jerk reaction of "patents are bad!" might not apply.

Before your little intellectual escapade, everyone was having a nice circle jerk criticizing the evils of human greed to try to make a buck based upon little knowledge and much angst.

Your kind of informed opinion isn't appreciated here!

Re:I don't understand it.

[Daniel Dvorkin]

Without some protection of a genetic discovery, it makes no financial sense for a company to actually do the research and discover which genes control an aspect of a plant or animal's composition.

Which is why most such research is done in university labs, not corporate. There has been for decades a perfectly good method of advancing scientific knowledge and turning it into usable technology: academic researchers, paid primarily with public funds, do the basic science, and that fraction of it which turns out to be commercializable gets taken up by corporate engineers. This balance started to fall apart with Bayh-Dole and Diamond v. Chakrabarty, and things have been getting worse ever since.

Re:I don't understand it.

[gambino21]

I think this is what you were getting to, but I just wanted to clarify. The constitution actually doesn't grant us any rights. By default you have the freedom to do whatever the hell you want, and the only thing the government can do is decide which of your innate rights it wants to take away. The founders understood this and argued about whether a bill of rights was necessary, because all it does is state rights that we already have. The first ten amendments don't actually grant us any new rights, they only list rights that the government is not allowed to take away.

It's too bad that most people don't understand this and believe that they only have the rights that they are given by the government. It should be the other way round, meaning you have all rights except for those that the government explicitly takes away.

Re:I don't understand it.

[drinkypoo]

Not my elected official, ours. While you are technically correct, attitudes like yours are self-defeating. We make them our official again by holding them accountable. We begin by making people aware of their culpability.

The greatest trick the two-party system ever pulled was convincing voters that voting for "third" parties is a waste.

Re:I don't understand it.

[TooMuchToDo]

As an IT professional/business owner who took up farming for the fun of it (124 acres to start, slowly buying up more land), farming is like owning a vineyard. You barely break even most years. So do I blame farmers who are trying to make their lives easier with Montasano products? No. I do blame Montasano for their practices, and because of that don't use their products myself.

Re:I don't understand it.

[Zordak]

Just to add a little clarity, you cannot patent anything that occurs in nature. But these folks managed to convince the courts that these genes are not naturally occuring because they don't occur alone in nature. They always occur in some kind of gene sequence. It's somewhat analogous to if gold only occurred naturally in ore, and you were therefore granted a patent on pure gold once you figured out how to extract it. I'm not saying this is good (in fact, I think it's ridiculous), but that's the theory.

Re:I don't understand it.

[Ikonoclasm]

They're patenting the sequence of amino acids. They say this is patentable because it excludes the introns and is after the post-transcription modifications. Patent law excludes naturally occurring phenomenon. The sequence is a naturally occurring phenomenon after the excision of the introns (don't ask about the language, we know it's goofy) and post-transcription modifications. It all occurs in nature and is thus unpatentable. However, the USPTO has decided that whatever happens after translation is patentable, which makes no sense from either a legal or scientific standpoint (which I happen to have experience in both).

I was finishing my undergrad degree in Genetics and working for a patent agent writing claims and detailed descriptions for biotech patents when I discovered this loophole in patent law. I was livid as I knew first hand how toxic IP law is to scientific fields and had assumed, based on the explicit language of the law, that my chosen field would be only minimally affected.

Basically, the prosecution is going to have to call on some good expert witnesses to explain every stage of how DNA is translated and transcribed into proteins. They'll need to put it in language a judge/jury can understand while also constantly pointing out what the law currently says you cannot patent a natural occurrence, which a gene sequenced from a living organism most certainly is.

As others have mentioned, custom genes that are made in a lab and did not evolve naturally, those are perfectly reasonable to patent. Hell, even mixing and matching parts of different, naturally-occurring genes into a new gene is reasonably patentable. Patenting a naturally occurring sequence that exactly matches the gene as it has evolved to function in the cell is a gross violation of the law.

Re:I don't understand it.

[John Newman]

it's just that without Myriad, *no one* would know that having the BRCA1 gene was a precursor to breast cancer.

Are you ^!&%! kidding? Are people so bamboozled by the FUD of pharmaceutical companies that anyone who doesn't know the truth assumes that the big, nice company must have sunk a ton of time and money into finding this gene from scratch, and without them the gene would never have been found? The truth is very, very different, and this is why Myriad is so hated in the scientific community.

BRCA1 was discovered by Mary-Claire King, now a geneticist at the University of Washington, following over a decade of government-funded basic science work that started when she was a graduate student and then junior faculty at UC Berkeley. Back then genetics was hard work - not hard like today, *really* hard. When she started no one really believed that one could even find a gene for a trait that wasn't expressed 100%, it just seemed too complicated to pick one mutation out of a huge haystack when you had to allow for some people having the bad mutation yet having a normal phenotype. Remember this is before the human genome project, before automated sequencing; she even started before PCR. Just pinning the candidate gene down to one small region of one chromosome took over a decade of work by dozens of people.

As the process came towards fruition, they first narrowed the field to a small part of chromosome 17 (paper), then made a laborious map of the region of interest (paper), and then together with a group at the NIH, they identified the actual single gene we now know as BRCA1, sequenced it, and spelled out the mutations in it that caused breast cancer in the affected families (paper1, paper2). Notice that all of this was done completely in the public eye, with all of her lab's results published immediately so as to help other researchers advance the field with her. It was good science.

But wait, where's Myriad genetics so far? What's left to do? Didn't we already "discover" BRCA1? How could anyone patent it now? All good questions. The next thing to do was to make a copy of this gene, by itself, in a test tube. This would be preliminary work for all sorts of biochemical analysis. The act of copying a gene off of a chromosome onto a separate loop of DNA in a test tube is called "cloning". Cloning is still pretty hard even today, especially for long genes like BRCA1. It can take months, especially since you usually need to copy it in bits and then glue those bits together.

What Myriad understood, and perhaps Dr. King did not, is that a cloned gene (that loop in a test tube) is patentable because it's considered "artificial", even if it's a perfect copy of a natural sequence of DNA. Myriad jumped in at this point, threw their whole company into cloning the gene and then patenting it, and did it before Dr. King or anyone else realized they were in a race. Ironically, Dr. King's lab had probably already cloned it in pieces (usually a prerequisite to sequencing) but hadn't made a complete intact copy yet, and certainly hadn't filed any patents. Myriad did none of the prior work on BRCA1. They did not come up with the idea of hereditary breast cancer. They did not do the laborious work of mapping where BRCA1 might be. They did not pinpoint the gene that was BRCA1. They did not sequence

Re:A sad day

[bothemeson]

Surely if you patent the trolls parts instead then you've got them by their own petards :-)

New Business Model

[arthurpaliden]

Patent a gene and then sue anyone who has it. Even better would be to copyright it and then get $700 per copy in the body.

Re:New Business Model

[TheRealMindChild]

You poke fun, but this happens with genetically modified corn

Michael Crichton would be pleased

[Supp0rtLinux]

Michael Crichton just popped up in his casket and gave these guys a huge HIGH 5

Michael Crichton's Gene Patenting Rant

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[account_deleted]

Comment removed based on user account deletion

Re:Bingo!

[Darby]

Of course, you are welcome to disagree that this will work because neither regulation nor free markets have a pristine track record, hence the continued debate,

Well, you're falling into a very serious error here by setting up a false dichotomy. "Regulation" and "Free Markets" aren't in any way opposites. Regulation is absolutely 100% necessary to the existence of anything even remotely approximating a free market. "Unregulated markets" and "Regulated markets" are actual opposites. Unregulated markets will never be anything like a free market. A properly regulated market can approximate a free market.
An actual free market doesn't exist, has never existed, and can't possibly ever exist under any conceivable set of circumstances. It's an idealized hypothetical thing like the various frictionless planes, pulleys and such from high school physics.

As long as people keep pretending that the debate is how you framed it, then there will never be reasonable discussion of the issue in the public domain. This is especially true since the people who benefit from un or poorly regulated markets are the ones framing the debate since they're the ones who own all of the media outlets etc.

claiming that the "right" wants to be ruled by powerful corporations because of deregulation is like claiming that the "left" likes to kill babies because they want to allow the choice of abortion.

The right consists primarily of the people who own the powerful corporations and the idiots who have been duped into believing that "the Right" means "Liberalism" (Small government, fiscal responsibility, individual liberty etc) when the right is an inherently elitist philosophy. Heck, the right is called the right because the representatives of the church and aristocrats sat on the right in the French assembly. The right *is* theocracy, feudalism, fascism etc. The representatives of the people sat on the left, hence the term "left", and hence the association of the left with "the people" against the "elites".

Liberalism came later and was a rejection of *both* the left and the right. Left and right are both about using the power of the state to screw people for your benefit. Liberalism is the philosophy that nobody or group should be able to use the power of the state for the purpose of screwing individuals.

It is the philosophy that America was explicitly founded on. People today don't even know that. They think "Liberalism" means "whatever somebody calling themselves a 'Liberal' says" which is obviously a worthless definition. There doesn't exist another word in the English language apart from "Liberalism" to describe America's founding philosophy, so it makes it tough to discuss since the Left have coopted and the Right have demonized the term. This is because both the right and the left *despise* Liberalism and always have.

So, you, by pretending that the right stands for liberalism and the actual right doesn't even exist aren't helping to promote a more honest dialog, you're helping promote a redefinition which removes the terms necessary to accurately describe the political landscape.

The powerful corporations are perfectly happy to have massively oppressive regulation of the people for their benefit. The recent bailout is a right wing initiative. *I*, the individual, was robbed at the behest of said corporations for their benefit.
When "the rich" are robbed for the benefit of "the people", that's the left. When nobody is robbed by anybody by the government, that is a distinctly different position from either of the above.

That very real and very critical distinction is entirely eliminated by the redefinitions you're going with.

That is one of if not the most critical thing standing in the way of honest, non-partisan debate in this country. We don't even have to words to have such debate.