US Court Rules Again That Natural Phenomena Cannot Be Patented, Casting Further Doubt On Gene Patents

Back in June, Mike wrote about the important Myriad Genetics judgment from the Supreme Court, which said that naturally-occuring genetic material could not be patented. However, because of some hedging from the judges, there were concerns about how much this would block gene patents in practice. Last week we had an indication that the impact is indeed likely to be significant, as VentureBeat reports: 

On Techdirt.

How Long Before A Patent Kills A Hundred Million People?

Recent news that Angelina Jolie underwent a preventive double mastectomy because of her elevated risk of developing breast cancer has drawn attention to the Myriad Genetics case currently before the US Supreme Court, and to the whole area of gene patents. Myriad's monopoly has allowed it to set a high price for its tests -- $3000 -- and this is bound to have acted as a disincentive for those who were unable to afford such a sum. It is therefore quite likely that people have died as a result of Myriad's patents. 

On Techdirt.

The Main Problem With Patented GM Food Is The Patent, Not The Fact That It's GM

The acrimonious debate and serious lobbying that developed around California's Proposition 37, which would have required the labelling of genetically-modified ingredients in food products had it passed, is an indication that the subject inspires extreme views and involves big money. But an interesting post in Slate argues that GM labelling is really a minor issue compared to the main problem -- gene patents: 

On Techdirt.

James Watson, Co-Discoverer Of DNA's Structure, Says 'Patenting Human Genes Was Lunacy'

Techdirt has been covering the important Myriad Genetics case for a while. Although the CAFC decided that isolated genes could be patented, the Supreme Court has asked the appeals court to review the case in light of the former's rejection of medical diagnostic patents. 

On Techdirt.

How Gene Patents Cause Suffering

Here's a textbook case of how gene patents not only do *not* promote innovation, as is so frequently claimed, but slow it down - and will probably cause millions to suffer as a result.

An AIA lawsuit filed in February 2010 against the Jackson Laboratory in Bar Harbor, Maine — a source of laboratory mice funded by the US National Institutes of Health (NIH) — now threatens hundreds of government-sponsored Alzheimer's researchers with litigation.

But wait, what patent might that be?

The suit concerns an AIA patent on a human DNA sequence used in mouse models of Alzheimer's disease. The sequence encodes the 'Swedish mutation' (discovered in a Swedish family), which causes early-onset Alzheimer's. Michael Mullan, a biomedical researcher who is now head of the Roskamp Institute in Sarasota, Florida, patented the sequence in 1995, then sold it to the AIA.

So this concerns a *human* DNA sequence, found in a Swedish family. That is, it is something natural, that was discovered, not invented in any sense. And yet a patent was granted on this non-invention, and this ill-considered move is now casting a chill over an entire field of research that could potentially alleviate the suffering of millions.

Now, tell me again how gene patents promote innovation and progress...?

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Enclosing the Ocean Commons

The oceans belong to everyone - well, more or less. That is, they form a classic commons. But of course, that fact doesn't stop people claiming that they own stuff even here:

Molecules derived from marine resources and used for medical applications were worth over $1 billion in 2005, and heat-stable enzymes obtained at undersea vents were worth $150 million. Not surprisingly, the business community has responded by patenting genes derived from marine organisms; the authors were able to identify over 8,500 sequences derived from a total of 520 species in a US gene patent database.

This is a double insult to humanity. Genes are part of the DNA commons, and "belong" to everyone or to no one, but certainly not to any one entity. Those genes were extracted from marine animals, which form part of another commons, the oceans' ecosystems, that also belong to everyone or to no one.

But instead of simply recognising those commons, and letting everyone benefit from them directly, the best the patent maximalists can come up with is a cartel, a.k.a. patent pool:

they also suggest that, in the case of marine materials, a patent pool organized within this framework might improve access to genetic information and distribute the risk and profits broadly among far more nations, rather than limiting it to the few countries that can afford high-throughput DNA sequencing.

The logic here seems to be that of course we need patents otherwise nobody will go to the trouble of sequencing all these interesting organisms. What this overlooks is that the cost of sequencing genomes has come down from a billion dollars (for the first human genome) to a few thousand. Next year it will probably be under $1000, and the year after that a few hundred. In a decade, sequencing will cost almost nothing.

What this means is that, once more, intellectual monopolies are being given away needlessly - no quid pro quo is in fact necessary because practically anyone will be able to do this for very low cost. And once again it's you and me who lose out, as knowledge is sent to the intellectual equivalent of Davey Jones's Locker....

Speaking of Monsanto and Gene Patents...

And right on cue, like the catastrophe of the old comedy, comes some fresh news about Monsanto and its gene patents:

Monsanto Co., facing antitrust probes into its genetically modified seeds, may benefit from previous court rulings in which intellectual property rights trumped competition concerns, antitrust lawyers say.

Got that? Intellectual monopolies, as well as being inherently bad, are also a "Get Out of Jail Card" for companies breaking anti-trust law. Broken, or what? (Via @schestowitz.)

Where Do I Stand on GMOs?

I'm conscious that I've written a lot of negative posts about genetically-modified organisms on this blog. That might lead readers to believe I'm against them. That's not the case: I am naturally pro-technology, and GMOs are potentially an important tool for addressing many of the world's most pressing problems. But I have my concerns, and I was pleased to find that Salon's Andrew Leonard not only shares them, but has expressed them rather well:

I don't actually have a position on whether GMOs are by definition good or bad for the environment or human health or even the challenge of alleviating hunger in the developing world. My basic stance, in fact, is pro-science: I believe technological advances have greatly advanced human health and affluence, and will continue to do so, if properly regulated. My concern re GMOs has always stemmed from a profound skepticism that profit-seeking corporations can be trusted to responsibly serve the public good. One need look only at the constant stream of reports detailing unethical and criminal behavior by major pharmaceutical companies to realize that this is hardly a hypothetical concern.

In the case of GMOs we are dealing with a remarkable concentration of intellectual property ownership in just a handful of corporations. Like all well-endowed corporate actors, these companies do not shy from vigorously lobbying governments in favor of putting into place place legal frameworks that are designed to maximize profits and minimize caution.

Exactly: what worries me is the way that global companies are using GMOs, and the intellectual monopolies they represent, as instruments of power - particularly over poor farmers in developing countries - purely to bolster their market and financial positions. The sooner we can de-fang companies like Monsanto - for example by revoking gene patents - and explore the potential of GMOs in an objective and scientific manner, the better.

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No Patents on Seeds...or We're Really Stuffed

Good to see that I'm not a lone voice crying in the wilderness:

The continuing patenting of seeds, conventional plant varieties and animal species leads to far-reaching expropriations of farmers and breeders: farmers are deprived of their rights to save their seeds, and breeders are under strong limitations to use the patented seeds freely for further breeding. The patent holder controlls the sale of the seeds and the planting, decides about the use of herbicides and can even collect royalties at the harvest – up to the finished food product.

Our food security is increasingly dependent on a few transnational chemical and biotechnological companies.

The European Patent Office (EPO) has continuasly broadened the scope of patentability and undermined existing restrictions, in the interest of multinational companies.

Allthough plant varieties and animal species are by law exempt from patentability several hundret patents on genetically modified plants have been granted already. Basis for these decissions is the highly controversial EU Biotech Patents directive and a decission by the EPO's Enlarged Board of Appeal, which ruled in 1999 that in principle such patents could be granted.

Now the European Patent Office again has to deal with a basic question: Patents on conventional plants and animals!

The Enlarged Board of Appeal of the EPO will use a patent on broccoli (EP 1069819) for a fundamental ruling, on whether or not conventional plants are patentable. The broccoli in question was merely diagnosed using marker assisted breeding methods to identify its natural occuring genes. The genes were not modified. All other broccoli plants with similar genes are considered as "technical inventions“ by the patent. Thus even their use for breeding and the plants themselves are monopolised. Through this the provision which prohibits the patenting of "essentially biological proceses" is to be undermined. The EPO has already granted similar patents: e.g.: only recently the company Enza Zaden Beheer received a patents on pathogene resitant lettuce ( EP1179089B1)

Should the Enlarged Board of Appeal uphold the patent, then this decission (case T0083/05) will be binding for all other pending patent applications and even for animals and their offspring.

This exactly parallels the situation with software patents, where the EPO is using every trick in the book to approve them; except it's even worse.

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Intellectual Monopolies Kill: Two Examples

One of the reasons I object to the term "intellectual property" is that its cuddly familiarity makes it hard for people to understand that intellectual monopolies kill thousands of people every year - something that seems unlikely for "property". Here are just two of the many ways in which they do so - both involve patents on genetic material.

First example:

This week, genetic patents came under a full-bore legal assault when groups representing more than 100,000 doctors and researchers, working together with lawyers at the Public Patent Foundation and the American Civil Liberties Union, filed suit against the PTO and Myriad Genetics, a Utah-based genetic testing company. It's a lawsuit two years in the making.

The suit's immediate goal is to invalidate seven patents that give Myriad the sole rights to administer tests and do research connected to a pair of genes closely connected to breast and ovarian cancer, BRCA-1 and BRCA-2 (pronounced "bracka-one" and "bracka-two.") Should the plaintiffs prove successful, though, their strike against the PTO would have far-reaching implications.

...

Myriad is a ripe target for a several reasons. First, the patents it holds are on tests that diagnose breast and ovarian cancer. That got the attention of ACLU lawyers who focus on women's rights. Second, Ravicher says that—unlike some corporate patent-holders that widely grant low-cost licenses to researchers—Myriad has aggressively enforced its patents, making them particularly harmful.

"They have gone around and shut down researchers who are doing BRCA1 and BRCA2 research and providing clinical services," Ravicher says. "That includes universities like the University of Pennsylvania and New York University. They send cease and desist letters, and threaten to sue people."

This affects people directly and adversely:

Six named plaintiffs in the case are women who have been diagnosed with ovarian or breast cancer and have been unable to get proper treatment because of Myriad's patents. Lisbeth Ceriani, for example, is a single mother from Massachusetts who was diagnosed with breast cancer in May 2008; she can't her blood samples processed by Myriad because they won't accept her coverage from MassHealth, a Medicaid insurance program for low-income people. Another plaintiff, 39-year-old Genae Girard, wanted a second opinion after she tested positive for a dangerous mutation under Myriad's test—but because of Myriad's enforcement of its patent rights, is unable to get that second opinion.

If people with breast cancer genes are demonstrably suffering in this way, statistics tells us that some of them will be dying as a direct result of Myriad's aggressive defence of its unwarranted intellectual monopolies.

Example two:

Tara Lohan: Farmer suicides in India recently made the news when stories broke last month about 1,500 farmers taking their own lives, what do you attribute these deaths to?

Vandana Shiva: Over the last decade, 200,000 farmers have committed suicide. The 1,500 figure is for the state of Chattisgarh. In Vidharbha, 4,000 are committing suicide annually. This is the region where 4 million acres of cotton have been grown with Monsanto's Bt cotton. The suicides are a direct result of a debt trap created by ever-increasing costs of seeds and chemicals and constantly falling prices of agricultural produce.

When Monsanto's Bt cotton was introduced, the seed costs jumped from 7 rupees per kilo to 17,000 rupees per kilo. Our survey shows a thirteenfold increase in pesticide use in cotton in Vidharbha. Meantime, the $4 billion subsidy given to U.S. agribusiness for cotton has led to dumping and depression of international prices.

Squeezed between high costs and negative incomes, farmers commit suicide when their land is being appropriated by the money lenders who are the agents of the agrichemical and seed corporations. The suicides are thus a direct result of industrial globalized agriculture and corporate monopoly on seeds.

This is a particularly clear example of how intellectual monopolies take away at every level: they make seeds *less* useful, more controlled and more expensive. For hundreds of thousands of the farmers, who had managed to eke out an existence using natural seeds, the shift to those with built-in DRM and protected as part of an intellectual monopoly has not just been disastrous, but literally fatal.

So when people extol the virtues of "IP", remember that these monopolies may only be "intellectual", but they have very real blood on their virtual hands.

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The Common Thread: Open Data, Open Access

Sir John Sulston is one of this country's - and the world's - heroes. Already a one-time Nobel prize winner for his work on worms (well, cell death, more precisely), he stands a good chance of winning another one for his work on the human genome project. But his contribution there is even greater: he was one of the main people behind making the human genome data freely available immediately, with no strings attached - one of the first, and still biggest, wins for open data.

One knock-on effect was that this made patenting genes harder in those jurisdictions benighted enough to allow it - something that Sulston has railed against loudly. As it happens, there is currently a major court case in the US is trying to undo some of the stupid earlier decisions in this respect: this is a biggie, so let's keep our fingers crossed.

But Sulston is not resting on his considerable laurels; he's at it again, working this time with a traditional publisher to edit a major new series of books that will be freely available online under a CC licence:

Sir John Sulston, Nobel prize winner and one of the architects of the Human Genome Project, has teamed up with Bloomsbury to edit a new series of books that will look at topics including the ethics of genetics and the cyber enhancement of humans.

The series will be the first from Bloomsbury's new venture, Bloomsbury Academic, launched late last year as part of the publisher's post-Harry Potter reinvention. Using Creative Commons licences, the intention is for titles in the imprint to be available for free online for non-commercial use, with revenue to be generated from the hard copies that will be printed via print-on-demand and short-run printing technologies.

As for the topics:

Sulston and Harris's series, Science, Ethics and Innovation, will be aimed "at a very wide market", covering subjects from "the interplay between science and society, to new technological and scientific discoveries and how they impact on our understanding of ourselves and our place in society", and the responsibility of science to the wider world. Authors they will be looking to commission will range from academics to policymakers, opinion formers, those working in commercial scientific roles, "and maybe even politicians". "They'll be non-technical books which will appeal to any intelligent person," said Harris. "The proverbial Guardian reader."

This is whole area of openness is one where Sulston has been active for decades. Indeed, alongside open data and open access he is also a big supporter of free software, and hugely savvy about the ethical aspects of this movement. If you want to find out more about this extraordinary man and his amazing career, I strongly recommend his autobiography: The Common Thread.

How Sick Are Patents? Ask Indonesia

Some time back I noted that one of the crazier consequences of an obsession with intellectual monopolies was that vital health information - specifically, DNA sequences of bird flu viruses - were not being released to other laboratories for fear that the unscrupulous might patent the damn things (as if naturally-occuring DNA could be patented). Fortunately, the country in question, Indonesia, was persuaded to release them to the scientific community for the common good. And what happens? This:

A recent patent search has revealed that the CDC, which is a WHO collaborating centre, is applying for a patent for a new vaccine against influenza, particularly for bird flu (H5N1). The vaccine incorporates genes from a H5N1 strain isolated from an Indonesian human victim of bird flu in 2005.

The strain that contains the genes was transferred to the WHO GISN by Indonesia for characterization for public health purposes, but may wind up as the property of the US government.

Under US law, the US government agencies would offer licenses to the technology to pharmaceutical companies. The patent application indicates that the US government intends to pursue the claim in most countries of the world, including Indonesia itself, as well as neighboring countries.

Got that? Indonesia releases the sequences, and the US CDC does indeed patent that information, a situation which could then force Indonesia to pay for vaccines based on its own sequence data to protect its citizens. This probably means that fewer vaccines will be bought, more people will die, more mutations in the flu virus, and more deaths globally. So how, exactly, is this particular intellectual monopoly good for the world?

I just hope that one day a book is written about this, and the people responsible are named - and utterly shamed - for actions that are not only morally despicable in themselves, but which endanger literally the whole of humanity. How sick is that...? (Via How the World Works.)

A New Institute for Science, Ethics and Innovation

One of the most remarkable men around today is Sir John Sulston. He's already won a Nobel Prize for his work on nematode worms/apoptosis, and he seems certain to share another for his work on the Human Genome Project. He really ought to get a couple for that, since he was the leader of the forces that kept the human genome free and (relatively) unpatented - think of him as the RMS of the genome (he's also a big fan of free software).

So it's great to see his passion for ethics being channelled in a new institute, which opened last Saturday:

The mission of the Institute for Science, Ethics and Innovation (iSEI) is to observe and analyse the role and moral responsibilities of science and innovation. The institute will examine the ways in which science is used in the 21st century, evaluate possible or desirable changes, and consider the forms of regulation and control of the process that are appropriate or required.

More power to his elbow.

The Genome Goes Read-Write

Good Craig:

Craig Venter, the controversial DNA researcher involved in the race to decipher the human genetic code, has built a synthetic chromosome out of laboratory chemicals and is poised to announce the creation of the first new artificial life form on Earth.

...

Mr Venter said he had carried out an ethical review before completing the experiment. "We feel that this is good science," he said.

Bad Craig:

He has further heightened the controversy surrounding his potential breakthrough by applying for a patent for the synthetic bacterium.

The old dichotomy....

The Bad Boy of Genomics Strikes Again

When I was writing Digital Code of Life, I sought to be scrupulously fair to Craig Venter, who was often demonised for his commercial approach to science. Ind fact, it seemed to me he had often gone out of his way to make the results of his work available.

So it's with some sadness that I note that the "Bad Boy of Genomics" epithet seems justified in this more recent case:

A research institute has applied for a pat­ent on what could be the first largely ar­ti­fi­cial or­gan­ism. And peo­ple should be al­armed, claims an ad­vo­ca­cy group that is try­ing to shoot down the bid.

...

The ar­ti­fi­cial or­gan­ism, a mere mi­crobe, is the brain­child of re­search­ers at the Rock­ville, Md.-based J. Craig Ven­ter In­sti­tute. The or­gan­iz­a­tion is named for its found­er and CEO, the ge­net­icist who led the pri­vate sec­tor race to map the hu­man ge­nome in the late 1990s.

The re­search­ers filed their pat­ent claim on the ar­ti­fi­cial or­gan­ism and on its ge­nome. Ge­net­i­cally mo­di­fied life forms have been pa­tented be­fore; but this is the first pa­tent claim for a crea­ture whose genome might be created chem­i­cally from scratch, Mooney said.

This is problematic on a number of levels. For a start, it shouldn't be possible to patent DNA, since it is not an invention. Simply combining existing sequences is not an invention either. There is also the worry that what is being created here is the first genomic operating system: locking others out with patents maans repeating all the mistakes that have been made in some jurisdictions by allowing the patenting of conventional software.

Softly, Softly on Software Patents

This response to an e-petition "to make software patents clearly unenforcible" is interesting:

The Government remains committed to its policy that no patents should exist for inventions which make advances lying solely in the field of software. Although certain jurisdictions, such as the US, allow more liberal patenting of software-based inventions, these patents cannot be enforced in the UK.

The test used to discern between patentable and non-patentable subject matter in the UK has recently been clarified by the courts, and is applied rigorously by the Patent Office. Under this test, the true nature of the advance being claimed in a patent application must be determined, and if this advance lies solely in the field of software, or another non-technical field such as methods of doing business, the patent will not be granted. If the advance being made by an invention does lie in a technical field, it must also be non-obvious and sufficiently clearly described for the invention to be reproduced before a patent will be granted by the Patent Office.

The recently published Gowers Review of Intellectual Property, an independent review commissioned by the Government, recommended that patent rights should not be extended to cover pure software, business methods and genes. The Government will implement those recommendations for which it is responsible, and will therefore continue to exclude patents from areas where they may hinder innovation: including patents which are too broad, speculative, or obvious, or where the advance they make lies in an excluded area such as software.

Although it is little more than a statement that the current position will be maintained, it does contain the important confirmation that there are no plans to follow the US down the primrose path to the fiery furnace, and that US software patents are not enforceable in the UK. I suppose we should be grateful for small mercies.

Credit, too, to the 10 Downing Street site for responding in this fashion to a petition that garnered relatively few signatures (I didn't see it and so didn't sign).