US Says Genes Should Not Be Patentable

Geoffrey.landis writes "A friend-of-the-court brief filed by the US Department of Justice says that genes should not be patentable. 'We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA,' they wrote (PDF). The argument that genes in themselves (as opposed to, say, tests made from genetic information, or drugs that act on proteins made by genes) should be patentable is that 'genes isolated from the body are chemicals that are different from those found in the body' and therefore are eligible for patents. This argument is, of course, completely silly, and apparently the US government may now actually realize that."

Comments

Monsanto will most likely get this reversed

[bl8n8r]

Because it will affect their monopoly, which is anti-capitalist. http://www.sourcewatch.org/index.php?title=Monsanto,_Genetic_Pollution_and_Monopolism

Re:Monsanto will most likely get this reversed

[h4rm0ny]

All the more reason to write to your representatives and tell them how you feel about this. Of course I'm in the UK, but if the US rejects patenting genes, that will help the cause for all of us.

Re:Monsanto will most likely get this reversed

[echucker]

You beat me to it. Monsanto was the first thing I thought of when I heard "patent" and "gene" in the same sentence.

Re:Monsanto will most likely get this reversed

[toppavak]

The majority of Monsanto's patents actually deal with the process of generating the transgenic organism and would be unaffected by this ruling. Similarly, any company with patents on a method for testing for a mutation would be similarly unaffected- only patents that explicitly claim a specific sequence would be undermined. Cambia has an awesome tool that will let you search the USPTO databases for whether patents on certain organisms actually claim gene sequences or just reference them.

Re:Monsanto will most likely get this reversed

[Schadrach]

Wouldn't this at least keep them from declaring that fields adjacent to fields that use their seeds and somehow end up with genes from their "sterile" plants are somehow in violation of some kind of agreement or patent, since the genetic sequence itself can't be owned by Monsanto?

Re:Monsanto will most likely get this reversed

[khallow]

which is anti-capitalist

"Anti-capitalist" would mean that they oppose in some way private ownership of capital (which clearly they don't have a problem with). "Anti-competitive" is the better term.

Re:Monsanto will most likely get this reversed

[Dachannien]

The present case has nothing to do with Monsanto's products or patents. What's more, patenting genetically modified organisms is already settled case law.

http://en.wikipedia.org/wiki/Diamond_v._Chakrabarty

Re:Monsanto will most likely get this reversed

[Dachannien]

You apparently don't understand case law, then. Case law doesn't arise from a jury's finding of fact, because the jury doesn't make or interpret the law, they only decide the facts of the case. The judge, on the other hand, interprets the law and determines how it applies to the case at hand, and the precedents that judges make on their own court and lower courts is what forms the basis of case law.

If you find a case where evidence was excluded, for example, and point out that in your murder case, evidence should be excluded for the same reasons, you very well could get off, ultimately based on case law. But you can't just say that a jury acquitted Joe Sixpack of murder, so that's case law and you should be set free, because it's not case law.

In this case, the Supreme Court decided that GMOs were patentable (albeit by a 5-4 decision where none of the justices sitting on that case are part of the Court anymore). Since the judicial system is the arbiter of the law, and (generally) the courts respect the precedential decisions of their superior courts (the Supreme Court being the big daddy of them all), the only recourse for changing the law is to either convince the Supreme Court to change their mind or to legislate a change in the statute.

Re:Monsanto will most likely get this reversed

[shaitand]

"Read the whole judgement, the farmer found some plants which he knew were herbicide-resistant and selectively bred them to get enough seed to cover a significant portion of is crop."

So? Sorry but I see no reason you should be able to own a plant or genes in the plant that could be bred into subsequent generations.

Monsanto has the only seed you can be certain is resistant and has a patent to guarantee that. Subsequent generations could exhibit the gene only partially or to a lesser extent. That is all the market advantage they need.

Re:Monsanto will most likely get this reversed

[GooberToo]

Genes exist completely independent of man's awareness of them or not. By legal definition they are a discovery, not invention. Again, by legal definition, they do not and never have qualified for patent status. As such, I've never understood why they have ever been allowed in the first place.

Imagine someone patenting oil, air, cotton, atoms, so on and so on. All of these are discoveries, not inventions. Literally, allowing gene patents is the exact same thing as being required to pay a royalty on breathing and yet everyone says that would be completely absurd - and yet, we are all holding our collective breaths here.

Now if only I could patent stupidity in government...

Re:Monsanto will most likely get this reversed

[Valdrax]

Read the whole judgement, the farmer found some plants which he knew were herbicide-resistant and selectively bred them to get enough seed to cover a significant portion of is crop.
This isn't an "oops, 'somehow' some seed blew onto my field" situation.

Why isn't that his right with plants found on his land? It's not like he stole from his neighbor's farm or from the company itself. If an advantageous strain of a crop finds its way onto your land through no fault of your own, why should you have to pay someone else for it? It was basically given to him.

Claiming ownership of all descendants of a single plant is simply not how we did agriculture before the invention of GM crops and gene patenting. So why should we change the law to support this?

It's not like the DNA was already functioning

[RichMan]

It's not like the DNA in-situ was already functioning perfectly. Opps, I guess it was.
So what did the pharma company "invent" to earn the patent?

Re:It's not like the DNA was already functioning

[RsG]

That's my basic take on it as well.

Genetic modification and tailored organisms should be patentable. For example, if someone were to develop a useful modified single celled organism that processed sewage into biofuel, I could see patenting that as valid. It's engineering after all, just with genes instead of gears.

But discovery has never been patentable in any other field, and that's what's being discussed in TFA. You can't patent if there's prior art, can't patent something you've found rather than made, and can't patent abstract scientific knowledge. You cannot patent the lever or pulley, and in a mechanics to biology comparison, those are the best analogues to genes. Except it's even worse, because those two examples were developed by humans in the first place, so at least somebody long dead could claim ownership, whereas genes are strictly a natural occurrence.

Re:It's not like the DNA was already functioning

[RsG]

Except in patent law, there is a distinction between discovery and creation, at least in theory.

It is arbitrary where we choose to differentiate, you're right about that. But the line is drawn on the basis of observation versus utilization.

If I observe that objects of differing mass fall at the same velocity if air resistance is taken away from the equation, I cannot patent that. If I use this observation to determine that slowing decent via increasing surface area is possible, and create a parachute, I can patent that. Or I could if those examples weren't hundreds of years old and therefor covered under prior art.

Identifying genes, where they are and what they do, is observation. Tinkering with them is utilization.

Re:It's not like the DNA was already functioning

[MartinSchou]

Personally, I think deconstructing the human genome is somewhat more complex than designing an opamp, but hey, that's just me.

It may be more complex, but that does not make it an invention.

Show me where I can find a ratchet wrench, and I'll call it a discovery.
On the other hand, I can tell you where to find pretty much all the genes that are patented - in organisms that nature derived on its own.

Now - if, on the other hand, some company designs a gene, that does something that has never existed in nature - that'd be an invention. But moving genes from a fish into a plant isn't an invention, any more than adding "on the internet" onto already existing technology makes that worthy of being patented. Very neat, and you should probably be allowed a patent on the technology used for it.

Re:It's not like the DNA was already functioning

[devent]

Except if the genes are already "discovered" by nature, which I read some story about bred pigs from a farm which had a gene from the breeding but Monsato patented the gene. The story is here http://www.globalresearch.ca/index.php?context=va&aid=2480

Take patent application WO 2005/017204. This refers to pigs in which a certain gene sequence related to faster growth is detected. This is a variation on a natural occurring sequence -- Monsanto didn't invent it. It was first identified in mice and humans.

Than of course are the patent infringement issues if the neighbor of a farm using Monsanto's patented seeds and some seed are landing on his farm by wind. You can't tell the difference until you send the genome to a laboratory to test, and until then you are selling Monsanto's "intellectual property".

Re:It's not like the DNA was already functioning

[Patch86]

IANAL and all that, but the /. beloved obviousness test should apply here.

For something to be patentable, it has to be non-obvious to a person working in the relevant field. The relevant field here is genetic biology. They are simply lifting the pattern straight out of the naturally occurring genome, without altering it.

It would seem that this would be an exceedingly obvious application of genetics- anyone with the appropriate (and probably patented) equipment can do it, no skill or ingenuity required.

Customised, altered genetic code is a different matter though.

Re:It's not like the DNA was already functioning

[toppavak]

Interestingly enough the first patents on this came from the University of Utah, Myriad is a licensee. That a public university receiving federal funding to support this research with a mandate to further scientific knowledge for the public benefit would pursue patents on such a fundamental discovery is itself a separate series of issues. Groups like Universities Allied for Essential Medicine have been fighting from the academic side to ensure that Universities license technology responsibly and include terms in the license to guarantee that companies make the commercialized products as widely available as possible. This includes license terms like exemptions for non-profit and government institutions using the claimed technology for research- a right you would expect Universities to fight tooth and nail to preserve but sadly they often don't out of fear of turning off potential licensees. This is particularly true in a recession when every royalty dollar makes a huge impact.

Re:It's not like the DNA was already functioning

[dAzED1]

moving minerals from a rock into a bar of iron which is forged in to a wrench is just just taking technology that already existed and moving it somewhere else.

That's silly. If you find a fish that glows in the dark, a bacteria that produces less harmful byproducts, and another bacteria that can eat crude oil - and you combine the three traits into a bacteria that glows in the dark, eats crude oil, and has less toxic byproducts...you've created something new. No less so than taking wheat that someone else invented, grinding it up, and combining it with water that someone else invented to make bread.

Re:It's not like the DNA was already functioning

[DRJlaw]

Show me where I can find a ratchet wrench, and I'll call it a discovery.
On the other hand, I can tell you where to find pretty much all the genes that are patented - in organisms that nature derived on its own.

Now show me where you can find the isolated gene, the isolated cDNA, or other forms of the gene (apart from a the unisolated form appearing among 2.9 million base pairs of material) that make the isolate useful for diagnostic testing, genetic and proteomic research, and the like.

Nobody has patented the gene as part of a functioning human being (or animal, or natural organism), yet that is what you're claiming already existed. You still need to get from the natural form to the isolated form and explain how that is "discovery" rather than something made by man before you have much of an argument.

Geoffrey Landis may think that the argument is completely silly, but the "discovery" counterargument is equal rubbish. "Gene patents" do not claim the gene. They claim isolated sequences of DNA, cDNA, and the like that are only made by man. The district court ignored that fact, disregarding the chemistry and focusing upon the "information" encoded by the chemical, and of course also within the genome, to say that genes are not even eligible for patenting. Neither the Federal Circuit nor the Supreme Court are going to buy that argument.

Re:It's not like the DNA was already functioning

[Grond]

Except in patent law, there is a distinction between discovery and creation, at least in theory.

No there isn't. "The term "invention" means invention or discovery." 35 USC 100(a) (emphasis added). "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title." 35 USC 101 (emphasis added).

The line is drawn at the laws of nature, physical phenomena, and abstract ideas. Diamond v. Chakrabarty, 447 U. S. 303 (1980). Note, however, that those limitations are judge-made, and are not present in the statute.

As in Chakrabarty, the isolated genes claimed here are "a nonnaturally occurring manufacture or composition of matter - a product of human ingenuity having a distinctive name, character use." Isolated, purified genes do not occur in nature, and they have a distinctive character and use separate from the naturally occurring gene (e.g. performing genetic tests, as opposed to being by cells in vivo).

Re:It's not like the DNA was already functioning

[Anonymous Coward]

No less so than taking wheat that someone else invented, grinding it up, and combining it with water that someone else invented to make bread.

And thank God we had patents!

Can you imagine where humanity would be if we hadn't been granted patent protection? Nobody would have had the incentive to invent bread. All that work: inventing agricultural methods, refining plant products, taming fire, finding the right combinations of everything... it just wouldn't have been worth it without the knowledge that the bread inventor would get his patent.

We'd all be sitting around forest fires, unwilling to make our own bread (because what would be the benefit without patents?), waiting for our meals to come to our mouths and starving to death. Humanity would stagnate and disappear.

You see, this is why patents are vital. Without patents, humans wouldn't create new things.

Re:It's not like the DNA was already functioning

[biryokumaru]

That's unfair to the inventor. The vast majority of new technologies often seem totally obvious in retrospect, but were unheard of before hand. You can't draw the line there, that definition is not explicit enough.

Re:It's not like the DNA was already functioning

[shaitand]

"Isolated, purified genes do not occur in nature"

Neither do clean floors. But floors do exist in nature and so do genes therefore neither is patentable. The product or process used to clean the floor or to isolate and/or purify the gene might be the floor or gene itself is not.

And your process of isolating and/or purifying would need to be composed of methods that aren't being used to isolate and/or purify other genes otherwise it isn't non-obvious it is just a progressive improvement that any of your peers could have and would have made eventually if you weren't granted a patent.

A Missed opportunity.....

[rajeevrk]

Awww, now i cannot patent my own genome, and sue the world for infringing on my *Original* genetic composition.....

Seriously, It is so welcome to see a wee bit of sanity returning to this madhouse that is the current IPR regime....

RkR

Re:A Missed opportunity.....

[AnonymousClown]

What popped in my head is an Environmental organization suing companies that patent genes on behalf of "Mother Nature" for infringement.

So for illustration purposes, some company patents the gene for Sickle Cell Anemia for whatever reason and starts making money off of it somehow (royalties from folks studying the disease?), organization sues them for infringement and uses the money to saves the whales or whatever.

This Just In From the "No Shit" Department

[RobinEggs]

You can't legally patent something with 7 billion instances of prior art, nor should you be able to acquire a patent that all seven billion people in the world will involuntarily infringe ten million times a day.

Thank you, Justice Department, for another flash of the blindingly obvious.

Of course, if the DOJ has to spell this out, and the institutes that control our federal research dollars in health still can't see it, how does this bode for truly cooperative health research in the US? Not well, I'm guessing.

Surprising

[magus_melchior]

What's more surprising to me isn't that the DoJ issued this amicus curiae brief, it's that they issued this even with former RIAA lawyers in its top echelons. If their top lawyers believe that companies should be "free" to control information, then they would no doubt have a problem with this brief.

On the other hand(s), they may not have a problem with freeing genes from patents, they may not personally believe what their former employers believe and were merely doing their jobs (which is pretty common among lawyers-- they turn into stalwart defenders of the worst ideas because that's how the adversarial legal system works), or they don't see the philosophical connection between strict control of copyright and strict control of any other "license" (for lack of a better term) on information.

An example for software patents

[ciaran_o_riordan]

It's also an example for how we can do our software patents lobbying.

The US govt pleading for a narrowing of patentable subject matter is rare (AFAIK), so this is a juicy example of how they justify a narrowing and how, in legal terms, they argue for a narrow interpretation.

If anyone has info about these angles, please add it to what I've got here:
http://en.swpat.org/wiki/Excluding_gene_patents_in_the_USA