Supreme Court Strikes Down Gene Patents

from the good-news dept

Here’s a bit of good news: the Supreme Court has effectively said you can’t patent genes, though in typical Supreme Court fashion, it hedged a bit. Basically, they found that merely separating out naturally occurring DNA is not patentable, but that synthetically made “complementary DNA” or (cDNA) can be patentable. This case has been going on for quite some time, involving a company called Myriad Genetics, which isolated two genes, BRCA1 and BRCA2, where mutations indicate a high likelihood of developing breast cancer. Myriad then set up a very lucrative, extremely high priced set of tests to find those mutations and argued that others testing for those genes violated its patents — because stopping breast cancer should be prohibitively expensive, apparently.

The unanimous ruling found that merely separating out naturally occurring genes cannot be patentable, because that would be ridiculous:

It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable.

And that doesn’t make much sense under patent law:

Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes)by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome.

Myriad’s main argument was that it basically had to put a lot of work into finding and isolating the genes, but the court noted that “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy [the conditions for patent eligibility].”

The court also rejects the idea that just because the US Patent Office regularly granted gene patents for years, it should be allowed to continue to do so. The court does say that complementary DNA, made by Myriad, can be patentable:

… the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible…

The court also points out that you can still patent a form of a test for DNA, if that method is innovative, but you can’t patent the underlying genetic structure if it’s naturally occurring. However, Myriad’s method was not new or innovative. As the court notes, it was “well understood by geneticists at the time.”

On the whole this is a good ruling that will invalidate a large number of bogus gene patents. While patent extremists are complaining that this will destroy the biotech field, more reasonable minds are pointing out that it should have little effect. I’d argue that, if anything, it may drive greater efforts in biotech, since companies can now do more exploration on genes without fearing being sued by someone who discovered and isolated a particular gene first — and this should also lead to significantly cheaper genetic testing, creating even more opportunities for biotech firms to innovate on top of widespread genetic testing.

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Companies: myriad genetics

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Comments on “Supreme Court Strikes Down Gene Patents”

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40 Comments
Josh in CharlotteNC (profile) says:

Re: Re: Monsanto

Since we’re talking about Monsanto and artificial genes, it’s important to note that the ‘RoundUp Ready’ gene is not artificial by any definition of artificial that I’m aware of.

“Some micro-organisms have a version of 5-enolpyruvoyl-shikimate-3-phosphate synthetase (EPSPS) that is resistant to glyphosate inhibition. The version used in the initial round of genetically modified crops was isolated from Agrobacterium strain CP4 (CP4 EPSPS) that was resistant to glyphosate.[125][126] This CP4 EPSPS gene was cloned and transfected into soybeans.”
https://en.wikipedia.org/wiki/RoundUp#Genetically_modified_crops

The RoundUp Ready gene was isolated from another organism.

It is also interesting to note that the particular bacteria mentioned is known to use horizontal gene transfer between itself and plants. It’s not a stretch to imagine that the gene itself could have been naturally occurring either in that bacteria OR a plant it swapped genes with at some point in its evolutionary past.

And its also interesting to note that other plants have developed similar glyphosphate resistance on their own (or may have gotten their resistance from a bacteria they swapped genes with outside of the lab).

https://en.wikipedia.org/wiki/Amaranthus_palmeri

So what really is artificial when we’re talking about genes?

John Fenderson (profile) says:

Re: Re: Re: Monsanto

The EPSPS gene is natural and cannot be patented. But I can imagine this case being made:

By inserting that gene into another organism’s DNA, the resulting DNA as a whole is artificial, as it is not naturally occurring. It could therefore be patented. After all, if you build a new invention of of wood, the new invention is no less patentable just because you can’t patent wood.

Anonymous Howard (profile) says:

Re: Re: Re:2 Monsanto

And here we are, where is the limit on derivative works should be under a certain patent.

Monsanto made a patentable (independent) DNA using 2 natural.

What if I breed a new crop by crossing the patented plant with natural? Is that derivative enough? If not, then what is?
What about accidental breeding, like from a neighbour’s farm?

Anonymous Coward says:

Not far enough, the ruling still does incredible damage

This ruling still does incredible damage. If you want proof of that look at Myriad’s stock, it went UP 6% when the ruling was announced, which shows how weak and pitiful it really was.

There’s apparently already people who saying that the court left a major loophole in it’s ruling that seems to basically allow Myriad to keep doing mostly the exact same thing, with a bit of extra work so it’s not actually patenting the gene itself.

Some Other AC says:

Re: Not far enough, the ruling still does incredible damage

As stated above, their stock price is currently lower than the opening value. It peaked for a short period and then dropped like a drunken sorority girl’s panties.
Opened above 33 almost 34 a share and now barely 32 a share.
Needs to drop even more…give these guys a financial kick in the gonads.

Anonymous Coward says:

Re: Not far enough, the ruling still does incredible damage

Patenting cDNA might be a loophole, but it is not relevant to genetic testing. This case is in fact shutting down their posibility of suing if they decide to take the cDNA-patent.

When that is said, cDNA is complementary to DNA which makes it basically a mirrored version of DNA. It is possibly a huge hole for future patents on nature. It is certainly letting Monsanto have a far bigger field for patentability.

Anonymous Coward says:

encouraging

Myriad has been charging ~$5000 a test, in a normal free market other researchers will see that prize and say, “I want some of that money, I’ll devise a different test for the same thing.” this obscene pricing would encourages INNOVATION, and the patenting of other tests,

This patent on the underlying discovery of the genes causing this cancer and death, allowed Myriad to charge a monopoly rate for their test. It Blocked subsequent INNOVATION or improvements by others.

It defeated the purpose of patents as defined in the US constitution. It did line up nicely with the purpose of patents as Uses in medival europe.

Rick Smith (profile) says:

Missed opportunity

Am I the only one that see this ruling negatively? I wish they would have been granted the patent.

Then someone with breast cancer could have sued to have Myriad clean-up after its patented material. I mean their patented gene would be damaging that individual’s personal property, namely the body. Since you can’t remove the gene (at least to my knowledge) therefore any damage it caused should be cleaned up by the patent holder; again and again if it keeps coming back. Only seem fair to me.

After that I bet that companies will think twice about trying to patent nature.

horse with no name says:

Important to note:

Myriad’s main argument was that it basically had to put a lot of work into finding and isolating the genes, but the court noted that “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy [the conditions for patent eligibility].”

This is the rub in all of this. Had Myriad known that they would have no actual direct benefit from the discovery and costly development in these areas, perhaps they would have not gone there to start with. If that would mean a delay of X number of years, are we all not worse off?

The courts may have gotten this right on a purely technical level, but does it perhaps stunt or harm the advancement of science in these sorts of areas in the future by removing commercial interests from the game?

Niall (profile) says:

Re: Important to note:

I don’t give a flying horse crap how much work they put in. They shouldn’t be able to patent something that can be found in nature, something that can be created naturally, control something that reproduces naturally, and certainly they shouldn’t be able to prevent people from investigating and creating their own novel tests for gene occurrences. It would be like Edison patenting the whole lightbulb concept, not just a particular way of making one work.

Niall (profile) says:

Re: Important to note:

To clarify: people should be able to attempt to get recompense for hard work, but it’s their gamble. They aren’t ‘owed’ an income based on its simple existence. Other people can compete in their own way – something as common and important as breast cancer will attract plenty of money anyway.

No-one is saying Myriad can’t get any benefit – but no-one made them charge obscene monopoly rents for a test for an element of nature. That’s like patenting the Geiger counter and charging someone $1000 every time they use one!

They could have don a better model like licensing large users to get it cheaper in bulk, charging a lot less which would have improved its uptake, and so on – lots of things that are regularly discussed on these pages. Instead, they’ve made themselves hate figures with their abuse of broken IP law and they only have themselves to blame. If you don’t abuse the system, you give people much less incentive to invalidate your dodgy patents.

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