SCOTUS: No, you cannot patent naturally-occuring human genes

posted at 2:41 pm on June 13, 2013 by Erika Johnsen

In the batch of decisions they released earlier today, the highest court in the land handed down an interesting and unanimous ruling concerning patent law that has some major potential to influence the research and business practices the burgeoning biotechnology industry. In Association for Molecular Pathology v. Myriad Genetics, all nine SCOTUS justices ruled that scientists cannot patent naturally-occurring human DNA, but struck some middle ground by adding that synthetically-created DNA — or cDNA — does indeed fall into the realm of patentable material. Via the NYT, the case concerned patents held by Utah-based Myriad Genetics for genes that correlate with the increased risk of hereditary breast and ovarian cancer that were being challenged by rights groups arguing that companies should not be able to lock up the uses of new DNA that could benefits patients if it was made widely available:

The patents were challenged by scientists and doctors who said their research and ability to help patients had been frustrated. The particular genes at issue received public attention after the actress Angelina Jolie revealed in May that she had had a preventive double mastectomy after learning that she had inherited a faulty copy of a gene that put her at high risk for breast cancer.

The price of the test, often more than $3,000, was partly a product of Myriad’s patent, putting it out of reach for some women. The company filed patent infringement suits against others who conducted testing based on the gene. The price of the test “should come down significantly,” said Dr. Harry Ostrer, one of the plaintiffs in the case decided Thursday. The ruling, he said, “will have an immediate impact on people’s health.” …

The decision hewed closely to the position of the Obama administration, which had argued that isolated DNA could not be patented, but that complementary DNA, or cDNA, which is an artificial construct, could. The patentability of cDNA could limit some of the impact on industry from the decision.

Pretty neat stuff — you can glance over decision, authored by Justice Thomas, here, and Lyle Denniston over at SCOTUSblog has some of the plain-English background on what went into the justices’ decision:

The Supreme Court long ago ruled that an inventor who discovers a phenomenon in nature, or figures out a “law of nature,” cannot get an exclusive right to use or sell that by obtaining a patent from the federal government.  Natural phenomena are the basic tools with which every would-be inventor starts, so locking up the right to use them in a monopoly held by a specific patent owner will frustrate others who might want to look for new ways to interpret that phenomena, the Court has said.

The exclusion of natural substances from eligibility for patents was the theory on which the Court relied Thursday in its unanimous ruling that a company cannot get a patent monopoly on the use and study of human genes that it isolates in the bloodstream, and them takes them out — without changing their natural character — for research.

In a nutshell, the Court ruled that the company didn’t actually create anything, but only extracted the human DNA and then set it aside for study. I haven’t been following the case closely, but my biggest question was whether Myriad and similar companies would be able to profitably protect their research and retain their ability to compete — but the NYT adds that Myriad’s stock price was up about 10 percent in early trading, so it sounds like the Court allowing for the possibility of patents on synthetically created versions of those genes was at least something of workable compromise. Thoughts?


Related Posts:

Breaking on Hot Air

Blowback

Note from Hot Air management: This section is for comments from Hot Air's community of registered readers. Please don't assume that Hot Air management agrees with or otherwise endorses any particular comment just because we let it stand. A reminder: Anyone who fails to comply with our terms of use may lose their posting privilege.

Trackbacks/Pings

Trackback URL

Comments

I read a really strong Michael Crichton book a few years back, Next, and if memory serves it was this issue that he based it around, and this would’ve been the desired court outcome as well.

MikeknaJ on June 13, 2013 at 2:50 PM

Aren’t Levi’s patented? Huh?

Akzed on June 13, 2013 at 2:51 PM

So, who owns the gay gene?

faraway on June 13, 2013 at 2:51 PM

Sorry. I’m more interested in the voting rights case and the affirmative action case. We need conservative turns on those before Obama turns every single aspect of this country into a matter of race and national origin.

BuckeyeSam on June 13, 2013 at 2:52 PM

So, who owns the gay gene?
faraway on June 13, 2013 at 2:51 PM

There’s no such thing but JetBoy has one.

Akzed on June 13, 2013 at 2:52 PM

As a genetics major, I was interested to see how this would turn out. They made the right decision and I am please to see more genetics news on HA.

antisense on June 13, 2013 at 2:53 PM

I assume standard patent rules apply? If not, then when the synthetic genes get passed on, do they become naturally occurring?

nobar on June 13, 2013 at 2:55 PM

Damn it, I was hoping to patent my own awesome gene.

NotCoach on June 13, 2013 at 2:57 PM

I assume standard patent rules apply? If not, then when the synthetic genes get passed on, do they become naturally occurring?

nobar on June 13, 2013 at 2:55 PM

More litigation for the future. We’ll see synthetic genes in animals first before we see them in humans. And we haven’t seen any yet, so it will be awhile before we need to worry about it.

NotCoach on June 13, 2013 at 2:58 PM

I assume standard patent rules apply? If not, then when the synthetic genes get passed on, do they become naturally occurring?

nobar on June 13, 2013 at 2:55 PM

Beat me to it — how does one distinguish cDNA from natural DNA in the next generation?

cthulhu on June 13, 2013 at 2:59 PM

When does the Tea Party gene get banned?

faraway on June 13, 2013 at 3:00 PM

Damn it, I was hoping to patent my own awesome gene.

NotCoach on June 13, 2013 at 2:57 PM

If you could patent your own genes, you could file injunctions against using them….against women you’d canoodled with, for instance….

cthulhu on June 13, 2013 at 3:01 PM

If you could patent your own genes, you could file injunctions against using them….against women you’d canoodled with, for instance….

cthulhu on June 13, 2013 at 3:01 PM

Doesn’t the canoodling constitute a voluntary surrendering of my genes?

NotCoach on June 13, 2013 at 3:04 PM

Doesn’t the canoodling constitute a voluntary surrendering of my genes?

NotCoach on June 13, 2013 at 3:04 PM

That depends on what your definition of “is” is.

nobar on June 13, 2013 at 3:06 PM

So, who owns the gay gene?

faraway on June 13, 2013 at 2:51 PM

Someone fabulous?

There Goes the Neighborhood on June 13, 2013 at 3:07 PM

Beat me to it — how does one distinguish cDNA from natural DNA in the next generation?

cthulhu on June 13, 2013 at 2:59 PM

I suspect that most of the synthetic genes will closely match naturally occurring ones, but there should be enough difference to say otherwise (at least until gen 1).

nobar on June 13, 2013 at 3:07 PM

This is really twisted.

faraway on June 13, 2013 at 3:08 PM

SCOTUS: No, you cannot patent naturally-occuring human genes

…GOD holds that patent.

BDU-33 on June 13, 2013 at 3:08 PM

Rumor…Roberts changed his vote on Obamacare due to NSA info used against him…

PatriotRider on June 13, 2013 at 3:09 PM

There’s a great new show on BBC America called Orphan Black about human cloning and genetic ownership. The lead actress has been getting all sorts of accolades.

commodore on June 13, 2013 at 3:10 PM

Rumor…Roberts changed his vote on Obamacare due to NSA info used against him…

PatriotRider on June 13, 2013 at 3:09 PM

I would believe it.

nobar on June 13, 2013 at 3:11 PM

I sure hope no one has one of their cells divide and, by spontaneous mutation, end up being built of proprietary genes, in which case they would have to kill themselves, I guess, or pay royalties to the patent holder for the pleasure of existing (just as with BarkyCare, actually).

Aside from that, I really couldn’t care less what this retarded SCOTASS has to say about anything. This SCOTASS is a joke. A nasty, evil, moronic joke that wouldn’t know the Rule of Law if it bit them in their fat azzes.

ThePrimordialOrderedPair on June 13, 2013 at 3:12 PM

This is fascinating. And totally what the Supreme Court should be focusing on when the executive branch is collecting virtually every bit of data Americans transmit and perjuring itself before Congress regarding said practices.

Shump on June 13, 2013 at 3:12 PM

I’m still wondering why so many on the left don’t have the Hy-gene.

RadClown on June 13, 2013 at 3:13 PM

But…but…but…the “Free Market”!

HB3 on June 13, 2013 at 3:15 PM

so it sounds like the Court allowing for the possibility of patents on synthetically created versions of those genes was at least something of workable compromise

@Erica, you meant the process of creating the genes? Or did you mean synthetic genes that are similar? The way it reads is difficult — it seems to imply that I could make the exact same gene, and by virtue of having made it, it would be patentable.

Axe on June 13, 2013 at 3:16 PM

*by virtue of having been made, I mean.

Axe on June 13, 2013 at 3:16 PM

*sigh*

*Erika, I mean.

Axe on June 13, 2013 at 3:17 PM

The GOP owns all the Stupid Genes.

faraway on June 13, 2013 at 3:17 PM

Will be interesting to see how this ruling affects various “genome projects,” where the claims generally include (1) describing the DNA sequence and (2) identifying the expressed trait(s) for which the DNA codes. Broadly speaking, it would appear that claims resting on the PTO’s practice of treating isolated sequences as patentable “compositions of matter” are suspect. Moreover, the holding seems certain to affect non-human DNA claims as well, such as those on plant genes which underlie any number of GMO products, to the extent that those claims are to unmodified, naturally occurring DNA.

Barnestormer on June 13, 2013 at 3:20 PM

Natural phenomena are the basic tools with which every would-be inventor starts, so locking up the right to use them in a monopoly held by a specific patent owner will frustrate others who might want to look for new ways to interpret that phenomena

Damn, there goes my patent on global warming!

pain train on June 13, 2013 at 3:50 PM

Wethal/other SCOTUS experts: Any idea when we’re getting a decision on Fisher?

Good Solid B-Plus on June 13, 2013 at 3:51 PM

The price of the test, often more than $3,000, was partly a product of Myriad’s patent, putting it out of reach for some women. The company filed patent infringement suits against others who conducted testing based on the gene. The price of the test “should come down significantly,” said Dr. Harry Ostrer, one of the plaintiffs in the case decided Thursday. The ruling, he said, “will have an immediate impact on people’s health.”

I can understand patenting the test, but the gene itself? No way.

Hopefully the cost of this test will come down so more women can be screened, but the way things are with Obamacare and these insurance companies, I’m not holding my breath.

Dr. ZhivBlago on June 13, 2013 at 3:55 PM

Obama toady Kagan has been in a huff ever since Myriad Genetics swore no desire to patent her genes. Never, ever, ever.

viking01 on June 13, 2013 at 4:02 PM

Hi Erika,

Have you heard of Sissel vs. US Dept of Health and Human Services? PLF is making the case at SCOTUS that the law, if a tax, could not be valid since it originated in the Senate.

AshleyTKing on June 13, 2013 at 4:20 PM

One step closer to Gattica.

goflyers on June 13, 2013 at 4:21 PM

The Court reached the wrong conclusion. The case is not about patenting “genes,” but about patenting “isolated nucleic acids” which have nucleotide sequences that correspond to part(s) of the naturally-occurring genes. The isolated nucleic acid sequences are not naturally-occurring but are man-made products that do not exist in nature.

Unfortunately, both the court and the public have gotten caught up in misinformation, and have wrongly concluded that companies are tryig to patent products of nature.

This decison will curtail research. Myriad, for example, would not have spent tens of millions of dollars on the research needed to discover the natural genes and, more important, the mutations which cause breast and ovarian cancer, if they could not recoup their costs by selling the diagnostic tests. Now they, and others, will not spend the money to research other diseases, or will keep the results secret unless and till they develop a diagnostic or therapeutic product that can be patented.

SwampYankee on June 13, 2013 at 4:23 PM

Beat me to it — how does one distinguish cDNA from natural DNA in the next generation?

cthulhu on June 13, 2013 at 2:59 PM

The same way they do it in sci-fi movies. You use a really powerful microscope that zooms in to the DNA molecules themselves until you see the logo of the originating company on the proteins. /sarc

Some people believe that there is such a marking on naturally occurring DNA right now. IOW, we were created by aliens. Yes, that goes against a whole lot of beliefs, etc. I’m just a sci-fi junkie and I love this stuff. Especially about genes that turn on or off. These don’t seem to follow the normal course of evolution… if we go by that theory.

MrX on June 13, 2013 at 4:30 PM

I sure hope no one has one of their cells divide and, by spontaneous mutation, end up being built of proprietary genes, in which case they would have to kill themselves, I guess, or pay royalties to the patent holder for the pleasure of existing (just as with BarkyCare, actually)….

ThePrimordialOrderedPair on June 13, 2013 at 3:12 PM

Actually, that’s the outcome SCOTUS is trying to avoid with this ruling. That hypothetical mutation is a natural phenominon and thus outside the scdope of patent protection.

Steve Eggleston on June 13, 2013 at 4:43 PM

The Court reached the wrong conclusion. The case is not about patenting “genes,” but about patenting “isolated nucleic acids” which have nucleotide sequences that correspond to part(s) of the naturally-occurring genes. The isolated nucleic acid sequences are not naturally-occurring but are man-made products that do not exist in nature.

Unfortunately, both the court and the public have gotten caught up in misinformation, and have wrongly concluded that companies are tryig to patent products of nature.

This decison will curtail research. Myriad, for example, would not have spent tens of millions of dollars on the research needed to discover the natural genes and, more important, the mutations which cause breast and ovarian cancer, if they could not recoup their costs by selling the diagnostic tests. Now they, and others, will not spend the money to research other diseases, or will keep the results secret unless and till they develop a diagnostic or therapeutic product that can be patented.

SwampYankee on June 13, 2013 at 4:23 PM

Er, not so much. Myriad claimed that the fact that it isolated the naturally-occuring nucleic acid first meant that it was the only entity allowed to isolate said nucleic acid by any possible means. It would be equivalent to saying that the first person who discovered how to separate out a neutron from an atom could patent the neutron and thus prevent everybody else from separating out the neutron by any possible means.

I’ll direct you to part III of the opinion (emphasis in the original, any uncaught errors in spacing are my miss of the glitchy copy/paste from the PDF version):

It is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents “were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach,” 702F. Supp. 2d, at 202–203, and are not at issue in this case.

Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences,
Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications.” 689 F. 3d, at 1349.

Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.

Steve Eggleston on June 13, 2013 at 4:52 PM

This decision will curtail research. Myriad, for example, would not have spent tens of millions of dollars on the research needed to discover the natural genes and, more important, the mutations which cause breast and ovarian cancer, if they could not recoup their costs by selling the diagnostic tests

Precisely. However, they were certainly overcharging for the test but probably did so knowing they had a limited window in which to at least recoup some of their research costs.Unless you are working on government grants or just doing research for the hell of it, why do any of this type of work if you can’t recoup your cost and then some.

JohnnyL on June 13, 2013 at 4:54 PM

I assume standard patent rules apply? If not, then when the synthetic genes get passed on, do they become naturally occurring?

nobar on June 13, 2013 at 2:55 PM

Beat me to it — how does one distinguish cDNA from natural DNA in the next generation?

cthulhu on June 13, 2013 at 2:59 PM

Given the relatively-short exclusivity on drug patents (the likely model for cDNA patents), the “next generation” (children) issue likely won’t come into play. I would expect that, if the cDNA-sourced gene is one not found in human nature, that for the short lifetime of the patent, it would not be available to other companies even from second-generation human hosts.

Steve Eggleston on June 13, 2013 at 5:11 PM

Synthetic DNA is not cDNA.

cDNA stands for “Complementary DNA” and refers to the product of reverse-transcribing RNA into DNA through the use of reverse transcriptase.

Synthetic DNA refers to the direct synthesis, of specified DNA sequences by service providers (e.g. DNA 2.0, Sigma-Aldrich etc.).

Companies are investing significantly in engineering gene sequences to yield improved gene products (e.g. enzymes capable of desirable chemical modifications). Many of these are obtained through processes like Directed Evolution, which have nothing to do with living organism populations, but rather use a process called Polymerase Chain Reaction (PCR).

Johndakota on June 13, 2013 at 5:29 PM

Why not?We protect naturally occurring words in our language./

CW on June 13, 2013 at 5:52 PM

The isolation of compounds from nature has long been recognized as conferring patentability. All sorts of chemical compounds are isolated from organisms including antibiotics, anti cancer drugs like taxol etc. DNA is a chemical compound and should be not be considered differently. That the order of bases in DNA holds information should not be relevant. This is not a victory “for the children” or for anyone else and will have negative consequences.

Er, not so much. Myriad claimed that the fact that it isolated the naturally-occuring nucleic acid first meant that it was the only entity allowed to isolate said nucleic acid by any possible means. It would be equivalent to saying that the first person who discovered how to separate out a neutron from an atom could patent the neutron and thus prevent everybody else from separating out the neutron by any possible means.

Steve Eggleston on June 13, 2013 at 4:52 PM

This is incorrect. Being first and obtaining a patent to a composition means that you can exclude others, even if other ways are discovered to prepare the composition. That is what a composition patent provides. Whether a neutron is patentable is not precluded per your suggestion, but if it met the other requirements for patentability (i.e, useful, novel, inventive, described, and enabled) it would be. I doubt it though, since neutrons have been isolated. However, if you could prepare a pure composition of neutrons, it could be patentable. For example, a pure mole of neutrons… though I am not sure what that would be useful for.

SparkyZ on June 13, 2013 at 6:33 PM

I am unsympathetic to Myriad about having a patent on particular genes. If they had discovered a particular process, be it a specific diagnostic test or indicator chemical or whatnot, that made identifying the genes in question reliable etc., then I would think that the process, if it was unique and not a commonly used one, would likely be patentable.

Russ808 on June 13, 2013 at 7:03 PM

Damn it, I was hoping to patent my own awesome gene.

NotCoach on June 13, 2013 at 2:57 PM

Would it be hateful to want a genetic package which results me being tall, smart, athletic, white, and heterosexual?

Part of me wants to live long enough to see how politically correct society is once they can design their own babies.

Daemonocracy on June 13, 2013 at 7:15 PM