Supreme Court Rules Human Genes Cannot Be Patented

Thanks to the Supreme Court, your DNA cannot be patented.

DNA Strand

Handing down a decision in of the first of the highly anticipated pending cases in these final weeks of its term, the Supreme Court ruled today that naturally occurring human genes cannot be patented:

WASHINGTON — Isolated human genes may not be patented, the Supreme Court ruled unanimously on Thursday. The case concerned patents held by Myriad Genetics, a Utah company, on genes that correlate with increased risk of hereditary breast and ovarian cancer.

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 court’s ruling will also shape the course of scientific research and medical testing in other fields, and it may alter the willingness of businesses to invest in the expensive work of isolating and understanding genetic material.

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.

Myriad’s stock price was up about 10 percent in early trading, a sign that investors believed that Myriad had retained the ability to protect its business from competition.

“I think everybody that was paying close attention to this case pretty much guessed what they were going to do,” said Robert Cook-Deegan, a research professor at Duke University’s Institute for Genome Sciences and Policy, who has closely followed the case and the issue of gene patenting.

Dr. Cook-Deegan said he thought Myriad would now face competition for testing for the breast cancer risk genes.

“I think there might be some blustering or saber rattling, but I would be really surprised if they sue anybody for patent infringement for a diagnostic test,” he said about Myriad.

He said that there were only a small number of diagnostic companies that relied on isolated DNA patents to protect their business, and that the impact of the decision on the broader biotechnology industry might be limited.

The central question for the justices in the case, Association for Molecular Pathology v. Myriad Genetics, No. 12-398, was whether isolated genes are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection.

Myriad’s discovery of the precise location and sequence of the genes at issue, BRCA1 and BRCA2, did not qualify, Justice Clarence Thomas wrote for the court. “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” he said. “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.”

“Groundbreaking, innovative or even brilliant discovery does not by itself satisfy the criteria” for patent eligibility, he said.

SCOTUSBlog’s Lyle Denniston has more:

Justice Clarence Thomas’s opinion for the Court ran only to eighteen pages, but those were densely packed with virtually impenetrable references (for the lay person) to such things as nucleotides, covalent bonds, introns, exons and pseudogenes.  Many readers no doubt will share the view of Justice Antonin Scalia, in a short, separate opinion refusing to join in a section “going into the fine details of molecular biology,” of which he said he had neither knowledge or belief.  Scalia said he did understand enough to accept that naturally isolated genes are different from synthetic ones, and that makes a difference in patent law.

The scientific and legal key to the Court’s denial of patent protection to isolated, natural forms of DNA were these sentences: “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.”

While that was not disputed, because the legal controversy focused rather on what Myriad claimed it did to locate and then isolate the forms of genetic DNA, those agreed-upon factors were enough to convince the Court that “Myriad did not create anything.”   As Justice Thomas commented further: “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.  Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [patent law] inquiry.”

The opinion conceded that Myriad probably did create something when it synthesized DNA, in a form that it called “complementary DNA,” or cDNA.  The challengers to Myriad on cDNA had contended that the sequence in that form had also been dictated by nature.  That may be so, Thomas said in reaction, “but the lab technician unquestionably creates something new when cDNA is made.”

The opinion said in a footnote, however, that the Court was not actually ruling that cDNA is specifically entitled to a composition patent, and noted that the federal government had raised other objections under patent law to that phenomenon.

As Denniston notes in his post, most of Thomas’s opinions is filled with a technical discussion of the science involved in this case, and it’s an area of law in which I am far from being an expert. However, I tend to agree with Kevin Drum that the outcome here strikes me as a victory for common sense. The idea that an entity, public or private, could patent a section of the human genome doesn’t seem to comport at all with the purpose of Patent Law. This seems to be especially true in this case where Myriad Genetics was attempting to use its patent to control access to the diagnostic testing necessary to detect the breast cancer genes in question. Because of that, the test itself has been enormously expensive and typically not covered by insurance plans. Had Myriad done something unique here then their patent claim would have been much stronger, but they really didn’t, all they did was identify one portion of the human genome that indicates that a woman has a higher probability of developing breast cancer. That’s a great achievement, but it’s not the kind of innovation that patents were meant to cover.

Although it wasn’t part of the issues the court was considering, it is worth noting that there will be a net benefit arising out of this decision. Because it no longer has a patent, Myriad Genetics will not be able to claim exclusivity for the test to detect the BRAC1 and BRAC2 genes. This means that other companies are likely to come into the marketplace with their own tests, which will likely drive the price of the test significantly. It won’t make the test dirt cheap, of course, because genetic testing is generally an expensive endeavor regardless of the status of any patent claims. However, it’s likely to make the test more widely available, and that will allow women to make decisions about how they want to face the future if they test positive, or peace of mind if they test negative. And they won’t have to have a net worth as high as Angelina Jolie’s in order to make that decision.

Here’s the opinion for anyone interesting in slogging through the technical discussion:

Association of Molecular Pathology et al v. Myriad Genetics, et al by dmataconis

FILED UNDER: Health, Law and the Courts, US Politics
Doug Mataconis
About Doug Mataconis
Doug holds a B.A. in Political Science from Rutgers University and J.D. from George Mason University School of Law. He joined the staff of OTB in May 2010. Before joining OTB, he wrote at Below The BeltwayThe Liberty Papers, and United Liberty Follow Doug on Twitter | Facebook

Comments

  1. Dave Schuler says:

    I agree. It’s a commonsense decision.

  2. Anderson says:

    Good news, because Mom and Dad are now going to have to drop their royalties suit they filed when their grandchild was born. IN YOUR FACE!

  3. PD Shaw says:

    “most of Thomas’s opinions is filled with a technical discussion of the science involved in this case, and it’s an area of law in which I am far from being an expert.”

    That’s all right, Doug, Thomas probably didn’t write the opinion either.

  4. Matt Bernius says:

    First thank God (or you’re personal deity or unifying belief) that (a) they got this one right, and (b) it was unanimous.

    An open, and interesting question is whether or not this is extended to patenting of other naturally occurring chemical structures (including, but not necessarily restricted to, plant and animal DNA sequences). Or does this essentially resolve that issue?

  5. HarvardLaw92 says:

    Now if they’ll just get on board with the idea that genetic material can’t be patented at all, regardless of source or subsequent manipulation / modification, we’ll be good to go.

  6. Argon says:

    The key point is that these genes are found in nature and are not a product of human invention. It would be like patenting the crystal structure of ice. Derivative work like modifying the sequence to do something else may be patentable. However, Iwould argue that simply fabricating cDNA also doesn’t rise to the level of a patent. That’s a pretty damn obvious extension of existing knowledge as is using the sequence for a diagnostic test.

  7. Argon says:

    @HarvardLaw92: I would disagree with that notion. For example there is a lot of work that’s happened with the development of industrial enzymes. Many of these are enzymes that have been highly engineered by scientists to work under conditions or with reactants or expressed in organisms in ways that they couldn’t previously. I think a great case can be made that the sequences of these enzymes (for both amino acid and the encoding DNA) can be patented. The question that has to be determined on a case by case basis is whether the novelty is ‘obvious’ as defined by the normal patent process.

  8. HarvardLaw92 says:

    @Argon:

    I respect that it’s problematic, but patents are supposed to protect original ideas. Improving something that already exists in nature isn’t an original idea, IMO.

    They do the same thing with antibiotics. They take a naturally occurring substance and patent it. Then, once the patent runs out, they move a hydroxyl group or some such thing to another place on the molecule and call it a new discovery, then patent it again. It isn’t a new discovery or a new idea. It’s a rehashed existing idea that shouldn’t have been patentable in the first place.

    We’re, frankly, treading the line of the patent process being misused to create ongoing constructive monopolies.

  9. HarvardLaw92 says:

    Don’t mind me though – I’m the guy that thinks Monsanto should be liable to farmers for polluting the genetic integrity of their crops.

    Novel idea they had there – we’ll genetically modify seeds, then when our pollen introduces our modification into your unmodified crops, we’ll hold you accountable for “stealing” our idea.

    Anybody else think that if Monsanto wants to control their product, it should be incumbent on them to modify it in such a way that it can’t be spread? They’ve essentially co-opted the wind and bees as a marketing lead pipe.

  10. Matt Bernius says:

    @HarvardLaw92:
    Yes on both of these posts. Patent extenders, especially in the drug industry are an absolute mockery of the patent system. Likewise the Monsanto stuff — and much of the patenting of non-native plants — is another sign of how out of control the bio-pharma section of patent law is.

    That said, copyright still seems far more broken. But that could just be because I’m more aware of those issues.

  11. James in Silverdale, WA says:

    @Matt Bernius:

    I don’t think patents, trademarks, or copyrights will remain enforceable for long. It’s a losing battle as it is. Between government and corporate data collection, demand is growing for strong encryption to a person. Combine that with the growing cloud of always-on devices, and the ISP, where all the filtering must occur, will become redundant.

  12. Argon says:

    @HarvardLaw92: Well, you see, once you take the original gene out of its original context, apply a great deal of technical knowledge to alter the function of its product (eg. Creating an industrial enzyme that works at high temperature in acetone which can take many rounds of derivation and targeted changes) and then produce the enzyme in a different expression system that is itself highly derived, then you run into the question of what constitutes ‘natural’. It’s like saying one can’t patent something that covers a new chemical derivative of cotton because cotton is naturally created. The fact is, in cases like industrial enzymes or engineered metabolic pathways the ideas and applications are original. Bioengineering and drug discovery is not all about tiny tweaks. Patents on slight modifications of previous patents is an interesting topic but one can’t use that to argue that all biotech innovations are similar.

    Monsanto is an especially weak case (IMHO as Biochemist) where I don’t think the originality or novelty is sufficient. The mutations built into the genes were isolated in nature from resistant plants. Further, the ridiculous lawsuits against farmers obtaining resistant, next generation plants are unrealistic because they attempt to ‘rule’ against something that happens naturally: Recombination and cross-fertilization. If Monsanto doesn’t have a realistic means of ensuring that its IP doesn’t freely go somewhere they can’t control and in fact contaminates other seed lines, that’s their own damn problem. That is not something that is properly addressed through patent law but other legislation instead that addresses the peculiar issues of replicating entities and ownership.

    Yes, patent law and the system is f-ed up. But that doesn’t mean that some genetic/biotech innovations wouldn’t be worthy of patenting in a good system.

  13. HarvardLaw92 says:

    @Argon:

    That’s a valid point.