Are human genes patentable?

by Jessica Martin
genes
This image shows the coding region in a segment of eukaryotic DNA. Credit: National Human Genome Research Institute

(Medical Xpress)—On April 15, the Supreme Court will hear oral argument in Association for Molecular Pathology v. Myriad Genetics, a case that could answer the question, "Under what conditions, if any, are isolated human genes patentable?" Kevin Emerson Collins, JD, patent law expert and professor of law at Washington University in St. Louis, believes that layered uncertainties make this case an unusually difficult case in which to predict the outcome.

During the early 1990s, Myriad Genetics made important related to mutations in the and BRCA 2 genes, which are biomarkers for increased risk of breast and . Based on this work, Myriad sought, and obtained, for "isolated" DNA molecules that embody these sequences.

The 's opinion in Myriad will determine whether Myriad's gene patents are valid or, alternatively, whether they were improperly issued from the beginning.

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Kevin Emerson Collins, patent law expert and professor of law at Washington University inSt. Louis, discusses the Myriad Genetics case before the Supreme Court. This case could answer the question, “Under what conditions, if any, are isolated human genes patentable?” Collins believes that layered uncertainties make this case an unusually difficult case in which to predict the outcome.

"The legal controversy centers on 's 'products of nature' doctrine—a doctrine that prevents the patenting of newly made products that do not display a 'marked difference' from naturally occurring products," Collins says.

"A perfectly circular section cut out of a leaf of a newly discovered plant may be technically new at the time that it is first made – and it may be socially useful if the leaf contains chemicals that are natural wound healers, but it's likely an unpatentable product of nature because there is no marked difference between the newly created product and the naturally occurring product.

"Importantly, the Myriad gene patents only encompass DNA molecules in an 'isolated' state, separate from the remainder of the chromosome in which they exist in a human body, and they thus describe molecules that were technically new when Myriad first made them."

The question before the Court is whether the structural and functional differences between naturally occurring DNA molecules and in an isolated state is sufficiently significant to constitute a "marked difference" and to sanction the patenting of the isolated DNAs.

Behind the legal controversy is an economic controversy that may (or may not) influence the Supreme Court's pronouncement on the products of nature doctrine. "The social costs of the exclusive rights to inventions granted by patents are normally justified by the incentives that patents provide for self-interested entities to invest in research and development and generate the socially valuable inventions," Collins says.

However, under some circumstances, there are legitimate concerns that the incentive-based benefits of patents may not outweigh these costs.

"One function of the products of nature doctrine is to ensure that the basic tools of scientific and technological work are not constrained by claims of patent rights and remain free for all to use as inputs into future research," says Collins.

"To the extent that isolated genes are essential technological and scientific building blocks, the costs of Myriad's in the form of slower innovation in the future may be so great that they will outweigh the benefits of the patent-induced incentives that speed up the creation of the isolated genes themselves."

The verdict

Collins says it is difficult to predict how the Supreme Court will decide this case because of three compounded uncertainties.

First, the Supreme Court has to date not offered a clear legal framework for identifying products of nature, so it is unclear how high a hurdle the markedly different standard will prove to be.

Second, it is unclear how strongly the Court's legal determination will be influenced by the underlying economic concerns about the privatization of the building blocks of technological progress.

Third, the relationship between the Supreme Court and the Federal Circuit Court of Appeals—the court that authored the opinion below in Myriad—is not likely to lead to much of any deference.

"Recent Federal Circuit patent decisions have been poorly received by the Supreme Court," Collins says. "The Federal Circuit upheld the patentablity of these genes, but, given recent history, this is not much of an indicator as to Supreme Court will handle this case."

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Lurker2358
1.7 / 5 (6) Apr 11, 2013
"Importantly, the Myriad gene patents only encompass DNA molecules in an 'isolated' state, separate from the remainder of the chromosome in which they exist in a human body, and they thus describe molecules that were technically new when Myriad first made them."


I disagree because genes are commonly broken away from the chromosomes, such as in allele swapping.

Besides, DNA is in many respects a polymer, composed of chains of the more simplified bases and base pairs, which are molecules which also exist independently in nature.

If patents on human genome are upheld it will be a human rights violation, i.e. "the right to life" not to mention the spirit of the 13th through 15th amendments.

It seems reasonable to me that you can patent a process of isolating a DNA molecule, or you can patent an artificial gene or some other artificial DNA machine, but patenting the DNA molecules or sub-molecules should not be legal.
aroc91
2 / 5 (4) Apr 11, 2013
not to mention the spirit of the 13th through 15th amendments.


So if genes can be patented, slavery will be legalized and black people will have their citizenship revoked?
Moebius
2.6 / 5 (5) Apr 11, 2013
My genes are MY GENES, not yours.
TheKnowItAll
2.6 / 5 (5) Apr 11, 2013
The answer to patenting nature's code is an imperative "NO" and I'm sure we can all agree on that. For them this is a complicated debate because they've already issued unlawful patents and now they have to figure out a way to get out of it without losing credibility. Perhaps their illegal actions should truly be the focus here.
Lurker2358
2.6 / 5 (7) Apr 11, 2013
So if genes can be patented, slavery will be legalized and black people will have their citizenship revoked?


The consequence of gene patenting, especially human genes, is a human rights violation because a research firm could one day use that patent to withhold potential cures for disease, or to produce harmful compounds, products, or GM organisms based on that gene.

Moreover, suppose you have a unique or rare gene sequence. If you go to the hospital or clinic and have a biopsy or other test where your DNA is sent to a lab. The lab could potentially isolate the unique/rare gene from YOUR DNA, and patent it. Then they could conceivably prohibit you from working with another firm to develop a drug or cure of your own, based on your own gene, even though the gene is biologically yours...

This is conceivable, because hospitals, clinics, government agencies, and even some schools are already developing DNA databases on random people, BECAUSE they hope to patent the genes...
aeschylus
3 / 5 (2) Apr 12, 2013
Wow, the gall of these medicopharmaceutical entities. I remember--and was afraid--the first time I heard teams of medical experts profiling the genes of natives all over the world that they'd come with this in the end, and now it's happening.
verkle
1 / 5 (7) Apr 12, 2013
I don't believe there is anything in patent law that states that some particular item cannot be patentable. If scientists are really making these amazing discoveries and inventions, then they should be entitled to their 18 years of protected coverage under the law.

That doesn't mean that others won't be able to use their inventions, it justs means that these scientists will be reimbursed for their inventions over a period of a few years.

Over the long term, all of this knowledge will become free for everyone to use in whatever way they want.

verkle
1.1 / 5 (7) Apr 12, 2013
The consequence of gene patenting, especially human genes, is a human rights violation because a research firm could one day use that patent to withhold potential cures for disease, or to produce harmful compounds, products, or GM organisms based on that gene....


Sorry, I have to disagree with you here. Holding a patent does not mean that you have the power to stop anyone who wants to use it. It is not the same as human rights.

alfie_null
4.5 / 5 (4) Apr 12, 2013
New work is patentable. If you are plugging genes together in your lab in some way that hasn't been done before - yes, patentable. Existing genes - no.
Figuring out what particular genes do costs a lot currently. This won't always be the case, as we gain better understanding of the whole biological process. Patent protection as an incentive might be beneficial in the short term, but will be harmful to society in the long term.
Sinister1811
2.6 / 5 (5) Apr 12, 2013
Over the long term, all of this knowledge will become free for everyone to use in whatever way they want.


Except things that are patented aren't usually free or aren't always available to everyone.
neversaidit
5 / 5 (2) Apr 12, 2013
New work is patentable. If you are plugging genes together in your lab in some way that hasn't been done before - yes, patentable. Existing genes - no.

came here to say this. you can't patent gravity. but you sure can patent planes. you can't patent a naturally existing molecule. the process of it's synthesis/purification, maybe. but if someone can make it in a different way, it's fair game. only if you make a completely new material/molecule, unseen in nature, is where i see the option of a "full" patent.
nowhere
5 / 5 (4) Apr 12, 2013
I don't believe there is anything in patent law that states that some particular item cannot be patentable.

Yes there is. You currently can't patient something that is naturally occuring. Imagine someone patenting air? Maybe electricity? It's ridiculous actuallly.

Sorry, I have to disagree with you here. Holding a patent does not mean that you have the power to stop anyone who wants to use it. It is not the same as human rights.

Actually that is exactly what it does. If those who want to use it cannot pay your set price, they get no access. Problems then arrise when people who need access to the knowledge for their physical well being cannot afford the cost, and also when futher genetic research is stifled.
grondilu
5 / 5 (3) Apr 12, 2013
Human genes are not a creation, they are a discovery. DNA is a book that anybody can read with enough technological competence. When someone is the first to read it, (s)he can't prevent other people to be able to read it later as well. Thus, I think it should not be allowed to patent human genes. If someone wants to keep a privilege on a human gene, (s)he should keep it secret, not try to patent it.
aroc91
not rated yet Apr 13, 2013
The consequence of gene patenting, especially human genes, is a human rights violation because...


That's fine and dandy, but what does it have to do with the amendments you mentioned?

BW1954
5 / 5 (1) Apr 13, 2013
"Sorry, I have to disagree with you here. Holding a patent does not mean that you have the power to stop anyone who wants to use it. It is not the same as human rights"

Actually, the patent owner has the exclusive right (i.e., the right to stop) anyone else from making, using, selling, offering to sell, or importing the product or process covered by the Claims in the Patent. The "exclusive rights" afforded to the patent owner are often confused because the word "exclusive" has dual meanings.

Lurker2358
1 / 5 (3) Apr 13, 2013
It would seem obvious that no genes should be patentable.

Works like this.

You can't patent nature.

If you want to patent an artificial gene you cannot prove that it doesn't exist in nature, and you certainly cannot prove that it could not exist in nature.

If it could exist in nature, then patenting the gene would be a violation of the patent rules.

Otherwise, all corporations on Earth should generate a patent applicaton document for all possible combinations of base pairs in DNA for submission to patent immediately, so that when IF the judge rules in favor of patenting genes all the patents offices would be immediately flooded with them. Moreover, it would just be a matter of a race to the patent offices by all the wealthy corporations or individuals with the technology, funds, manpower, and oppurtinity to make these applications.

It would be a legal feeding frenzy.

"I declare myself to be the owner of the first infinity of combinations of non-patented genes. Patent pending."