US court says human genes cannot be patented (Update 4)

by Jesse J. Holland
A technician loads patient samples into a machine for testing at Myriad Genetics Friday, May 31, 2002, in Salt Lake City. DNA samples are moved from one tray to another by the eight-needle apparatus at left. The Supreme Court ruled Thursday, June 13, 2013 that Myriad Genetics Inc. cannot patent the BRCA genes, which are tested to check a woman's risk for breast and ovarian cancer. Mutations in these genes are what led Angelina Jolie to have both her breasts removed because she had such a high cancer risk. Some experts think the court ruling may lead to lower cost testing because there could be more competition. (AP Photo/Douglas C. Pizac)

The U.S. Supreme Court on Thursday unanimously threw out attempts to patent human genes, siding with advocates who say the multibillion-dollar biotechnology industry should not have exclusive control over genetic information found inside the human body.

But the high court also approved for the first time the patenting of synthetic DNA, handing a victory to researchers and companies looking to come up with ways to fight—and profit—from medical breakthroughs that could reverse life-threatening diseases such as breast or ovarian cancer.

The decision "sets a fair and level playing field for open and responsible use of genetic information," said Dr. Robert B. Darnell, president and scientific director of the New York Genome Center. "At the same time, it does not preclude the opportunity for innovation in the genetic world, and should be seen as an important clarifying moment for research and the healthcare industry."

The high court's judgment, written by Justice Clarence Thomas, reverses three decades of patent awards by government officials and throws out patents held by Myriad Genetics Inc. involving a breast cancer test brought into the public eye recently by actress Angelina Jolie's revelation that she had a double mastectomy.

Jolie said she carries a defective BRCA1 gene that puts her at high risk of developing breast and ovarian cancers, and her doctor said the test that turned up the faulty gene link led Jolie to have both of her healthy breasts removed. Jolie's mother died of ovarian cancer and her maternal grandmother also had the disease.

The high court's ruling immediately prompted one of Myriad's competitors to announce it would offer the same test at a far lower price.

Justice Clarence Thomas, who wrote the court's decision, said Myriad's assertion—that the DNA it isolated from the body for its proprietary breast and ovarian cancer tests were patentable—had to be dismissed because it violates patent rules. The court has said that laws of nature, natural phenomena and abstract ideas are not patentable.

"We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," Thomas said.

However, the court gave Myriad a partial victory, ruling that while naturally-occurring DNA was not patentable, synthetically-created DNA, known as cDNA, can be patented "because it is not naturally occurring," as Thomas wrote.

The split decision mitigates potential damage to the multibillion-dollar biomedical and biotechnological industries in the U.S., experts said. It will affect companies like Myriad and others doing similar work, said Courtenay Brinckerhoff, a lawyer at Foley & Lardner.

"The decision is likely to have the greatest impact on diagnostic/genetic screening patents similar to those at issue in Myriad, but the ruling will impact the patent-eligibility of other newly discovered compounds that are 'isolated' from nature, such as medicinal compounds isolated from plants, beneficial proteins isolated from human or animal sources, and beneficial microorganisms isolated from soil or the deep sea," she said.

For the most part, biotech companies already have moved on from trying to patent isolated DNA, instead looking at synthetic options and other ways of protecting their multimillion-dollar investments, said Matthew McFarlane of Robins, Kaplan, Miller & Ciresi L.L.P.

"On a day-in and day-out basis, I don't see this changing that part of the industry," McFarlane said. "Isolated DNA itself is not something that companies seek to protect anymore."

Patents are the legal protection that gives inventors the right to prevent others from making, using or selling a novel device, process or application.

The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years, but opponents of Myriad Genetics Inc.'s patents on the two genes linked to increased risk of breast and ovarian cancer say such protection should not be given to something that can be found inside the human body.

The company used its patents to come up with its BRACAnalysis test, which looks for mutations on the breast cancer predisposition gene, or BRCA. Women with a faulty gene have a three to seven times greater risk of developing breast cancer and also have a higher risk of ovarian cancer.

Myriad sells the only BRCA gene test, which costs around $3,000. Opponents said the company has used its patents to keep other researchers from working with the BRCA gene to develop other tests. The challenged patents would have expired in 2015.

"Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, a lawyer for the American Civil Liberties Union Women's Rights Project. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."

American Medical Association President Dr. Jeremy A. Lazarus agreed. "Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights," he said.

Not long after the ruling, DNATraits, part of Gene By Gene, Ltd., said it would offer BRCA gene testing in the United States for $995—less than a third of the current price.

Thomas noted there are still ways for Myriad to make money off its discovery. "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," he said. And he noted that the case before the court did not include patents on the application of knowledge about the two genes.

For its part, Myriad focused on what the ruling left intact.

"We believe the court appropriately upheld our claims on cDNA and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," said Peter D. Meldrum, Myriad's president and CEO. "More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples' lives and lowering overall healthcare costs."

Companies had billions of dollars of investment and years of research on the line in this case. Their advocates argue that without the ability to recoup their investment through the profits that patents bring, breakthrough scientific discoveries to combat all kinds of medical maladies wouldn't happen.

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Modernmystic
1 / 5 (20) Jun 13, 2013
Electrons are a product of nature, I guess isolating and using them in electronics shouldn't be patentable.

Might put a damper on the industry, but hey we "stuck it to the man!!!"...

pfft.
antialias_physorg
4.3 / 5 (11) Jun 13, 2013
Might put a damper on the industry, but hey we "stuck it to the man!!!"...


Well, how would you feel iff you ad breast cancer and then had to pay royalties to Myriad Genetics for every cell that gene is in?
That doesn't sound sensible, does it?

Stuff that is found freely in nature shouldn't be patentable at all. If it were then I'll just patent sunlight and see you in court for every one of my photons you use.
Milou
2 / 5 (2) Jun 13, 2013
In the end corporations will win out. After all, they are now considered individual entity. They are like you and I.
Grallen
5 / 5 (5) Jun 13, 2013
This is a wonderful thing. Medical research has been hampered for so long due to fears of getting sued. No appeal at this level either. 25 days until the widow for rehearings is closed (and I doubt after a unanimous decision that a rehearing will be granted) and cures for genetic disorders can be freely researched again.

This is a good day.
dogbert
3.8 / 5 (10) Jun 13, 2013
Good ruling but too narrow.

Genes in general are natural occurrences and should not be patentable.
Grallen
5 / 5 (2) Jun 13, 2013
"Genes in general are natural occurrences and should not be patentable."
@dogbert: Maybe any naturally occurring gene. Or possible any gene loose in nature.

If I designed a new protein on a computer(Completely novel protein), then painstakingly created a gene that would encode that protein(Completely novel gene) so that I could vat grow that protein. I think that that gene should be patentable. Unless that gene got loose in nature, then the patent should end in-case it causes trouble. Or maybe limit the patent to its use in vat growing that protein.

Though, I feel anything in the biosphere is public domain.
antialias_physorg
4.6 / 5 (11) Jun 13, 2013
--"Though, I feel anything in the biosphere is public domain"--

Monsanto would beg to differ.

Because what you describe is exactly what they do. And they are already suing farmers who raise corn that has been - even inadvertently - cross pollinated with corn of their manufacture.

It's a rather sick thing to watch.
krundoloss
2.4 / 5 (5) Jun 13, 2013
I think this is good for everyone, but bad for Big Genetic Business. What will motivate a business to do in-depth genetic research if the information ends up being shared by all, and there is no payback for thier research dollars? Will this stifle the industry?
Grallen
4 / 5 (4) Jun 13, 2013
Universities will do the research anyways. To attract grants, students and prestigious researchers. Not to mention charities, and government research labs.
gwrede
3.5 / 5 (8) Jun 13, 2013
Whew! Now I can have children without paying royalties to American companies!

I think this was the right decision.
And I think even the industry itself profits from this in the long run.
Modernmystic
1 / 5 (5) Jun 13, 2013
"Well, how would you feel iff you ad breast cancer and then had to pay royalties to Myriad Genetics for every cell that gene is in?"


Better than I'd feel than if I had no cure and DIED...oh wait, I guess then I wouldn't feel ANYTHING. Touche'
MarcoF
5 / 5 (4) Jun 13, 2013
"However, the court gave Myriad a partial victory, ruling that while naturally-occurring DNA was not patentable, synthetically-created DNA could be patented. The court said that synthetically created DNA, known as cDNA, can be patented "because it is not naturally occurring,""

As I understand it, this is not a victory at all! If they can still patent cDNA then it all remains the same, all genetic testing and study requires the production of cDNA, which is chemicaly indistinguishable from the isolated natural DNA anyway, it's all a "legal words game". Myriad can still block scientific investigation if they want, and genetic tests will continue to be more expensive than necessary, a qPCR reaction would be enough and could be performed at any lab much more cheaper.
beleg
1.5 / 5 (4) Jun 13, 2013
Chimeric skin and hair cells put you at an advantage. Wear gloves though.
MarcoF
1 / 5 (1) Jun 13, 2013
[...] cDNA, which is chemicaly indistinguishable from the isolated natural DNA anyway,.

Sorry, apparently they are talking about DNA synthesized from a messenger RNA (mRNA), therefore it is different from the isolated natural DNA, but the problem persists, if cDNA is patentable then other companies and scientists can't use it
socean
3 / 5 (2) Jun 13, 2013
I think I should be able to own the IP rights of my own DNA. Its not just "God Given" ( assuming you believe in such things ) I modify it all the time through my lifestyle choices that affect epigenetics and mutations. My DNA is "product" of my life.

Why can't I have the rights? Who else has any right to them? Who can say that I don't have them? Aren't they inalienable?

Individuals should be able to patent their own DNA.
dutchman
5 / 5 (1) Jun 13, 2013
In the end corporations will win out. After all, they are now considered individual entity. They are like you and I.


So, when can we get to see the DNA (cDNA would not count here) of a MONSANTO critter?
dutchman
not rated yet Jun 13, 2013
"Well, how would you feel iff you ad breast cancer and then had to pay royalties to Myriad Genetics for every cell that gene is in?"


Better than I'd feel than if I had no cure and DIED...oh wait, I guess then I wouldn't feel ANYTHING. Touche'


MOST cancers can end in a slow and painful death. Something you would not wish on any other being.
MikeBowler
1 / 5 (2) Jun 13, 2013
"Well, how would you feel iff you ad breast cancer and then had to pay royalties to Myriad Genetics for every cell that gene is in?"


Better than I'd feel than if I had no cure and DIED...oh wait, I guess then I wouldn't feel ANYTHING. Touche'


MOST cancers can end in a slow and painful death. Something you would not wish on any other being.


if genes weren't patented cures would be less expensive to find, in contrast any cures that exist while/if natural genes are patented will be few and far between so not only will it cost you a lot of time and money if a cure is applicable and available where and when you are but you'll also have been very fortunate assuming you could have somehow afforded it
antialias_physorg
3.7 / 5 (3) Jun 13, 2013
---"Better than I'd feel than if I had no cure and DIED...oh wait, I guess then I wouldn't feel ANYTHING. Touche' "---

How does non-patentability of a gene prevent a cure from being developed? You can still patent your drug.
malapropism
5 / 5 (2) Jun 13, 2013
Electrons are a product of nature, I guess isolating and using them in electronics shouldn't be patentable.

You're partly right and partly wrong. Electrons are a product of nature so it is not possible to patent them. However there's nothing to stop someone from devising a method (and presumably apparatus) to isolate them and to patent that method (and apparatus).

Similarly you cannot patent using electrons in electronics however you can patent the circuits in which the electrons flow if those circuits are your invention.
malapropism
5 / 5 (2) Jun 13, 2013
"Well, how would you feel iff you ad breast cancer and then had to pay royalties to Myriad Genetics for every cell that gene is in?"


Better than I'd feel than if I had no cure and DIED...oh wait, I guess then I wouldn't feel ANYTHING. Touche'

I think you misunderstand what is at stake.

Myriad Genetics had a patent on the 2 BRCA genes, that meant that nobody else could work on a *better* cure without Myriad's say-so, and probably some quite big fees changing hands. That stifles innovation in an area that really needs smart people working on better 'cures' than simply chopping off parts of someone's anatomy. The principle extends to lots of other "problem" or "mutant" genes also of course.

There's nothing to prevent Myriad from patenting (or retaining the patents they already have on) their methods for analyses results of tests, determining if a problem gene is present, creating a gene-therapy-based therapeutic treatment, etc, just like any other lab in the world.
malapropism
5 / 5 (1) Jun 13, 2013
Sh*t, what have they done with this site's commenting?!

Sorry about the duplicate posts but, really, that shouldn't be possible. C'mon guys, it's not rocket science, just a bit of slightly-clever coding.
VendicarE
not rated yet Jun 14, 2013
"In the end corporations will win out. After all, they are now considered individual entity. They are like you and I." - Milou

That form of idiocy comes from America. Why emulate idiots?
VendicarE
not rated yet Jun 14, 2013
"I think I should be able to own the IP rights of my own DNA." - FoofieWoofie

Corporations have just won the right to own their own DNA, but since they have none to own, they own nothing.

Perfect.
VendicarE
not rated yet Jun 14, 2013
"To attract grants, students and prestigious researchers. Not to mention charities, and government research labs." - Markie Warkie

Perhaps this is why Conservatives are trying to destroy education, the University system, and halt Government funded Scientific research.
TheKnowItAll
1 / 5 (2) Jun 14, 2013
Why the focus on human genes only? It should be "naturally occurring genetics" Because you own a tool that allows you to map a genome of anyone and anything and proceed to classify the gene segments doesn't make you an inventor of a product or process of anything, the genetic codes and it's functions have always been there and will continue to evolve (change).
Jaeherys
not rated yet Jun 14, 2013
@TheKnowItAll
They are not only referring to human DNA but all DNA isolated from any organism like fungi or bacteria.

Although I find it quite amazing that we can no longer patent genes themselves, what is even more troubling is that copy DNA (cDNA) can now be patented under these ridiculous claims that they are not naturally occurring and synthetic. The reverse transcriptase reaction, used by viruses that contain RNA as their primary information carrier, has existed for millions of years. cDNA is created by producing a complementary DNA strand from an RNA template, destroying the RNA strand, adding a new complimentary DNA strand, and finally inserting it into the hosts' genome in order to perform a multitude of virus specific functions.

In the lab, cDNA is used as an amplicon, a piece of DNA that will be replicated thousands of times, i.e. amplified.

cont...
Jaeherys
not rated yet Jun 14, 2013
We produce cDNA from mRNA for multiple reasons but usually it is to quantify a difference in mRNA expression between a control and multiple treatment cells. Moreover, it is used extensively for creating what we call cDNA libraries. Typically we use them for cell type specific mRNA levels, also called the transcriptome of a cell. This is typically what most people refer to when talking about cell phenotype as the culmination of translated mRNA is what directs the cellular response to most stimuli, i.e. receptors, transcription factors, etc. This has two fold uses, but mainly they are integral for microarray analysis for comparing cell type expression differences of control and treatment cells for example.

As you can see, cDNA is extremely important and is used in almost every biology lab in the world. We did not create this synthetically, we discovered an organism, the virus, that did this naturally and used it for our own purposes; similar to the Taq polymerase.
Jaeherys
not rated yet Jun 14, 2013
Taq polymerase is used in the polymerase chain reaction, part of the process we use to amplify the cDNA produced by a reverse transcripatse (RT) reaction. The entire process is usually referred to as qPCR or RT-PCR.

If what they say is true that all cDNA can be patented now, we may be in for a serious change when it comes to research. If companies can patent cDNA libraries, the already quite expensive analysis of the transcriptome using microarrays will go up by who knows how much. Currently, the average microarray costs $3000 CAN per block.

I specifically am involved in research of microRNA interation to a mRNA target which we think may be a key factor in poor placental-uterine vascularization which is a primary cause of pre-eclampsia, a disease that is life threatening if left alone throughout gestation. At least once a week cDNA is created and we analyse specific mRNA levels. If we had to pay a royalty each time, the research would be severely hindered.
beleg
1 / 5 (1) Jun 15, 2013
Humans have a sense of ownership.
And the owner of the following words will recognize his/hers words:
"Property is theft"
MikeBowler
1 / 5 (1) Jun 16, 2013
-----delete please-----