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SCOTUS: Human Genes are not patentable


StrangeSox

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http://www.nytimes.com/2013/06/14/us/supre...ented.html?_r=0

 

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.”

 

These tests can be run for a few dollars each, but the patent protection allowed Myriad to charge thousands of dollars for each test. I think this ruling is going to be extremely important for decades to come.

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QUOTE (StrangeSox @ Jun 13, 2013 -> 03:17 PM)
There's dozens of rulings all the time nobody but lawyers pay attention to.

 

I'm kinda surprised this one came back 9-0, though. I'll have to read it later.

From what I heard they split the decision...that the company could patent their process for identifying the gene but couldn't patent the code of the gene itself. What that means in terms of another company actually being able to develop a test for the gene in this case, for example, I'm just not sure.

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I seem to remember these companies running tests on people who showed certain unexplained immunity or defenses to particular ailments or conditions and then patenting their extraordinary genes without really getting their permission or even giving them any notice...this was like 7-8 years ago though when I read it...

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QUOTE (Balta1701 @ Jun 13, 2013 -> 02:19 PM)
From what I heard they split the decision...that the company could patent their process for identifying the gene but couldn't patent the code of the gene itself. What that means in terms of another company actually being able to develop a test for the gene in this case, for example, I'm just not sure.

Myriad's patent was over a genetic marker, BRCA, that's an indicator for breast cancer. Their patent was so broad that they held the rights to any possible test that identified a BRCA mutation, essentially to BRCA1 or BRCA 2 themselves. It was absurd because it's simply a naturally occurring gene mutation. They didn't apply for a patent for their process because it was not at all novel.

 

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," 702 F. 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.

 

cDNA is still patent-able because it's not naturally occurring.

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QUOTE (iamshack @ Jun 13, 2013 -> 04:22 PM)
I seem to remember these companies running tests on people who showed certain unexplained immunity or defenses to particular ailments or conditions and then patenting their extraordinary genes without really getting their permission or even giving them any notice...this was like 7-8 years ago though when I read it...

Is this what you were thinking of? Maybe not, this case was from 1990.

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QUOTE (farmteam @ Jun 13, 2013 -> 03:27 PM)
Is this what you were thinking of? Maybe not, this case was from 1990.

Yeah, probably...I was referring to the time I read it (when I was in law school) rather than the time of the case, I guess...

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QUOTE (iamshack @ Jun 13, 2013 -> 05:45 PM)
Yeah, probably...I was referring to the time I read it (when I was in law school) rather than the time of the case, I guess...

Oops, you did say that.

 

I read it in Health Law, though, not an IP class.

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