USSC Rules on Human Genes

althea_gwJune 13, 2013

This is good news I guess. I haven't read the fine print.

he Supreme Court unanimously ruled Thursday that human genes isolated from the body can't be patented, a victory for doctors and patients who argued that such patents interfere with scientific research and the practice of medicine.

The court was handing down one of its most significant rulings in the age of molecular medicine, deciding who may own the fundamental building blocks of life.

Here is a link that might be useful: wsj

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david52 Zone 6

This is good news. And it was unanimous.

    Bookmark   June 13, 2013 at 11:26AM
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nancy_in_venice_ca Sunset 24 z10

And it was unanimous.

Phew!

    Bookmark   June 13, 2013 at 12:33PM
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marshallz10(z9-10 CA)

I am so happy. The biotech industry had been on a roll, patenting all kinds of lifeforms and potentially valuable parts of organisms, with the earlier blessings of the Federal courts.

    Bookmark   June 13, 2013 at 10:45PM
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batyabeth

Since I've been lurking like a madwoman at the SCOTUS sites, I've been reading about this more than I probably would have normally. Yes, although it seems that it's a good decision for those who would like to use genes for research and not pay patent holders, and who would not want to see human genes become someone's personal property, the biotech companies can alter a gene very, very slightly and then, as it's not a naturally occurring gene, patent it. The court watchers say the judges' decision actually was middle of the road, and the biotech folks got what they wanted as much as the other side.

As a life-long science fiction reader I've been aware for decades what biotech could do if they only could do so legally and out in the open. For all the good that would come of it (curing MS etc), the nefarious ones are still going to continue trying to tweak the law and cross all sorts of boundaries, ethical and legal.
This particular court has been characterized as being very pro-business, and allowing all sorts of legal justification that might not look so good down the road. But these decisions are usually done quietly and pass under our radar.

    Bookmark   June 14, 2013 at 4:08AM
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david52 Zone 6

another opinion that gives more detail:

-snip -

The Court’s decision was relatively simple. It began with a largely accurate, and lengthy, recitation of the molecular biology behind transcription and translation. This factored significantly into the Court’s discussion of the differences between isolated genomic DNA and cDNA, particularly the absence of introns from cDNA molecules. It then assessed the patents’ claims at issue, which were generally directed to “an isolated DNA” of varying lengths and sequences. The opinion noted that, “Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes… by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome.” And the Court concluded its opinion by declaring that claims directed to molecules of isolated genomic DNA, themselves, were unpatentable “products of nature” because Myriad did not “alter any of the genetic information encoded in the BRCA1 and BRCA2 genes,” nor did the isolated genomic DNA possess “markedly different characteristics from any found in nature.”

The Court rejected Myriad’s claim that it created a new chemical entity because, in isolating the genes from their surrounding chromosomes, Myriad necessarily cleaved the chemical bonds of the chromosomes’ phosphate backbones. This was irrelevant because “Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.”

As for Myriad’s cDNA claims, however, the Court - in a single, short paragraph - declared them eligible for patent protection because the “non-coding regions have been removed,” thus creating a new molecule not found in nature. Interestingly, the Court recognized the possibility of retrovirii potentially creating identical DNA transcripts to the cDNAs at issue, but dismissed this concern in a footnote: “The possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable.”

Bizarrely, Justice Scalia joined the Court’s opinion in its entirety except for its preliminary scientific discussion. In a separate concurrence, Justice Scalia wrote: “I am unable to affirm those details on my own knowledge or even my own belief.” Typically, Justice Scalia does not qualify the factual portions of opinions he joins, even where they involve science. And notably, in the Court’s recent decision in Maryland v. King involving the constitutionality of warrantless DNA tests for arrestees, Justice Scalia’s dissent is replete with the factual differences between DNA and fingerprint testing.

This likely brings to a close Myriad Genetics’ saga of aggressively enforcing its patents directed to BRCA1 and BRCA2 testing. Myriad will continue to offer its BRACAnalysis product, which, because of its trade secret mutational database, is likely still the most robust BRCA test on the market. And competitors will be able to enter the BRCA testing market and make use of Myriad’s methods, although they will have to do so without the benefit of certain cDNA molecules or Myriad’s clinical data.

But the decision leaves a number of legal questions unanswered: What about other patents directed to “isolated and purified” natural products? Are cDNAs nonetheless obvious, and therefore unpatentable for that reason? And, considering the Court’s mention of retrovirii, how “unusual and rare” must a “natural phenomena” be to still be patent eligible if synthetically created? These are issues that the lower courts are likely to struggle with going forward, and issues that may, one day, be back in the hands of the Supreme Court.

Here is a link that might be useful: link

    Bookmark   June 14, 2013 at 10:19AM
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jodik_gw

I'm glad... this could lead to huge issues if not corralled.

    Bookmark   June 14, 2013 at 10:33AM
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marshallz10(z9-10 CA)

The catch in this decision is retaining for the industry the right to patent a genetic element if the company has striped the DNA of extraneous base pairs, in other words, cleaned up the genetic material, making the material "synthetic".

A reminder: the gene often codes for making proteins, the same gene can produce variants or even different proteins depending on transcription factors (telling the gene in essence what to produce.)

    Bookmark   June 15, 2013 at 8:28AM
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jodik_gw

But isn't there always a catch? This is the world we live in... gluttonous and greedy, using any method to take full advantage of the human population that will surely be affected by such decisions...

I would ask, "what is wrong with people?"... but the answers are all too clear.

It's a case of we should be happy with the little scraps we get tossed...

    Bookmark   June 15, 2013 at 1:23PM
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david52 Zone 6

OK - isolating a snip of viable DNA from the rest of the strand and then putting it to some use.

Like what? If its to cure some sort of congenital disease, I don't see why that shouldn't have a patent.

    Bookmark   June 15, 2013 at 2:36PM
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duluthinbloomz4

Obviously I need to look at this more closely. But, the "viable DNA from the rest of the strand" occurs in nature and that precludes it from patent. If a test, treatment, etc. results in the isolating of the snip, that test or treatment could be patented.

If I'm misinterpreting this, tell me.

    Bookmark   June 15, 2013 at 2:49PM
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marshallz10(z9-10 CA)

As I read it (and that is not that closely), the "wild" DNA is not patentable but the tests are protected by patenting. Another company can use the same DNA snippets to work up new tests and patent that as its own. Before the court ruling, the company with the original test claimed that patenting the gene precluded any other company to use the gene for research toward other tests (and perhaps treatments.) FWIW

    Bookmark   June 15, 2013 at 3:02PM
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duluthinbloomz4

Think we're on the same page here. Was listening to Debbie Wasserman-Schultz talk about her 7 cancer surgeries on Hardball. Myriad held the patent on the test that confirmed her diagnosis. When she inquired about a second opinion (before submitting to having her breasts removed, her ovaries as well, and all the reconstructive surgeries) she was told it was impossible; Myriad was the only game in town.

Now there are extant, or in the pipeline, tests - and at much lesser cost than Myriad's.

    Bookmark   June 15, 2013 at 3:21PM
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