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SCOTUS rules on Myriad BRCA1, BRCA2 patent case

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A naturally occurring DNA segment is not eligible for a patent simply because it has been isolated, the Supreme Court of the United States ruled Thursday. DNA that is not a product of nature may be patent eligible, however.

The ruling came in Association for Molecular Pathology, et al. v. Myriad Genetics Inc., et al., 12-398, in which Myriad filed several patents after discovering the precise location and sequence of what are known as BRCA1 and BRCA2 genes. Mutations in these genes can significantly increase a person’s risk of developing breast and ovarian cancer.

Other organizations offered BRCA testing after Myriad discovered the genes, but the company asserted that testing infringed on its patents.

The United States Court of Appeals for the Federal Circuit held both isolated DNA and cDNA – which is an exons-only molecule that is created in a lab – are patent eligible. Two of the three judges on the panel held that the act of isolating DNA allows a company to obtain a patent.

The question in this case is whether Myriad’s discovery of the location and genetic sequences of the genes render it patentable under 35 U.S.C. Section 101.

 “In this case … Myriad did not create anything. 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,” the opinion states, delivered by Associate Justice Clarence Thomas. All of the justices joined, with Associate Justice Antonin Scalia joining in part.

“The court said that you can't get a patent on a DNA sequence that has been isolated from its surrounding material because it's a ‘product of nature,’ but you can potentially get a patent on a DNA sequence that has been altered in the lab,” explained Mark D. Janis, director of the Center for Intellectual Property Research at Indiana University Maurer School of Law.

Thomas noted what was not implicated by this decision. There are no method claims before the court; the processes used by Myriad to isolate the DNA were well understood and widely used. The case doesn’t involved patents on new applications of knowledge about these genes. And the court did not consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.

“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.”

Janis believes the impact of Thursday’s decision will be modest.

“There are many alternative ways to claim biotechnology inventions, and the court's decision is directed only to one of those strategies,” he said. “In the long term, I think it will be viewed largely as a symbolic gesture by the court – a reminder that at least some subject matter does lie in the zone of ineligible products of nature. I do not think it will be regarded as a particularly memorable exposition of patent law principles.”


 

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  1. Major social engineering imposed by judicial order well in advance of democratic change, has been the story of the whole post ww2 period. Contraception, desegregation, abortion, gay marriage: all rammed down the throats of Americans who didn't vote to change existing laws on any such thing, by the unelected lifetime tenure Supreme court heirarchs. Maybe people came to accept those things once imposed upon them, but, that's accommodation not acceptance; and surely not democracy. So let's quit lying to the kids telling them this is a democracy. Some sort of oligarchy, but no democracy that's for sure, and it never was. A bourgeois republic from day one.

  2. JD Massur, yes, brings to mind a similar stand at a Texas Mission in 1836. Or Vladivostok in 1918. As you seemingly gloat, to the victors go the spoils ... let the looting begin, right?

  3. I always wondered why high fence deer hunting was frowned upon? I guess you need to keep the population steady. If you don't, no one can enjoy hunting! Thanks for the post! Fence

  4. Whether you support "gay marriage" or not is not the issue. The issue is whether the SCOTUS can extract from an unmentionable somewhere the notion that the Constitution forbids government "interference" in the "right" to marry. Just imagine time-traveling to Philadelphia in 1787. Ask James Madison if the document he and his fellows just wrote allowed him- or forbade government to "interfere" with- his "right" to marry George Washington? He would have immediately- and justly- summoned the Sergeant-at-Arms to throw your sorry self out into the street. Far from being a day of liberation, this is a day of capitulation by the Rule of Law to the Rule of What's Happening Now.

  5. With today's ruling, AG Zoeller's arguments in the cases of Obamacare and Same-sex Marriage can be relegated to the ash heap of history. 0-fer

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