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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. From his recent appearance on WRTV to this story here, Frank is everywhere. Couldn't happen to a nicer guy, although he should stop using Eric Schnauffer for his 7th Circuit briefs. They're not THAT hard.

  2. They learn our language prior to coming here. My grandparents who came over on the boat, had to learn English and become familiarize with Americas customs and culture. They are in our land now, speak ENGLISH!!

  3. @ Rebecca D Fell, I am very sorry for your loss. I think it gives the family solace and a bit of closure to go to a road side memorial. Those that oppose them probably did not experience the loss of a child or a loved one.

  4. If it were your child that died maybe you'd be more understanding. Most of us don't have graves to visit. My son was killed on a state road and I will be putting up a memorial where he died. It gives us a sense of peace to be at the location he took his last breath. Some people should be more understanding of that.

  5. Can we please take notice of the connection between the declining state of families across the United States and the RISE OF CPS INVOLVEMENT??? They call themselves "advocates" for "children's rights", however, statistics show those children whom are taken from, even NEGLIGENT homes are LESS likely to become successful, independent adults!!! Not to mention the undeniable lack of respect and lack of responsibility of the children being raised today vs the way we were raised 20 years ago, when families still existed. I was born in 1981 and I didn't even ever hear the term "CPS", in fact, I didn't even know they existed until about ten years ago... Now our children have disagreements between friends and they actually THREATEN EACH OTHER WITH, "I'll call CPS" or "I'll have [my parent] (usually singular) call CPS"!!!! And the truth is, no parent is perfect and we all have flaws and make mistakes, but it is RIGHTFULLY OURS - BY THE CONSTITUTION OF THIS GREAT NATION - to be imperfect. Let's take a good look at what kind of parenting those that are stealing our children are doing, what kind of adults are they producing? WHAT ACTUALLY HAPPENS TO THE CHILDREN THAT HAVE BEEN RIPPED FROM THEIR FAMILY AND THAT CHILD'S SUCCESS - or otherwise - AS AN ADULT.....

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