Today's Myriad Genetics Decision, Simplified: Everyone Wins
Lets start this off with a little disclaimer: We, the lawyer-bloggers of FindLaw.com, are not scientists. We'd venture a guess that neither are you. And according to his confused concurrence, neither is Justice Scalia.
We do understand one thing from this case, however: the human genetic code cannot be patented, no matter how much effort went in to discovering the DNA sequences. Synthetic cDNA, however, can be. Lost in the alphabet soup? It'll make sense soon enough.
DNA 101
Genes are small portions of your DNA that use a clever chemical code to tell the body how to build pieces of you. Certain blips, or mutations, in the coding can lead to predispositions for diseases. Myriad Genetics researched, tested, and retested until they had identified the BRCA1 and BRCA2 genes that, when mutated, can result in an abnormally high predisposition to breast and ovarian cancer. Women with the variant BRCA1 gene are five times more likely to develop breast cancer.
Obviously, such a discovery is important. Women can be tested for the BRCA genes, and if necessary, preventative measures can be taken to reduce their chances of developing cancer.
Myriad, as any research company would do, patented their discoveries. Their patents included the methods of testing, the DNA sequences of the BRCA genes, and cDNA sequences developed in a lab from the genes. cDNA is created by "stripping" unused portions from the natural DNA strand, resulting in a synthetic DNA code that can also be used in testing.
Nature's Own or Mankind's Creation?
A basic proposition of patent law is that it does not apply to abstract concepts or discoveries of things already existing in nature. That's what Myriad was doing with the patents on the BRCA DNA. The Supreme Court invalidated their patents today for exactly that reason.
"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."
cDNA is a different story. The lab techs add to existing genetic material, creating a new, shortened strand of synthetic DNA free of all of the unimportant (for testing purposes) code. Because cDNA does not exist in nature, the Supreme Court upheld the patent on Myriad's cDNA creations.
Obviously, this is a bit over-simplified, but if you are like us, and Justice Scalia, DNA coding discussions hurt your brain. Scalia's concurrence was one paragraph long and can be paraphrased as, "I don't understand science so I can't join the majority, but per the experts' affidavits and court opinions, I'm going to agree with the holding."
Impact
So far, everyone wins. Myriad kept some patents, and due to the case's uncertain outcome, are the only company currently doing BRCA testing. Their stock has soared since the holding. On the other hand, with the actual DNA sequences open to the public, research on these incredibly important genes can continue unimpeded. Even better, according to the ACLU, tests for the BRCA genes can be done without Myriad's patented cDNA sequences.
June 13, 2013 Editor's Note: This post has been updated to more accurately describe what DNA is and how it works. We've had some good advice, but please keep in mind, we are still just lawyers.
Related Resources:
- Ass'n for Molecular Pathology v. Myriad Genetics (U.S. Supreme Court)
- Will the SCOTUS Actually Resolve Genetic Patents This Time? (FindLaw's U.S. Supreme Court Blog)
- Mayo, Prometheus Medical Patent Case Overturned by SCOTUS (FindLaw's Federal Circuit Blog)