It’s Nature’s way

The Justice Department recognizes that DNA can indeed be used to invent things (pdf):

…the district court erroneously cast doubt on the patent eligibility of a broad range of man-made compositions of matter whose value derives from the information-encoding capacity of DNA. Such compositions — e.g., cDNAs, vectors, recombinant plasmids, and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops, created with the aid of such molecules — are in every meaningful sense the fruits of human ingenuity and thus qualify as “‘human-made inventions’” eligible for patent protection…

At the same time, the DOJ distinguishes between the above inventions and isolated genomic DNA, which does not qualify:

…genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible. Unlike the genetically engineered microorganism in Chakrabarty, the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a “human-made invention.” Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell — that is, the relationship between genotype and phenotype — is simply a law of nature.

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4 Responses to It’s Nature’s way

  1. Pingback: Quick Links | A Blog Around The Clock

  2. David / Abel says:

    So, Misha, I’m a bit confused with how the BRCA ruling affects biotech companies. If genomic DNA is not an invention, is cDNA? It does not technically exist in the cell but must be made from mRNA. Even if not codon-optimized or with codon substitutions for stabilizing amino acids, does this ruling make cDNAs unpatentable?

    By the way, heartiest congratulations on the release of the book! I hope that you’ll have a big splash so we can promote your excellent work.

  3. Dan Vorhaus says:


    This is an amicus brief in ongoing litigation, so it’s not a ruling and, as such, has no *immediate* impact on biotechnology companies. In a hypothetical world in which the same or similar reasoning is adopted by the Federal Circuit (the court currently hearing the Myriad case), the government’s brief singles out cDNA in particular several times as an example of a molecule that *would* constitute a patentable invention.


  4. mangrist says:

    Thanks Dan, as always, for your succinctness and clarity.