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June 13, 2013

Supreme Court Upends Patentability of Genes, but Not cDNA

  • The U.S. Supreme Court this morning delivered a mixed decision for companies looking to patent human genes, ruling against Myriad Genetics’ patent claims for breast cancer susceptibility genes BRCA 1 and 2—but also holding that companies can patent composite DNA (cDNA) and other synthetic genetic material that  does not meet the “product of nature” exemption from patentability.

    “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring,” the court stated in an opinion written by Justice Clarence Thomas.

    “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a 'product of nature' and is patent eligible,” under Section 101 of Title 35 of the U.S. Code, the decision added.

    While the decision was technically unanimous, Justice Antonin Scalia concurred with the judgment but not with all of the justices’ reasoning, saying it involved “fine details of molecular biology” that he was unable to affirm “on my own knowledge or even my own belief.”

    Myriad responded to the decision with a statement posted to its Facebook page saying the case hinged on more than patent claims: “It was about human health, and innovation to make sure that cancer tests are accessible and affordable to women who need them.”

    “It’s time now to move on,” Myriad declared.

    At issue is the validity of the seven patents issued to Myriad Genetics for BRCA 1 and 2 by the U.S. Patent and Trademark Office (USPTO). In 2009, 20 medical associations and individual doctors led by the Association for Molecular Pathology (AMP) and assisted by the American Civil Liberties Union (ACLU) and Public Patent Foundation (PUBPAT) sued Myriad and USPTO over the patents, as well as Myriad’s method for analyzing sequences of those genes for mutations associated with breast cancer.

    AMP and co-plaintiffs have said that the patents on BRCA 1 and 2 are unconstitutional and invalid, arguing that human genes are unpatentable “products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought” under Section 101.

    The Supreme Court agreed with that argument.

    “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 decision stated.

    The court cited the fact Myriad did not create or alter any genetic information encoded in the BRCA1 and BRCA2 genes, but instead uncovered the precise location and genetic sequence of the genes within chromosomes 17 and 13.

    “Many of Myriad’s patent descriptions simply detail the 'iterative process' of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought,” the decision stated. “But extensive effort alone is insufficient to satisfy the demands of §101.”

    “Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents” and are not at issue in this case, the decision stated. “Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes.”

    In its statement today, Myriad sought to shift focus away from the patentability of the genes. Myriad noted that under the Affordable Care Act, the BRACAnalysis® test is considered preventative, and insurance is required to cover 100% of the cost “for many women. We offer financial assistance to uninsured patients with the greatest need.”

    “We also want to reach out to patient advocates and the research community. The battle that really matters isn’t in court; it’s the one against cancer,” Myriad concluded.

    The Supreme Court paved the way for patenting genes by allowing for patentability of human-made microorganisms as a valid new and useful “manufacture or composition of matter” its landmark decision in Diamond v. Chakrabarty (1980), the justices noted in their decision at the time that the Chakrabarty bacterium was new, “with markedly different characteristics from any found in nature.”

    “In this case, by contrast, 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,” today's decision stated.

Posted 6/19/2013 by SMH

cDNA is "composite DNA"? Or is it "complementary DNA," the strand synthesized by reverse transcription of the messenger RNA (mRNA) coding for the functional part of the gene? The only thing that the decision of SCOTUS reveals is the complete inability of the justices to grasp concepts of biology: while the statement of one justice is true that cDNA itself is not "naturally occurring," that product is a derivative of the natural product mRNA (by first-strand synthesis techniques that also make use of products of nature, such a reverse transcriptase). Seems like a great deal of hair-splitting was done here. The fact is, Myriad has created a diagnostic tool that allows individuals at risk of breast cancer (family history, other factors) to determine whether they have the BRCA1/2 truncations that assess probability of a future cancer. If Myriad cannot work out a business model that allows high-throughput, high-volume screening of hundreds of thousands to millions of individuals affordable to all on a mass scale, then it is a despicable and unethical business model that chooses few winners and many losers in a matter that really is about life and death. I understand the BRACAnalysis system includes DNA sequencing (a considerable costly use of sources), but is it not possible to develop a low-cost, low false-negative screening test that is high throughput and high volume (e.g., qPCR) and then use sequencing as confirmatory on positives? Pardon me if this is already the model. People would be confused in thinking that the ruling of not being able to patent genes has affected Myriad's exclusive right to BRCA testing. Myriad has a web page indicating its vindication for being able to continue deciding who gets tested and who does not (namely, who can pay its price). I am all for a business profiting off its hard work and genius, but that stops at people dying to maintain that profitability.


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