Human Genes Are Not Patent Eligible Subject Matter

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Today, the U.S. Supreme Court held that human genes are not patent eligible subject matter under 35 U.S.C. §101 simply because they have been isolated from the surrounding genetic material. The Court’s opinion was directed only to claims directed to compositions of matter and not to claims directed to methods.

In Association for Molecular Pathology et al. v. Myriad Genetics et al., the Supreme Court in a unanimous decision affirmed in part and reversed in part the Federal Circuit’s judgment that both isolated DNA and cDNA were patent eligible under §101. The Supreme Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.”

As background, Myriad discovered the precise location and sequence of the BRCA1 and BRCA2 genes, mutations in which can dramatically increase the risk of developing breast and ovarian cancer. Knowledge of the location of the BRCA1 and BRCA2 genes allowed Myriad to develop medical tests useful for detecting the mutations and determine whether a patient had an increased risk of cancer. Myriad was subsequently issued several patents. A representative claim recited “[a]n isolated DNA coding for a BRCA1 polypeptide,” which has “the amino acid sequence set forth in SEQ ID NO:2.”

The Supreme Court explained the issue as follows:

Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable.

The Supreme Court concluded that although isolating DNA from the human genome severs chemical bonds thereby creating a non-naturally occurring molecule, Myriad’s claims were not expressed in terms of chemical composition. Rather, the Court stated that the claims focus on the genetic information encoded in the BRCA1 and BRCA2 genes and not with the specific chemical composition of a particular molecule. The Court also dismissed Myriad’s argument that the PTO’s past practice of awarding gene patents is entitled to deference, noting that the United States argued in the Federal Circuit and in the Supreme Court that isolated DNA was not patent eligible under §101.

Regarding cDNA, the Court stated that it does not present the same obstacles to patentability as naturally occurring, isolated DNA segments, because creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring. As a result, the Court held that cDNA is not a “product of nature” and is patent eligible under §101, except when a very short segment of DNA that has no intervening introns to remove when creating cDNA. In that case, such a short strand of cDNA may be indistinguishable from natural DNA. The Court, however, noted that they were not commenting on whether cDNA was patentable under other sections of the patent statute.

It is very important to note what was not implicated by this decision. First, there were no method claims before the Supreme Court in this case. The Court noted that methods involving manipulating genes while searching for the BRCA1 and BRCA2 genes could possibly be patentable, but yet appeared to question their lack of obviousness. In addition, methods of using the genes may also be patentable. Second, the Court noted that this case did not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Of course, the validity of diagnostic claims is presently being questioned in the Prometheus line of cases. Third, the Court also did not consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.

The complete decision can be found at http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf.