Are human genes patentable? On June 13, 2013, the U.S. Supreme Court held in Association for Molecular Pathology, et al. v. Myriad Genetics Inc. that isolated segments of naturally occurring DNA are not patent eligible, while synthetically created DNA, such as complementary DNA (cDNA), is patent eligible.
Representative claims at issue in the case are shown below.
1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.
Claims 1 and 2 were considered to cover the DNA code that tells a cell to produce a specific (BRCA1) string of amino acids. Because the DNA sequence covered by claims 1 and 2 contained no exons, the Supreme Court determined that they represented cDNA sequences that were created in the laboratory from mRNA and were not naturally occurring. These claims were considered patent eligible.
On the other hand, claims 5 and 6 were held patent ineligible. The Supreme Court based this decision on the fact that Myriad did not create or alter any genetic information in claims 5 and 6. The court stated that separating a gene from its surrounding genetic material is not considered an act of invention. Claims 5 and 6 focus on nature-given genetic information rather than a unique chemical composition or chemical changes undercut the significance of any chemical distinctions caused by isolating DNA. The high court justices also supported its decision with Myriad’s patent specification, which highlighted Myriad’s discovery as a discovery and therefore as a law of nature.
What This Means to You
In the wake of this decision, patent portfolios should be reviewed to determine whether patents having claims to isolated DNA sequences exist. If such patents are identified, issues raised by this decision can potentially be addressed through the use of re-examination and/or reissue proceedings. Claims pending in patent applications also should be reviewed from the perspective of patent eligibility.