Containing Myriad

On June 14, 2013, a unanimous Supreme Court decision in Ass'n for Mol. Pathology v. Myriad Genetics, Inc., held that Myriad's claims directed to "...a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated." 569 U.S. ___ (2013), Slip Op. at 18. In addition, the Court held that "...cDNA is patent eligible because it is not naturally occurring." Id.

What remains unclear is the reach of the Myriad holding to other patented inventions that also rely on "isolation" as the basis for patent eligibility. A number of useful and commercially-valuable therapeutics are isolated forms of naturally-occurring products such as proteins (e.g., fully-human monoclonal antibodies). Following Myriad, the validity of claims directed to such isolated products may soon be called into question in U.S. courts or by examiners at the U.S. patent office.

Containing the reach of Myriad in such venues will ultimately require patent practitioners to explain why Myriad should be limited to DNA and not extended to other naturally-occurring products (that were not at issue in Myriad). Without offering more, success may be difficult to come by since the parallels between isolated DNA molecules encoding naturally-occurring (i.e., genomic) sequences and isolated therapeutic proteins originally expressed within cells harboring these genomic sequences are so readily apparent. Isolating these molecules from their natural source allowed them to be characterized and exploited in new and previously unimaginable ways. The novel utilities of such isolated therapeutic molecules have provided the theoretical underpinnings for their patent eligibility. Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103 (C.C.S.D.N.Y. 1911). Now, after Myriad, mere isolation may not suffice to confer patent eligibility, raising the spectre that therapeutic proteins encoded by any organism's genome also may be excluded from patent eligibility as a "product of nature."

It can therefore be challenging to see a path for continued patent eligibility of other biologically-encoded molecules if Myriad's holding is construed to mean that DNA molecules carrying genomic sequences are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material. However, in explaining its decision, the Myriad Court pointed out that: "genes and the information they encode are not patent eligible under §101 simply because they...