The 13 June 2013 Decision of the US Supreme Court in the "Myriad" case (Association for Molecular Pathology et al. v. Myriad Genetics Inc. et al) was received by Biotech patent practitioners around the world with great interest. The Court held that "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."
This represents a significant narrowing of patent eligible subject matter in the USA and is in sharp contrast to the situation in Europe where the Biotech directive states that "Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature." (Article 3(2)).
There is concern that the Myriad decision leaves the boundary between synthetic and naturally occurring products unclear - exactly how different from the natural product does a synthetic product have to be?
After all, the step of "isolating" a DNA segment is not simply a matter of separating out the components of a mixture; it requires breaking covalent bonds in genomic DNA and the formation of a new chemically distinct molecule: a segment of DNA.
The decision also creates uncertainty for patent eligibility of all biological products, such as metabolites, antibodies, proteins and viruses, as well as genetic material.
Nevertheless, it should be noted that the chemical differences between isolated DNA and genomic DNA were not overlooked by the Court. It was pointed out by Thomas J. that Myriad's claims were not "expressed in terms of chemical composition," and instead focused on "the genetic information encoded in the [genes in question]." Thomas J. also stressed that the case did not involve method claims, new applications of knowledge about particular genes, or DNA in which the natural...