In a unanimous opinion, the Supreme Court has found that isolated DNA is not patentable, while cDNA (a version of DNA with the non-coding regions removed) is patentable.
According to the court, DNA is really about information, and “Myriad [Genetics] did not create or alter either the genetic information encoded [in the genes] or the genetic structure of the DNA. [Myriad] found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [statutory patentable subject matter requirement].”
The court found that the differences between naturally occurring DNA and isolated DNA don’t change the informational component of DNA relative to its naturally occurring state. Thus, simply isolatingDNA from the human genome is not patentable. However, the creation of cDNA in the laboratory does affect this informational component by removing the non-expressing portion (introns) of theDNA sequence, thus producing a non-naturally occurring DNA sequence. This change in the informational content is sufficient to render the cDNA sequence patentable. It is important to note that the court did not rule on method claims, new applications of knowledge about genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.
In the short term, the genetic diagnosis market will open up so that other laboratories can offer genetic tests without having to deal with an array of isolated DNA patents for individual sequences. This should result in cheaper tests that are available to more people. However, in the long term, the effects may be more negative. For example, in the absence of patents, biotechnology companies may move to trade secret to protect key discoveries. Alternatively, without patent protection, biotechnology companies may simply choose not to invest in research that lead to diagnostic products.
Dr. Shine (Sean) Tu is an Associate Professor of Law. Prior to joining the faculty at WVU Law in 2011, Professor Tu was an associate with Foley & Lardner LLP and was a member of the firm’s Chemical, Biotechnology & Pharmaceutical Practice, and the Life Sciences and Nanotechnology Industry Teams. He holds a J.D. from the University of Chicago Law School, a Ph.D. in Pharmacology from Cornell University, and bachelor’s degrees in Chemistry and Microbiology from the University of Florida.