In a landmark decision, the U.S. Supreme Court has unanimously ruled that human genes cannot be patented because they are "products of nature." This sets an important precedent for the biotech industry, and especially those organizations engaged in diagnostics based on naturally occuring human gene sequences. For example, Myriad Genetics (the company which developed the groundbreaking genetic testing for BRCA mutations linked to cancer) has had 5 of their patents invalidated as a result of this ruling.

While human genes are no longer patentable, the court did affirm the novelty and patentability of human cDNA. These are human genes that contain only the coding regions of human genes, called exons. The court ruled that these constructs are man-made and thus patentable inventions. Therefore, organizations that are engaged in research of cDNAs as potential therapeutic interventions still have opportunities for developing their work as intellectual property. Further, supposedly any other non-natural DNA construction or modification would also presumably be patentable under the new ruling

In addition, the pahramcetuical science of human gene/cDNA drugs is also similarly suitable intellectual property for patenting: including ADME, targeting, delivery, etc. At CDR, we have an active program in drug delivery research for these types of biological drugs using novel biomaterials and modern techniques in nanotechnology. This is an important and devloping field in pharmaceutical sciences, highlighted by the recent European approval of the gene therapy drug, Glybera. Glybera is a genetic therapy for human lipoprotein lipase deficiency, and it is the first gene therapy product approved in the Western world.