Patent Docs recently highlighted McDonnell Boehnen Hulbert & Berghoff’s (MBHB) panel at BIO’s IP and Diagnostics Symposium (IPDx). Moderated by Donald Zuhn at MBHB, panelists from MBHB, Roche Diagnostics, and the USPTO discussed the impact of the Myriad decision on obtaining patent protection for genetic diagnostics. The panel concluded the following:
“While there was agreement that the Myriad holding is not limited to human DNA, there was spirited disagreement regarding its long-term impact on patents claiming naturally occurring DNA. On the one hand, it is true that the vast majority of patents covering human DNA are nearing the end of their lifespan, thus reducing the significance of the Myriad opinion here. However, on the other hand, the biotechnology industry must consider the possible ramifications beyond human genes, particularly in sectors like biofuels that rely on lower-order organisms. Since the genes of these lower-order organisms often lack introns, claims directed to their cDNA will not fall within the exception stated in Myriad.
Further, under Myriad, there are questions regarding the fate of isolated polypeptides, stem cells, and all other compositions based on natural products. These compositions represent platform technologies for many biotech firms, and this uncertain climate is causing hesitation disclosing such technologies in patent applications. The risk of failing to secure adequate patent protection may be too great. The panelists noted the possibility that the biotechnology industry shifts away from patenting diagnostic products, moving instead towards the trade-secret and/or service provider model. In this model, samples would be tested in-house, and the biotech company would keep the biomarker information and diagnostic algorithms as trade secrets. This in-house testing model may also have the added benefit of avoiding any future FDA regulation of such diagnostic testing, which represents another unsettled issue in the field of diagnostics discussed at the Symposium.”