On July 22, BIO hosted the first IP and Diagnostics (IPDx) Symposium in Alexandria, Virginia, which was organized to open a dialogue regarding the latest developments in diagnostics and personalized medicine. The symposium covered a wide range of topics in the field, including obtaining patent protection, regulatory & reimbursement, and business development & strategic deals. Despite the range of topics, one unifying theme applying to all aspects of this burgeoning field is uncertainty.
Patent protection in diagnostics is crucial, for there is no market or data exclusivity attributed to diagnostic testing. Industry members must attempt to predict at an early stage whether patent protection over a diagnostic can be achieved, and if the prediction is negative, the diagnostic may not be pursued. This prediction has become much more difficult recently, and not unexpectedly at the forefront of the symposium discussion was the impact of the recent Supreme Court decisions in Mayo and Myriad. The first panel, moderated by Patent Docs author Donald Zuhn of MBHB, was comprised of Patent Docs author Kevin Noonan of MBHB, Duane Marks of Roche Diagnostics, and Mary Till of the USPTO, with each panelist providing their recommendations on how to successfully navigate patent prosecution under the limitations imposed by these Court decisions. Drafting claims to recite method of treatment steps or to include non-natural compositions (such as the transformed cells from claim 20 in Myriad) were two potential strategies discussed that may avoid § 101 scrutiny under Mayo and Myriad.
Of course, Myriad explicitly exempts cDNA from § 101 scrutiny, which came as a relief to many sectors of biotechnology, who consider cDNA as (arguably) the most commercially important aspect of so-called "gene patents." However, the scope of the Myriad decision was the topic of debate between the panelists and audience members. 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.