Intellectual Property An inventive concept limited to the discovery of the significance of the acquired data, or to its understanding or interpretation, is considered to be abstract or a mental method, and thus not statutory.
If the Prometheus decision is given a broad interpretation by the Federal Circuit, some are concerned that since routine, conventional activity is typically engaged in when isolating a DNA sequence, the Prometheus decision could have adverse consequences on claims to genes per se. In particular, some fear that the Federal Circuit will find that the gene sequence is just a product of nature and the additional steps of isolating and purifying the DNA molecule do
not transform it into a patentable invention. The Myriad case also contained diagnostic method and screening assay claims. The Federal Circuit previously held the screening assay claims patentable but found against the diagnostic method claims because the claims used terms such as “analyzing” and
“comparing” for identifying the presence of the breast cancer mutations. In particular, the Court held that such steps could be conducted solely in the mind and thus were not patentable. After Myriad, it was thought that adding steps such as “determining” or “administering” would be sufficient to transform the claim. However, Prometheus has made it clear that more may be needed. There is no doubt that the biotechnology community will be on pins and needles awaiting the Federal Circuit’s review of its Myriad decision, hoping that it will view Prometheus narrowly, relating to its particular facts, where the additional steps were clearly known and used in the prior art. In Canada, patent eligible subject matter has also been a hot topic of late. In November 2011, the Federal Court of Appeal released its decision in Amazon.com, holding that claims should be given a purposive construction when considering patentable subject matter. On the heels of the Amazon. com decision, the Canadian Intellectual Property Office (CIPO) released three draft practice notices on April 2, 2012, for a 30day consultation period, including a notice related to Office Practice Respecting Claims to Diagnostic Methods and Medical Uses. Unfortunately, the CIPO notice puts an
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Ontario Bioscience Innovation Organization Why? It fits better. OBIO™ members lead innovation in the life sciences. Every facet of health care with a stake in innovation is represented on OBIO Advisory Boards. Together, we’re building a bioscience cluster that nurtures and promotes development of innovative products and services to meet the health needs of growing Canadian and global markets. Ontario Bioscience Innovation Organization is a trade name of Ontario Bioscience Industry Organization.
June 2012 BIOTECHNOLOGY FOCUS 7