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Diagnostic methods patenting debates set to heat up in Canada

This summer, the Canadian Intellectual Property Office (CIPO) released a practice notice on medical diagnostic method patents. This has been in the works for many years. A draft version was released for public consultation in 2012 and CIPO had indicated in 2013 that the practice notice was forthcoming.

The immediate effect of the practice notice is the resumed examination of diagnostic method patent applications which had been put on hold by examiners pending the release of these guidelines. Is the new practice favourable to patenting diagnostic methods? It is too soon to say how examiners in the Patent Office will apply the guidelines. The answer may be, in any event, it depends – the practice notice indicates that attention will be paid to the specifics of the diagnostic methods.

In short, examiners will be looking to see whether the method includes a physical step of acquiring data, which must be essential to solving a "data acquisition problem". Thus, for example, the notice indicates that if (i) the method relates to an analyte not within the common general knowledge, or emphasizes deficiencies in prior means to identify or quantify a particular analyte; and (ii) includes steps such as detecting or measuring the concentration of the analyte, which provide a solution to the problem, the method will likely be patentable.

On the other hand, the notice indicates that the diagnostic method will not be patentable if (i) the method relates to a "data analysis problem", for example by emphasizing the discovery of a correlation between a commonly known analyte and a disease, or stating that the described means to acquire data about a particular analyte are common general knowledge; and (ii) "disembodied" or mental steps, e.g. relating the presence of the analyte to the disease diagnosis, are the only essential elements to solving the problem.

The practice notice does not have the force of law. In this regard, judicial guidance may be forthcoming from an ongoing patent impeachment proceeding in respect of patents relating to genes and genetic testing methods. In that case, the Children's Hospital of Eastern Ontario contends that certain patents of Transgenomic Inc. prevent it from conducting a genetic screening program for long QT syndrome (an inherited cardiac disorder). The case raises issues of the patentability of matters purportedly directed to natural phenomena or to abstract comparisons (for example between patient and reference genetic sequences) involved in diagnoses. If the litigation proceeds to a decision – an "if", since the parties are apparently trying to settle according to the public Court database, and the hospital has indicated that, as a charity, it has limited funds for the litigation – judicial guidance may be available, albeit likely not for another two years or more.