The Canadian Patent Office Issues New Examination Guidelines for Medical Diagnostic Methods.
On June 29, 2015, the Canadian Intellectual Property Office (CIPO) issued a long-awaited Practice Notice PN 2015-02 ("Notice") on the subject of medical diagnostic methods.
The examination of Canadian patent applications with claims pertaining to diagnostics has been on hold pursuant to the November 2011 decision of the Federal Court of Appeal in respect of the Amazon 1-Click application.1 In response to routine status checks, CIPO returned a standardized form letter indicating that it considered this decision to be relevant to medical diagnostics, but that examination guidelines had not yet been established. Consequently, examination of such applications was deferred.
Practice Notice PN2015-02 provides these guidelines to CIPO examiners, and should mean that the three- and-a-half-year backlog of diagnostic-related applications awaiting an Office Action, or a Notice of Allowance, will now begin to clear.
The Notice indicates that examiners should apply the "problem and solution" approach established in a previous Practice Notice (PN 2013-02) to construe claims and identify their essential elements. Under this framework, once the underlying technical problem is discerned, the examiner may ignore, as non-essential, any claim feature that is considered to be extraneous to the solution.
Two categories of technical problems are described for diagnostic methods:
- "Data acquisition" problems are said to be those solved, e.g., by disclosure of a new analyte ("non-common general knowledge" analyte2 is the term used), or by overcoming some technical problem related in the identification, detection, or measurement of an analyte. The Notice states that if an application provides a significant amount of technical detail on how the analyte is measured, this provides a clue that the invention solves a data acquisition problem.
- "Data analysis" problems are said to be those solved by recognizing the significance of data, such as in the case of a new correlation. The Notice says that one clue that an invention solves a data analysis problem will be a relative lack of technical detail about data acquisition, or an indication that any known methods may be used. In this last point, the reader may discern parallels to the "conventional post-solution steps" element of the analysis applied by the U.S. Supreme Court in Mayo3 and Alice4.
The Notice states that if a claim includes a physical step of data acquisition that is determined to be essential, then it is likely to be statutory. On the other hand, claims having essential elements limited to the mental analysis and/or intellectual significance of data (so-called "disembodied" steps) are likely not statutory. The Notice indicates that the latter would "generally apply to situations where the identified solution is only provided by an element or set of elements associated with the analysis or significance of the acquired data (e.g., the correlation)."
Under the framework, identification of the technical solution informs the entire analysis of essentiality, and so the way in which the underlying technical problem is understood by an examiner is very important. On the positive side, the new Notice grants examiners significant discretion to make decisions about subject matter eligibility, and flexibility to frame and reframe the problem and solution throughout examination, if necessary.
However, the Notice also leaves many questions unanswered. What qualifies as a "non-common general knowledge analyte", for instance? Is it only an absolutely new molecule, or can it be a new variant in a known molecule, a known molecule or variant that has never before been associated with disease, or a novel selection of known biomarkers in a particularly advantageous panel? Here, the Notice provides no specific insight.
In the absence of a Mayo-like test for subject matter eligibility in Canada, a finding that data acquisition is somehow "inessential" to a diagnostic involving a new correlation seems illogical. CIPO may be attempting to draw parallels here to the allegedly dispensable nature of computers to some computer- implemented business methods (e.g. when steps can purportedly be carried out mentally). There is a clear distinction here: it would be quite impossible to carry out a diagnostic method without a data acquisition step. Therefore, it may be argued that a claim is statutory simply by referring to the Practice Notice's own provision that an essential physical step of data acquisition is sufficient.
Of course, there are also many situations in which data acquisition problems and data analysis problems are inextricably tied together, making the assignment of claims to one of two distinct categories both contrived and arbitrary.
At the drafting stage, the new guidelines indicate that it may be important to highlight any data acquisition problems overcome by the inventors in the course of their work. Post-drafting, those considering national filings in Canada can take heart that the door is not shut to diagnostic methods by the Notice, and that the law may be clarified before their applications are examined. Those with pending applications in Canada may find comfort in the flexibility of Canadian practice with regard to claim amendments, and the lack of excess claims fees. The Notice is squarely limited to the assessment of "method" claims, and there may be opportunities to assert related claim formats in response to an objection.
For the three-and-a-half years that it took to publish, the Notice seems to maintain and codify the status quo; the practical impact will probably be similar to objections some applicants saw prior to CIPO's decision to defer the examination of these applications. While the Notice builds on other Practice Notices released in the wake of Amazon, it is devoidof specific case law citations itself. This is curious, given that Canadian courts have on more than one occasion cautioned against the refusal of patents based on policy considerations.5,6
1. Canada (Attorney General) v Amazon.com Inc, 2011 FCA 328 [Amazon].
2. The Notice indicates that the term "analyte" is used broadly to mean a chemical substance or biomarker that is the subject of analysis.
3. Mayo Collaborative Services v Prometheus Laboratories Inc, 80 USLW 4225 (US 2012) [Mayo].
4. Alice Corp v CLS Bank International, 82 USLW 4508 (US 2014) [Alice ].
5. Harvard College v Canada (Commissioner of Patents), 2002 SCC 76 at para 144, cited with approval in Amazon supra note 1 at para 31.
6. Abbott Laboratories (Bermuda) Ltd v Abbvie Biotechnology Ltd, 2014 FC 1251 at para125.
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