Wednesday, 2 November 2016
In Canada, the situation has become dire for many patent applications pertaining to diagnostics. In June 2015, the Canadian Intellectual Property Office (CIPO) released the latest in a series of Practice Notices pertaining to its new approach to so-called "purposive claims construction" and the assessment of subject matter eligibility for medical diagnostic methods. The ensuing year has seen applicants grappling with its application.
The Diagnostic Practice Notice
Practice Notice PN2015-02 instructs CIPO examiners to use the description and common general knowledge to identify an unaddressed "problem" that inventors set out to solve, and its proposed "solution". For diagnostics, only two types of mutually exclusive problems are recognised: data acquisition problems and data analysis problems. The Practice Notice tells examiners that the “essential elements” of a claim are limited to those that work together solve this restricted problem. Other claim elements are said to be purportedly “non-essential” ones that “merely define the context or the environment of a specific working embodiment, but do not actually change the nature of the solution to the problem…”. These non-essential elements are excluded from later analysis.
A "data analysis problem" is always selected if the biomarker (or the method for its measurement) is not novel in its own right. Following this, the "data acquisition features" are read out of the claims as purportedly non-essential, and the claims are objected to for encompassing only non-statutory mental steps, i.e. the correlation between the biomarker and the disease.
The approach is to be contrasted with the European problem-and-solution approach to inventive step. In Canada, the claim language is effectively redrafted based on an examiner's determination of the pre-existing problem and its solution.
The Practice Notice has thus created a hostile situation for diagnostic claims in Canada that is remarkably similar to an earlier analysis of “contribution” over the prior art that was developed by CIPO, and later struck down by courts in the Amazon.com 1-Click decisions pertaining to business methods. The new approach is also very similar to the “conventional post-solution activity” test that prevails in the U.S., though it lacks a legal basis in Canada. Where the Supreme Court of Canada has indicated that the analysis of essentiality must consider the material effect of substitution of a particular element on the working of theinvention as claimed, the Practice Notice's analysis is tied to a restricted problem defined by prior art.
Access to Information Request
Merpel has learned that a request has been submitted under the Canadian Access to Information Act to probe the origins of PN2015-02. Material released to date has been published on the web site https://ipflyonthewall.wordpress.com and excerpts have also been posted.
The request is ongoing, but material released to date from 2011 and 2012 reveals remarkable disagreement within CIPO during those years.
For instance, a 2011 French language report indicates significant discord within the biotechnology examining division, with certain examiners and Sections Heads expressing such disagreement that the report's author warned that certain examiners may not comply with the new practice CIPO had in mind at the time.
A 2012 background document suggests a subject matter sensitivity may have arisen in the response to government funding for personalised medicine research, and involvement of the private sector in health care. However, internal emails sent amongst policymakers in early 2012 reveal concerns about compliance with jurisprudence, with one individual asking "Why is it that the Office must have liberty to create new legal principles?"
An email sent to the Assistant Commissioner of Patents regarding a report on the new practice expresses agreement that "nothing much has changed relatively [sic] to previous practice although... under certain circumstances language choice is very important". This is remarkable if the "previous practice" is the "contribution" approach overturned by the Federal Court of Appeal.
Later in the 2012 documents, an examiner and a Section Head weigh to express their strong disagreement with the practice change CIPO was contemplating at that time, with the former characterising the approach as "contribution analysis as previously formulated and reborn now as the inventive concept analysis".
Jumping ahead, the 2015 Briefing Notes to the then Deputy Minister for Industry reveal that the examination of about 300 diagnostic patent applications had been on hold as CIPO worked to develop its policy pursuant to the November 2011 Amazon.com 1-Click decision. The Briefing Notes anticipate a negative reaction from the Canadian patent agent profession and from industry, and indicate that those in disagreement with CIPO's position may challenge it in court.
In view of the internal disagreement and strong dissent amongst examiners, it remains unclear how and why CIPO arrived at the guidelines embodied by PN2015-02, which seem very much like a mere rebranding of contribution analysis.
Merpel will continue to monitor developments as further instalments of the Access to Information documents are released.