{"id":5591,"date":"2021-02-22T11:40:42","date_gmt":"2021-02-22T16:40:42","guid":{"rendered":"https:\/\/perlaw.ca\/?p=5591"},"modified":"2023-10-04T10:47:03","modified_gmt":"2023-10-04T14:47:03","slug":"diagnostics-update-subject-matter-eligibility-in-canada","status":"publish","type":"post","link":"https:\/\/perlaw.ca\/fr\/2021\/02\/22\/diagnostics-update-subject-matter-eligibility-in-canada\/","title":{"rendered":"Diagnostics update: Subject matter eligibility in Canada"},"content":{"rendered":"

Helping you streamline allowance<\/strong><\/p>\n

Personalised medicine shows tremendous promise in revolutionizing the way we diagnose and treat disease.\u00a0 However, in recent years securing patents in this rapidly evolving field has proven challenging. \u00a0Such technology is often heavily reliant on computer-implemented data analytics to decipher a patient\u2019s unique molecular make-up, and inventions in the computer-implemented arts are especially prone to subject matter eligibility rejections.\u00a0 Claims containing computer computation steps are often viewed by patent examiners as disembodied ideas and thus deemed ineligible for patenting under section 2 or 27(8) of the Patent Act<\/em>.\u00a0 Nonetheless, the recent Yves Choueifaty v. Attorney General of Canada<\/em> [2020 FC 837] decision provide a glimmer of hope for patent applicants seeking to secure patent protection in this emerging field.<\/p>\n

To provide historical context, previous Practice Notice 2015-2<\/a> issued by the Canadian Intellectual Property Office (CIPO) instructed Canadian patent examiners to first determine those elements of a claim which are essential by analyzing the problem solved by the invention.\u00a0 The problem was identified as either a \u201cdata analysis problem\u201d or a \u201cdata acquisition problem\u201d depending on what was written in the patent specification.\u00a0 A data analysis problem was characterized as one describing the need for a correlation between a condition (e.g., a disease) and an analyte and a data acquisition problem was one that related to a problem concerning data that was acquired about an analyte.\u00a0 The essential elements of the claim were identified as those that solved either the data analysis problem or the data acquisition problem.\u00a0 The legal challenge with such approach was that the non-essential elements, namely those determined as not providing a solution to one of these problems, were disregarded from further analysis. \u00a0The result was that claims reciting various physical features were being disregarded in patent eligibility assessments by examiners.\u00a0 Interestingly, there was no legal precedent in the case law to support such an approach to claim construction.<\/p>\n

The essential elements of the claim construed as per the Practice Notice 2015-02 were then analyzed to determine if they were directed to statutory subject matter.\u00a0 As indicated in Practice Notice 2015-02, \u201c[w]here a physical step of data acquisition is identified as an essential element of the construed claim, the claimed subject-matter will likely be statutory\u201d.\u00a0 However, if the essential elements of a claim were characterized as a data analysis problem and solution, (e.g., a correlation) then the claim was generally rejected by the Examiner as being directed to non-statutory subject matter.\u00a0 This is because the correlation was seen as a disembodied mental process.\u00a0 Many personalized medicine patent applications were falling afoul of CIPO\u2019s examination policy and repeatedly rejected for failure to recite patent-eligible subject matter.<\/p>\n

Choueifaty<\/em> rejected a \u201cproblem-solution\u201d approach to claim construction that was applied by patent examiners and found claims directed to a computer-implemented invention patentable.\u00a0 A new Practice Notice titled \u201cPatentable Subject -Matter under the Patent Act<\/a>\u201d was issued after Choueifaty<\/em> in 2020 and is generally a positive for patent applicants seeking protection of medical diagnostic subject matter.<\/p>\n

The new Notice sets out the current understanding of the Patent Office regarding the legal principles applicable in determining whether the subject-matter defined by a claim is patent eligible subject-matter and specifically states that the \u201ccontribution of a claim\u201d and \u201cproblem solution\u201d approach in the identification of essential elements during purposive construction should no longer be applied.<\/p>\n

With regard to medical diagnostic claims, the new Practice Notice states that:<\/p>\n

a diagnostic method claim that defines a combination of elements that cooperate together so as to form a single actual invention that includes physical means for testing or for identifying, detecting, measuring, etc. the presence or quantity of an analyte in a sample would be considered to be patentable\u00a0subject-matter\u00a0and not to be prohibited under subsection\u00a027(8) of the\u00a0Patent Act<\/em>.[1]<\/a><\/p>\n

The Notice also provides an example of a diagnostic claim that is eligible and another that is ineligible:<\/p>\n

    \n
  1. A method of diagnosing whether a human subject is at risk for developing cancer, comprising:\n
      \n
    1. measuring the level of X in a biological sample from the subject; and<\/li>\n
    2. comparing said level to the level of a\u00a0non-cancerous\u00a0reference sample, wherein an increase in the level of X relative to said reference indicates the subject is at risk for cancer.<\/li>\n<\/ol>\n<\/li>\n
    3. A method of diagnosing whether a human subject is at risk for developing cancer, comprising:\n
        \n
      1. receiving a report summarizing the level of X in a sample from the subject; and<\/li>\n
      2. comparing said level to the level of a\u00a0non-cancerous\u00a0reference sample, wherein an increase in the level of X relative to said reference indicates the subject is at risk for cancer.<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n

        The Notice states that claim 1 is subject matter eligible for the following reason:<\/p>\n

        Recognizing that step a) is directed to physically measuring the level of X in the sample, this satisfies the physicality requirement and makes the\u00a0subject-matter\u00a0of the claim patentable\u00a0subject-matter.[2]<\/a><\/p>\n

        Claim 2 above is considered ineligible since, \u201c[u]nlike claim 1, data about the level of X is not provided by an element that physically measures the level\u201d.\u00a0 This suggests that providing a step having a physical existence or that manifests a discernable physical effect or change is sufficient to render the claim subject matter eligible.<\/p>\n

        Of course, patent prosecution is highly fact-dependent and often complex in the unpredictable arts such as biotechnology.\u00a0 Consequently, the above discussion should not be taken as legal advice.\u00a0 We will be happy to assist you with legal advice tailored to your unique facts.<\/p>\n

        The foregoing information provides only an overview. Specific legal advice should be obtained. If you have any questions, please reach out to Wendy Lamson<\/a>, Partner and Patent Agent in the Intellectual Property Law Group at Perley-Robertson, Hill & McDougall. <\/em>She can be contacted at 613.566.2748 or\u00a0wlamson@perlaw.ca<\/a>.<\/em><\/p>\n

         <\/p>\n

        [1]<\/a> See Canadian Intellectual Property office (CIPO) Practice Notice \u201cPatentable Subject-Matter under the Patent Act\u201d, 2020, under \u201cMedical diagnostic methods\u201d, third paragraph, available at https:\/\/www.ic.gc.ca\/eic\/site\/cipointernet-internetopic.nsf\/eng\/wr04860.html<\/a><\/p>\n

        [2]<\/a> Ibid<\/em>, \u201cExamples of Patentable Subject-Matter Analysis\u201d under \u201cDiagnostic Method Example\u201d.<\/p>\n","protected":false},"excerpt":{"rendered":"

        Helping you streamline allowance Personalised medicine shows tremendous promise in revolutionizing the way we diagnose and treat disease.\u00a0 However, in recent years securing patents in this rapidly evolving field has proven challenging. \u00a0Such technology is often heavily reliant on computer-implemented data analytics to decipher a patient\u2019s unique molecular make-up, and inventions in the computer-implemented arts […]<\/p>\n","protected":false},"author":3,"featured_media":6945,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"wds_primary_category":0,"wds_primary_expertise_area":0,"footnotes":""},"categories":[82],"tags":[],"class_list":["post-5591","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-publication","expertise_area-intellectual-property","expertise_area-patents"],"acf":[],"_links":{"self":[{"href":"https:\/\/perlaw.ca\/fr\/wp-json\/wp\/v2\/posts\/5591","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/perlaw.ca\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/perlaw.ca\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/perlaw.ca\/fr\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/perlaw.ca\/fr\/wp-json\/wp\/v2\/comments?post=5591"}],"version-history":[{"count":2,"href":"https:\/\/perlaw.ca\/fr\/wp-json\/wp\/v2\/posts\/5591\/revisions"}],"predecessor-version":[{"id":5593,"href":"https:\/\/perlaw.ca\/fr\/wp-json\/wp\/v2\/posts\/5591\/revisions\/5593"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/perlaw.ca\/fr\/wp-json\/wp\/v2\/media\/6945"}],"wp:attachment":[{"href":"https:\/\/perlaw.ca\/fr\/wp-json\/wp\/v2\/media?parent=5591"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/perlaw.ca\/fr\/wp-json\/wp\/v2\/categories?post=5591"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/perlaw.ca\/fr\/wp-json\/wp\/v2\/tags?post=5591"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}