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Summary: The Abbvie Case

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NB: for the purpose of this answer it is assumed a physician is required perform the injections. Patentable subject matter is limited to “art, process, machine, manufacture or composition of matter, or any new and useful improvement...thereto” (s 2). EXO will argue this is a ‘process’ and this patentable subject matter (s 2). Relevantly however, although new uses for known compounds are patentable (Shell Oil), Canadian courts have held methods of medical treatment are not (Tennessee; Imperial Chemical Industries; CIPO guidelines). Notwithstanding this, dosage forms or pharmaceutical kits/packages that embody a fixed dosage regime that do not involve “any professional decision-making have been accepted as patentable” (Abbvie, at para. 112]; CIPO). …show more content…

However, per AbbVie citing CIPO, the mere presence of a fixed dosage and fixed dosing schedule cannot always be sufficient “to avoid the method of medical treatment prohibition” (AbbVie at [18]). Furthermore, per CIPO guidelines certain “essential elements…(which)...are not considered to point to a limitation of a physician's professional skill or judgment” (CIPO; citing AbbVie para 114). Arguably a number of these essential elements are missing: A fixed dosage: unlike cases where the actual physical measurement was articulated i.e. AbbVie (40 mg) or Merck 1 (70 mg), the facts merely state “ten measured doses”. What is the measurement? Does this mean a different measurement is required for each patient (akin to Axcan)? If so, clearly this requires a physician to be “alert and responsive to a patient’s profile” (AbbVie at [118] citing Janssen at [26]) and hence unpatentable (Janssen; Novartis) A fixed

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