Examination of Methods of Medical Use Claims at the Canadian Intellectual Property Office The Canadian Intellectual Property Office is in the process of revising its examination guidelines for claims directed to “Methods of Medical Treatment”. The revision is as a result of the recent Federal Court of Canada case AbbVie Biotechnology Ltd. v. Canada (Attorney General) (“AbbVie”)¹, which addressed claims directed to dosages and dosing schedules. In the interim, prosecution of Canadian Patent Applications relating to Methods of Medical Treatment, including medical use claims, dosage regimen and dosage range claims, and diagnostic claims have been put “on hold”. Methods of Medical Treatment – Canadian Law By way of brief background, Canadian patent law has long held that claims directed to “methods of medical treatment” relate to non-statutory subject matter that is not a patentable “invention” under Section 2 of the Patent Act. Methods of Medical Treatment are generally defined as methods providing a practical therapeutic benefit, even where such benefit is not the primary or intended purpose. The Patent Office also takes the position that methods that involve performing surgery on the human or animal body are excluded, whether the effect of the surgery is therapeutic or not. Claims directed to methods of medical use or methods of diagnosis, and claims reciting dosage regimes may be permissible, but must be assessed on a caseby-case basis to ensure that they do not equate to a medical or surgical method. The Canadian courts have consistently held that, to be patentable, medical treatment claims must be directed to a vendible product that does not require the skill or judgment of a medical practitioner. This principle was upheld in AbbVie, where the FCC confirmed that the claims to a preloaded syringe of 40mg of a Humira for the treatment of arthritis or an inflammatory bowel disease administered subcutaneously every 14 days were not methods of medical treatment. In overturning the Commissioner of Patents, the FCC held that the claims were directed to a fixed dosage at a fixed interval that did not require any skill or judgement by a medical practitioner. Methods of Medical Treatment – Examination CIPO “ON HOLD” Notwithstanding that AbbVie appears to be consistent with Canadian jurisprudence, CIPO recently issued a “Patent Notice: Revised Examination Practice Respecting Medical Uses – PN2015-01” , which serves to revise the previous “Examination Practice Respecting Medical Uses” issued in June, 2013 . Briefly, in the new PN2015-01, CIPO mandates the use of “purposive construction” for medical treatment claim analysis and states: “To perform a purposive construction, an examiner identifies the problem the inventors set out to address and the solution disclosed. This exercise generally must be performed considering the specification as a whole, recognizing that the description guides the identification of the problem and the solution. … After identifying the problem and solution, a proper construction of the claims includes a determination of which elements in the claims are essential and non-essential to the solution. Having identified the essential elements, the subject-matter of the claim is then assessed for patentability. … Medical inventions, in particular, have been subject to a number of jurisprudential interpretations whereby certain types of matter have been found to fall outside the scope of section 2. For instance, it is well established that methods of medical treatment and surgery are not statutory subject-matter and are excluded from the definition of invention. Medical use claims, however, are generally permitted as long as they do not equate to medical or surgical methods (e.g. do not include an active treatment or surgical step) and they satisfy all other requirements of patentability. The Federal Court has concluded, however, that inventions preventing physicians from exercising their skill and judgment in using a known compound for an established purpose effectively cover a method of medical treatment. … Where an essential element only serves to instruct a medical professional “how” to treat a patient, rather than “what” to use to treat the patient, it must be determined whether the essential element prevents, interferes with or requires the professional skill of a physician. If the answer is “yes”, this will lead to the conclusion that the claimed use encompasses a method of medical treatment that does not comply with section 2 of the Patent Act”. In addition to the new PN2015-01, CIPO is also in the process of revising its internal examination guidelines and Examiners have been asked to place Canadian patent applications relating to “Methods of Medical Treatment” on hold pending the revision. Although the timing to complete the revisions is unknown, prosecution of applications where examination of the application has been delayed will be given priority. Conclusions Given that the Court in AbbVie found the claims at issue to be patentable, it is unlikely that the decision or the resulting revised examination guidelines will restrict the patentability of “medical use” subject matter in Canada, provided that subject matter does not restrict a physician’s skill or judgment to determine if the claimed use is appropriate for the patient, that is – where the claims are “one size fits all”. Disclaimer This post is intended to provide general information concerning developments in the law and is not intended to provide legal advice in respect of any particular situation. AbbVie Biotechnology Ltd. v. Canada (Attorney General) 2014 FC 1251 (published January 20, 2015), http://decisions.fct-cf.gc.ca/fc-cf/decisions/en/item/100275/index.do PN2015-01, Patent Notice: Revised Examination Practice Respecting Medical Uses, March 18, 2015, http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03916.html PN2013-04, Examination Practice Respecting Medical Uses, June 10, 2013, http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03655.html