据加拿大法什么可申请专利？What Does Patentable Mean Under Canadian Law?

长期以来，加拿大一直禁止“医疗方法”授予为发明专利。专利上诉委员会于2019年发布了一项决定，明确了发明何时被视为一种医疗方法，何时视为一项可申请专利的对象。
It has a long-standing prohibition in Canada against granting patents for inventions that are “methods of medical treatment.” A decision of the Patent Appeal Board (PAB) issued in 2019 provides some clarity on when an invention will be considered a method of medical treatment and when it will be considered patentable subject matter.
根据加拿大专利法第2条，发明被定义为“任何新的并有用的艺术、工艺、机器、制造、物质组成，或任何艺术、工艺、机器、制造或物质组成中新的并有用的进步。”描述一系列步骤以获得所需结果的“方法”通常属于“艺术”类别。
Under section 2 of the Canadian Patent Act, an invention is defined as “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.” A “method” claim that describes a series of steps to obtain a desired result will generally fall within the category of “art.”
然而，根据加拿大判例法，医疗和手术方法不属于第2条中的发明定义。这种排除的基础是这些方法与贸易、工业或商业无关，而是与专业人员的技能和判断力有关。出于政策原因，法院可能担心若手术方法获得专利，这可能会导致医生（和其他专业人员）在执业时考虑是否造成专利侵权而不施展全力。因此在加拿大，一种为人类或动物患者提供治疗的方法将不被允许为申请项目。
However, case law in Canada has held that methods of medical treatment and surgical methods do not fall within the definition of invention under section 2. The basis for this exclusion is that these methods are not related to trade, industry or commerce, but instead are related to a professional’s skill and judgment. For policy reasons, the courts were likely wary of permitting surgical methods to be patented as this could hinder a physician’s (and other professionals) ability to practise their profession without fear of patent infringement. So, where a method provides a therapeutic benefit to a human or animal patient, it will not be permitted subject matter in Canada.
从实际角度来看，以对医疗方法改变表述可避免将发明包含医疗方法。例如，声称“通过给患者用X药物来治疗癌症的方法”，可以改写为“使用药物X治疗癌症”，后者将被视为可接受的专利申请事项。外科手术治疗的方法可能更难转换，专利局通常会拒绝任何具有积极治疗步骤的申请。
From a practical perspective, claims directed to methods can often be drafted in a way to avoid characterizing the invention as a method of medical treatment, such as, a claim “A method of treating cancer by administering drug X to patient,” can be recast as “Use of drug X to treat cancer.” The latter will be deemed acceptable subject matter. Methods to surgical interventions can be more difficult to convert, as the patent office will typically reject any claim having an active treatment step.
加拿大专利局区分了治疗“疾病或病理”的有关方法（非可申请专利）和可受专利保护的“自然条件”有关方法。专利局以非病理性、自然性情况的形式展现衰老、怀孕、秃顶和皱纹的例子。
The Canadian patent office makes a distinction between methods related to the treatment of “ailments or pathological” conditions, which are not patentable subject matter, and “natural conditions” which can be subject to patent protection. The patent office gives the examples of ageing, pregnancy, baldness and wrinkles as non-pathological, natural occurring conditions.
委员会第1491号决定，关于最终于2019年10月8日发布的专利，就允许申请内容提供了有效的指导。CooperVision国际公司已提交加拿大专利申请2760920——直接用于“在提供眼科镜片时的通融误差测量”。该申请声称提供和使用镜片的方法顺序可减慢近视发展或防止近视。因为人会变老，因此眼疾会越来越严重。
Commissioner’s Decision No. 1491, related to a patent ultimately issued on Oct. 8, 2019, provides some helpful guidance on permissible subject matter claims. CooperVision International Holding Company had filed Canadian patent application 2,760,920 directed to “Use of accommodative error measurements in providing ophthalmic lenses.” The application claimed methods of providing and using lenses sequentially to reduce or prevent the progression of myopia (i.e., nearsightedness), an eye condition that is known to get worse as a person gets old.
审查申请的专利审查员最初拒绝了作为医疗方法的主张，因此驳回了该申请专利的事项。这一决定被提交到专利上诉委员会，专利上诉委员会认为应允许这申请。这是基于近视是眼科医生评估的自然人类状况的事实，他是相关领域的专家。这些专家不会认为近视是一种病理性疾病。因此，专利上诉委员会决定不能将该申请视为医疗方法。
The patent office examiner reviewing the application had originally rejected the claims as methods of medical treatment and therefore non-patentable subject matter. This decision was appealed to the PAB, which held that the claims should be allowed. The PAB based this decision on the fact that myopia is a natural human condition as assessed by ophthalmologists, being experts in the relevant field. These experts would not consider myopia a pathological disease. Therefore, the PAB determined that the claims could not be considered methods of medical treatment.
专利上诉委员会继续就评估与病理状况直接相关的发明作进一步指导。专利上诉委员会指出，应区分出只针对“如何”治疗病人的申请，与针对发明“什么”来治疗病人的申请。
The PAB went on to provide further guidance on assessment of claims for instances where the invention is directed to a pathological condition. The PAB indicated that a distinction should be made between claims that are directed only to “how” to treat a patient, as opposed to claims directed to inventions for “what” to use to treat a patient.
如果申请的基本内容是指示保健专业人员“用什么”来治疗病人，那么申请不能视为一种医疗方法。然而，如果被引导到“如何”治疗病人，则需要进一步考虑。审查员必须评估申请事项的实施是否会干扰保健专业人员的专业技能和判断力。如果答案是肯定的，申请将作为治疗方法而被驳回。因此，如果这种申请不限制专业人员行使其技能和判断的能力，则针对“如何”对待的申请可能是法定申请内容。
If the essential elements of a claim give instruction to health care professionals on “what” to use to treat a patient, then the claims are not directed to a method of medical treatment. However, if the essential elements are directed to “how” to treat a patient, further consideration of the subject matter is needed. An examiner must assess whether the performance of the claim would interfere with the professional skill and judgment of a health care professional. If the answer is yes, the claim will be rejected as an unpatentable method of medical treatment. Thus, claims that are directed to “how” to treat could be statutory subject matter if such claims to not restrict the ability of a professional to exercise their skill and judgment.
虽然大部分情况下可以重新起草申请事项，将医疗方法改写为在加拿大专利申请中使用的表述，但第1491号决定对因标的申请而被拒绝的申请人很有帮助。如果某一情况可以认定为与自然老化过程有关，则不应将申请视为一种医疗方法。此外，第1491号决定指示审查员评估：（一）申请是否针对使用“什么”与“如何”治疗；（二）在“如何”治疗情况时，只有那些妨碍专业技能和判断的申请才应被视为非法定申请内容。如果申请人的发明符合这些原则，则可以作出判断。
While claims can often be redrafted to convert methods of treatment to use claims in Canadian patent applications, Decision No. 1491 is helpful to applicants that are encountering rejections in prosecution on the basis of subject matter. If a condition can be characterized as relating to the natural ageing process, the claim should not be deemed to be a method of medical treatment. Furthermore, Decision No. 1491 instructs examiners to assess whether (i) a claim is directed to “what” to use vs. “how” to treat, and (ii) for “how” to treat claims, only those that impede professional skill and judgment should be considered non-statutory. This decision can be asserted where the applicant’s invention is in alignment with these principles.