背景
2017年9月，加拿大根据行业部的建议，根据《专利法》提出了“补充保护证书”（CSP）。CSP的实施允许加拿大的药品（并获得第一市场授权）可能在两年内扩展专利保护。为了在《综合经济和贸易协定》中维持加拿大对欧盟的承诺，需要对加拿大专利格局的这种变化。
专利期限扩展s (PTEs) have long been established in countries such as the US, Australia, European nations, Japan and South Korea (Table 1). They were designed to allow pharmaceutical companies that have received the first market authorisation, the opportunity to be compensated for their financial investments and time spent on clinical research, in order to obtain market approval. By extending the period of protection on a patent that claims a medicinal ingredient or medicinal combination, generic competitors are impeded from entering the market. The amendments to the Patent Act in Canada allow companies to obtain this form of protection with the Therapeutic Products Directorate (TPD). CSPs can only be applied to a drug product that is market authorised with a Notice of Compliance (NOC) by Health Canada, after the law has come into effect.
| Country | 名称 | Year Implemented | Period of Protection （最大学期） |
| 澳大利亚 | 专利期限扩展 | 1998 | 5 years |
| Canada | CSP | 2017 | 2年 |
| 法国 | 补充保护证书（SPC） | 1992 | 5 years |
| United Kingdom | SPC | 1992 | 5 years |
| Germany | SPC | 1992 | 5 years |
| 日本 | 专利期限扩展 | 1988 | 5 years |
| South Korea | 专利期限扩展 | 1987 | 5 years |
| United States | 专利期限扩展 | 1984 | 5 years |
表1：在方舟专利智能中跟踪的专利期限扩展名和SPC的示例
CSP标准
The regulations along with the Patents Act outline the amendments, which have been used to establish the CSP criteria. Defined in sections 104-134 of the Patents Act, the Regulations have outlined the specific details of when a CSP can be applied and the scope of coverage. The following summarises a portion of the application criteria:
Medicinal ingredients
每个药物成分或药用组合只能授予一个CSP，其中NOC是加拿大特定药用成分的首个市场授权。
如果两种药物成分的分子结构相对于彼此而变化，则该化合物是酯，盐，复合物，螯合物，氯酸盐，氯酸酯或非共价类似物；两种药物成分将被认为是相同的。如果它们的变异属于以下类别：映异构体或对映异构体的混合物，溶剂化物，多晶型物或体内或体外翻译后翻译后修饰相对于彼此，则两种药物也被认为是相同的。
在加拿大，还可以批准包含两种不同药品的药用组合。该专利法则定义了任何两种组合彼此含有相同的药物成分，但剂量或强度不同，都不是不同的。
专利资格
CSPapplications that are filed must be placed on a patent that is in force according to subsection 3(1) of the CSP Regulations. The patent itself should claim one or more of the following: the same medicinal ingredient(s), the use of the same medicinal ingredient(s), or the same medicinal ingredient(s) by process of preparation, in which it was market authorised for sale. For patents that claim the ‘use’ of the medicinal ingredient(s), the use specified in the claims does not need to match the approved use when receiving market authorisation, however, the claimed use must set out the use in humans or animals. Applications concerning combinations require all the medicinal ingredients that have been market authorised in the medicinal product to be mentioned in the claims, in order to be eligible. Only one eligible claim is required for the CSP application.
Patent claims that are specific for formulations containing the medicinal ingredient(s) or preparations of a formulation containing the medicinal ingredient(s) will not be considered eligible for CSP applications.
Timely submission
The Patent Act outlines that a CSP application must be filed with the TPD prior to, or within a reasonable time period from, when approval was sought for the drug or drug combination in the CSP application.
可以在以下情况下提交CSP申请。
- 向加拿大卫生提交了新药物提交（NDS），并且已经在以下一个国家之一中批准了药物成分或lol买外围用什么软件药用组合：欧盟（或其欧盟国家），美国，澳大利亚，瑞士或日本（指定CSP法规的第6（1）（a）段）。
- Marketing approval has been submitted in aforementioned countries and within 12 months of when the NDS was filed in Canada.
- NDS提交在上述任何国家的营销批准申请后的24个月内，直到2018年9月21日（这是由于CSP实施的过渡时期）。
注册的CSP
With more and more drug products facing generic competition, the implementation of CSPs into Canada will be beneficial for pharmaceutical companies attempting to maintain market share for longer periods. Canada, however, has only implemented a maximum term of two years for PTE, whereas other countries with established PTE regulations have opted for a maximum term of five years (Table 1).
CSP期限是通过从市场批准日期中减去专利申请日期，然后减去5年来计算的。如果这段时间超过2年，则保护期将减少2年。
目前，仅提交了少量的CSP申请。可以在ARK专利智能中找到此信息，其中CSP将显示状态，主题和计算的扩展期到期日期。
概括
With the change in the Canadian Patent Act, any new innovator drugs that are approved for the Canadian market can apply for CSPs, potentially delaying the entry of generic and biosimilar competition for an additional two years. While CSPs cannot be filed for all drug products that are currently market authorised in Canada, there is the potential for some drug products that are in the market to have their period of protection extended if they fall within the criteria of the Patent Act. Generic manufacturers looking at the Canadian market will need to monitor patent term extension expiries, as this could affect the launch of their products.
方舟专利情报是由伊克维亚（Iqvia）生产的，伊克维亚（Iqvia）是制药部门智能的全球智能提供商，并为每个大陆的制药公司提供解决方案。要了解更多信息，请访问//m.kolayalmanca.com/our-customers/generics-manufacturers/ark-patent-intelligence