近期，在Canada (Health) v. Glaxosmithkline Biologicals S.A., 2021 FCA 71 （2021年4月14日）一案中， 加拿大联邦上诉法院(FCA) 首次对《补充保护证书法规》（“《CSP法规》”）做出解释。FCA认为卫生部拒绝给予葛兰素史克生物制品公司（“GSK”）针对SHINGRIX带状疱疹疫苗的加拿大专利2,600,905 (“905 专利”)补充保护证书(“CSP”， 即专利期延长)是合理的。本判决核心问题为CSP对“药物成分”的定义。

Recently, Canada’s Federal Court of Appeal (“FCA”) considered the Certificate of Supplementary Protection Regulations for the first time in Canada (Health) v. Glaxosmithkline Biologicals S.A., 2021 FCA 71 (April 14, 2021). The FCA held that the Minister of Health’s  (“Minister”) refusal to issue a Certificate of Supplement Protection (“CSP”) to Glaxosmithkline Biologicals S.A. (“GSK”) in respect of Canadian Patent No. 2,600,905 (“905 Patent”) and the vaccine SHINGRIX was reasonable. At the center of the decision is the meaning of “medicinal ingredient”.

近期，在Canada (Health) v. Glaxosmithkline Biologicals S.A., 2021 FCA 71 （2021年4月14日）一案中， 加拿大联邦上诉法院(FCA) 首次对《补充保护证书法规》（“《CSP法规》”）做出解释。FCA认为卫生部拒绝给予葛兰素史克生物制品公司（“GSK”）针对SHINGRIX带状疱疹疫苗的加拿大专利2,600,905 (“905 专利”)补充保护证书(“CSP”， 即专利期延长)是合理的。本判决核心问题为CSP对“药物成分”的定义。

Key Findings

判决要点

In particular, the FCA found the following:

加拿大的CSP制度

In 2017, Canada implemented the CSP regime as required by the Canadian-European Union Comprehensive Economic and Trade Agreement (“CETA”). The CETA requires the Parties to provide a period of sui generis protection for eligible patented pharmaceutical products in order to compensate for a portion of the patent term spent in research and development and in obtaining market approval. However, each Party shall be free to determine the appropriate method implementing CETA’s provisions within its own legal system and practice.

2017年，加拿大履行《加欧全面经济贸易协定》(“CETA”)的要求引入了CSP制度。CETA要求各缔约方为合格的专利药品提供一段特定的补充保护期，以部分补偿研发和获得市场批准所占用的专利期。但是，各方应在自己的法律体系和实践中自由决定实施CETA规定的适当方法。

The term of a CSP in Canada is the difference between the date of the filing of the application for the patent and the date of issuance of the authorization for sale (known as Notice of Compliance or NOC), reduced by five years, and capped at two years (i.e. CSP term = [Notice of Compliance date – Patent filing date] – five years, with a cap of two years).

CSP的期限为在加拿大专利申请日和药品许可日（即合规通知， 简称NOC）的间隔减去5年， 最长为两年(保护期 ＝ （NOC日 － 专利申请日） － 5年， 最长为两年)。

Section 106(1) of the Patent Act and section 3(2) of the CSP Regulations set out the CSP eligibility

requirements. A CSP eligible patent must contain a claim for:

◆ a claim for the use of the medicinal ingredient or combination of all the medicinal ingredients contained in the approved drug.

《专利法》第106(1)条和《CSP法规》第3(2)条列出了符合CSP的专利资格要求。符合CSP资格的专利必须包含以下权利要求:

卫生部的拒绝决定

The Minister refused to issue a CSP for GSK’s 905 Patent and the drug SHINGRIX.

卫生部拒绝给予GSK针对SHINGRIX带状疱疹疫苗的905 专利CSP。

The 905 Patent claims an immunogenic composition comprising an antigen, an adjuvant and other non-medicinal ingredients, uses of the composition, and a kit comprising the composition. It is not disputed that while the antigen induces the immune response in humans to prevent shingles, it could not do so in the absence of the adjuvant, which enhances the immune response to a level necessary for its use in a vaccine.

905专利权利要求包括一种免疫原性组合物，该组合物包括抗原、佐剂和其他非药物成分，该组合物的用途以及包含该组合物的产品。虽然抗原诱导人体的免疫反应来预防带状疱疹，但在没有佐剂的情况下，抗原无法起到有效预防作用，佐剂可将免疫反应增强到疫苗所需的要求。这些没有争议。

GSK’s CSP application identified the antigen as the single medicinal ingredient.

GSK的CSP申请将抗原列为唯一的药物成分。

The Minister found that the single medicinal ingredient listed in the NOC for SHINGRIX is the antigen. The Minister held that the adjuvant does not independently contribute to the therapeutic use of the vaccine, although it enhances the antigen’s efficacy. Therefore, the claims of the 905 Patent are all directed to a formulation (i.e. a combination of active ingredient and non-active ingredients) and the patent is CSP ineligible.

卫生部认为SHINGRIX NOC中列出的的唯一药物成分是抗原。佐剂虽然能增强抗原的有效性，但不能单独被用作疫苗。因此，905专利的权利要求都只针对制剂 (即活性成分和非活性成分的组合)，该专利不符合获得CSP的要求。

GSK appealed the Minister’s refusal to the Federal Court (“FC”).

GSK将卫生部的拒绝上诉到联邦法院（“FC”）。

联邦法院判决

The FC found that the Minister’s refusal was unreasonable, noting its view that “active ingredient” used in the CETA would include an ingredient such as the adjuvant whose biological activity is necessary for the vaccine’s clinical efficacy (2020 FC 397, April 7, 2020). The Minister appealed to the FCA.

联邦法院认为卫生部的拒绝是不合理的。法院认为CETA中使用的“活性成分”一词包括例如佐剂之类的成分，如果该成分对于疫苗的临床疗效是必要的(2020 FC 397, 2020年4月7日)。卫生部将联邦法院判决上诉到联邦上诉法院。

联邦上诉法院判决

On appeal, the FCA reversed the FC’s decision and determined the following two questions both in the affirmative:

2. whether the Minister’s exclusion of patent claims directed to a formulation from CSP eligibility was reasonable.

联邦上诉法院推翻了联邦法院的判决，并对以下两个问题给予肯定的答复:

“药物成分”

Regarding the meaning of the “medicinal ingredient” under the CSP regime, the FCA noted that this term is not defined in the Patent Act or any regulations issued under it. It nevertheless held that there is a “definite link” in the CSP Regulations between the medicinal ingredient listed in the NOC for SHINGRIX and the medicinal ingredient referred to at section 106(1) of the Patent Act. The medicinal ingredient referred to in the Patent Act and CSP Regulations is the medicinal ingredient listed in the NOC.

关于CSP制度对“药物成分”的定义，联邦上诉法院指出，专利法或者其下任何法规都没有定义该术语。尽管如此，上诉法院仍然认为依照《CSP法规》，SHINGRIX的NOC中列出的药物成分和《专利法》第106(1)条中提到的药物成分这两者之间存在“确定的关联”。《专利法》和《CSP法规》中提到的药物成分均为NOC中列出的药物成分。

The FCA concluded that in this case, the Minister adopted a reasonable interpretation of the “medicinal ingredient” and made a scientific determination that the adjuvant was not in fact a medicinal ingredient because it had no independent therapeutic effect on the body. Thus, the Minister’s decision was based on a legal and scientific position backed up by the consistency between the medicinal ingredient listed in the NOC and the medicinal ingredient referred to in GSK’s application for a CSP and the Patent Act.

联邦上诉法院认为卫生部对本案的“药物成分”进行了合理的解释，并做出了科学的判断，即佐剂实际上不是药物成分，因为它对人体没有独立的治疗作用。因此，卫生部的决定是具有法律和科学依据的，即基于SHINGRIX NOC中列出的药物成分与GSK的CSP申请中提到的药物成分之间的一致性。

CSP不包括制剂专利

The FCA also held that in this case, the Minister’s interpretation and application of the CSP provisions to exclude formulations claims was reasonable.

联邦上诉法院还认为，在本案中，卫生部对CSP条款的解释和应用将制剂专利排除在CSP之外是合理的。

The FCA noted that product claims, product-by-process claims, formulation or composition claims and use claims are well understood patent law concepts.  Canadian Courts have used “formulation claims” or “composition claims” to refer to a claim for “a mixture of active and non-active ingredients.”

联邦上诉法院指出产品权利要求、通过工艺取得的产品的权利要求、制剂或组分权利要求以及用途权利要求都是众所周知的专利法概念。加拿大法院使用“制剂权利要求”或“组分权利要求”来指代“活性成分和非活性成分的混合物”的权利要求。

The FCA held that the Minister’s interpretation of section 3(2) of the CSP Regulations to exclude formulation claims was supported by the accompanying Regulatory Impact Analysis Statement (“RIAS”), which expressly excluded formulation claims from CSP eligibility as they “do not protect the medicinal ingredient or combination of medicinal ingredients per se”.

联邦上诉法院还认为卫生部对《CSP法规》第3(2)条排除制剂权利要求的解释得到了《法规立法分析声明》(“RIAS”)的支持。该声明将制剂权利要求明确排除在CSP资格之外，因为制剂权利要求“不保护药物成分或药物成分组合本身”。

The FCA further held that although SHINGRIX is more efficient than previous vaccines for shingles, this is not enough to make it eligible for a CSP because the 905 Patent does not include the prescribed patent claims.  It stated that “it is not for judges to rewrite government policies when they are of the view that such policies are not fair or broad enough to cover, as in this case, a vaccine that they believe to be a welcome improvement”.

联邦上诉法院进一步认为，尽管SHINGRIX比之前的带状疱疹疫苗更有效，但这并不足以使其有资格获得CSP，因为905专利不包括合格的权利要求。联邦上诉法院指出，"法官不应重写政府政策，虽然他们认为这些政策不够公平或者不够宽限，例如在本案中，政策不足以涵盖他们相信是一种受欢迎的改进的疫苗"。

小结

This FCA decision demonstrates that a Canadian Court applies a deferential approach of reasonableness to Health Canada’s interpretation and application of the CSP provisions, as Health Canada has specialized knowledge of the subject matter at issue.  Therefore, administrative decisions of Health Canada may be difficult to challenge on judicial review.  Consequently, in order to qualify for a CSP in Canada, it is important to match the medicinal ingredient(s) in an approved drug product as listed in the NOC and the patent claims.