Canada (Health) v. Glaxosmithkline Biologicals S.A.

Canada (Health) v. Glaxosmithkline Biologicals S.A.
Court (s) Database
Federal Court of Appeal Decisions
Date
2021-04-14
Neutral citation
2021 FCA 71
File numbers
A-138-20
Notes
Reported Decision
Decision Content
Date: 20210414
Docket: A-138-20
Citation: 2021 FCA 71
CORAM:
GAUTHIER J.A.
RIVOALEN J.A.
LOCKE J.A.
BETWEEN:
THE MINISTER OF HEALTH
Appellant
and
GLAXOSMITHKLINE BIOLOGICALS S.A.
Respondent
Heard by online video conference hosted by the Registry on February 10, 2021.
Judgment delivered at Ottawa, Ontario, on April 14, 2021.
REASONS FOR JUDGMENT BY:
GAUTHIER J.A.
CONCURRED IN BY:
RIVOALEN J.A.
LOCKE J.A.
Date: 20210414
Docket: A-138-20
Citation: 2021 FCA 71
CORAM:
GAUTHIER J.A.
RIVOALEN J.A.
LOCKE J.A.
BETWEEN:
THE MINISTER OF HEALTH
Appellant
and
GLAXOSMITHKLINE BIOLOGICALS S.A.
Respondent
REASONS FOR JUDGMENT
GAUTHIER J.A.
[1] This is an appeal from the Federal Court decision (per Barnes J., 2020 FC 397) (FC Decision) setting aside the Minister of Health’s decision refusing to issue a Certificate of Supplementary Protection (CSP) to Glaxosmithkline Biologicals S.A. (GSK) in respect of Canadian Patent No. 2,600,905 (905 Patent) and the drug SHINGRIX, a vaccine against shingles.
[2] This is the first time that the Minister’s interpretation of the expressions “medicinal ingredient” and “a claim for the medicinal ingredient or combination of all the medicinal ingredients” under subsection 3(2) of the Certificate of Supplementary Protection Regulations, S.O.R./2017-165 (CSP Regulations) are challenged before this Court.
[3] For the reasons below, I find that the Federal Court erred in concluding that the Minister’s interpretation of “medicinal ingredient” under the CSP Regulations was unreasonable, that the Minister’s decision to refuse the CSP in this case was reasonable and that the appeal should be allowed.
I. General Background
[4] GSK is the owner of the 905 Patent, which relates to a vaccine useful in the prevention or amelioration of shingles. The 905 Patent contains five claims: claim 4 claims an immunogenic composition comprising an antigen, an adjuvant referred to as AS01B and other non-medicinal ingredients, claims 1 to 3 claim uses of the said composition, and claim 5, a kit comprising the composition components.
[5] 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 the level necessary for its use in a vaccine to prevent or ameliorate shingles.
[6] The 905 Patent was filed on March 1, 2006; it would normally expire on March 1, 2026. In the CSP application referred to below, it is identified as an eligible patent. The goal of the CSP regime is to extend the rights under an eligible patent but only with respect to the making, using and selling of the actual drug or pharmaceutical product containing the medicinal ingredient or combination of medicinal ingredients set out in the CSP for a maximum of two years (see sections 115 - 116 of the Patent Act, R.S.C., 1985, c. P-4 (Patent Act)).
[7] Health Canada issued a Notice of Compliance (NOC) for SHINGRIX on October 13, 2017, which identifies the antigen as the only medicinal ingredient (Appeal Book, Volume 1 at p. 111 (AB), Janet Wagner affidavit, Exhibit A). On the same day, SHINGRIX was listed in the register of innovative drugs where again the antigen is the only medicinal ingredient identified. This listing entitles GSK to benefit from the period of data protection described in subsection C.08.004.1(3) of the Food and Drug Regulations, C.R.C., c. 870.
[8] On January 25, 2018, GSK filed its CSP application for the 905 Patent in relation to SHINGRIX and identified the antigen as the single medicinal ingredient (AB, Volume 1 at p. 256, Janet Wagner affidavit, Exhibit F).
[9] On April 10, 2018, the Minister informed GSK that she was of the preliminary view that the 905 Patent did not meet the requirements of subsection 3(2) of the CSP Regulations since its claims were directed to a formulation (a composition containing medicinal ingredients and non-medicinal ingredients) and not to “the medicinal ingredient or combination of all the medicinal ingredients” contained in the SHINGRIX vaccine, as contemplated in subsection 3(2) of the CSP Regulations. The Minister also noted that the antigen itself was not novel, having been the subject of two prior patents.
[10] On May 24, 2018, GSK submitted written representations, including the affidavit of Dr. Brian Barber, an expert immunologist, in response to the preliminary decision. At this stage, GSK’s position was that the adjuvant was itself an active ingredient, in that it had biological activity, and that the 905 Patent was directed to a combination of medicinal ingredients (an immunogenic composition). It argued that the claims at issue were not formulation claims.
[11] On August 3, 2018, the Minister issued the final decision refusing the CSP to GSK. The Minister held that, contrary to paragraph 106(1)(c) of the Patent Act, and subsection 3(2) of the CSP Regulations, the 905 Patent does not include a claim for the approved medicinal ingredient (the antigen) contained in the drug SHINGRIX. The Minister explained that after reviewing various documents referred to by GSK, Health Canada’s position is that adjuvants, even those with biological activity, are not medicinal ingredients. This is clearly set out in the Health Canada Guidance Document “Harmonized Requirements for the Licensing of Vaccines and Guidelines for the Preparation of an Application”. The Minister also dealt with GSK’s submissions regarding various alleged inconsistencies in her position regarding the classification of adjuvants and in other documentation relating to SHINGRIX.
[12] The Minister held that an adjuvant in a vaccine is not responsible for the vaccine’s desired effect in the body as it only improved the specific cellular and immune response induced by the antigen itself. This, even if the response without the adjuvant is itself too negligible to be efficient for use in a vaccine. I understand that the Minister meant to apply here the definition of “medicinal ingredient” she normally uses when applying other regulations such as the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (PMNOC Regulations) to the particular facts of this matter.
[13] The Minister found that because the claims are directed at compositions comprising medicinal and non-medicinal ingredients i.e. a formulation, the patent is ineligible for a CSP. Relying on the CSP Regulations Regulatory Impact Analysis Statement (RIAS) and the Health Canada Guidance Document on the CSP Regulations, the Minister held that her position in that respect is consistent with the Canada–European Union Comprehensive Economic and Trade Agreement (CETA), which only requires the protection of a medicinal ingredient or a combination of medicinal ingredients when claimed “as such”.
[14] GSK applied for judicial review of this decision, and the Federal Court allowed the application, ordering the matter to be remitted to the Minister for redetermination. In doing so, the Federal Court noted its view that “active ingredient”, the term used in CETA, would include an ingredient such as the adjuvant whose biological activity is necessary for the clinical efficacy of the vaccine.
[15] I note that although GSK argued that the Minister failed to consider the objective of the legislation in interpreting the CSP Regulations, it never argued before the Minister or before the Federal Court that “active ingredient”, the term used in CETA, contemplated biological activity and that therefore, the Minister had failed to interpret the CSP Regulations consistently with CETA. GSK’s argument was that the Minister had adopted an interpretation of medicinal ingredient that was not in line with the judicial definition of this term under the PMNOC Regulations.
[16] In the reviewing court’s view, the Minister adopted administrative tunnel vision by requiring that a medicinal ingredient have an independent desired effect on the body, i.e. in this case, the antigen specific cellular and immune response. The Court also commented that the Minister’s interpretation of “claim for the medicinal ingredient” was hard to justify, for nothing other than the RIAS could support the exclusion of formulation claims nor justify excluding novel and useful vaccines, such as SHINGRIX.
II. Legislative Background
[17] As this is the first time that this Court deals with this regulatory scheme, it is worth describing in more detail than is normally expected the background of the particular provisions before us.
[18] CETA covers a large number of subjects including, at Chapter 20, intellectual property. Section A contains the general provisions that apply to the Chapter as a whole. It includes at article 20.1 two general objectives:
a. Facilitate the production and commercialisation of innovative and creative products, and the provision of services, between the Parties; and
b. Achieve an adequate and effective level of protection and enforcement of intellectual property rights.
[19] Obviously the reference to innovative and creative products is a somewhat general description given that the Chapter deals with a variety of topics such as copyright, protection of technological measures, trademarks and geographical indications, data protection for pharmaceutical products, designs and patents, etc.
[20] At article 20.2, it states that each Party shall be free to determine the appropriate method for implementing CETA’s provisions within its own legal system and practice.
[21] Section B includes a definition of “pharmaceutical product” which applies to the most relevant portion of this Chapter in so far as the present matter is concerned, that is sub-section E entitled “Patents” and more particularly article 20.27 which deals with the sui generis protection for pharmaceuticals (see the most relevant portions reproduced in Appendix A).
[22] After CETA was signed, the parties issued a Joint Interpretative Instrument dealing with many important subject matters covered. It does not include anything specific about Chapter 20 of CETA dealing with intellectual property. It does however put emphasis on the fact that the Parties preserved their ability to adopt and apply their own laws and regulations that regulate economic activity in the public interest and to achieve legitimate public policy objectives in respect of various issues including public health and social services.
[23] Thereafter, the Canadian government adopted the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act, S.C. 2017, c. 6 (Implementation Act). The two most relevant sections of the Implementation Act in this case are sections 3 and 7, which respectively deal with the need for the Canadian legislation to be interpreted in a manner consistent with CETA and its purpose and objectives. The most relevant objective here is set out in paragraph 7(f) viz:
(f) [p]rovide adequate and effective protection and enforcement of intellectual property rights in the territory where [CETA] applies.
[24] The Canadian government then issued a Canadian Statement on Implementation (of more than 275 pages) that purports to explain what it understood its rights and obligations to be under CETA. The portion that is most relevant to our purpose here is brief. It is found under the title “Patents” and includes a paragraph dealing expressly with article 20.27 of CETA as follows:
Article 20.27 requires the Parties to provide a period of additional protection of two to five years for eligible new patented pharmaceutical products. This protection is intended to address a portion of the patent term that is spent in research and development and regulatory review towards the approval of a pharmaceutical product that contains a new active ingredient or a new combination of active ingredients. This protection takes effect after the expiration of the term of the patent on which it is granted and gives the same rights as the patent but only as it pertains to the active ingredient or combination of active ingredients when used in a drug, subject to limitations and conditions. The Article allows for an exception to the protection to enable export of generic versions of products that would otherwise infringe the protection during the period of protection. It also allows the Parties to limit the availability of protection in various ways, such as having deadlines for applying for the protection and limiting the circumstances when the protection can be sought. (My emphasis)
[25] The Canadian legislator thereafter adopted a new section in the Patent Act entitled “Supplementary Protection for Inventions — Medicinal Ingredients” which comprises sections 104 to 134. Subsection 106(1) sets out the conditions to obtain a CSP and paragraph 106(1)(c) deals with patent eligibility. It is worth reproducing the key elements here (full text in Appendix A):
106 (1) On the payment of the prescribed fee, a patentee may apply to the Minister for a certificate of supplementary protection for a patented invention if all of the following conditions are met:
106 (1) Le titulaire d’un brevet peut, sur paiement des taxes réglementaires, présenter au ministre une demande de certificat de protection supplémentaire pour l’invention à laquelle le brevet se rapporte si, à la fois :
(a) the patent is not void and it meets any prescribed requirements;
a) le brevet n’est pas nul et il satisfait aux exigences réglementaires;
[…]
[…]
(c) the patent pertains in the prescribed manner to a medicinal ingredient, or combination of medicinal ingredients, contained in a drug for which an authorization for sale of the prescribed kind was issued on or after the day on which this section comes into force;
c) le brevet est lié, de la manière prévue par règlement, à un ingrédient médicinal ou à une combinaison d’ingrédients médicinaux contenus dans une drogue pour laquelle une autorisation de mise en marché prévue par règlement a été délivrée à la date d’entrée en vigueur du présent article ou après cette date;
(d) the authorization for sale is the first authorization for sale that has been issued with respect to the medicinal ingredient or the combination of medicinal ingredients, as the case may be;
d) l’autorisation de mise en marché est la première autorisation de mise en marché à avoir été délivrée à l’égard de l’ingrédient médicinal ou de la combinaison d’ingrédients médicinaux, selon le cas;
(e) no other certificate of supplementary protection has been issued with respect to the medicinal ingredient or the combination of medicinal ingredients, as the case may be;
e) aucun autre certificat de protection supplémentaire n’a été délivré à l’égard de l’ingrédient médicinal ou de la combinaison d’ingrédients médicinaux, selon le cas;
[26] Under paragraphs 134(1)(c) and 12(1)(h) of the Patent Act, the Governor in Council is given authority to regulate the form and content for CSP applications and to adopt regulations necessary to put into effect the terms of any treaty. The CSP Regulations were adopted on the recommendation of the Minister of Industry pursuant to paragraphs 12(1)(g), (h), (k) and subsection 134(1) of the Patent Act. They provide among other things for the prescribed eligibility referred to as a main condition in paragraph 106(1)(c) of the Patent Act. Subsection 3(2) of the CSP Regulations reads as follows:
3(2) For the purpose of paragraph 106(1)(c) of the Act, the prescribed manners in which a patent may pertain to a medicinal ingredient or combination of medicinal ingredients are the following:
3(2) Pour l’application de l’alinéa 106(1)c) de la Loi, le brevet est lié à un ingrédient médicinal ou à une combinaison d’ingrédients médicinaux de l’une ou l’autre des manières suivantes :
(a) the patent contains a claim for the medicinal ingredient or combination of all the medicinal ingredients contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued;
a) le brevet contient une revendication de l’ingrédient médicinal ou de la combinaison de tous les ingrédients médicinaux contenus dans une drogue pour laquelle l’autorisation de mise en marché mentionnée dans la demande de certificat de protection supplémentaire a été délivrée;
(b) the patent contains a claim for the medicinal ingredient or combination of all the medicinal ingredients as obtained by a specified process and contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued; and
b) le brevet contient une revendication de l’ingrédient médicinal ou de la combinaison de tous les ingrédients médicinaux tels qu’ils sont obtenus au moyen d’un procédé déterminé et tels qu’ils sont contenus dans une drogue pour laquelle l’autorisation de mise en marché mentionnée dans la demande de certificat de protection supplémentaire a été délivrée;
(c) the patent contains a claim for a use of the medicinal ingredient or combination of all the medicinal ingredients contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued.
c) le brevet contient une revendication d’une utilisation de l’ingrédient médicinal ou de la combinaison de tous les ingrédients médicinaux contenus dans une drogue pour laquelle l’autorisation de mise en marché mentionnée dans la demande de certificat de protection supplémentaire a été délivrée.
[27] The RIAS is lengthy and addresses in some detail all the main concepts. I have reproduced in Appendix A the portion dealing with the conditions referred to in subsection 106(1) including particularly patent eligibility. It is worthwhile to quote the first part of the section entitled “Rationale” (full paragraph in Appendix A):
The Canadian CSP regime is created with the aim of meeting obligations under Article 20.27 of the CETA, which requires Parties to provide an additional period of protection for patent-protected pharmaceutical products, while continuing to balance the interests of stakeholders and the public within the Patent Act.
[28] As indicated to the Senate Committee reviewing the bill that would become the Implementation Act, it appears that both the text of the CSP Regulations and of the RIAS were the subject of intensive consultation with the various players in the pharmaceutical industry (Senate, Standing Committee on Foreign Affairs and International Trade, Evidence, 42-1, No. 23 (4 May 2017) (A. Raynell Andreychuk)).
[29] It is important to describe what appears to be the policy that is embodied in article 20.27 of CETA as understood by Canada. For later on in construing the CSP Regulations, one will have to determine, among other things, if the text properly reflects this policy.
[30] Although generally, the objective is to grant some “patent-like rights” to compensate for the time lost in obtaining approval of innovative drugs and vaccines, Canada only understood and agreed to a very specific and limited way of doing so.
[31] Indeed, if one only considers the general objective, Canada could have simply agreed to grant such sui generis protection for all newly patented innovative drugs (or pharmaceutical products to use the CETA wording). However, this is not the policy described in the various documents issued to explain the Canadian position. It is only those innovative drugs or pharmaceutical products that contain a new active or medicinal ingredient or a new combination of active or medicinal ingredients that are eligible. Moreover, not all those innovative drugs or pharmaceutical products will be eligible for protection. Indeed, to benefit from this additional period of supplementary protection, the authorization for sale for the pharmaceutical product or drug must be the first issued in Canada with respect to this new active or medicinal ingredient or new combination of active or medicinal ingredients.
[32] Thus, a drug or pharmaceutical product may well be innovative but not have the benefit of a CSP if it is not the first to make actual use of the medicinal ingredient or combination of medicinal ingredients. Further, if a CSP has already been issued for the active or medicinal ingredient, it will not be entitled to the supplementary protection. The policy appears focused on rewarding those that bring to the Canadian market the actual benefit of new medicinal ingredients or new combinations of medicinal ingredients. At the core, it would appear that the goal is to promote research into new medicinal ingredients or new combinations of medicinal ingredients and to give an incentive to put them into practice for the benefit of the public. That incentive is to compensate for part of the time lost in obtaining approval for that first drug or pharmaceutical product.
III. Issues
[33] The issues before us are as follows:
Is the Minister’s interpretation and application of the term “medicinal ingredient” reasonable?
Is the Minister’s interpretation and application of the CSP provisions to exclude patent claims directed to a formulation, particularly the one at issue, reasonable?
IV. Standard of Review
[34] It is not disputed that the standard of review chosen by the Federal Court — reasonableness – was the appropriate standard to apply. This is consistent with the Vavilov framework, because the presumption of reasonableness applies when no exception calls for derogation from that standard, as in this case (Canada (Minister of Citizenship and Immigration) v. Vavilov, 2019 SCC 65, at para. 17).
V. Analysis
[35] As there is no dispute that the Federal Court applied the appropriate standard of review, our Court’s task is simply to assess whether it applied it correctly. In performing this exercise, our Court must focus on the administrative decision rather than the decision of the reviewing court; our Court effectively steps in the shoes of the Federal Court (Agraira v. Canada (Public Safety and Emergency Preparedness), 2013 SCC 36, [2013] 2 SCR 559, at para. 46). As mentioned, I must now assess whether the Minister’s construction of the expressions “medicinal ingredient” and “claim for the medicinal ingredient” is reasonable. I will deal first with the expression “medicinal ingredient”.
[36] It is trite law that this Court must apply the modern approach to statutory interpretation which calls for reading the words of the statute in their context harmoniously with the scheme and object of the legislation at issue and the intention of Parliament (Re Rizzo & Rizzo Shoes Ltd., [1998] 1 S.C.R. 27, 154 D.L.R. (4th) 193; Bell ExpressVu Limited Partnership v. Rex, 2002 SCC 42, [2002] 2 S.C.R. 559; Canada Trustco Mortgage Co. v. Canada, 2005 SCC 54, [2005] 2 S.C.R. 601).
[37] I have already described the scheme and object of the CSP Regulations and of the relevant provisions of the Patent Act as well as all the information available as to the intention of Parliament. There is no need to repeat it. I have reviewed all the relevant transcripts of debates and found nothing that would be particularly relevant here.
A. Medicinal Ingredient
[38] There is no definition of “medicinal ingredient” in the Patent Act or any regulations issued under it, even though the expression is used abundantly in the new sections 104 to 112 of the Patent Act. As will be mentioned later on, this expression is also used in the PMNOC Regulations issued pursuant to section 55.2 of the Patent Act. The expression is further found in a few instances in the Food and Drug Regulations, Part C, Division 8, C.08.001 “New Drugs” in the definition of “pharmaceutical equivalent” and C.08.004.1(1) in the definition of “innovative drug”.
[39] The parties are agreed that the only guiding definition in Canada at this stage is the one used in Bayer Inc. v. Canada (Health), 2009 FC 1171, affirmed in 2010 FCA 161 (Bayer), which has since been used in the case law. GSK agrees that, although used in the context of the PMNOC Regulations, this definition can and should be used for construing the CSP Regulations. As will be discussed, both sides rely on the same words used in Bayer to reach a different conclusion as to what “medicinal ingredient” means in this case. As a matter of first impression, this may indicate that both parties’ interpretations may be consistent with the definition used in Bayer as applied to the particular facts of this case.
[40] In Bayer, the Federal Court had to determine whether a patent including a claim to a formulation containing two medicinal ingredients could be listed under the PMNOC Regulations (subsection 4(2)) as it read after the 2006 amendments), in respect of a drug containing a formulation, which only included one of the medicinal ingredients (a combination) claimed.
[41] To better understand the Bayer decision, it is worth reproducing the following definitions contained in the PMNOC Regulations:
[…]
[…]
claim for the formulation means a claim for a mixture that is composed of medicinal and non-medicinal ingredients, that is contained in a drug and that is administered to a patient in a particular dosage form; (revendication de la formulation)
revendication de la formulation Revendication à l’égard d’un mélange formé d’ingrédients médicinaux et non médicinaux qui est contenu dans une drogue et est administré à un patient sous une forme posologique donnée. (claim for the formulation)
claim for the medicinal ingredient includes a claim in the patent for the medicinal ingredient, whether chemical or biological in nature, when prepared or produced by the methods or processes of manufacture particularly described and claimed in the patent, or by their obvious chemical equivalents, and also includes a claim for different polymorphs of the medicinal ingredient, but does not include different chemical forms of the medicinal ingredient; (revendication de l’ingrédient médicinal)
revendication de l’ingrédient médicinal S’entend, d’une part, d’une revendication, dans le brevet, de l’ingrédient médicinal — chimique ou biologique — préparé ou produit selon les modes ou procédés de fabrication décrits en détail et revendiqués dans le brevet ou selon leurs équivalents chimiques manifestes, et, d’autre part, d’une revendication pour différents polymorphes de celui-ci, à l’exclusion de ses différentes formes chimiques. (claim for the medicinal ingredient)
[…]
[…]
claim for the use of the medicinal ingredient means a claim for the use of the medicinal ingredient for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms; (revendication de l’utilisation de l’ingrédient médicinal)
revendication de l’utilisation de l’ingrédient médicinal Revendication de l’utilisation de l’ingrédient médicinal aux fins du diagnostic, du traitement, de l’atténuation ou de la prévention d’une maladie, d’un désordre, d’un état physique anormal, ou de leurs symptômes. (claim for the use of the medicinal ingredient)
[…]
[…]
[42] It is important to note that there was no dispute in Bayer that both ingredients claimed in the formulation were medicinal ingredients (Bayer at para. 68), nor was there a dispute as to the meaning of “medicinal ingredient” (Bayer at para. 67). The Federal Court had to consider the new definition of “formulation” as this term was introduced for the first time in the 2006 version of the PMNOC Regulations in the definition of “claim for the formulation” under section 2 of the said Regulations.
[43] It is clear that the Federal Court in Bayer relied on the 2006 PMNOC Regulations RIAS to say that “medicinal ingredient” refers to the substance in the formulation, which, once administered, is responsible for the drug’s desired effect in the body (Bayer at paras. 21, 86 and 88).
[44] In the course of its analysis, and while discussing the difference between a compound patent and a formulation patent, the Federal Court described the compound patent as containing a claim for the approved medicinal ingredient which is the key active part of the drug formulation (Bayer at para. 77).
[45] The Minister says that in the case of the SHINGRIX vaccine, the antigen is the only active ingredient that has the desired effect in the body that is, for inducing the antigen specific cellular and humoral immune response against shingles (AB, Volume 1 at p. 57). As mentioned, in the expert opinion of the Minister, the adjuvant does not independently contribute to the proposed therapeutic use of the vaccine. It may have biological activity, but this activity only enhances the efficacy of the antigen, i.e. the medicinal ingredient. It is thus not itself a medicinal ingredient.
[46] For GSK, the key active part of the vaccine can and must include the adjuvant because it is a key biologically active ingredient of the composition claimed in the 905 Patent. Without it, the vaccine would not provide sufficient immunological response to prevent shingles. The whole composition in this case is the medicinal ingredient or combination of medicinal ingredients.
[47] As one can appreciate, Bayer is not helpful in determining whether the key active ingredient refers simply to the biological activity necessary for the drug to be clinically useful. We do not know on this record whether there is another adjuvant or composition that could also make the antigen sufficiently effective, albeit offering a different level of protection. Nor does Bayer tell us precisely whether the key active ingredient refers to an ingredient that actually produces the therapeutic effect as understood by the regulator. The Court in Bayer never had to turn its mind to this particular issue.
[48] The Minister relied on her own scientific expertise to say that her interpretation is in line with the general understanding of what is an active ingredient in the pharmaceutical field and what role the adjuvant plays in this case (as confirmed by Health Canada’s Therapeutic Product Directorate in consultation with the Biologics and Genetic Therapies Directorate) (AB, Volume 1 at p. 55). She says that her position in this respect is in line with the understanding of working groups dealing with such issues in the Pan American Network for Drug Regulatory Harmonization and the World Health Organization. The Minister also notes that the composition includes ingredients other than QS21 (adjuvant enhancer) that are indisputably non-medicinal such as cholesterol and dioleoyl phosphatidylcholine (AB, Volume 1 at pgs. 55 and 57).
[49] GSK relies on common sense and logic, saying that it is a logical fallacy to understand that key active ingredient would not include an ingredient that is clinically useful, if not indispensable, because of its biological activity, as found by the Federal Court (Federal Court decision at para. 38). At the hearing before this Court, it also appeared to support the position developed by the Federal Court that “biological activity” was the measure by which CSP relief under CETA was to be made available in Canada (FC decision at para. 35). It is not clear to me whether it continues to support this view after I reviewed its additional submissions filed after the hearing (particularly paragraph 33). Its main argument now seems to be that whatever the meaning of “active ingredient” in the European Union (a subject that I will discuss later on), “medicinal ingredient” as defined in Bayer is wider and it does not require that a key ingredient have an independent therapeutic effect.
[50] Be that as it may, it is appropriate as mandated by section 3 of the Implementation Act to consider whether the Minister’s interpretation is consistent with CETA. In my view, it is appropriate to do so, considering that examining international law may bring to light, and possibly resolve, latent ambiguities in the domestic legislation (Entertainment Software Association v. Society of Composers, Authors and Music Publishers of Canada, 2020 FCA 100 at para. 84).
[51] That said, one should be careful not to put aside a regulator’s interpretation of a term that is used across the regulatory system dealing with pharmaceutical products, albeit for a variety of purposes, solely because of a seemingly logical alternative interpretation. This is so unless there is some clear indication that the words can and should be construed in a specific manner, at least in the context of the CSP Regulations, because of CETA.
[52] As is readily apparent, the expression “medicinal ingredient” is not used in CETA. Instead, the expression “active ingredient or combination of active ingredients of a pharmaceutical product” is used to define “product”. I note that the use of the word “product” may lead to some confusion with the defined term “pharmaceutical product” (the actual drug or vaccine, article 20.6 of CETA). They are not the same, and one should be careful in using them indistinctly. For my part, to avoid any confusion, I will use the words “pharmaceutical product” and “active ingredient” as this is what the definition of “product” in CETA refers to (article 20.27(1)).
[53] It is not disputed that the definition of “product” comes from the EU Regulations dealing with Supplementary Protection Certificates, a regime put in place in 1992 (see article 1(b) of the latest version of Regulation 469/2009/EC) (see Appendix A). This will also be discussed later on (in section B) in my analysis of “basic patent” found in CETA at article 20.27. It is also not disputed that Canada was entitled to adapt this wording in its domestic legislation to ensure that the new rules can be applied effectively within its institutional framework of domestic law (Ruth Sullivan on the Construction of Statutes, 6th Edition, Markham, Ontario: Lexis Nexis 2014 at §18.45).
[54] As one can see, the wording in CETA is not particularly illuminating and certainly not more precise than the definition of key active ingredient in the formulation used in Bayer. There is nothing in the Joint Statement on CETA that is particularly helpful. I note that in the Canadian Statement on Implementation, the Canadian government uses the words “active ingredient” (as well as the word “drug” when referring to pharmaceutical product) and that there is no indication that the government understood the words “active ingredient” as something other than the term regularly used in its domestic legislation.
[55] I also note that in my experience active pharmaceutical ingredient (API) is a word commonly used by regulators around the world and by IP lawyers in Canada in their memoranda or oral submissions. In fact, the words “active ingredient” were used regularly in the case law when dealing with whether or not a substance was a medicine in the pre 2006 version of the PMNOC Regulations. I will discuss this further in examining the second issue before us, but my understanding for this change is that the word “medicine” in “claim for a medicine (médicament) itself” was construed in our case law to include a claim to the drug itself i.e. a formulation of active and non-active ingredients (see for example, Hoffmann-La Roche Ltd. v. Canada (Minister of National Health & Welfare) 62 C.P.R. (3d) 58, [1995] F.C.J. No. 985 (F.C.T.D.), aff’d [1995] F.C.J. No. 1775 (F.C.A.), leave to appeal to SCC refused, 25136 (12 September 1996) (Hoffmann)). The legislator decided to clarify its intention by removing the reference to medicine and claim to a medicine, and used the words “claim for the medicinal ingredient” to make it clearer that such claim was not a claim to the drug. It did however add a definition for “claim for the formulation” i.e. a mixture of medicinal and non-medicinal ingredients (in other words a drug). In 2015, the legislator added subsection 2(2) of the PMNOC Regulations, to clarify that for the purpose of the definition of “claim for the formulation”, the claim for the formulation did not need to specify all of the non-medicinal ingredients contained in the drug.
[56] This indicates to me that “active ingredient” and “medicinal ingredient” referred to the same thing in these regulations. I simply cannot discern any other intention of Parliament in respect of CETA or the CSP Regulations in that respect.
[57] I ought to mention that the Canadian Generic Pharmaceutical Association had sought leave to intervene in this appeal. However, leave was refused because its main contribution would have been to highlight the similarity of the Minister’s interpretation concerning the term “medicinal ingredient” with the interpretation given by the European Court of Justice (ECJ) to “active ingredient” as to whether it encompasses substances that do not have a therapeutic effect on their own.
[58] This similarity in interpretation is relevant to determine the reasonableness of the Minister’s decision for, as mentioned, the Canadian case law on the meaning of “medicinal ingredient” had yet to provide a sufficiently precise answer in this respect. I agree with the parties that one must be cautious in using foreign case law, but in this particular case, I find it persuasive based on its reasoning.
[59] I note here that CETA negotiations ended in 2014, the review of the English text was completed in February 2016, and the agreement was signed in October 2016.
[60] During this period, the ECJ, to whom national courts of the members of European Union referred matters of interpretation in respect of the European SPC Regulations, had already judicially considered the meaning of “active ingredient” in the definition of “product” in the European Regulation from which the definition in CETA originates. It first did so in 2006 in Massachusetts Institute of Technology, case C-431/04, May 4, 2006 (MIT), and then in a decision that GSK was presumably aware of, given that it was a party to it and it involved another vaccine comprising an antigen and an adjuvant known as the AS03, which also appear to have been necessary to make the vaccine Prepandrix clinically effective (Glaxosmithkline Biological S.A. v. Controller General of Patents, Design and Trademarks, case C-210/13, November 14, 2013 (Glaxo)).
[61] In Glaxo, the regulatory body in the U.K. (the Patent office which has a similar role to that of the Minister in this respect) refused to issue a supplementary protection certificate because the adjuvant was not an active ingredient within the meaning of the definition of “product”. From my review of this decision, it appears that the adjuvant in question had biological activity and that its mechanism of action was somewhat similar to the one described in the SHINGRIX Product Monograph (see Glaxosmithkline Biologicals S.A., BL O/506/12, December 19, 2012 at paras. 3, 27-31). GSK applied to the Patents Court of England and Wales, who referred the matter to the ECJ. The ECJ first noted that it is “generally accepted in pharmacology that the term active ‘ingredient’ does not include substances forming part of the medicinal product which do not have an effect of their own on the human or animal body” (Glaxo at para. 28). This was the definition adopted by the ECJ in MIT. In the ECJ’s view, though an excipient such as the one under review in that case could contribute to the pharmaceutical form of the medicinal product, it did not form part of the definition of “product”. Therefore, “[w]hether a substance without any therapeutic effect of its own is necessary for the therapeutic efficacy of the active ingredient [could not] be regarded as a sufficiently precise test” (Glaxo at para. 29). The ECJ held that the “active ingredient” does not cover a substance that does not have any therapeutic effect on its own (Glaxo at para. 30). It also stated at paragraph 32 that the fact “that the substance without any therapeutic effect of its own