2021 FCA 71, 2021 FCA 71

A-138-20 2021 FCA 71 The Minister of Health ( Appellant ) v. GlaxoSmithKline Biologicals S.A. ( Respondent ) Indexed as: Canada (Health) v. GlaxoSmithKline Biologicals S.A. Federal Court of Appeal, Gauthier, Rivoalen and Locke JJ.A.—By videoconference, February 10; Ottawa, April 14, 2021.

Patents — Appeal from Federal Court decision setting aside Minister of Health’s decision refusing to issue certificate of supplementary protection (CSP) to respondent in respect of its Canadian Patent No. 2600905 (′905 patent), drug SHINGRIX — Notice of compliance issued for SHINGRIX identifying antigen as only medicinal ingredient — Minister of view ′905 Patent not meeting Certificate of Supplementary Protection Regulations ( CSP Regulations ), s. 3(2) requirements since claims directed to formulation, not to “the medicinal ingredient or combination of all the medicinal ingredients” contained in SHINGRIX vaccine — Holding that ′905 patent not including claim for approved medicinal ingredient (antigen) contained in drug SHINGRIX — Also holding that position consistent with Comprehensive Economic and Trade Agreement between Canada and the European and its Member States (CETA) — Respondent arguing key active part of vaccine must include adjuvant — Federal Court noting that “active ingredient”, term used in CETA, would include adjuvant — Of view that Minister adopting administrative tunnel vision by requiring that medicinal ingredient have independent desired effect on body — Whether Minister’s

interpretation, application of term “medicinal ingredient” reasonable — Whether Minister’s

interpretation, application of CSP provisions to exclude patent claims directed to a formulation reasonable — Minister’s decision reasonable — Federal Court not applying applicable standard of review correctly — Legislator using words “claim for the medicinal ingredient” in Patented Medicines (Notice of Compliance) Regulations ( PMNOC Regulations ) to make it clearer that such claim not a claim to the drug — Terms “active ingredient”, “medicinal ingredient” referring to same thing — Minister adopting construction consistent with CETA,

interpretation of medicinal ingredient applied under Canada’s domestic legislation — Minister adopting reasonable

interpretation of words “medicinal ingredient” — Making scientific determination that adjuvant not medicinal ingredient — Minister reasonably concluding that antigen only medicinal ingredient here — Not incumbent on legislator to exclude expressly from eligibility patent claims directed to a formulation — 2006 amendments to PMNOC Regulations acknowledging distinction between claim for medicinal ingredient, claim for formulation — New

definitions intending to bear their established meaning under extensive body of case law interpreting “claim for the medicine itself” — Reasonable to conclude that claim for medicinal ingredient referring only to claim for antigen, not mixture of ingredients in approved drug — Legislator endeavouring to adopt text consistent with definition of “basic patent” at CETA,

Article 20.27 — No reason to conclude that s. 3(2) inconsistent with Canada’s obligation under

Article 20.27 — Patent protecting the product (i.e. active ingredient) consistent with requirement that there be claim for medicinal ingredient — Appeal allowed. This was an appeal from a Federal Court decision setting aside the Minister of Health’s decision refusing to issue a certificate of supplementary protection (CSP) to the respondent in respect of its Canadian Patent No. 2600905 (′905 patent) and the drug SHINGRIX, a vaccine against shingles.

The CSP regime extends 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. A notice of compliance issued for SHINGRIX in 2017 identifies the antigen as the only medicinal ingredient.

The Minister informed the respondent that she was of the preliminary view that the ′905 Patent did not meet the requirements of subsection 3(2) of the Certificate of Supplementary Protection Regulations ( 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.

The respondent’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. In refusing the CSP, the Minister held that, contrary to paragraph 106(1) (

c) of the Patent Act , and subsection 3(2) of the CSP, the ′905 patent did not include a claim for the approved medicinal ingredient (the antigen) contained in the drug SHINGRIX. The Minister also 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 [1] (RIAS), the Minister held that her position in that respect is consistent with the Comprehensive Economic and Trade Agreement between Canada and the European and its Member States (CETA). For the respondent, 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. The Minister relied on her own scientific expertise to say that her

interpretation was 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. The Federal Court noted that “active ingredient”, the term used in the CETA, would include an ingredient such as the adjuvant whose biological activity is necessary for the clinical efficacy of the vaccine. The Federal Court was also of the view, inter alia , that 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.

At issue was whether the Minister’s

interpretation and application of the term “medicinal ingredient” was reasonable, and whether the Minister’s

interpretation and application of the CSP provisions to exclude patent claims directed to a formulation, particularly the one at issue, was reasonable. Held , the appeal should be allowed. The Minister’s decision was reasonable. The Federal Court did not apply the applicable standard of review correctly. It needed to be determined whether the Minister’s

interpretation was consistent with CETA. 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”. 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 Patented Medicines (Notice of Compliance) Regulations ( PMNOC Regulations ). The legislator removed 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.

The legislator also added a definition for “claim for the formulation” i.e. a mixture of medicinal and non-medicinal ingredients (in other words a drug), and 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. This indicates that “active ingredient” and “medicinal ingredient” referred to the same thing in these regulations. One cannot discern any other intention of Parliament in CETA or the CSP Regulations in that respect.

The construction adopted by the Minister is consistent with CETA and with the

interpretation of medicinal ingredient applied under Canada’s domestic legislation pertaining to pharmaceutical products. That consistency does not mean that the Canadian system must be identical to the system that was already in place in the European Union (EU). Nor should it be inferred from the reasons herein that foreign case law binds Canadian courts in any way. It is obvious that the administrative classification of adjuvants is a non- binding administrative policy; it cannot supplant the words of the legislation. Here, the Minister adopted a reasonable

interpretation of the words “medicinal ingredient” and made a scientific determination that in this case, the adjuvant was not in fact a medicinal ingredient because it had no independent therapeutic effect on the body. 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 issued under the Food and Drug Regulations , the medicinal ingredient referred to in the application for a CSP and the Patent Act . It was reasonable for the Minister to conclude that the only medicinal ingredient here was the antigen. When paragraph 3(2)(

a) of the CSP Regulations is read alongside paragraphs 3(2)(

b) and (c), one would conclude that paragraph 3(2)(

a) does not include a product-by- process claim for the medicinal ingredients for these are expressly covered by paragraph (b). Given the enumeration at subsection 3(2), and the fact that unless listed, another specific type of claim will not be sufficient to qualify a patent in the prescribed manner, it was not incumbent on the legislator to exclude expressly from eligibility patent claims directed to a formulation.

Courts have been quite capable of excluding pure process claims or other types of claims (such as claims for intermediate compounds) from the definition of “claims for the medicine” without the need for express exclusions. Courts have also been capable of including compositions or formulation claims when the wording of the subject matter of the claim enabled them to do so. The 2006 amendments to the PMNOC Regulations acknowledged the distinction between a claim for a medicinal ingredient and a claim for a formulation. It is clear that the new

definitions were intended to bear their established meaning under the extensive body of case law interpreting “claim for the medicine itself”. It was reasonable to conclude that a claim for the medicinal ingredient refers only to a claim for the antigen and not a mixture of ingredients in an approved drug. It is made clear in the

section of the RIAS dealing with patent eligibility that there is no need for the patent to protect the medicinal ingredient that was approved, but only that it protect what is described as “the same medicinal ingredient” in the RIAS. This is understood to mean that if the approved medicinal ingredient only differs from the claimed medicinal ingredient with respect to a minor variation such as an enantiomer or an appendage (e.g. ester or salt) within a particular molecular structure, it is nevertheless eligible for a CSP. The same concept applies to use claims and product-by-process claims.

On a fair reading of the RIAS, one could reasonably conclude that the legislator endeavoured to adopt a text that would be consistent with the definition of “basic patent” at

Article 20.27 of CETA. There was no reason to conclude that subsection 3(2), as it was intended to be read and applied by the legislator, is inconsistent with Canada’s obligation under

Article 20.27. A patent that protects the product (i.e. the active ingredient) as such is consistent with the requirement that there be a claim for the medicinal ingredient; that is, a claim which defines the subject matter of the invention as the medicinal ingredient or the combination of medicinal ingredients. STATUTES AND REGULATIONS CITED Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act, S.C. 2017, c. 6, ss. 3 , 7 . Certificate of Supplementary Protection Regulations , SOR/2017-165, ss. 2 , 3(2) European Community.

Regulation (EC) No. 469/2009 of the European Parliament and of the Council of May 6 2009, concerning the supplementary protection certificate for medicinal products , [2009] OJ L 152/1. Food and Drug Regulations, C.R.C., c. 870 , ss. 2, C.08.001, C.08.004, C.08.004.1(1),(3), C.08.004.01. Patent Act , R.S.C., 1952 c. 203, s. 41. Patent Act , R.S.C., 1985, c. P-4, ss. 12(1) (g),(h),(k), 55.2 , 104 –112, 104–134, 105, 106(1),(4), 115, 116, 134(1).

Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2(1) “claim for the formulation”, “claim for the medicinal ingredient”, “claim for the use of the medicinal ingredient”, 2(2), 4(2). TREATIES AND OTHER INSTRUMENTS CITED Comprehensive Economic and Trade Agreement between Canada and the European Union and its Member States , done at Brussels on October 30, 2016, Arts. 20.1, 20.2, 20.6, 20.27.

CASES CITED APPLIED: Canada (Minister of Citizenship and Immigration) v. Vavilov, 2019 SCC 65, [2019] 4 S.C.R. 653, 441 D.L.R. (4th) 1; Re Rizzo & RizzoShoes Ltd., (SCC), [1998] 1 S.C.R. 27, (1998), 36 O.R. (3d) 418, 154 D.L.R. (4th) 193; Bell ExpressVu LimitedPartnership 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. DISTINGUISHED: ViiV Healthcare ULC v. Canada (Health), 2020 FC 756. CONSIDERED: Bayer Inc. v.

Canada (Health), 2009 FC 1171, 79 C.P.R. (4th) 1, affd 2010 FCA 161, 86 C.P.R. (4th) 81; Hoffmann-La Roche Ltd. v.Canada (Minister of National Health & Welfare) (1995), 62 C.P.R. (3d) 58, [1995] F.C.J. No. 985 (QL) (T.D.), affd (1995), 67 C.P.R.(3d) 25, [1995] F.C.J. No. 1775 (QL) (C.A.), leave to appeal to S.C.C. refused [1996] 3 S.C.R. xi; Glaxosmithkline Biological S.A. v.Comptroller-General of Patents, Designs and Trade Marks, [2013] EUECJ C-210/13 (BAILII); Commissioner of Patents v. FarbwerkeHoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, (SCC), [1964] S.C.R. 49, (1963), 41 C.P.R. 9.

REFERRED TO: Agraira v. Canada (Public Safety and Emergency Preparedness), 2013 SCC 36, [2013] 2 S.C.R. 559; Entertainment SoftwareAssociation v. Society of Composers, Authors and Music Publishers of Canada, 2020 FCA 100, [2020] 1 F.C.R. 374; MassachusettsInstitute of Technology, [2006] EUECJ C-431/04 (BAILII); Glaxosmithkline Biologicals S.A, [2012] UKInteIP o50612 (BAILII);Deprenyl Research Ltd. v. Apotex Inc. (1994), 55 C.P.R. (3d) 171, [1994] F.C.J. No. 542 (QL) (T.D.), affd (1995), 60 C.P.R. (3d) 501,[1995] F.C.J. No. 532 (QL) (C.A.); Actavis Group PTC EHF et al. v. Boehringer Ingelheim Pharma GmbH & Co.

KG, [2015] EUECJC-577/13 (BAILII). AUTHORS CITED Canada. Parliament. Senate. Proceeding of the Standing Senate Committee on Foreign Affairs and International Trade, Evidence, 42ndParl., 1st Sess., Issue No. 23 (May 4, 2017) (Chair.: A. Raynell Andreychuk). Health Canada. Guidance Document. “Harmonized Requirements for the Licensing of Vaccines and Guidelines for the Preparation of anApplication”, Minister of Public Works and Government Services Canada, 2016. Oxford English Dictionary Online, Oxford University Press, sub verbo “claim”. Regulatory Impact Analysis Statement, SOR/2006-242, C. Gaz. 2006.II.1510.

Regulatory Impact Analysis Statement, SOR/2017-165, C. Gaz. 2017.II.6 (Extra No. 1). Sullivan, Ruth. Ruth Sullivan on the Construction of Statutes, 6th ed., Markham, Ontario: Lexis Nexis, 2014. Uexküll, Alexa von and Oswin Ridderbusch, European SPCs Unravelled: A Practitioner’s Guide to Supplementary ProtectionCertificates in Europe, Wolters Kluwer, 2018.

APPEAL from a Federal Court decision (2020 FC 397, 173 C.P.R. (4th) 362) setting aside the Minister of Health’s decision refusing toissue a certificate of supplementary protection to the respondent in respect of Canadian Patent No. 2600905 and the drug SHINGRIX.Appeal allowed. APPEARANCES J. Sanderson Graham, Abigail Browne and Charles Maher for appellant. Kristin Wall, Morgan Westgate and Colin Hyslop for respondent. SOLICITORS OF RECORD Deputy Attorney General of Canada for appellant. Norton Rose Fulbright Canada LLP, Toronto, for respondent.

The following are the reasons for judgment rendered in English by [1] Gauthier J.A.: This is an appeal from the Federal Court decision (per Barnes J., Glaxosmithkline Biologicals S.A. v. Canada(Health), 2020 FC 397, 173 C.P.R. (4th) 362) (F.C. decision) setting aside the Minister of Health’s decision refusing to issue a certificateof supplementary protection (CSP) to GlaxoSmithKline Biologicals S.A. (GSK) in respect of Canadian Patent No. 2600905 (′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 medicinalingredient or combination of all the medicinal ingredients” under subsection 3(2) of the Certificate of Supplementary ProtectionRegulations, SOR/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 AS01 B 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 (AB), Vol. 1, at page 111, 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, Vol. 1, at page 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, SOR/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) [ C.

Gaz. 2017.II.6 (Extra No. 1)] and the Health Canada Guidance Document on the CSP Regulations, the Minister held that her position in that respect is consistent with the Comprehensive Economic and Trade Agreement between Canada and the European and its Member States , done at Brussels on October 30, 2016 (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:

Article 20.1 – 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 subsection 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 : Purpose 7 … (

f) provide 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 limits 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): Application 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: (

a) the patent is not void and it meets any prescribed requirements; … (

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;

(

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; (

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. [ 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 …. Eligible patents — manners of pertinence to medicinal ingredients

(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: (

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; (

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 (

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. [ 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) [ C. Gaz . 2017.II.6 (Extra No. 1), at page 14]: Rationale 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, Proceedings of the Standing Senate Committee on Foreign Affairs and International Trade, Evidence, 42nd Parl., 1st Sess., Issue No. 23 (4 May 2017) (Chair.: 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: 1. Is the Minister’s

interpretation and application of the term “medicinal ingredient” reasonable? 2. 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 toapply. This is consistent with the Vavilov framework, because the presumption of reasonableness applies when no exception calls forderogation from that standard, as in this case (Canada (Minister of Citizenship and Immigration) v. Vavilov, 2019 SCC 65, [2019] 4S.C.R. 653, 441 D.L.R. (4th) 1, at paragraph 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 assesswhether it applied it correctly. In performing this exercise, our Court must focus on the administrative decision rather than the decision ofthe reviewing court; our Court effectively steps in the shoes of the Federal Court (Agraira v. Canada (Public Safety and EmergencyPreparedness), 2013 SCC 36, [2013] 2 S.C.R. 559, at paragraph 46).

As mentioned, I must now assess whether the Minister’sconstruction of the expressions “medicinal ingredient” and “claim for the medicinal ingredient” is reasonable. I will deal first with theexpression “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 thestatute in their context harmoniously with the scheme and object of the legislation at issue and the intention of Parliament (Re Rizzo &Rizzo Shoes Ltd., (SCC), [1998] 1 S.C.R. 27, (1998), 36 O.R. (3d) 418, 154 D.L.R. (4th) 193; Bell ExpressVu LimitedPartnership 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 asall the information available as to the intention of Parliament. There is no need to repeat it. I have reviewed all the relevant transcripts ofdebates 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 isused abundantly in the new sections 104 to 112 of the Patent Act.

As will be mentioned later on, this expression is also used in thePMNOC Regulations issued pursuant to

section 55.2 of the Patent Act. The expression is further found in a few instances in the Foodand Drug Regulations,

Part C, Division 8, C.08.001 “New Drugs” in the definition of “pharmaceutical equivalent” and C.08.004.1(1) inthe 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, 79 C.P.R. (4th) 1 (Bayer), affirmed in 2010 FCA 161, 86 C.P.R. (4th) 81, which has since been used in the case law. GSKagrees that, although used in the context of the PMNOC Regulations, this definition can and should be used for construing the CSPRegulations.

As will be discussed, both sides rely on the same words used in Bayer to reach a different conclusion as to what “medicinalingredient” means in this case. As a matter of first impression, this may indicate that both parties’

interpretations may be consistent withthe 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 medicinalingredients could be listed under the PMNOC Regulations (subsection 4(2)) as it read after the 2006 amendments), in respect of a drugcontaining 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: 2 (1) … claim for the formulation means a claim for a mixture that is composed of medicinal and non-medicinal ingredients, that is contained ina drug and that is administered to a patient in a particular dosage form; (revendication de la 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 theirobvious chemical equivalents, and also includes a claim for different polymorphs of the medicinal ingredient, but does not includedifferent chemical forms of the medicinal ingredient; (revendication de l’ingrédient médicinal) … 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’ingrédientmédicinal) [42] It is important to note that there was no dispute in Bayer that both ingredients claimed in the formulation were medicinalingredients (Bayer, at paragraph 68), nor was there a dispute as to the meaning of “medicinal ingredient” (Bayer, at paragraph 67).

TheFederal Court had to consider the new definition of “formulation” as this term was introduced for the first time in the 2006 version of thePMNOC Regulations in the definition of “claim for the formulation” under subsection 2(1) of the said Regulations. [43] It is clear that the Federal Court in Bayer relied on the 2006 PMNOC Regulations [SOR/2006-242] RIAS to say that “medicinalingredient” refers to the substance in the formulation, which, once administered, is responsible for the drug’s desired effect in the body(Bayer, at paragraphs 21, 86 and 88). [44] In the course of its analysis, and while discussing the difference between a compound patent and a formulation patent, theFederal Court described the compound patent as containing a claim for the approved medicinal ingredient which is the key active part ofthe drug formulation (Bayer, at paragraph 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, Vol. 1, at page 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, Vol. 1, at page 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, Vol. 1, at pages 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 (F.C. decision, at paragraph 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 (F.C. decision, at paragraph 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 , [2020] 1 F.C.R. 374 , at paragraph 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 (EC) No. 469/2009 of the European Parliament and of the Council of May 6, 2009, concerning the supplementary protection certificate for medicinal products , [2009] O.J. L. 152/1) [European Regulation] (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 ed., 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) (1995), 62 C.P.R. (3d) 58, [1995] F.C.J. No. 985 (QL) (T.D.) ( Hoffmann ) , affd (1995), 67 C.P.R. (3d) 25, [1995] F.C.J. No. 1775 (QL) (C.A.) , leave to appeal to SCC refused, 25136 (12 September 1996) [[1996] 3 S.C.R. xi]). 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 [SOR/2015-169, s. 2], 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 (E.C.J.) 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 E.C.J., 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 [[2006] EUECJ C-431/04 (BAILII)] ( 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.

Comptroller- General of Patents, Designs and Trade Marks , case C-210/13, 14 November 2013 [[2013] EUECJ C-210/13 (BAILII)] ( 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 [[2012] UKIntelP o50612 (BAILII)], at paragraphs 3 and 27–31). GSK applied to the Patents Court of England and Wales, who referred the matter to the E.C.J.

The E.C.J. 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 paragraph 28). This was the definition adopted by the E.C.J. in MIT . In the E.C.J.’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 paragraph 29). The E.C.J. held that the “active ingredient” does not cover a substance that does not have any therapeutic effect on its own ( Glaxo , at paragraph 30).

It also stated at paragraph 32 that the fact “that the substance without any therapeutic effect of its own renders possible a pharmaceutical form of the medicinal product necessary for the therapeutic efficacy of the substance which does not have therapeutic effect cannot invalidate that

interpretation” (my emphasis). [ 62 ] The E.C.J. then concluded at paragraph 45 that “just as an adjuvant does not fall within the definition of ‘active ingredient’ within the meaning of [article 1(b)], so a combination of two substances, namely an active ingredient having therapeutic effect on its own, and an adjuvant which, while enhancing those therapeutic effects, has no therapeutic effect on its own, does not fall within the definition of ‘combination of active ingredients’” .

This essentially confirmed the definition given to “active ingredient” back in 2006 in MIT . [ 63 ] Although the parties referred to other authorities, I do not consider it necessary to deal with them for I am satisfied that the construction adopted by the Minister is consistent with CETA and with the

interpretation of medicinal ingredient applied under our domestic legislation pertaining to pharmaceutical products. I ought to mention that consistency does not mean that the Canadian system must be identical to the system that was already in place in the European Union. Nor should it be inferred from these reasons that foreign case law binds Canadian courts in any way. This is simply not so. [ 64 ] To conclude on this line of reasoning, given the

interpretation adopted by the Federal Court and the arguments put forth by GSK, I am prepared to accept that there is not only one possible reasonable

interpretation of the expression “medicinal ingredient” . That said, in such circumstances, it is not for reviewing courts to choose the one they prefer or that they find the most logical from their point of view.

This is not what the applicable standard of review calls for. [ 65 ] Although the above goes a long way in dealing with the reasonableness of the Minister’s decision in respect of whether the adjuvant in this matter is a medicinal ingredient, I will deal with the other arguments raised before the Minister by GSK. [ 66 ] I will also say a few words about the view expressed by the Federal Court, which GSK adopted before us, that in this case, the Minister adopted tunnel vision unduly based on administrative efficiency and a “perceived need for administrative consistency” to “the exclusion of several highly relevant considerations” (F.C. decision, at paragraphs 29–33). [ 67 ] First, there is a definite link in the CSP Regulations between the medicinal ingredient listed in the NOC issued by Health Canada for SHINGRIX and the medicinal ingredient referred to at paragraph 106(1) (

c) of the Patent Act (see subsection 106(4) ). The medicinal ingredient referred to in the Patent Act and CSP Regulations is the medicinal ingredient listed in the authorization for sale, i.e. the NOC issued under the Food and Drug Regulations ,

section C.08.004 or C.08.004.01. [ 68 ] As mentioned earlier, the NOC for SHINGRIX listed only one medicinal ingredient, the antigen. This is the sole medicinal ingredient for which GSK had applied for a CSP. I therefore see no reviewable error in the Minister’s perceived desire for consistency

between the two regimes. It is unfair to characterize her approach as based on unwarranted tunnel vision. [ 69 ] In fact, the Minister had to offer a coherent and consistent treatment of the same subject i.e. what is the “medicinal ingredient” in the drug at issue. [ 70 ] It is obvious that the administrative classification of adjuvants is a non-binding administrative policy; it cannot supplant the words of the legislation. But as mentioned, this is not what has happened here. The Minister adopted a reasonable

interpretation of the words “medicinal ingredient” and made a scientific determination that in this case, 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 issued under the Food and Drug Regulations , the medicinal ingredient referred to in the application for a CSP and the Patent Act . [ 71 ] Thus, whether or not in other contexts one regulatory regime may influence another is irrelevant.

It all depends on the particular facts of the matter. In this case, there is no doubt that the link between these two regulatory regimes is established. [ 72 ] GSK had raised inconsistencies between the Minister’s position on its application and an email received from the Minister, and with the content of the SHINGRIX Product Monograph that the Minister approved. In her reasons, the Minister deals with each of these, and I have not been persuaded that her position on these issues was unreasonable in any respect.

In fact, the Minister was responsive to all the concerns expressed by GSK in its submissions before her and it is evident that she considered the scientific opinion and evidence that GSK put forward. [ 73 ] I find the following passage from Vavilov especially instructive as to inform a reviewing court on the manner it should approach a situation like the one before us [at paragraph 93]: An administrative decision maker may demonstrate through its reasons that a given decision was made by bringing that institutional expertise and experience to bear: see Dunsmuir , at para. 49.

In conducting reasonableness review, judges should be attentive to the application by decision makers of specialized knowledge, as demonstrated by their reasons. Respectful attention to a decision maker’s demonstrated expertise may reveal to a reviewing court that an outcome that might be puzzling or counterintuitive on its face nevertheless accords with the purposes and practical realities of the relevant administrative regime and represents a reasonable approach given the consequences and the operational impact of the decision.

This demonstrated experience and expertise may also explain why a given issue is treated in less detail. [ 74 ] This leads me to the next point; that is, that the Minister’s decision was unreasonable because it does not address specifically the consistency of her

interpretation with CETA, particularly the meaning of “active ingredient” and the general purpose of the CSP Regulations . [ 75 ] As mentioned earlier, GSK never raised expressly the issue of “active ingredient” in CETA being different from “medicinal ingredient” in the CSP Regulations . It simply referred generally to the overall purpose of

Article 20.27 and of the CSP Regulations . Thus, there was no express need to discuss this in the Minister’s reasons with respect to what was (were) the medicinal ingredient(

s) in SHINGRIX other than to respect the criteria of justification discussed in Vavilov . As noted in Vavilov at paragraphs 119 and 120 , although the merits of an administrative decision maker’s

interpretation must be consistent with the text, context and purpose of the legislative provisions, he or she is not required to engage in a formalistic statutory

interpretation exercise in every case. In fact, as mentioned by the Supreme Court, like other aspects of the reasonableness review, the key question remains whether the omitted aspect of the analysis causes the reviewing court to lose confidence in the outcome reached by the decision maker ( Vavilov , at paragraph 122 ). [ 76 ] In this particular case, the lack of an express reference to CETA with regard to her

interpretation of medicinal ingredient does not make me lose confidence in the reasoning of the Minister and the conclusion she reached. This is especially so considering that, as will be discussed in the next

section of my analysis, she did refer to the RIAS and was thus clearly aware of the objective and rationale spelled out in it. [ 77 ] Before addressing the second question before us, I wish to note that the present case may be quite different from the one before the Federal Court in ViiV Healthcare ULC v. Canada (Health) , 2020 FC 756 , which GSK relies on. In that case, it appears that the Minister failed to grapple with quite specific submissions made before her on the issues referred to in paragraphs 26 to 28 of the reviewing court’s decision.

In addition, I have a specific concern, similar to that mentioned in paragraph 52 above, regarding the use of terminology in that case. It is not clear to me that the reviewing court was as careful as it should have been in its choice of words. At paragraph 26 of its decision (see also paragraph 18), it stated that it was persuaded by the view that the patent at issue “protects the product (i.e. JULUCA) as such” and that this view “is not inconsistent on its face with CETA” .

However, JULUCA was the drug or pharmaceutical product and not the product i.e. medicinal ingredient or combination of the medicinal ingredients in this drug or pharmaceutical product. As this matter is not before us, I will not comment on whether or not this wording resulted from a misunderstanding or was simply a lack of precision in the wording used. Moving forward, reviewing courts must be careful as these kinds of errors can have serious consequences and distort the meaning intended by Parliament. [ 78 ] At this stage, I have not identified any reviewable error that would justify our intervention.

I will therefore examine the second issue before us. B. Subsection 3(2) of the CSP Regulations and the formulation in the ′905 Patent [ 79 ] The second reason given by the Minister for refusing the issuance of a CSP was that the ′905 Patent did not pertain to the antigen, i.e. the medicinal ingredient, within the meaning of subsection 3(2) of the CSP Regulations . [ 80 ] GSK described this as a core issue in its oral arguments before us.

However, its arguments before the Minister in that respect were quite limited and mostly interconnected with those advanced with respect to what a “medicinal ingredient” is within the meaning of the CSP Regulations .

[81] This is especially so considering that, having received the preliminary decision of the Minister on April 10, 2018 (AB, Vol. 1, atpages. 261–267), GSK was fully aware that: (

i) The Minister considered its claim as directed to a formulation; i.e. a mixture composed of medicinal and non-medicinal ingredients; (ii) The only medicinal ingredient described on its NOC, the antigen, was not claimed as such under the ′905 Patent as it was disclosedin EP0405867 and EP192902 (see description in the ′905 Patent, AB, Vol. 1, at pages 186–187 and 266). [82] In its written representations to the Minister, as mentioned, GSK submitted that the ′905 Patent did not claim a formulation, butrather a composition that was itself a combination of medicinal ingredients.

Its claims did not include non-medicinal ingredients, as boththe antigen and its proprietary adjuvant system (a single structure) were medicinal ingredients (AB, Vol. 5, at pages 1046–1047). [83] It argued that there was nothing in the grammatical and ordinary sense of the words in subsection 3(2) of the CSP Regulationsthat excluded claim 1 of the ′905 Patent. For GSK, it qualified as a claim for the medicinal ingredient or a combination of medicinalingredients.

Also, other claims could be viewed as for the use of such medicinal ingredient in the preparation of a medicament againstshingles for people of 50 years of age or older, and those with an immunocompromised system (AB, Vol. 5, at page 1049). According toGSK, this

interpretation is consistent “with the object and purpose of the CSP Regulations to provide an additional period of protectionfor drugs containing new medicinal ingredients, like SHINGRIX, in order to compensate for the time such drugs spend in research anddevelopment and obtaining marketing authorization” (my emphasis). GSK did not dispute that the antigen had already been disclosedand could not therefore be claimed as a compound. [84] In the circumstances, it is not surprising that the Minister did not go into an elaborate statutory analysis of the wording ofsubsection 3(2) in her decision.

In my view, on a fair reading of the decision, she did consider all the arguments put forth by GSK, eventhough they are not all grouped under the same heading given their interconnection with the determination of what was the medicinalingredient in SHINGRIX. [85] First, as already mentioned, the Minister made it clear that the claims included many non-medicinal ingredients. Apart from theadjuvant enhancers per se—QS21 and 3D-MPL, there were other non-medicinal ingredients such as cholesterol (see last paragraph inAB, Vol. 1, at page 57 and at paragraph 48 above).

She then clearly found that the claim at issue was for a formulation within thegenerally understood meaning of such claims i.e. a mixture of medicinal and non-medicinal ingredients. The use claims were directed tosuch formulations only. As will be explained later on, previous case law used this definition of formulation before it was included in thedefinitions of the 2006 version of the PMNOC Regulations (see paragraph 41 above). In fact, GSK itself had made reference to one ofthose decisions, Hoffmann, in its submissions (see AB, Vol. 7, at page 1687, footnote 15).

In the Minister’s view, there was no provisionin subsection 3(2) that made claims for a formulation sufficient to be eligible. [86] With respect to GSK’s argument that there was no legislative reference to exclude certain types of claims from CSP eligibility,the Minister expressly states that she disagrees and that her reading of subsection 3(2) was confirmed by the RIAS. The Minister alsorelied on a clear passage to that effect in the Health Canada Guidance Document dealing with the CSP Regulations, at page 17, whichconfirmed her understanding.

She finally noted, quoting the RIAS, that this was understood to be consistent with the wording in CETAwhich includes the expression “as such”. [87] I have already summarized the legislative background and will not repeat it at length here. [88] The word “claim” has many ordinary meanings. Among its dictionary

definitions, the most appropriate here is “a right or title tosomething” (Oxford English Dictionary Online, Oxford University Press, sub verbo “claim”). [89] Obviously, when one construes the words used, one has to consider their particular context. Here, subsection 27(4) of the PatentAct provides that claims in a patent are meant to define distinctly and in explicit terms “the subject matter of the invention” for which anexclusive privilege or property is claimed. [90] The CSP Regulations prescribe the criteria to determine whether a patent pertains to the medicinal ingredient or the combinationof medicinal ingredients as required at paragraph 106(1)(

c) of the Patent Act. It is important here to recall that this new

section of thePatent Act is entitled “Supplementary Protection for Inventions—Medicinal Ingredient” (my emphasis). [91] In this context, the following patent law concepts are well understood and have been often used in the case law: product claims,product-by-process claims, formulation or composition claims and use claims. Today, there is rarely a need for one to explain what onemeans when referring to those expressions. This was so, even before the Governor in Council included

definitions of “claim for medicineitself ” or “claim for use of the medicine” in the 1993 version of the PMNOC Regulations and “claim for the formulation”, as well as“claim for the medicinal ingredient” in the 2006 version of the said Regulations; but when it did so, it gave rise to many judicialdecisions which helped the Governor in Council refine those expressions. As will be explained, this case law can to a certain extent beuseful here—just as Bayer was useful in providing a definition of active or medicinal ingredient.

The object of these regulations may bedifferent but they have a link (see the numerous references to CSPs added to the PMNOC Regulations as part of the implementation ofCETA). [92] In this context, it would appear somewhat straightforward to say that a claim for a medicinal ingredient or a combination of allthe medicinal ingredients would normally be understood as a claim for these compounds (products claims).

Or they could be understood,given the particular history of medicines which were the subject of restrictions as to how they could be claimed under the Patent Act inthe past, as including product-by-process claims (see for example

section 41 of the Patent Act, R.C.S. 1952 c. 203 as discussed inCommissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, (SCC), [1964]S.C.R. 49, (1963), 41 C.P.R. 9 [Farbwerk]). In such claims, the “medicinal substance” (wording from Farbwerke) had to be defined interms of the process by which they were made. [93] When paragraph 3(2)(

a) is read alongside paragraphs 3(2)(

b) and (c), one would conclude that paragraph 3(2)(

a) does not includea product-by-process claim for the medicinal ingredients for these are expressly covered by paragraph (b).

[ 94 ] A claim for the use of a medicinal ingredient or a combination of all medicinal ingredients is also a well-understood concept. They include Swiss-type claims and are particularly helpful when the compounds are already known and the subject matter of the invention is the new use. [ 95 ] Given this enumeration at subsection 3(2), and the fact that unless listed, another specific type of claim will not be sufficient to qualify a patent in the prescribed manner, I do not believe that it was incumbent on the legislator to exclude expressly from eligibility patent claims directed to a formulation.

It would have certainly been easier for our statutory analysis, but it is not a sufficient reason in itself to find that the Minister’s conclusion is unreasonable or to disregard the explanations in the RIAS as evidence of the legislative intent (F.C. decision, at paragraph 44). [ 96 ] Courts have been quite capable of excluding pure process claims or other types of claims (such as claims for intermediate compounds) from the definition of “claims for the medicine” without the need for express exclusions (see for example Deprenyl Research Ltd. v. Apotex Inc. (1994), 55 C.P.R. (3d) 171, [1994] F.C.J.

No. 542 (QL) (T.D.) , affd (1995), 60 C.P.R. (3d) 501, [1995] F.C.J.

No. 532 (QL) (C.A.) and Hoffmann , at page 74 [paragraph 48]). [ 97 ] Courts have also been capable of including compositions or formulation claims when the wording of the subject matter of the claim enabled them to do so. [ 98 ] This is exactly what happened in Hoffmann when the Federal Court (confirmed by our Court) had to determine whether a claim for a composition of active and non-active ingredients in an approved drug was a “claim for the medicine itself” . [ 99 ] I will start by noting that in Hoffmann the expressions “formulation claim” and “composition claim” were used interchangeably .

There was no issue that both expressions referred to a claim for a mixture of active and non-active ingredients ( Hoffmann , at page 72 [paragraph 42]). What mattered was whether the claim was for the medicine ( médicament ). Using the modern approach to statutory

interpretation, Noël J. (as he then was) concluded that “medicine” was not used in contradistinction to “drug” . Rather, the word medicine was used to exclude a disinfectant, which would be included in the definition of drug at

section 2 of the Food and Drug Regulations ( Hoffmann , at pages 69 and 74 [paragraphs 37 and 47]). As the word “medicine” could refer either to the active ingredient itself or to the approved drug containing it, a claim to the formulation or composition, i.e. the mixture of active and inactive ingredients included in the approved drug, was a claim for the medicine. [ 100 ] This

interpretation was adopted in all cases until 2006, when as mentioned earlier, the PMNOC Regulations were amended to clarify certain matters. Among those was the acknowledgment of the distinction between a claim for a medicinal ingredient (i.e. as explained, the active ingredient in a drug or pharmaceutical product) and a claim for a formulation, i.e. a mixture composed of medicinal and non-medicinal ingredients in an approved drug. This even though the legislator agreed to keep both types of claims within the scope of the PMNOC Regulations . It is clear from the relevant RIAS that the new

definitions were intended to bear their established meaning under the extensive body of case law interpreting “claim for the medicine itself” (RIAS, SOR/2006-242, Canada Gazette , Vol. 140, No. 21, at page 1516). [ 101 ] Thus, given that I have already determined that it was reasonable for the Minister to conclude that the only medicinal ingredient here is the antigen, it also appears reasonable at this stage of the analysis (words read in context) to conclude that a claim for the medicinal ingredient refers only to a claim for the antigen and not a mixture of ingredients in an approved drug. [ 102 ] The object and purpose of the CSP Regulations is not really in dispute.

Nor is the purpose of the new

section in the Patent Act . Those are clearly spelled out in the RIAS to which the Minister refers in her decision. It would be difficult, if not improper to presume that the Minister did not consider the RIAS because she does not recite it at length.

The said RIAS starts by stating the following: Issues The Certificate of Supplementary Protection Regulations (the Regulations ) are required, in conjunction with amendments to the Patent Act in the Canada -European Union Comprehensive Economic and Trade Agreement Implementation Act , to establish an additional period of protection for drugs containing a new medicinal ingredient, or a new combination of medicinal ingredients, protected by an eligible patent.

The legislative and regulatory changes are required to meet Canada’s commitment under the Canada -European Union Comprehensive Economic and Trade Agreement (CETA). Background In order to meet Canada’s CETA obligations, the Patent Act (the Act) was amended to create a framework for the issuance and administration of certificates of supplementary protection (CSP), for which patentees with patents relating to human and veterinary drugs may apply.

As set out in the Act, the new CSP regime, which will be administered by the Minister of Health (Minister), will provide additional protection from the date of the expiry of the eligible pharmaceutical patent based on the first authorization for sale of a drug containing a new medicinal ingredient or combination of medicinal ingredients in Canada. This new protection, which is intended to partly compensate for time spent in research and obtaining marketing authorization, provides patent -like rights in respect of drugs containing the same medicinal ingredient or combination.

The scope of protection can be no broader than the scope of protection afforded by the patent set out in the CSP, and is subject to the same limitations and exceptions as the patent. [ 103 ] In its submissions to the Minister, GSK only referred to the RIAS to argue that its

interpretation was consistent with the object and purpose pertinent to construing subsection 3(2) (AB, Vol. 7, at page 1685). [ 104 ] What the Minister expressly referred to as evidencing the intention of the legislator (here the Governor in Council) is the

section of the RIAS dealing with patent eligibility which deals more specifically with the issue before her. [ 105 ] In this section, the RIAS makes it clear that there is no need for the patent to protect the medicinal ingredient that was approved, but only that it protect what is described as “the same medicinal ingredient” in the RIAS (AB, Vol. 7, at page 1472,

section 105 of the Patent Act , and

section 2 of the CSP Regulations).

[ 106 ] I understand this to mean that, as explained at page 8 of the RIAS (see AB, Vol. 7, at page 1470) under the

section entitled “Same medicinal ingredients” , if the approved medicinal ingredient only differs from the claimed medicinal ingredient with respect to a minor variation such as an enantiomer or an appendage (e.g. ester or salt) within a particular molecular structure, it is nevertheless eligible for a CSP. The same concept applies to use claims and product-by-process claims.

I need not discuss the comments made in respect of combinations of medicinal ingredients as they are not relevant here. [ 107 ] The RIAS also mentions that pure process claims do not make the patent eligible, as they do not protect “the product” —which, as discussed above, means the “active ingredient or combination of active ingredients” under CETA.

This is an understanding that would also be derived from case law mentioned earlier. [ 108 ] The RIAS then states: Also, claims that are directed to a formulation containing the medicinal ingredient, including compositions, preparations or similar claim types, do not make a patent eligible for a CSP. A claim to a formulation does not protect the medicinal ingredient or combination of medicinal ingredients per se. A claim to a formulation may be directed, for example, to the improvement of the stability of medicinal ingredients.

This is consistent with CETA, which only requires the protection of the medicinal ingredient or combination of medicinal ingredients when claimed “as such.” [ 109 ] The first sentence expresses very clearly a legislative intention in line with the meaning derived from the words used in subsection 3(2) read in their context. [ 110 ] I note that the Federal Court appears to somewhat criticize the use of the words “ per se ” in this

section of the RIAS stating that there are no such express words in the statutory provisions

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