2010 FCA 334, 2010 FCA 334

[2012] 2 F.C.R. 618 2010 FCA 334 A-352-09 Apotex Inc. ( Appellant ) v. The Minister of Health and the Attorney General of Canada ( Respondents ) and Eli Lilly Canada ( Respondent ) A-360-09 Canadian Generic Pharmaceutical Association ( Appellant ) v . The Attorney General of Canada and the Minister of Health ( Respondents ) and Canada’s Research-Based Pharmaceutical Companies ( Respondent ) Indexed as: Canadian Generic Pharmaceutical Association v. Canada (Health) Federal Court of Appeal, Nadon, Sharlow and Layden-Stevenson JJ.A.—Toronto, June 7; Ottawa, December 9, 2010.

Food and Drugs –– Appeals from Federal Court decision dismissing judicial review applications of appellants seeking declaration that Food and Drugs Act , s. 30(3) , Food and Drug Regulations , s.

C.08.004.1 (Data Protection Regulation (DPR)) ultra vires, without legal force, effect — Federal Court declaring DPR intra vires federal Parliament — Whether DPR properly delegated by Parliament to Governor in Council — Principle that Parliament having broad power to delegate by regulations, subject to scope of enabling legislation, maintained — Act, s. 30(3) granting Governor in Council authority to enact regulations deemed necessary to implement North American Free Trade Agreement, Art. 1711, Agreement on Trade-Related Aspects of Intellectual Property Rights, Art. 39, paragraph 3 regarding protection of innovator’s specified data — DPR therefore properly delegated by Parliament to Governor in Council — Act, s. 30(3) giving broad latitude to Governor in Council to devise means by which treaty provisions to be implemented — DPR in clear accord with enabling provision — Therefore, DPR intra vires Governor in Council’s authority pursuant to Act, s. 30(3) — Appeals dismissed.

Constitutional Law — Distribution of Powers — Appellants seeking declaration that Food and Drugs Act , s. 30(3) , Food and Drug Regulations , s.

C.08.004.1 (Data Protection Regulation (DPR)) ultra vires, without legal force, effect — Whether DPR intra vires federal legislative competence pursuant to Constitution Act, 1867, ss. 91(2) , 91(27) or residual peace, order, good government power — Federal Court wrong in concluding that DPR, in pith, substance constituting exercise of trade, commerce power; wrong in determining pith, substance of DPR without situating DPR within overall scheme of which becoming part thereof — Purpose of Regulations to protect public health, safety — DPR’s true purpose to ensure Canadians having reasonable access to new, safe and effective drug at reasonable prices — DPR not separable from overall scheme of criminal law (protection of public health, safety) found in Regulations to which contributing; forming integral part of overall scheme to protect public health, safety — Therefore, DPR rationally, functionally connected to federal legislative scheme for new drug approval.

These were appeals from a Federal Court decision dismissing the judicial review applications of the appellants seeking a declaration that subsection 30(3) of the Food and Drugs Act and

section C.08.004.1, the Data Protection Regulation (DPR), of the Food and Drug Regulations were ultra vires and without legal force and effect. The Federal Court declared the DPR intra vires the federal Parliament. More particularly, it found the DPR to be intra vires Parliament’s power to make laws respecting trade and commerce under subsection 91(2) of the Constitution Act, 1867 and that the provision was valid because it is both rationally connected to its enabling provision (subsection 30(3) of the Act) and a permissible sub-delegation to the Governor in Council by Parliament.

Subsection 30(3) of the Act grants the Governor in Council authority to enact regulations that are deemed necessary for the purpose of implementing specified data protection provisions of the North American Free Trade Agreement (NAFTA) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The DPR introduces a period of market exclusivity for manufacturers of innovative drugs by imposing an eight-year moratorium on the approval of the marketing of generic copies of previously-approved new drugs.

The issues were whether (1) the DPR was properly delegated by Parliament to the Governor in Council pursuant to the permissible sub- delegation of treaty implementation responsibilities and, if so, whether the DPR was intra vires the authority of the Governor in Council pursuant to subsection 30(3) of the Act and (2) whether the DPR was intra vires federal legislative competence pursuant to subsections 91(2) , 91(27) or the residual peace, order and good government power of the Constitution Act, 1867 . Held , the appeals should be dismissed.

There was no basis to depart from the principle enunciated by the Supreme Court of Canada in Gray (in re) that Parliament has a broad power to delegate by way of regulations, subject to the scope of the enabling legislation. In the present case, subsection 30(3) of the Act grants the Governor in Council authority to make such regulations as the Governor in Council deems necessary so as to implement, in relation to drugs,

Article 1711 of NAFTA or paragraph 3 of

Article 39 of TRIPS. There was no evidence that subsection 30(3) negates

Parliament’s ability to revoke or nullify the authority given to the Governor in Council or to do the same as regards the DPR enactedpursuant to the enabling legislation. The DPR was therefore properly delegated by Parliament to the Governor in Council. The DPR is in clear accord with the enabling provision. It is a regulation, the purpose of which is to implement, in relation to drugs,Article 1711 of NAFTA and paragraph 3 of

Article 39 of TRIPS. These provisions seek to provide protection to innovators in respect of“undisclosed test or other data” that they must provide to government entities in order to obtain approval for their new drugs. Marketexclusivity, conferred by the DPR on an innovator, is the means chosen by the Governor in Council to give effect to the relevantprovisions of NAFTA and TRIPS. More particularly, the DPR is a step taken by the Governor in Council to ensure that the data areprotected against unfair commercial use.

The terms of subsection 30(3) give very broad latitude to the Governor in Council to devise themeans by which the treaty provisions will be implemented. The DPR is thus intra vires the authority of the Governor in Council pursuantto subsection 30(3) of the Act. The Federal Court wrongly concluded that the DPR is, in its pith and substance, an exercise of the trade and commerce power. It waswrong in principle to determine the pith and substance of the DPR by referring to the language of the regulation itself and its enablinglegislation, without situating the DPR within the overall scheme of which it became a part.

Parliament chose not to enact subsection30(3) of the Act as a stand-alone statute but as an amendment to the Act, an existing statute that has long been accepted asconstitutionally valid. Thus, the critical question was whether subsection 30(3), and thus the DPR, was a valid exercise of theconstitutional authority for the Act. The DPR was introduced to implement

Article 1711 of NAFTA and paragraph 3 of

Article 39 ofTRIPS so as to encourage the development of new drugs. It is a mechanism deemed necessary to balance the effects of the regulatoryscheme set forth in the Regulations, the purpose of which is to protect public health and safety. The Federal Court erred in failing toconsider the entire context in which the DPR finds itself. The true purpose of the DPR is not to balance the commercial interests ofinnovators and generic drug manufacturers but rather to ensure that Canadians have reasonable access, at reasonable prices, to new, safeand effective drugs.

The Regulations as a whole encourage the research and development of new medicines that save lives, preventdiseases, heal and cure and improve the health of Canadians. The Federal Court questioned the statement in the Regulatory ImpactAnalysis Statement that the DPR was enacted to foster the development of new drugs. It wrongly found that this statement constitutedmore of a logical assertion than a clear demonstration that, without this provision, new drugs are not or would not be submitted forapproval.

The Federal Court was mistaken on this point in that, in determining the pith and substance of a law, courts are not to beconcerned with the efficacy of the law or whether it does, in fact, achieve the intended goal. It was indisputable that the legislative scheme found in the Regulations contributes to the protection of public health and safety, one ofthe “ordinary ends” of the criminal law. The DPR is clearly not separable from the overall scheme of criminal law found in theRegulations to which it contributes.

The Federal Court was unable to appreciate that the DPR contributes to and, thus, forms an integralpart of the overall scheme to protect public health and safety. Therefore, the DPR is rationally and functionally connected to the federallegislative scheme for new drug approval. In view of this conclusion, the question of whether the DPR fell under another head of federallegislative jurisdiction did not need to be answered. STATUTES AND REGULATIONS CITED Constitution Act, 1867, 30 & 31 Vict., c. 3 (U.K.) (as am. by Canada Act 1982, 1982, c. 11 (U.K.),

Schedule to the Constitution Act,1982, Item 1) [R.S.C., 1985, Appendix II, No. 5], ss. 91(2),(27), 92(10). Food and Drug Regulations, C.R.C., c. 870, ss. C.08.002 (as am. by SOR/93-202, s. 24; 95-411, s. 4), C.08.002.1 (as enacted idem, s. 5),C.08.003.1 (as enacted by SOR/2001-203, s. 5), C.08.004 (as am. by SOR/95-411, s. 6), C.08.004.1 (as enacted idem; 2006-241, s. 1). Food and Drugs Act, R.S.C., 1985, c. F-27, s. 30(3) (as am. by S.C. 1994, c. 47, s. 117), 31 (as am. by S.C. 1997, c. 6, s. 91). War Measures Act, 1914 (The), S.C. 1914 (2nd Sess.), c. 2, s. 6.

TREATIES AND OTHER INSTRUMENTS CITED Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C of the Marrakesh Agreement Establishing the WorldTrade Organization, signed in Marrakesh, Morocco, 15 April 1994, 1869 U.N.T.S. 299, Art. 39. North American Free Trade Agreement Between the Government of Canada, the Government of the United Mexican States and theGovernment of the United States of America, December 17, 1992, [1994] Can. T.S. No. 2, Art. 1711. CASES CITED applied: Gray (in re) (1918), (SCC), 57 S.C.R. 150, [1918] 3 W.W.R. 111, 42 D.L.R. 1; RJR-MacDonald Inc. v.

Canada(Attorney General), (SCC), [1995] 3 S.C.R. 199, (1995), 127 D.L.R. (4th) 1, 100 C.C.C. (3d) 449. distinguished: Bayer Inc. v. Canada (Attorney General), 87 C.P.R. (3d) 293, 243 N.R. 170 (F.C.A.), affg (FC),[1999] 1 F.C. 553, (1998), 84 C.P.R. (3d) 129, 155 F.T.R. 184 (T.D.), leave to appeal to S.C.C. refused [2000] 1 S.C.R. vi. considered: Attorney General of Canada v. Canadian National Transportation, Ltd. et al.; Attorney General of Canada v. Canadian PacificTransport Co. Ltd. et al., (SCC), [1983] 2 S.C.R. 206, (1983), 49 A.R. 39, 3 D.L.R. (4th) 16; General Motors of CanadaLtd. v.

City National Leasing, (SCC), [1989] 1 S.C.R. 641, (1989), 58 D.L.R. (4th) 255, 43 B.L.R. 225; Bristol-MyersSquibb Co. v. Canada (Attorney General), 2005 SCC 26, [2005] 1 S.C.R. 533, 253 D.L.R. (4th) 1, 39 C.P.R. (4th) 449; R. v. J.P., 2003

17492 67 O.R. (3d) 321 (C.A.); Reference re Firearms Act (Can.), 2000 SCC 31, [2000] 1 S.C.R. 783, 261 A.R. 201, 185 D.L.R.(4th) 577. referred to: Law Society of Upper Canada v. Canada (Minister of Citizenship and Immigration), 2006 FC 1489, [2007] 4 F.C.R. 132, 58 Admin.L.R. (4th) 293, 307 F.T.R. 141; Canada (Attorney General) v. Giacomelli, 2010 ONSC 985 317 D.L.R. (4th) 528; CanadianWestern Bank v. Alberta, 2007 SCC 22, [2007] 2 S.C.R. 3, 409 A.R. 207, 281 D.L.R. (4th) 125; Standard Sausage Co. v. Lee (1933),(BC CA), 47 B.C.R. 411, [1933] 4 D.L.R. 501, [1934] 1 W.W.R. 81 (B.C.C.A.); R. v.

Wetmore et al.,(SCC), [1983] 2 S.C.R. 284, (1983), 2 D.L.R. (4th) 577, [1984] 1 W.W.R. 577; C.E. Jamieson & Co. (Dominion) v. Canada (AttorneyGeneral), (FC), [1988] 1 F.C. 590, (1987), 46 D.L.R. (4th) 582, 37 C.C.C. (3d) 193 (T.D.). AUTHORS CITED Hogg, Peter W. Constitutional Law of Canada, 5th ed. supplemented. Toronto: Thomson/Carswell, 2007. Regulatory Impact Analysis Statement, SOR/2006-241, C. Gaz. 2006.II.1495.

APPEALS from a Federal Court decision (2009 FC 725, 77 C.P.R. (4th) 407, 348 F.T.R. 29) dismissing judicial review applicationsseeking a declaration that subsection 30(3) of the Food and Drugs Act and

section C.08.004.1, the Data Protection Regulation, of theFood and Drug Regulations were ultra vires and without legal force and effect. Appeals dismissed. APPEARANCES Harry B. Radomski for appellant in A-352-09. Edward Hore and Geoffrey Langen for appellant in A-360-09. Frederick B. Woyiwada for respondents Minister of Health and Attorney General of Canada in A-352-09 and A-360-09. Richard G. Dearden and Wendy J. Wagner for respondent Eli Lilly Canada Inc. in A-352-09. Martin W. Mason and Graham Ragan for respondent Canada’s Research-Based Pharmaceutical Companies in A-360-09.

SOLICITORS OF RECORD Goodmans LLP, Toronto, for appellant in A-352-09. Hazzard & Hore, Toronto, for appellant in A-360-09. Deputy Attorney General of Canada for respondents Minister of Health and Attorney General of Canada in A-352-09 and A-360-09. Gowling Lafleur Henderson LLP, Ottawa, for respondents Eli Lilly Canada Inc. and Canada’s Research-Based PharmaceuticalCompanies in A-352-09 and A-360-09.

The following are the reasons for judgment rendered in English by [1] Nadon J.A.: These are appeals from a decision of Mandamin J. (the Judge) of the Federal Court, 2009 FC 725, 77 C.P.R. (4th)407, dated July 17, 2009, which dismissed the judicial review applications of the appellants, Apotex Inc. (Apotex), appellant in Court fileA-352-09, and the Canadian Generic Pharmaceutical Association (the CGPA), appellant in Court file A-360-09, seeking a declarationthat subsection 30(3) [as am. by S.C. 1994, c. 47, s. 117] of the Food and Drugs Act, R.S.C., 1985, c.

F-27 (the Act) and sectionC.08.004.1 [as enacted by SOR/95-411, s. 6; 2006-241, s. 1]—the Data Protection Regulation (the DPR) of the Food and DrugRegulations, C.R.C., c. 870 (the Regulations)—were ultra vires and without legal force and effect. [2] In dismissing the applications, the Judge declared the DPR intra vires the federal Parliament. More particularly, he found theDPR to be intra vires Parliament’s power to make laws respecting trade and commerce under subsection 91(2) of the Constitution Act,1867 [30 & 31 Vict., c. 3 (U.K.) (as am. by Canada Act 1982, 1982, c. 11 (U.K.),

Schedule to the Constitution Act, 1982, Item 1)[R.S.C., 1985, Appendix II, No. 5]] (Constitution Act). He further found the provision valid because it is both rationally connected to itsenabling provision, subsection 30(3) of the Act, and a permissible sub-delegation. [3] On November 13, 2009, a notice of constitutional question was filed by the CGPA. It reads as follows: The Appellant, the Canadian Generic Pharmaceutical Association, intends to question the constitutional validity, applicability or effect ofthe Food and Drugs Act (“FDA”), R.S.C. 1985, c.

F-27, ss. 30(3), and regulations purportedly enacted thereunder, namely theRegulations Amending the Food and Drug Regulations (Data Protection) (hereinafter referred to as the “2005 DP Regulations”),published October 18, 2006, in the Canada Gazette

Part II, Vol. 140, No. 21, SOR/DORS/2006-241 at pages 1493-1494, purportedlyamending the Food and Drug Regulations, C.R.C., c. 870, s. C.08.004.1…. [4] Subsection 30(3) of the Act and the DPR are at the heart of these appeals and they read as follows: The Act 30. …

Regulations re the North American Free Trade Agreement and WTO Agreement

(3) Without limiting or restricting the authority conferred by any other provisions of this Act or any Part thereof for carrying into effect the purposes and provisions of this Act or any Part thereof, the Governor in Council may make such regulations as the Governor in Council deems necessary for the purpose of implementing, in relation to drugs,

Article 1711 of the North American Free Trade Agreement or paragraph 3 of

Article 39 of the Agreement on Trade- related Aspects of Intellectual Property Rights set out in Annex 1C to the WTO Agreement. Data Protection Regulation (DPR) C.08.004.1

(1) The following

definitions apply in this section. … “ innovative drug ” means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. … “pediatric populations” means the following groups: premature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age.

(2) This

section applies to the implementation of

Article 1711 of the North American Free Trade Agreement , as defined in the definition “Agreement” in subsection 2(1) of the North American Free Trade Agreement Implementation Act , and of paragraph 3 of

Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the World Trade Organization Agreement, as defined in the definition “Agreement” in subsection 2(1) of the World Trade Organization Agreement Implementation Act .

(3) If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug, (

a) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and (

b) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug.

(4) The period specified in paragraph (3)(

b) is lengthened to eight years and six months if (

a) the innovator provides the Minister with the description and results of clinical trials relating to the use of the innovative drug in relevant pediatric populations in its first new drug submission for the innovative drug or in any supplement to that submission that is filed within five years after the issuance of the first notice of compliance for that innovative drug; and (

b) before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug, the Minister determines that the clinical trials were designed and conducted for the purpose of increasing knowledge of the use of the innovative drug in those pediatric populations and this knowledge would thereby provide a health benefit to members of those populations. (5) Subsection (3) does not apply if the innovative drug is not being marketed in Canada. (6) Paragraph (3)(

a) does not apply to a subsequent manufacturer if the innovator consents to the filing of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission by the subsequent manufacturer before the end of the period of six years specified in that paragraph. (7) Paragraph (3)(

a) does not apply to a subsequent manufacturer if the manufacturer files an application for authorization to sell its new drug under

section C.07.003. (8) Paragraph (3)(

b) does not apply to a subsequent manufacturer if the innovator consents to the issuance of a notice of compliance to the subsequent manufacturer before the end of the period of eight years specified in that paragraph or of eight years and six months specified in subsection (4).

(9) The Minister shall maintain a register of innovative drugs that includes information relating to the matters specified in subsections (3) and (4). [Emphasis added.] [ 5 ] Subsection 30(3) of the Act grants the Governor in Council authority to enact regulations, as he deems necessary, for the purpose of implementing specified data protection provisions of the North American Free Trade Agreement [ North American Free Trade Agreement Between the Government of Canada, the Government of the United Mexican States and the Government of the United States of America , December 17, 1992, [1994] Can. T.S.

No. 2] (NAFTA) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as set out in Annex 1C to the WTO Agreement [ Marrakesh Agreement Establishing the World Trade Organization , signed in Marrakesh, Morocco, 15 April 1994, 1869 U.N.T.S. 299]. [ 6 ] The DPR introduces a period of market exclusivity for manufacturers of “innovative drug[s]” by imposing an eight-year

moratorium on the approval of the marketing of generic copies of previously approved new drugs. More particularly, paragraph 3(

a) thereof prohibits a generic manufacturer, seeking a notice of compliance (NOC) for a new drug “on the basis of a direct or indirect comparison between the new drug and an innovative drug”, from filing a new drug submission (NDS) “before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug”. In addition, paragraph 3(

b) of the DPR prohibits the Minister of Health (the Minister) from issuing a NOC to a generic drug manufacturer “before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug.” The Regulatory Impact Analysis Statement [SOR/2006-241, C. Gaz. 2006.II.1495] (the RIAS), issued with the DPR, sets out the purpose thereof as follows [at page 1495]: Description The amendments to

section C.08.004.1 of the Food and Drug Regulations (“Regulations”) are intended to provide new drugs with an internationally competitive, guaranteed minimum period of market exclusivity of eight years.

An additional six months period of data protection is available for innovative drugs that have been the subject of clinical trials designed and conducted for the purpose of increasing the knowledge of the behaviour of the drug in pediatric populations. [ 7 ] Prior to the enactment of the DPR, the only impediment to a generic drug manufacturer’s ability to obtain approval of the right to market a generic drug was the existence of an unexpired patent.

Since the enactment of the DPR, generic drug manufacturers cannot obtain approval for their generic drug until the period of market exclusivity of the innovative drug has expired, even where there is no patent protection for that drug. [ 8 ] A brief review of the regulatory scheme enacted by Parliament with respect to the marketing of drugs in Canada and of the relevant provisions of NAFTA and TRIPS will help to facilitate an understanding of the issues raised by these appeals.

REGULATORY SCHEME [ 9 ] It is a criminal offence in Canada to market a new drug unless the manufacturer thereof has received a NOC, i.e. the Minister’s confirmation that the manufacturer has complied with the Regulations, which seek to ensure the safety and effectiveness of new drugs. [ 10 ] The Regulations prescribe the manner in which the safety and effectiveness of the drug may be shown and they set out a process allowing manufacturers to qualify for exemption from criminality. They also set out in detail the information which a manufacturer must provide to the Minister in order to obtain a NOC.

Thus, a manufacturer must obtain a NOC pursuant to

Part C, Division 8 [ss. C.08.001 to C.08.018] of the Regulations, failing which the selling or advertising of the drug in Canada will be subject to criminal prosecution. [ 11 ] In order to obtain a NOC, a manufacturer must either file a new drug submission (NDS) or an abbreviated new drug submission (ANDS) as required by subsection C.08.002(1) [as am. by SOR/95-411, s. 4] of the Regulations. Generally speaking, an NDS is filed by innovator drug companies (innovator(s)).

The information provided by innovators in an NDS serves to establish that their drug meets the regulatory requirements with regard to the safety, efficacy and quality of the drug. More particularly, the NDS data will identify the drug, its benefits, adverse reactions, manufacturing process and the results of clinical trials on healthy volunteers and on patients. [ 12 ] An NDS is comprised of various sections, including pre-clinical, clinical, chemistry and manufacturing sections.

The pre-clinical portions thereof will consist of all the information pertaining to the experiments that the innovator has conducted in a laboratory so as to test the action and toxicity of the drug. The clinical portions of an NDS provide information with regard to clinical trials with volunteer subjects and/or patients to test the safety and efficacy of the new drug. Further information may be required by the Minister.

The content, size and cost of an NDS will vary, but it can be safely said that an NDS for a new active drug, in the words of the Judge, is “a significant undertaking by the innovator drug company and can contain as many as one to three hundred volumes of data” (Judge’s reasons, paragraph 15). [ 13 ] Once satisfied by the information provided by the innovator, the Minister may issue a NOC.

The drug will then be listed as a Canada reference product and will be issued a drug identification number (DIN). [ 14 ] An ANDS is available to generic drug manufacturers who wish to copy a marketed drug without having to provide the detailed reports and substantial data clinically demonstrating the safety and effectiveness of their drug.

An ANDS will provide the Minister with information pertaining to the composition and manufacture of the drug, as well as studies demonstrating that the generic drug contains the identical amount of the same medicinal ingredient in comparable dosage as the Canadian reference product, that it is pharmacologically equivalent and that it has the same bio-availability as the Canadian reference product. [ 15 ] Thus, rather than making a direct assessment of the clinical safety or efficacy of its drug on the basis of clinical studies, a generic manufacturer uses the Canadian reference product to demonstrate the latter’s bio-equivalence to its own product.

A typical ANDS will contain fewer volumes of data in comparison to the volumes of data filed in an NDS, ranging from a dozen to two dozen volumes. [ 16 ] Once satisfied, the Minister will issue a NOC to the generic manufacturer. The generic drug will also be listed as a Canada reference product and issued a DIN. [ 17 ] I now turn to a brief review of the relevant provisions of NAFTA and TRIPS. As I indicated earlier, the purpose of subsection 30(3) of the Act is to allow the Governor in Council to enact regulations so as to implement specified data protection provisions of both NAFTA and TRIPS.

More particularly, the Governor in Council is authorized to make regulations that are deemed necessary for the purpose of implementing

Article 1711 of NAFTA or paragraph 3 of

Article 39 of TRIPS. [ 18 ]

Article 1711 of NAFTA (which was signed on December 17, 1992) provides as follows:

Article 1711: Trade Secrets 1. Each Party shall provide the legal means for any person to prevent trade secrets from being disclosed to, acquired by, or used by others

without the consent of the person lawfully in control of the information in a manner contrary to honest commercial practices, in so far as: (

a) the information is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons that normally deal with the kind of information in question; (

b) the information has actual or potential commercial value because it is secret; and (

c) the person lawfully in control of the information has taken reasonable steps under the circumstances to keep it secret. 2. A Party may require that to qualify for protection a trade secret must be evidenced in documents, electronic or magnetic means, optical discs, microfilms, films or other similar instruments. 3. No Party may limit the duration of protection for trade secrets , so long as the conditions in paragraph 1 exist. 4.

No Party may discourage or impede the voluntary licensing of trade secrets by imposing excessive or discriminatory conditions on such licenses or conditions that dilute the value of the trade secrets. 5.

If a Party requires , as a condition for approving the marketing of pharmaceutical or agricultural chemical products that utilize new chemical entities, the submission of undisclosed tests or other data necessary to determine whether the use of such products is safe and effective, the Party shall protect against disclosure of the data of persons making such submissions, where the origination of such data involves considerable effort, except where the disclosure is necessary to protect the public or unless steps are taken to ensure that the data is protected against unfair commercial use . 6.

Each Party shall provide that for data subject to paragraph 5 that are submitted to the Party after the date of entry into force of this Agreement, no person other than the person that submitted them may, without the latter’s permission, rely on such data in support of an application for product approval during a reasonable period of time after their submission.

For this purpose, a reasonable period shall normally mean not less than five years from the date on which the Party granted approval to the person that produced the data for approval to market its product, taking account of the nature of the data and the person's efforts and expenditures in producing them. Subject to this provision, there shall be no limitation on any Party to implement abbreviated approval procedures for such products on the basis of bioequivalence and bioavailability studies. 7.

Where a Party relies on a marketing approval granted by another Party, the reasonable period of exclusive use of the data submitted in connection with obtaining the approval relied on shall begin with the date of the first marketing approval relied on. [Emphasis added.] [ 19 ] After the signing of NAFTA, an earlier version of subsection 30(3) of the Act was brought into effect on January 1, 1994, and an earlier version of the Regulations—section C.08.004.1 (the ffirst DPR)—was enacted (published in the Canada Gazette on September 6, 1995). [ 20 ] TRIPS was signed on April 15, 1994.

This was approximately one year prior to the enactment of the first DPR. However, the earlier version of subsection 30(3) of the Act which delegated this power to the Governor in Council came into effect on January 1, 1994 and thus, made no mention of TRIPS until subsection 30(3) was amended, coming into force on January 1, 1996. [ 21 ]

Article 39 of TRIPS reads as follows:

Article 39 1. In the course of ensuring effective protection against unfair competition as provided in

Article 10 bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3. 2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices so long as such information: (

a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; (

b) has commercial value because it is secret ; and (

c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret . 3. Members, when requiring , as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use .

In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use. [Emphasis added; footnote omitted.] [ 22 ] The RIAS, under the heading “Background” [at page 1495], explains the obligations which signatories to NAFTA and TRIPS have agreed to: Background The amendments to

section C.08.004.1 of the Food and Drug Regulations are intended to clarify and effectively implement Canada’s North American Free Trade Agreement (“NAFTA”) and the Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) obligations with respect to the protection of undisclosed test or other data necessary to determine the safety and effectiveness of a pharmaceutical or agricultural product which utilizes a new chemical entity. The obligations in TRIPS require that signatories provide

protection against the unfair commercial use of the data, whereas NAFTA requires that signatories provide a reasonable period of timeduring which a subsequent manufacturer is prohibited from relying on the originator’s data for product approval. The reasonable periodof time is specified as normally not being less than five years from the date on which regulatory approval was granted to the originator ofthe data.

In keeping with the provisions, the government has decided to provide this protection by allowing the innovator, or theoriginator of the data submitted for regulatory approval, to protect investments made in the development of the product by providing aperiod of market exclusivity. [23] The first DPR was amended in 2006 to the version at issue in these proceedings (coming into force on October 5, 2006 withpublication in the Canada Gazette on October 18, 2006). [24] Before turning to the Judge’s decision, it will be useful to say a few words concerning the decisions rendered by the Federal appellants rely in regard to one of the questions raised by the appeals. [25] In Bayer, the innovator brought a motion for a declaration that the first DPR provided a five-year protection period forinnovators in respect of new drugs for which a NOC had been issued.

The first DPR, under consideration in Bayer, read as follows: C.08.004.1.

(1) Where a manufacturer files a new drug submission, an abbreviated new drug submission, a supplement to a new drugsubmission or a supplement to an abbreviated new drug submission for the purpose of establishing the safety and effectiveness of thenew drug for which the submission or supplement is filed, and the Minister examines any information or material filed with the Minister,in a new drug submission, by the innovator of a drug that contains a chemical or biological substance not previously approved for sale inCanada as a drug, and the Minister, in support of the manufacturer’s submission or supplement, relies on data contained in theinformation or material filed by the innovator, the Minister shall not issue a notice of compliance in respect of that submission orsupplement earlier than five years after the date of issuance to the innovator of the notice of compliance or approval to market that drug,as the case may be, issued on the basis of the information or material filed by the innovator for that drug. (2) Subsection (1) does not apply where the manufacturer of a new drug for which a notice of compliance was issued pursuant to sectionC.08.004 gives written permission to another manufacturer to rely on the test or other data filed in respect of that new drug. (3) Subsection (1) does not apply where the data relied upon by the Minister was contained in information or material filed by theinnovator before January 1, 1994. [Emphasis added.] [26] The version of subsection 30(3) of the Act at the time of Bayer, read as follows: 30. … Regulationsre NorthAmericanFree TradeAgreement

(3) Without limiting or restricting the authority conferred by any other provisions of this Act or any Part thereof forcarrying into effect the purposes and provisions of this Act or any Part thereof, the Governor in Council may, for thepurposes of implementing

Article 1711 of the North American Free Trade Agreement, make regulations respecting theextent to which, if any, a person may, in seeking to establish the safety and effectiveness of a new drug for the purposes ofany regulations made under subsection (1) or (2), rely on test or other data submitted by any other person to the Minister inaccordance with such regulations. [Emphasis added.] [27] Thus, the first DPR prohibited the Minister from issuing a NOC to a generic manufacturer for a period of “five years after thedate of issuance to the innovator of the notice of compliance or approval to market” its new drug.

However, this prohibition only appliedin those instances where the Minister, in determining whether to issue a NOC to a generic manufacturer following the filing of an ANDS,examined “any information or material filed” with him in an NDS by an innovator of a drug and relied on the data contained in thatinformation or material. [28] The main issue before both the Federal Court (Evans J., as he then was) and this Court in Bayer was whether the Minister, inexamining an ANDS submitted by a generic manufacturer seeking approval of the safety and effectiveness of its new drug by comparingit to that of an innovator, examined and relied on the confidential detailed safety report and evidence of clinical effectiveness filed by theinnovator with its NDS.

Evans J. and this Court answered the question in the negative. Rothstein J.A. (as he then was) wrote the reasonsof this Court. He made the following remarks at paragraphs 15 and 18 [paragraphs 12 and 15 on The NAFTA provisions are intended to protect trade secrets. If the generic manufacturer exercises the option of having the Ministerexamine the confidential information filed by the innovator in support of its application for a Notice of Compliance, it is, in effect,relying on that information within the meaning of

section 6 of

Article 1711. It is apparent that if confidential data is not relied upon, thetrade secrets provisions of the NAFTA are not applicable. Specifically, if a generic manufacturer is able to establish the safety andeffectiveness of its product on the basis of bioequivalence or bioavailability studies without the Minister having to examine and rely uponconfidential data filed by the innovator, there is no reason or justification for the minimum five-year protection from competition. Thisinterpretation of subsection C.08.004.01(1) is consonant with

section 5 and 6 of

Article 1711 of the NAFTA. … Subsection C.08.004.1(1) and sections 5 and 6 of

Article 1711 of NAFTA are responsive to the requirement on innovators ofpharmaceutical products of having to disclose confidential proprietary information to the government. They provide for the use of thatconfidential or trade secret information by the government on behalf of the generic manufacturer and when that occurs, the minimumfive-year protection from competition for the innovator applies. Where the government does not use that confidential or trade secretinformation on behalf of the generic manufacturer, the provision is not applicable. [Emphasis added.] [29] I now turn to the Judge’s decision.

THE FEDERAL COURT DECISION [ 30 ] The Judge concluded that the DPR was intra vires a valid exercise of the federal constitutional power respecting trade and commerce under subsection 91(2) of the Constitution Act.

He also concluded that the DPR was rationally connected to subsection 30(3) of the Act and that it came within the regulatory authority given to the Governor in Council by Parliament. [ 31 ] In coming to this conclusion, the Judge reviewed the process by which manufacturers of drugs gain approval to market their drugs in Canada and the legislative history of the DPR and subsection 30(3) of the Act , including the international agreements which underlay that provision. In the course of this review, the Judge also summarized the jurisprudence pertaining to the

interpretation of these provisions. [ 32 ] The Judge summarized the evidence adduced by the parties and made the following findings at paragraph 46 of his reasons: 1. NDS require extensive research and clinical data on the safety and efficacy of the new drug which is compiled by innovative drug companies through considerable effort, time and cost; 2.

ANDS for generic copies also require significant pharmacological and clinical information to prove safety and efficacy by comparison to a proven safe drug that which generic drug companies compile at significant but comparatively less development time and cost; 3. generic drugs are available to the public at less cost than newly approved drugs to some degree as a consequence of lower development costs; 4. the protection of data required by governments for the approval of new drugs is the subject of international agreements, NAFTA and TRIPS, to which Canada is signatory; and 5.

Canada is not seen as being in compliance to the same degree with the NAFTA and TRIPS data protection requirements as other countries, notably the United States and the European Union. [ 33 ] The Judge then turned to the question of whether the DPR was intra vires the federal criminal law power under subsection 91(27) of the Constitution Act. [ 34 ] First, he proceeded to determine the pith and substance of the DPR. In order to make that determination, he carefully examined the DPR, its stated purpose, its legal and economic effects and the language of NAFTA and TRIPS.

He concluded that the purpose of the DPR was to implement specific provisions of NAFTA and TRIPS and that the DPR’s legal effect was the protection of information submitted by innovators in their NDS.

In his view, the intended effect of the DPR was the balancing of the commercial interests of both innovators and generic manufacturers, in that the DPR sought to protect the research and development costs of innovators while achieving lower drug costs by allowing the entry into the market of generic drugs. [ 35 ] These determinations led him to conclude, at paragraph 79 of his reasons: I conclude that the pith and substance of the Data Protection Regulation is the balancing of commercial considerations between the protection of an innovator drug manufacturer’s investments in preparing the NDS information in order to obtain an NOC for a new drug and the eventual NOC approval of generic drug manufacturer’s ANDS for a lower cost generic version of the new drug. [ 36 ] Following that conclusion, the Judge indicated that he could not agree with the respondent’s position that the DPR was an integral part of the overall scheme pertaining to the marketing of drugs in Canada, the essence of which is the protection of public health and safety by prohibiting all drugs except those that had been proven to be safe and effective, thus making the scheme a matter of federal legislative jurisdiction under Parliament’s criminal law power found in subsection 91(27) of the Constitution Act. [ 37 ] More particularly, the Judge found that the balancing of commercial considerations in respect of innovators and those in respect of generic drugs manufacturers did not form part of the scheme to protect the health and safety of the public.

Thus, in his view, it could not be said that the DPR was an integral part of the Regulations. Rather, the relationship between the DPR and the scheme was an adjunct one. At paragraph 84 of his reasons, he made the following remarks: The Data Protection Regulation is not a public safety provision so as to come within the federal criminal law powers pursuant to subsection 91(27) of the Constitution Act, 1867 notwithstanding that the overall drug regulation scheme does.

Nor is the regulation integral in that public health and safety is not enhanced without the data protection provision. [ 38 ] The Judge thus concluded that the DPR was not intra vires the federal criminal law powers pursuant to subsection 91(27) of the Constitution Act. [ 39 ] The Judge then went on to consider whether the Regulations might be intra vires by reason of another head of federal legislative jurisdiction.

He looked at subsection 91(2) (the regulation of trade and commerce power) and the national concern aspect of the residual peace, order and good government power (POGG). [ 40 ] He first considered the question of whether the DPR could fall under the general regulation of trade and commerce branch of subsection 91(2) and began this inquiry by canvassing the relevant jurisprudence. In particular, he referred to the Supreme Court of Canada’s decision in Attorney General of Canada v. Canadian National Transportation, Ltd. et al.; Attorney General of Canada v. Canadian Pacific Transport Co.

Ltd. et al. , [1983] 2 S.C.R. 206 ( Canadian National Transportation ), where the Supreme Court enunciated the criteria pursuant to which courts can distinguish between federal trade and commerce matters and provincial local matters. At paragraph 97, the Judge summarized the Court’s pronouncement as follows: In Canada (A.G.) v. Canadian National Transportation , [1983] 2 S.C.R. 206 ( Canadian National Transportation ), Justice Dickson,

writing separate reasons, built upon Chief Justice Laskin’s suggested criteria for validity under the second branch of the trade andcommerce power.

In addition to: (1) the provision was part of a general regulatory scheme; (2) the scheme was monitored by anoverseeing agency; and (3) the legislation was concerned with trade as a whole rather than a particular industry, Justice Dicksonincluded: (4) that the provinces jointly or severally would be constitutionally incapable of passing such an enactment; and (5) the failureof one or more provinces would jeopardize the successful operation in other parts of the country.

Transportation, “represented a principled way to distinguish between federal trade and commerce matters and provincial local matters”(Judge’s reasons, paragraph 100). [42] With those principles in mind, the Judge made a number of findings. [43] First, he found that the Regulations established a valid regulatory drug scheme for the approval of new drugs and generic drugs,overseen by the Minister.

In his view, the presence of this scheme satisfied the first two criteria of Canadian National Transportation. [44] He then found that the DPR, although an adjunct rather than an integral part of the regulatory scheme, rounded out a validregulatory drug scheme established for the marketing of drugs in Canada. He said that the DPR dealt with the manufacturing andmarketing of drugs which, in his view, was a local matter in a single industry. Still, he added, it “has implications of a nationaldimension” (Judge’s reasons, paragraph 104) in that it was enacted to comply with international treaties, NAFTA and TRIPS.

Canada’simplementation or failure to implement these agreements “has a national dimension that relates to Canada’s ability to participate in worldtrade” and that the DPR deals with a “genuine national economic concern of the kind considered by Justice Dickson in CanadianNational Transportation” (Judge’s reasons, paragraph 105). [45] Lastly, at paragraph 106 of his reasons, the Judge then dealt with the last criterion enunciated in Canadian NationalTransportation: The Data Protection Regulation deals with the approval of the marketing of new drugs.

Provincial legislatures cannot enact legislationthat delays the approval of generic drugs since provincial approvals of drugs for the market place would seriously interfere with thefederal s. 91(27) criminal law power to prohibit the marketing of drugs but for exceptions where drugs are proven safe and effective.Given the inability of provincial governments to enact legislation to stage approval of generic drugs, the fifth criteria enunciated byChief Justice Dickson, the failure of one or more provinces jeopardizing the successful operation in other parts of the country, does notarise. [46] As a result of the above analysis, the Judge concluded that the DPR was a constitutionally valid exercise of the federal legislativepower under subsection 91(2) of the Constitution Act. [47] He then turned to the question of whether subsection 30(3) of the Act and the DPR were intra vires the federal legislative powerunder the POGG.

He did not reach any conclusion on this question because he found it unnecessary to do so. [48] The Judge then addressed the question of whether the DPR fell outside the regulatory authority of the Governor in Council fornot being rationally connected to the grant of authority pertaining to trade secrets and confidential information in subsection 30(3) of theAct. [49] The Judge began by summarizing the appellants’ arguments at paragraphs 111 to 117 of his reasons.

He then reviewed therelevant provisions of NAFTA and TRIPS, which led him to say that the information protected by these provisions was “not necessarily‘secret’ information but rather includes data that was gathered at considerable cost which is not otherwise publicly available in thatassembled form” (Judge’s reasons, paragraph 120). [50] Next, he determined that the information and material found in innovators’ NDS was data that met the relevant

definitions ofboth NAFTA and TRIPS. Although, in his view, that information may not be secret in all respects, it was, in its compilation, “unique tothe innovator drug manufacturer and has value” (Judge’s reasons, paragraph 123). As a result, he concluded that the data found in theNDS came within the scope of the DPR. [51] He then referred to paragraph 5 of

Article 1711 of NAFTA and to TRIPS, noting that while NAFTA identified a mechanism ofmarket exclusivity protection, TRIPS did not outline what measures were to be taken by signatories. The content of these provisions ledthe Judge to state that the federal government had recognized that the first DPR was insufficient to meet its obligations under NAFTAand TRIPS. He so opined, inter alia, because of the comment found in the RIAS issued with the DPR. In particular, he had in mind thatpart of the RIAS which made reference to this Court’s decision in Bayer.

At paragraphs 126 and 127 of his reasons, the Judge made thefollowing comments: The federal government recognized that the previous regulation did not satisfy its obligations under NAFTA and TRIPS as was indicatedby its reference in RIAS to the Court’s findings in Bayer FC. In enacting the current version of the Data Protection Regulation, thefederal government is providing protection for a drug manufacturer’s investment in compiling the extensive research and clinical dataneeded in order to obtain an NOC for a new drug by a market exclusivity mechanism.

The regulation provides the innovator drugmanufacturer the opportunity to recoup and profit by its costly investment for a period of time before others may also benefit by makinggeneric copies of a that drug. The making of a generic copy of an approved drug circumvents the need to generate the research and clinical data. The ANDS processindirectly takes advantage of the innovator drug manufacturer’s production of the necessary NDS information. The result is a secondstage or subsequent reliance on the innovator’s work in securing an ANDS approval.

In Bristol-Myers, Justice Binnie explained how thegeneric manufacturer ‘relies’ on the innovator drug manufacturer’s approved new drug. 21 The NOC Regulations do not use the term "generic manufacturer", but a manufacturer that obtains a NOC on the basis of

pharmaceutical equivalence to a "Canadian reference product" can conveniently be called by that name. 22 Generally speaking, the "second person" intends to manufacture and distribute a "copy-cat" version of the active medicinalingredient. If it copies the approved product, it can rely on the safety and efficacy data and the clinical studies submitted by the"innovator" first person.

Such reliance reduces the amount of required supporting data and the approval time, and the shortenedsubmission is therefore known as an Abbreviated NDS (ANDS). [Emphasis in original.] [52] On the basis of the Supreme Court’s decision in Bristol-Myers Squibb Co. v.

Canada (Attorney General), 2005 SCC 26, [2005] 1S.C.R. 533 (Bristol-Myers), the Judge said at paragraph 130 that “[t]he proof of the safety and efficacy of a generic drug by comparisonto a previously approved [innovative drug] necessarily relies on the earlier NDS information”, adding that he was satisfied that the DPRprovided protection to innovators which was consistent with both NAFTA and TRIPS.

Thus, in his view, by providing a period of marketexclusivity for innovators, the DPR provided “an alternative to [sic] protection against disclosure in a manner contemplated in the twointernational agreements” (Judge’s reasons, paragraph 131). [53] The Judge then turned to the last issue before him, namely, whether subsection 30(3) of the Act constituted an impermissiblesub-delegation by Parliament of its international treaty implementation responsibilities.

The appellant argued that Parliament’sdelegation to the Governor in Council, pursuant to subsection 30(3), was contrary to parliamentary supremacy and oversight oflegislation. The subsection allowed the Governor in Council to exercise sweeping peace time powers, without parliamentary review, todetermine the scope of Canada’s international obligations, to undertake indeterminate obligations on Canada’s behalf and to revise itsregulations with new developments in international law which would be both uncertain and outside of Parliament’s control.

The Judgeconcluded that these arguments were without merit. [54] In his view, Parliament had granted the Governor in Council “the authority to enact regulations in a narrow area specified by theboundaries of the NAFTA and TRIPS provisions” (Judge’s reasons, paragraph 134). He added that it could not be said that Parliamenthad left the scope of the Governor in Council’s regulatory power indeterminate, in that the reference to

Article 1711 of NAFTA and toparagraph 3 of

Article 39 of TRIPS served to constrain subsection 30(3) of the Act. At paragraph 135 of his reasons, the Judge wrote: The scope of the NAFTA and TRIPS drug provisions are limited. The subject matter may only deal with: 1. the timing of approval for proposed generic drug formulations; 2. situations where the initial new drug was proven safe by the assembly of data gathered with considerable effort; 3. the subsequent generic drug was proved safe by reliance on the prior proven safety of the innovative new drug; and 4. minimum time delay for generic copies for five years.

THE ISSUES [55] There are two issues for determination in these appeals: 1. Was the DPR properly delegated by Parliament to the Governor in Council, pursuant to the permissible sub-delegation of treatyimplementation responsibilities and, if so, whether the DPR is intra vires the authority of the Governor in Council, pursuant tosubsection 30(3) of the Act (the delegation issue)? 2.

Is the DPR intra vires federal legislative competence, pursuant to subsections 91(2), (27) or the residual POGG power of theConstitution Act (the constitutional issue)? [56] I will first deal with the delegation issue and then with the constitutional issue. I should indicate that, not surprisingly, all partiesare agreed that the standard of review for both issues is that of correctness. I see no reason to disagree with that point of view. I.

THE DELEGATION ISSUE [57] I will first address the question of whether the DPR was properly delegated by Parliament to the Governor in Council, since, ifthe sub-delegation is impermissible, it is irrelevant whether the DPR as enacted is intra vires the regulatory authority of the Governor inCouncil. [58] The appellants argue that the scope of Parliament’s power to authorize the Governor in Council to make regulations wasaddressed by the Supreme Court in Gray (in re) (1918), (SCC), 57 S.C.R. 150 (Re Gray), “a case that is now almost100 years old, in the context of war measures”.

In that light, the appellants say that it is time for the courts to determine those powers “inthe modern globalized era in light of Canada’s position in the international community” (Apotex’ memorandum of fact and law,paragraph 74). [59] In Re Gray, the Supreme Court dealt with

section 6 of The War Measures Act, 1914, S.C. 1914 (2nd Sess.), c. 2, a provisionwhich delegated broad powers to the Governor in Council. The majority of the Court upheld the constitutional validity of

section 6 eventhough the grant of power to the Governor in Council to make regulations was couched in very broad terms and allowed for theamending or repealing of other legislation.

At pages 166–167, Duff J. referred to the provision at issue in the following terms: The words … are comprehensive enough to confer authority, for the duration of the war, to “make orders and regulations” concerningany subject falling within the legislative jurisdiction of Parliament—subject only to the condition that the Governor-in-council shalldeem such “orders and regulations” to be by reason of the existence of real or apprehended war, etc., advisable. [60] He then went on to make the following remarks, at page 170: There is no attempt to substitute the executive for parliament in the sense of disturbing the existing balance of constitutional authority by

aggrandizing the prerogative at the expense of the legislature. The powers granted could at any time be revoked and anything done underthem nullified by parliament, which parliament did not, and for that matter could not, abandon any of its own legislative jurisdiction.

Thetrue view of the effect of this type of legislation is that the subordinate body in which the law-making authority is vested by it is intendedto act as the agent or organ of the legislature and that the acts of the agent take effect by virtue of the antecedent legislative declaration(express or implied) that they shall have the force of law…. [Emphasis added.] [61] Anglin J., with whom Davies J. concurred, couched Parliament’s power to delegate in very broad terms, at page 176: A complete abdication by Parliament of its legislative functions is something so inconceivable that the constitutionality of an attempt todo anything of the kind need not be considered.

Short of such an abdication, any limited delegation would seem to be within the ambit ofa legislative jurisdiction…. [62] He went further and said, at page 182: At all events all we, as a court of justice, are concerned with is to satisfy ourselves what powers Parliament intended to confer and that itpossessed the legislative jurisdiction required to confer them. [63] I have not been persuaded that there is any basis to depart from the principle enunciated by the Supreme Court in Re Gray, thatParliament has a broad power to delegate by way of regulations, subject to the scope of the enabling legislation.

With respect, I declinethe appellants’ invitation to take a fresh look at Parliament’s authority to delegate to the Governor in Council the power to makeregulations. Recent decisions of the Federal Court and the Ontario Superior Court of Justice have relied on the principle enunciated in ReGray (see Law Society of Upper Canada v. Canada (Minister of Citizenship and Immigration), 2006 FC 1489, [2007] 4 F.C.R. 132, andCanada (Attorney General) v. Giacomelli, 2010 ONSC 985 317 D.L.R. (4th) 528). In particular, the Ontario Court of Appealin R. v.

J.P., 67 O.R. (3d) 321, at paragraphs 20 to 23, cited Re Gray with approval and the Court expressly referredto the above passages from the judgments of Duff and Anglin JJ. [64] In the present instance, subsection 30(3) of the Act grants the Governor in Council authority to “make such regulations as theGovernor in Council deems necessary” so as to implement, in relation to drugs,

Article 1711 of NAFTA or paragraph 3 of

Article 39 ofTRIPS. No evidence was adduced nor was any compelling argument made that subsection 30(3) negates Parliament’s ability to revokeor nullify the authority given to the Governor in Council or to do the same as regards the DPR enacted pursuant to the enablinglegislation. [65] I now turn to the question of whether the DPR is intra vires the authority of the Governor in Council pursuant to subsection30(3) of the Act. [66] In

summary, the appellants make the following arguments. First, they say that the DPR was enacted to implement specificprovisions of NAFTA and TRIPS; second, these provisions seek to protect trade secrets and confidential information; third, the DPRseeks to provide protection to innovators without regard to whether the information disclosed in the NDS is secret or confidential.

Inother words, the appellants say that there is no rational connection between data submitted by innovators in their NDS and the type ofdata which the relevant provisions of NAFTA and TRIPS seek to protect. [67] The appellants further say that the Judge erred in concluding that the generic manufacturers relied on the “secret” NDSinformation, since they do not rely on such information in seeking approval for their generic drugs.

The appellants go further and saythat they do not “indirectly” rely on the data found in an innovator’s NDS, adding once again that generic manufacturers do not use orrely on any of the secret or confidential information found in innovators’ NDS, nor does the Minister. [68] Invoking this Court’s decision in Bayer, the appellants say that if the Minister does not examine the confidential data found in aninnovator’s NDS nor rely on it in the course of approving a generic manufacturer’s ANDS, the trade secrets provisions of NAFTA arenot at issue.

At paragraph 60 of its memorandum of fact and law, Apotex says that “[i]n so holding, this Honourable Court [in Bayer]determined that indirect reliance, even if it is established, is not relevant to protections sought to be established by these internationaltreaty obligations”. [69] Finally, the appellants say that the Judge was wrong to conclude that the first DPR did not allow Canada to meet its obligationsunder NAFTA and TRIPS.

In their view, the first DPR was in conformity with Canada’s international treaty obligations and, as a result,there was no necessity for the enactment of the DPR. [70] As indicated above, Re Gray, stands for the principle that Parliament has a broad power to delegate by way of regulation, subjectto the scope of the enabling legislation. Subsection 30(3) allows the Governor in Council to make such regulations deemed necessary forthe purpose of implementing

Article 1711 of NAFTA and paragraph 3 of

Article 39 of TRIPS. [71] Paragraph 3 of

Article 39 of TRIPS is specific. It imposes a duty on Members, who require the submission of “undisclosed test orother data, the origination of which involves a considerable effort” as a condition of approving pharmaceutical products using newchemical entities, to “protect such data against unfair commercial use.” The provision also requires Members to “protect such data againstdisclosure … unless steps are taken to ensure that the data are protected against unfair commercial use.” The provision does not specifyhow Members are to provide protection for the data or what steps they should take to ensure protection “against unfair commercial use.” [72] While the entirety of

Article 1711 of NAFTA is referred to in subsection 30(3) of the Act, only paragraphs 5, 6 and 7 thereofappear to have inspired the DPR. These paragraphs, like paragraph 3 of

Article 39 of TRIPS, deal with a Member’s obligations in regardto the protection of data provided to governmental authorities as a condition of approving the marketing of pharmaceutical products.Paragraph 5 of

Article 1711 of NAFTA obliges Members to provide protection similar to that required under paragraph 3 of

Article 39 ofTRIPS. Paragraph 6 of

Article 1711 provides that Members are to take steps to prevent generic manufacturers from relying on NDS data“in support of an application for product approval during a reasonable period of time after their submission.” The provision goes on tosay that a reasonable period “shall normally mean not less than five years” from the time when a NOC is granted to an innovator for itsinnovative drug.

[ 73 ] The above provisions of NAFTA and TRIPS do not, in my respectful view, pertain to the protection of trade secrets. The provisions which do pertain to the protection of trade secrets are paragraphs 1, 2 and 3 of

Article 1711 of NAFTA and paragraph 2 of

Article 39 of TRIPS. In that regard, paragraph 1 of

Article 39 of TRIPS makes a clear distinction between “trade secrets” and “data protection”, which is the subject of paragraph 3 of

Article 39:

Article 39 1. In the course of ensuring effective protection against unfair competition as provided in

Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information [ i.e. trade secrets ] in accordance with paragraph 2 and data submitted to governments or governmental agencies [ i.e. data protection ] in accordance with paragraph 3. [Emphasis added.] [ 74 ] The same can be said with regard to

Article 1711 of NAFTA, where paragraphs 1 to 4 clearly address the subject of “trade secrets”, whereas paragraphs 5 to 7 pertain to the protection, in respect of the marketing of pharmaceutical products that utilize new chemical entities, “of undisclosed tests or other data necessary to determine whether the use of such products is safe and effective”. In other words, these provisions clearly seek to constrain the use by generic manufacturers of information created by innovators in relation to the approval of their “innovative drugs”. [ 75 ] The DPR, at paragraph 2 thereof, states that it applies to the implementation of

Article 1711 of NAFTA and to paragraph 3 of

Article 39 of TRIPS. It then states, at paragraph 3, that where a manufacturer, i.e. a generic manufacturer, seeks to obtain a NOC for a new drug “on the basis of a direct or indirect comparison between the new drug and an innovative drug”, the generic manufacturer may not file its ANDS prior to the expiry of six years after a NOC has been issued to the innovator in respect of its innovative drug.

It further states that the Minister may not issue a NOC to the generic manufacturer before the expiry of eight years after the issuance of a NOC to the innovator. [ 76 ] In my view, the DPR is in clear accord with the enabling provision. It is a regulation, the purpose of which is to implement, in relation to drugs,

Article 1711 of NAFTA and paragraph 3 of

Article 39 of TRIPS. Market exclusivity, conferred by the DPR on an innovator, is the means chosen by the Governor in Council to give effect to the relevant provisions of NAFTA and TRIPS. More particularly, the DPR is, in my view, a step taken by the Governor in Council “to ensure that the data are protected against unfair commercial use.” [ 77 ] I therefore must reject the appellants’ argument that there is no rational connection between the data found in an innovator’s NDS and the type of data which the relevant provisions of NAFTA and TRIPS seek to protect. It is clear that the data which

Article 1711 of NAFTA and paragraph 3 of

Article 39 of TRIPS seek to protect is precisely the type of data in regard to which the DPR offers market protection, i.e. the data found in an innovator’s NDS for an innovative drug. Consequently, I can detect no error in the findings made by the Judge, at paragraphs 120 and 123 of his reasons, where he states: It is evident from the wording of paragraphs 1 and 5 of

Article 1711 of NAFTA and paragraph 3 of

Article 39 of TRIPS that the information is not necessarily “secret” but rather includes data that was gathered at considerable cost which is not otherwise publicly available in that assembled form. … In my view, the innovator drug manufacturers’ NDS data meets the

definitions in both NAFTA and TRIPS. The information may not be secret in all respects, but in its compilation, it is unique to the innovator drug manufacturer and has value. I find it is information that comes within the scope of the Data Protection Regulation . [ 78 ] The appellants, in making their argument that the Judge erred in regard to the type of data which

Article 1711 of NAFTA and paragraph 3 of

Article 39 of TRIPS seek to protect, say that that issue was decided by this Court in Bayer , where Rothstein, J.A., at paragraph 15 of his reasons, concluded that

Article 1711 was meant to protect “confidential data” and that its purpose was the protection of “trade secrets”. [ 79 ] In my view, the Court in Bayer , did not make a determination which binds us. First, none of the issues raised by the appeal in Bayer pertained to the question of whether the data which

Article 1711 of NAFTA sought to protect was “confidential data” or “trade secrets”. Rather, as I indicated earlier, the case focused on the question of whether the Minister examined or relied upon the innovator’s NDS data in approving an ANDS. Second, because the issue now before us was not raised, the Court in Bayer , appears to have simply taken for granted that the type of data which gave rise to the dispute was either “confidential information” or “trade secrets”. It should also be noted that paragraph 3 of

Article 39 of TRIPS was not before the Court in Bayer and that, it goes without saying, both subsection 30(3) of the Act and the DPR were worded differently than the provisions which are at issue in these appeals. [ 80 ] I therefore conclude that, contrary to the appellants’ assertion, the Judge’s findings, at paragraphs 120 and 123 are not “directly contradictory to this Honourable Court’s

interpretation of the same provisions in Bayer ”. [ 81 ] I now turn to the appellants’ submission that the Judge erred in concluding that the market exclusivity period granted to innovators by the DPR was an appropriate mechanism to facilitate the protection found in both NAFTA and TRIPS.

The appellants say “such a conclusion was in error since the application judge failed to appreciate that there is no reliance by a generic manufacturer on the purportedly ‘secret’ information contained in an NDS and thus there is no rational connection between a market exclusivity period and the enabling treaty provisions”. [ 82 ] More particularly, the appellants challenge the Judge’s finding, at paragraph 127 of his reasons, where he states that generic manufacturers, by way of the ANDS process, “indirectly takes advantage of the innovator drug manufacturer’s production of the necessary NDS information” and that the result “is a second stage or subsequent reliance on the innovator’s work in securing an ANDS approval.” In my view, the appellants’ argument is based on a misunderstanding of subsection 30(3) of the Act and of the DPR.

I say this because of my view that the appellants’ position fails to recognize that both subsection 30(3) of the Act and the DPR have been amended since this Court rendered its decision in Bayer .

[83] It is true that paragraph 6 of

Article 1711 of NAFTA requires Members to take steps to prevent, in respect of the data fallingwithin the scope of paragraph 5 thereof, i.e. “undisclosed test or other data necessary to determine whether the use of such products[innovative drugs] is safe and effective”, persons other than persons that submitted the data from relying “on such data in support of anapplication for product approval during a reasonable time after their submission.” Thus, the provision seeks to prevent genericmanufacturers from making use of the protected data in support of their ANDS. [84] As to paragraph 3 of

Article 39 of TRIPS, it simply provides that Members shall protect such data “against unfair commercialuse.” [85] Subsection 30(3) of the Act, as I have already indicated, allows the Governor in Council to make regulations which are deemednecessary to implement the relevant provisions of NAFTA and TRIPS.

Thus, Parliament has left it to the Governor in Council todetermine the manner in which innovators’ data will be protected “against unfair commercial use.” There can be no doubt that the termsof subsection 30(3) give very broad latitude to the Governor in Council to devise the means by which the treaty provisions will beimplemented. The previous version of subsection 30(3) was not as broad as the present one, in that it authorized the Governor in Council,for purposes of implementation of

Article 1711 of NAFTA, to “make regulations respecting the extent to which, if any, a person may …rely on test or other data” submitted by innovators. [86] Consequently, under the authority of subsection 30(3) of the Act, the Governor in Council enacted the DPR and provided thatprotection would be afforded to innovators by way of market exclusivity for a determined period when a generic manufacturer sought aNOC for a new drug “on the basis of a direct or indirect comparison between the new drug and an innovative drug”.

Thus, in my view,the debate which our Court addressed in Bayer, is not relevant for the purposes of these appeals. This is made clear by the followingextract from the RIAS issued with the DPR [at pages 1495–1496]: Background … Under the current Regulations [the first DPR], the data protection exclusivity period arises when the Minister of Health examines andrelies on an innovator’s undisclosed data in order to grant a notice of compliance to a generic manufacturer.

However, to receive a noticeof compliance in Canada, a generic manufacturer need only demonstrate bioequivalence by comparing its generic product to theinnovator’s product. Therefore, in actual practice, the Minister typically does not examine the data contained in the innovator’ssubmission in order to grant a notice of compliance for a generic product. As a result, data protection does not arise wherebioequivalence forms the basis of a generic submission, as affirmed by the Federal Court in Bayer Inc. v. Canada (Attorney General),(FCA), 87 C.P.R. (3d) 293.

While the comparison necessary to demonstrate bioequivalence rarely involves an examination of the innovator’s data, it does involvereliance on the innovator’s product. Therefore, these amendments are being introduced to clarify that the aforementioned reliance willgive rise to an exclusivity period. [Emphasis added.] [87] As is pointed out in the RIAS, the DPR, unlike the first DPR considered in Bayer, does not make the granting of marketexclusivity conditional on the Minister having examined or relied on innovators’ data.

The DPR simply provides that genericmanufacturers may not seek a NOC for a new drug before the expiry of a period of six years after a NOC was issued to an innovator foran “innovative drug”, nor will the Minister grant a NOC before the end of a period of eight years after the granting of a NOC to aninnovator where a generic manufacturer seeks its NOC “on the basis of a direct or indirect comparison” between its new drug and aninnovative drug. [88] In other words, the test is not reliance on an innovator’s data, either by the Minister or by the generic manufacturer, but ratherwhether there has been a comparison, direct or indirect, between the generic manufacturer’s new drug and an innovative drug.

The RIASputs it in different terms when it says that “[w]hile the comparison necessary to demonstrate bio-equivalence rarely involves anexamination of the innovator’s data, it does involve reliance on the innovator’s product.” [89] At paragraph 130 of his reasons, the Judge concluded that the test found at paragraph 3 of the DPR was met. He put it as follows: Bristol-Myers answered the question of the use of NDS information in the ANDS process.

The proof of the safety and efficacy of ageneric drug by comparison to a previously approved [sic] necessarily relies on the earlier NDS information. [90] Those remarks should be read with the statement found at paragraph 127 of his reasons, where he indicated that the obtaining ofa NOC by a generic manufacturer, following the filing of an ANDS, “circumvents the need to generate the research and clinical data.”Thus, in his view, the ANDS process took advantage of “the innovator drug manufacturer’s production of the necessary NDSinformation.” For that proposition, he relied on the following words of Binnie J., at paragraphs 21 and 22 of his reasons in Bristol-Myers: The NOC Regulations do not use the term “generic manufacturer”, but a manufacturer that obtains a NOC on the basis of pharmaceuticalequivalence to a “Canadian reference product” can conveniently be called by that name.

Generally speaking, the “second person” intends to manufacture and distribute a “copy-cat” version of the active medicinal ingredient. Ifit copies the approved product, it can rely on the safety and efficacy data and the clinical studies submitted by the “innovator” firstperson. Such reliance reduces the amount of required supporting data and the approval time, and the shortened submission is thereforeknown as an Abbreviated New Drug Submission (“ANDS”). [91] The appellants say that the Judge was wrong to rely on Bristol-Myers. I disagree.

While it is true that the Minister does notusually examine the information provided by innovators in granting a NOC to a generic manufacturer following the filing of an ANDSon the basis of bio-equivalence, there cannot be much doubt that the ANDS process involves, at the very least, indirect reliance on thesafety and efficacy information derived from innovators’ NDS. In other words, a generic manufacturer relies on the information found inan innovator’s NDS in that: (

i) that information provides the actual knowledge about the safety and efficacy of the drug and its

conditions of use; (ii) without that knowledge, it would not be possible for a generic manufacturer to produce its new drug without conducting extensive non-clinical and clinical studies (see the affidavit of Ann Elizabeth Bowes, appeal book, Vol. II, page 472). It is in that sense that a generic manufacturer relies upon the data provided by an innovator in its NDS.

The following extract from the RIAS [at page 1497] is apposite and I reproduce it: Triggering mechanism The triggering mechanism is intended to capture generic and second entrant manufacturers that are seeking to rely on direct or indirect comparison between their drug and the innovative drug. As was observed by the Supreme Court of Canada in Bristol-Myers Squibb Co. v.

Canada (Attorney General) , 2005 SCC 26 , such direct or indirect comparisons would exclude submissions in which the submission sponsor does not rely on another manufacturer’s safety and efficacy data in seeking approval under the Food and Drug Regulations . This is consistent with

Article 1711 of NAFTA and paragraph 3,

Article 39 of TRIPS, since there would be no unfair commercial use of data or the reliance on such data for the a

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