2012 FCA 106, 2012 FCA 106

A-215-11 2012 FCA 106 Teva Canada Limited ( Appellant ) v . The Minister of Health and Sanofi-Aventis Canada Inc. ( Respondents ) Indexed as: Teva Canada Limited v. Canada (Health) Federal Court of Appeal, Blais C.J., Noël and Stratas JJ.A.—Toronto, March 19; Ottawa, April 10, 2012. Food and Drugs — Appeal, cross-appeal from Federal Court decision dismissing judicial review of Minister of Health (respondent) decision refusing to remove drug Eloxatin from register of “innovative drugs” maintained by respondent under Food and Drug Regulations , s.

C.08.004.1(9) — Appellant requesting that respondent remove Eloxatin from register on ground not meeting definition of “innovative drug” under Regulations, s.

C.08.004.1(1) — Arguing that respondent having “previously approved” drug, authorizing thousands of uses of Eloxatin by way of emergency treatment under Special Access Programme set out in Regulations — Respondent concluding that authorizations under Special Access Programme not constituting previous approval for purposes of definition of “innovative drug” — Whether previously granted authorizations under Special Access Programme making drug “previously approved” under Regulations, s. C.08.004.1(1) — Respondent’s

interpretation of Regulations correct — Correctly finding that Eloxatin meeting definition of “innovative drug” in Regulations, s.

C.08.004.1(1); thus, respondent right to keep drug on register of innovative drugs — Under Regulations, safety, effectiveness of new drug having to be established before being marketed in Canada — Special Access Programme different from usual way in which new drugs marketed in Canada, allowing for use of certain drugs despite fact safety, efficacy not demonstrated — Appellant’s submission that medicinal ingredient in Eloxatin “approved” within meaning of definition of “innovative drug” under Regulations, s.

C.08.004.1(1) creating lack of clarity, uncertainty — Under Regulations, approval signalled by issuance of notice of compliance, drug identification number — Regulations, s. C.08.004.1(1) constituting limited, special purpose

section designed to implement certain specific treaty obligations undertaken by Canada (Regulations, s. C.08.004.1(2)) — Accepting appellant’s

interpretation that “previously approved” including authorizations granted under Special Access Programme would undercut treaty provisions — Therefore, drugs for which previous authorizations under Special Access Programme having been granted not “previously approved” within meaning of Regulations, s. C.08.004.1(1) — Respondent correct in deciding that Eloxatin constituting "innovative drug” under Regulations, s. C.08.004.1(1); that Eloxatin should remain on register of innovative drugs under Regulations, s.

C.08.004.1(9) — As to c ross-appeal, directed against Federal Court’s reasons for dismissing preliminary objections — Cross-appeal lying against judgments, orders, not reasons — Appeal, cross-appeal dismissed.

Practice — Cross-appeal — Appeal, cross-appeal from Federal Court decision dismissing judicial review brought by appellant — Cross-appeal in present case brought by respondent Sanofi-Aventis; concerning, in particular, certain preliminary objections to appellant’s standing, ability to assert matter in Federal Court, Federal Court of Appeal — Cross-appeal not lying in present case — Federal Court’s order not adversely affecting Sanofi-Aventis — Cross-appeal herein directed against Federal Court’s reasons for dismissing preliminary objections — Cross-appeal lying against judgments, orders, not reasons.

Practice — Parties — Standing — Appeal, cross-appeal from Federal Court decision dismissing judicial review brought by appellant — In cross-appeal, respondent Sanofi-Aventis raising certain preliminary objections to appellant’s standing — Whether appellant having standing to bring application for judicial review — Sanofi-Aventis claiming appellant not “person directly affected by matter in which relief sought” as required under Federal Courts Act , s. 18.1(1) but Federal Court right to dismiss objection — Accepting Sanofi-Aventis’ submission would do nothing to improve delivery of justice, would serve no good purpose.

Administrative Law — Judicial Review — Examination of word “decision” in Federal Courts Acts, s. 18.1(2) — Whether decision of Minister of Health (respondent) not to remove drug Eloxatin from register of “innovative drugs” maintained by respondent constituting fresh “decision” within meaning of Federal Courts Act , s. 18.1(2) — Respondent’s decision not to remove drug Eloxatin from register constituting “fresh” decision within meaning of Federal Courts Act, s. 18.1(2); constituting fresh exercise of discretion — Accordingly, respondent’s decision constituting “decision” susceptible to judicial review under Federal Courts Act, s. 18.1 .

This was an appeal and cross-appeal from a Federal Court decision dismissing an application for judicial review brought by the appellant. In 2007, the Minister of Health (respondent) placed Sanofi-Aventis Canada Inc.’s drug, Eloxatin, on a register of “innovative drugs” maintained by the respondent under subsection C.08.004.1(9) of the Food and Drug Regulations . Later, the appellant requested that the respondent remove Eloxatin from the register because it did not meet the definition of an “innovative drug” under subsection C.08.004.1(1) of the Regulations.

Under that definition, to be an “innovative drug”, Eloxatin must contain “a medicinal ingredient not previously approved by the respondent. The appellant argued that the respondent has “previously approved” the drug, authorizing thousands of uses of Eloxatin by way of emergency treatment under the Special Access Programme set out in the Regulations. The respondent rejected the appellant’s request, concluding that authorizations under the Special Access Programme do not constitute a previous approval for the purposes of the definition of “innovative drug”.

The respondent’s decision was the subject of the appellant’s application for judicial review in the Federal Court and its appeal in this case. With respect to Sanofi-Aventis’ cross-appeal, it concerned certain preliminary objections to the appellant’s standing and ability to assert this matter in the Federal Court and on appeal to the Federal Court of Appeal. It was unsuccessful in raising these objections in the Federal Court.

The issues were whether previously granted authorizations under the Special Access Programme make a drug “previously approved” under subsection C.08.004.1(1) of the Regulations ; whether the appellant had standing to bring its application for judicial review; and whether the respondent’s decision not to remove the drug Eloxatin from the register constituted a fresh “decision” within the meaning of the Federal Courts Act , s. 18.1(2) .

Held , the appeal and cross-appeal should be dismissed. The respondent’s

interpretation of the Regulations was correct. The respondent correctly found that Eloxatin met the definition of “innovative drug”; thus, the respondent was right to keep it on the register of innovative drugs. While the definition of “innovative drug” is found in subsection C.08.004.1(1) of the Regulations, the term “previously approved” in the definition of “innovative drug” is not itself defined. The appellant submitted, in particular, that “previously approved” must be interpreted to include mass authorizations under the Special Access Programme.

It also submitted that the respondent incorrectly interpreted “previously approved” as meaning whether a drug has received market authorization. While the appellant saw the definition of “innovative drug” in subsection C.08.004.1(1) and more broadly the Regulations as being aimed at achieving a compromise between providing monopolies to innovators for a period of time and allowing generics to obtain timely market access, the wording, architecture and purpose of the Regulations suggest a different prism—that of the safety and efficacy of drugs.

Under the Regulations, a new drug may not be marketed in Canada unless its manufacturer has first obtained a notice of compliance and a drug identification number:

section C.08.004 and subsection C.01.014(1) of the Regulations. To obtain these, there must be a demonstration directly or indirectly founded upon data and studies that, in the respondent’s view, have established safety and effectiveness. The Special Access Programme is different: it allows for the use of certain drugs despite the absence of data and studies demonstrating the safety and efficacy of the drug.

Drugs available under the Special Access Programme are not founded upon data and studies that, in the respondent’s view, have established safety and effectiveness but rather are made available in emergency situations as a treatment of last resort where conventional treatments have failed or are unavailable. The appellant’s submission that the medicinal ingredient in Eloxatin was “approved” within the meaning of the definition of “innovative drug” under subsection C.08.004.1(1) of the Regulations created lack of clarity and uncertainty, something that the Regulations try to eliminate.

Whether or not a drug is approved and authorized for market and sale in Canada is of importance to the manufacturer, its competitors, medical professionals, pharmacists and patients. Clarity and certainty on this is essential. Under the Regulations, the magic moment of approval is signalled by the issuance of a notice of compliance and a drug identification number. The appellant’s

interpretation would lead to complicated factual inquiries and difficult questions that run counter to the theme of clarity and certainty in the area of approvals under the Regulations. Many of the appellant’s submissions embodied the view that subsection C.08.004.1(1) of the Regulations is about achieving a compromise between providing monopolies for a period of time to innovative drug manufacturers while allowing timely market access to generic drug manufacturers. In fact, this is not the case. Subsection C.08.004.1(1) of the Regulations is a limited, special purpose

section designed to implement certain specific treaty obligations undertaken by Canada: subsection C.08.004.1(2) of the Regulations. These obligations are found in provisions in the three treaty provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights , Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization and the 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 .

Broadly, the provisions in question aim to protect an innovator who submits undisclosed data in support of an application for approval to market a drug containing a new chemical entity. Given that the definition of “innovative drug” in subsection C.08.004.1(1) of the Regulations was intended to implement these treaty provisions, “previously approved” in subsection C.08.004.1(1) must mean a previous marketing approval. Accepting the appellant’s

interpretation that “previously approved” in subsection C.08.004.1(1) of the Regulations includes authorizations granted under the Special Access Program would undercut the treaty provisions in question. Therefore, drugs for which previous authorizations under the Special Access Programme have been granted are not “previously approved” within the meaning of subsection C.08.004.1(1) of the Regulations. Although many authorizations had been granted for Eloxatin under the Special Access Programme, Eloxatin had not previously received a notice of compliance or a drug information number.

Therefore, the respondent was correct in deciding that Eloxatin was an "innovative drug” under subsection C.08.004.1(1) of the Regulations and that it should remain on the register of innovative drugs under subsection C.08.004.1(9) of the Regulations. A cross-appeal did not lie in this case. The Federal Court’s order did not adversely affect Sanofi-Aventis but rather gave it exactly what it wanted: a dismissal of the appellant’s application for judicial review. In reality, Sanofi-Aventis’ cross-appeal was directed against the Federal Court’s reasons for dismissing the preliminary objections.

A cross-appeal lies against judgments and orders, not reasons. As for Sanofi-Aventis’ preliminary objection that the appellant was not a person “directly affected by the matter in which relief is sought” as required under subsection 18.1(1) of the Federal Courts Act , the Federal Court was right to dismiss that objection. The Federal Courts Act is aimed at achieving, inter alia , justice, fairness, practicality, order and efficiency. Accepting Sanofi-Aventis’ submission would do nothing to improve delivery of justice and would serve no good purpose.

In the face of a dismissal, the appellant would simply restart its application with direct standing. Regarding the respondent’s decision not to remove the drug Eloxtain from the register of innovative drugs, it constituted a “fresh” decision within the meaning of subsection 18.1(2) of the Federal Courts Act . The respondent is obligated to maintain the register of innovative drugs pursuant to subsection C.08.004.1(9) of the Regulations , which includes the power to add or delete information to or from the register, as necessary.

The respondent’s decision refusing the appellant’s request was a decision concerning the maintenance of the register and was a fresh exercise of discretion. Accordingly, the respondent’s decision was a “decision” susceptible to judicial review under

section 18.1 of the Federal Courts Act . STATUTES AND REGULATIONS CITED Federal Courts Act , R.S.C., 1985, c. F-7, ss. 1 (as am. by S.C. 2002, c. 8 , s. 14), 18.1 (as enacted by S.C. 1990, c. 8, s. 5; 2002, c. 8, s. 27 ). Federal Courts Rules , SOR/98-106, rr. 1 (as am. by SOR/2004-283, s. 2), 341(1)( b ). Food and Drug Regulations , C.R.C., c. 870, ss.

C.01.014(1) (as enacted by SOR/81-248, s. 2), C.08.002 (as am. by SOR/93-202, s. 24; 95-411, s. 4), C.08.002.1 (as enacted by SOR/95-411, s. 5), C.08.004 (as am. by SOR/95-411, s. 6), C.08.004.1(1) “innovative drug” (as enacted by SOR/2006-241, s. 1), (2) (as enacted idem ), (3) (as enacted idem ), (4) (as enacted idem ), (9) (as enacted idem ), C.08.010, C.08.011.

Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 3(2). 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 considered: Celgene Corp. v.

Canada (Attorney General), 2009 FCA 378, [2011] 1 F.C.R. 78, 315 D.L.R. (4th) 270, 100 Admin. L.R. (4th) 244, affd2011 SCC 1, [2011] 1 S.C.R. 3, 327 D.L.R. (4th) 513, 14 Admin. L.R. (5th) 1. referred to: Dunsmuir v. New Brunswick, 2008 SCC 9, [2008] 1 S.C.R. 190, 329 N.B.R. (2d) 1, 291 D.L.R. (4th) 577; Hospira HealthcareCorporation v. Canada (Attorney General), 2010 FCA 345, 92 C.P.R. (4th) 1, 414 N.R. 262; Canadian Generic PharmaceuticalAssociation v. Canada (Health), 2010 FCA 334, [2012] 2 F.C.R. 618, 90 C.P.R. (4th) 223, 413 N.R. 89; Kligman v.

M.N.R., 2004 FCA152, [2004] 4 F.C.R. 477, 239 D.L.R. (4th) 1, [2004] 3 C.T.C. 211; Froom v. Canada (Minister of Justice), 2004 FCA 352, [2005] 2F.C.R. 195, 245 D.L.R. (4th) 577, 20 Admin. L.R. (4th) 313; League for Human Rights of B’nai Brith Canada v. Canada, 2010 FCA307, [2012] 2 F.C.R. 312, 93 Imm. L.R. (3d) 1, 409 N.R. 298; Rothmans of Pall Mall Canada Limited v. Minister of National Revenue(No. 1), (FCA), [1976] 2 F.C. 500, (1976), 67 D.L.R. (3d) 505, [1976] C.T.C. 339 (C.A.); Bell ExpressVu LimitedPartnership v.

Rex, 2002 SCC 42, [2002] 2 S.C.R. 559, 212 D.L.R. (4th) 1, [2002] 5 W.W.R. 1; Merck Frosst Canada Inc. v. Canada(Minister of National Health and Welfare), (FC), [1997] 3 F.C. 752, (1997), 74 C.P.R. (3d) 307, 133 F.T.R. 184(T.D.); Air Canada v. Toronto Port Authority, 2011 FCA 347, [2013] 3 F.C.R. 606, 426 N.R. 131.

APPEAL, CROSS-APPEAL from a Federal Court decision (2011 FC 507, 95 C.P.R. (4th) 423, 390 F.T.R. 1) dismissing an applicationfor judicial review of the Minister of Health’s refusal to remove the drug Eloxatin from a register of “innovative drugs” maintained bythe respondent under subsection C.08.004.1(9) of the Food and Drug Regulations. Appeal, cross-appeal dismissed. APPEARANCES Robert W. Staley, Dominique T. Hussey and Christopher D. Heer for appellant. Eric Peterson for respondent Minister of Health. Judith Robinson and Brian Daley for respondent Sanofi-Aventis Canada Inc.

SOLICITORS OF RECORD Bennett Jones LLP, Toronto, for appellant. Deputy Attorney General of Canada for respondent Minister of Health. Norton Rose OR LLP, Montréal, for respondent Sanofi-Aventis Canada Inc.

The following are the reasons for judgment rendered in English by [1] Stratas J.A.: This is an appeal and cross-appeal from the Federal Court’s dismissal of an application for judicial review broughtby the appellant, Teva Canada Limited: 2011 FC 507, 95 C.P.R. (4th) 423 (per Justice Campbell). [2] In 2007, the Minister of Health placed Sanofi-Aventis Canada Inc.’s drug, Eloxatin, on a register of “innovative drugs”maintained by her under subsection C.08.004.1(9) [as enacted by SOR/2006-241, s. 1] of the Food and Drug Regulations, C.R.C., c. 870[the Regulations].

As will be seen, the presence of Eloxatin on the register has meant that Teva cannot market its own version ofEloxatin. [3] In 2010, Teva requested that the Minister remove Eloxatin from the register because it does not meet the definition of an“innovative drug” [as enacted idem] under subsection C.08.004.1(1) of the Regulations. Under that definition, to be an “innovative drug”Eloxatin must contain “a medicinal ingredient [oxaliplatin] not previously approved by the Minister”.

In Teva’s view, the Minister has“previously approved” it: since 1999, the Minister authorized thousands of uses of Eloxatin by way of emergency treatment under theSpecial Access Programme set out in the Regulations. [4] The Minister decided to reject Teva’s request. This is the decision that is the subject of Teva’s application for judicial review inthe Federal Court and its appeal to this Court.

The Minister interpreted the Regulations and concluded that authorizations under theSpecial Access Programme do not constitute a previous approval for the purposes of the definition of “innovative drug”. [5] For the reasons set out below, like the Federal Court, I find that the Minister’s

interpretation of the Regulations was correct. TheMinister correctly found that Eloxatin met the definition of “innovative drug” and so she was right to keep it on the register of innovativedrugs. Therefore, I would dismiss the appeal. [6] Sanofi-Aventis’ cross-appeal concerns certain preliminary objections to Teva’s standing and ability to assert this matter in the

Federal Court and on appeal to this Court. It raised these objections in the Federal Court and was unsuccessful. For reasons set out below, these objections should not have been advanced by way of cross-appeal and, in any event, they are not well founded. Therefore I would dismiss the cross-appeal. A. The standard of review that should apply to the Minister’s decision [ 7 ] At the heart of the Minister’s decision is a question of legislative

interpretation: whether authorizations under the Special Access Programme can constitute a “[previous] approv[al]” under subsection C.08.004.1(1) of the Regulations . The Federal Court held that the Minister’s decision should be reviewed on the basis of correctness. [ 8 ] Before us, Sanofi-Aventis and the Minister submit that the Minister’s decision should be reviewed on the basis of the deferential standard of reasonableness: see Dunsmuir v. New Brunswick , 2008 SCC 9 , [2008] 1 S.C.R. 190, at paragraph 50 . [ 9 ] In my view, the Minister’s

interpretation of the Regulations was correct and so this question need not be determined. B. Can previously granted authorizations under the Special Access Programme make a drug “previously approved” under subsection C.08.004.1(1) of the Regulations ? [ 10 ] The Minister answered this question in the negative. Teva answers it in the affirmative. [ 11 ] As mentioned previously, the definition of “innovative drug” is found in subsection C.08.004.1(1) of the Regulations : 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. [ 12 ] The term “previously approved” in the definition of “innovative drug” is not itself defined. [ 13 ] Teva says that “previously approved” must be interpreted to include mass authorizations under the Special Access Programme.

To hold otherwise is to give Sanofi-Aventis an inordinate and unjustifiable monopoly for a number of years. In this case, Eloxatin had been widely available abroad for many years to treat colorectal cancer. It had been widely available in Canada for more than eight years under the Special Access Programme. It had been genericized in Canada and around the world. Yet, in 2007, the Minister granted it “innovative” status, forcing generics off the market. Teva says that that is against the purpose of

section C.08.004.1 and the Regulations generally. [ 14 ] Teva also submits that the Minister incorrectly interpreted “previously approved” as meaning whether a drug has received market authorization, i.e., whether a notice of compliance or drug identification number allowing the drug to be marketed was previously issued under the Regulations . In Teva’s view, had the Minister adopted an interpretive approach mindful of the need to avoid an inordinate and unjustifiable monopoly, she would have made a different decision. [ 15 ] In Teva’s view, an

interpretation of “approved” that encompasses authorizations under the Special Access Programme would allow for other relevant questions to be asked, all of which are in accordance with the purposes of

section C.08.004.1 and the Regulations generally. Had the drug been made widely available with the assent of the Minister? In granting so many authorizations under the Special Access Programme, had the Minister satisfied herself of the drug’s safety and efficacy? [ 16 ] Finally, Teva submits that “innovative drug” must be read consistently with Canada’s obligations under paragraphs 5 and 6 of

Article 1711 of the 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 and paragraph 3 of

Article 39 of the Agreement on Trade-Related Aspects of Intellectual Property Rights [Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization , signed in Marrakesh, Morocco, 15 April 1994], 1869 U.N.T.S. 299. Teva says that these treaty provisions compel consideration of whether the drug contains a new chemical entity, whether the drug submission contains undisclosed data necessary to determine safety and efficacy, and whether this data involved considerable effort.

Focusing on marketing approval (i.e., the granting of a notice of compliance and a drug information number), or what Teva calls market authorizations, ignores these considerations and, thus, is inconsistent with the treaty provisions. [ 17 ] I disagree with Teva’s submissions for three main reasons:

(1) The wording, architecture and purpose of the Regulations . Teva sees the definition of “innovative drug” in subsection C.08.004.1(1) and more broadly the Regulations as being aimed at achieving a compromise between providing monopolies to innovators for a period of time and allowing generics to obtain timely market access. This is the prism through which Teva interprets the word “approved” in subsection C.08.004.1(1) of the Regulations. But the wording, architecture and purpose of the Regulations suggest a different prism, that of the safety and efficacy of drugs, a matter that is evidenced only by approvals based on data and studies, strictly defined under the Regulations.

(2) Lack of clarity and uncertainty. Accepting Teva’s position would create uncertainty and lack of clarity, something that the Regulations try to eliminate.

(3) Subsection C.08.004.1(1) of the Regulations is a limited, special purpose provision. The definition of “innovative drug” in subsection C.08.004.1(1) of the Regulations was aimed at a limited, specific purpose, that of implementing Canada’s specific treaty obligations. Teva’s

interpretation of the subsection, which unduly narrows the definition of “innovative drug,” would run counter to these treaty obligations. The Minister’s

interpretation—defining “approved” as meaning the existence of a notice of compliance and a drug identification number—is consistent with Canada’s treaty obligations.

I develop these reasons below.

(1) The architecture and wording of the Regulations [ 18 ] Teva’s essential submission is that previous authorizations under the Special Access Programme can make a drug “previously approved” under

section C.08.004.1 of the Regulations . A full understanding of the architecture and wording of the Regulations shows that that cannot be so. [ 19 ] Under the Regulations, a new drug may not be marketed in Canada unless its manufacturer has first obtained a notice of compliance and a drug identification number:

section C.08.004 [as am. by SOR/95-411, s. 6] and subsection C.01.014(1) [as enacted by SOR/81-248, s. 2] of the Regulations . In order to obtain these, broadly speaking and as explained below, there must be a demonstration directly or indirectly founded upon data and studies that, in the Minister’s view, have established safety and effectiveness. [ 20 ] Notices of compliance can be obtained by one of two routes. Each route is founded upon the preparation and provision of data and studies that, in the Minister’s view, have established safety and effectiveness: • The first route is to file a new drug submission:

section C.08.002 [as am. by SOR/93-202, s. 24; 95/411, s. 4] of the Regulations . Typically, a new drug submission will contain voluminous clinical trial data and detailed studies. On the basis of the data and studies, the Minister evaluates the safety and effectiveness of the drug. If satisfied, the Minister grants a notice of compliance. • The second route is to file an abbreviated new drug submission:

section C.08.002.1 [as enacted by SOR/95-411, s. 5] of the Regulations . Generic drug manufacturers often follow this route. It allows these manufacturers to copy a marketed drug without having to provide clinical data demonstrating safety and effectiveness. Instead, the abbreviated drug submission need only show that the generic drug is bioequivalent to the marketed drug.

Where that is shown, the generic drug can piggyback on the data and studies concerning the marketed drug and the safety and effectiveness of the generic drug is established. [ 21 ] As for drug identification numbers, no manufacturer may sell a drug in dosage form unless one has been assigned: Regulations , at subsection C.01.014(1). A drug identification number is an eight-digit numerical code that identifies drug product characteristics including manufacturer, brand name, medicinal ingredient, strength of the medicinal ingredient, pharmaceutical form, and route of administration.

Through the drug identification number, a drug can readily be tracked or recalled in the event of an adverse drug reaction in the population. [ 22 ] In the case of a new drug, a new drug submission or an abbreviated new drug submission filed under Division 8 [of

Part C] of the Regulations serves as an application for a drug identification number. [ 23 ] When a drug is not “new” (as that term is defined), it is not subject to the requirements of Division 8. In that case, the application for a drug identification number is made through a drug identification number submission, and the drug is regulated primarily under

Part C, Division 1 of the Regulations . To receive a drug identification number, a drug manufacturer must file sufficient data to allow the Minister to evaluate the safety and efficacy of the drug for its intended use. [ 24 ] As with notices of compliance, there is a demonstration directly or indirectly founded upon data and studies that, in the Minister’s view, have established safety and effectiveness. [ 25 ] The Special Access Programme is different.

It allows for the use of certain drugs despite the absence of data and studies demonstrating the safety and efficacy of the drug. [ 26 ] The Programme is set out in sections C.08.010 and C.08.011 of the Regulations under the heading “Sale of New Drug for Emergency Treatment”. [ 27 ] This Court has described the Special Access Programme in the following way: … the Director (Assistant Deputy Minister, Health Products and Food Branch, Health Canada) may authorize the sale of a new drug to a physician under the Special Access Programmeme (SAP) for the emergency treatment of a patient.… … When requesting Health Canada for an authorization under the SAP, a physician must: (

i) describe the patient’s medical condition; (ii) explain why the medicine is the best choice for treating the condition; and (iii) provide data on the use, safety and efficacy of the medicine requested. If granted, an SAP authorization authorizes, but does not require, a manufacturer to sell a specified quantity of the medicine to the requesting physician for the emergency treatment of a specified condition of a named patient under the care of the physician.

The physician must report to Health Canada on the use of the medicine, including any adverse effects. … SAP authorizations…. are normally granted for serious or life-threatening conditions when conventional treatments have proved ineffective or are not suitable for the particular patient. Typically, medicines authorized under the SAP are treatments of last resort and are not subject to the same level of scrutiny for safety and efficacy as medicines for which an NOC has been issued.

Nonetheless, Health Canada reviews the SAP request and any other available data on the new medicine in order to “manage the risk” of its use. See Celgene Corp. v. Canada (Attorney General) , 2009 FCA 378 , [2011] 1 F.C.R. 78, at paragraphs 4 , 10 and 12, affd 2011 SCC 1 , [2011] 1 S.C.R. 3; see also Hospira Healthcare Corporation v. Canada (Attorney General) , 2010 FCA 345 , 92 C.P.R. (4th) 1. [ 28 ] Drugs available under the Special Access Programme are not founded upon data and studies that, in the Minister’s view, have established safety and effectiveness.

Rather, they are made available in emergency situations as a treatment of last resort where

conventional treatments have failed or are unavailable. As this Court has already held, sales under the Special Access Programme alone are not evidence of a determination by the Minister of the safety and efficacy of a drug: Hospira , above, at paragraph 6. Indeed, it is theoretically possible that drugs available under the Special Access Programme are not entirely safe or effective, but, owing to the grievous circumstances of the patient, they may have some upside and are worth the risk. Authorizations under the Special Access Programme are best seen as compassionate permissions, not as approvals for the drug.

(2) Lack of clarity and uncertainty [ 29 ] Before us, Teva submitted that this is an unusual and exceptional case. In this case, the Minister has authorized thousands of uses of Eloxatin under the Special Access Programme. She received reports regarding any adverse effects and, by 2007, had sufficient information for her to evaluate the safety and effectiveness of Eloxatin. Indeed, Teva suggests that the information available to the Minister was massive. It characterizes the matter as, in effect, a huge clinical trial that yielded more information than what appears in many new drug submissions.

On the basis of this information, Teva notes that the Minister continued to issue authorizations for its use.

This, it says, must mean that, in this unusual and exceptional case, the medicinal ingredient in Eloxatin was “approved” within the meaning of the definition of “innovative drug” under subsection C.08.004.1(1) of the Regulations . [ 30 ] Teva’s submission creates lack of clarity and uncertainty, something that the Regulations try to eliminate. [ 31 ] Whether or not a drug is approved and authorized for market and sale in Canada is of importance to the manufacturer, its competitors, medical professionals, pharmacists and patients. Clarity and certainty on this is essential.

For this reason, the Regulations have been carefully drafted to create clarity and certainty as to when a drug is approved. Under the Regulations, the magic moment of approval is signalled by the issuance of a notice of compliance and a drug identification number. [ 32 ] Teva’s

interpretation would lead to complicated factual inquiries and difficult questions that run counter to the theme of clarity and certainty in the area of approvals under the Regulations . How many authorizations under the Special Access Programme would be required in order to make a drug “approved” under subsection C.08.004.1(1) of the Regulations? Does the basis underlying each authorization need to be examined? Do we need to examine exactly what information was received by the Minister in response to the authorizations? When does inaction by the Minister in response to that information mean that the drug is “approved”?

(3) Subsection C.08.004.1(1) of the Regulations is a limited, special purpose provision [ 33 ] Many of Teva’s submissions embody the view that subsection C.08.004.1(1) of the Regulations is about achieving a compromise between providing monopolies for a period of time to innovative drug manufacturers while allowing timely market access to generic drug manufacturers. [ 34 ] In fact, this is not the case. Subsection C.08.004.1(1) of the Regulations is a limited, special purpose section.

It is designed to implement certain specific treaty obligations undertaken by Canada: subsection C.08.004.1(2) [as enacted by SOR/2006-241, s. 1] of the Regulations. These obligations are found in three treaty provisions: paragraphs 5 and 6 of

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

Article 39 of the Agreement on Trade-Related Aspects of Intellectual Property Rights , both above . [ 35 ] Broadly speaking, these treaty provisions aim to protect an innovator who submits undisclosed data in support of an application for approval to market a drug containing a new chemical entity. The treaty provisions accomplish this by preventing others from using the innovator’s data in support of their own applications for drug approval. This encourages the development of new drugs: Canadian Generic Pharmaceutical Association v.

Canada (Health) , 2010 FCA 334 , [2012] 2 F.C.R. 618, at paragraph 117 . [ 36 ] As mentioned in paragraph 16, above, Teva emphasizes that the treaty provisions require consideration of whether the drug contains a new chemical entity, whether the drug submission contains undisclosed data necessary to determine safety and efficacy, and whether the data involved considerable effort.

That may be true, but that does not shed direct light on the meaning of “previously approved” in subsection C.08.004.1(1) of the Regulations . [ 37 ] Of more relevance to the meaning of “previously approved” is the repeated mention in these treaty provisions of the concept of marketing approval or, as Teva puts it, market authorization.

Article 1711, paragraphs 5 and 6 of the North American Free Trade Agreement obligate Canada to protect data necessary for “approving the marketing” of pharmaceutical products for at least five years from when Canada granted “approval to the person that produced the data for approval to market its product.”

Article 39, paragraph 3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights similarly refers to data required “as a condition of approving the marketing of pharmaceutical” products.

In Canada, market approval under the Regulations means the issuance of a notice of compliance and a drug information number. [ 38 ] Given that the definition of “innovative drug” in subsection C.08.004.1(1) of the Regulations was intended to implement these treaty provisions, “previously approved” in subsection C.08.004.1(1) must mean a previous marketing approval, i.e., the previous issuance of a notice of compliance and a drug information number.

If someone has previously received a notice of compliance and a drug identification number for a particular drug, providing that person with data protection would go beyond the scope of the treaty provisions. Accordingly, the definition of “innovative drug” in subsection C.08.004.1(1) does not include drugs that have been “previously approved”. [ 39 ] Accepting Teva’s

interpretation—interpreting “previously approved” in subsection C.08.004.1(1) of the Regulations to include authorizations granted under the Special Access Program—would undercut the treaty provisions. The following scenario illustrates this. Suppose that a company submits undisclosed data to the Minister for a first-time approval of a drug containing a new chemical entity. Immediately after the submission, the Minister starts to grant authorizations for the emergency use of the drug under the Special Access Programme. Under Teva’s

interpretation, a certain number of authorizations would make the drug “previously approved”, stripping the drug of its status as an “innovative drug”, and allowing others to rely on the data submitted for their own applications for drug approval. Under this scenario, if Teva’s

interpretation is correct, the treaty protections would be undercut almost immediately. [ 40 ] Another scenario is where the Minister starts to grant authorizations for the emergency use of the drug under the Special Access

Programme before the manufacturer makes a submission. Under this scenario, if Teva’s

interpretation is correct, the treaty protectionsmight never apply. [41] These scenarios show that Teva’s

interpretation cannot be correct.

Section C.08.004.1 of the Regulations is aimed atimplementing the treaty provisions, not undercutting them. [42] Therefore, I conclude that drugs for which previous authorizations under the Special Access Programme have been granted arenot “previously approved” within the meaning of subsection C.08.004.1(1) of the Regulations. Although many authorizations had beengranted for Eloxatin under the Special Access Programme, Eloxatin had not previously received a notice of compliance or a druginformation number.

It follows that in these circumstances the Minister was correct in deciding that Eloxatin was an “innovative drug”under subsection C.08.004.1(1) of the Regulations and that it should remain on the register of innovative drugs under subsectionC.08.004.1(9) of the Regulations. C. The cross-appeal: Sanofi-Aventis’ preliminary objections [43] As mentioned at the outset of these reasons, Sanofi-Aventis advanced some preliminary objections to Teva’s application forjudicial review in the Federal Court. Sanofi-Aventis submitted that Teva lacked standing to bring its application for judicial review.

Italso submitted that the Minister’s decision was not a fresh decision, but rather was just a repeat of its original decision, made some threeyears earlier, to list Eloxatin on the register of innovative drugs. The Federal Court dismissed these objections. [44] In this Court, Sanofi-Aventis advances the same objections. It has chosen to do so in the form of a cross-appeal. [45] But a cross-appeal does not lie in this case. The Federal Court’s order does not adversely affect Sanofi-Aventis.

The FederalCourt’s order gave Sanofi-Aventis exactly what it wanted—a dismissal of Teva’s application for judicial review, with costs. Seegenerally Kligman v. M.N.R., 2004 FCA 152, [2004] 4 F.C.R. 477. [46] In reality, Sanofi-Aventis’ cross-appeal is directed against the Federal Court’s reasons for dismissing the preliminary objections.A cross-appeal lies against judgments and orders, not reasons: Froom v.

Canada (Minister of Justice), 2004 FCA 352, [2005] 2 F.C.R.195; Federal Courts Rules, SOR/98-106 [r. 1 (as am. by SOR/2004-283, s. 2)], paragraph 341(1)(b). [47] Even though Sanofi-Aventis has chosen the wrong mechanism for asserting its preliminary objections in this Court and eventhough I would dismiss Teva’s appeal on its merits, nevertheless I will address the preliminary objections.

We have had the benefit offull and helpful submissions on them and preliminary objections such as these may be asserted in similar cases. [48] Sanofi-Aventis’ first preliminary objection is that Teva is not a person “directly affected by the matter in which relief is sought”under subsection 18.1(1) [as enacted by S.C. 1990, c. 8, s. 5] of the Federal Courts Act, R.S.C., 1985, c. F-7 [s. 1 (as am. by S.C. 2002,c. 8, s. 14)]. [49] To consider this, the operation of the Regulations must be considered. When Eloxatin was placed on the register of innovativedrugs, there were two main effects.

First, Sanofi-Aventis, as the manufacturer of the drug, received an eight-year monopoly for Eloxatin.Second, for the first six years of the monopoly, Teva and all other generic manufacturers were prohibited from filing an abbreviated newdrug submission relating to Eloxatin.

This stopped them from seeking authorization to market their generic Eloxatin. (See generallysubsections C.08.004.1(3) [as enacted by SOR/2006-241, s. 1] and (4) [as enacted idem] of the Regulations.) [50] In both the Federal Court and in this Court, Sanofi-Aventis conceded that Teva would be a person “directly affected” by theMinister’s refusal to delist Eloxatin if Teva had filed an abbreviated new drug submission for its generic drug.

That is a fair concession.Those who file an abbreviated drug submission and have it rejected because of the listing of a drug on the register of innovative drugsare directly affected by that listing. They suffer an impact on their legal rights and they are prejudicially affected in a practical sense.They have direct standing under subsection 18.1(1) of the Federal Courts Act: League for Human Rights of B’Nai Brith Canada v.Canada, 2010 FCA 307, [2012] 2 F.C.R. 312, at paragraph 58; Rothmans of Pall Mall Canada Limited v.

Minister of National Revenue(No. 1), (FCA), [1976] 2 F.C. 500 (C.A.). [51] However, Sanofi-Aventis maintains its objection to Teva’s direct standing on two grounds. [52] First, Sanofi-Aventis submits that there is no evidence that Teva filed an abbreviated new drug submission for its generic drug.On this, Sanofi-Aventis is wrong.

There was evidence before the Federal Court to that effect: see pages 180–181 of the appeal book.Based on that evidence, the Federal Court found at paragraph 18 of its reasons that Teva did attempt to enter the market by filing anabbreviated drug submission. [53] Second, Sanofi-Aventis submits that Teva needed to have direct standing at the time it brought its application for judicial review.At that time, however, it lacked standing. At that time, it had not attempted to file an abbreviated new drug submission. [54] The Federal Court dismissed this ground of objection and so do I.

The direct standing requirement is found in subsection 18.1(1)of the Federal Courts Act and, like all statutory provisions, it falls to be interpreted in accordance with its plain words, other words of thestatute, and the purposes of the provision and the statute: Bell ExpressVu Limited Partnership v. Rex, 2002 SCC 42, [2002] 2 S.C.R. 559. [55] Here, the purposes of the Federal Courts Act significantly bear upon this matter.

Among other things, the Act is aimed atachieving justice, fairness, practicality, order, efficiency, and the minimization of cost, delay and waste in matters governed by the Act.The Act achieves these purposes by imposing various requirements, of which the requirement of direct standing is one.

Thoserequirements must be interpreted and applied with a view to achieving the purposes of the Act—not with a view to laying traps for theunwary or providing fodder for the mischievous. [56] I adopt the Federal Court’s conclusion at paragraph 18 of its reasons that accepting Sanofi-Aventis’ submission would “donothing to improve delivery of justice” and would serve “no good purpose”. In the face of a dismissal, Teva would simply restart its

application, this time with direct standing. If necessary, it would seek an extension of time to do so and would likely get it. Theneveryone would file the same evidence and, perhaps years later, would make the same submissions. All that will have been accomplishedis pointless cost, delay and waste. [57] Sanofi-Aventis raises one last preliminary objection. It notes that in 2007, the Minister had added Eloxatin to the register ofinnovative drugs. In 2010, in rejecting Teva’s request to remove it, the Minister simply made the same decision.

Sanofi-Aventis statesthat the Minister did not make a fresh “decision” within the meaning of subsection 18.1(2) [as enacted by S.C. 1990, c. 8, s. 5; 2002, c. 8,s. 27] of the Federal Courts Act. [58] I disagree. The Minister is obligated to “maintain” the register of innovative drugs: subsection C.08.004.1(9) of the Regulations.This includes the power to add or delete information to or from the register, as necessary: see Merck Frosst Canada Inc. v.

Canada(Minister of National Health and Welfare), (FC), [1997] 3 F.C. 752 (T.D.), decided in the context of the registermaintained under subsection 3(2) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-103. The Minister’s decisionrefusing Teva’s request was a decision concerning the maintenance of the register and was a fresh exercise of discretion. Accordingly,the Minister’s decision was a “decision” susceptible to judicial review under

section 18.1 of the Federal Courts Act. The presence orabsence of entries on the list may also be reviewable as a “matter” under subsection 18.1(1) of the Federal Courts Act: Air Canada v.Toronto Port Authority, 2011 FCA 347, [2013] 3 F.C.R. 606, at paragraph 24. However, it is unnecessary in this case to consider thatfurther. D. Proposed disposition [59] For the foregoing reasons, I would dismiss the appeal with costs. I would dismiss the cross-appeal with costs to the appellant andthe respondent Minister. I thank all counsel for their helpful and excellent submissions. Blais C.J.: I agree. Noël J.A.: I agree.