Monday, January 26, 2015

Claim Defined in the Alternative: A Circle of Logical Contradiction

Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC (NOC) 2015 FC 17 de Montigny J
            2,226,784 – tadalafil– CIALIS

In law we are accustomed to issues with two conflicting lines of authority. But when it comes to s 27(5) of the Act, which concerns claims framed in the alternative, we have one single line of authority – that ends of up contradicting itself, like a snake swallowing its own tail. There are two questions: (1) when a claim is framed in the alternative, so that s 27(5) applies, does the validity of the alternative in issue depend on the validity of the other alternatives?; (2) when a claim is not framed in the alternative, so that s 27(5) does not apply, does the validity of the alternative in issue depend on the validity of the other alternatives ? There are four possible answers to these two questions, and now, with de Montigny J’s Tadalafil decision, the courts have given all four answers, all based on one leading authority.

Friday, January 23, 2015

Date for Assessing Obviousness-Type Double Patenting Is Priority Date of Earlier Patent

Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC (NOC) 2015 FC 17 de Montigny J
            2,226,784 – tadalafil– CIALIS

The claims at issue in this NOC proceeding were to tadalafil (CIALIS) for the treatment of ED in men, specifically by oral administration [18]-[25]. As discussed yesterday, de Montigny J rejected Mylan’s utility attack.

The second substantive issue was obviousness type double-patenting over the 2,181,377 patent. Smooth muscle tissue, including heart and vascular muscles, as well as penile tissue, is relaxed by the so-called NO/cGMP pathway, with the end result that increased concentration of cGMP causes the smooth muscle tissue to relax [7]. Relaxation of penile tissue induces an erection. A class of enzymes known as PDEs break down cGMP. A compound that inhibits PDE can therefore prevent the breakdown of cGMP, resulting in increased concentration of cGMP, relaxation of the smooth muscle tissue, including penile erectile tissue. This was all known before sildenafil and tadalafil were discovered to treat ED. The ‘377 patent is a compound claim to tadalafil, and it discloses that tadalafil is a potent and selective PDEV inhibitor. The essential obviousness argument in this proceeding (as well as in various earlier proceedings regarding sildenafil), was that the information regarding the NO/cGMP pathway, combined with the knowledge that tadalafil was a selective PDEV inhibitors, made it obvious that tadalafil would be effective in treating ED.

The main legal question on this issue turned on the fact that the ‘377 patent, which revealed that tadalafil is a selective PDEV inhibitor, was not published until 27 July 1995, two weeks after the claim date of the ‘784 patent (14 July 1995). Thus the ‘377 patent could not be raised in a straight obviousness argument, because under s 28.3 obviousness is assessed in light of information disclosed before the patent's claim date. 

Mylan therefore relied on obviousness-type double patenting. The key contested legal issue was whether the date for assessing obviousness type double-patenting should be the priority date of the ‘784 patent or the priority date of the ‘377 patent [134]-[135]. That is, in assessing whether the ‘784 patent is obvious in light of the ‘377 patent, should the art that arose after the ‘377 date, but prior to the ‘784 date, be taken into account?

de Montigny J held that the priority date of the earlier, ‘377 patent, was appropriate, for two main reasons. First:

[134] If, as Mylan would have it, the relevant date was to be the priority date of the second patent (in this case, July 14, 1995), the obviousness-type double patenting analysis would morph into a pure obviousness analysis, with the added benefit that the timing requirements of section 28.3 of the Patent Act would be circumvented.

This strikes me as a very strong point. The judicially created obviousness type double-patenting cannot be used to do an end-run around a clear statutory provision.

His second point was that the rationale for the doctrine of obviousness type double-patenting is to prevent evergreening of the earlier patent by a claim to subject matter which makes no further inventive contribution [142]. Consequently, the question is “whether the claims of the ‘784 Patent disclose novelty or ingenuity over the ‘377 Patent” [133]. If it does, then the later expiry date of the second patent is not impermissible evergreening, but a reward for a further inventive contribution. That point also strikes me as compelling.

Having decided that the appropriate date was the ‘377 priority date, de Montigny J held that it was clear that there was no obviousness type double-patenting. The fact that tadalafil was a PDE inhibitor, and was useful for relaxing smooth muscle tissue, did not make it obvious that it would be useful for treating ED, because prior to the sildenafil patent and related publications, everyone had thought that relaxing smooth muscle tissue would cause ED, rather than treat it, by generally lowering the patient’s blood pressure [136]. The breakthrough that lead to the realization that tadalafil (and sildenafil) could be used to treat ED was the discovery that the the main PDE activity in human penile tissue is due to a particular type of PDE, PDEV, so that oral administration of PDEV would relax penile tissue but not vascular tissue [109]. That was far from obvious at the priority date of the ‘377 patent.

While important, the question of the appropriate date for assessing obviousness type double-patenting was not determinative, because de Montigny J also held on the facts that the use of tadalafil to treat ED would not have been obvious over the ‘377 patent and the common general knowledge even at the priority date of the ‘784 patent [149], for essentially the same reason: the state of the art had not changed significantly in the interim, and even at that later date it was still thought that oral administration of any PDE inhibitor, including a PDEV, inhibitor, would result in systemic hypotension.

Thursday, January 22, 2015

Utility of CIALIS Patent Upheld on the Facts

Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC (NOC) 2015 FC 17 de Montigny J
            2,226,784 – tadalafil– CIALIS

In this NOC proceeding, de Montigny J held that Lilly had established that its ‘784 patent was valid in the face of Mylan’s allegations of lack of utility and obviousness-type double patenting. The utility issue turned on the facts, and Lilly won comprehensively, so that alternative constructions of the promise of the patent were largely rendered moot. Perhaps the point of most general interest is that de Montigny J rejected the proposition that the word "treatment" implies lack of undue side effects. The obviousness-type double patenting issue raised one novel point of law, namely the appropriate date for assessing obviousness in the context of double patenting. Tomorrow’s post will look at that question. Perhaps the most interesting legal question raised by this case, albeit tangentially, turned on the interpretation of s 27(5), which provides that when a claim is framed in terms of alternatives, each alternative is to be considered a separate claim. A third post will discuss that issue.

The claims at issue were to tadalafil and 3-methyl tadalafil, or a pharmaceutical composition comprising those compounds, for the treatment of ED in men, specifically (Claim 18) by oral administration [18]-[25]. The argument relating to utility turned on the promise of the patent. The contentious issues were whether the patent merely promised the treatment of erectile dysfunction (ED) by use of tadalafil, as Lilly argued, or whether it also included efficacy in oral administration [76], and / or lack of toxicity [87], as argued by Mylan. Some interesting points of law were raised tangentially, but were largely rendered moot by de Montigny J’s holdings on the facts.

Monday, January 19, 2015

A Rule Without a Principle: Patentability of Methods of Medical Treatment

AbbVie Biotechnology Ltd v Canada (Attorney General) 2014 FC 1251 Kane J
2,385,745* – anti-TNF-α antibodies / HUMIRA dosage regime

Kane J’s Humira dosage regime decision is the latest chapter in the continuing saga of the patentability of methods of medical treatment. While Kane J’s holding that the claims in question are patentable is defensible, I am not persuaded by her view that the case law is consistent [84], as there is support in the case law for the opposite result. So far as I can tell, the case law is incoherent in the sense that it cannot be explained on the basis of any unifying principle, and progress in this area of the law will not be possible until that fact is generally acknowledged.

Tuesday, January 13, 2015

When is a New Drug Submission "Administrative"?

Pfizer Canada Inc v Canada (Attorney General) 2014 FC 1243 Gleason J
            2,409,059 – exemestane – AROMASIN.

Yesterday’s post discussed Gleason J’s holding that the standard of review of the Minister’s interpretation of s 5(1) of the PM(NOC) Regulations is correctness. Today’s post looks at the substantive question: when a first generic has received an NOC, is a second generic which licenses from that first generic subject to s 5? If the answer is yes, this means that a patentee can decide whether to respond to each NOA in light of the threat it perceives from the particular generic; if the answer is no, a patentee must respond to every NOA it receives, or take the risk that the generic in question will subsequently license. As a matter of law, this resolution of this question turns on the interpretation of the word “submission” for an NOC in s 5(1).

To recap the facts, GMP filed an ANDS with the Minister with respect to exemestane using Pfizer’s exemestane product, AROMASIN, as the reference product [45]. GMP served Pfizer with an NOA, and Pfizer chose not to respond. An NOC was then issued to GMP. On the same day, Health Canada also issued an NOC to Teva with respect to exemestane. This NOC was granted on the basis of an “administrative” ANDS filed by Teva, based on a licensing agreement with GMP. The NOC issued to Teva also shows AROMASIN as the Canadian Reference product [46]. Teva never served an NOA on Pfizer.

Teva undoubtedly did file a submission with Health Canada requesting an NOC, and the NOC was granted. The reference product was AROMASIN, and it is consequently clear on the authorities, and now on the face of the Regulations, that Teva’s ANDS compared its product “directly or indirectly” with Pfizer’s product. The only argument, then, is that the ANDS submitted by Teva is not a “submission” for the purpose of the Regulations. As noted yesterday, the AG carried the argument on this question.

The AG’s first argument was that the purpose of the Regulations is to allow the “early working” by a generic company of a patented drug, and Teva did not take advantage of the early-working exception – GMP did – so therefore, that under a purposive approach, Teva’s submission is not a “submission for an NOC.” Gleason J rightly rejected this purposive argument, noting that “The Regulations exist not only to allow generic companies to early work patented medicines to develop generic formulations and to have them ready as soon as possible but, also, to balance these interests with those of the patentee in obtaining protection for innovations that are legitimately patented” [133]. As noted in yesterday’s post, the proposition that the Regulations implement a balance is very well established. Moreover, the AG’s submission on the purpose of the provision seems to miss the point. S 5(1) does not implement the early working exception at all, which is found in s 55.2(1) of the Act. S 5(1) strikes the other half of the balance, namely the protection of the patentee’s interests. The Regulations as a whole strike the balance alluded to by Gleason J, and the purpose of s 5(1) in particular is almost the opposite of that suggested by the AG.

The AG’s next submission was in effect that the case law has established that not all submissions are “submissions” for the purpose of s 5(1); in particular, “administrative” submissions are not considered “submissions” which trigger s 5(1) [129]. The question then is what makes a submission an “administrative” submission?

The AG relied in particular on a series of cases holding that certain supplemental NDSs, specifically, those required where there is a change in the name of a drug, a drug manufacturer, or a change of manufacturing site, are not “submissions” for the purpose of submitting a patent list under s 4: see eg Hoffman-LaRoche 2005 FCA 140 [25]. Gleason J held that those cases were not relevant, on the basis that the concern in those cases – that the patentee should not be able to extend its entitlements under the Regulations with administrative filings – is very different from concerns as to whether the patentee should be required to address a particular generic [143]. While this strikes me as sound as a matter of purposive analysis, the textual argument that the word “submission” should be interpreted in the same way in both s 4 and s 5 is strong. But even if we accept that textual point, the cases cited are not particularly helpful, as the types of changes they discussed were different, and arguably less significant, than a submission by an entirely different party based on a licence.

The AG then appealed to the GlaxoSmithKline 2004 FC 1302 decision, in which Lemieux J held that Health Canada’s Name Change Policy did not trigger s 5. The product in GSK was a salbutamol inhaler. GSK has obtained a NOC for its salbutamol inhaler product, VENTOLIN, and it also obtained a formulation patent which it listed against that product. 3M obtained an NOC for its its salbutamol inhaler product, AIROMIR, on the basis of an entirely separate NDS. 3M also obtained a formulation patent which it listed against its product [13]. 3M and Apotex then entered into a licensing agreement permitting Apotex to sell 3M’s product under Apotex’s name. Apotex sought an NOC based on that agreement. GSK argued that Apotex’s submission triggered s 5, requiring Apotex to address GSK’s patent.

Gleason J held that GSK was distinguishable because Apotex was not required to address GSK’s patents because it was not using GSK’s product as a reference. That is, Apotex was not comparing its product, directly or indirectly, with GSK’s [142]. In this respect, GSK anticipates Biolyse 2005 SCC 26.

While I agree that GSK is strictly distinguishable for that reason, the fact that the comparison was indirect was something of a secondary consideration in Lemieux J’s decision. He also addressed the name change issue. On that point, Lemieux J’s decision in GSK turned on the fact that in its submission, Apotex certified that

...all aspects of the submission pertaining to: Apo-Salvent CFC Free submitted by: Apotex Incorporated are identical to Airomir... submission(s) except for a change in the manufacturer/sponsor's name and/or product name and that the product will be manufactured in the same location with identical specifications and procedures". [Lemieux J’s emphasis] [20]

Lemieux J held that the administrative NDS was not a submission because the purpose of the Food and Drug Regulations, which impose the requirement for an NOC, is to ensure the safety and effectiveness of drug products on the Canadian market [66]. The changes in the submission by Apotex were not relevant to the safety and effectiveness of the drug in question – it was “identical” to 3M’s product down to the point of being made in exactly the same plant – so the application for an NOC should not be seen as a “submission” for the purposes of the Food and Drug Regulations [68]. Moreover, because of the linkage between those Regulations and the PM(NOC) Regulations, the meaning of “submission” in the PM(NOC) Regulations should be given a similar interpretation [64].

Lemieux J’s purposive analysis strikes me as sound. In this case, if Teva would be manufacturing in a different plant from GMP, then GSK would be clearly distinguishable, and indeed, it strongly implies that the submission would not be purely administrative in that case. From an NOC perspective, the argument is reinforced; particularly in the case of a formulation patent (such as the 059 patent) the plant in which the product is made might be very significant in a patentee’s decision whether to address an NOA, because the likelihood of infringement would be directly affected. On the other hand, if Teva would be purchasing its product in final form from GMP, the argument that the filing was administrative is much stronger. GSK would still be distinguishable, because of the comparison point discussed at the outset, but the question would be very different. The question would be whether the patentee would be entitled to decide whether to challenge a particular NOA based on its assessment of the business practices of the generic in question, rather than the technical aspects of the product.

It is not clear to me which scenario is at issue in Exemestane. The nature of the license between GMP and Teva is not spelled out, and are details of Teva’s ANDS are not provided, so it is not apparent whether it has a certification similar to that emphasized by Lemieux J in GSK. Nor is s 3.4.1 of the PM(NOC) Guidance Document clear, at least to me. It applies only when the licensee seeks to sell the “identical” drug, but that term is not defined in that Guidance document. The policy on Changes in Manufacturer’s Name and/or Product Name does specify that for the purposes of that policy, a drug is considered identical only when the conditions of manufacture and sale are identical, but it is not obvious to me that that definition is intended to apply across all technical guidance documents.

Gleason J also relied on Nu-Pharm 1 (1997), 73 CPR (3d) 510, [22], aff’d (1998), 80 CPR (3d) 74 (FCA) and Nu-Pharm 2 [1999] FCJ No 1825, aff’d (2000), 5 CPR (4th) 138, holding that these cases were not distinguishable. I don’t know if I agree. In the Nu-Pharm decisions Generic 1 had obtained an NOC using a patentee’s product as a reference product, and Generic 2 sought to avoid having to address the patents by using Generic 1's product as a reference product. The FCA held that Generic 2 could not avoid addressing the patents by this strategy. This has been legislatively affirmed by the reference to an “indirect” comparison in the current s 5(1).

Gleason J held that the Nu-Pharm decisions were not distinguishable because “In both Nu-Pharm cases the generic company, just like Teva, had acquired the right to produce the drug in question under a licence from another generic company” [141]. However, I could not find any reference to a licence in any of the Nu-Pharm decisions. (And I don’t really see what kind of proprietary interest Generic 1 might have had in the right to produce the drug, so it’s not clear to me why Generic 2 would have required a licence.) So it is not clear to me if the Nu-Pharm cases are distinguishable. If, in this case, Teva intends to purchase the final product from GMP, then it seems to me that the cases are distinguishable, because it appears that in the Nu-Pharm cases Generic 2 was going to manufacture the product itself. On the other hand, if Teva intends to manufacture at a different plant than GMP, then I agree with Gleason J the cases are not distinguishable. That this is the case is suggested by Gleason J saying that Teva acquired “the right to produce the drug in question” under licence from GMP, implying that Teva, not GMP will be the manufacturer. But as discussed above, the case as a whole is not clear on this point.

In conclusion, some facts that seem to me to be quite important are simply not clear to me, and consequently I cannot assess the merits of the decision. While the facts in question were no doubt clear to the parties and to Gleason J, for the sake of guidance for future applicants and litigants, I hope that on the inevitable appeal, the FCA will clarify these issues or explain why the questions I have discussed are not relevant.

Monday, January 12, 2015

Correctness Standard of Review for Minister's Interpretation of S 5 of the PM(NOC) Regulations

Pfizer Canada Inc v Canada (Attorney General) 2014 FC 1243 Gleason J
            2,409,059 – exemestane – AROMASIN.

Under s 3.4.1 of the most recent (2012) Guidance Document: Patented Medicines (Notice of Compliance) Regulations, if one generic has received an NOC by comparing its product with a patentee's reference product, and a second generic obtains a licence from the first, the licensee is not required to comply with s 5 of the PM(NOC) Regulations, which is to say that the licensee need not serve an NOA on the patentee and need not address the patents listed against the drug [33]. Prior to April 2012, when the new Guidance document came into effect, a licensee would have been required to comply with s 5 [31]. Under the new policy Health Canada will require only an “administrative” drug submission, such as is used when a party that has received an NOC changes its name as a result of a corporate restructuring [28].This change in policy was made as a matter of Health Canada’s changed interpretation of the Regulations; there was no change to the Regulations themselves.

In this case, Pfizer successfully challenged that new policy (though an appeal will no doubt follow). Note that counsel for the Attorney General carried the argument in this case [51], so Health Canada evidently (and rightly) views this as a policy issue of general significance.  

Generic Medical Partners Inc. [GMP] filed an ANDS with the Health Canada with respect to exemestane, using Pfizer’s exemestane product, AROMASIN, as the reference product [45]. In August 2013 GMP sent Pfizer an NOA with respect to the ‘059 Patent, which was listed by Pfizer against AROMASIN. Pfizer chose not to commence a prohibition application against GMP, apparently because GMP does not sell products in Canada [44]. The NOC was issued to GMP for exemestane in October [45]. On the same day, Health Canada also issued an NOC to Teva with respect to exemestane. This NOC was granted on the basis of an administrative ANDS filed by Teva, based on a licensing agreement with GMP. The NOC issued to Teva also shows AROMASIN as the Canadian Reference product [46]. Teva never served an NOA on Pfizer. Pfizer sought judicial review to set aside the NOC granted to Teva [1].

There were two main issues. The first was the standard of review applicable to the Minister’s interpretation of the PM(NOC) Regulations. I discuss that issue in this post. The second was the substantive interpretation of the relevant provisions. I will discuss that in tomorrow’s post.

There were three main issues relating to the standard of review: (1) whether prior case law of the Federal Courts applying a correctness standard to decisions of the Minister of Health under the PM(NOC) Regulations were still binding in light of recent SCC case law [58]; (2) whether it mattered that the decision-maker was the Minister as opposed to an administrative tribunal [59]; and third, whether the decision of the SCC in Canadian National Railway v Canada 2014 SCC 40 [CN] meant that a reasonableness standard is always applicable when an administrative decision-maker interprets its constituent statute or regulation, or a statute or regulation that is closely connected with its function, unless the decision falls into one of four exceptions which were not suggested to be relevant in this case [60].

On the first issue, Gleason J agreed with the Attorney General that pre-Dunsmuir 2008 SCC 9 case law of the FC and FCA [58] cannot be considered determinative, and that in light of Dunsmuir and subsequent SCC cases, the reasonableness standard is “presumptively” applicable whenever an administrative decision-maker interprets its constituent statute or a statute or regulation that is closely connected with its function [67].

While the conclusion that pre-Dunsmuir case law of the Federal Courts can no longer be determinative seems fair enough, I am puzzled by the fact that the SCC Biolyse 2005 SCC 26 decision was not discussed in this context. The question at issue in this Exemestane case was the Minister’s interpretation of “submission" for an NOC in s 5(1) of the Regulations [123]. The question at issue in Biolyse was the interpretation of the word “submission” in s 5(1.1) as it then was [Biolyse 40ff]. The changes to s 5 were aimed at addressing when a patentee's product is considered a reference product (when a comparison is made "directly or indirectly" in the current provision), and not what constitutes a "submission." That is, the question was the deference to be given to the Minister’s interpretation of the very same word, in functionally the same provision. This is the very next thing to being exactly the same question.

In Biolyse, the SCC held that “On the question of interpretation, the Minister's opinion is not entitled to deference. The Federal Court quite properly said that the standard of review on that point is correctness” [36]. The discussion was brief, but this is evidently because the SCC thought the point was clear, and in any event it was undoubtedly part of the ratio of the case. It is true that the FC’s 2002 FCT 1205 [20]-[29] assessment of the standard of review in Biolyse was based on the “ pragmatic or functional analysis” that is no longer the accepted approach. But my understanding is that Dunsmuir was intended to simplify the previous three-standard model (correctness, reasonableness and patent unreasonablness) that had proven too difficult to apply: “What is needed is a test that offers guidance, is not formalistic or artificial, and permits review where justice requires it, but not otherwise. A simpler test is needed” [Dunsmuir 43]. In particular, the crux of the difficulty was that "lower courts were struggling with the conceptual distinction between patent unreasonableness and reasonableness simpliciter" [40]. So, the problem is not that SCC itself was getting wrong answers, but that it was not providing sufficient guidance. I don't see this as saying that the highly contextual functional test which had been previously applied was wrong in principle, just that it was too difficult to apply. None of this calls into question the specific results of the contextual, functional analysis, properly applied. 

Given the difficulty of applying the previous test, we might well doubt whether it was properly applied by lower courts, but I don’t see why Dunsmuir should call into question the outcome of the functional analysis when the previous test was applied by the SCC itself. In this case, the SCC Biolyse decision was discussed at length in other parts of Gleason J’s decision, but not at all in the context of the standard of review, presumably because it was not argued. It seems that the parties must have thought it so clear that Biolyse was implicitly overruled that it was not worth even discussing the specific SCC holding in Biolyse. This is quite remarkable. Biolyse itself was not discussed in Dunsmuir, so if it is no longer good law on this point, it can only be because Dunsmuir implicitly over-ruled all prior SCC decisions, not just on the general approach, but on the specific holding of all those cases on their facts. This seems to me to be far-fetched, given that the SCC built its new approach by a synthesis of the strengths of its prior case law (see eg [54]). Moreover, all of the members of majority in Dunsmuir, except Bastarache J, were also members of the majority in Biolyse that held the standard of review to clearly be correctness. Could they really have changed their minds so dramatically about judicial review in the intervening three years as to want to repudiate their own specific holdings? 

I am not an administrative law expert, so I may well be missing something glaring. But it certainly looks to me like the SCC itself has already held that the appropriate standard of review for the Minister's interpretation of the word "submission" in s 5 of the PM(NOC) Regulations is correctness, and this holding is still good law.

Moving on, Gleason J also agreed with the Attorney General that the fact that the Minister was the decision-maker does not in itself alter that presumption [84], given that FCA case law was split on this point [80].

However, Gleason J rejected the view that CN implies that the presumption of a reasonableness standard can only be rebutted in the four enumerated exceptions [88]. After an extensive review of the SCC authorities, Gleason J held that while the SCC case law as a whole does establish a presumption that the standard is reasonableness, the SCC authority requires a contextual analysis as to whether the presumption has been rebutted [98]. The four exceptions in which a correctness standard applies are only four cases where it has been settled, by a contextual analysis, that the presumption of a reasonableness standard has been rebutted; they do not constitute an exhaustive taxonomy of the only times the reasonableness standard can possibly be rebutted.

Again, I am not an administrative law expert, but Gleason J’s analysis appears to me to be sound in light of the many cases she cites. Moreover, it seems to me that the four exceptions cannot be exhaustive. For example, if the relevant statute explicitly provided that the administrative decision-maker was not entitled to deference, then a correctness standard would necessarily apply, even though that situation is not one of the four enumerated exceptions. (The closest is the existence or absence of a privative clause, which is a contextual factor, not an enumerated exception.) The discussion of the standard of review in CN is quite brief – only eight paragraphs ([55] - [62]) – and it strikes me as nothing but an application of the established framework of analysis, resulting in a finding of a reasonableness standard on the facts of the particular case. I think Gleason J is right to say that “[i]t would take a much more deliberate treatment of the issue by the Supreme Court than that which is contained in CN” to effect a change in the approach endorsed by the SCC [98].

The question then was whether, on a contextual analysis, the presumption of a reasonableness standard should be considered to be rebutted in this case. Gleason J held that it was rebutted. One key point was that the Minister has no discretion as to when to issue an NOC [114], and indeed,

the Governor in Council left the ultimate determination of whether an NOC should be issued under the PMNOC Regulations to this Court as it is the Court that is required to rule on prohibition applications made by innovator companies who wish to forestall the issuance of an NOC to a generic company through an ANDS. The role assigned to this Court under the PMNOC Regulations is inconsistent with application of the reasonableness standard to interpretations of the Minister or officials at Health Canada of the Regulations. [115]

This latter point in particular strikes me as compelling. A purposive analysis plays an important role in the modern approach to statutory interpretation. The purpose of the provision must be considered, but it must be considered in light of the purpose of the legislation as a whole. That is particularly true in the case of the PM(NOC) Regulations, where both the case law and the RIAS accompanying the 2006 amendments make it clear that the PM(NOC) Regulations are intended to strike a balance between the goals of promoting timely entry of generics, and providing effective patent enforcement: [16], [134], Biolyse [2]. The Minister of Health has no particular expertise in the construction of the PM(NOC) Regulations as a whole. The various provisions have been heavily litigated before the courts, and often the Minister, though a party to the proceeding, does not participate. This is true even of cases which raise issues of the interpretation of the Regulations. So, for example, the Minister has no view as to whether the allegations in the NOA must be correct as of the date of the hearing or as of the date the NOA was served: 2009 FC 648 [7]. Indeed, some of the provisions will never be interpreted by the Minister, even nominally, because they are only applicable in an action between the generic and the patentee (eg the s 8 remedial provisions). Because the Federal Courts are called on to interpret and apply all aspects of the Regulations, they have a better understanding of the balance sought by the Regulations as a whole. When the legislative history insists that the Regulations must be understood as a whole, it seems to me very unlikely that when the legislature would have intended to give deference to an interpretation by the Minister, who actively engages with only a part of those Regulations.

Finally, on a personal note, Dunsmuir was the clerk of the court in Fredericton, New Brunswick (the full name of the case is Dunsmuir v New Brunswick), and my wife and I were married in 2004 at the Fredericton City Hall, by David Dunsmuir, about a year before he was removed from office. He did a brief Elvis impersonation, which my wife particularly enjoyed, but so far as I know he performed competently, and we are validly married.