Gliclazide Dosage Form Patent Obvious and Not Infringed

Les Laboratoires Servier v Apotex Inc / gliclazide (NOC) 2015 FC 108 Roy J
            2,629,670 / gliclazide / DIAMICRON MR

In Gliclazide Dosage Form Roy J dismissed Servier’s application for an order of prohibition, primarily on the basis of non-infringement [147], though he went on to hold the patent to be obvious and lacking in utility. The findings of non-infringement and obviousness turned largely on the facts and do not raise any novel legal issues, but the discussion of utility is noteworthy for holding explicitly that the factual basis for demonstrated utility must be disclosed in the patent. This post discusses the first points, and tomorrow’s will discuss utility.

Gliclazide is a known compound used for treating diabetes. The original dosage form was a breakable immediate release tablet [4]. Subsequently, a modified (slow) release tablet was developed, but it was not breakable [5]; some modified release formulations should not be broken, as dividing the tablet will alter the release profile. The invention of the ‘670 patent is related to a breakable modified release table with an identical dissolution profile whether or not it has been subdivided [70]. It was not disputed that the essential elements of claim 1 of the ‘670 patent are to a “gliclazide, a cellulose derivative which provides the modified release of the active ingredient, a binder and, once subdivided, that the gliclazide tablet has an identical dissolution profile to that of the whole tablet” [101]. The other asserted claims were variations on this theme [80].

There was dispute as to whether Apotex’ product had a binder: Apotex argued that it’s product was held together by compression, without a separate binder, while Servier argued that the cellulose derivative that was present in Apotex' product can serve both as a binder and a modified release matrix [113], [116]. There was also dispute as to whether the “identical dissolution profile” referred to the profile measured in vitro or in vivo. Apotex prevailed on both these point, which turned primarily on the terms of the patent itself. Without going into the details, I will simply say that Roy J’s analysis on these issues struck me as entirely sound.

The finding of non-infringement followed almost directly from the claim construction. There are two points of some general interest. First, Servier argued that Apotex’ evidence of its manufacturing process, which goes to the point that it tablets were held together by compression, without a binder, was inadmissible because it was not disclosed in the NOA [133]. Roy J rejected this on basis “that Apotex did not have to anticipate the position Servier chose to take,” which is to say the position that the patent should be construed to that the cellulose derivative could serve a dual purpose [133]. Roy J at [136] quoted the FCA 2005 FCA 270 [16]: “A second person [the generic] should not be required to anticipate every theory of possible infringement, however speculative, in the detailed statement supporting its allegations.”

The second point of some interest is that Servier argued that the fact that Apotex had obtained regulatory approval by showing bioequivalence with Servier’s product showed that Apotex’ product must have had an identical in vivo dissolution rate [141]. Roy J rejected this on the basis that even if that is true, the patent, properly construed, speaks to in vitro dissolution rate [142]. So, while infringement in NOC proceedings is often conceded, regulatory approval using the patentee’s product as a comparator, does not necessarily imply infringement of a patent covering that product.

The obviousness aspect of the Roy J’s decision turned straightforwardly on the facts: “[185] In my opinion, Apotex has in effect shown that the skilled worker would have been able to combine the mosaic of prior art into the claimed invention. The step was not high. The gap was not broad.”

Golden Bonus Rule Applied

Janssen Inc v Teva Canada Ltd / bortezomib (NOC) 2015 FC 184 Barnes J
            2,435,146 – bortezomib formulation – VELCADE

In this NOC proceeding Barnes J held the claimed invention to be obvious using an obvious-to-try analysis. While the case turned largely on the facts, it does make one important legal point of general interest, which is that the discovery of a non-obvious characteristic of an otherwise obvious invention cannot support a patent. This is known in UK law as the “golden bonus” rule. And while not as legally noteworthy, Barnes J’s decision is a very good example of the application of the obvious to try analysis to hold a patent invalid. Finally, the argument turned in part on the identity of the skilled person, and the case illustrates the established law that the patent must be read as a whole when identifying the expertise of the person skilled in the art.

More File Wrapper Estoppel in Canada

Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC / tadalafil (NOC) 2015 FC 125 de Montigny J
            2,371,684 – tadalafil dosage form – CIALIS

The ‘684 patent was for tadalafil in a dosage form of less than 20mg, with separate claims to various specific dosage forms (eg “5. The dosage form of claim 3 comprising about 5 mg of the compound in unit dosage form”). A question arose as to whether a maximum daily dosage of 20mg should be considered to be an essential element of the claims [150]. de Montigny J rejected this argument, relying in part on the file history. The application originally filed with the Patent Office contained claims reciting the method of treating sexual dysfunction comprising administering about 1 to 20 mg tadalafil, up to a maximum total dose of 20 mg per day. These claims were rejected for claiming a method of medical treatment. In response, Lilly redrafted these claims as “use” claims and removed any reference to a maximum total dose per day [154]. Citing his own prior decision in Distrimedic 2013 FC 1043, [209-10], held that it was proper to use this file history in interpreting the claims:

[154] While the file history of a patent application is generally considered as extrinsic evidence and not admissible, I have already held that a change in the wording of a claim as a result of an objection from the Patent Office is an objective fact that can be considered and from which an inference may de drawn

This is notwithstanding the SCC’s insistence in Free World 2000 SCC 66 that in light of the objective nature of claim construction “To allow . . . extrinsic evidence [such as statements or admissions made in the course of patent prosecution] for the purpose of defining the monopoly would undermine the public notice function of the claims, and increase uncertainty as well as fuelling the already overheated engines of patent litigation” [66]. As I argued in my post on Distrimedic, de Montigny J is right to allow this use of the file history and the SCC is wrong. This Tadalafil Dosage Form decision provides another illustration of why it is wrong to allow a patentee to try to reclaim in litigation a limitation that it gave up in prosecution. As discussed here, the alternative approach to dealing with this kind of shifting position is to invoke s 53(1), potentially resulting in the invalidation of the entire patent. Patentees might prefer to embrace file wrapper estoppel.

Promise of the Patent and Obviousness

Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC / tadalafil (NOC) 2015 FC 125 de Montigny J
            2,371,684 – tadalafil dosage form – CIALIS

In Plavix 2013 FCA 186 the FCA held that utility will only be measured against the promise of the patent when an “explicit” promise is made and “it should not be taken to have assumed that every patent contains an explicit promise” [49]-[50]. As I noted in my post on that decision “The crucial question will be how explicit a promise must be in order to establish the standard for utility.” I predicted that direct statements of use such as ‘The compounds of this invention . . . are useful” for a particular purpose would be treated as promises. de Montigny J’s decision in Tadalafil Dosage Form confirms this prediction. (For a similar decision, see also 2014 FC 638, blogged here). Consequently, it seems that while Plavix may have restrained some of the more aggressive applications of the doctrine, the promise of the patent remains very much a central feature of Canadian patent law. The case also illustrates that the promise doctrine is unnecessary to deal with defects that are better addressed by the non-obviousness requirement.

It’s significant that de Montigny J began his discussion of utility with the following statement:

[85] The promise of a patent is fundamental to the utility analysis and must be ascertained at its outset. As stated by the Federal Court of Appeal in Sanofi-Aventis v Apotex, 2013 FCA 186, at para 47, “[t]he promise of the patent is the standard against which the utility of the invention described in the patent is measured”.

This would have been uncontroversial pre-Plavix, but it is difficult to square with the holding in Plavix that “it should not be taken to have assumed that every patent contains an explicit promise.” This reversion to this pre-Plavix premise suggests that Plavix’s impact may be quite limited.

The ‘684 patent was for tadalafil in a dosage form of less than 20mg. Lilly’s position was that the promise of the patent is that the claimed doses are efficacious and have a better side effects profile than sildenafil [86], while Mylan argued that the patent promised not just an improved side effects profile, but to reduce side effects to “clinically insignificant levels” [95]. The particular side effects in question were flushing, vision abnormalities, and a potentially life-threatening reduction of blood pressure when tadalafil is co-administered with nitrates, which are used to treat heart conditions. The last was most important because it is potentially fatal [90].

Key language in the patent included the following statements [93]-[94]:

Most unexpectedly, the product also can be administered with clinically insignificant side effects associated with the combined effects of a PDE5 inhibitor and an organic nitrate. Thus, the contraindication once believed 20 necessary for a product containing a PDES inhibitor is unnecessary when Compound (I) is administered as a unit dose of about 1 to about 20 mg, as disclosed herein. (4)

The present invention is based on detailed 25 experiments and clinical trials, and the unexpected observations that side effects previously believed to be indicative of PDE5 inhibition can be reduced to clinically insignificant levels by the selection of a compound and unit dose. (10)

de Montigny J construed this and other similar language as promising a reduction of side effects to clinically insignificant levels. The promise was held not to be satisfied, in part because co-administration of tadalafil and nitrates is strictly contraindicated by both US and Canadian health regulatory authorities [61]. Thus, the patent was construed as promising a regulatory standard of utility [99]. Since it is well-established that regulatory approval is not the general standard for patentable utility, it is clear that the patent was construed as promising a much higher utility than the minimum which would be required to establish patentable utility in the absence of an explicit promise.

Consequently, the patent was held to be invalid for failing to meet this stringent standard for the promised utility [122]. However, the heightened promise was not determinative, as de Montigny J held that even the promise proposed by Lilly, namely an improved side effects profile as compared with sildenafil, had not been established [144].

This decision shows that the promise doctrine continues to play a central role in the Canadian law of utility. I have been and continue to be critical of that doctrine: see Form and Function in the Law of Utility: A Reply to Gold & Shortt, (2015) 30(2) CIPR 109 (draft version available here). As I see it, even Lilly put the promise too high. The ‘684 patent is clearly useful, because the claimed invention is effective in treating ED.

With that said, the fact that tadalafil does not have an improved side effects profile as compared with sildenafil is certainly relevant to the validity of the '684 patent, but it goes to obviousness, not utility; and, as discussed yesterday, the patent was properly held to be invalid on that basis. Indeed, the question of whether the side effects are reduced to clinically insignificant levels is relevant to obviousness. This is not because obviousness is measured against statements made in the patent. Rather, as discussed in yesterday’s post, on the facts a reduced dosage is expected to result in reduced side effects, and therefore a reduced dosage form would only be inventive if the side effects were reduced to an unexpected degree. The assertion that the side effects were reduced to clinically insignificant levels was likely made to convince the examiner that the reduction in side effects was sufficiently unexpected to satisfy the inventive step requirement. This does not mean that the patentee should be held to such promises of utility, as some have suggested. On the contrary, it is will established that the standard for obviousness is objective; it is what a skilled person would find obvious, not what the inventor thought was obvious. (See eg Nichia Corporation v Argos Ltd, [2007] EWCA Civ 741 [13].) The proper response is simpler. Regardless of what the patentee might have “promised” or not “promised” if the reduction in side effects are not in fact large enough to be unexpected to a person skilled in the art, then the patent will be invalid for obviousness. That is exactly what happened in this case.

Reduced Dosage Form of Tadalafil Obvious to Try

Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC / tadalafil (NOC) 2015 FC 125 de Montigny J
            2,371,684 – tadalafil dosage form – CIALIS

In this NOC proceeding de Montigny J held that Lilly’s tadalafil dosage form patent was invalid for failure to satisfy the promise of the patent, as being anticipated, and for obviousness. While the decision raises some interesting legal points regarding the promise of the patent, anticipation, and prosecution history estoppel, the holding respecting obviousness was quite straightforward and it is convenient to begin by discussing that aspect of the case.

Both sildenafil and tadalafil were known in the prior art for the treatment of ED. Lilly’s ‘784 patent, claiming tadalafil for the treatment of ED, disclosed unit doses of tadalafil from 0.2 to 400 mg [4] (and see 2015 FC 17, blogged here, holding the ‘784 patent to be valid). Sildenafil was marketed in doses of 25 mg, 50 mg, and 100 mg, with 100mg being the most common dose [6], [10]. Sildenafil has a variety of side effects, including flushing, vision abnormalities, and a negative interaction with nitrates that are used to treat heart conditions [6]. Early studies with tadalafil used 100mg doses. Lilly researchers discovered that despite being equipotent with sildenafil, tadalafil did not need high doses, and lower doses of tadalafil could be used effectively and with reduced side effects. This discovery was the basis for the ‘684 patent [12]..

There was some debate as to whether the inventive concept included reduced side effects, or was simply a dosage of less than 20mg for the treatment of ED [164]. If the inventive concept was simply the dosage, then it seems to me that it must be obvious, as the ‘784 patent disclosed that dosages of tadalafil including that range would effectively treat ED, so there would be no technical contribution to what was already known. For the invention to be non-obvious, there must be something surprising about the claimed dosage range, such as unexpectedly reduced side effects. In any event, de Montigny J did not need to resolve this debate as he found that the invention was obvious even if the inventive concept included reduced side effects. He found on the facts that in drug development it is standard practice to lower the dosage to reduce side effects [168] and there is a standard process for determining a minimal effective dose [169], so it would have been routine for a skilled person to carry out a dose escalation study starting at 5mg and moving up to 50mg [170]. Even though the optimal dosage regime could not have been predicted in advance, that lower dosages were effective with reduced side effects was the unsurprising outcome of a routine research program that a skilled person would be motivated to carry out [172]. This is a classic case of an invention that is obvious to try. Lilly argued that a skilled person would not have been motivated to try doses of less than 50mg, but de Montigny J rejected this on the facts [165].

Moot NOC Proceedings Remain Moot Despite Impending CETA

Janssen Inc v Teva Canada Ltd 2015 FCA 36

This is an appeal from a decision of Barnes J in an NOC proceeding (2014 FC 1192, not yet publicly available), refusing to grant an order of prohibition [5]. The NOC was issued eight days after the judgment [6]. The patentees appealed four days later. Unsurprisingly, the FCA has dismissed the appeal as moot, in accordance with its long-established jurisprudence.

The FCA noted that while it does have the discretion to hear a moot appeal, to date it has exercised that discretion only once [8], [11]. Janssen’s main argument that the FCA should hear the appeal in this case is that Art 9 bis of the IP chapter of CETA gives all litigants “equivalent and effective rights of appeal” [12]. But as the FCA pointed out, CETA is not yet part of Canadian law [14].

Compound Pre-Judgment Interest Arrives in Canadian Patent Litigation

Eli Lilly and Co v Apotex Inc / cefaclor, 2014 FC 1254 Zinn J [Cefaclor Damages]
            1,133,007 – 1,146,536 – 1,133,468 – 1,150,725 [the Lilly Patents]
            1,095,026 – 1,132,547 – 1,136,132 – 1,144,924 [the Shionogi Patents]

Zinn J’s Cefaclor Damages decision is a major step in taking the law of pre-judgment interest in an economically sound direction. The first step was taken by Gauthier J in the liability phase of this bifurcated action, Cefaclor Liability 2009 FC 991 aff’d 2010 FCA 240. As described in more detail in my blog post on the interest issue in that decision, the common law traditionally prohibited interest and while that prohibition was statutorily reversed those statutes did not allow for compound interest. In Bank of America 2002 SCC 43, (aka Clarica Trust), the SCC recognized that simple interest is not fully compensatory, and consequently, the SCC held that even if compound interest was not available under the relevant statute, it was available under the common law of contract as compensation, so long as it was claimed as such and proven.

Allegation of Non-infringement Need Not Be Put “In Play”

Bristol-Myers Squibb & Gilead Sciences v Teva / efavirenz (NOC) 2015 FCA 3 Near JA: Dawson, Stratas JJA aff’g 2014 FC 30 Barnes J
             2,279,198 / efavirenz / ATRIPLA

In this NOC proceeding, the FCA has affirmed Barnes J’s decision that the patentee failed to established that Teva’s product would infringe the ‘198 patent for a particular crystalline form of efavirenz. The decision at first instance (blogged here) turned entirely on the facts, and the FCA affirmed on the basis that the appellant patentee had not established and palpable and overriding error.

The only point of general legal interest is that the FCA held that when non-infringement is alleged in an NOC proceeding, there is no evidentiary burden on a generic to adduce evidence in order to put that allegation “in play.” It is enough to make the allegation in the NOA, and the burden is then on the patentee to prove infringement on the balance of probabilities [11], [8]. This is in contrast to an allegation of invalidity, in which the generic must adduce some evidence to put the allegation of invalidity into play before the burden shifts to the patentee to disprove invalidity. The reason for the difference is the presumption of validity under s 43(2) of the Act [10].

"That Mode Is Adopted Which Is . . . the Least Burthensome to the Defendant"

Eli Lilly and Co v Apotex Inc / cefaclor, 2014 FC 1254 Zinn J [Cefaclor Damages]
            1,133,007 – 1,146,536 – 1,133,468 – 1,150,725 [“Lilly Patents”]
            1,095,026 – 1,132,547 – 1,136,132 – 1,144,924 [“Shionogi Patents”]

In the liability phase of this bifurcated action, Cefaclor Liability 2009 FC 991 aff’d 2010 FCA 240, Gauthier J held that at least one valid claim of each of the eight patents was infringed by Apotex. Lilly elected damages, which were assessed by Zinn J in the decision at hand. Sunday’s post concerned the misnamed “NIA defence,” which turned entirely on a question of law. Today’s post looks at what I will call “reverse springboard” damages, though that is probably also a misnomer. The question is whether Lilly should be able to claim lost profit damages for sales it would have made in the but for world, even though in the relevant period in the actual world Apotex was selling non-infringing product.

At issue were two set of four patents relating to processes for producing cefaclor. (The so-called “Shionogi patents” had been assigned to Lilly by Shionogi. The different sets of patents related to somewhat different processes.) There were essentially three processes used to make the cefaclor imported and sold by Aptoex: Kyong Bo, Lupin 1 and Lupin 2. The first two processes were infringing, but Lupin 2 was non-infringing. (More precisely, Lilly failed to prove that Lupin 2 infringed and Zinn J took this as tantamount to a finding of non-infringement for the purposes of the damages phase [61].) In the liability phase it was established that the last shipment of infringing cefaclor was received by Apotex on June 3, 1998 [Liability 228-29], [58]. Presumably there was some subsequent period during which Apotex sold infringing product that it had imported prior to that time, but unfortunately, it is not clear from either the liability decision or the damages decision exactly when the last infringing product was sold by Apotex in Canada.

On the question of when Apotex would have entered the market with non-infringing product in the “but for” world, Apotex argued that

proof of what it would have done in the but-for world is established by what it did in the real world. In the real world, when it determined that the process being used infringed the patents, it sought out a non-infringing process and continued selling in the marketplace. [63]

Zinn J rejected this, and held that in the but for world, Apotex would not have been in the cefaclor market under April 19, 2000, when the last of the Shionogi patents expired [70]. It is implicit in this exchange that in the real world, the last infringing product was sold by Apotex prior to that time. My understanding is that Apotex stopped selling infringing product by the summer of 1999 at the latest, so that all product sold in the real world in the period from (at least) the late summer of 1999 to April of 2000 was non-infringing.

So, my analysis of this point proceeds on the basis that Lilly was awarded lost profit damages on sales it would have made in the but for world for a period during which Apotex was selling non-infringing product in the real world.

On its face, Zinn J’s reasoning is based simply on the construction of the but for world on the facts. The main evidence relied on by Apotex to establish that in the but for world it would have used a non-infringing process, at least as of the summer of 1999, is that it did so in the actual world. Specifically, in the real world, Apotex “sought out” a non-infringing process “when it determined that the process being used infringed the patents” [63]. Zinn J accepted this as true [63], but he was not persuaded that that is what Apotex would have done in the but for world. His reasoning is quite brief, but if I understand it correctly, he is saying that Apotex developed an NIA only because it was in the market and wanted to stay in the market. If it had not entered the market in the first place, it would not have had any incentive to develop the NIA [63]-[64]. That is, while it would have been technically feasible for Apotex to have marketed non-infringing product, it would not have been motivated to do so. Instead, it would have stayed out of the market entirely and Lilly would have had the market to itself until the expiry of the last Shionogi patent, which would have allowed Apotex to produce non-infringing product using the Kyong Bo process [69].

This reasoning calls to mind Open Window Bakery 2004 SCC 9, in which the plaintiff had been wrongly dismissed without cause and without notice. The trial judge held that but for the breach of contract, the plaintiff would not have been dismissed, but would have been retained for the entire remainder of the contract term. The defendant argued that on the contrary, but for the wrongful dismissal, the plaintiff would have been dismissed without cause but with notice. (The putative cause for dismissal involved dishonesty, and while the plaintiff had acted inappropriately [2000] OJ 5004 [70], the trial judge held that dishonesty was not established [112]. The trial judge also held that the employees who had made honest mistakes were generously treated by defendant’s CEO [115].)

So, in Open Window Bakery there were two ways in which the defendant might have avoiding wrongdoing: (1) it might have retained the plaintiff for the duration of the contract; or (2) it might have terminated the plaintiff without cause but with notice. The trial judge found that in fact the defendant would have chosen option (1), though option (2) would have been less burdensome. This case presents much the same scenario. Apotex might have avoided infringement by (1) staying out of the market for until the expiry of the patents at issue; or (2) by developing a non-infringing alternative. Zinn J found that in fact Apotex would have chosen option (1), though option (2) would have been less burdensome.

The SCC in Open Window Bakery reversed the trial judge, without disputing his finding of fact, on the basis that as a matter of law, “where there are several ways in which the contract might be performed, that mode is adopted which is . . . the least burthensome to the defendant” [11] (and see similarly [20], [21]). Now, in Open Window Bakery the SCC emphasized this is a principle of contract law, and distinguished it from “a tort-like inquiry as to what would have happened if [the plaintiff] had not breached its contractual obligations to [the defendant]” [19]. But I am not sure that the trial judge’s approach really reflected a tort-like analysis. The tort analogy would be more exact if there were two ways of avoiding liability, and one would have resulted in harm to the defendant. I’m not sure how tort law would handle such a case, but it is not clear to me that it would necessarily be strictly by an inquiry as to what most likely would have happened. I suggest that rather than considering the principle of “least burdensome performance” as being a unique aspect of contract law, it can be explained as a presumption of law regarding the most likely course of action in fact, which simply happens to arise more commonly in contract.

In any event, while patent infringement is often described as a kind of “statutory tort” [10], it is not a tort as such, and the principles of patent damages must be interpreted in a manner that is consistent with the purposes of the Patent Act. The relevant principle is that the patentee should be rewarded commensurately with the social value of its invention, and that is the difference between the value of the invention and the value of the best non-infringing alternative. To posit that Apotex would not have entered with a non-infringing method means that Lilly would be rewarded as if it process were more valuable than it is really is. Consequently, it seems to me that the principle of least burdensome performance should apply, at least presumptively, under the Patent Act as much as in contract.

" 'I Could Have Gone Down Metcalfe Street Instead"

Eli Lilly and Co v Apotex Inc / cefaclor, 2014 FC 1254 Zinn J [Cefaclor Damages]
            1,133,007 – 1,146,536 – 1,133,468 – 1,150,725 [“Lilly Patents”]
            1,095,026 – 1,132,547 – 1,136,132 – 1,144,924 [“Shionogi Patents”]

Zinn J’s Cefaclor Damages decision raises a couple of interesting legal issues related to causation, the first of which is the relevance of a non-infringing alternative to the assessment of damages:

Apotex urges the court to find that if there is a non-infringing alternative [NIA] to the infringing product or process that was available to the infringer in place of the infringing product or process, then, even though the infringer did not employ the NIA in the real world, it must be considered in the but-for world. I shall refer to this as the NIA Defence.[21]

The phrase “NIA defence” is certainly convenient, but it is something of a misnomer, as will be discussed below. Zinn J rejected the NIA defence as a pure matter of law [57]. Zinn J’s conclusion in rejecting the NIA defence was the same as that of Snider J in Lovastatin Damages 2013 FC 751 (blogged here), whom he agreed with [52]. An appeal in Lovastatin Damages was heard in mid-January, and presumably we will be getting the FCA’s view on this issue in due course. As Zinn J’s holding is likely to be overtaken by that of the FCA, I will not try to address every argument on this issue. Instead I will focus on what I see as the intuition behind Zinn J’s rejection of the NIA defence, as I suspect that his intuition is widely shared.

Apotex’s argument was that but for the infringement, it could have would have competed just as effectively with a non-infringing alternative. Lilly’s losses were therefore not caused by the infringement, because it would have suffered exactly the same losses in the but for world in which there was no infringement. Because Zinn J rejected the argument as a matter of law, he did not explicitly address whether Apotex could have established the NIA defence on the facts (though there was some evidence to that effect, as will be discussed my next post.) But by the same token, for the purposes of this analysis we can assume that in fact Apotex would have been able to compete just as effectively using a non-infringing alternative, for at least some of the infringing production.

The essence of Zinn J’s objection to the NIA defence seem to me to be captured in these paragraphs:

[32] I concur with Mr. Creber who said: "I am not aware of any Canadian case that has allowed a tortfeasor, the person who committed the tort, to pretend they could have acted differently whether that be personal injury, whether it be negligence, whether it be patent infringement. ... If I drove my car down Elgin Street and I hit somebody, it would be not open to me to argue, 'I could have gone down Metcalfe Street instead and would have avoided hitting the person'."

[35] In short, the causal connection must be examined in the real world. Damages arise if Lilly proves in the real world that, but for Apotex selling infringing product, it would have made some or all of those sales. The causal connection is not examined in the hypothetical world where the infringer engages in different conduct than that in which it actually engaged. Such an approach permits the wrong-doer to escape all responsibility for its conduct.

That is, the NIA defence would allow a wrongdoer to say “But for the wrong, I would have acted so as to avoid the wrong, and so I should escape all responsibility.”