Wednesday, March 15, 2017

How Much Experimentation Is Permitted Before a Specification Is Insufficient?

Bombardier Recreational Products Inc v Arctic Cat Inc. and Arctic Cat Sales Inc, 2017 FC 207 Roy J
            2,293,106 / 2,485,813 / 2,411,964 / 2,350,264

As discussed in yesterday’s post, the Rider Position Patents at issue in Bombardier v Arctic Cat survived all validity attacks but one, and Roy J held they would have been infringed if valid. However, Roy J held the patents invalid for insufficiency, on the basis that the patents “do not describe how the inventions are to be put in operation [605]. That a person skilled in the art would be able to make the invention in light of the disclosure, was, according to Roy J, “beside the point” [561]:

Ever since Consolboard, the law has been clear that the specification alone is to be used to put the invention into practice, without the assistance of a minor research project.”

See similarly [549], [568], emphasizing that if even a “minor” research project is required, the specification is inadequate. The above reference to Consolboard notwithstanding, Roy J’s primary authority for this point is the Viagra decision, Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60, which was cited throughout Roy J’s decision.

The proposition that a specification is insufficient if it requires the skilled person to carry out a minor research project to put the invention into practice, is with due respect, an error of law. This proposition is not entirely novel. Some very early cases did indeed suggest that the specification had to explain in detail how to work the invention, “without the necessity of trying experiments” Turner v. Winter (1787) 99 Eng. Rep. 1274, 1276-77, 1 WPC 77, 80 (KB); and see R v Arkwright (1785) 1 WPC 64, 66; Morgan v Seaward (1836), 1 WPC 170, 175. But these cases did not address the precise degree of experimentation permissible. The difficulty with a strict rule excluding any experimentation at all, is that in almost any field there are some steps that require some degree of routine trial and error. To require a patentee to describe all steps with sufficient particularity to avoid such trials would leave the patent open to technical attacks. In some cases it might be impossible to frame a valid claim, even though a skilled person would easily be able to work the invention on the basis of the disclosure. Such remarks were therefore immediately tempered by the principle that they are addressed to a person skilled in the relevant art; as Jessel MR said in Otto v. Linford (1882) 46 L.T.(NS) 35 at 41, in the course of holding that the disclosure was not insufficient because it did not specify the precise proportions for fuel and air necessary for combustion, “[t]he first thing to be remembered, in specifications of patents, is that they are addressed to those who know something about that matter.” And even before that, in Morgan v Seaward, Alderson B at 175, stated that the specification “must actually and plainly set forth what the invention is, and how it is to be carried into effect, so as to save a party the trouble of making experiments and trials,” but he went on to say, at 176, that the workman brings his “ordinary knowledge” to the job and if the size of the parts is not specified, this is not fatal: “He says, ‘I see this will not work because it is too small,’ and then he makes it a little larger, and finds it will work.”

Tuesday, March 14, 2017

Experimental Use Exception to Anticipation Applied

Bombardier Recreational Products Inc v Arctic Cat Inc. and Arctic Cat Sales Inc, 2017 FC 207 Roy J
            2,293,106 / 2,485,813 / 2,411,964 / 2,350,264

In Bombardier Recreational Products v Arctic Cat Roy J held that the asserted patents were invalid by reason of insufficiency and ambiguity [572], but all other validity attacks failed, and the patents would have been infringed if valid. Today’s post provides an overview of the case and a few points, the most interesting of which is that Roy J applied the experimental use exception to anticipation. Tomorrow’s post discusses the insufficiency issue.

In the late 1990s, Bombardier Recreational Products (BRP) made a “significant breakthrough” in snowmobile design [415]. Its so-called radical evolution vehicle (REV), introduced in 2002, moved the rider weight forward, so that instead of sitting back as if on a couch, the rider is balanced forward, as if riding a dirt bike [414]. The REV was a great commercial success that left other snowmobile makers “swallowing hard and running fast to catch up” [417]. BRP obtained four patents related to its new design. The three Rider Position Patents (106, 813 and 964), claimed a snowmobile with a rider forward position; the 264 patent, aka the Frame Construction Patent, claimed a new frame design with enhanced rigidity [100]. While it seems that the frame construction claimed by the 264 patent was used in BRPs commercial REVs, the frame construction was not specifically directed at the rider forward position, so that the two groups of patents were quite distinct. Roy J held that the 264 patent was not infringed, in a holding which turned on claim construction [379], [382], but the Rider Position Patents were infringed – or would have been had they been valid. While the patentee fended off attacks based on anticipation [521], obviousness [539-40], and material misrepresentation [574], Roy J held the Rider Position Patents to be invalid for ambiguity and insufficiency [560].

Non-infringement of the Frame Construction Patent turned on standard claim construction issues, so I will say no more about it, in order to focus on the more interesting Rider Position Patents. 

The key point on both infringement and validity was the way in which these patents were drafted. They all claimed a snowmobile comprising all the usual parts, but the key innovation was not described in terms of the structure of the snowmobile itself, but rather in terms of the position of the rider on the snowmobile. For example, Claim 1 of the 106 patent was as follows:

1. A snowmobile, comprising: [standard parts] constructed and arranged such that, when the standard rider is . . . in a biomechanically neutral position . . . the snowmobile has a first center of gravity without the standard rider and a second center of gravity with the standard rider and a distance between a vertical line passing through the first center of gravity and a vertical line passing through the second center of gravity is between 0 cm and 14 cm inclusive.

Since the rider is a significant part of the weight of a snowmobile, and the rider sits behind the center of gravity of the snowmobile itself, the center of gravity of the combination of the rider and sled will be behind the center of gravity of the sled alone. The further back the rider sits, the further back the combined center of gravity will be. By defining a maximum distance between the two, the claim is to a snowmobile constructed such the rider will normally sit in a forward position. As another example, Claim 1 of the 964 patent claims a snowmobile constructed such that, when the rider is in the normal position, “the hips of the standard rider are disposed above its knees.” That is contrasted with the prior art, where the rider was in a more reclined position. Other claims added refinements, such as specifying that the ankles should be behind the knees. The 813 patent was similarly drafted, except it defined the rider position in terms of angles, rather than body parts or centre of gravity. None of the claims specify how the sled should be constructed to achieve this result.

The defendant Arctic Cat raised a number of claim construction issues related to phrases such as a “standard rider,” but Roy J had no difficulty construing these in light of the disclosure, with “a mind willing to understand” [298], and stressing that “common sense is not excluded from the Court room” [299]. In light of the recent debate, it is worth noting that Roy J used a disclosure-first approach rather than a claim-first approach, but this did not appear to have been a point of contention. Very unusually, Roy J also adverted to the prosecution history during claim construction, but this did not have any impact on the claim construction [323].

The claim drafting method came to the fore in determining infringement.“In order to perform measurements that would be compared, it was deemed necessary to follow a protocol which would reflect the three Patents-in-suit” [429], and there questions, for example, as to what position should be taken by the rider to determin the steering, footrest and seating position [430], and to define the “biomechanically neutral” position that was specified in the 106 and 813 patents [431]. BRPs experts were able to follow the definitions provided by the patents, so as to replicate the conditions – down to the drop in height caused by the weight of the rider – to calculate the various centers-of-gravity [432]. Roy J was very impressed with the experts [425], [434], who “had nothing to hide and had excellent expertise” [434]. One further obstacle was that BRP’s experts had only measured 17 of Arctic Cat’s models, while 378 models were alleged to infringe. BRP was nonetheless able to establish that all models infringed [469]. BRPs expert showed that AC’s models fell into nine groupings, with models in each grouping sharing the same overall geometry, and the models that were measured were representative of each group [452-54]. AC’s response was to challenge the validity of the groupings, and rather than offering its own measurements. While the defendants are entitled to adopt this strategy, Roy J was not impressed: “the Defendants take the posture that they should sit back and challenge peripherally groupings that they are capable of reviewing with great precision” [457], and he concluded that AC’s challenge to the groupings was not sufficient to displace BRP’s evidence. (Of course, that is not to suggest that AC’s strategy was unsound, as direct measurements of its own models might have reinforced BRPs conclusions even more forcefully.)

Turning to validity, Roy J held that the Rider Position Patents were not anticipated or obvious [476], and they also survived a few other “last-ditch” attacks [581]. The holding of non-obviousness was straightforward on the facts [536], particularly in view of the “overwhelming” secondary evidence of non-obviousness, such as commercial success [540].

Several of the anticipation arguments similarly turned on the facts. The most interesting anticipation issue was one of the “last-ditch” arguments. Some of the testing of BRPs prototypes was carried out in public or semi-public locations, though precautions, such as riding at night or while shielded between other sleds, were taken to avoid being seen. AC argued that that constituted public disclosure “because someone could have witnessed the rider’s hips above his knees, and the ankles behind the knees, and the hips behind the ankles” [581]. Roy J rejected this argument primarily on the authority of Conway v Ottawa Electric Railway Co., (1904), 8 ExCR 432, 442, which was recently revived in litigation related to YAZ, as discussed here and here. He noted that “Conway would appear to be good law” [492], citing Hughes J in the YAZ litigation, 2014 FC 436. I summarized Hughes J’s decision as holding that “This seemingly establishes a broad experimental use exception to what would otherwise be anticipating disclosure, which applies to any clinical trial, so long as reasonable steps are taken to ensure that the unused tablets are returned.” Roy J went on to apply this law to the facts:

[582] There is not even a suggestion by AC that the use of public trails was anything but for reasonable experimentation. Since at least 1904, our law has recognized the need to experiment in order to bring the invention to perfection [Conway]. This exception was recognised recently by our Court. In this case, the evidence is that BRP was conscious of the need for confidentiality and took steps to ensure it would be protected. The experimentation was necessary in view of the many uses that would be available for that new configuration. Actually, AC did not address at all the well-recognized experimental use exception, making its argument on the sole basis that prototypes were out on public trails and that a passerby would have been able to identify the positioning. In my view, the experimental use exception would suffice to dispose of that argument.

The comment that “BRP was conscious of the need for confidentiality and took steps to ensure it would be protected,” echoes Hughes J’s comment in YAZ [121] that “Bayer took reasonable steps to ensure the confidentiality of the relevant documents and to ensure that unused tablets were returned.” Roy J did go on to hold that even if there was disclosure, it was not enabling, though I am not entirely satisfied with this reasoning on that point, for reasons I will explain in tormorrow’s post. In any event, the experimental use exception to anticipation was clearly the primary basis for his decision. In YAZ, Hughes J had described the exception as long established [119], and in my post I suggested that “ one decision more than a century old is not strong enough authority to say this point is well-established.” Now we have another decision holding that a public disclosure that is necessary for reasonable experimentation will not constitute anticipation if the inventor took reasonable steps to ensure confidentiality. In both YAZ and BRP v Arctic Cat, it was not clear that there was actually enabling disclosure at all, and the true test of this doctrine will come when the disclosure is clearly enabling on the facts, notwithstanding the reasonable efforts to keep it confidential. But for now we can at least say that the rule is increasingly well-established.

Monday, March 13, 2017

Interlocutory Injunctions Update Part III: Trade-marks

Sleep Country Canada Inc v Sears Canada Inc 2017 FC 148 Kane J

Reckitt Benckiser LLC v Jamieson Laboratories Ltd 2015 FC 215 Brown J aff’d 2015 FCA 104 Noël CJ: Gauthier, Webb JJA

This is the third in a series of three posts looking at some more-or-less recent interlocutory injunction decisions. Last Thursday’s post considered some patent cases, Friday’s post discussed copyright cases, and today’s post focuses on a couple of trade-mark decisions. As discussed in Thursday’s post, most Canadian jurisdictions use a risk-balancing approach to interlocutory injunctions. In contrast, for about the last 25 years, the Federal Courts have used a high-threshold approach to irreparable harm, with the result that interlocutory injunctions have been very difficult to get in IP cases. Sleep Country and Reckitt are two trade-mark cases in which interlocutory injunctions have been granted. The question is whether the approach used in these cases can be reconciled with the high-threshold approach.

Friday, March 10, 2017

Interlocutory Injunctions Update Part II: Copyright Cases

Unilin Beheer BV v Triforest Inc 2017 FC 76 Gascon J
            2,475,076 2,522,321 / glueless locking laminate flooring

As discussed in yesterday’s post, most Canadian jurisdictions use a risk-balancing approach to interlocutory injunctions. The Federal Courts, in contrast, use a high-threshold approach to irreparable harm, with the result that interlocutory injunctions have been very difficult to get in IP cases. However, a series of copyright cases have held that in cases of blatant copying, the threshold for irreparable harm is much lower, and perhaps even nonexistent. These include the following copyright cases in which an interlocutory injunction was granted: IBM v Ordinateurs Spirales Inc (1984), 80 CPR (2d) 187 (FCTD), Reed J; Universal City Studios (1983), 73 CPR (2d) 1 (FCTD), Walsh J; Jeffrey Rogers Knitwear 6 CPR (3d) 409, Dubé J; 75490 Manitoba (1989) 29 CPR(3d) 89, Rouleau J; Diamant Toys 2002 FCT 384 Nadon J; Bell Canada 2016 FC 612 Tremblay-Lamer J. The question is whether these copyright cases can be reconciled with the patent cases, such as Unilin, and TearLab 2016 FC 606 J aff’d 2017 FCA 8 (discussed in yesterday’s post).

Thursday, March 9, 2017

Interlocutory Injunctions Update Part I: Patent Cases

TearLab Corp v I-Med Pharma Inc 2016 FC 606 Manson J aff’d 2017 FCA 8 Scott JA: Boivin, de Montigny JJA
2,494,540 / TearLab System / i-Pen System

Unilin Beheer BV v Triforest Inc 2017 FC 76 Gascon J
            2,475,076 2,522,321 / glueless locking laminate flooring

In TearLab and Unilin v Triforest, interlocutory injunctions were refused in two patent cases. This is not very surprising, as this result is line with the restrictive approach in my article on Interlocutory Injunctions and Irreparable Harm in the Federal Courts, (2010) 88 Can Bar Rev 517. TearLab was a particularly strong case for granting an interlocutory injunction, and, unusually, the decision was appealed, and affirmed; but otherwise these cases serve mainly to affirm the established restrictive approach to interlocutory injunctions in patent cases. However, there have also been some more or less recent cases that have granted interlocutory injunctions in copyright and trade-mark cases. This invites the question of whether all of these cases can be reconciled, particularly as Gascon J addressed the copyright cases at length in his Unilin decision. Today’s post will provide some background, and discuss the patent cases, and the next couple of posts will discuss the copyright and trade-mark cases.

Monday, February 27, 2017

Blogging Pause

Regular readers may have noticed the lack of activity on my blog in the past couple of weeks. I've fallen behind because what had started as a brief post on a couple of recent interlocutory injunction decisions, has ballooned into a minor research project, at the same time as other new decisions have come out. The interlocutory injunction post (or posts) are still not ready, and between that and my other teaching and research obligations, it will be a few more days before my next post. I hope to have my first post on interlocutory injunctions out early next week, and then I'll catch up on the other recent decisions and get back to my regular blogging schedule.

Friday, February 17, 2017

The Value of the Standard

My article, co-authored with Professor Tom Cotter, on “The Value of the Standard,” has just been published in Volume 101(3) of the Minnesota Law Review. Here is the abstract:

Standard-setting organizations (SSOs) often require member firms to license their standard-essential patents (SEPs) on undefined “fair, reasonable, and nondiscriminatory” (FRAND) terms. Courts and commentators in turn have proposed various principles for calculating FRAND royalties, among them that the royalty should not reflect “the value of the standard.” As we show, however, this principle could be understood to mean any or all of three distinct concepts, namely that the royalty should not reflect the implementer’s sunk costs; that the patentee should not be able to extract any of the value resulting from network effects; or that the royalty should be proportionate to the patent’s contribution to the standard.

This Article proposes, as an alternative benchmark, that a FRAND royalty should reflect the incremental contribution of the patent to the value of the standard to the user. This principle combines two related ideas: first, that royalties should reflect the hypothetical bargain the parties would have struck ex ante (prior to incurring sunk costs) in view of the incremental value of the technology over unpatented alternatives as revealed ex post; and second, that multiple patents reading on a standard should be valued in proportion to their marginal contribution (“ex post Shapley pricing”). Our proposal would prevent patentees from extracting sunk costs or a disproportionate share of standard value, but (contrary to some approaches) it would enable them to draw some of the increased value resulting from network effects. We show that our approach is more consistent with sound innovation policy, and suggest some practical applications.

Tuesday, February 14, 2017

Specific v General Motivation in the Obviousness Analysis

AstraZeneca Canada Inc. v. Mylan Pharmaceuticals ULC 2017 FC 142 Diner J
            2,449,098 / naproxen-esomeprazole dosage form / VIMOVO / NOC

In this decision Diner J held AstraZeneca’s 098 patent to be invalid for obviousness, relying in part on the obvious-to-try analysis set out in Sanofi 2008 SCC 61. The decision turned essentially entirely on the facts. There were a few legal points of some interest, the most notable being the discussion of the distinction between specific and general motivation in the obviousness analysis. More broadly, I must admit that I did not find the obvious-to-try analysis as set out in Sanofi itself to be pellucid, but the Federal Courts have nonetheless consistently applied it in a robust and principled manner to invalidate patents for invention which were the result of routine testing of alternatives that was more or less guaranteed to arrive at a solution to the problem at hand, even if the precise solution could not have been predicted in advance.

Before turning to obviousness, there are a couple of other issues worth mentioning. As discussed here, there has been an ongoing debate as to whether recourse to the disclosure as an aid to construing the claims is always permissible, or is permissible only if the claims are ambiguous on their face. While claim construction was not particularly controversial in this case [28], and Diner J did not address the debate directly, he provided the following summary of the law (citations omitted):

[26] In sum, a patent is to be construed through the eyes of the POSITA having a mind willing to understand the invention, and the claims are to be approached in a purposive manner and construed in light of both the disclosure and the claims. That said, while it is permissible to read the disclosure in order to assist in understanding the terms used in the claims, the disclosure cannot be used to construe the claims more narrowly or widely than the text of the claims allows

This strikes me as both sensible and an accurate summary of the law.

The issue of blinding the experts also arose. Mylan argued its experts should be preferred because they were blinded to the NOA, and AstraZeneca responded that Mylan’s experts should be ignored because they failed to address the NOA [74], [76]. Diner J stated that “Blinding experts does not necessarily produce a more reliable outcome” [77]:

[78] In this case, the approach of both sides in the preparation of their witnesses was acceptable, and as a result neither warrants exclusion or less weight. Rather, my analysis turns on which of the experts provided the most compelling evaluations of the common general knowledge held by the POSITA, the state of the art, and other factors in the obviousness analysis.

While the debate over blinding is not over yet, and no doubt is will continue to be a helpful practice in some situations, Diner J’s remarks seem to me to reflect and reinforce a trend towards not putting too much weight on the question of blinding.

The key substantive issue was obviousness. Naproxen was a known NSAID, and like other NSAIDs it can cause gastrointestinal [GI] injuries if taken alone [5]. Various mitigating strategies were known, including co-administration with a PPI [6], but co-therapy was known to have patient compliance problems [7]. The asserted claims of the 098 patent solved this problem with a sequential release tablet comprising esomeprazole, a PPI, in immediate release form (not surrounded by an enteric coating), with a delayed release of naproxen, an NSAID [107]. The parties largely agreed that the difference between that inventive concept and the state of the art was the sequential release profile, which was achieved by the decision not to fully enteric coat the PPI [113]. This was arguably inventive, because PPIs were sensitive to acid, so that it was common practice to enteric coat PPIs [46]. After a review of the facts, including consideration of the obvious-to-try factors, Diner J found the difference between the invention and the state of the art to be obvious [130], [171]. This holding turned largely on the facts, but one statement of law is worth quoting, as it reflects a common thread through the Federal Court’s obvious-to-try decision:

[134] Furthermore, neither the fact that (i) no one knew whether the claimed invention would provide any additional benefit (i.e. the non-enteric coated PPI), nor that (ii) there were other options amongst gastroprotective agents apart from PPIs, render the claims non-obvious. The following words of Justice Barnes in Janssen Inc v Teva Canada Limited, 2015 FC 184 at para 113, are apposite:

…The fact that the formulator had a few choices to make and would need to test the formulation to ensure its efficacy does not render this exercise non-obvious. Here I adopt the point made by Justice Roger Hughes in Shire Biochem Inc. v. Canada (Minister of Health), 2008 FC 538 (F.C.) at para 80, [2008] F.C.J. No. 690 (F.C.), that the existence of number of possible routes to solve a problem does not mean that the route taken was not obvious. In Brugger v. Medicaid Ltd. (No. 2), [1996] R.P.C. 635 (England P.C.) at p 661, the same point was stated in the following way:

First a route may still be an obvious one to try even if it is not possible to be sure that taking it will produce success, or sufficient success to make it commercially worthwhile. ... Secondly, if a particular route is an obvious one to take or try, it is not rendered any less obvious from a technical point of view merely because there are a number, and perhaps a large number, of other obvious routes as well. If a number of obvious routes exist it is more

Finally, Diner J’s discussion included a fairly extensive discussion of the significance of general vs specific motivation in the obviousness analysis [148ff]. AstraZeneca seems to have argued that the invention would not be obvious unless the POSITA would have had a specific motivation to come up with the particular inventive concept of the 098 patent [140], while Mylan argued that specific motivation is not required [150]. Diner J agreed with Mylan [150].

Diner J suggests that a “general” versus “specific” motivation distinction “may be a false dichotomy” [152]. He made two suggestions. First, “the measure to be taken is one of difference or degree, not kind. Like with many subjective measures, the notional skilled person’s motivation would at best be identified as somewhere along a spectrum” [153]. This means it would be confusing rather than helpful to require a binary determination[154].

Diner J also had a second suggestion:

[159] [S]pecific motivation arguably cuts both ways. It could be said that its existence indicates that it was likely obvious that someone would eventually get there, without inventiveness. On the other hand, it could be said that the existence of specific motivation before the claimed invention was patented only reinforces Beloit’s classic question (at para 21): if it was obvious – and there was specific motivation to try it – why didn’t you?

Similarly, in Janssen-Ortho 2007 FCA 217 [25.5], the FCA suggests that general motivation is important because if there has been a long-standing general motivation to solve a problem, and no one has been able to do so, this is evidence that the solution someone finally does come up with was not obvious. On the other hand, if there wasn’t any general motivation to solve a problem, then the answer to Beloit’s classic question may be “no one bothered to try.” This suggests that even if motivation were a binary question, “[i]ts relative importance will depend on the context and factual backdrop of each case” [151]. Again, this leads to the conclusion that a distinction between general and specific motivation is a false dichotomy. That does not mean that general and specific motivations are the same, but rather than the effect of motivation on the obviousness analysis depends on how it interacts with the other relevant facts, and not which category it falls into.

Monday, February 13, 2017

Is Litigation Insurance Separable?

Apotex Inc. v. ADIR 2017 FCA 23 Dawson JA: Boivin, Woods JJA rev’g in part 2015 FC 721 Gagné J
            1,341,196 / perindopril / COVERSYL

As discussed in Friday’s post, Perindopril Accounting is the accounting portion of a bifurcated action. In the liability decision, 2008 FC 825 aff’d 2009 FCA 222, Snider J held that the defendants had infringed the plaintiff’s ‘196 patent and she allowed the plaintiff to elect an accounting of profits. A substantial amount of the infringing material manufactured by Apotex in Canada was destined for export to markets such as the UK and Australia. Friday’s post dealt with the issue of whether Apotex might have made the same profits by manufacturing in some other jurisdiction for export to those markets.

The subject of today’s post is a second question raised on appeal, relating to the provision of litigation insurance by Apotex as part of the transfer price agreements [8.ii]. Apotex Inc sold the infringing product to affiliated companies, Apotex UK and GenRX, for sale in the UK and Australia respectively. The transfer price agreements had two different prices defined, with a higher price payable by the purchaser when the product was considered a “Patent Challenge Product,” which meant that there were good reasons for expecting the affiliate to be subject to patent litigation in the export market (ie the UK or Australia). The same transfer price agreement also provided that Apotex would pay all legal expenses and indemnify the foreign purchaser against any such claims that might be brought [37]. (See here for more detail.)

Apotex argued that it was really selling two things in a single contract, namely infringing perindopril and litigation insurance, and the profits due to the infringing perindopril should be disgorged, but not those derived from litigation insurance. At trial, Gagné J accepted Apotex’s argument in principle on the basis that “that the provision of foreign litigation services and of an indemnity for liability under foreign patents does not constitute an infringement of the 196 Patent” [30]. While she held that it was not established on the facts that the increased payments for a Patent Challenge Product really were in the nature of insurance payments [67], this implies that this the same basic argument might succeed if the transfer pricing agreement were drafted differently.

Apotex appealed this point, and the FCA affirmed, but on entirely different grounds:

[79] What drove Apotex’ sales of perindopril were the new and useful characteristics of the drug. Had perindopril not been protected by the 196 Patent, there would have been no need for Apotex to provide an indemnity to protect the fragility of its affiliates. “But for” the infringing qualities of perindopril, Apotex would have earned nothing on its sale, whether attributable to the drug itself or to the indemnity required to protect the affiliates. Thus, the profit resulting from the sale of perindopril was entirely causally attributable to the invention. It follows that no apportionment is warranted.

That is, in the ‘but for’ world, Apotex would have sold non-infringing perindopril, and if it had sold non-infringing perindopril, it would not have had to provide litigation insurance, as there would have been no risk of litigation. On this approach, it would not matter how the agreement is drafted, because no matter how the agreement is drafted, Apotex would never be in a position to sell litigation insurance where there is no risk of litigation.

On its face, this logic is a compelling and straightforward application of ‘but for’ causation.The answer to Gagné J’s point is that the profits to be disgorged are those caused by the infringement, not the profits associated with infringing products; so the question is not whether provision of litigation insurance is an infringement, but whether Apotex would have made those profits but for the infringement. There is a parallel with convoyed goods, where a patentee may recover lost profits on the lost sale of unpatented goods, if it would have made those sales but for the infringement: see eg Jay-Lor 2007 FC 358, [198].

I have just a couple of questions. First, suppose that the litigation insurance would not be required in the ‘but for’ world, and suppose also that in the real world the litigation insurance had been provided by an entirely independent firm, rather than by Apotex. Would the patentee be able to get an accounting of the insurer’s profits on the basis that those profits were caused by the infringement, even though the insurer itself had not infringed? If so, on what basis? If not, why should Apotex be treated differently in respect of its insurance business? I have no good answer to these questions, one way or the other.

Second, the FCA indicated that litigation insurance was required because perindopril was protected by the Canadian 196 patent [79]. But my understanding from the trial decision is that litigation insurance was required because of the possibility of litigation based on a patent that was effective in the export country, ie a UK or Australian patent: see [FC 38]. So, according to Apotex’s version of the but for world, as I understand it, if Apotex had not manufactured perindopril in Canada that infringed the 196 patent, it would have manufactured in some other jurisdiction in which perindopril was not patented, but it would still have exported to the UK and Australia, where there was a risk of litigation based on the UK and Australian patents. If that’s right, then it seems to me that Apotex would have provided the same litigation insurance, even though it would not have infringed the 196 patent. The FCA’s discussion of this point was quite brief, and it may be that I’ve misunderstood either the reasoning or the factual underpinnings. In any event, this point was not essential to the disposition of the case, as the FCA nonetheless went on to consider the specific contracts and the facts of the case, and held that Apotex had not demonstrated that the transfer price agreements had intended to apportion the revenue between the product and the litigation insurance [106-7]. However, if that conclusion turns on the particular contract rather than on a general principle of causation, then the possibility remains open that the revenues might be apportioned if the contract were differently drafted.

Friday, February 10, 2017

Instantaneous Availability of Non-Infringing Alternative

Apotex Inc. v. ADIR 2017 FCA 23 Dawson JA: Boivin, Woods JJA rev’g in part 2015 FC 721 Gagné J
            1,341,196 / perindopril / COVERSYL

In its Perindopril Accounting decision, the FCA has once again affirmed the centrality of the differential profits approach to causation, and in particular the need to consider any non-infringing alternatives (NIA) that would have been used by the infringer but for the infringement. This decision builds on the foundational authority of Monsanto v Schmeiser, 2004 SCC 34, and the FCA’s subsequent decisions in Lovastatin Damages 2015 FCA 171 and Venlafaxine s8 2016 FCA 161. The FCA decisions since Schmeiser have consistently affirmed the basic principle that it is necessary, not optional, to consider any non-infringing alternative in the causation analysis (as discussed here, here and here). There have, however, been some refinements in the details. In Venlafaxine, as discussed here, the FCA developed the principles relating to the burden of proof. And now, in Perindopril, the FCA has apparently retrenched from its earlier position that an NIA could be considered only if it was “instantaneously” available.

This case is the accounting of profits portion of a bifurcated trial. In the liability decision, Laboratoires Servier v Apotex Inc, 2008 FC 825 aff’d 2009 FCA 222, Snider J held that the defendants had infringed the plaintiff’s ‘196 patent and she allowed the plaintiff to elect an accounting of profits. A substantial amount of the infringing material manufactured by Apotex in Canada was destined for export to markets such as the UK and Australia. In the accounting portion of the trial, on appeal in this case, Apotex had argued that there were a number of viable, non-infringing alternative sources of both bulk perindopril API and perindopril tablets (in particular manufacture in jurisdictions other than Canada) [18] [FC 79]-[80]. Apotex argued that the profits it would have made by manufacturing abroad (the non-infringing alternative), should be deducted from the profits actually made by the infringing manufacture in Canada, to arrive at the profits to be disgorged [18], [FC 121]. As I explained here, Gagné J rejected consideration of potential the non-infringing alternatives as a matter of law [25], [FC 126] and Apotex appealed this point [8.i].

The FCA has now held that “the Federal Court erred in law by rejecting the relevance at law of any available non-infringing perindopril” [9]. This is not very surprising. Gagné J’s decision was released prior to the FCA decisions in Lovastatin Damages 2015 FCA 171 and Venlafaxine s8 2016 FCA 161, in which the FCA affirmed the need to consider any non-infringing alternative in the causation analysis (as discussed here, here and here), in light of Schmeiser, 2004 SCC 34. This Perindopril Accounting decision reaffirms the same point.

Perindopril Accounting is nonetheless significant in a few respects. First, Lovastatin Damages and Venlafaxine s8 were both damages cases, while Perindopril is an accounting case. The damages cases were in some ways more debatable, as Schmeiser, which established the NIA analysis, was an accounting of profits decision, and it was argued that the reasoning did not apply in the damages context. Lovastatin Damages [60] held that the basic causation analysis is the same in both contexts, and this point has now been reaffirmed in Perindopril: “While Lovastatin considered a claim for compensatory damages for patent infringement, the comments have equal application to an accounting for profits” [34] (and to the same effect, [40]). Thus it is now perfectly clear that NIA analysis is equally applicable in both the damages and accounting contexts. This is undoubtedly correct, as the causation inquiry is fundamentally the same in either context. As the SCC explained in the accounting context, “A comparison is to be made between the defendant’s profit attributable to the invention and his profit had he used the best non-infringing option” Schmeiser [102]. The only change in the damages context is to substitute the words “plaintiff’s profits” in place of “defendant’s profits.”

While Gagné J recognized that Schmeiser had endorsed the NIA analysis, she noted that the SCC has stated only that the differential profits approach is the “preferred” method, and consequently Gagné J felt that the SCC had left it open to the courts to apply a different approach on the facts of a particular case [FC 118-19]. The FCA acknowledged that [28, my emphasis]:

in Schmeiser the Supreme Court referred to the differential profit approach as the ‘preferred means’ of calculating an accounting of profits – not the only means. However, at bottom is the need to ensure that a patentee only receives that portion of the infringer’s profit that is causally attributable to the invention

In my view, this is entirely correct. It is necessary, as a matter of law, that the profits (whether those of the infringer or the patentee) are only those which are causally attributable to the infringement. The differential profit analysis, including consideration of the NIA, is the best way of implementing this fundamental causation requirement. Other ways of implementing the same causation analysis may be permitted, but it is not open to the courts to use an approach which ignores the causation requirement.

The FCA did state that “in this circumstance” it was an error for the Federal Court not to take into account the NIA (the availability of non-infringing perindopril for export), [28], [30]. This leaves open the question of exactly when it might be appropriate not to use the differential profits analysis. In my view, it is understandable that the SCC and the FCA would not want to set down a strict rule that must be applied regardless of the vagaries of the case at hand. I would suggest that the main, and perhaps only, circumstances in which it need not be used is when it is clear that not all of the profits at issue are attributable to the infringement, and yet the evidence does not allow a differential profit analysis. Lubrizol [1997] 2 FC 3 (FCA), might be an example. But what is essential, as per the above underlined statement by the FCA, is that the causation requirement be respected. Given that the differential profits approach, including the NIA, is the best method for implementing the causation requirement, I would suggest that it must be used whenever the evidence allows it.

So far, this is all to clarify or reinforce the law as set out in Schmeiser, Lovastatin Damages and Venlafaxine s8. There is one important new development. In Lovastatin the FCA held that an in order to be considered in the differential profit analysis, the NIA had to be available “instantaneously”:

[79] Dealing first with whether Apotex could have sold non-infringing lovastatin, Merck argues that the alleged alternative must have been actually available to replace Apotex’ infringing sales as they were made. Otherwise, Merck, not Apotex, would have replaced those sales. I believe this submission to be correct both in fact and in law. In Advanced Building Systems Pty Ltd et al. v. Ramset Fasteners (Aust) Pty Ltd, [2001] FCA 1098, (2001) 52 I.P.R. 305 the Federal Court of Australia rejected the relevance of a non-infringing alternative, but held that if it was legally relevant, it could only apply “if at the moment of infringement […] there is available on the market instantaneously the appropriate substitute” in the reconstituted market. I agree.

This is in sharp contrast with Perindopril Accounting. In the result, the FCA held that the issue of whether Apotex “would have and could have” obtained quantities of non-infringing perindopril from other sources for sale abroad, should be remitted to the Federal Court for determination on the facts [65]. The FCA further directed the Federal Court as follows (my emphasis):

[67] [I]t may be that the Federal Court could conclude in the hypothetical world that one or more suppliers would not or could not supply perindopril in time to replace the initial infringing sales. However, this would not end the inquiry as the Federal Court would still have to consider whether at some later point in time a supplier would and could have provided replacement non-infringing tablets.

I don’t see how the two statements can be reconciled, but both decisions were written by Dawson JA, so I can’t see this as a disagreement between different panels of the court. Instead, it appears to be a significant retrenchment from the “instantaneous availability” test for an NIA set out in Lovastatin. This is a welcome develolpment, because, in my view, as explained here, the “instantaneous availability” test is inconsistent with the fundamental principle of “but for” causation.

Overall, then, Canadian law on causation and non-infringing alternatives is shaping up very well. Lovastatin took a large step in the right direction, and Venlafaxine and Perindopril have made modest course corrections to bring the law onto the right path. This is how the common law is supposed to work.

I do see one issue which may require further consideration (though it was wasn't raised at all in this case.) That is the question of whether the but for world should be approached as one world, established on the balance of probabilities, or multiple worlds considered in terms of weighted possibilities. In both Lovastatin and Venlafaxine the FCA held that the burden lies on the defendant to establish the factual relevance of a non-infringing alternative “on the balance of probabilities. Mere possibilities short of probabilities do not suffice” Venlafaxine [56] (and to the same effect Lovastatin [74]). On its face this is a sensible position, and the FCA cited as authority Rainbow Caterers [1991] 3 SCR 3, 14, which does indeed say that the but for world must be established “on a balance of probabilities.” The problem is that this is difficult to reconcile with Athey v Leonati [1996] 3 SCR 458 (citations omitted):

[27] Hypothetical events (such as how the plaintiff’s life would have proceeded without the tortious injury) or future events need not be proven on a balance of probabilities. Instead, they are simply given weight according to their relative likelihood. For example, if there is a 30 percent chance that the plaintiff’s injuries will worsen, then the damage award may be increased by 30 percent of the anticipated extra damages to reflect that risk. A future or hypothetical possibility will be taken into consideration as long as it is a real and substantial possibility and not mere speculation.

The “but for” world is a hypothetical event; how the plaintiff’s life would have proceeded without the tortious injury is the equivalent, in the personal injury context, of how the patentee’s market would have developed without the infringement. Thus Athey directly implies that the defendant need not establish the relevance of the NIA on the balance of probabilities; if there is a 30% chance that the infringer would have been able to supply the market with an NIA, then the profits to be disgorged should be reduced by the same percentage.

The FCA in Venlafaxine [56] also cited Tervita 2015 SCC 3, [49]-[51], [66], citing F.H. v. McDougall, 2008 SCC 53, [40], [49]. I don’t think these are relevant. As Athey also stated (citations omitted)

[28] By contrast, past events must be proven, and once proven they are treated as certainties. In a negligence action, the court must declare whether the defendant was negligent, and that conclusion cannot be couched in terms of probabilities. Likewise, the negligent conduct either was or was not a cause of the injury. The court must decide, on the available evidence, whether the thing alleged has been proven; if it has, it is accepted as a certainty:

As I understand it, there is a distinction between proving the wrong and assessing damages. The wrong itself is always proven on the balance of probabilities, and, as I understand it, that was the point in Tervita and McDougall. That is not inconsistent with assessing damages using weighted probabilities.

But Rainbow Caterers is certainly directly relevant, and it is not clear to me how to reconcile that case with Athey v Leonati. To the extent that there is a conflict between the two cases, Athey is probably the stronger authority. In Rainbow Caterers the choice was between two 'but for' worlds, one proposed by the plaintiff and the other by the defendant, and it does not appear that the option of taking both possibilities into account on the basis of their relative likelihood was before the court. In Athey, in contrast, that was a central question. Moreover, probability based adjustments for hypothetical events (eg the crumbling skull doctrine) and future contingencies are routine in the tort context, particularly in personal injury cases. With that said, neither approach is obviously superior in principle, and the Rainbow Caterers approach has the practical advantage of simplicity. My only conclusion at this point is that the problem of whether the 'but for' world should be constructed on a balance of probabilities, or with weighted possibilities, is a difficult one. It may be that the two approaches can indeed be reconciled; or that one is superior in principle; or that there is some sound reason for using a different approach in patent law than in tort law.

Friday, February 3, 2017

Miscellaneous Issues in Frac Shack v AFD

Frac Shack Inc v AFD Petroleum Ltd 2017 FC 104 Manson J
2,693,567 / Fuel Delivery System and Method

In this infringement action, Manson J held Frac Shack’s 567 patent to be largely valid and infringed by AFD’s “Frac Trailer.” The decision turned on the facts and on claim construction. Manson J granted a permanent injunction, an accounting of profits, and a reasonable royalty for pre-grant / post-publication ‘infringement’ under s 55(2). While no new law was applied, there are a few points of interest as confirming some existing trends.

The invention relates to a system for refueling well site equipment while the engines are running. It was primarily intended for use on fracking sites. Fracking typically requires multiple diesel engines running in close quarters. Ideally the equipment would run 24 hours a day, but an engine will run out of fuel in 3-4 hours [13]-[14]. Shutting down the engines to refuel wastes time, and can also cause downhole problem which reduce the effectiveness of the fracking operation [13]. Refueling while the fracturing equipment is operational is therefore often required. Prior to the invention, this had involved “manual hot refueling,” which requires a worker to pull fuel-laden hoses to each piece of equipment’s fuel tank and manually discharge diesel fuel into the tank, typically working between equipment that is spaced about a meter apart, with pumping equipment that is operating at high pressures [15]. While there was some debate as to exactly how often fires occurred, there was no real dispute that manual hot refueling was as dangerous, unpleasant and environmentally dirty as it sounds [18].

Claim Construction
As discussed here, there is an ongoing debate in Canadian law as to whether recourse to the disclosure as an aid to construing the claims is always permissible, or is permissible only if the claims are ambiguous on their face. Manson J’s approach in this case was very much in the former camp. In his recent Mediatube 2017 FC 6 decision, Locke J was very careful to analyze the claims first, and determine there was an ambiguity, before turning to the disclosure for clarification. In contrast, in discussing the first two disputed terms, Manson J began by quoting from the disclosure [159]-[160], [171], before consideration of the claims themselves, and nowhere did he consider whether the claims were ambiguous on their face. Rather, he simply read the claims in light of the common general knowledge, in the context of the disclosure and the other claims (eg [167]-[168]), in a manner much more akin to Gauthier J’s approach in LOSEC 2017 FCA 9. I won’t repeat the discussion of the case law on this issue that can be found in my post contrasting those two earlier decisions, but I will say that the holistic and contextual approach, as applied by Manson J in this case, resulted in a claim construction that was straightforward, easy to follow, and persuasive.

Validity
AFD tried a classical sufficiency attack, arguing that the disclosure would not allow a POSITA to make the invention. Manson J had no difficulty in holding this argument failed on the facts [209], [213]. An obviousness attack failed on the facts. The fact that AFD, in a SR&ED grant application submitted to the Canadian government, had argued that their infringing device was innovative, did not help their case [252].

Manson J did find some claims to be overbroad. Some of the claims did not include a remote fuel level sensor, which means that an operator “would have to go into the hot zone to determine the level of fuel in a tank, and would have to physically monitor the filling of the tank to ensure that there was no overflow” [216]. Since the purpose of the invention was to reduce the hazards of manual hot refueling by removing people from the hot zone, Manson J held that the claims without the fuel sensor were overly broad [218]. On the other hand, an overbreadth attack was also made on claims including a pressurized hose near the equipment end of the tank, which could be dangerous if a pin-hole leak sprayed pressurized fuel near the running engine [220]. Manson J held this did not make the claimed invention overbroad, because “having pressurized hoses anywhere in the invention is possibly not optimal from a safety perspective, whether or not an invention, or part of an invention, is optimal is not relevant to the question of whether claims are overly broad” [222]. This contrasts with the holding regarding the fuel sensor. These holdings can be reconciled on the basis that the inventive concept “is to design a system and method for efficient and safe hot fueling to multiple pieces of equipment, in remote and semi-permanent well site locations, that removes the operators from the hot zone during fracturing operations at a well site” [247, emphasis added]. It seems reasonable that the question of overbreadth should turn on the scope of the inventive concept. There was, however, other evidence suggested that the aim of the invention was to address a number of defects in manual hot refueling, which included risk to the operator, but also environmental risks and general fire safety [29]. That suggests that perhaps the overbreadth holding turned on patentee’s failure to sufficiently emphasize the other advantages of the invention during the obviousness argument. In any event, it would be wrong to read too much into Manson J’s relatively brief overbreadth discussion. While the law respecting overbreadth is easy enough to state – the invention cannot be broader than the invention made or disclosed [202] – this decision, among others, illustrates that we do not yet have a fully coherent framework for identifying exactly what it is that makes an invention too broad.

Infringement
The holding that AFD’s Frac Trailer infringed various valid claims followed directly from the holdings on claim construction [257]-[280].

Remedy
An accounting of profit is a discretionary remedy, and there is a question as to whether a successful patentee is presumptively entitled to elect an accounting. The general practice is that a successful patent will be entitled to an accounting, absent some specific reason for denying it, though there are a few cases which have suggested to the contrary: see here for a discussion. Manson J’s holding in this case, allowing the patentee to an elect an accounting, is consistent with the general practice. His general statement of principle indicated that an patentee is presumptively entitled to an account ([282]), and he concluded that “there is no reason that [the Plaintiffs] should not be allowed to elect for accounting of profits” [290]. This is not really very remarkable, given that AFD’s arguments as to why Frac Shack should be denied an accounting were weak. But nonetheless, if the burden was on Frac Shack to show it was entitled to an accounting, the result might have been different. On the whole, Manson J’s decision on this point is by no means a major development, but it is one more case that reinforces the mainstream view that a patentee is presumptively entitled to an accounting.

There were a couple of technical issues in actually calculating the accounting that Manson J resolved on the facts [296]-[309]. Of more interest was his holding that manual hot refueling is not an non-infringing alternative, so that AFD was required to disgorge its gross profits from the rental of its infringing Frac Trailer, not the differential profits as compared with hot refueling. He held that [312]

manual hot refueling is not a non-infringing alternative to using the ‘567 invention. Even if accidents due to manual hot refueling are rare, the fact that reducing the risk of an accident creates a significant improvement over the alternative hot fueling system, because the consequences of such an accident can be life threatening or cause millions of dollars’ worth of damage to the fracturing operation.

This holding would make sense if, after the invention was commercialized, everyone in the industry had abandoned manual hot refueling. However, even the President of the patentee Frac Shack admitted that “some fracturing companies still find manual hot refueling to be an acceptable method of refueling, regardless of whether the equipment in the hot zone is depressurized,” and that “that there was no one correct way for fracturing companies to perform a risk matrix and that companies may assess risks differently” [36]. This suggests that manual hot refueling, though substantially inferior, was still a viable alternative. On the other hand, AFD only had one Frac Trailer operating. Even if the whole industry had not abandoned manual hot refueling, if the market demand for the patented system was not saturated, it is possible that all of its customers for the infringing trailer would have considered manual hot refueling to be an unacceptable alternative, and would have used the plaintiff’s system instead. In that case, attributing the AFD’s gross profit from the rental of the Frac Trailer to the infringement would be sound.

Manson J also awarded “reasonable compensation” for pre-grant / post-publication infringement under s 55(2), and the parties agreed with the standard view that a reasonable royalty would be the appropriate measure of compensation for this period [314]. This is of some interest because there are few cases to have actually awarded reasonable compensation, but there is nothing novel in the law that was applied.

Finally, Manson J also refused to award punitive damages [323], [329]. This is consistent with the general reluctance of Canadian courts to award punitive damages. With that said, Manson J’s decision is not particularly significant in reinforcing that general trend, because, as he found, the facts were very far from anything that would warrant punitive damages.

Friday, January 20, 2017

"One Method is Enough"

Apotex Inc v AstraZeneca Canada Inc 2017 FCA 9 Gauthier JA: Pelletier, Scott JJA var’g 2015 FC 322 as amended by 2015 FC 671 Barnes J
            1,292,693 / omeprazole formulation / LOSEC

Barnes J’s holding that the ‘693 patent valid and infringed turned primarily on the facts, as did the FCA affirmation, but the FCA decision shed interesting light on the proper approach to claim construction. That was subject of yesterday’s post. Today's post turns to the FCA's discussion of Biogen v Medeva.

The ‘693 patent pertains to pharmaceutical preparations containing omeprazole. Omeprazole was a known to be useful in treating gastric and duodenal ulcers, but it turned out to be a particularly difficult compound to formulate. It had to be enteric coated to prevent contact with acidic gastric juice, but a conventional enteric coating would react with omeprazole and cause degradation, particularly in storage. The claimed invention solved this problem with an inert subcoating between the omeprazole core and the enteric coating. The disclosure of the 693 patent contemplated that the subcoating would be applied “by conventional coating procedures in a suitable coating pan or in a fluidized bed apparatus using water and/or conventional organic solvents for the coating solution” (p6). In Apotex’s product, in contrast, the putative subcoating was the end product of an in situ chemical reaction that occurs when the enteric coat is applied by Apotex to the pellet cores. The main issue at trial was claim construction: Apotex argued that the claims did not cover a subcoat which forms in situ. Barnes J rejected this argument as a matter of claim construction. (See my post on the FC decision for details.) This holding was affirmed on appeal.

But Apotex had another arrow in its quiver. The ‘693 patent did disclose how to make the claimed invention using conventional coating procedures, but it did not disclose how to make the claimed invention use the in situ process, for the simple reason that the in situ process was developed several years after the patent was issued [80]. Apotex argued that the disclosure was therefore insufficient [80], [81], relying on Teva (VIAGRA) 2012 SCC 60, and Biogen v Medeva [1996] UKHL 18, [1997] RPC 1.

Gauthier J easily distinguished Teva [80], but the Biogen discussion was more interesting. She distinguished Biogen as follows:

[81] [I]n [Biogen], the reason Lord Hoffman held that the disclosure was insufficient was because of the hybrid nature of the claim and the nature of the invention. In that case, the inventor could not claim a product because the DNA molecule (Dane particle) he had made was not new. He could not claim the process because the process itself was also known; thus, he had to draft the claim to describe the product he was trying to monopolize partly through the way it worked and partly through how it was made.

[82] As indicated above, the 693 Patent is a product claim describing the essential elements of the final structure of the product, thus the nature of the claims in the 693 Patent are not at all similar to the one dealt with in Biogen.

This is not entirely convincing. It is true that the nature of the claims is different, but that in itself does not provide a distinguishing principle. The claim at issue in Biogen was to “A recombinant DNA molecule characterized by a DNA sequence coding for a polypeptide or a fragment thereof displaying HBV antigen specificity. . .” There is no doubt that the disclosure did enable a skilled person to make such a DNA molecule (Biogen, 50), but Lord Hoffmann went on to say (51, my emphasis):

there is more than one way in which the breadth of a claim may exceed the technical contribution to the art embodied in the invention. The patent may claim results which it does not enable, such as making a wide class of products when it enables only one of those products and discloses no principle which would enable others to be made. Or it may claim every way of achieving a result when it enables only one way and it is possible to envisage other ways of achieving that result which make no use of the invention.

It was on this second branch, now known as “Biogen insufficiency,” that the claim failed: “Its excessive breadth is due, not to the inability of the teaching to produce all the promised results, but to the fact that the same results could be produced by different means” (51-52). The defendant Medeva’s method used a different means to produce the same result (52).

With that said, I intend no criticism of Gauthier J in so distinguishing Biogen, because she was simply adopting Lord Hoffmann’s own subsequent explanation in Lundbeck CA aff’g [2008] EWCA Civ 311 aff’d [2009] UKHL 12, [2009] RPC 13, which she then went on to cite and discuss. In that case Lord Hoffmann said, in a passage quoted by Gauthier J [86, Gauthier J's emphasis]:

[27] In an ordinary product claim, the product is the invention. It is sufficiently enabled if the specification and common general knowledge enables the skilled person to make it. One method is enough.

Lord Justice Jacob agreed, in a passage also relied on by Gauthier J [89]:

[52] I turn to sufficiency. There is a very short answer to this point. The claim is to the (+) enantiomer. That is novel and non-obvious. If one asks the straightforward question "Does the patent enable the skilled man to make it?" the answer is an equally straightforward: "Yes."

Gauthier J is more than justified in adopting the explanation of Lord Hoffmann’s decision in Biogen provided by Lord Hoffmann himself. But I must say that I don’t find Lord Hoffmann’s distinction based on the form of the claim to be persuasive. The real point of Lord Hoffmann’s Biogen opinion, it seems to me, was to draw a distinction based on the inventive concept, or “technical contribution” as he called it. As stated in the passage quoted above, he was concerned that “the breadth of a claim may exceed the technical contribution to the art embodied in the invention,” and he focused on “the technical contribution to the art which [the inventor] made in 1978 and disclosed in [the patent application]” (51). He concluded by noting that the defendant’s methods “owe nothing” to the invention (52).

But if that is right, then “one method” of enabling the invention is not necessarily enough; it might be, or it might not be, depending on the nature of the inventive concept. Now, on the facts of this particular case, as I understand them, Apotex would have lost even on Biogen insufficiency, because the inventive contribution was not a method of depositing an inert subcoating, but the idea of using an inert subcoating, regardless of the method of deposition. But that conclusion would have required an investigation of the inventive concept, rather than merely an assessment of the nature of the claim.

As I see it, the problem with Biogen insufficiency is that it is not really a sufficiency objection at all, but rather an objection of overbreadth (see eg see Sandvik v Kennametal [2011] EWHC 3311 (Pat) Arnold J at [106]-[124] describing three types of insufficiency in modern UK law as being classical insufficiency, ambiguity and excessive breadth, with the latter corresponding to Biogen insufficiency). As the High Court of Australia perceptively noted in Lockwood (No 1) [2004] HCA 58, [67] the House of Lords' reasoning in Biogen boils down “to the following Voltairean aphorism: ‘Since the fair basis doctrine no longer exists, it is necessary to invent it.’” In Canada, the overbreadth objection is reflected in the principle that an inventor cannot claim more than he has invented: see eg Farbwerke Hoechst AG v. Commissioner of Patents, [1966] ExCR 91, 106; Radio Corp v Raytheon (1957) [1956-60] Ex CR 98, 117; Lovell Manufacturing Co v Beatty Bros (1962), 41 CPR 18, 66 (Ex Ct). The difficulty is that this principle, while very well established, does not have a clear basis in the Act. (The nearest thing is perhaps Rule 84, requiring that the claims be supported by the disclosure, but this is not a particularly clear statement of a prohibition on overbroad claims, and it is in any event discomfiting to have such a fundamental principle found only in the regulations, rather than the Act itself). Nonetheless, in my view, it is probably best to recognize overbreadth as an independent objection, rather than trying to shoehorn it into sufficiency, with the confusing fallout that we have seen from Biogen. So, in my view, the correct approach to sufficiency is indeed that articulated by Gauthier J, following Lord Hoffmann and Lord Justice Jacob in Lundbeck CA, but I would suggest it should apply regardless of the nature of the claim. This is not to say that Biogen is a dead letter, but rather than the problem it raised should be addressed, in Canadian law at least, as a matter of overbreadth.

Wednesday, January 18, 2017

Claim-First or Disclosure-First in Claim Construction?

Apotex Inc v AstraZeneca Canada Inc 2017 FCA 9 Gauthier JA: Pelletier, Scott JJA var’g 2015 FC 322 as amended by 2015 FC 671 Barnes J
            1,292,693 / omeprazole formulation / LOSEC

As discussed here, Barnes J's decision at first instance, holding that AstraZeneca’s ‘693 patent to be valid and infringed, turned primarily on the facts. Unsurprisingly, the FCA has upheld Barnes J. The FCA decision is nonetheless interesting for its approach to claim construction, particularly in contrast with Locke J’s decision in Mediatube Corp v Bell Canada 2017 FC 6 (blogged here on the costs issue). That aspect of the decision is the focus of this post.

By way over overview, while Apotex raised a number of issues on appeal, the most important related to claim construction [27]. On that issue, Apotex acknowledged that Barnes J had correctly stated the applicable principles, but argued that he had misapplied them [31]. This argument was rejected by Gauthier J, essentially on the basis that it took passages from Barnes J’s decision out of context, and when read as a whole, it was evident that Barnes J had indeed applied the claim construction principles he had articulated (see eg [43]).

The FCA did vary Barnes J’s decision on a limitations period point, which was governed by s 39 of the Federal Courts Act, as this case was decided under the old Act [8]. Section 39 provides that the provincial limitations period applies in respect of any cause of action arising entirely in one province, and a general six year period is otherwise applicable. The FCA held that on the facts, Barnes J had wrongly applied the six year period to all the infringing acts, even though some of them might have arisen entirely in one province [124]. Rather than remanding, the FCA held that the difficult issue of assessing the limitation period applicable in respect of each act could be undertaken in the damages portion of this bifurcated trial [126]. The legal error is of little significance going forward, as s 55.01 of the current Patent Act provides for a general six year limitation period, regardless of where the cause of action arose.

Claim Construction

There is an ongoing debate in Canadian law as to whether recourse to the disclosure as an aid to construing the claims is always permissible, or is permissible only if the claims are ambiguous on their face. The latter position seems to stem from Procter & Gamble Co v Beecham Canada Ltd (1982) 61 CPR(2d) 1 (FCA) at 11, where the FCA reviewed the cases and summarized by saying:

in construing the claims in a patent recourse to the remainder of the specification is (a) permissible only to assist in understanding terms used in the claims; (b) unnecessary where the words of the claim are plain and unambiguous; and (c) improper to vary the scope or ambit of the claims.

(See also Dableh v. Ontario Hydro [1996] 3 FC 751 (FCA), repeating this.) Now, “unnecessary” does not mean “impermissible,” but in Mylan v Eli Lilly (CIALIS) 2016 FCA 119 [39] the FCA took that next step and held that “the judge erred in referring to the specification when construing the claims of the ‘377 patent. The rules of patent construction preclude reference to the specification when the claims are clear, and improper if reference varies the scope of the claims” [sic] (my emphasis). On the other hand, in Whirlpool 2000 SCC 67 Binnie J, for the Court, said that:

"[t]erms must be read in context, and it is therefore unsafe in many instances to conclude that a term is plain and unambiguous without a careful review of the specification". In my view, it was perfectly permissible for the trial judge to look at the rest of the specification, including the drawing, to understand what was meant by the word “vane” in the claims, but not to enlarge or contract the scope of the claim as written and thus understood.

In his recent decision in Mediatube Corp v Bell Canada 2017 FC 6 Locke J had a very careful analysis of this “tension” [37] in the jurisprudence. On that point he quoted and agreed with Zinn J’s discussion in Janssen-Ortho 2010 FC 42, [115-116], [119], including this paragraph:

[115] In my view, the whole of the specification (including the disclosure and the claims) may be examined to ascertain the nature of the invention. Where the words of the claims are plain and unambiguous and capable of only one interpretation by a person skilled in the art, recourse to the disclosure is unnecessary. This is not to say that the interpreter should not examine the disclosure. In my view, one should do so, but with caution. Recourse may be had to the disclosure for the purpose of confirming the interpretation arrived at from examining the claims alone or to disclose an ambiguity in the language of the claims that was not otherwise evident. However, the patentee cannot expand the monopoly specifically expressed in the claims by borrowing phrases from the disclosure and placing them into the language of the claims.

This threads the needle between the two approaches, though rightly favouring the SCC position that reference to the disclosure is permissible even when the claims are unambiguous. Nonetheless, Locke J was very careful to first read the words of the claims alone to determine whether they were ambiguous. He did have recourse to the specification in interpreting each disputed terms, but in almost every case, this was only after expressly concluding the claim alone was ambiguous. See eg his discussion of “audio/video signals,” concluding examination of the claim alone “certainly gives rise to enough ambiguity in this term to justify recourse to the disclosure in order to assist in understanding its scope” [49]. This implies that recourse to the disclosure, if not strictly impermissible, would not be “justified” absent the ambiguity. See similarly [58], [74], [81]. (The only exception was in considering the term “server,” where he adverted to the disclosure without expressly holding the claim was ambiguous on its own [66]).

Contrast Locke J’s analysis with Gauthier J’s approach in this case:

[41] As the issue of construction of the patent is to be reviewed on the correctness standard, I have performed my own analysis of the 693 Patent. I have thus considered, as proposed by Apotex, what the invention is by reading the full specification.

The first sentence is explicit that Gauthier J is performing her own analysis, which means the approach she takes would be also appropriate for a judge at first instance. The second sentence indicates that Gauthier J very first step in construing the claims is to read the disclosure, without a word as to whether there is any ambiguity in the claims themselves. She also stated (my emphasis) that

[48] It is trite law that a court will consider the disclosure when it construes the claims. I considered the disclosure as it may help to determine if the inventor gave a particular meaning to an expression or word in the claim by adopting a special lexicon. However, the disclosure cannot be used “to enlarge or contract the scope of the claim as written and thus understood” (Whirlpool at para. 52 in fine; see also Justice Rothstein’s comment in the seminal decision of Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 at para. 77 in fine, [2008] 3 S.C.R. 265).

This was not merely a statement of principle; Gauthier J’s analysis of the claims at hand began with a twelve paragraph discussion of the disclosure [49]-[60], before turning to the claims themselves.

The two approaches are not strictly inconsistent in principle, in that Locke J did acknowledge that it is permissible to look to the disclosure. Nonetheless, there is a striking contrast between Locke J’s claims-first approach and Gauthier J’s disclosure-first approach.

How can this tension be resolved? First, all of the cases agree on one fundamental principle: use of the disclosure is “improper to vary the scope or ambit of the claims,” and “improper if reference varies the scope of the claims”; “the patentee cannot expand the monopoly specifically expressed in the claims by borrowing phrases from the disclosure and placing them into the language of the claims”; “the disclosure cannot be used ‘to enlarge or contract the scope of the claim as written’”; and, from Sanofi [77] “Of course, it is not permissible to read the specification in order to construe the claims more narrowly or widely than the text will allow.” I am not aware of any case holding to the contrary.

In light of this principle, it is easy enough to see why recourse to the disclosure is unnecessary when the words of the claim are plain and unambiguous; it is unlikely to change anything. Even if reading the disclosure suggests a meaning that was inconsistent with the claims, the court would say, in effect, “I see what you should have said, but you didn’t say it, and I won’t redraft the claim for you.” If that’s right, whether one starts with the claims, or starts with the disclosure, should make no difference in the end. The point made by the SCC in Whirlpool is that there may be cases where the claims appear clear when read on their own, but the disclosure clarifies the true meaning. An example might be Catnic, where the word “vertical” in the claim might be taken to mean “90 degrees”, but reading the disclosure makes it apparent that it really means “sufficiently vertical to carry out the load bearing function.”* In that case, reading the disclosure changes our understanding of the claim, but does not read limitations from the disclosure into the claim. Rather the disclosure makes it apparent that the initial reading of the claim alone was wrong, because a word that appeared clear was in fact ambiguous. In such a case, it would be wrong to avoid recourse to the disclosure on the basis that the claims were unambiguous.

The really difficult case is when the claim says “up” and the disclosure defines “up” to mean “down.” I don’t have a ready answer for that case, except to say that would be a very poorly drafted patent. It would be better to address the such a case on its facts, in light of the underlying principles that claim defines the monopoly, but the skilled person reads the patent, rather than debating whether it is permissible or not to read the disclosure.

Finally, what about  the statement in CIALIS that "[t]The rules of patent construction preclude reference to the specification when the claims are clear," and also "as there was no ambiguity in the claims here, there could be no recourse to the specification" [43]? I acknowledge that these statements of principle are inconsistent with a disclosure-first approach, but there is no inconsistency on the facts, because in CIALIS the real problem was that the trial judge had indeed read in a limitation from the disclosure into the claim: see [40]. Thus the holding would have been the same on a disclosure-first approach

*This oversimplifies Catnic, where the claim construction at trial was not merely “a purely literal one derived from applying to it the kind of meticulous verbal analysis,” as suggested by the HL.