Saturday, June 16, 2018

Unclear Whether Location of Server Outside Canada Avoids Infringement

Canadian National Railway Co v BNSF Railway Co 2018 FC 614 Locke J
            2,922,551 / 2,880,372 /2,958,024

CNR’s patents at issue claim a system for conducting an online rail-shipment inquiry system, which CNR alleges are infringed by two of BNSF’s online rail-shipment tools. The claims are variously framed as being to a method, a server arrangement and a computer [15]. BNSF brought a motion to strike based in part on the fact that its server is located in Fort Worth, Texas, where it is based, and consequently many of the steps in the claims in issue would be performed outside Canada [36]. Locke J held that this argument would not sustain a motion to strike, on the basis that it is not clear as a matter of Canadian law whether such claims may be infringed even if the server is located outside Canada:

[46] I agree with CN that the debate over whether all steps of the claims in issue must be put into effect in Canada for there to be infringement is a question of law, which should not be decided on a motion to strike. In my view, the jurisprudence on this question is not sufficiently settled that CN should be prevented at this stage from advancing its position. BNSF relies on Varco Canada Limited v Pason Systems Corp, 2013 FC 750 at paras 265-266, for the principle that patents are territorial and that Canadian patents cannot be infringed outside Canada. I agree with this general principle, but there remains the more specific question of whether infringement of a claim to a method (or a sever arrangement or a computer) can be avoided by locating one component thereof (a server) outside Canada. BNSF cites a US authority (Home Gambling Network, Inc v Piche, 2013 US Dist Lexis 141595 at 5-6 (D Nev)) in support of its view that this is indeed sufficient to avoid infringement. However, CN cites a UK authority (Menashe Business Mercantile Ltd v William Hill Organisation Ltd, [2002] EWCA Civ 1702, [2003] 1 All ER 279 at para 32) for the opposite conclusion. There does not appear to be a Canadian decision directly on point. BNSF argues that the UK law concerning the territoriality of patents is different from Canada’s, and that the US authority should be preferred. Having considered the authorities cited by the parties, I am not convinced that it is plain and obvious that CN’s position is without merit.

Friday, June 8, 2018

For the Third Time, Infringement of Claim 17 was Induced

Grenke v DNOW Canada ULC 2018 FC 565 Phelan J

The original liability decision in this case was Weatherford v Corlac 2010 FC 602. This was largely affirmed on appeal, 2011 FCA 228, but remanded on the sole issue of inducement as it related to Claim 17. Phelan J’s decision on remand 2012 FC 76 (discussed here),was again remanded by 2012 FCA 261, on the basis that Phelan J had not properly appreciated the scope of the issues remanded. In particular, he did not revisit a crucial factual finding, considering it to be res judicata. The FCA clarified that it had intended him to consider the factual issue as well.

This decision is therefore Phelan J’s third time addressing this issue. The question is moot, as it has no effect on the damages decision (blogged yesterday), and the parties had urged Phean J not to address the issue. While acknowledging that the issue is moot, Phelan J felt bound by the instructions of the FCA to reconsider it [3]-[4].

As I noted in my post on the remand decision, “the factual finding was implicit in Phelan J’s original decision,” and consequently, “it would be surprising if his determination were to change now that he will be required to make it explicitly.” It is entirely unsurprising, therefore, that Phelan J on reconsideration has re-affirmed his original holding that the defendants induced infringement of Claim 17.

Thursday, June 7, 2018

Compound Interest is Here to Stay

Grenke v. DNOW Canada ULC 2018 FC 564 Phelan J

This decision is the damages portion of a bifurcated action, following Weatherford Canada Ltd v Corlac Inc 2010 FC 602,, in which Phelan J held the plaintiff Grenke’s 937 patent to be valid and infringed by the defendants. (Weatherford, a licensee of Grenke, has settled, and the names of various parties, including Corlac, have changed through acquisition and otherwise, which is why the case names are so different: [11]-[17]). The patentee elected damages rather than an accounting [2].

In oil production, a “stuffing box” is used to seal the top of an oil well and prevent leakage of the oil as it is being pumped out of the ground. The 937 patent claims a new type of environmentally-friendly seal assembly, which minimizes leakage [18]-[19]. There was substantial regulatory and environmental pressure to minimize leakage, and the patented technology was a game-changer [21], [45]. The decision is quite straightforward, and it is a good example of damages assessment in the context of a simple product, in which the patented technology contributed a major part of the value of the end-product. (This is in contrast to complex products, such as a smartphone, where any single technology contributes only a small part of the overall value.) Perhaps the most legally interesting aspects are that Phelan J allowed full recovery for convoyed sales, refused to grant punitive damages, and granted compound interest.

To begin, Phelan J emphasized the need to use a “broad axe” in assessing damages: while perfect compensation is the goal, the reality of litigation is that perfection can rarely be achieved: [71]-[73]. This point was repeated at a number of instances, though in most cases the inaccuracy in question would be small in any event: [84], [99], [101], [119], [130], [168]

The basic framework is to assess how many sales the patentee lost as a result of the infringing competition, and to calculate lost profits on those sales, and then to assess a reasonable royalty on all the remaining infringing sales. The parties did not really disagree on this framework, or indeed any major conceptual issues, but only on the application to the facts.

Phelan J accepted that market share was appropriately used by the plaintiffs in this case as a proxy for determining the plaintiff’s lost sales [91], [96], pointing out that “This is not a case with a small number of customers. . . which might require “customer-specific” evidence” [97]. Phelan J held on the facts that the appropriate market was “the ‘environmentally friendly stuffing box market’” [105]. There is something of a debate as to whether and when fixed costs can be deducted in calculating profits (see here, here, and here), but in this case the parties apparently agreed that only variable costs should be deducted [115].

Reasonable Royalty
With respect to the reasonable royalty, Phelan J remarked:

[136] In constructing the hypothetical negotiation of the royalty rate, it is important to take into account the realities on the ground. It is particularly relevant that GrenCo had market strength because of its technology and also important is that all the evidence suggests Grenke would have been an unwilling seller, difficult to deal with, and prepared to push the limits of “reasonableness” to the edge (and perhaps over). This all suggests a rate at the upper end of reasonableness. It is somewhat ironic that Grenke would be deemed, under this hypothetical negotiation, to accept any amount of royalty rate given his general intransigence to the point of “going down with his ship” rather than to settle. However, the Court must accept some of the realities in constructing the hypothetical negotiation and resolution.

There is indeed considerable artificiality in constructing a hypothetical negotiation in a case in which it is clear on the facts that the patentee would never have licensed in reality. But recall that a reasonable royalty is only assessed in respect of sales which the patentee would not have made in the real world; if the patentee can prove that it would have made the sale, then it will be entitled to lost profits. Sometimes, this will be because the infringer was selling into a market that the patentee had not entered. In this case, the parties were competing in the same market, and patentee is seeking lost profits on infringing sales that would not have been captured by the patentee, but which would instead have gone to a different competitor with a non-infringing product. That is, for reasons of pre-existing relationships, distribution, etc, if the particular customer had not bought from the defendant, it would have bought from a non-infringing third party. In that case it makes sense for the patentee to accept that since it would not have made the sale in any event, it would be better to allow the infringer to make the sale as a licensee, so that the patentee gets a return in the form of a royalty, rather than losing out altogether. The artificiality arises because it is only with hindsight that we know that the patentee would lose the sale in any event. At the time, it would have made sense for the patentee to fight for the sale, rather than license the defendant, because (unlike the case in which the defendant is selling into a different market), the patentee would rather have the profits on the sale than a royalty, and it can’t license only for those sales it won’t get, because it doesn’t know at the time that it won’t get the sale.

The larger point, perhaps, is that the objective is to assess a royalty which is reasonable in the circumstances, and a hypothetical negotiation is no more than a useful heuristic, which should not be taken too literally if problems arise in applying it. With that all said, I am not suggesting that it is wrong to assess a reasonable royalty “at the upper end of reasonableness” when the patentee was competing in the same market. I don’t have an opinion on that issue. My point is that the hypothetical negotiation framework is not particularly helpful in resolving the issue.

Turning to the calculation itself, the parties both used the “anticipated profits approach,” supplementing this analysis with the “minimum willingness to accept (MWA) versus maximum willingness to pay (MWP)” [135].

The anticipated profits approach supposes that the parties to a hypothetical negotiation, which takes place at the time of first infringement, split the profits they anticipate the infringer will make from the use of the patented technology. As noted by Phelan J, this approach has previously been used in Jay-Lor 2007 FC 358, and AlliedSignal 1998 CanLII 7464, 78 CPR (3d) 129 aff`d (1999) 86 CPR (3d) (FCA). In “A New Framework for Determining Reasonable Royalties in Patent Litigation,” (2016) 68 Florida Law Review 929, Tom Cotter and I argue that instead of anticipated profits, a split of the actual profits should be used. The difference is important only when actual profits are different from the profits that would have been anticipated at the time of first infringement. Despite the name “anticipated profits” approach, I believe that using actual profits would be consistent with Canadian cases. Note that the anticipated profits already relies on actual profits to a large extent. Profits are sales multiplied by profit margin per unit, and the “anticipated” profits approach normally (always, in Canadian cases) uses the actual sales, not anticipated sales, in calculating the “anticipated” profits. We argue that there is no good reason to use actual sales combined with anticipated profit margin. Further, it appears that in AlliedSignal, the calculation did use the actual profits [213]-[214],though it is a bit difficult to tell as the detailed calculations are in a confidential Appendix. (Note that AlliedSignal never used the “anticipated profits” terminology.) Jay-Lor did refer to anticipated profits, but in calculating anticipated profit margin, it appears that actual post-infringement costs (“over the past four years”) were used to assess the profits that would have been anticipated [142]. If that is right, Jay-Lor used an actual profits approach, with an anticipated profits terminology, or, at most, there was no difference between actual and anticipated profits. In this case, the details of the calculation are not discussed, as the parties were largely in agreement, so it is not clear whether actual or anticipated per unit profits were used. In summary then, if there is a case in which anticipated and actual profits are different, it would be open to Canadian courts to use an actual profits methodology, and in my view this would be preferable in principle, for reasons explained in detail in my article with Professor Cotter.

With respect to the MWP versus MWA analysis, Phelan J noted that in Merck v Apotex 2013 FC 751, (blogged here) “the Federal Court indicated that if there were no overlap between the MWA and the MWP, then the reasonable royalty is the MWA. The “minimum” of the MWA must, logically, be the lower end of the range – therefore, the application of Merck FC to this case leads to the conclusion that 8% is a reasonable royalty rate” [143]. Here again, I would suggest that we keep in mind that a reasonable royalty is being assessed only in respect of sales which the patentee would not have captured. In such circumstances, the patentee’s MWA will be its marginal cost, normally zero, because if the negotiation breaks down, the patentee will not make the sale itself, and so will not get any return at all. If the MWA is higher than the MWP, it must be that there was a conceptual error in assessing the MWA (assuming the patented technology is actually valuable, not detrimental, as was clearly true in this case). The details of the assessment of the MWA was not described. However, the MWP / MWA analysis gave much the same result as the anticipated profits analysis.

In US law, the most commonly used approach to assessing a reasonable royalty is to look to comparable licences. In this case, the defendants suggested that lower rates that had been negotiated in respect of the same technology by Weatherford should be used. Phelan J rejected this, correctly in my view, noting that the deal included cross-licensing which would have depressed the rates.

Phelan J also allowed recovery of lost profits for convoyed sales, on the basis of but for causation, without any further restriction:

[163] If compensation is not provided for such add-on items, then the patentee is not being put in the position that they would have been in but-for the infringement (resulting in less than perfect compensation). If the Plaintiffs can show, on a balance of probabilities, that such sales would have been made by the Plaintiffs in the but-for world, then in my view this is a loss for which they should be compensated. This approach is consistent with the limited Canadian case law on the topic, and I would reject the requirement suggested by the Defendants that such convoyed sales must have no function independent of the patented object.

In my view, Phelan J’s conclusion is sound for the reasons he gives. If the convoyed sales are reasonably foreseeable from the sale of the patented technology, as was clearly the case here, then the patentee would face a choice between charging a higher price for the patented goods, and losing some sales and convoyed sales, or charging a lower price for the patented good, in anticipation of profits from convoyed sales. These are just different strategies for realizing the value of the patented technology, and the damages award should not turn on which marketing strategy was chosen.

Punitive Damages
The plaintiff sought punitive damages. Phelan J noted that:

[186] At the liability phase of this action, the Court found that the Defendants:
a) intentionally set out to create a product which they knew or ought to have known would infringe the Patent;
b) have used a stuffing box design which is the same as the Grenke design, and profited from the sale of the infringing articles over a 10 year span (until enjoined by this Court from further infringement);
c) were considered by this Court to have been unjustified and egregious; and
d) had denied infringement of the Patent, yet at the same time claimed ownership in the Patent and argued that the Plaintiffs had in fact infringed their patent rights.

Phelan J refused to award punitive damages, emphasizing that “patent infringement alone, even knowing infringement, is not sufficient to ground an award of punitive damages,” [185] (citing Bauer Hockey 2014 FCA 158 [29]), and similarly, “there must be something more than knowing infringement to support an award of punitive damages”[189]. The various allegations regarding infringement and validity were considered part of the “brawl” over rights in the technology. No doubt this can be distinguished on the facts from Martineau J’s Eurocopter decision (blogged here), but it does evince the traditional reluctance of the Canadian courts to award punitive damages.

The Federal Court has historically been reluctant to grant compound pre-judgment interest, in part for the very good reason that the relevant statutes relating specifically to interest did not allow compound interest: see Federal Courts Act, s 36(4)(b), as noted by Phelan J at [205] (and the discussion here). There has been a recent and welcome trend to granting compound interest nonetheless, based not on the interest provisions, but on the basis that the loss is recoverable as an element of compensation, under s 55(1). The rationale is that in reality, a party with more money in its pocket will put that money to work, and reinvest the profits, which will also go to work, and compound interest is therefore required to provide full compensation. That is the approach taken by Phelan J at [193], [209]following Zinn J in Eli Lilly / cefaclor, 2014 FC 1254 (discussed here). Phelan J stated that “I concur with Justice Zinn’s comments that in today’s world, compound interest is an accepted form of redress” [194].

An interesting point arises from the approach of awarding compound interest on the basis of s 55(1). Phelan J began his discussion of interest by noting that the award of interest under s 36 of the Federal Courts Act, is subject to judicial discretion to disallow interest under s 36(5), which discretion is “to assist the court in controlling the litigation process and to avoid inappropriate compensation” [191], quoting Apotex v Merck 2006 FCA 323 [140]. Phelan J also stated that compound interest was also awarded “[a]s a matter of discretion taking into account the equities and the conduct of the Defendants” [211]. But s 55(1) is normally understood as entitling the patentee to its legal damages, with only equitable remedies, such as an accounting, being subject to discretion. If compound interest is awarded as compensation under s 55(1), can it be discretionary? I’m not sure of the answer to this question, particularly in light of the argument for allowing the court to use its discretion in order to control the litigation process. The question did not arise in this case, as Phelan J did not exercise his discretion to disallow compound interest for the period for which it was claimed, but it presents something of a conundrum. No doubt the best solution would be updated interest provisions in the Federal Court Act, but there is little prospect of that happening, and I expect the issue will have to be resolved judicially.

Monday, June 4, 2018

Last Spasms of the Corpse of the Promise Doctrine

Safe Gaming System v Atlantic Lottery Corporation 2018 FC 542 McVeigh J
             2,331,238 / Safe Gaming System

The corpse of the promise doctrine has given a post-mortem gurgle in a problematic utility analysis in Safe Gaming System v Atlantic Lottery Corp. Nonetheless, I doubt this presages a zombie return.

The invention of the ‘238 patent pertains to a system for controlling online gambling. The general scheme of the invention includes an Internet Web site which serves as a portal to Internet-based gambling sites. The user sets up a profile specifying parameters, such as the amount of time spent gambling online or the amount of money lost, and the system cuts the user off from gambling sites when the parameters are triggered. The core of the decision is McVeigh J's holding that the asserted claims are invalid for lack of utility [136]. She also held them to be invalid for insufficiency [159], but not invalid for obviousness [180] or anticipation [184], but the problematic utility analysis permeated her conclusions on the other issues. She also held on the facts that the patent was not infringed by the defendant’s My-Play system [200].

Wednesday, May 23, 2018

Testing in not Invention

MIPS AB v Bauer Hockey Ltd 2018 FC 485 Gagné J
            2,798,542 [MIPS Patent]
            2,784,316 / 2,821,540 / 2,838,103 / 2,847,669 [Bauer Patents]

MIPS v Bauer concerns an invention near and dear to me, namely sports helmets designed to absorb rotational energy in order to minimize brain injury. (I do a lot of cycling, and all of my current helmets are equipped with MIPS technology.) Both Bauer and MIPS had developed and patented technology addressed at this problem. In this litigation, MIPS alleged that it was a co-inventor of the Bauer technology; that the Bauer products infringed the MIPS patent, and that the Bauer patents were invalid. In response, Bauer attacked the validity of the MIPS patent. The decision, that the MIPS employees were not co-inventors of the Bauer technology, the MIPS patents were valid but not infringed, and that the narrower claims of the Bauer patents were valid, turned on the facts and claim construction.

MIPS was an early leader in this technology, which is at the core of MIPS’ business. MIPS was founded in 2001 [15], and a patent for its first generation technology (MIPS I) was granted in Sweden in 2002. MIPS I used a sliding facilitator apparatus to allow rotational movement between the hard outer shell of the helmet and the inner energy-absorbing layer [13]. Its first product using this technology, an equestrian helmet, was launched in 2007 [16]. MIPS II technology was developed starting in 2009 [19], to address in-mold helmets, in which the inner energy absorbing layer is fused directly to the outer shell, making it impossible to place a sliding facilitator between the two. MIPS II technology uses an “attachment device” (3) as an interface between the wearer’s head and the inner energy absorbing layer, allowing relative rotation between the head and the inner layer.

Concussions are an increasing concern in hockey, and around the same time as MIPS was developing MIPS II, Bauer was also developing a technology to address rotational impact, specifically in hockey helmets, known as RE_AKT, using a SUSPEND-TECH floating liner.

Rotational impact is a relatively new concern in helmet design, and older testing equipment had been made to test only linear impact. The inventorship dispute arose because part-way through its development cycle, Bauer lost its academic partner responsible for testing, and Bauer, which had become aware of the MIPS I helmet, approached MIPS with the aim, as Gagné J held, of having MIPS test the Bauer designs. Gagné J’s decision recounts the details of the collaboration, but at the end of the day, she held that the MIPS team were not co-inventors of the Bauer product. The legal principle is that a party who tests an invention does not thereby become a co-inventor [93], and in this case Bauer employees had wholly conceived of the inventive concept, which had only been tested by MIPS [94], [100]. She noted that a series of events and coincidences (such as the fact that the inner liner on both products happened to be made of yellow material) had contributed to MIPS’ misperception of the facts [91].

On the issue of infringement, the MIPS products use an attachment device which is fixed securely to the head, with elastic fixation members between the attachment device and the inner energy absorbing layer. The attachment device and inner layer slide freely against one another, and energy absorption is achieved by deformation of the fixation members. The Bauer helmets, in contrast, have a floating liner, which is not securely attached to the head, and there are no fixation members as such, but rather energy absorption is provided by friction between the liner and the inner layer [184]. As Gagné J noted, to determine infringement, the defendant’s product is compared with the patent, not with the plaintiff’s product, even if that product embodies the invention. She held that using friction as a mechanism for absorbing rotational energy did fall within the broadest claims of the MIPS patent [163]. However, she also held that the claimed attachment device had to be coupled to the head, both before and during impact, and Bauer’s SUSPEND-TECH floating liner did not operate in that manner [192]. In effect, MIPS had not invented the concept of permitting rotation decoupling between the head and the helmet, but only one way of achieving that decoupling, and Bauer had independently developed another method. Because the attachment device was a crucial element of the claims, the Bauer products did not infringe [192], [197]. (MIPS also lost on other independent points, so the finding of no infringement did not rest on this issue alone [219].)

Bauer’s attack on the MIPS patent on the basis of anticipation and obviousness failed in large part because MIPS got caught in an infringement / validity squeeze [231], [243]. Because the court construed the “attachment device” more narrowly than MIPS’ experts, the validity attacks failed but so did infringement claim. A broader interpretation of the element would have led to a finding of invalidity [244]. (An overbreadth attack also failed on the facts [256].)

MIPS attacked the Bauer patents as being obvious in light of the MIPS II technology, which was on sale before the Bauer patent application was filed [257]. The broadest Bauer claim was held to be invalid for obviousness, on the basis that it would have been obvious to a skilled person to put a MIPS attachment device inside a hockey helmet, and that would fall within the claims [286], [287]. However, the narrow claims, addressed to Bauer’s specific implementation, were upheld [294].

Thursday, May 17, 2018

Formal Protective Orders Largely Unnecessary in Light of the Strength of the Implied Undertaking Rule

Seedlings Life Science Ventures LLC v Pfizer Canada Inc 2018 FC 443 Tabib J

While I do not normally blog on procedural decisions, Tabib J’s opinion in Seedlings Life Science v Pfizer is an important decision on an important point, namely the exchange of commercially sensitive information in litigation.

In her decision in Live Face on Web, LLC v Soldan Fence and Metals (2009) Ltd, 2017 FC 858 Tabib J held that, given the existence of the implied undertaking rule, the Court ought no longer to routinely issue consent protective orders [4]. In this case, Pfizer nonetheless sought a formal protective order. Pfizer did not attempt to distinguish Live Face on Web, but in effect asked Tabib J to overrule her own recent decision [6]. Unsuprisingly, Tabib J refused to do so, and consequently she refused to grant the order sought. But Pfizer nonetheless largely achieved its purpose. Pfizer’s concern was that notwithstanding Live Face on Web, there remains such uncertainty as to the scope, application and enforceability of the implied undertaking rule, that the clarity and certainty provided by an express protective order is necessary [37]. Tabib J acknowledged the merit of Pfizer’s “thoughtful and helpful” submissions, which “highlighted the specific areas where intellectual property practitioners may have had concerns as to the scope and certainty of application of the implied undertaking rule” [66]. Rather than issuing a protective order for clarification, Tabib J clarified the law itself.

Tabib J reviewed the history and meaning of a variety of mechanisms which can be used to protect sensitive information. These include the implied undertaking rule, “pursuant to which a party to whom documents or information are transmitted in the course of pre-trial discovery is taken to have given an undertaking to the Court that he or she will not disclose or use them for any purpose other than the litigation in which they are produced. Any collateral or ulterior use constitutes a contempt of court” [3]. Tabib J explained the distinction between a protective order, relating to information that the parties will exchange between themselves in the pre-trial phase of an action, and a confidentiality order, which allows information which would be filed with the court, and so would otherwise be available to third parties, to be filed under seal. In addition, she noted that private agreements between the parties can also be used to supplement these other mechanisms.

The gist of Tabib J’s decision is that generally, the implied undertaking rule, supplemented by a private agreement between the parties, will provide adequate protection, so routine protective orders are no longer useful or necessary, and absent special circumstances they should be avoided as wasteful of the Court’s time and resources [67], [73], [74].

As to the scope and application of the implied undertaking rule, Tabib J emphasized that the sanctions for breach of the implied undertaking rule as every bit as clear and immediate as for breach of a formal protective order [60]. Further, she reiterated her holding in Live Face on Web, to the effect that [34]

an express agreement between the parties, whereby they recognize that such measures constitute undertakings given to the Court as additional protection to their privacy interest for the purposes of the litigation, is amenable to enforcement by this Court, including by way of contempt proceedings, without the need to be first acknowledged by the Court or enshrined in an order:

(See also [75].) This is very important to her broader conclusion that protective orders are generally not needed, as she held that, given that an express agreement between the parties is enforceable by the Court, many of the specific concerns raised by Pfizer could be addressed in that manner rather than by a protective order. For example, limits on the number or categories of people who can access designated information can be addressed by supplementary undertakings.

Tabib J further clarified that the implied undertaking rule binds third parties, such as experts, consultants and service providers:

[40] Discovery information is primarily disclosed to and controlled by the parties and their solicitors. Pursuant to the implied undertaking, they have no right to disclose that information to anyone, including third party experts, consultants or service providers, unless it is necessary for the conduct of the litigation. In that role, these third parties act as agents or sub-contractors for the parties. It would be unthinkable that these agents would not be bound by the same obligation as their principals. To entertain the contrary would be to accept that the important protection intended to be afforded by the implied undertaking could be defeated and rendered nugatory simply by allowing a party to act through an agent.

She further held that the law is clear that:

[49] A person who is aware of the application of the implied undertaking rule or of any order issued by this Court, whether or not they have given an express undertaking to attorn to the Court’s jurisdiction, is under a duty to this Court not to interfere with justice by acting in such a way as to breach the intent and purpose of the rule or order

She acknowledged that it may be difficult to enforce the implied undertaking rule on persons outside the Court’s jurisdiction, but she noted that that difficulty stems from the fact that it may be difficult to enforce a contempt judgment in a foreign jurisdiction. But that difficulty is not addressed by granting a formal protective order, which is also ultimately enforceable through contempt [50]. She suggested that consequently “a party may be more likely to obtain effective relief against breach of protective measures by asking the foreign court to recognize and enforce the underlying obligation” [50].

She also held that “the case law has clearly recognized that the implied undertaking does not prevent use of information that was obtained from other [non-confidential] sources [59].

She did leave open the question of whether protective orders should be issued in proceedings other than actions, in which the implied undertaking rule might not be applicable [58].

In concluding, Tabib J suggested that some misconceptions about the nature of the implied undertaking rule may stem from the “climate of uncertainty” as to the nature of the rule up to the 1990s, before clarifying jurisprudence had developed, and as a result of familiarity with US practice. Tabib J emphasized the distinction from US practice, “where the concept of the implied undertaking does not exist and where, as a result, protective orders are routinely issued” [67]. She emphasized the need for lawyers dealing with clients who are familiar with US practice to educate those clients “of the existence of the implied undertaking rule, of the restrictions on the use of this information and of the penalties they may face if the restrictions are breached, even in the absence of a formal order or agreement” [69].

Sunday, May 13, 2018

No new cases

No new substantive patent cases were released last week.

Monday, April 30, 2018

Formal Confidentiality Order Not Always Required

MediaTube Corp. v. Bell Canada 2018 FC 355 Locke J
            2,339,447 / Internet Protocol Televsion / Fibe TV, FibreOp

This decision raises a couple of interesting points regarding procedure and substantive law of confidentiality orders. As discussed here, MediaTube's infringement action against Bell fell apart during discovery, and Locke J’s decision on the meritslargely addressed costs: 2017 FC 6. (And see 2017 FC 495 discussed here further clarifying the costs order.)

During the trial, in an exchange with the Court, Bell identified certain exhibits and transcripts that it felt should be treated as confidential. MediaTube did not object at that time, but it did object after retaining new counsel, and just after the trial decision was issued, MediaTube filed a motion seeking a declaration that these exhibits and transcripts are part of the public domain, and that they be made available to the public [4]-[6]. (The Court of Appeal has indicated that the hearing of the appeal would not be scheduled until after a decision on this motion [7].)

No formal evidence was submitted on the issue of confidentiality and no formal Confidentiality Order had ever been granted, but Bell had raised the issue of confidentiality several times during the trial, asking that certain material be treated as confidential, and Locke J had agreed [15], [16], [18]. Thus the issue of confidentiality had been duly raised, considered and decided at trial [20], and Locke J held that the matter was therefore res judicata notwithstanding the absence of a formal order (citations omitted):

[20] The fact that no formal Confidentiality Order was issued does not render null my rulings on confidentiality, and does not impede the application of the principle of res judicata. In addition, I am concerned about potential negative effects on the efficient conduct of trials in the future if I were to give weight now to Bell’s failure to make a formal motion, supported by formal evidence, for a formal Confidentiality Order. . . . The issuance of the order sought by MediaTube, and the consequent loss of confidentiality of Bell’s information, would likely prompt future litigants with information that all parties agree is confidential to devote unnecessary resources to obtain formal Confidentiality Orders.

This is not to say that a formal order is never advisable, but only that the need for a formal order at trial should be left to the trial judge [20].

MediaTube also relied on the fact that the court had not been formally closed when the confidential testimony was heard. After noting that it was unlikely that any member of the public had actually had access to the confidential evidence [23], Locke J rejected this argument as well, for similar reasons of judicial economy:

[24] As with the issue of Bell’s failure to request a formal Confidentiality Order, I am concerned about potential negative effects on the efficient conduct of trials in the future if I were to give weight now to Bell’s failure to request that the courtroom be formally closed during discussion of confidential information during trial. Requiring a party to take this step when it has no practical effect would impede the efficient conduct of trial.

The decision also raised a significant point on the substantive law related to confidentiality. In Sierra Club of Canada 2002 SCC 41, the SCC held that a confidentiality order should only be granted when it is necessary “to prevent a serious risk to an important interest, including a commercial interest.” The SCC elaborated by saying “In order to qualify as an ‘important commercial interest’, the interest in question cannot merely be specific to the party requesting the order; the interest must be one which can be expressed in terms of a public interest in confidentiality” [53], [55]. While the primary basis for his decision is that the matter was res judicata, Locke J also remarked that

[22] . . . I am satisfied that, where a party that finds itself involved in litigation (especially as a defendant in an action that is without merit) and is compelled by the rules of discovery to divulge sensitive and confidential information, there is a strong public interest in that party being able to maintain the confidentiality of that information. Otherwise, no confidential information is safe. I am satisfied that the salutary effects of maintaining the confidentiality of the information in question in the present motion, outweigh its deleterious effects on the right to free expression, including the public interest in open and accessible court proceedings.

This strikes me as a sensible interpretation of the SCC’s remarks.

Sunday, April 29, 2018

No new cases

No new substantive patent cases were released last week.

Note that I generally only blog on substantive patent / pharma cases. If you want to keep abreast of all new Canadian decisions, including procedural decisions and copyright and trade-mark cases, I recommend subscribing to the Daily Intellectual Property News service from Alan Macek's IPPractice.

Friday, April 20, 2018

Late Request to Amend Priority Date

Bayer Cropscience LP v. Canada (Attorney General) 2018 FCA 77 Nadon JA: Webb, Gleason JJA aff’g 2017 FC 178 O'Reilly J

In this decision the FCA has affirmed O'Reilly J’s decision affirming the Commissioner’s decision to refuse Bayer’s request to amend the priority date, essentially for the same reasons given by O’Reilly J, namely that the request was outside the sixteen month window set in by Rule 88(1)(b).

As discussed here, this case turned on a narrow point of law in the context of unusual facts. Bayer filed a US patent application on 3 April 2012. The USPTO refused to assign a filing date for it on the basis that Bayer had failed to file accompanying drawings. Bayer filed the drawings on 19 April 2012, and the USPTO assigned that as the filing date. The following year, on 15 March 2013, Bayer filed a PCT application claiming priority from the US application. Bayer asked for a filing date of 3 April 2012, but WIPO pointed out that the US application had a filing date of 19 April. Therefore Bayer requested, and was given, a filing date of 19 April 2012. Two years after that, Bayer persuaded the USPTO that the drawings were not required after all, and on 14 April 2015, the USPTO amended the filing date for the US application to 3 April 2012. However, the USPTO, which acted as the international receiving office for the PCT application, refused to amend the PCT filing date. On 7 August 2015, the PCT application entered the national phase in Canada as Canadian Patent Application No 2,907,271. Bayer requested that the ‘271 application be given a filing date of 3 April 2012 on the basis that it was claiming priority from the ‘691 US Priority Application, which had an amended filing date of 3 April 2012.

Bayer’s argument was essentially that it had physically filed the complete and proper US application on 3 April 2012, and it should therefore be entitled to claim priority based on that date [47], [76]. The problem is that Rule 88(1)(b) provides that the request for priority must be made “before the expiry of the sixteen-month period after the date of filing of [the US application].” Bayer’s request was simply out of time. It was in effect asking for a waiver of the sixteen month period set out in the Rules, and there is no basis for such a waiver [77].

Wednesday, April 18, 2018

Non-infringing Alternative and Non-economic Factors

Adir v Apotex Inc 2018 FC 346 Gagné J
            1,341,196 / perindopril / COVERSYL

This decision concerns the accounting of profits portion of a bifurcated trial. In the liability decision, Apotex had been held liable for infringement and Servier elected an accounting: 2008 FC 825 aff’d 2009 FCA 222. 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, Apotex argued that it had a non-infringing alternative (NIA) which would have allowed it to compete in those markets, namely by sourcing perindopril from third party manufacturers based outside Canada. Apotex argued that the profits it would have made by manufacturing abroad should be deducted from the profits actually made by the infringing manufacture in Canada, to arrive at the differential profit to be disgorged. As discussed here, Gagné J rejected consideration of the NIA as a matter of law: 2015 FC 721. Her decision was delivered 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). It was therefore unsurprising that the FCA allowed Apotex’s appeal in part, remanding on the NIA issue: 2017 FCA 23 Perindopril Accounting FCA rev’g in part and remanding 2015 FC 721 (here). 

The sole question in this decision on remand was “whether any of Apotex’s profits from export sales of perindopril could have and would have been realized through use of a non-infringing alternative [NIA],” with a consequent reduction in the amount to be disgorged [2]. In a striking application of the “would” branch of the test, Gagné J held that even though Apotex could have sourced non-infringing perindopril from a third party, albeit with a delay of one year, it would not have done so. Consequently, no reduction was ordered in the award of $56,000,000 plus interest.

Tuesday, April 10, 2018

NEXIUM Saga Is Not Over Yet

AstraZeneca Aktiebolag v Apotex Inc 2018 FC 185 Locke J
            2,139,653 / esomeprazole / NEXIUM

While the SCC abolished the promise doctrine in AstraZeneca v Apotex 2017 SCC 36 rev’g 2015 FCA 158 rev’g 2014 FC 638, the associated litigation is not over yet. To recap, Apotex had prevailed in NOC proceedings (2010 FC 714). The subsequent infringement action was bifurcated to carve out any experimental and regulatory use exemption, as well as the quantum of any damages or profits [5]. In the first part of the bifurcated action, AstraZeneca initially lost, on the basis that the 653 patent was invalid for lack of utility, but then ultimately won when the SCC in AstraZeneca abolished the promise doctrine. At first instance, Rennie J had held that the 653 patent was invalid for failure to meet the promised utility, but had rejected all other validity attacks. The FCA had upheld the decision on the basis of lack of promised utility, but did not address Apotex’s appeal of the other validity attacks. In the meantime, Apotex brought a s 8 action consequent on its victory in the NOC proceeding. This went to trial before Locke J, after the SCC hearing but before its decision [9]. The parties agreed that Locke J should not issue his decision until after the SCC had issued its decision [10]. When the SCC decision issued, and after hearing supplemental submissions, Locke J dismissed Apotex’s s 8 NOC claim: 2018 FC 181. The second part of the birfurcated infringement action is ongoing, and this decision concerned motions as to how to proceed in light of the SCC AstraZeneca decision. The difficulty is that SCC had concluded its decision by holding that “The `653 patent is not invalid for want of utility” [64]. Apotex argued that this was not the same as a holding that the patent was valid, and the trial should be re-opened to allow the parties an opportunity to address the validity issues, in particular those which had not been addressed by the FCA, with additional evidence [27]. AstraZeneca, on the other hand, argued that the SCC decision had finally determined the validity of the 653 patent, and consequently the second part of the bifurcated trial, should proceed. Locke J ruled in favour of AstraZeneca, on the basis that he had decided in dismissing Apotex’s s 8 claim, in 2018 FC 181, [30]-[36] that “the validity of the 653 Patent was finally decided by the SCC, and that there remains no other validity issue to debate” [29].

Thursday, April 5, 2018

Remedies and Extraterritoriality

In a recent post I pointed out that Canadian and US law have different approaches to the problem which arises when domestic acts of infringement cause losses in a foreign country (see also here). In Canada, it appears that all losses which are proximately caused by the domestic infringement are recoverable, regardless of where the loss itself occurs, though the courts will offset foreign awards in assessing damages. In contrast, several US Federal Circuit cases have held that recovery may be barred if the loss itself occurred abroad, even if the loss was caused by domestic infringement The US Supreme Court will address this issue in WesternGeco LLC v. ION Geophysical Corp., No 16-1011. Many of the briefs, including that of the US Solicitor General, are urging that the position of the US Federal Circuit is wrong (see here), and yesterday Professor Tom Cotter had a post on his Comparative Patent Remedies blog, also arguing, in effect, that the Canadian position is correct.

Thursday, March 22, 2018

Correction of Ownership Does Not Necessarily Require Direct Evidence from Assignor

Copperhead Industrial Inc. v. Canada (Attorney General) 2018 FC 311 Gleeson J
            2,614,533 / 2,919,266

Copperhead Industrial concerns a contested application to vary the ownership records of the Patent Office. The applicant’s legal corporate name is Copperhead Industrial Inc, and its Ontario Corporation Number is 002152706 [2]. The applicant’s sole director mistakenly believed that its legal name was 002152706 Ontario Ltd., and that Copperhead was its trade name [8]. Consequently, the inventor of the patents at issue assigned them to 002152706 Ontario Ltd, and that was the name reflected in the Canadian Patents Database. Copperheard subsequently commenced actions alleging infringement by Charger & Dresser, who responded in part by arguing that because 002152706 Ontario Ltd. is not a legal corporate entity, all the patent rights remain with the inventor. (The inventor was seriously ill when the action was commenced and is now deceased [11]-[12].) Copperhead therefore brought this application, pursuant to s 52, to have the records corrected to show Copperhead Industrial Inc. as the owner of the patents. While the Patent Office did not oppose the application, and did not appear, Charger & Dresser opposed the application as an intervener [5]-[6].

Gleeson J held that the Federal Court has jurisdiction, as there is no question of a contested interpretation of a contract of assignment [21]. He further held that while non-hearsay evidence from relevant inventors and assignors is commonly provided, and is of assistance to the Court, it is not required [22]-[23]. (The inventor was too ill to provide an affidavit before his death.)

Gleeson J also held that when the Patent Office records are varied, an effective date of variation is not required [34] . He explained that the effect of an order pursuant to section 52 is to correct an error or mistake; it does not serve to alter the effective date of the assignment or other underlying contractual documents, and consequently there is no requirement to identify an effective date for such an order [35].

On the facts, Gleeson J held that the error was due to an honest misunderstanding on the part of the applicant, and the intervener would not suffer any substantive prejudice in the related litigation as a result of the correction [36]. He therefore ordered the Patent Office records corrected to show Copperhead Industrial Inc. as the owner of the patents.

Friday, March 16, 2018

Legal Facts in the “But For” World: Does it Matter Who Might Have Been on the SCC in Calculating Damages?

Apotex Inc v AstraZeneca Canada Inc 2018 FC 181 Locke J
            2,139,653 / esomeprazole / NEXIUM / S 8 NOC

In AstraZeneca 2017 SCC 36, an action involving the 653 patent, the SCC abolished the promise doctrine (here). In so doing, it held the 653 patent to be valid,1 reversing the decisions in the courts below which had applied the promise doctrine to invalidate it. But before that action, in 2010 FC 714, Apotex had prevailed in the NOC proceeding. This decision, by Locke J, is the s 8 damages decision following from that NOC decision. Section 8 proceedings entitle the generic to recover damages for having wrongly been kept out of the market as a result of the statutory stay triggered by the NOC proceedings in which it prevailed. But what if ultimately, in the infringement action, the patentee prevails? The key question is whether Apotex should be entitled to recover s 8 damages for having been wrongly kept out of the market, when it turns out that it never had the right to enter the market. In AstraZeneca v Apotex 2017 FC 726 Barnes J held that the answer was no: see here. Locke J has now come to the same conclusion, and he therefore dismissed Apotex’s s 8 action [112]. While Locke J’s reasoning is somewhat different from that of Barnes J, the decisions are consistent. 

The relationship between s 8 damages and damages in a subsequent infringement action will soon be of historical interest only, as the new NOC proceeding will take the form of an action. This decision does, nonetheless raise a point of more general importance regarding the nature of hypothetical legal facts in the “but for” world. For example, does it matter who is on the Supreme Court of Canada in the but for world?

The technical point is that s 8 damages, like all damages, are assessed as the difference between the plaintiff’s actual position and the position it would have been in “but for” the wrong (ie but for the statutory stay in the case of s 8 damages). The patentee’s general argument in a case in which the patent is subsequently held to be valid is that in the but for world, the generic would have infringed, and would have liable to the patentee for infringement, and that liability in the “but for” world would offset any profits the generic would have made had the statutory stay not prevented it from entering the market. In effect, the generic did not suffer any lost profits as a result of the statutory stay, because the patent, which we now know to be valid, would have prohibited it from entering the market anyway.

It is clear from prior FCA decisions, in particular Lovastatin 2011 FCA 364 (here) and Omeprazole 2013 FCA 77 (here), that liability for damages for infringement should be taken into account in assessing s 8 NOC damages. There was a preliminary dispute in this case as to whether it should be taken into account under s 8(1), which establishes liability (AstraZeneca’s position), or under s 8(5), which allows the court to consider all relevant matters in assessing quantum (Apotex’s position). Locke J, relying on Lovastatin, held that Apotex’s “but for” infringement should be taken into account using s 8(5) [62]. I think that’s right as a matter of the interpretation of Lovastatin, but I have to admit that it is not entirely clear to me what difference it makes: as Locke J pointed out, it wouldn’t have made any difference on the facts of this case: [64].

The more interesting point was how to construct the “but for” world:

[76] . . .Apotex argues that there is no evidence that any of the following would have happened in the but-for world: (i) AstraZeneca would have sued Apotex for patent infringement, (ii) the parties would not have settled the matter before a trial, (iii) the SCC would have granted leave to appeal, or (iv) the SCC would have decided such an appeal the same way. Accordingly, Apotex argues that, for the purposes of constructing the but-for world, the 653 Patent should be treated as invalid just as it was in the real world during the Delay Period.

On the details, Apotex argued, for example, that the SCC would not necessarily have decided the same way because in the “but for” world, the matter would have come to trial at a time when Rowe J, who wrote the AstraZeneca decision, was not on the Court [88].

AstraZeneca’s position was that this should all be irrelevant:

[77] It argues that we now know that the 653 Patent was valid during the Delay Period, and that it should be treated as such for the purposes of the assessment of compensation under s. 8 of the Regulations, regardless of whether it would have been found valid in the but-for world.

Locke J found it unnecessary to decide the question. Relying in large part on the principle from Ramipril s 8 2014 FCA 67 [145] that “All steps that were taken in the real world should be assumed to have been taken in the but-for world unless there is evidence upon which the trier of fact may reasonably conclude that different steps would have been taken,” he concluded that all of Apotex’s hypotheticals should be resolved against Apotex. Since AstraZeneca prevailed on the facts, it was not necessary for Locke J address the legal argument.

The point is nonetheless an important, to the extent that different facts might warrant a different conclusion. In my view, AstraZeneca was right on this point. The reason for this is emphasized in an article by David Taylor: “reasonable royalties should reflect the value of patented technology rather than patent rights” (49 Ga Law Rev 79. 89, original emphasis). Taylor made that observation in the context of reasonable royalties, by way of explaining the established rule that in determining a reasonable royalty using the hypothetical negotiation approach, the patent should be assumed to be valid, even though in the hypothetical “but for” negotiations, the parties would not have known it to be valid. The same principle applies in the context of lost profit damages. To elaborate, the purpose of assessing damages for patent infringement is to preserve the incentive to invent. In order to promote socially beneficial inventions, the incentive to invent should be commensurate with the social value of the invention. That social value is equal to the incremental value of the invention over the best non-infringing alternative: see eg The Sedona Conference, Commentary on Patent Damages and Remedies, 23-24; David O. Taylor, David, Using Reasonable Royalties to Value Patented Technology,” 49 Ga Law Rev 79. 91-97; Lee & Melamed, “Breaking the Vicious Cycle of Patent Damages,” (2016) 101 Cornell Law Rev 385, 411-12. As I said in my article “A Remedial Benefit-Based Approach to the Innocent User Problem” 920014) 20 CIPR 79, “A patent is ‘nothing very special’ when it provides only a small advantage over the next best publically available alternative. The differential profit approach, by comparing the actual profits with those which would have been made with the next best alternative, provides a precise means of identifying a patent which is ‘nothing very special.’”

The “but for” world is a construct for determining the true social value of the patent invention. The “but for” world should therefore be sensitive to factors which affect the value of the patented technology. If a drug treats a disease that has become an epidemic, it should be more valuable than one that treats a disease that was anticipated but which never emerges. This gives the inventor a strong incentive to focus its efforts on inventions that it believes will be socially valuable. The “but for” world should not be sensitive to factors which solely affect the value of the patent rights, such as whether an injunction would have been granted, or whether the patent would have been held invalid. The grant of an injunction by a court may increase the value of the patent right to the patentee, but it does not increase the social value of the patented technology.

This suggests that legal facts about the “but for” world should be treated like past events: “past events must be proven, and once proven they are treated as certainties” (Athey v Leonati [1996] 3 SCR 458, [28]). This is consistent with Locke J’s observation in response to Apotex’s argument that the SCC’s decision to change the law and reject the promise doctrine was not foreseeable (my emphasis):

[96] Even accepting all of the facts asserted in the preceding two paragraphs, the fact remains that the 653 Patent is, and always was, valid. This is the case in the real world even if I accept Apotex’s allegations that the law on the Promise Doctrine would not have evolved in the but-for world as it did in the real world. Whether or not such allegations are justified, the fact is that Apotex claims compensation for loss as a result of being prevented from infringing AstraZeneca’s valid patent.

1There was a preliminary dispute as to whether the SCC in AstraZeneca had held the 653 patent to be valid, or merely that it is not invalid for lack of utility. Locke J held that the SCC had held the 653 patent to be valid [30].

Thursday, March 15, 2018

Promise Doctrine Zombie Watch: Part III

Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research 2018 FC 259 Phelan J
            2,261,630 / infliximab / REMICADE / INFLECTRA

In this case (discussed more generally in my previous post), Hospira had initially based its utility argument on “promise of the patent,” but after the trial, AstraZeneca 2017 SCC 36 was released, abolishing the doctrine: [253]. Phalen J allowed the parties to make submissions on the effect of AstraZeneca [254], and Hospira "recast its argument to link 'promise of the patent' to the absence of sound prediction and to insufficiency and overbreadth" [255]. The exact nature of Hospira’s argument is not entirely clear, but what is clear is that Phelan J was having none of it:

[258] Hospira attempts to import the discarded “promise” doctrine into insufficiency and overbreadth. Certainly AstraZeneca does not do so and it would be inconsistent to discard that doctrine only to have it resurface under another principle without clear language to do so.

This is in line with the other post-AstraZeneca cases, which have consistently refused to entertain any attempt to resurrect the promise doctrine in another guise: see here and here.

Tuesday, March 13, 2018

More Support for Experimental Use Exception to Anticipation

Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research 2018 FC 259 Phelan J
            2,261,630 / infliximab / REMICADE / INFLECTRA

The 630 patent, held by Kennedy Trust, covers the adjunctive use of methotrexate [MTX] and infliximab for the treatment of rheumatoid arthritis [RA] in patients who do not respond fully to MTX alone. Infliximab is only approved for treatment of RA when used in combination with MTX [16]. Kennedy Trust’s licensee, Janssen, markets infliximab for use in combination with MTX under the name REMICADE [18]. Hospira’s infliximab product INFLECTRA, is a biosimilar of REMICADE, sold for the same purpose [18] (and see the product monograph). Hospira brought an action for a declaration that Kennedy’s 630 patent is invalid, and that INFLECTRA would not infringe, while Kennedy brought a counterclaim to the opposite effect [5].

MTX was a popular prior art treatment for severe RA [111], but for some patients — “incomplete responders” — MTX alone did not adequately control their RA. The efficacy of infliximab was also part of the cgk [113], but the duration of effect was limited [11]. It turned out that the combination of MTX and infliximab, as claimed in the 630 patent, exhibited enhanced efficacy over either drug alone as well as a sustained duration of effect [15]. On the facts, Phelan J concluded that this particular combination therapy was not obvious or obvious to try [230].

Hospira argued “an astonishing number and veritable panoply of patent law issues.” [24], including standing, ownership, improper priority, and double patenting plus along with the full range of the usual attacks, including anticipation, obviousness, sufficiency, utility, and overbreadth (and this list isn’t complete). As an academic, I hesitate to comment on litigation strategy, but I can’t help but feel that Hospira’s scattershot approach undermined the strength of its better arguments, particularly given that several of the arguments were thinly argued, occasionally without any supporting authority (see eg [159]). On overbreadth, Phelan J remarked that “Its submissions seem to have been made in the hope that something would “stick” – the patent law equivalent of the Hail Mary pass” [249]. At the end of the day, nothing stuck: Phelan J held the 630 patent to valid and infringed. I won’t run through all of the arguments, but only those that raise a point of interest.

Experimental Use Exception to Anticipation

A couple of interesting points were raised by Hospira’s novelty attack. First, Phelan J endorsed the experimental use exception to anticipation, albeit in obiter [198]. Hospira argued that the patient consent forms used in Kennedy’s Phase II clinical trials were anticipatory. Phelan J rejected this primarily on the basis that confidentiality was established on the evidence (in part on the basis that the industry practice with clinical trials is to expect the maintenance of that confidence) [196i]. He also rejected it on public policy grounds, as it would effectively put an end to informed consent or to the patenting of medication [196i]. And he also suggested that “the experimental use exception is not as defunct as Hospira would have one conclude,” citing with approval Fothergill J’s decision in Bayer v Apotex 2016 FC 1013, discussed here (and see also Bayer v Apotex 2014 FC 436, Hughes J, discussed here). This experimental use defence to anticipation had some basis in the early case law, but it was not previously well-established; we now have three different Federal Court judges who have recently lent credence to the idea.

Speculative Anticipation

Hospira argued anticipation on the basis of a number of prior art documents which suggested trying infliximab or another anti-TNF-α antibody in combination with MTX, or referenced a trial in which that combination was being tried [196]. This is a bit of a twist on the usual anticipation attack, where the prior art says “We did X” and the question is whether X necessarily falls within the claims of the patent at issue. In this case (to oversimplify), the prior art says “Someone should try X” where X is exactly what the patent claims, namely combining MTX and infliximab to treat RA. (More precisely, the prior art references didn't all reference infliximab specifically.) Phelan J dismissed the prior art references as all being speculative [167], [191]. This calls to mind the case-law arising in the context of a conflict proceeding under the first-to-invent system, where in order to establish inventorship, it had to be shown that at the asserted date “the invention was no longer merely an idea that floated through the inventor's brain but had been reduced to a definite and practical shape” Ernest Scragg & Sons Ltd v Leesona Corp (1964), 45 CPR 1, 33. The allegedly anticipatory prior art in this case was really no more than “an idea that floated though the brain” of the proponents. It strikes me that just as a speculative idea cannot be an invention for the purposes of establishing priority over an inventor who had actually reduced the idea to practice, so it cannot be a disclosure sufficient to anticipate an invention that had actually reduced the idea to practice.

Blinding the Witness

Hospira’s experts were blinded. Phelan J gave little weight to this, saying “blinding alone is not a guarantee of reliability and it is not a sufficient reason to prefer the evidence of one witness over another” [203], consistently with 2016 FC 382 (discussed here). Phelan J also questioned whether blinding was even possible, at least on the facts of this case:

Further, given the involvement of the experts in this case in the development of RA treatments during the relevant time period, it is at least questionable whether blinding holds any value. It is impossible to believe that these experts were not aware of the development of Remicade prior to this trial.

Methods of Medical Treatment

Hospira argued that the 630 patent was invalid as being an unpatentable method of medical treatment [136]-55]. Phelan J recognized that “[t]he jurisprudence with respect to the unpatentability of methods of medical treatment is not entirely consistent” [141]. This is not very surprising, given that the FCA has also called for “full consideration [of the patentability of methods of medical treatment] by this Court or the Supreme Court in a case where the issue is squarely raised on the facts” 2015 FCA 116 [101]. Phelan J’s observation further emphasizes the need for reform in this area of the law.

On the facts, Phelan J held that the patent at issue was not a method of medical treatment, essentially because “the use of X in combination with Y to treat disorder Z” is no different in substance from “the use of X to treat disorder Z” and the latter is clearly patentable: [147]. A claim of that type was at issue in Wellcome / AZT, 2002 SCC 77; and see the discussion here.