Thursday, April 27, 2017

Springboard Profits Awarded in an Accounting

Dow Chemical Co v NOVA Chemicals Corp 2017 FC 350 Fothergill J
            2,160,705 / film-grade polymers / ELITE, SURPASS

In the liability phase of this action, Dow Chemical Co v NOVA Chemicals Corp 2014 FC 844 aff’d 2016 FCA 216, O'Keefe J held Dow’s 705 patent related to film-grade polymers to be valid and infringed by Nova: for more background see Wednesday’s post. Fothergill J’s decision in the remedies phase addresses various issues to allow the parties’ accountants to calculate the actual sums owed by Nova to Dow [6]. Dow elected an accounting [107], and one of the issues requiring clarification was whether Nova had to account for so-called “springboard profits” [112]-[130].

When a patent expires some time is normally required before a competitor can enter the market with a product that would have infringed. Infringement allows a competitor a head start in gaining market share; a competitor who infringed prior to the expiry will have a larger market share on expiry than one who started competing only the day the patent expired. The patentee’s lost sales during this post-expiry ramp-up period are known as springboard damages, and similarly, the infringer’s excess profits during the same period are springboard profits. In this case, Fothergill J awarded Nova’s springboard profits as part of the accounting [130], for what appears to be the first time in Canadian patent law [115]. While the award is novel in that narrow sense, it is by no means groundbreaking, as the possibility has previously been recognized both in Canadian law [113], and in other jurisdictions [114]. More importantly, an award of springboard profits is firmly based on “but for” causation. As Forthergill J held:

[124] An accounting of profits is to be assessed in relation to a “but-for”world in which the defendant has not infringed the plaintiff’ patent. The assumption is that at the time of the patent’ expiry, the defendant had not yet produced the infringing product. I agree with Justice Barnes [in AstraZeneca 2015 FC 671, [7]], that springboard damages are nothing more than a type of loss to be proven with evidence, and I see no reason why this principle should operate differently to a plaintiff’s gains in the context of an accounting of profits.

Wednesday, April 26, 2017

Can Lost Profits Be Claimed as Reasonable Compensation under 55(2)?

 Dow Chemical Co v NOVA Chemicals Corp 2017 FC 350 Fothergill J
            2,160,705 / film-grade polymers / ELITE, SURPASS

In the liability phase of this action, Dow Chemical Co v NOVA Chemicals Corp 2014 FC 844 aff’d 2016 FCA 216, O'Keefe J held Dow’s 705 patent related to film-grade polymers to be valid and infringed by Nova’s SURPASS product: see discussion of the FC decision here and the FCA decision here. He also held that Dow was entitled to damages under s 55(2) of the Patent Act for pre-grant ‘infringement’, and that Dow was entitled to elect between damages and an accounting for post-grant infringement. Dow subsequently elected an accounting [107]. Fothergill J’s decision in the remedies reference provides helpful clarification on a number of issues. This post discusses reasonable compensation under s 55(2) of the Act.

Dow’s ‘705 patent relates to film-grade polymers, used to make products such as plastic bags, and in particular metallocene linear low-density polyethylene [mLLDPE], which includes both ELITE, manufactured by Dow, and SURPASS, manufactured by Nova. Both these products have superior strength and processing characteristics as compared with conventional linear low-density polyethylene products, and they occupy a distinct market segment from conventional film-grade polymers [15], [92].

Reasonable Compensation
Subsection s 55(2) of the Act provides that “A person is liable to pay reasonable compensation to a patentee . . . for any damage sustained by the patentee,” for ‘infringing’ acts committed between the time of publication and the time of grant [63]. The parties agreed that the proper measure of damages under s 55(2) is a ‘reasonable royalty’ to be determined using a hypothetical negotiation between Dow and Nova for a licence authorizing Nova’s use of the patented technology [64], [65]. To determine the reasonable royalty, the parties used essentially the same framework as was used in Airbus v Bell Helicopter 2017 FC 170 (discussed here), in which the boundaries of the hypothetical negotiation are the patentee’s “minimum willingness to accept” [MWTA or MWA] and the infringer’s “maximum willingness to pay” [MWTP or MWP]. The difference between the two is the “gains to trade,” which are divided between the parties [67].

This approach runs into a problem when the patentee’s MWA is higher than the infringer’s MWP – that is, when there is no price that the infringer would be willing to pay that the patentee would be willing to accept. This is not uncommon, given that it often happens that a reasonable royalty is assessed in favour of a patentee who, in reality, was using the patent to enforce market exclusivity for its own product. The minimum the patentee would accept is its own profit margin on all its lost sales, and it is rare that the infringer’s profit margin will be higher than that the patentee’s margin. This means that in reality, the patentee would not have been willing to licence on any terms the infringer would have been willing to accept. That is what happened in this case. The experts agreed that Dow’s MWA would be the lost profit on sales that would be diverted from Dow to Nova due to the infringing competition [68]. Fothergill J concluded on the facts that Nova’s MWP would be lower than Dow’ MWA. 

So, what to do? Forthergill J held, with the agreement of the experts, that the way to solve this problem is that the reasonable royalty is the patentee’s MWA, i.e., the higher figure:

[87] If Nova’ MWTP is lower than Dow’ MWTA of 8.8%, then there is no bargaining range between the parties. As Dr. Heeb stated, “[s]ince a bargain is compulsory in this hypothetical negotiation, the reasonable royalty rate is simply Dow’ MW[T]A”. Dr. Leonard did not dispute this approach. There is therefore no need to consider the division of gains to trade.

Dow’s MWA was equal to its profit margin on its ELITE product, that competed with the infringing SURPASS [80], [81] (albeit with a “diversion ratio” discount that I will ignore for the present purposes), so in effect Dow was awarded its lost profits on the sales that were diverted to Nova by Nova's use of the patented technology during the laid-open period.

In the context of reasonable royalty damages generally, I think that using the patentee's MWA is the wrong solution to this problem in the hypothetical negotiation framework. The reason, in a nutshell, is that we should never end up in this situation in the first place: if the patentee’s MWA is higher than the infringer’s MWP, this could only be because the patentee’s best option would have been to sell the product itself, in which case it should be seeking lost profits. Very often in this kind of case the patentee does indeed seek lost profit damages, or an accounting of the infringer’s profits, and this problem does not arise. Nor does the problem arises when the infringer was selling to a market that would not have been tapped by the patentee, and so there are no lost profits to prove. That is the classic reasonable royalty scenario, where there are gains from trade and the MWA / MWP approach works well.

But sometimes the patentee is unable or unwilling to prove damages in the form of lost profits in litigation, and so ends up claiming a reasonable royalty, even though in the real world the patentee would have refused a licence, and made its own profits. In that case, allowing the patentee to insist on an MWA that is equal to its own profit margin would allow it to smuggle lost profits damages into a reasonable royalty assessment. Having failed to prove lost profits directly, the patentee shouldn’t be able to get them indirectly, disguised as a reasonable royalty. The problem in such a case is not with the hypothetical negotiation construct, but rather with the assessment of the MWA on the facts. If the patentee did not claim, or failed to prove lost profits, then it should not be able to assert that its MWA would have been defined by those same lost profits: see here for more.

With that said, in this case, I think the approach adopted by the parties, and by Fothergill J is right. This is not a case in which the patentee failed to claim or prove lost profits. By statute, the patentee was confined to “reasonable compensation,” and the real question is what is meant by “compensation.” Does it include lost profits? On its face, the answer is yes. It is very well-settled that the purpose of patent damages, including lost profit damages, is to compensate the patentee. Compensation is achieved by putting the patentee back in the position it would have been in but for the wrongful act: see e.g. Lovastatin Damages 2015 FCA 171 [41]-[43], [49]-[50]. Section 55(2) also requires “compensation” of the patentee. Prima facie, the term “compensation” in a remedial provision of the Act should mean the same thing that it means in remedies law generally. From that it follows directly that when the patentee has lost profits as a result of the wrongful act, it should be entitled to recover those lost profits in compensation. On this view, the only substantive difference between 55(1) and 55(2) is that, in the former, the wrongful act is infringement of a granted patent, and in the latter, the wrongful act is any act that would have constituted an infringement of the patent, during the laid open period.

The only obstacle to this analysis, which was no doubt the reason that the parties agreed that reasonable compensation should be assessed as a reasonable royalty, and not lost profits, is Snider J’s decision in Jay-Lor 2007 FC 358, in which the patentee also claimed reasonable compensation under s 55(2). The patentee specifically argued that that reasonable compensation should take the form of damages on lost sales, i.e. lost profits [121]. Snider J rejected this:

[122] In my view, such an award is not warranted. In addition to relying on the comments of Justice Gibson in Baker Petrolite, I base this view on my reading of the relevant statutory provisions. For the period after the grant of the patent, s. 55(1) of the Patent Act provides that “a person who infringes a patent is liable . . . for all damage sustained by the patentee”. In contrast, s. 55(2) provides that a person is liable to pay “reasonable compensation . . . for all damage sustained by the patentee” during the laid open period. In s. 55(2), Parliament could have provided for the same assessment of damages as in s. 55(1). It did not do so. Accordingly, to give effect to the different words in the two provisions, I believe that the better view is that “reasonable compensation” during Period 1 must be something other than damages as contemplated by s. 55(1). It may be that there are other means to provide reasonable compensation beyond a royalty. However, in the case before me, no alternatives were presented. Thus, in this case, I intend to equate “reasonable compensation” to a “reasonable royalty”.

With respect, Snider J’s holding on this point is, in my view, wrong. Compare the provisions:

55(1) A person who infringes a patent is liable to the patentee and to all persons claiming under the patentee for all damage sustained by the patentee or by any such person, after the grant of the patent, by reason of the infringement.

55(2) A person is liable to pay reasonable compensation to a patentee and to all persons claiming under the patentee for any damage sustained by the patentee or by any of those persons by reason of any act on the part of that person, [during the laid open period].

The most basic problem with Snider J’s interpretation is that a patentee who has in fact suffered damages in the form of lost profits during the laid open period, and who claims under a provision, s 55(2), that explicitly entitles them to “compensation. . . for any damage,” will nonetheless not be entitled to compensation for its lost profits. This flies in the face of the plain words of the Act. Moreover, Snider J’s view is premised on the need to give effect to the different wording in the two provisions. This implies that if 55(2) had said “A person is liable to a patentee ...” omitting the words "reasonable compensation" then it would include lost profits, because then the provisions would be exactly parallel. So, not only is a patentee denied compensation under a provision that explicitly entitles it to compensation; it is disentitled to compensation because the provision explicitly entitles it to compensation. This strikes me as doubly absurd.

Further, if Snider J is right as a matter of statutory interpretation, the Fothergill J’s holding in this case must also be wrong as a matter of law, because the effect of his decision is to allow a patentee to recover its lost profits during the laid open period. If Snider J’s interpretation of the Act is right, than this would countenance an end-run around a statutorily imposed substantive limitation on recovery under 55(2).

In my view, Forthergill J was right, and that necessarily implies that Snider J’s interpretation of 55(2) was wrong. Ideally, the courts would recognize explicitly that “reasonable compensation” under 55(2) can include lost profits when appropriate on the facts.

But the more important point is that Forthergill J’s holding that when there is no bargaining range between the parties, the reasonable royalty rate is the patentee’s MWA, but it should not be uncritically extended to the context of reasonable royalties. It is acceptable, though not ideal, as a way of avoiding Snider J’s interpretation of 55(2),so long as it is confined to that context. Otherwise, we may have a situation of cascading errors, where a problem in the interpretation of one relatively narrow provisions, gets magnified into a much bigger problem.

Wednesday, April 19, 2017

Important Course Correction on Inventive Concept

Bristol-Myers Squibb Canada Co v Teva Canada Ltd 2017 FCA 76 Pelletier JA: Near, Rennie JJA aff’g 2016 FC 580 Mactavish J
            2,317,736 /atazanavir / REYATAZ / NOC

The FCA’s Atazanavir decision is a welcome course correction dealing with the role of the inventive concept in the obviousness analysis. Since Sanofi / Plavix 2008 SCC 61, [67], endorsed the four-step Windsurfing/ Pozzoli framework, identifying the “inventive concept” in the second step has become an increasingly lengthy and contested aspect of an obviousness attack. The FCA’s Atazanavir decision has now pressed the reset button on this approach, emphasizing that Sanofi did not effect any radical change in the law on this point. This important – and short – decision is essential reading on the issue of obviousness.

Thursday, April 13, 2017

Late Request to Amend Priority Date

Bayer Cropscience LP v. Canada (Attorney General) 2017 FC 178 O'Reilly J
            2,907,271

In this case O'Reilly J affirmed the Commissioner’s decision to refuse Bayer’s request to amend the priority date, on the basis that the request was outside the sixteen month window for such a request under Rule 88(1)(b). This case turned on a straightforward reading of the Rules in the context of unusual facts.

Bayer filed a US patent application on 3 April 2012. The USPTO refused to assign a filing date 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 later (April 2015), on Bayer’s request, the USPTO conceded that the drawings were not required after all, and it 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 application, which had an amended filing date of 3 April 2012 [4].

The problem was that under Rule 88(1)(b), a request for priority must be made with sixteen months of the filing from which priority is claimed [15]. Bayer had made a request within that period, namely on 15 March 2013, but there was no basis for it at that time, as the US application was still dated 19 April 2012 [14]. The US application had been amended by the time of Bayer’s August 2015 request to CIPO, but that second request was well out of time [15].

Bayer also argued that the priority date should be amended pursuant to the Commissioner’s duty to ensure the Register is correct. O’Reilly J dismissed this argument, noting that the failure to request an amendment in a timely manner does not create an inaccuracy in the Register [16]. That conclusion must be right, or the time limits would be nugatory.

Wednesday, April 12, 2017

Section 8 Damages Law is Mature

Teva Canada Limited v Pfizer Canada Inc 2017 FC 332 Phelan J
            pregabalin / LYRICA / NOC s 8

It seems that the law related to s 8 damages is now mature. Phelan J’s decision in Pregabalin s 8 runs to 78 pages, without raising any new points of law. This had to happen eventually, as s 8 damages are based on the same basic principle of ‘but for’ causation that is applicable to monetary remedies generally, in which the actual world is compared with a “but for” world (“BFW” to adopt Phelan J’s abbreviation). There were a number of legal issues peculiar to the s 8, because the statutory provisions limit ‘but for’ causation in some ways (in particular with respect to the compensable period), and raise some unique puzzles (ie should it be assumed that the NOC Regulations would not exist at all in the ‘but for’ world), but those issues have largely been hammered out, most importantly in the Apotex s 8 Damages FCA 2014 FCA 68 aff’d 2015 SCC 20 (blogged here, here, and here) aff’d 2015 SCC 20, and the companion case Teva s 8 Damages FCA 2014 FCA 67. No doubt narrow legal issues raised by unusual fact patterns will continue to arise, as in any area of law, but the main issues are settled.

Following Apotex s 8 Damages FC 8) 2012 FC 553 [11], Phelan J noted that there are five steps in assessing s 8 damages [8]

• determine the duration of the period of liability [the Liability Period];
• determine the overall size of the Pregabalin market during the Liability Period;
• determine the portion of the Pregabalin market that would have been held by Teva and any other generic manufacturers during the Liability Period – the generic market;
• determine the portion of the generic market that would have been held by Teva – its lost volumes; and
• quantify the damages that would have been suffered by Teva in respect of its lost volumes (net lost profits).

I won’t go through the details of each determination, which all turned on their facts. I do have just a couple of general observations.

First, Phelan J stated that [13], [14]:

The real world plays a significant role in the construction of the BFW [‘but for’ world]. The BFW is to mirror, as much as possible, the real world experiences and circumstances – to use history as the basis for assessing the assumptions advanced in the BFW scenarios.

So for example, Ratiopharm (now Teva) had failed to follow up promptly on the patent hold letter in the real world, and that failure to act expeditiously in the real world undermined Teva’s argument that it would have acted expeditiously to obtain an NOC in the ‘but for’ world [147]. With that said, Phelan J did not hesitate to find that the BFW would have differed from the real world when the facts so established. For example, Pfizer argued that it in the BFW it would have entered with its own generic, GenMed, as it did on genericization of the market in the real world [220], but the evidence established that GenMed was not a part of Pfizer’s “toolbox” in 2010 [223].

There is also one factual issue that has more general ramifications for s 8 actions. The more generics that would have entered the market in the ‘but for’ world, the lower Teva’s market share and therefore the lower Pfizer’s s 8 liability. This meant that Pfizer wanted to prove that other generics would have entered. This meant that Pfizer had to elicit evidence that would ultimately be helpful to Pfizer from generic drug company executives. That is easier said than done. Phelan J noted that [95, [96]:

Pfizer called six generic drug companies who competed with Teva in the Pregabalin market. All appeared under subpoena and only one agreed to meet with counsel beforehand. Some of the evidence was confidential because of the competitive circumstances. The Court recognizes the difficulty faced by counsel trying, in direct examination, to elicit positive evidence from competitors, even where such examination is skillfully and artfully done as in this case.”

The evidence given was ultimately unhelpful in establishing potential generic entry [98]. Despite the rivalry between innovators and generics, there is no suggestion that the witnesses were trying to undermine Pfizer’s case; rather, “[f]or most it was an exercise too remote from what they did in real life – too theoretical for their comfort” [97]. This illustrates a difficulty than any patentee will face in making its case in s 8 proceedings. With that said, I can’t be too sympathetic to Pfizer’s dilemma; the argument is that but for the statutory stay, the patentee would have lost market share to some generic, just not to the particular generic that had filed the NOA and triggered the NOC proceedings. But the other generics that would have entered in the BFW would not be able to claim damages because they had not actually filed an NOA in the real world. So in arguing that other generics would have entered, the patentee is trying to avoid being held liable for loss it actually caused, albeit not to the particular party in s 8 action. Put another way, the legal rule that entry by other generics must be considered is in itself favourable to the patentee, so patentees can’t complain too much about difficulties of proof they might face in establishing the point on the facts.

Tuesday, April 11, 2017

Another Piece of the Double Patenting Puzzle

Bristol-Myers Squibb Canada v Apotex Inc 2017 FC 296 Manson J
            2,366,932 / 2,519,898 / dasatinib / SPRYCEL / NOC

Patent law has a reputation of being an arcane and technical area of law. To me, it doesn’t generally seem that much worse than, say, corporate law, or even administrative law (where as soon as everyone figures out what the law is, the SCC changes it). But double patenting definitely lives up to the billing of being both arcane and technical. Manson J’s Dasatinib decision is significant in holding that the appropriate date for assessing obviousness-type double-patenting is the claim date of the second patent, in a case in which it actually mattered on the facts. However, the holding was not strictly necessary to the result, as the claims in question were invalid under a standard obviousness analysis, and Manson J’s reasons for selecting that date were brief. On the whole, the question of whether the claim date of the first or second patent is appropriate, remains open.

Obviousness-type double patenting is a judicially created doctrine which prevents an inventor from obtaining a second patent for an invention which is an obvious variant of an invention disclosed in its own prior unpublished prior application, even though that prior application is not part of the state of the art defined in s 28.3. The problem arises when the first patent is published after the claim date of the second patent (because otherwise it will typically be prior art in any event). The problem has normally been framed as involving a choice between three possible dates (from earliest to latest) (see Mylan FCA 2016 FCA 119, [45]):

(1) the claim date of the first patent (First Claim date);
(2) the claim date of the second patent (Second Claim date);
(3) the publication date of the second patent (Second Publication date):

The question is important only when the state of the art has changed in the interim. Keep in mind that when we are considering the correct date for assessing double patenting, it must already have been established that the double patenting doctrine applies, and so it is established that the first patent is considered to be part of the state of the art against the second, regardless of what date is used.

Recently, the law has been developed primarily in the context of NOC litigation dealing with two patents related to tadalafil, the earlier 377 patent, and the later 784 patent. In Mylan FC 2015 FC 17, discussed here, de Montigny J held that the appropriate date was (1), the First Claim date. Then, in Apotex Tadalafil FC, dealing with the same two patents, Gleason J expressed a preference for (2), the Second Claim date, but on the facts it was not necessary for her to decide between the First and Second claim dates: see here. The next decision, chronologically, was Mylan FCA, the appeal from Mylan FC. As discussed here, the Rennie JA, speaking for the FCA, definitively ruled out (3), the Second Publication date, but held that it was an open question as to whether the First or Second Claim date was correct. This effectively over-ruled de Montigny J’s holding that (1), the First Claim date, was appropriate, though he was affirmed in the result, because on the facts the result was the same whether the First or Second Claim date was used. Then, in Apotex Tadalafil FCA, Apotex argued that Whirlpool 2000 SCC 67 had held that (3), Second Publication date, was correct. The FCA rejected that argument and encouraged some out-of-the-box thinking: see here. Thus, coming in to this case, we have a clear holding from the FCA eliminating (3), the Second Publication date, but otherwise an entirely open question as between (1) and (2), the First or Second Claim date.

In this case, Manson J held that (2), the Second Claim date, is the correct date. This mattered on the facts, because Manson J held the claim at issue to be obvious as a consequence, but if the First Claim date was used, the claim at issue would not have been obvious [207]. With that said, he had already held that claim to be obvious on a traditional obviousness analysis [202].

I must say that I find Manson J’s reasoning on this issue more difficult to follow that the rest of his decision. He said that in Apotex Tadalafil FCA the FCA had

declined to affirm Justice Rennie’s exclusion of the Second Publication date (Apotex Tadalafil FCA at para 41). Therefore, the law as it currently exists on the appropriate date for the obviousness-type double patenting analysis is inconclusive. [212]

I find this passage confusing. It might be read as suggesting that Apotex Tadalafil FCA had doubted Rennie JA’s holding and re-opened the Second Publication date as a possibility, but I can’t read the decision that way. Apotex’s argument in Apotex Tadalafil FCA was Mylan FCA was wrongly decided because it was inconsistent with Whirlpool. This FCA rejected the inconsistency argument, and that is why Pelletier JA said “there is no reason for us to depart from Mylan FCA” [41]; he was not suggesting that Mylan FCA was doubtful authority and might be reconsidered.

Manson J then went on to say that he found the policy arguments made by Apotex for using Second Publication date to be persuasive in principle [209], [213]. However, those arguments were only briefly described, as being to the effect that the evil of double patenting “is to force the public to endure a prolonged monopoly on an invention,” and the publication date of the second patent “is the first date at which the patentee can enforce the second patent and the public is threatened by the risk of liability for infringement” [209]. I must say that I don’t see the force in this at all. An inventor is entitled to an invention which is not obvious as of the claim date, so the monopoly is “prolonged” only if the patent was obvious as of the claim date. Many valid patents are granted for inventions which would be obvious as of their publication date. And while the point about enforcement and liability is more or less true (though strictly, the patentee can’t enforce the patent until it is granted), I don’t really see the relevance. Manson J made the point only briefly, and no doubt it was clearer from the submissions.

No doubt Manson J’s discussion of the policy arguments was so cursory because he then went on to say, albeit in a roundabout way, that he was in any event bound by Mylan FCA to reject the Second Publication date [213]. Then, quoting a passage from Apotex Tadalafil FC [132] in which Gleason J said that “a sound argument” could be made for using (2), the Second Claim date, Manson J held that the Second Claim date, or more specifically, the Second Priority date, was indeed the correct date [216]. As discussed here, while Gleason J made a number of good points in her careful analysis, she did not definitively come down in favour of the Second Claim date. (I note that Manson J referred to the “Second Priority date,” while I have been referring to the “Second Claim date.” As discussed here, I think it is implicit in the decisions that it is really the choice between the earlier or later claim date that is at issue, even though in most of the cases this has been the priority date.)

In summary, Manson J’s Dasatinib decision is significant in holding that the appropriate date for assessing obviousness-type double-patenting is the Second Claim date, in a case in which it actually mattered on the facts. However, the holding was not strictly necessary to the result, as the claims in question were invalid under a standard obviousness analysis. Moreover, Manson J’s decision was thinly reasoned on this point. Given that Gleason J in Apotex Tadalafil FC did not feel bound to follow the much more thoroughly reasoned decision of de Montigny J in Mylan FC, I would say that it remains an open question as to whether the First or Second Claim date is appropriate.

Monday, April 10, 2017

Promise Doctrine Applied

Bristol-Myers Squibb Canada v Apotex Inc 2017 FC 296 Manson J
            2,366,932 / 2,519,898 / dasatinib / SPRYCEL / NOC

Apotex sought an NOC for APO-Dasatinib, using BMS’ SPRYCEL as the Canadian reference product [3]. In response, BMS sought an order of prohibition based on the 932 and 898 patents, both of which are related to dasatinib [2]. Manson J held the 932 patent to be invalid for lack of sound prediction of utility, in reasons which don’t make any new law, but which do demonstrate the continued impact of the promise doctrine. He also held the 898 patent to be invalid as being obvious-to-try and for double patenting. The obvious-to-try aspect of the decision turned on the facts, but there were a couple of legal points of passing interest. I’ll address double-patenting in a subsequent post.

Dasatinib is used to treat a form of chronic myelogenous leukemia (“CML”). Claim 27 of the 932 patent, the only independent claim at issue [52], claims the compound dasatinib [75], while various uses of dasatinib are claimed by dependent claims [55]. Claim 27 of the 932 patent was held invalid for lack of sound prediction of utility, but this result was driven by the analysis of the promise of the patent. As is normal in disputes over the promise of the patent, the patentee argued for a relatively modest patent, and the generic argued for a more demanding promise. In this case, Manson J adopted the promise proposed by the expert for Apotex, which required, inter alia, that the compounds were therapeutically useful [97]. The patentee did not dispute that there was no sound prediction of therapeutic utility for dasatinib at the claim date [99], and so the finding of lack of sound prediction followed directly from the construction of the promise of the patent. The main point of general interest is that Manson J distinguished Apotex Imatinib 2013 FC 141 (blogged here), on the followin basis (my emphasis):

[95] In the ‘932 Patent, the language used in the specification is not equivocal in the same manner as the Apotex Imatinib patent (i.e., “can be used”). There are numerous instances in the Utility section where the inventors have stated that the compounds “are” useful for treatment of disease.

In other words, in describing the uses of the invention, the word “are” can sink your patent, while the words “can be used” may save it, notwithstanding that the information communicated to the public is substantively the same. This type of “meticulous verbal analysis,” of the type disparaged in Catnic [1982] RPC 183, 243 (HL) is now entrenched in our law, unless and until the SCC addresses the promise doctrine in its forthcoming NEXIUM decision.

Turning to the 898 patent, the only claims at issue were to the oral use of dasatinib for treating imatinib-resistant CML (Claims 1 and 3, respectively) [126]. While both parties agreed that it was not obvious at the relevant date that dasatinib would be an effective oral treatment for these purposes[173], Manson J agreed with Apotex that it would have been obvious to try [186], [202]. This holding turned on the factual finding that the work needed to arrive at the invention was routine, in light of the relevant prior art.

Two points made in passing are of some interest. First, there was a dispute as to whether two patent applications that would have been publically available before the relevant date for assessing obviousness [151], were part of the prior art. In ruling that they were, Manson J stated that “The Federal Court of Appeal has held that prior art relevant for the purposes of assessing obviousness is limited to that which the POSITA “would locate conducting a reasonably diligent search” (E Mishan & Sons Inc v Supertek Canada Inc, 2015 FCA 163)” [154]. I’m not sure that is quite right; it is more accurate to say, as Locke J said in Pollard Banknote 2016 FC 883, [193], that the FCA “declined an opportunity to revisit the question,” whether it was so limited: see here. With that said, it didn’t make any difference in this case, because the immediate question was whether Apotex was limited to prior art found by its experts, or could also consider prior art found by the respondent. Manson J’s real holding was that “while it may be best practice when asking experts to opine on prior art or the common general knowledge to have them perform the necessary searches, the NOC process can constrain a respondent, who must ensure that all facts that they will rely upon at trial are part of the NOA; therefore, a respondent is likely to have curated the prior art before hiring experts” [154].

Secondly, Manson J also held, rightly, in my view that “[t]he fact that there are multiple obvious routes towards an invention does not necessarily render any or all of them all non-obvious,” noting that “[t]his is particularly true given the methods through which scientists screen compounds for potential therapeutic activity” [196].

Tuesday, April 4, 2017

Subjective or Objective Test for Sound Prediction?

Teva Canada Limited v Leo Pharma Inc 2017 FCA 50 Gauthier JA: De Montigny, Gleason JJA aff’g 2015 FC 1237 Locke J
            2,370,565 / calcipotriol & betamethasone / DOVOBET

In Teva v Leo Pharma the FCA affirmed the decision of Locke J (blogged here) granting an order of prohibition. Yesterday's post discussed the FCA holding regarding sufficiency. Teva also raised an interesting technical argument regarding sound prediction.

The test for sound prediction set out in AZT, 2002 SCC 77, requires a sound line of reasoning from which the desired result can be inferred from the factual basis [11]. In Bell Helicopter 2013 FCA 219 [154], the FCA held that the elements of the sound prediction doctrine, including the line of reasoning, need not be explicitly disclosed in the specification if they would be self-evident to the skilled person [12]. Teva argued that the line of reasoning which supports a sound prediction must nonetheless be the actual line of reasoning followed by the inventors of the invention at hand [15.1]. Teva referred to this, appropriately, as a “subjective” approach [28]. This is in contrast to an objective approach, under which it would suffice if a sound line of reasoning would be apparent to the notional skilled person, whether or not the inventors did not have that particular line of reasoning in mind.

The FCA rejected this argument, treating it essentially as a factual matter. It is undisputed that a skilled person would have to have a sound line of reasoning, and it is open to the court of first instance to infer, as a matter of fact, that the inventors shared that line of reasoning, even if the inventors were not personally called to testify [28]. Gauthier JA pointed out that such an inference must be permissible if the inventor had died before trial, and if it is permissible in that case, it must be generally permissible, as being simply a matter of how the patentee has chosen to prove a fact [29]-[30].

While that response was sufficient to dispose of the issue, it leaves open the technical question of whether the correct test for a sound line of reasoning is indeed subjective, or objective. Given the FCA’s point regarding how the facts may be proven, this will not often make any difference, but I’m not sure it will always be moot. Gauthier JA noted that

[31] From the perspective of a person skilled in the art, I see no difference in this case between an express sentence [stating the inventor’s line of reasoning] and conveying the same logic through technical information disclosed in the specification read as a whole. In both instances, the inventor conveys his or her logic to the person to whom the patent is addressed, thereby fulfilling its part of the patent bargain if this line of reasoning is held to be reasonable and sound at the relevant times. In short, in both instances, the person to whom the patent is addressed, namely, the person skilled in the art, understands the sound line of reasoning of the inventors premised on what is said in the patent.

In my view, this is a compelling argument for the objective approach. The patent bargain is an objective one; it is what the inventor actually gave the world, not what she might have thought she was giving the world. If an inventor truly believes that she was making full and sufficient disclosure, but in fact she was not, the patent will be invalid notwithstanding her subjective intent. The converse should also hold; if the inventor in fact make a disclosure that was sufficient for a skilled person, and thereby gave the invention to the world, that fulfils the bargain, even if the inventor subjectively did not understand her own invention.

Monday, April 3, 2017

Viagra Did Not Change the Test for Sufficiency

Teva Canada Limited v Leo Pharma Inc 2017 FCA 50 Gauthier JA: De Montigny, Gleason JJA aff’g 2015 FC 1237 Locke J
            2,370,565 / calcipotriol & betamethasone / DOVOBET

In Teva v Leo Pharma the FCA has affirmed the decision of Locke J (blogged here) granting an order of prohibition. Teva raised two arguments on appeal, relating to sound prediction and insufficiency. While the appeal was dismissed largely on the facts, the decision is noteworthy for the FCA’s brief but helpful discussion of Viagra / Sildenafil 2012 SCC 60, which clarifies both what Viagra did and did not hold.

Like Arctic Cat in 2017 FC 207, blogged here, Teva in this case argued that Viagra had changed the standard for sufficiency, so that now, not even a minor research project is permitted [57]. The FCA rejected this with a brief explanation of the true import of Viagra:

[58] The case before us is very different from the one that was before the Supreme Court of Canada in Sildenafil, where the patentee had deliberately omitted essential information, thereby obscuring the fact that only one of the compounds claimed actually worked (Sildenafil at paras 72, 73 and 76) . Thus, the invention itself was not even properly disclosed.

That is, Viagra concerns a situation where the patentee has deliberately obscured the nature of the invention. The FCA continued:

[59] Furthermore, the Supreme Court refers to the factual findings of the Federal Court in Sildenafil which found that in that case, one would require a minor research project to determine the true invention. This statement of Justice Lebel is, as mentioned, perfectly in line with the law as I understand it, not only in Canada but elsewhere, such as the U.K. and Europe, which recognizes that some non-inventive trial and error may be required to put a properly disclosed invention into practice. Had the Supreme Court wished to change the law on this point in Sildenafil, one would have expected a much more fulsome analysis of the issue and discussion of the relevant authorities. In the absence of such a discussion, I do not believe that the Supreme Court changed the law in Sildenafil in the manner Teva argues.

So, Viagra did not change the standard for sufficiency. I agree with Gauthier JA’s holdings on both these points.

Otherwise, Teva was largely trying to re-argue the facts, and the appeal failed for that reason [54].

(A post on the punitive damages issue in Airbus v Bell Helicopter 2017 FC 170 will be forthcoming soon, but I am taking a break from that case to clear up my blogging backlog.)