Friday, November 24, 2017

Inventive Concept R.I.P.

Ciba Specialty Chemicals Water Treatments Ltd v SNF Inc 2017 FCA 225 Pelletier JA: Rennie, Woods JJA aff’g 2015 FC 997 Phelan J
            2,515,581

As discussed in yesterday’s post, in Ciba v SNF Pelletier JA and Rennie JA held that all matter available to the public may be used in an obviousness attack, not just that which was generally known or reasonably discoverable, though Woods JA expressed no opinion on this point. This was not the only clarification made to the obviousness analysis. The FCA, unanimously on this point,* also stated that the focus of the obviousness inquiry should be on the claims, not the inventive concept:

[77] There may be cases in which the inventive concept can be grasped without difficulty but it appears to me that because “inventive concept” remains undefined, the search for it has brought considerable confusion into the law of obviousness. That uncertainty can be reduced by simply avoiding the inventive concept altogether and pursuing the alternate course of construing the claim. Until such time as the Supreme Court is able to develop a workable definition of the inventive concept, that appears to me to be a more useful use of the parties’ and the Federal Court’s time than arguing about a distraction or engaging in an unnecessary satellite debate.

In particular, the FCA noted that “[p]art of the difficulty in the search for the inventive concept is the use made, or to be made, of the disclosure portion of the specification of the patent,” and stated, quoting Conor v Angiotech [2008] UKHL 49, [19], “[t]he patentee is entitled to have the question of obviousness determined by reference to his claim and not to some vague paraphrase based upon the extent of his disclosure in the description” [74]. This is consistent with s 28.3 which refers to “the subject-matter defined by a claim” [75].

This is a more emphatic restatement of a similar point made in BMS v Teva / atazanavir 2017 FCA 76, in which, as discussed here, the FCA downplayed the importance of the inventive concept. (Pelletier JA also wrote the reasons in Atazanavir, with Rennie and Near JJA concurring.) I agree entirely with the Court on this point. The pursuit of the inventive concept had in many cases turned into a major satellite debate which brought confusion rather than clarity. Indeed, it may be that it is time to reconsider the entire Windsurfing/Pozzoli framework. While that approach was endorsed by the SCC in Sanofi / Plavix 2008 SCC 61, the FCA pointed out in Wenzel Downhole Tools 2012 FCA 333, [105], “the Supreme Court of Canada in Sanofi clearly indicated that there is no single or mandatory approach in the obviousness inquiry,” and as the FCA pointed out in Atazanavir “[i]t is true that the Windsurfing/Pozzoli framework does provide structure but it is not obvious that it has been useful.” [64]. In any event, that is a question for another day.

The FCA held that Phelan J had erred in his formulation of the Windsuring/Pozzoli framework [63], but I would suggest the errors are ultimately a reflection of problems with the Windsuring/Pozzoli framework itself. The second and third steps of that framework are [45]:

2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;

3) Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim or the claim as construed;

The FCA noted that in effect, Phelan J had “first defined the invention, then referred to the fact that the invention is an advance over the common general knowledge, and concluded that the difference between the two is the inventive concept” [65]

[66] This methodology appears to conflate steps 2 and 3 of the Windsurfing/Pozzoli framework as it was paraphrased by the Federal Court but instead of comparing the inventive step to the common general knowledge, it compares the invention to the common general knowledge to arrive at the inventive step.

While this observation is true enough, Phelan’s J’s approach has considerable appeal: after all, in the absence of any other guidance from the SCC, it seems quite reasonable to define the “inventive concept” as the difference between the state of the art and the invention. But, as the FCA pointed out, if that is the definition of the inventive concept, then the second and third steps of the Windsuring/Pozzoli framework are circular. On the other hand, if that is not the inventive concept, what is? No wonder the FCA held the whole inquiry is an unnecessary distraction.

Because the FCA held that Phelan J had applied the wrong legal test, the Court undertook the obviousness analysis de novo [69]. In so doing, Pelletier JA identified two distinct differences between the claim as construed and the prior art relied upon by SNF, namely the notions of an “effective rigidifying amount” and of “an aqueous solution of a water soluble polymer” [91]. Pelletier JA then considered separately whether either of these aspects of the claimed invention was inventive, at [94]-[95] and [93], respectively. Having concluded that both differences were obvious, it followed that the claimed invention was obvious [97].

This approach, of looking at different aspects of the invention separately to see whether any aspect might be inventive, calls to mind the approach used by the EPO, albeit in the context of the problem-solution approach to obviousness. For example, in T 0920/10, the BoA stated (citations omitted):

[14] Article 56 EPC stipulates that "an invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to the skilled person". Therefore, in the board's understanding, the decision on whether or not the requirements of Article 56 EPC are fulfilled requires a mandatory examination as to whether or not the claimed subject-matter is obvious. Therefore, it has been established by case law that, if an initially formulated problem is found not to have been solved, the problem is reformulated to one which is considered as having been solved and the obviousness of the claimed subject-matter is then assessed on that new basis.

*Woods JA reserved opinion “on the issue discussed at paragraphs 51 to 63" [99]. The discussion of the role of the inventive concept is later in Pelletier JA’s reasons, at [74]ff.

Thursday, November 23, 2017

The State of the Art on State of the Art?

Ciba Specialty Chemicals Water Treatments Ltd v SNF Inc 2017 FCA 225 Pelletier JA: Rennie JA, concurring reasons by Woods JA aff’g 2015 FC 997 Phelan J
            2,515,581

Under the “old” Patent Act the body of prior art that may be set up against the patent in an obviousness attack did not include all publicly available information that could be set up in a novelty attack, but only that which was generally known to a person skilled in the art or which would be discovered in a reasonably diligent search. As Hughes J noted in Merck v Pharmascience 2010 FC 510, [37], there is a “quaere” as to whether codification of the obviousness requirement in s 28.3 of the new Act, which requires a person skilled in the art to have regard to information “available to the public” as of the claim date, has changed the law in this respect, so that all publicly available prior art may be used in an obviousness attack, regardless of whether it would have been discovered by a reasonably diligent search. In my article, What is the State of the Art for the Purpose of an Obviousness Attack? (2012) 27 CIPR 385, I reviewed the debate. While the text of 28.3 does imply that all publicly available prior art may be set up against the patent in an obviousness attack under the new Act, I concluded, based on contextual and purposive considerations, that on balance the better view is that s. 28.3 was not intended to change the law.

In Ciba Specialty Chemicals Water Treatments Ltd v SNF Pelletier JA, with Rennie JA agreeing, held that all prior art that is available in a novelty attack is also part of the state of the art for the purposes of an obviousness attack [51]-[63]. This implies that the codification did indeed change the law, though Pelletier JA did not say so expressly. Woods JA concurred in the result, but declined to express an opinion on this point [99], saying “The issue is better addressed in an appeal where it is relevant to the outcome and in which the Court has the benefit of full submissions from counsel, which was not the case here” [100]. I must say that I agree entirely with Woods JA. While the position taken by Pelletier JA is a reasonable one which is supported by the text of s 28.3, some important interpretive arguments were not addressed, presumably because the Court did not have the benefit of full submissions on this point.

Pelletier JA relied primarily on the text of 28.3 [51], [57], which does indeed clearly support his position. The remainder of the points made by Pelletier JA are, in my view, more questionable.

Pelletier JA stated that “In Anglo-Canadian jurisprudence, the comparison at step 3 is to the prior art” [51]. Pelletier JA cited no cases on point, and it may be that Pelletier JA did not intend this as a description of what the courts had previously done, but rather a statement of his conclusion. To the extent that he intended it as describing the actual practice of the courts, I am not sure it is right. As discussed in my article, it was not true in English law prior to the Act of 1977 and it was not true in Canadian law prior to 1993. Since then, the question has remained unsettled in Canadian law. In 2006 FC 1234, [109] Hughes J expressed the view, albeit in passing, that codification was not intended to change the law. In Novartis v Teva / deferasirox 2015 FC 770 blogged here, O’Reilly J held that indeed the law had not changed, while in Pollard v BABN 2016 FC 883 [192-95], Locke J suggested the opposite. The question was noted, but not addressed, in 2015 FCA 163 [21]: see here for a discussion. None of these cases were discussed by Pelletier JA. And indeed, as Pelletier JA acknowledged [59], he himself had expressed the opposite view in BMS v Teva 2017 FCA 76, [48]. This is not to say that BMS v Teva settled the question, as it was not directly at issue, and also referred to “prior art” in other paragraph, as Pelletier JA pointed out. But it does indicate that the point was open.

Pelletier JA also relied on Windsurfing [1985] RPC 59 (CA) for the proposition that the state of the art encompasses all prior art. Windsurfing does indeed take that position, but, as discussed in my article, it was in obiter and in conflict with the well known decision in General Tire [1972] RPC 457, 497 (CA).

He also relied at [56] on the SCC’s use of the phrase “prior art” in Sanofi / Plavix 2008 SCC 61, [70]-[71]. However, the issue there was not the precise definition of the prior art, but rather the significance of the actual course of conduct of the inventor.

Finally, Pelletier JA relied on the parallel between s 28.3 and the legislation under the UK Patent Act, 1977 [58]. In my article, at 389, I argued that the better parallel is the UK Act of 1949, both because the structure of the 1977 Act is different, and because it was widely recognized as effecting a change in the law, whereas 28.3 was thought to be to be merely a codification.

None of this is to say that Pelletier JA's conclusion was wrong, but only that it is not clearly right. (Note that the above is not an exhaustive review of the relevant considerations which are discussed in my article, but only touches on those raised by Pelletier JA.)

Despite the clear holding by Pelletier JA, I am not sure where the law stands on this point. The authority of the holding is undermined by the fact that it was a decision of only two members of the panel, the point was not fully argued, it did not review the relevant Canadian cases, and it was strictly obiter. In Lilly v Apotex / cefaclor, 2009 FC 991 [349]-[370], Gauthier J declined, quite rightly in my view, to follow the SCC holding as to “standard of review” of a granted patent set out in Wellcome / AZT 2002 SCC 77 [44], in part because the issue was not argued before the SCC [356, fn126] and the point was obiter [357]. (With that said, the situations are not entirely parallel because the SCC in Wellcome / AZT was clearly wrong, for the reasons given by Gauthier J, while the position taken by Pelletier JA is entirely reasonable, even though the counter-arguments were not fully considered.) Apart from any question of the authority of this decision, it does seem to me undesirable for a court to make a holding in obiter on a point of law which has not been argued, because, as Wellcome / AZT illustrates, such holdings may not be as well considered as when the issue is fully argued.

Monday, November 13, 2017

Promise Doctrine Zombie Watch

Pfizer Canada Inc v Apotex Inc 2017 FC 774 Brown J
2,436,668 / desvenlafaxine (ODV) / PRISTIQ / NOC

Bristol-Myers Squibb Canada Co v Apotex Inc 2017 FCA 190 [Dasatinib FCA] Gleason JA: Webb, Near JJA var’g 2017 FC 296 [Dasatinib FC] Manson J
            2,366,932 / 2,519,898 / dasatinib / SPRYCEL / NOC

The promise doctrine was abolished by the SCC in AstraZeneca 2017 SCC 36 (see here). Will it rise from the dead, in some other guise? So far, the indications are that it will not.

The issue was addressed by Brown J in Desvenlafaxine (blogged here on the obvious-to-try issue). In its post-hearing submissions directed AstraZeneca, Apotex submitted that the 668 Patent "overpromises" in violation of the requirements of subsection 27(3) of the Patent Act [355]. In particular [356], Apotex argued (emphasis added):

33. As noted above, in AstraZeneca, the Supreme Court directed that overpromising violates the require[ments] of subsection 27(3) of the Patent Act. An invention is subject matter that has demonstrated utility as of the filing date, or subject that matter that constitutes a sound prediction as of the filing date. The statements in the 668 patent to the effect that the compounds of the patent have the utilities (1)-(3) above were thus not 'correct and full' descriptions of the invention but rather were overpromises. As such, they ought to invalidate the 668 patent as a whole.

The argument turns on the SCC’s statement in AstraZeneca [45]-[46] (quoted at [362]):

[45] Supporters of the doctrine assert that the consequences of the Promise Doctrine play a key role in ensuring patentees do not "overpromise" in their patent applications. . . . The utility requirement should not be interpreted, however, as the Federal Courts have done, to address such concerns. Nonetheless, overpromising is a mischief.

[46] The scheme of the Act treats the mischief of overpromising in multiple ways.

The SCC noted [46] that these ways include the disclosure requirements of s. 27(3), overbreadth, and s 53, which provides that a patent is invalid where overpromising in a specification amounts to an omission or addition that is "willfully made for the purpose of misleading".

Does this mean that the promise doctrine is fundamentally sound, and the only error was to implement it through the utility requirement? The answer is no. As Brown J stated:

[360] If the Supreme Court intended to say, in effect, that the Promise Doctrine was not good law in terms of utility under s 2, but was good law in terms of patent specifications under subsection 27(3) it could have done so; it did not.

Moreover, the SCC identified specific functional defects of the promise doctrine – that it risks invalidating an otherwise useful invention [50], and that it impedes fulsome disclosure [51]. As Brown J pointed out, if the SCC removed the promise doctrine from the utility analysis, but functionally replicated it under another name, the “major underlying problem identified by the Supreme Court itself would remain” [363].

Consequently, Brown J rejected Apotex’s argument, agreeing with Pfizer that [361.5]:

Read purposively, the Court was referring to those extraordinary circumstances in which the statements in a patent prevent a skilled reader from understanding "the nature of the invention" or "how it is put into operation." These have always been (and remain) the core requirements of s. 27(3). . .

That is, “overpromising” as the term was used in AstraZeneca, refers to the types of defects that are already addressed by other aspects of the Act. The justifications that have been offered by supporters of the promise doctrine, do not in fact justify that doctrine, because, to the extent that they identify a proper goal of the patent system, those goals are already addressed by other aspects of the Act: see eg AstraZeneca [46]; Siebrasse, The False Doctrine of False Promise, (2013) 29(1) CIPR 3, 51-52; Siebrasse, Form and Function in the Law of Utility, (2015) 30(2) CIPR 109 (generally). The role that is unique to the promise doctrine, and which is not replicated by any other aspect of the Act, namely to protect the discretion of the Crown in the grant of patents, is not an aspect of our patent system: AstraZeneca [45]-[46], citing Siebrasse, The False Doctrine of False Promise, (2013) 29(1) CIPR 3.

Dasatinib FCA, the only FCA decision to deal with utility since AstraZeneca, is important for the guidance it provided regarding the scintilla standard, but Dasatinib FCA also faced a zombie promise doctrine. The SCC in AstraZeneca [54] held that the first step in the utility analysis is to “identify the subject-matter of the invention claimed in the patent.” In Dasatinib, the claim at issue was to the compound dasatinib as such [22] (see here). Apotex argued that the subject-matter of claim 27 of the 932 patent was the potential therapeutic uses for dasatinib [37]. While the FCA did not say so expressly, this seems to have been an attempt by Apotex to raise the promise doctrine in the context of the utility itself; if the therapeutic uses, set out only in the disclosure, were considered to be the subject-matter of the invention, we would be back to the problem of assessing utility against the statements made in the disclosure. The FCA rejected this argument, saying “the subject-matter of claim 27 is merely the compound, dasatinib, itself” [37].

So, both of the post-AstraZeneca decisions to address utility have squarely rejected any attempt to resurrect the promise doctrine. My sense is that the prior to AstraZeneca, the Federal Courts were committed to the promise doctrine as being established law, but not as a matter of patent policy (see eg here), and consequently they have fully embraced the SCC’s repudiation of the doctrine. This contrasts with the reception of the Viagra 2012 SCC 60 decision, which could have been read as undermining the basic principle that claims stand and fall independently: see Siebrasse, The Duty to Disclose "The Invention" (2013) 25 IPJ 269. The courts have rejected this reading (rightly, in my view), and instead interpreted the decision as standing for the principle that a patentee cannot attempt to “game the system”: see here. It is early days yet, but I am nonetheless reasonably confident that we will not see the promise doctrine re-emerge under another guise.

Wednesday, November 8, 2017

Obvious-to-try in the EWCA

Actavis v ICOS [2017] EWCA Civ 1671 Kitchin LJ: Lewison, Floyd LLJ rev’g [2016] EWHC 1955 (Pat) Birss J
EP (UK) 1,173,181 / tadalafil dosage / CIALIS

I don’t usually blog on foreign cases, but the decision of the EWCA in relevant to the on-going confusion regarding the obvious-to-try test that I blogged about last month. The general question is whether, for the invention to be obvious, it must be more or less self-evident that the specific invention would succeed, or whether it is enough that the invention is self-evident to try, and it did in fact succeed when tried, even though success could not have been predicted in advance. So, in a routine salt-screen (and this is not to suggest that all salt screens are necessarily routine), it might be obvious to try the most common pharmaceutically acceptable salts, with a reasonable expectation that one of them would work, even though it could not be predicted in advance which particular one would be the best.

This was the key issue in Actavis v ICOS, and the EWCA gave a clear answer, reversing Birss J on this point. The invention disclosed in the 181 patent was the discovery that tadalafil can be administered at low doses of up to 5mg per day in a manner which is clinically effective but also has low adverse side effects [49]. The patent correspondingly claimed a low dosage form of tadalafil [43]. The main issue was obviousness over WO 97/03675 (“Daugan”), the application which matured to, inter alia, the Canadian 2,226,784 patent. As described by Kitchin LJ, in the lead judgment

[103] Daugan teaches the use of PDE5 inhibitors for the treatment of ED. Tadalafil (compound A) is specifically disclosed, its IC50 against PDE5 is given and examples of a tablet containing a 50mg dose are described. It explains that doses of tadalafil will generally be in the range of from 0.5 to 800mg daily for the average adult patient.

The difference between Daugan and the key claims of 181 patent is that Daugan did not specifically disclose a 5mg daily dose of tadalafil or that such a dose is an effective treatment for sexual dysfunction [105]. In effect, the patentee's argument was that the 181 patent was a valid low-dose selection patent over Daugan.

Given Daugan and the great commercial success of the related compound sildenafil, Birss J found that would be entirely obvious for a skilled team to take tadalafil forward into a routine pre-clinical and clinical trial programme as an oral treatment for male ED, including at least 25, 50 and 100mg doses [110]. This was not contentious. While the point was disputed, Birss J also found that the skilled team would have gone on to test lower doses, including a 5mg dose, would have discovered this dose was efficacious, and would have taken it on to Phase III trials and clinical approval [123]. Birss J also found – and this finding was not challenged on appeal – that prior to actual testing, the team would have no reasonable expectation that a 5mg dose would produce a clinically relevant effect [120], [146], [165]. In other words, on the facts it was obvious to try the 5mg dose, and when tried, there would have been no difficulty in establishing this dose was efficacious, but the success of the 5mg dose could not have been predicted, and indeed, would have been unexpected and surprising.

On these facts, Birss J held the key claims to be valid. The EWCA unanimously reversed, holding the claims to be invalid for obviousness. The concurring opinion of Floyd LJ sets out the Court’s reasoning most succinctly:

[155] If one notionally asks that question of the skilled team before it embarked on the investigations which Birss J chronicles in his judgment, the answer would be, of course, that it was not obvious. The skilled team would respond that it could not know without conducting appropriate tests what if any dose of tadalafil would achieve that goal.

[156] The law, as it has developed at least in this jurisdiction, does not halt its enquiry at this point, however. If it did, this would have been a very short issue to decide. It is recognised that a patent will not be granted for an invention which, though not obvious in this a priori sense, is nevertheless an invention which would be arrived at by a line of routine and uninventive enquiry which would be carried out by a skilled team.

See also [164]-[169]. The opinions of Kitchin LJ, at [145]-[152], and Lewison LJ [174]-[181], are to the same effect. The requirement of a reasonable expectation of success in English law, corresponding to the requirement in Canadian law that it be more or less self-evident that what is being tested ought to work, is directed to the research program, not to the specific outcome: see eg Floyd LJ at [165]. Kitchin LJ summarized by saying

[152] The judge has lost sight of the fact that, on his own findings, the claimed invention lies at the end of the familiar path through the routine pre-clinical and clinical trials’ process. The skilled but non-inventive team would embark on that process with a reasonable expectation of success and in the course of it they would carry out Phase IIb dose ranging studies with the aim of finding out, among other things, the dose response relationship. It is very likely that in so doing they would test a dose of 5mg tadalafil per day and, if they did so, they would find that it is safe and efficacious. At that point they would have arrived at the claimed invention. In my judgment claims 7 and 10 are therefore invalid.

In my view the reasoning of the EWCA in Actavis v ICOS is entirely sound. It is also consistent with the law set out in Sanofi 2008 SCC 61, though it clarifies some points that were left obscure in that decision, at least to me, and evidently to Birss J as well. (This consistency should not be too surprising, as the EWCA and the SCC were both approving the same line of cases.) The law set out in Actavis v ICOS is also consistent with the way the obvious-to-try test has actually been applied in the Federal Court (see my discussion last month and earlier); despite the lack of clarity in Sanofi and earlier cases, the Federal Court has generally done better than Birss J in applying the law correctly.

Sunday, November 5, 2017

No new cases

No new patent / NOC / data protection 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.