Delayed Release Esomeprazole Not Obvious on the Facts

Astrazeneca Canada Inc. v. Ranbaxy Pharmaceuticals Canada Inc / esomeprazole (NOC) 2013 FC 232 O’Keefe J
            NEXIUM / esomeprazole / 2,170,647

Obviousness was the only point in issue in this NOC proceeding related to a delayed release form of esomeprazole. O’Keefe J’s decision holding that the enteric coating formulation was not obvious, due to the difficulty of actually producing an effective coating, turned entirely on his assessment of the conflicting expert evidence.

The only point of more general interest is a brief review at [80]-[84] of the case law relating to the “motivation” aspect of the obvious to try test. O’Keefe J noted that in Allergan Inc. v Canada (Minister of Health), 2012 FC 767 a finding that there was a strong motivation to solve the problem at hand supported a finding of non-obviousness, on the logic that “If other parties were motivated to find the solution and yet were unable or unwilling to do so prior to the patent being obtained, this factor would point to a solution that was not ‘obvious to try’” [82]. On the other hand, in Janssen-Ortho Inc. v Novopharm Ltd. 2006 FC 1234, a finding that there was “no motivation exhibited by any outside persons to explore Ofloxacin enantiomers,” also supported a holding of non-obviousness, on the basis that absent Daiichi’s motivation, “there may well never have been levofloxacin” [84]. 

Note that in his recent decision in Apotex Inc. v. H. Lundbeck A/S / escitalopram 2013 FC 192 (not mentioned by O’Keefe J), Harrington J remarked that “I am troubled by the concept of motivation. Wishing does not make something come true. Wishing does not make something easier. A motive is defined as that which moves or tends to move a person to a particular course of action (Oxford Dictionary). On the other hand, there may not have been reason to do something at a particular point in time. For instance, there may have been little interest in increasing automobile fuel efficiency in the 1950s. Lack of interest would not give rise to a patent if what was eventually done was obvious” [99]. It seems that significance of motivation in the obvious to try test needs clarification.

O’Keefe J’s reasoning in this case did not ultimately turn on the question of motivation.

Sufficiency and Utility

Novartis Pharmaceuticals Canada Inc v Teva Canada Ltd / zoledronate (NOC) 2013 FC 283 Hughes J
            ZOMETA ACLASTA / zoledronate / 1,338,895

What is the relationship between sufficiency and utility? Recall that claim 14 of the ‘895 patent, which was to a broad class, was held to lack utility on the basis that the it was not possible to predict the potency of any individual compound without testing. Hughes J held the ‘895 patent to be insufficient for the following reason:

[177] For the same reasons as discussed with respect to utility, I find that the '895 patent, claim 14, is insufficient, even at the date that the patent was issued and granted. No further discussion is required in respect of that patent.

I have to admit this reasoning is not transparent to me. Hughes J made this statement at the very outset of his sufficiency analysis, so there is no context that might shed light on his reasoning. There was no suggestion in the discussion of utility (or anywhere in the decision) that the ‘895 patent did not adequately disclose how to make the compounds in question (“classic insufficiency”). I don't see an obvious link to Sildenafil insufficiency. Could this be a reflection of the US doctrine that an invention that lacks utility is necessarily insufficient, on the logic that “Obviously, if a claimed invention does not have utility, the specification cannot enable one to use it.” In re Brana, 51 F.3d 1560, 1565 (Fed. Cir. 1995)? But I had not understood that to be established in Canadian law; and in the UK it seems that this proposition has been rejected: see Tetra Molectric’s Application [1977] R.P.C. 290 (CA) at 297: “if much of Mr. Walton's argument on this branch of the case be right, every failure to achieve the promised result could, as my Lord pointed out during the argument, be attacked for insufficiency under section 14. For my part, I cannot think this is right."

Sufficiency Assessed as of Publication Date

Novartis Pharmaceuticals Canada Inc v Teva Canada Ltd / zoledronate (NOC) 2013 FC 283 Hughes J
            ZOMETA ACLASTA / zoledronate / 1,338,895, 1,338,937

As discussed in my last post, Hughes J held that the ‘937 patent was not invalid for Sildenafil insufficiency because it claimed only a single compound. Recall from the prior post that the ‘937 patent had been placed in conflict with the ‘837 patent, and both had originally claimed a broad class of compounds. The claims of the ‘937 patent had been narrowed to zoledronate after filing, as a result of a settlement between the parties. Hughes J remarked that:

[178] The [‘937] patent was issued and granted with only two claims – both specific to zoledronate. For the same reasons as previously set out, I have distinguished this patent from that considered by the Supreme Court in Teva [Sildenafil] on the basis that the claims were specific to zoledronate, only. However, when the application was filed in Canada, the application contained claims to many compounds, including genus claims and claims to specific compounds; including, but not restricted to, zoledronate. If I were to consider sufficiency as of the date of filing the application, I would find that the application was no different than that considered by the Supreme Court in Teva, and thus was invalid for lack of sufficient disclosure.

(As discussed in my last post, I’m not entirely sure that the situation would have been the same because of possible differences in the number of compounds that had been tested, but Hughes J did not explore this point.)

Hughes J dealt with this problem by addressing the issue of the date for assessing sufficiency. He noted that “Canadian law has not been clear as to what is the date for considering sufficiency” [179], and while the SCC in Free World Trust 2000 SCC 66 [53-54], had held that the date of publication is the correct date for claim construction, it had left open the question of whether this is also the correct date for assessing sufficiency [182]. He reviewed the case law, including in particular Biogen v Medeva [1996] UKHL 18, in which Lord Hoffmann had held that the appropriate date was the date of the application (that is, the filing date, not the date of the priority application, and not the date of publication), largely on the ground that otherwise an application that was insufficient when filed might be sufficient when published as a result of intervening advances in the common general knowledge. As Hughes J put it, “An applicant should not be able to take advantage of intervening advances in the state of the art so as to render sufficient an insufficient application as filed” [185].

While Hughes J accepted that this “would make sense” [186], he held that the Sildenafil decision mandated a different result:

[187] The Teva decision has caused me to distinguish the '937 patent at issue here from that considered by the Supreme Court on the basis that in the '937 patent, the claims were limited to a single compound. Claims can be added, removed or amended at any time during the application process, whether one is dealing with the “old” or “new” Patent Act. Even after a patent has been issued and granted it may, within a limited period, be reissued with fewer or more or different claims; claims may be reduced by disclaimer and possibly even by dedication. The patentee is not seeking advantages because of advances in the scientific state of the art; but rather, is seeking to keep up with the state of the jurisprudence.

[188] I find that the most appropriate date for consideration of sufficiency of a Canadian patent is, as found by Buckley LJ in Standard Brands, as referred to by Lord Hoffman in Biogen, that of the date of publication. That is the date that the public is seized with the application. That is the date that the person applying for the patent has committed to claims for the invention in a manner available to the public. In the case of an “old” Act patent, this would be the day that the patent was issued and granted. In the case of a “new” Act patent, it would be the date of publication.

While Hughes J relied primarily on Sildenafil, this reasoning and conclusion strikes me as consistent with the holding in Free World Trust that the claims are construed as of the publication date. We can’t know whether the invention is properly disclosed until we know what it is. If “the invention” is the invention as claimed, we don't know what the invention is until the publication date. (And see 2007 FC 596 Hughes J. at [140-41], and 2009 FC 638, Kelen J at [108] to this general effect).

But what if “the invention” is not the invention as claimed? If the invention is the inventive concept which emerges from the disclosure, then it would be possible to decide whether the disclosure is sufficient even in the absence of any claims at all. One difficulty with this argument is that it is not consistent with Sildenafil, in which the SCC held that “the specification as a whole must be examined.” The whole specification includes the claims: “We must look to the whole of the disclosure and the claims to ascertain the nature of the invention” and “It is possible . . .for each claim in a patent to disclose a separate invention” [64]. This seems to be clear that the claims must be considered, as well as the disclosure. This strongly supports Hughes J’s conclusion.

So, while Hughes J’s reasoning in light of Sildenafil seems sound, having sufficiency assessed as of the publication date does leave the policy objection that an invention that is insufficient at the filing date may be sufficient at the publication date because of advances in the common general knowledge. Perhaps this is not a conclusive objection – after all, no one will be relying on the disclosure before publication – but it is certainly disquieting. I cannot think of any entirely satisfactory answer to this problem.

Claim to Single Compound Distinguishes Sildenafil

Novartis Pharmaceuticals Canada Inc v Teva Canada Ltd / zoledronate (NOC) 2013 FC 283 Hughes J
            ZOMETA ACLASTA / zoledronate / 1,338,895, 1,338,937

The insufficiency at issue in Sildenafil 2012 SCC 60 is very different from the traditional how-to-make insufficiency, and it is convenient to give them different names. For now, at least, I will refer to “Sildenafil insufficiency” and “classical insufficiency” by analogy with “Biogen insufficiency” (overbreadth) and “classical insufficiency” in UK law.

Sildenafil insufficiency was raised in respect of the ‘937 patent. (For an overview the facts, see yesterday’s post.) While the patent claims zoledronate specifically, zoledronate is not singled out in the disclosure. The disclosure of the ‘937 patent begins by stating that it relates to a class of compounds with the following structure (formula I):


From pages 5-7 the patent lists compounds of formula I to which the invention “relates” or “relates more particularly” or “preferably relates” or “relates firsts and foremost,” but these are all classes of compounds. Zoledronate does fall within the class, but it is not specifically named [69]. The invention is also said to “relate[] specifically to the compounds of formula I and the salts thereof, especially the inner salts and pharmaceutically acceptable salts thereof with bases mentioned in the Examples” [70]. There are about thirty-two compounds specifically named in the twenty examples, and zoledronate appears in two examples. The examples are all examples of how to make the compounds. Note also that this statement says that the invention relates specifically to salts with bases mentioned in the Example, not to compounds mentioned in the examples. So, even though zoledronate is mentioned in the Examples, it is not being singled out as a particularly efficacious compound; it is the salts which are particularly useful. There is no statement in the disclosure of which compounds have been tested for potency, nor is there any evidence discussed by Hughes J as to which compounds had been tested as of the date of the priority application. Zoledronate itself was made and tested in July 1987, which is after the priority application was filed, but before the Canadian application was filed [107].

From this we see that the ‘937 patent is similar to the patent at issue in Sildenafil, in that “No specific attributes or characteristics are ascribed to [the claimed compound] that would set it apart from the other compounds,” and “the patent itself suggests that the entire class of claimed compounds will be effective” [134, quoting Sildenafil [66-67]]. Hughes J nonetheless held that:

the '937 patent, because it claims only one compound, zoledronate, is, on a case-by-case basis, distinguishable from that considered by the Supreme Court in Teva [138].

This distinction does have a sound basis in the passages from Sildenafil [80] quoted by Hughes J at [136]:

The skilled reader knows that, when a patent contains cascading claims, the useful claim will usually be the one at the end concerning an individual compound. . . . However, the public's right to proper disclosure was denied in this case, since the claims ended with two individually claimed compounds, thereby obscuring the true invention.

The SCC acknowledged that even though the disclosure did not specifically identify the compound of particular interest, the claims are part of the specification, and a skilled person would know that the claimed compounds are normally of particular interest. This implies that claiming individual compounds is tantamount to specifically identifying them in the disclosure. The difficulty in Sildenafil was that two compounds were identified, while only one was truly of interest. In this case, only one compound was claimed, so not even a “minor research project” would be needed to identify the compound of interest.

The distinction between one individual compound claim and two, is nonetheless a fine one. This is not to doubt the validity of the distinction. A line must be drawn somewhere, and as just discussed, there is a sound basis for this distinction both functionally and in Sildenafil itself. It does illustrate once again that the Federal Courts appear not to be inclined to use Sildenafil insufficiency aggressively.

On a slightly different point, while the Sildenafil decision formally turned on “what is the invention,” the "key issue in this appeal" was that "patentees cannot be allowed to 'game' the system" [80] (discussed here). It seems to me that the number of claims is not the only distinction to be drawn between this case and Sildenafil. In Sildenafil only one compound had been tested, while in this case it is not clear to me from the decision how many compounds had been tested. Zoledronate had been tested only after the priority application, and it seems unlikely that the priority application had been filed before any compounds at all had been tested. So I would suspect that as of the Canadian filing date, multiple compounds had been tested and shown to have had at least some efficacy. This means the situation may have been more like Imatinib (here), in which several compounds had been tested but none had emerged as the clear favourite. It would have been interesting to have had a more extensive discussion of the "gaming the system" issue from Hughes J, as was carried out by Snider J in her Imatinib decision (discussed here).

Utility / Obviousness Squeeze in Unpredictable Field

Novartis Pharmaceuticals Canada Inc v Teva Canada Ltd / zoledronate (NOC) 2013 FC 283 Hughes J
            ZOMETA ACLASTA / zoledronate / 1,338,895, 1,338,937

This NOC decision concerns a patent to zoledronate (‘937) and a separate patent to a broad class of compounds including zoledronate (‘895). Both patents were attacked for lack of utility, obviousness and insufficiency. The obviousness and utility issues were fairly straightforward on the facts, but the insufficiency argument raised two important points arising from Sildenafil 2012 SCC 60. This post will provide an overview and deal with the utility and obviousness points, and my next posts will deal with insufficiency.

Hughes J’s reasons are common to two applications brought by Novartis to prevent an NOC from being issued to Teva in respect of zoledronate, which is a bone mechanism regulator, used for treating conditions such as osteoporosis. The applications concerned ZOMETA and ACLASTA, which are different strength formulations. Both patents in issue relate to both formulations, and nothing in the decision turns on the strength of the formulations; the reasons would have been exactly the same if only one of the applications had been brought.

In the late 1960s researchers had discovered that a class of compounds known as bisphosphonates were useful (or perhaps more accurately, potentially useful) in controlling bone resorption, which is a bodily process implicated in bone diseases such as osteoporsis [84]-[95].

Research on second generation bisphosphonates focused on selecting molecules in the R1 and R2 position, and on “linkers” between these molecules and the geminal carbon. Both the inventors of the ‘895 patent, working for Boehringer, and the inventors of the ‘937 patent, working for Ciba-Geigy (now Novartis), developed a class of bisphosphonates with one CH2 linker molecule and a five-membered heteroaryl radical in the R1 position [57], [66]. The ‘895 patent claimed priority from a German application filed on 1 August, 1986, while the ‘937 patent claimed priority from a Swiss application, filed 21 November 1986 [9], [14]. The patents were placed in conflict under the old Act, and the parties settled so that Boehringer obtained the '895 patent with broad genus claims, and Ciby-Geigy obtained the '937 patent with claims to zoledronate alone. This is all by way of explaining why there are two patents in issue, rather than one patent with broad and narrow claims. Novartis listed both patents on the patent Register, presumably as licensee. 

The narrowest claim of the ‘895 patent, Claim 14, was the only claim in issue and it encompassed approximately 1.2 million compounds, one of which is zoledronate. The ‘937 patent had only two claims, to zoledronate and to zoledronate with pharmaceutical excipients.

The evidence accepted by Hughes J established that at the time of the filings, almost nothing was known about why bisphosphonates worked to inhibit bone resoption. It was not even known whether the mechanism was biological or physical-chemical. The target enzyme was not identified until the mid-1990s. Consequently, there was no structure / activity model allowing for prediction of the activity of any particular compound. Experimentally, small differences in structure could result in large differences in biological activity. This meant that each individual bisphosphonate had to be synthesized and tested in a biological model in order to assess its potency [153].

These factual findings led directly to the conclusion that neither invention was obvious [159], but also that Claim 14 of the ‘895 patent, to a broad class, was lacking in utility [167-68]: “In brief, the state of the art was at the empirical stage where compounds would have to be assessed individually.” This was a kind of obviousness / utility squeeze, favouring the individual compound claim; the lack of predictability that was the basis for a successful utility attack on the broad claim was also the basis for holding the individual compound claim to be non-obvious. As it happens, the ‘937 patent, which was held valid, expires on February 25, 2014, 3 weeks after the ‘895 patent, and an order of prohibition was granted accordingly.

Contribution Approach to Patentable Subject Matter Repudiated by CIPO

Guidelines Respecting Computer-Implemented Inventions PN2013-03

The new CIPO guidelines respecting computer-implemented inventions explicitly repudiate central aspects of the MOPOP Ch 16, that was revised as recently as October 1010. The Patent Notice introducing these guidelines says that the occasion for this further revision is the Amazon.com decision 2011 FCA 328, but it is probably more accurate to say that it reflects a general reconsideration of CIPO’s approach, particularly in light of the release of the poorly received proposed guidelines that were released last April. The problems with Ch 16 were apparent prior to Amazon.com and the FCA decision in Amazon.com was ambiguous and difficult to interpret (see my post on Amazon.com here) and so did not in itself compel revision of Ch 16. The new practice guidelines are a major improvement on Ch 16; they are clearer and easier to apply, and they are consistent with the SCC Shell Oil decision. The law itself remains confused as a result of the FCA decision in Amazon.com itself, but the problems with the law will be sorted out in the courts (or possibly the legislature), rather than in battles with the Patent Office. Considerable credit is due to CIPO for have been willing to make such a major change to its position in response to stakeholder feedback.

The debate over the patentability of computer-implemented inventions has played out in terms of the rule against claiming abstract ideas (“No patent shall be granted for any mere scientific principle or abstract theorem”) set out in s 27(8) of the Act. There are two contrasting views of that rule. On one view, the rule prohibits patents for invention where the inventive concept lies solely in an idea, rather than its application. On the alternative view, the rule prohibits only claims to an abstract idea as such; a claim to an application of an idea is acceptable, even if the inventive concept lies solely in the idea. Put another way, the first option sees a rule against claiming abstract ideas while the second view sees a rule against claiming abstract ideas. The difficulty with first view is that all inventions are ultimately based on an idea. If that were a prohibition on patenting, nothing would be patentable. The correct rule is the second, as set out in Shell Oil [1982] 2 SCR 536, 554:

A disembodied idea is not per se patentable. But it will be patentable if it has a method of practical application.

Despite this, the October 2010 revision of MOPOP Ch 16 on computer implemented inventions adopts the first approach: Ch 16.03.02 “Where a machine implements a non-statutory method, in contrast, inventive ingenuity associated with the method per se does not provide the inventive step necessary to support the patentability of a machine implementing that method. The inventive ingenuity necessary to make the machine patentable must arise in relation to adapting the machine to implement the method.” That is, the ingenuity must lie in the implementation of the algorithm or idea, and not in the algorithm or idea itself. This was referred to as “contribution approach.” The argument is that the inventive contribution must be statutory, and abstract ideas are non-statutory, so if the only inventive contribution is an idea, the invention is not patentable: see MOPOP Ch 13.05.03. This analysis is contrary to Shell Oil, which holds that the inventive contribution may be an idea, so long as the invention as claimed as a concrete application of that idea.

This analysis has been repudiated. PN 2013-03 states expressly that “the ‘contribution approach’ set out in MOPOP Chapter 13 is not to be used,” and sections of Ch 16 which invoke on that concept, including Ch 16.03, are no longer to be relied on.

With PN 2013-03, CIPO appears to have come down firmly in favour of the view expressed in Shell Oil. The guidelines indicates that fine arts and methods of medical treatment are excluded from patentability under s 2 of the Act, but computer-implemented inventions are not on this list. The guidelines also state, citing Shell Oil, that “disembodied inventions” will be unpatentable, as “where the claimed subject-matter is a mere idea” (my emphasis). In general, the guidelines indicate that computer-implemented inventions are not to be treated any differently from any other invention. The bulk of the guidance is concerned with how to identify the essential element of a computer-implemented invention so as to carry out a purposive construction, but it does not say that an invention is unpatentable if the essential element is an algorithm. On the contrary, it implies that an invention where the only contribution is an algorithm is patentable: “For example, if an examiner concludes that the solution to a given problem is to perform certain calculations according to a specific equation, the use of a computer to perform the calculations may expedite the mathematical manipulations without having a material effect on the operation of the equation itself. The examiner could therefore conclude that the computer is not an
essential element of the invention.” But the invention is not unpatentable for that reason.

The bottom line is that software remains patentable in Canada. (Despite Ch 16, software patents had routinely been granted in Canada, after a period of uncertainty subsequent to the FCA decision in Schlumberger [1982] 1 FC 845, 56 CPR (2d) 204 (CA).) The new guidelines are consistent with Shell Oil, and are a major improvement over Ch 16 as it stood. I should add that this is not to say that I believe that software patents are a good thing. That is a separate question, which, in my view, is a question for the legislature rather than the courts or the Patent Office.

The Notice releasing these guidelines says that “Subsequent practice guidance for medical use claims and diagnostic methods will follow shortly.” In light of these guidelines on computer-implemented inventions, we can be reasonably hope that the new practice guidance will not resemble the consultation document on Office Practice Respecting Claims to Diagnostic Methods and Medical Uses, which would have effectively made the USSC Prometheus decision part of the Canadian Patent Office practice.

Temporary Stay in Ontario “s 8" Disgorgement Action

Apotex Inc v Schering Corporation / ramipril, 2013 ONSC 1411 Stinson J

Dissatisfied with the ruling that disgorgement of the patentee’s profits is not available as a remedy in a claim under s 8 of the NOC Regulations (2011 FCA 358 blogged here), Apotex has turned to the Ontario courts to seek a disgorgement for the same wrong, that is being kept out of the market as a result of the statutory stay under the NOC Regulations, under a variety of legal theories. In this motion, Stinson J has ordered a temporary stay of Apotex’s action in respect of ramipril pending the outcome of the appeal taken by the defendants to the FCA Snider J's decision in Apotex v Sanofi / ramipril (s 8) 2012 FC 553 (an overview is given here). Stinson J held that while the causes of action were different, and the remedies would not necessarily be the same (certainly not according to Apotex’s submission), there was nonetheless a substantial overlap of the issues so that wasteful duplication of judicial resources was likely if the parallel proceedings were maintained [17]. Moreover, even though the causes of action are different, any amount awarded to Apotex in the s 8 proceeding would likely be relevant to the quantum in the Ontario proceeding, in order to avoid giving Apotex double recovery [14]. On the other hand, the only downside to ordering a stay is a delay in Apotex’s recovery of any damages which it might be awarded in the Ontario action [20]; in particular, the availability of generic ramipril would not be affected. Note that Sanofi is now focusing on having Apotex’s claim struck entirely [1] in light of Quigley J’s recent decision in Apotex v Abbott / lansoprazole 2013 ONSC 356 (blogged here).

Purposive Construction in the Patent Office

Examination Practice Respecting Purposive Construction PN2013-02

CIPO has issued new practice guidelines respecting purposive construction (PN2013-02) and computer-implemented inventions (PN2013-03). Both sets of guidelines strike me as basically sound. This post makes a few comments on the purposive construction guidelines. A subsequent post will comment on the guidelines regarding computer-implemented invention, which mark a radical departure from CIPO’s prior formal position.

The guidelines respecting purposive construction begin with a puzzling statement suggesting that while the approach to construction set out in Free World 2000 SCC 66 and Whirlpool 2000 SCC 67 will “continue to guide the courts,” these cases were not directed to patent examiners. The guideline relies for this on two paragraph from Gibson J’s decision in Genencor v Canada (Comm’r of Patents) 2008 FC 608, in which Gibson J at [61] quoted a passage from Whirlpool [52] to the effect that a “dictionary” approach to construction must be rejected and the claims must be construed with reference to the entire specification. It was in respect of this passage that Gibson J stated that “I am satisfied that the foregoing, in all its implications, was directed to trial judges and to judges of courts of appeal and not to patent examiners in the course of examinations.” To the extent that this suggests that a dictionary approach should be taken in examination, and the claims should not be read in the context of the patent as a whole, this statement is clearly wrong, and it would be disturbing if this approach were to be adopted in examination. But later on the guidelines emphasize that “it is critical that a purposive construction of the claim be performed considering the specification as a whole as read through the eyes of the person skilled in the art,” which is exactly what the SCC said in Whirlpool in the passage impugned by Gibson J. Also, the guidelines go on to note that “during examination of an application the language of the claim may change from that initially proposed by the applicant for a number of reasons,” and that construction of the patent “must take into account the role of the patent examiner and the purpose and context of examination.” This seems to me to be a reasonable proposition. For example, the courts are very reluctant to hold a patent invalid for ambiguity. In contrast, rejections in examination based on indefiniteness are relatively common. This difference seems reasonable, since the remedy is different. During examination, the patentee can amend the claims, and if the claims in an application are arguably ambiguous, they should be clarified before grant in order to provide clear notice to third parties. Once the patent has issued, it may be appropriate to give the best interpretation to those same claims, in light of the relatively draconian alternative of holding the claims invalid. More generally, the functional point the guidelines seem to be making is that the examiner is not obliged to engage in the same kind of detailed scrutiny and fine parsing of claim that might be undertaken at trial, and if the validity of a claim turns on its scope, the scope should by clarified be amending the claim rather than by engaging in a debate over claim construction. Genencor was presumably the best authority that could be found for this proposition, and that may well have been the real thrust of that decision, despite is peculiar treatment of Whirlpool.

Apart from that, the main feature of the guidelines is a focus throughout on identifying the problem and solution as part of the construction, relying on s 80(1)(d) of the Patent Rules, which require the description to “describe the invention in terms that allow the understanding of the technical problem, even if not expressly stated as such, and its solution.” The problem-and-solution approach is an accepted part of the obviousness analysis in the EPO, and while systematic focus on the problem and its solution is not similarly accepted in the Federal Courts, there are many cases which invoke similar language, as discussed here. My own view is that this is generally a useful approach, particularly in the obviousness context.

I also entirely agree with the statement that “Without having first considered the problem and solution, the identification of essential elements would be circular - it would begin and end with the language of the claim.” I make a similar point in my Essential Elements article, 22 I.P.J. 223 (2011).

The practice guidelines also invoke Rule 80(1)(d) as support for the promise of the patent doctrine for determining utility. My view is that the false promise doctrine is incompatible with the Canadian Act, but I can’t criticize CIPO for accepting it, given that the FCA has said it is the law.

Punitive Damages, Electing an Accounting, and Deduction of Fixed Costs

Apotex Inc. v. H. Lundbeck A/S / escitalopram 2013 FC 192 Harrington J
            CIPRALEX / escitalopram / 1,339,452

While Apotex had not launched prior to bringing its impeachment action, monetary remedies were still a live issue because it had stockpiled in the expectation of getting an NOC. When that prediction had turned out to be wrong, it sold some of the stockpiled product to affiliates in the Czech Republic and Australia [259-60], giving rise to profits and Harrington J permitted Lundbeck to elect an accounting [271]. In assessing the profit to be accounted for, Harrington J addressed one difficult remedial question, namely the deductibility of fixed costs in an accounting of profits. His approach to punitive damages and the patentee’s election of an accounting are also interesting.

Sildenafil Doctrine Not About Data Disclosure

Apotex Inc. v. H. Lundbeck A/S / escitalopram 2013 FC 192 Harrington J
            CIPRALEX / escitalopram / 1,339,452

With the recent Sildenafil 2012 SCC 60 decision, we can expect to see Sildenafil-type insufficiency raised regularly, at least until the bounds of the doctrine are fleshed out. This is second case to deal with the doctrine, and it is consistent with Snider J’s imatinib 2013 FC 141 decision (blogged here) in holding that the Sildenafil doctrine is not about disclosure of data, it is about disclosure of the invention.

The issue in this case was that the specification stated that “results upon administration to human beings have been very gratifying.” This was not true, as the enantiomers had not been tested on humans until after filing [225]. Apotex argued that the patent should therefore be declared void on the basis of s 27(3), which is to say on the basis of the disclosure requirement as interpreted in Sildenafil.

Apotex had raised the same statement in the NOC proceedings, arguing both s 27(3) and s 53 (though of course not relying on Sildenafil). In that case, Harrington J had dealt with it on the basis of s 53, which states that a patent is void “if any material allegation in the petition of the applicant in respect of the patent is untrue.” (He noted in this case that in so doing he had conflated the two provisions.) He had held in the NOC preoceedings that read in context, the statement was not misleading, nor had anyone been misled: 2009 FC 146 [147].

In this case, the point was based on s 27(3), not s 53 [229]. Harrington J again rejected the argument, but on an entirely different basis, tailored to the different provision. He held that the Sildenafil doctrine simply did not apply. In Sildenafil, “the invention was the use of sildenafil for the treatment of ED,” and it was this that had to be disclosed [233, quoting SCC [72]], whereas “In this case, the invention, (+)-Citalopram and how to get there, was properly disclosed” [235]. This strikes me as a correct interpretation of Sildenafil. It is also consistent with Snider J’s imatinib 2013 FC 141 [375] decision, in which she held that failure to disclose test data cannot in itself result in a finding of insufficiency. In imatinib the issue was failure to disclose test data, and in this case it was disclosure of erroneous data, but in either case, the basic principle is that the Sildenafil doctrine is not about disclosure of data, it is about disclosure of the invention.

Finally, I note that Harrington J accepted the view that the SCC in Sildenafil had “declared the patent void, notwithstanding that the appeal was in a PM (NOC) application” [234]. As discussed here, my own view is that the SCC did not hold the patent void in rem.

Proving What the POSITA Would Have Thought

Apotex Inc. v. H. Lundbeck A/S / escitalopram 2013 FC 192 Harrington J
            CIPRALEX / escitalopram / 1,339,452

The primary issue in this escitalopram decision was obviousness, and “the prime issue, really, is what two over-qualified experts in 2012 would think an ordinary pharmaceutical chemist would have thought of doing in 1988 [the claim date]" [161]. It is well-recognized that the obviousness determination must guard against the hindsight bias, which means that something may have seemed difficult at the time, but obvious in hindsight. But the problem in this case, while related, is even more basic: what kind of proof is need to today, to establish what a hypothetical person counter-factually would have thought 25 years ago?

Affirmed that Award under NOC Section 8 to Be Considered in Damages in Subsequent Infringement Action

AstraZeneca Canada Inc v Apotex / omeprazole (NOC) 2013 FCA 77 Sharlow JA: Blais CJ, Stratas JA aff’g 2012 FC 559 Hughes J (blogged here)
            LOSEC / omeprazole / 2,133,762, 1,292,693

AstraZeneca was unsuccessful in NOC proceedings against Apotex in respect of omeprazole, in which it sought an order of prohibition based on the ‘762 patent: 2004 FC 313. In this action, Apotex has now sought compensation under s 8 of NOC Regulations. But at the same time, AstraZeneca has brought an infringement action against Apotex, on the basis of the ‘693 patent, which is also related to omeprazole, with the action set down to be heard in April 2014 [FC 28]. The concurrence of the s 8 and infringement actions raises two questions. Substantively, if AstraZeneca is successful in the infringement action, how will this affect Apotex’s entitlement to s 8 compensation? Apotex's position is that the alleged infringement of the '693 patent is not relevant to Apotex's s 8 claim [FC 141]. AstraZeneca's position’s is that if it is successful in the infringement action, this operates as a defence to the s 8 claim; the claim is for sales that are lost as a result of the statutory stay, but if Apotex had made those sales, it would be liable in damages to AstraZeneca for infringement of the ‘693 patent, so there really are no losses as a result of the statutory stay [FC 140]. Put another way, Apotex is not entitled to damages for loss of a market that it had no right to enter. Consequently, AstraZeneca sought a delay of the s 8 proceeding pending the outcome of the infringement action. Hughes J had initially ordered that if AstraZeneca’s defence was determined to be viable in law, he would reserve judgment in the s 8 matter under final disposition of the infringement action [FC 28].

The decision under appeal dealt with this question of whether AstraZeneca’s defence is viable in law [FC 140 - 50]. As discussed in my post on that decision, Hughes J held that the infringement action could potentially serve as a basis for a defence in the s 8 proceeding on the basis of ex turpi causa. However, procedurally, he changed his mind and refused to reserve judgment in the s 8 proceeding. Instead, any such defence will be dealt with in the infringement action:

[148] This solution accords with what may properly be done in the present situation. A Court hearing the pending infringement action, if it concludes that the patent is valid and has been infringed by Apotex in making the omeprazole drug that is the subject of these proceedings, can at that time craft a remedy that is appropriate, having in mind any compensation awarded in these proceedings. It would be unconscionable for the present proceedings to come to a halt or for this Court to refuse to award compensation simply because another action on another patent was pending. To do so would be simply to encourage such actions to be brought. The best way to deal with the matter is as I have set out above.

Hughes J’s judgment on this point has now been affirmed by the FCA in brief reasons from the bench, quoting and agreeing with this paragraph [7-8].

Extended Release SEROQUEL is Obvious To Try

AstraZeneca Canada Inc v Teva Canada Ltd / quetiapine ER (NOC) 2013 FC 245, 2013 FC 246 Near J
            SEROQUEL XR / quietiapine fumarate extended release tablets / 2,251,944

Near J’s decision in this NOC proceeding is a good illustration of the application of the obvious-to-try analysis to invalidate a patent.

The patent claimed a sustained release formulation of quetiapine fumarate using the gelling agent hydroxypropyl methylcellulose (HPMC). Quetiapine was a known drug used for the control of psychiatric disorders such as schizophrenia [3]. It was known that less frequent dosing is desirable as it leads to better compliance [30]. HPMC was a known gelling agent; indeed, it was one of the most popular gelling agents for use in extended release formulations [31]. The question was whether it was obvious to try using quietiapine in combination with HPMC to create a sustained release formulation [34].

Unfair Competition Claim under Trade-marks Act Allowed to Stand

Apotex Inc v Eli Lilly / atomoxetine, 2013 ONSC 1135 Ducharme J refusing leave to appeal re 2012 ONSC 3808

As noted in my previous post, the Ontario Divisional Court granted leave to appeal respecting Macdonald J’s refusal to strike Apotex’s claim for disgorgement of Lilly’s profits. However, in the same decision, the Divisional Court refused to grant leave from Macdonald J’s refusal to strike Apotex’s claim for damages for unfair competition, under ss 7(a) and (d) of the Trade-marks Act. That claim, in effect, was that Lilly had abused the patent system by “by registering on the Patent Register a patent which was ultimately declared invalid and commencing the prohibition proceeding” [18].

The test for leave from a refusal to strike is an onerous one [5], so this says little as to the merits. When the issue is dealt with substantively, it will be interesting to see how Harris v GlaxoSmithKline 2010 ONCA 872 aff’g 2010 ONSC 2326 (blogged here) is dealt with. In that case, Harris was a representative plaintiff in a class action seeking damages on the basis that GSK had abused the NOC system by bringing "objectively baseless” NOC proceedings which had all failed [22-23]. Harris’ claim was based on the tort of abuse of process, conspiracy and waiver of tort. The ONCA affirmed the order of the Perell J striking the claims and dismissing the action. In so holding the ONCA remarked that

[46] GSK submits, correctly in my view, that the appellant "cannot convert the legitimate interest of a patentee in protecting (and monetizing) its intellectual property rights into anti-competitive monopoly practices in order to conjure up the improper predominant purpose required for the tort of conspiracy."

[50] Applying that test to the case at hand, the motion judge stated the following at para. 94 of his reasons:

In the case at bar, GSK's NOC Proceedings were not contrary to law or to statute. GSK's NOC Proceedings were the opposite of unauthorized; they were proceedings that GSK was entitled to bring. In other words, they were acts that GSK was at liberty to commit. The NOC Proceedings are actually a response to NOC's initiated by Apotex and two other generic manufacturers. GSK has a statutory right to show that the generic manufacturer's allegations are "not justified."

This seems to imply a broad rule that registering patents on the Patent Register and bringing NOC proceedings cannot be wrongful. The atomoxetine litigation is distinguishable both on the cause of action and because the plaintiff has a different interest, but this broad principle nonetheless seems applicable. It seems likely that this issue will eventually make its way to the ONCA once again, and it will be interesting to see whether that court holds that the same principle does indeed apply under the Trade-marks Act. If the ONCA were inclined to rethink the Harris decision without expressly reversing it, this might be an opportunity.

Leave to Appeal Granted re Disgorgement of Profits in Ontario S 8 Claim

Apotex Inc v Eli Lilly / atomoxetine, 2013 ONSC 1135 Ducharme J granting leave to appeal re 2012 ONSC 3808

The FCA has held that disgorgement of the patentee’s profits is not available as a remedy in a claim under s 8 of the NOC Regulations: 2011 FCA 358 blogged here. Apotex has turned to the Ontario courts to seek this remedy in two separate actions. In Apotex v Eli Lilly / atomoxetine 2012 ONSC 3808, MacDonald J dismissed a motion to strike such a claim. Earlier, in Apotex v Takeda and Abbott Labs / lansoprazole 2010 ONSC 6909, Whitaker J also dismissed a motion to strike such a claim (aff’d 2011 ONSC 3988 (Div Ct) blogged here), but then in the decision on the merits, 2013 ONSC 356, Quigley J dismissed Apotex’s claim for disgorgement in a summary judgment (blogged here). In the most recent development, the Divisional Court has granted leave to appeal of Macdonald J’s refusal to strike Apotex’s claim for disgorgement of Lilly’s profits in the atomoxetine case, relying in large part on the conflict between the decisions of Macdonald J and Quigley J. Presumably Apotex is also appealing Quigley J’s decision on the merits in the lansoprazole litigation. One way or the other, the stage is set for a definitive statement from the Ontario courts on this issue.

Claim in the Alternative

In Pfizer / pregabalin (NOC) 2013 FC 120 Hughes J held a claim to “a therapeutically effective amount of pregabalin or its racemate” to be invalid on the basis that the utility of the racemate was not established: see my post here. Anon commented on that post that “The patent didn't claim that the recemate ‘as well as’ pregabalin were effective, it claimed these in the alternative (see 27(5))!” On its face, s 27(5) certainly appears to be applicable:

27(5) Alternative definition of subject-matter

For greater certainty, where a claim defines the subject-matter of an invention in the alternative, each alternative is a separate claim for the purposes of sections 2, 28.1 to 28.3 and 78.3.

The “for the purposes of" includes utility which is a requirement by virtue of s 2. Thus it seems like the claim should or, at least, could have been construed as effectively two separate claims, one to pregabalin and one to the racemate, and therefore only the claim to the racemate should have been invalid.

First Application of the Sildenafil Disclosure Requirement

Teva Canada Ltd v Novartis AG / imatinib 2013 FC 141, Snider J

            GLEEVEC / imatinib mesylate / 2,093,203

Snider J’s Imatinib decision, at [336-387], is the first to apply the disclosure requirement since the SCC released Sildenafil 2012 SCC 60. Snider J has done an admirable job in applying a difficult doctrine, and she has clarified some important points. But the Imatinib decision also illustrates some difficulties that arise from unresolved ambiguities in Sildenafil itself.

Experimental and Regulatory Use Defence Available on the Facts in Imatinib

Teva Canada Ltd v Novartis AG / imatinib 2013 FC 141, Snider J

            GLEEVEC / imatinib mesylate / 2,093,203

Having successfully established the validity of its patent, Novartis sought a declaration of infringement in respect of certain volumes of bulk imatinib held by Apotex. Snider J held that the defence of regulatory use (s 55.2(1)) or the common law experimental use defence, preserved by s 55.2(6), was applicable in respect of bulk imatinib used for the following purposes [395]:

(a) developing suitable formulations and processes;

(b) obtaining regulatory approval to sell commercial formulations; and

(c) demonstrating that its manufacturing process could be carried out on a commercial scale.

Snider J did not deal with the statutory and common law defences separately, though she ultimately held that both were applicable [401.1]. This result is generally consistent with the cases following Micro Chemicals [1972] SCR 506, especially Merck / lisinopril, 2006 FCA 323 [109-13]. The facts on this case are very similar to those in Merck / lovastatin 2010 FC 1265, [631-32] in which Snider J also held the regulatory or common law defence to be available. As Snider J stated in Servier v Apotex / perindopril, “Of critical importance, in my view, none of the raw material or the actual formulations that were made in the course of that development process were ever sold or used for a commercial purpose” 2008 FC 825 [166] aff’d 2009 FCA 222 [24]. 

The importance of lack of commercial use was emphasized by Snider J’s holding with respect to a certain volume of bulk imatinib held in Apotex’s inventory. The defence was not available for this inventory material, so the material was infringing, but Snider J nonetheless declined to exercise her discretion to order delivery up [401.2]. This was primarily because the evidence indicated that this material would not be used for commercial purposes [397], and, importantly, Dr Sherman gave an formal undertaking, which was incorporated in the judgement, that the inventory bulk imatinib would never be used commercially [399-400].

Utility of Genus Claims Turns on the Expert Evidence

Teva Canada Ltd v Novartis AG / imatinib 2013 FC 141, Snider J

            GLEEVEC / imatinib mesylate / 2,093,203

Previous posts have discussed the key compound claims and use claims in the ‘203 patent. This post turns to the genus claims. Because not all of the compounds in the genus claims had been tested, their validity turned on the doctrine of sound prediction [248]. Snider J had concluded that all of the tested compounds had utility as kinase inhibitors, and the key question in respect of the genus claims was “whether it is reasonable to predict, on the basis of a few examples, that all of the compounds of the general claim will operate in a similar fashion” [250]. This is fundamentally a question of fact which Snider J answered on the basis of the testimony of the expert witnesses.

Must the Line of Reasoning be Disclosed in the Patent?

Teva Canada Ltd v Novartis AG / imatinib 2013 FC 141, Snider J

            GLEEVEC / imatinib mesylate / 2,093,203

In its Latanoprost decision, 2011 FCA 236, the FCA remarked on the disclosure requirement related to the “line of reasoning” branch of the sound prediction doctrine, suggesting that the line of reasoning must be disclosed in the patent itself, and even that the line of reasoning must be found entirely in the patent [original emphasis]:

[42] The inventor's line of reasoning is nowhere to be found in the disclosure of the '132 patent. When asked where, in the patent, was disclosed the line of reasoning, Dr. Wolff could not point to any excerpt. Dr. Fechtner’s was led to the same conclusion:

Q. Yes. So can you point me in the patent where the inventor say here’s the rational from Point A, one time single use, the tables, to Point B, lifelong chronic use, the claims? Where’s the description of that rational in the patent?

[…]

A. I don’t find explicitly what you’re describing.

[43] At the hearing, counsel for Pfizer argued that the line of reasoning was to be found in the studies listed in the "References" section of the patent (Patent '132, at pages 30 and 31). Pfizer also took the position that a POSITA, taking the prior art as a whole, would be able to infer that multiple doses of latanoprost would give the same results as the single dose studies.

[44] This position seems at odds with the concept of disclosure in patent law. In Wellcome AZT, Justice Binnie stated that if utility is not demonstrated at the time of filing, the quid pro quo the applicant offers in exchange for the patent monopoly is a sound prediction of utility (Welcome AZT, at paragraph 70). As the applicant is the one who will benefit from the monopoly, I am of the view that only he, and not the authors or inventors of the prior art, can discharge himself of the obligation of disclosure. Besides, our Court found in Eli Lilly Canada Inc. v. Apotex Inc., 2009 FCA 97, at paragraph 17 that a patent that provides no more disclosure than is available in the prior art does not provide a sound basis for the prediction.

In her imatinib decision, Snider J interpreted this passage as modestly as possible. The FCA went on to say that “Moreover, Pfizer pointed to no evidence on the record supporting its position. None of Pfizer's experts bridged the gap between the single doses studies and the claimed chronic use” [45]. Snider J seized on this, remarking that “In Latanoprost, the Court of Appeal acknowledged that expert evidence relating to the knowledge of the skilled person might bridge the gap between the factual basis disclosed in the patent and the prediction of the inventor” [292]. This is a reasonable alternative reading of Latanoprost; while the FCA, in the paragraphs quoted above, suggested that the line of reasoning had to be found in the patent, it also held that even if it were possible to bring the gap with evidence not in the patent, the patentee in this case had not done so. 

In my view, when faced with these alternatives, Snider J was entirely right to emphasize the potential for gap bridging. The notion that the line of reasoning must be entirely disclosed in the patent itself is absurd, as the facts in imatinib illustrate. It was well known that chronic myeloid leukemia was caused by BCR-ABL kinase, and it was well known that a kinase inhibitor that was selective for BCR-ABL would potentially treat that disease. The breakthrough was in finding a compound that acted as a selective BCR-ABL kinase inhibitor, not in drawing any of the links in the chain of reasoning. The only element of the line of reasoning that had been disclosed was the fact that the tested compounds selectively inhibit ABL kinase, and this is arguably part of the factual basis rather than the line of reasoning [313]. The gap to be bridged amounted to almost the entire line of reasoning. But there is nothing wrong with that. There is no good reason why the disclosure should include a discussion of what was already well-known in the art. It is precisely to avoid the need for such lengthy and redundant disclosure that the law takes the reader of the patent to be a person skilled in the art. It is true that Wellcome / AZT 2002 SCC 77 [70] suggests that there might be a need to disclose the line of reasoning in the patent, but it was no more than a hint, and it was expressly obiter. The common law method of reasoning is to test the principles according to the facts, and because the lower courts see far more patent cases than the SCC, they are in a good position to see when a hint dropped by the SCC makes sense, and when it does not. Similarly, inappropriate hints dropped by the FCA should also be modestly interpreted, as Snider J has done in this case.

(Note that I have previously criticized the FCA Latanoprost decision on the separate point that it construed the promise of the patent without reference to the text of the patent itself.)