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.)

Is Sound Prediction a "Free-Standing Doctrine"?

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

            GLEEVEC / imatinib mesylate / 2,093,203

[164] Sound prediction is not a free-standing statutory requirement. Rather, it is a way of showing that an invention is useful when the invention has not been directly demonstrated to work. Its introduction into Canadian law was not, as I understand it, to give a crushing hammer to those who challenge patents.

This is technically and historically correct, but it does not mean that patentees have no cause for complaint. Sound prediction originated as an aid to patentees, but some developments have been very problematic. These stem from a pregnant passage in Wellcome / AZT 2002 SCC 77 [70], that said that to support sound prediction, in addition to a factual basis and a sound line of reasoning:

there must be proper disclosure. . . . In this sort of case, however, the sound prediction is to some extent the quid pro quo the applicant offers in exchange for the patent monopoly. Precise disclosure requirements in this regard do not arise for decision in this case because both the underlying facts (the test data) and the line of reasoning (the chain terminator effect) were in fact disclosed, and disclosure in this respect did not become an issue between the parties. I therefore say no more about it.

While these remarks are expressly obiter, they suggest that when utility is based on sound prediction, there may be a requirement that the facts and line of reasoning be disclosed in the patent itself. This suggestion was taken up by Hughes J in Lilly / raloxifene 2008 FC 142 [164] and affirmed by the FCA 2009 FCA 97 [15], holding that the factual basis for sound disclosure be provided in the patent itself: see my article “Must the Factual Basis for Sound Prediction Be Disclosed in the Patent?” (2012) 28 CIPR 39, draft version here. Furthermore, in its Latanoprost decision, 2011 FCA 236, the FCA strongly implied that the line of reasoning must also be disclosed in the patent.

In her imatinib decision, Snider J held that the utility of some use claims and some genus claims was established based on sound prediction. Consequently her decisions navigates the shoals of these heightened disclosure requirements.

Miscellaneous Issues in Imatinib

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

            GLEEVEC / imatinib mesylate / 2,093,203

As well as the promise of the patent, discussed yesterday, Snider J’s imatinib decision is the first application of the SCC  Sildenafil disclosure requirement, and it also raises interesting issues related to sound prediction. I am still working on posts on those topics. In the meantime, this post discusses some miscellaneous emerging from the decision.

• Differentiated promise of utility
• What is a scintilla?
• Burden of proof
• POSITA may be an expert

Imatinib – Promise of the Patent

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

            GLEEVEC / imatinib mesylate / 2,093,203

Imatinib has proven to be a revolutionary treatment for chronic myeloid leukemia: “What once was a death sentence has now become a manageable chronic illness with overall survival rates equal to the general population” [71]. The ‘203 patent includes a compound claim to imatinib (Claim 29) and a claim to the use of imatinib for the treatment of tumours (Claim 46, read together with Claim 29) [184]. These were the key claims at issue, and both were held to be valid. (Other important claims included Claim 1, the broadest genus claim, which was held to be invalid, and Claim 5, a sub-genus claim encompassing imatinib, which was held to be valid. A number of other claims to individual compounds were also held to be valid.)

As is now standard with respect to pharmaceutical patents, the main attack on the patent was based on lack of utility [8], and a key argument turned on the promise of the patent. In the end, Snider J construed the promise modestly, in favour of the patentee, but her decision illustrates once again that under the false promise doctrine, validity of a pharmaceutical patent may turn on an extraordinarily fine parsing of the description. Whatever the result, this is problematic, as the description is intended to disclose the invention, not to define it; the false promise doctrine means that the same meticulous care that must be given to every word of the claims, should also be given to every word of the description when drafting a Canadian patent application.

Imatinib Procedural Posture

Novartis Pharmaceuticals Canada Inc v Apotex Inc / imatinib (NOC) 2013 FC 142, Snider J

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

            GLEEVEC / imatinib mesylate / 2,093,203

There is a lot of meat in Snider J’s decision relating to relating to Novartis’ GLEEVEC (imatinib mesylate). I started writing a general overview, and realized that even that was too much for one post, so I will start by dealing with the NOC proceeding and the somewhat unusual procedural posture.

Apotex and Teva both wished to sell a generic version of GLEEVEC, but in their initial ANDS, submitted in 2007 and 2010, respectively, they indicated that they would wait until the expiry of the ‘203 patent, which is listed against GLEEVEC on the Patent Register. In 2011 both changed their minds and submitted revised Form Vs purporting to amend their election to allege invalidity. At about the same time, each brought an action against Novartis seeking a declaration under s 60(1) that the ‘203 patent was invalid. All four proceedings were eventually consolidated, though Snider J gave separate reasons for judgment in respect of the declaratory action (2013 FC 141) and the NOC proceeding (2013 FC 142).

In lengthy reasons in 2013 FC 141, Snider J dismissed the declaratory action, holding the key claims not to be invalid. That conclusion was also determinative in the NOC proceedings, because “it follows that the allegations of invalidity contained in the NOAs cannot be justified,” [NOC 7]. A separate question in the NOC proceedings was whether the NOC Regulations permit the amendment of a Form V to change an election [NOC 28], as Apotex and Teva had done in 2011. I would infer that it was because Apotex and Teva had doubts as to whether they would prevail on this point in an NOC proceeding that they chose to adopt the unusual course of seeking a declaration of invalidity in addition to serving an NOA (though there is nothing in Snider J's decisions that states this, even implicitly). In the end, Snider J declined to answer that question, on the basis that it is not determinative in light of her conclusion the substantive question, and because it is a question of law on which she would be owed no deference on appeal “[b]y wading into this legal question – which has become purely academic – I would not be assisting either the parties before me or the Court of Appeal” [31]. Her NOC decision was therefore primarily devoted to setting out the factual background of the proceedings. 

Thalidomide Is Not an "Innovative Drug"

Celgene Inc. v. Canada (Health) / THALOMID 2013 FCA 43 Gauthier J, Sharlow J concurring: Nadon JA dissenting, rev’g 2012 FC 154 de Montigny J (blogged here)

Text, context and purpose are all important in statutory interpretation, and in hard cases, where these considerations do not all align, the result may depend on which element is emphasized. TheTHALOMID litigation over the interpretation of the term “innovative drug” under the Data Protection Regulations, shows three different judges weighing these factors differently. In the FC, de Montigny J focused almost entirely on what he saw as the purpose of the Regulations. In the FCA, Gauthier J, for the majority, adopted an approach centered primarily on the text, while Nadon J, dissenting, had a relatively balanced approach, and relied on text, context and purpose. The result on the facts is that the FCA reversed de Montigny J decision that thalidomide should be listed. The more general consequence is a negative one. de Montigny J’s interpretation would have had very wide ramifications for the interpretation of “innovative drug.” The FCA approach turns more on the particular and very unusual facts of this case. This is true in respect of both the reasons of Gauthier J for the majority, and Nadon J in dissent.

A Serious Matter

To wrap up your week, we have the decision of Phelan J in San Miguel Brewing Int'l Ltd v Molson Canada 2005 2013 FC 156. The question was whether the trade-mark RED HORSE for beer is confusing with the trade-mark BLACK HORSE. Phelan J began by noting that “The potential for the use of phrases such as ‘this is a horse of a different colour’ or equine and beer jokes jump out at one. The Court will refrain from such frivolities for this is a case about beer and a case of beer is a serious matter.”

Cryptic Obvious to Try Analysis

Pfizer Canada Inc v Pharmascience Inc / pregabalin (NOC) 2013 FC 120 Hughes J

            2,255,652 – LYRICA

The ‘652 patent claims the use of pregabalin for the treatment of pain. As discussed in a previous post, Hughes J found it to be invalid for lack of utility / overbreadth. However, he also held it was not obvious.

While the discussion of obviousness was brief, it appears the attack was based on an obvious-to-try argument, as Hughes J began his analysis at [186] by quoting the relevant passages from Sanofi 2008 SCC 61 and Pfizer / sildenafil (NOC) 2009 FCA 8. Pregabalin was a compound known to be useful as an anticonvulsant, and the evidence indicated that at the relevant time “physicians would try or expect that anticonvulsants would be useful in treating some forms of pain,” [193], though at the same time a skilled person “would not have an expectation that pregabalin would be useful to treat pain without making and testing it” [194].

Dicta on Disclosure of Utility

Pfizer Canada Inc v Pharmascience Inc / pregabalin (NOC) 2013 FC 120 Hughes J

            2,255,652 – LYRICA

As noted in yesterday’s post, Hughes J’s pregabalin decision provides an extended, 33 page discussion of the law of sound prediction and, particularly, disclosure of utility. As discussed yesterday, the entire discussion is obiter dicta. This is significant, as some of Hughes J’s analysis appears to go beyond established law.

So, without citing authority, Hughes J says at [103] (and see similarly [159] first bullet):

The law is clear that where a new compound, such as a pharmaceutical, is the invention, the specification must state the utility of that compound so as to satisfy the definition of “invention” in section 2 of the Patent Act.

This is at odds with the statement by the SCC in Consolboard [1981] 1 SCR 504, 526 that the inventor is not obliged “in his disclosure or claims to describe in what respect the invention is new or in what way it is useful. He must say what it is he claims to have invented. He is not obliged to extol the effect or advantage of his discovery, if he describes his invention so as to produce it.” The Consolboard position that the inventor is not required to state the utility at all is problematic, and I have argued in my Factual Basis article 28 CIPR 39, section 5, that ultimately the better view is that the utility must be disclosed in the specification, if it would not otherwise be obvious to a person skilled in the art. That is the law according to the US Federal Circuit, the EPO, the PCT Reg 5.1(vi), and the EPC Rule 42(1)(f). That is also how the Canadian Patent Office understands the requirement to disclose utility: Re Immunex CD 1302, 89 CPR(4th) 34 at 74. Consolboard is also consistent with this position on its facts, as the utility was obvious without an explicit statement. (The invention was a type of wooden board, which was obviously useful for construction.) But in Canada, in light of Consolboard, it cannot yet be said that it is clear law that utility must be disclosed even when it would not be obvious; and to say utility of a new compound must be stated in the disclosure, even if it would be obvious in any event, is very difficult to reconcile with existing law. It may well be that as a practical matter, the utility of a new compound will rarely be obvious, so a statement of utility will normally be necessary, and perhaps this is what Hughes J had in mind.

Hughes J also states that it is “established” that “where utility of a pharmaceutical has been established before the application for a patent was filed in Canada, it was sufficient to reference a study in the patent description” [153] first bullet. Even more strongly, he states at [159], third bullet, that:

there is a requirement in the jurisprudence that that [sic] the specification disclose information from which the utility can be confirmed or be said to be soundly predicted.

That studies supporting demonstrated utility must be disclosed in the patent is a novel proposition which would be very controversial if accepted. The only authority cited by Hughes J is a remark from Pfizer / sildenafil [Viagra] 2010 FCA 242 (rev’d on other grounds 2012 SCC 60) that “[s]o long as the disclosure makes reference to a study demonstrating utility, there do not appear to be any other requirements to fulfill section 2" [90]. But that remark was itself obiter, as the main point of the discussion by the FCA was that the argument that the patentee “was required to include evidence of demonstrated utility in the patent disclosure is without merit. The requirements for demonstrated utility can be provided in evidence during invalidity proceedings as opposed to in the patent itself” [90]. This passage in this FCA decision is essentially an affirmation of the holding of Kelen J at first instance 2009 FC 638 [82] that:

The Court finds that there is no requirement in patent law that evidence of the demonstrated utility of the patent must be included in the patent. It is sufficient that the patent states that the invention has been demonstrated to be useful, as the '446 Patent does by making reference to the clinical testing of the compound (Study 350), and that the patent-holder is able to show evidence of demonstrated utility if the validity of the patent is challenged.

In this passage, the reference to the study in the patent was simply the way in which this particular patent has made the necessary statement that the invention is useful. (As noted above, even such a statement is probably not generally required, though it was certainly necessary on the facts as the patent at issue was a use patent.) Therefore, Kelen J’s statement does not support the conclusion drawn by Hughes J, and the FCA statement really goes no further. Thus, the case law cited by Hughes J simply does not support his assertion that “there is a requirement in the jurisprudence that that [sic] the specification disclose information from which the utility can be confirmed or be said to be soundly predicted” [159].

Finally, I note that Hughes J also remarks confusingly that in the Viagra decision the SCC “said that there was no heightened requirement for disclosure in cases where utility is based on sound prediction,” [154] though in the next paragraph, he quotes the SCC as saying the point “does not arise in this case and need not be addressed,” [155], and he then emphasizes that “the comments as to sound prediction are strictly obiter” [156].

It remains to be seen whether Hughes J will give effect to the controversial statements of law set out in this discussion when they arise on the facts in a case before him. For now, we may note that this statements are obiter, and are by no means uncontroversial.

Be Sure to Claim the Commercial Compound

Pfizer Canada Inc v Pharmascience Inc / pregabalin (NOC) 2013 FC 120 Hughes J

            2,255,652 – LYRICA

Hughes J’s pregabalin decision is noteworthy for a curiously lengthy discussion of the law related to disclosure of utility. The discussion spanned 63 paragraphs [96 -159] and 33 pages of the 86 page decision. What is curious about the discussion is that it was entirely irrelevant to the case at hand! Hughes J remarked at the outset that “The manner in which our Courts have dealt with the matter of sound prediction has appeared to cause some to raise concerns, in Canada and elsewhere, as to how the subject is treated” [96], and he has apparently decided to take this judgment as an opportunity to set out his views. My next post will discuss those views. This post focuses on the issues raised in the case. The bottom line is straightforward: make sure to claim the commercial compound for the primary use.

Removing Inventors Post-Grant

Segatoys Co., Ltd. v. Canada (Attorney General) 2013 FC 98 O’Keefe J

            2,547,539 T-1472-12, Date: January 30, 2013

Somehow the Segatoys decision escaped my notice last week, even though I had been staring straight at it when looking at FC website. (Alan Macek’s useful daily IP update brought it to my attention.)

Segatoys was an uncontested application by Segatoys for an order to replace the named inventors on a granted patent by removing the two listed inventors, who had worked on the appearance of the final product without contributing to the inventive concept, and adding the two real inventors. It was uncontested that the error was inadvertent.

In Micromass 2006 FC 117 Layden-Stevenson J held that inventorship of a patent cannot be changed under s 8, which allows the Commissioner to make changes, as that relates only to clerical errors. Prior to grant, the change can be made under s 31(3), (4), which allow the Commissioner to remove or join an applicant to a pending application, but after grant, such a chance can only be made under s 52, which gives the Federal Court broad powers to rectify matters relating to title. Subsequently, in Plasti-Fab 2010 FC 172, O'Keefe J followed Micromass, and held further that when considering an application under s 52 to add an inventor to a granted patent, the Court will engage the test set out under s 31(4) that would be applied by the Commissioner in adding an applicant prior to grant. In Segatoys, O’Keefe J, in a straightforward extension of Plasti-Fab, held that when considering an application under s 52 to remove an inventor, the Court will engage the test set out under s 31(3) that would be applied by the Commissioner in removing an applicant prior to grant.

Apart from this, the decision suggests that the Court will try not to place unnecessary burdens on the applicant in this type of uncontested motion, where, as O’Keefe J noted “nothing suggests that third party rights will be affected” [26]. In particular, the facts were established by notarized declaration rather than affidavit, as specified in s 31(3) of the Act, but O’Keefe J held that this was adequate, as “the declarations thus fulfill the same function as an affidavit and it would be overly formalistic to reject them on the basis of their labelling” [18]

Motion for Default Judgment Must Be Supported by Affidavit Evidence

The only decision patent decision released this week by the Federal Courts was Monsanto Canada Inc v Verdegem 2013 FC 50. I had not intended to blog on it, as it is procedural, and so brief that it would be as fast to read the decision as to read this blog post. But since nothing else of interest was released, I will simply note that Verdegem was a motion for default judgment, which, under Rule 210(3) “shall be supported by affidavit evidence.” The plaintiffs did not provide any affidavit evidence directed to the substance of the claim. However, they had served a Request to Admit under Rule 255, which had not been answered. The plaintiffs argued that the unanswered Request to Admit sufficiently supported the allegations in the Statement of Claim even in the absence of an affidavit. Hughes J disagreed. He held that “such a Request cannot be a substitute for affidavit evidence required on a motion for default judgment.” Accordingly, he dismissed the motion for default judgment “without prejudice to a further motion based on proper affidavit evidence.”

“Obvious to Try” Not Appropriate on the Facts in Wenzel

Wenzel Downhole Tools Ltd v National-Oilwell Canada Ltd 2012 FCA 333 Gauthier JA: Nadon JA; Mainville JA concurring in a separate opinion aff’g 2011 FC 1323 Snider J

As described in my post on the anticipation aspect of the FCA decision, this litigation involved a bearing assembly for use in downhole drilling motors in oil and gas wells. Snider J held that the invention was obvious, invoking an “obvious to try” analysis. I suggested in my post on that aspect of her decision that it was not clear why Snider J felt an obvious to try analysis was warranted, and despite her reference to that doctrine, it did not seem to make any difference to her reasoning. The FCA has taken the same view of this aspect of her decision. While noting that the “obvious to try” approach might in principle be applicable in a mechanical field, depending on the facts of the case [95], the Court, unanimously on this point [108], held that “it was not appropriate to refer to the obvious to try approach in this case” [100]. The FCA noted that the mere fact that the bearing assemblies were tested before use did not mean the field was one in which advances are won by experimentation [99]. Nonetheless, “despite her reference to the ‘obvious to try’ approach, the Judge undertook a careful and objective analysis of the relevant factors referred to in Sanofi,” [106] in coming to her conclusion, which was supported by the evidence [103]. Consequently the FCA affirmed Snider J’s holding that the invention was obvious.

Withdrawal of an NOA Normally Renders Application Moot

Eli Lilly Canada Inc v Teva Canada Ltd / pemetrexed (NOC) 2013 FC 28 Barnes J

            injectable pemetrexed disodium – Altima – 1,340,794

Lilly sought an order of prohibition in response to Teva’s NOA related to injectable pemetrexed disodium. Teva failed to file evidence in support of its allegation of invalidity, and subsequently withdrew its NOA. The question was whether an order of prohibition should be granted (Lilly’s position), or whether the application should be dismissed as moot (Teva’s position).

Barnes J held that the application should be dismissed for mootness. He acknowledged that it would be an abuse of process for Teva to withdraw its application solely to overcome its failure to file evidence, but he noted that there was no clear evidence as to what motivated Teva’s withdrawal in this case [10], and while “this Court could issue an Order of prohibition in circumstances similar to these. . . it is [generally] preferable to deal with abuse of process concerns as and when they arise” [13]. He noted that “[t]he withdrawal of a NOA renders the second person’s submission to the Minister for a NOC non-compliant,” so there is no risk that the Minister would issue the NOC despite the withdrawal if an order of prohibition were not granted. In response to Lilly’s concern about potential exposure to s 8 damages if a subsequent NOA were successfully filed, avoiding abuse of process concerns, he noted that the Court would be mindful of its obligations under subsection 8(4) and 8(5) [11]. Subsection 8(5) in particular provides that the Court may take account of all relevant matters, “including any conduct of the first or second person which contributed to delay the disposition of the application.” This implies that if the circumstances warranted, any s 8 damages would be assessed from the time of the filing of the second NOA.

Split FCA Affirms That Enantiomers Are Per Se Ineligible for Data Protection

Takeda Canada Inc. v. Canada (Health) / DEXILANT 2013 FCA 13 Dawson JA: Pelletier JA; Stratas JA dissenting, aff’g 2011 FC 1444 Near J (blogged here)

            dexlansoprazole – DEXILANT

It is now trite law that legislation is to be interpreted “as a harmonious whole,” in light of its text, context and purpose: Canada Trustco 2005 SCC 54 [10]. But as Sullivan on the Construction of Statutes, points out (5th ed at 3):

In an easy case textual meaning, legislative intent and relevant norms all support a single interpretation. In hard cases, however, these dimensions are vague or obscure and point in different directions. In the hardest cases, the textual meaning seems plain, but cogent evidence of legislative intent (actual or presumed) makes the plain meaning unacceptable.

Takeda / DEXILANT presents a “hard case” in Sullivan’s sense, if perhaps not “the hardest case,” and the panel has split on the interpretation of the definition of “innovative drug” in the Data Protection Regulations. The majority held that enantiomers, along with salts, esters, solvates and polymorphs, are per se ineligible for protection under the Regulations, regardless of the effort necessary to originate the regulatory approval data.

No Vested Right to an NOC When Health and Safety is in Issue

Apotex Inc v Canada / omeprazole 2012 FCA 322 Dawson JA: Sharlow, Trudel JJA aff’g 2011 FC 1308 Barnes J (blogged here)

            omeprazole magnesium tablets

In March 2003 the Therapeutic Products Directorate advised Apotex that the examination of Apo-Omeprazole had been completed but Apotex’s application for a NOC was on patent hold. In the fall of 2009, while the application was still on patent hold, the TPD revoked the approval status on the basis that the bioequivalence study filed by Apotex with its ANDS had not been appropriately conducted. The TPD refused to reconsider this decision (for a review of the facts see 2010 FC 1310, [3], a motion to strike on this application). Apotex challenged the TPD’s decisions by way of an application. Barnes J dismissed the application as untimely under the Federal Courts Act s 18.1(2), and he held that time should not be extended. On the only substantive point that was discussed, Barnes J held that there can be no vested right to an NOC. The FCA has now affirmed the decision of Barnes J. Again, the important substantive point was whether Apotex had a vested right to an NOC. The issue was fully argued [21], and therefore, like Barnes J, the FCA gave full consideration to the point, notwithstanding its conclusion that the motion should be dismissed as being out of time.

The SCC Did Not Hold the Viagra Patent to Be Void in Rem

Apotex v Pfizer / sildenafil 2012 FC 1339 Zinn J
             2,163,446 / VIAGRA

In this decision in an impeachment action brought by Apotex, Zinn J granted a motion for summary judgment that the ‘446 patent is invalid, on the basis that the SCC had declared the ‘446 patent to be invalid with in rem effect in its Pfizer / sildenafil 2012 SCC 60 decision. (This decision was released in late November and posted by Alan Macek on IP Practice. I missed it as I was away on vacation at the time. It is still not posted on the FC website.) It seems to have been accepted by Pfizer that the SCC did hold the ‘446 patent invalid with in rem effect when it held at [91] that “Patent 2,163,446 is void.” So in this motion, Pfizer argued that the SCC exceeded its jurisdiction, and has filed a motion seeking amendment of the judgment, or for a rehearing on the issue of remedy [10]. Pfizer also argued that “as a consequence of the Judgment of the Supreme Court declaring the ‘446 Patent void,” the impeachment action is moot [15]. Pfzier also argued that the questions at issue were questions of mixed fact and law, and so were not binding [32]. All of these arguments take it for granted that the SCC held that patent void with in rem effect. I do not agree. The question is, what did the SCC mean when it said the patent is “void”? Did it mean “void in rem,” or “void inter partes”? In my view, it is very clear that the SCC intended the latter.

Disgorgement of Profits in NOC S 8 Claim Not Available in Ontario

Apotex Inc v Abbott Laboratories Ltd / lansoprazole 2013 ONSC 356 Quigley J

The FCA has held definitively that disgorgement of the patentee’s profits is not available as a remedy in a claim under s 8 of the NOC Regulations: Apotex Inc v Eli Lilly Canada Inc 2011 FCA 358 blogged here.  Apotex hoped to have better luck by bringing an action in the Ontario courts. That hope was kept alive when the Ontario courts dismissed a motion to strike Apotex’s claim is this case: Apotex v Abbott Labs / lansoprazole 2010 ONSC 6909, Whitaker J blogged here aff’d 2011 ONSC 3988 (Div. Ct.). Swinton J. But that hope has been now dashed by Quigley J’s long and thorough summary judgment decision on the merits, dismissing Apotex’s claim for disgorgement of Abbott and Takeda’s profits from the sale of lansoprazole [2], [212].