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.”