Section 8 Bifurcation Refused

Teva Canada ltd v Janssen Inc 2016 FC 318 Diner J
             bortezomib / VELCADE

In this decision Diner J upheld the case management Prothonotary’s order refusing to bifurcate the plaintiff’s s 8 action into liability and damages phases, and also refusing to bifurcate the s 8 action from the infringement counterclaim. Diner J held that the Prothonotary had considered the appropriate factors [9] and there was no basis for interfering with a discretionary order [10]. Without the Prothonotary’s order, it is hard to comment further.

Improper Priority Claim is Not a Material Misrepresentation

Uponor AB v Heatlink Group Inc 2016 FC 320 Manson J

2,232,376

I believe this is Manson J’s first patent decision since being appointed to the Federal Court. While the case spanned many grounds of validity and infringement, in the end it turned on its facts. The most interesting legal point relates to s 53 of the Act, but I also have a few miscellaneous comments on other aspects of the decision.

PEX is cross-linked polyethylene. It is used primarily for pipe and tubing (such as the new PEX water-pipes that I had just had installed in place of copper in my on-going kitchen renovation). The polyethylene used in making PEX is cross-linked by heating in the presence of an additive (such as peroxide) [77]. The ‘376 patent relates to a method of heating polyethylene (for the purpose of cross-linking, though that is not specified in the broadest claims), by heating it with infrared (IR) lamps “wherein wave lengths corresponding to the absorption peaks for the [polyethylene] material in respect of infrared radiation, have been eliminated in the infrared radiation irradiating the polymer material” [22, Claim 1]. Polyethylene has two absorption peaks, at 3.2 to 3.6 μm and 6.6 to 6.8 μm [20]. If it is heated by IR which includes those wavelengths, the surface layer of the polyethylene will absorb most of the radiation resulting in uneven heating and therefore uneven cross-linking. By excluding those wavelengths, the radiation will permeate though the entire thickness, giving more uniform cross-linking [21].

The main difficulty for the patentee is that the prior art, in particular the widely consulted “IR Handbook” [207-13] and US patent 4,234,624 [222-23] disclosed the idea of using short-wavelength IR (1.2 μm and 0.76 to 4 μm, respectively), to heat polyethylene for cross-linking. The ‘376 taught two methods of eliminating the undesired wavelengths, namely by filtering them out with a filter that blocks those wavelengths [38], or by using an IR source with a wavelength at 1.2 μm [39]. Thus it is clear that the term “eliminated” encompassed using a low wavelength source. Consequently, most of the broad claims were held to be anticipated or obvious [298]. Some of the claims specified that the undesired wavelengths were to be filtered out, but the patent did not disclose any suitable filter, so many more claims were invalidated. However, a few claims covering what the patent described as a preferred embodiment were held to be valid [251] and infringed [297]. These claims added the element of feeding the extrusion vertically through the IR lamps; this produces a more uniform pipe as it reduces distortions in the hot plastic due to gravity.

No New Cases for the Week of 14 March

No new patent / NOC / data protection cases were released for the week of 14 March 2016.

Transitional Troubles with Perfect Match Listing Requirement

Gilead Sciences Inc v Apotex Inc / (NOC) 2016 FC 231 Heneghan J
            2,261,619 / tenofovir (PMPA) / TRUVADA

Section 4 of the PM(NOC) Regulations governs whether a patent is eligible for listing on the patent register. In Gilead / COMPLERA 2012 FCA 254 (blogged here) and ViiV Healthcare 2015 FCA 93 (here) the FCA interpreted s 4 as requiring a perfect match between the patent claims and the medicinal ingredients in the approved drug – each of the medical ingredients in the drug would have to be specifically named in the a claim – before the patent can be listed. So, if a drug contained two medicinal ingredients, and the patent claimed one of those ingredients but not the other, the patent could not be listed. On 19 June 2015, shortly after Viiv was decided, the Regulations were amended by SOR/2015-169, to provide in s 4(2.1) that a patent is eligible for listing even if the drug contains more medicinal ingredients than are listed in the patent. The express intent of the amendment as set out in the accompanying RIAS was to reverse Gilead / COMPLERA and Viiv. To complicate matters, just before the amendment came into force, the FCA released its decision in Eli Lilly / TRIFEXIS 2015 FCA 166, which distinguished Gilead / COMPLERA, albeit not very convincingly, in my view, and allowed a patent to be listed even though the claims did not perfectly match the medicinal ingredients.

The overarching issue in this case is whether the ‘619 patent is eligible for listing against TRUVADA [1]. (While this is an NOC proceeding, a patent that is not eligible for listing need not be addressed pursuant to paragraph 6(5)(a) of the Regulations.) TRUVADA has two medicinal ingredients and the ‘619 patent did not claim one of them [117]. Thus, it was common ground that the ‘619 patent was not eligible for listing if Gilead / COMPLERA and Viiv stated the applicable law.

There were two sub-issues. First, did the amended Regulations apply? If not, did Eli Lilly / TRIFEXIS reverse Gilead / COMPLERA and Viiv?

On the first issue, the transitional provisions provide that the amended Regulations would apply to “any ongoing application. . .that are initiated during the period that begins on May 2, 2015 and ends on the day on which this section comes into force [June 19, 2015]” [19]. Heneghan J held, I think rightly, that the “plain and ordinary meaning” of those words “is that the Unamended Regulations apply in respect of any motion that was filed before May 2, 2015.” Since Apotex filed its Notice of Motion on March 6, 2015, it followed that unamended Regulations applied [113]. While Gilead raised a variety of counter-arguments, the strongest – or at least the most interesting – is that the RIAS expressly stated that the amendments “would restore the intent of the original and amended PM(NOC) Regulations, and clarify ambiguities regarding the listing requirements.” In Merck Frosst v Apotex / norfloxacin 2011 FCA 329, discussed here the FCA held that a clarifying provision is not retroactive and “is not evidence of a change of approach by legislators, but rather a desire to ensure that earlier laws ‘reflect the principles [legislators] had in mind and communicated when the law was passed’” [50]. The RIAS echoes this language, saying that the amendments were intended to “capture the original policy intent of the listing requirements.” If the amendments were merely clarifying, then they should apply regardless of when the motion was filed, as the law should not be taken to have changed. The difficulty with this argument is that if it was true that the amendments were merely clarifying, the transitional provision itself would be redundant and meaningless. Evidently the legislators recognized that while the amendments were restoring the original intent of the Regulations, they were changing the law which was set out in Gilead / COMPLERA and Viiv.

On the next issue, Gilead argued that even if the amended Regulations did not apply, the effect of Eli Lilly / TRIFEXIS was to reverse the earlier FCA cases. I have a great deal of sympathy for this view: my post on TRIFEXIS was titled “No More Perfect Match Requirement for Patent Register Listing.” But Heneghan J held that TRIFEXIS “made a distinction on the facts.” That is very reasonable view of the majority decision – indeed, it is how the majority in TRIFEXIS characterized its own decision: “this examination of the facts and holdings in Gilead FC and Gilead FCA distinguishes these decisions from the present appeal” [88]. I must add that Dawson JA in her concurrence could not see the basis for the distinction, and neither can I. And while Heneghan J said “I agree with Apotex that the three decisions can be read consistently” [112], she did not explain how that could be done. Nonetheless, Heneghan J was undoubtedly entitled to take the majority’s explanation of its decision at face value. The difficulty, as I said in my post on TRIFEXIS, is that “[t]he main justification for adhering to precedent is to provide certainty. But an unfounded distinction does the opposite; we now have two irreconcilable decisions that are both formally good law.” The result in any given case will turn on which of the two lines of precedent the subsequent court chooses to follow. Fortunately, the conflict between these FCA cases will be moot in future cases in which the amended Regulations apply.

Barnes J Disagrees with Rennie J as to Whether Enhanced Disclosure Requirement Applies Only in New Use Cases

Eli Lilly Canada Inc v Hospira Healthcare Corp (NOC) 2016 FC 47 Barnes J
            1,340,794 / pemetrexed / ALIMTA

In this decision Barnes J held Takeda’s ‘794 patent (licensed by Lilly [2]) covering pemetrexed to be invalid for lack of sound prediction of utility. The most interesting legal point is that Barnes J rejected Rennie J’s view, expressed in Apotex / esomeprazole 2014 FC 638, that the heightened disclosure requirement for sound prediction applies only in new use cases.

The ‘794 patent relates to a class of compounds including pemetrexed, which, according to the patent “are useful as anti-tumor agents” [31]. All the claims at issue are compound claims. Pemetrexed is not specifically claimed or disclosed, but it falls within Claims 7 and 9 [12], which claim a class of compounds. Only some compounds falling within those claims had been tested as of the filing date, and the key question was therefore whether “the person of skill in 1989 [the filing date] could have soundly predicted the promised utility of the untested compounds falling within Claims 7 and 9 from the test data reported in the Patent and from what was known in the art” [6]. Whether pemetrexed itself was useful was not even discussed, and even if established would have been relevant, at most, as one more data point in a prediction of utility of the untested compounds.

The parties had the usual dispute over the promise of the patent, with Hospira arguing for an elevated promise and Lilly for a much lower one [25]. Barnes J held that the promise was of “in vivo activity in relation to abnormal tissue” [33], which fell in between the position of the parties. The exact basis for his construction of the promise is not entirely clear. Barnes J found the opinions of the experts to be “largely unhelpful” [26], and he emphasized the statement in the patent that the invention relates to “which are useful as anti-tumor agents,” as well as mentioning similar references to “excellent” or “remarkable” antitumor effect [31], [32]. This is consistent with the trend that any phrase stating that the compounds “are useful”, without a qualifier, will be taken as promise, but it is not clear from his brief discussion why Barnes J construed “anti-tumor agent” to mean in vivo activity (though he did note some expert evidence to that effect [33]). The passages in the patent describing “excellent” or “remarkable” effects that were evidently being referenced by Barnes J mixed specific references to in vitro effect with general statements regarding in vivo effect. So, the specification stated that the compounds “have toxicities highly specific to tumor cells and excellent antitumor effects” (p2),; they “show excellent antitumor effects in mouse tumor cell strains (. . .) and human tumor cell strains (...), decrease the tumors carried by warm-blooded animals . . . and prolong the life-span of tumor-carrying warm-blooded animals” (p25); they “are excellent in inhibition of cell growth of [specified cell lines], while they do not exert a toxicity against [specified cell line]. The compounds (I) of this invention and the salts thereof are of low toxicity, having remarkable antitumor effect. Therefore, the preparations containing the compound (I) or salts thereof can be employed as antitumor agents for the treatment of tumors in warm-blooded animals, particularly mammals. . . .” (p27). The examples of the effects disclosed in the patent all referred to cell lines.

While the references to treatment of tumours in mammals support the view that the patent promised in vivo activity, recall that in Plavix 2013 FCA 186 (here), the FCA encouraged a restrained approach to construction of the promise of the patent, requiring that a promise be explicit [49], [50] and cautioned against ignoring “the distinction drawn in the jurisprudence between the potential use of an invention and an explicit promise to achieve a specific result is considered.” [67]. In Plavix the FCA held that the statement in the ‘777 patent that “the medicine of the invention can be usefully administered in the treatment and prevention of platelet disorders due to extracorporeal blood circuits or the consequence of complications in atheroma,” relied on by the trial judge [163] as indicating an explicit promise of use in humans, was no more than an indication of the “potential use in humans” which was “foreshadowed” in the patent [67]. It strikes me that it is at least arguable that the promise of the ‘794 patent could have been construed similarly, with the specific references to in vitro activity constituting the promise, and the more general references to in vivo treatment cell being foreshadowing of the potential use in humans. Barnes J’s construction of the promise in this case illustrates two points. First, while Plavix seemed to be a signal from the FCA that a more restrained approach should be taken to construing the promise of the patent, the reality seems to be that Plavix has had little effect; as I put it in the title of an earlier post, the “Promise of the Patent is Alive and Well Post-Plavix FCA.” The very brevity of Barnes J’s analysis of the promise emphasizes this point. Despite Plavix, he did not consider it necessary to explicitly consider the possibility that references to in vivo use were merely references to a potential use. The second point is the difficulty in predicting how the courts will construe the promise of the patent, in light of the variety of language touching on utility that is typically found in the disclosure. In this case, as noted above, the court considered that neither party’s submissions were even helpful.

In any event, in the end, Barnes J expressly rejected Lilly’s position that “any measurable in vitro antifolate activity would satisfy the promise of the Patent” [35], which he characterized as “effectively read[ing] the promise down to a ‘scintilla’ of utility” [25], so that Barnes J clearly held utility should be measured against a higher standard of utility than the scintilla that would be required in the absence of an express promise (though it is not clear that Lilly’s position really did amount to asserting a mere scintilla of utility as contrasted with a low promised utility).

On the main legal point of interest, recall that in Apotex / esomeprazole Rennie J, drawing in part of Gauthier J’s concurring remarks in Plavix 2013 FCA 186, held that the effect of the SCC’s obiter remarks in Viagra 2012 SCC 60 was to overturn previous FCA decisions, such as Raloxifene 2009 FCA 97 aff’g 2008 FC 142, which had held that there is a heightened disclosure requirement in all cases where utility is established by sound prediction, such that the factual basis for that prediction and the line of reasoning must be disclosed in the patent itself [142]. On Rennie J's view, the heightened disclosure requirement is now “limited to the context of ‘new use’ patents, assuming such a utility disclosure requirement exists at all” [141]. Barnes J disagreed, saying:

[48] While I have some sympathy for Justice Rennie's and Justice Gauthier's views, I am not persuaded that the state of the law on this issue has changed. In particular, it would take something more than Justice LeBel's apparent reservations [in Viagra] to displace the requirement for disclosure described by Justice Binnie in [AZT 2002 SCC 77] and, later, as clearly endorsed by the Federal Court of Appeal in [Raloxifene 2009 FCA 97], in [Olanzapine (No 1) 2010 FCA 197] and in many decisions of this Court.

Banres J therefore held that “where utility is based on a sound prediction, there remains an obligation to disclose in the patent specification the factual basis and a sound line of reasoning supporting the prediction” [49] I can’t agree with Barnes J’s suggestion that the cryptic comments of Binnie J in AZT established a requirement to set out the factual basis for a sound prediction in the patent itself, but the FCA decisions cited by Barnes J certainly did. And while Rennie J’s interpretation of AZT is very interesting in its own right, Barnes J makes a fair point in doubting whether the effect of Justice LeBel’s comments in Viagra was to overrule the FCA’s line of authority on this point. With both Rennie JA and Gauthier JA now on the FCA, this issue will no doubt be authoritatively decided at that level in due course.

Having accepted the established FCA case law, Barnes J held that Lilly could not rely on in house testing or a line of reasoning not found in the patent in order to establish a sound prediction of antitumour activity [51]. He noted that Lilly’s expert “based his opinion of a sound prediction of utility substantially on data that was not disclosed in the Patent” [53], and also that the patent “provides no line of reasoning from which the person of skill could draw a prima facia reasonable inference that the thousands of untested claimed compounds would be useful as antitumor agents in vivo or even in vitro” [51], or that would allow an inference of in vivo activity to be extrapolated from the reported in vitro data [52]. These “fundamental flaws in Lilly’s case” [54] would have sufficed to dispose of the case on the law as set out by Barnes J, but he nonetheless went on to address the evidence relied on by Lilly [54]. After reviewing the evidence of Lilly’s main expert on utility, including evidence not found in the patent (eg [65]), he concluded that “I do not agree with Lilly that a person of skill would have made a prediction of utility for the thousands of untested compounds included in the asserted claims. This is equally the case if one accepts Lilly’s assertion of the promise of the subject claims as being merely some antifolate activity in some cell line in vitro” [116] (and see similarly [108]). This indicates that Barnes J would have reached the conclusion that the patent is invalid even if he assessed utility against the standard proposed by Lilly and in light of all the evidence presented by Lilly.