Markman Hearings Come to Canada?

Viiv Healthcare Company v Gilead Sciences Canada, Inc 2020 FC 486 Manson J
            2,606,282 / bictegravir / BIKTARVY

The most significant aspect of this decision is the simple fact that Manson J granted a contested motion for a summary trial on a claim construction issue – essentially a Canadian version of a Markman hearing. ViiV had brought an action alleging that its 282 patent was infringed by Gilead’s bictegravir product, sold as BIKTARVY. Gilead responded with a motion for a summary trial, which Manson J granted despite ViiV’s objections and attempts to “derail” it [18]. This follows on last fall’s decision in Canmar Foods v TA Foods 2019 FC 1233 (see here and here), in which Manson J explained that for a decade after the FCA restricted the availability of summary trial in MacNeil Estate 2004 FCA 50, “summary judgment as a just, efficient and expeditious means to resolve disputes on a proportionate basis was lost” [45], until Hryniak v Mauldin, 2014 SCC 7 resulted in “a culture shift” that “opened the door for a more reasoned approach to the use of summary judgment motions” [46]. (The only other recent summary trial that I’m aware of is Cascade v Kinshofer 2016 FC 1117, but it was on consent.) It will be interesting to see whether other FC judges agree with Manson J’s view of the effect of Hryniak, and, when an appeal inevitably comes, whether the FCA agrees as well. (I must say it seems like a good idea to me, but procedure is not my area of expertise.) Manson J’s specific reasons for granting the motion on the facts of this case ([11]-[18]), will be of interest in future motions of this type, but since the discussion is brief and I don’t have anything to add, I won’t go through it.

Recourse to the disclosure in claim construction
The key substantive issue was the construction of a single claim term. The most interesting substantive point is that Manson J, after an extensive review of the case law, had recourse to the disclosure to construe the contested claim term, even though it appeared on its face “to be a clear and unambiguous term” [128]

All the claims at issue (Claim 1 is exemplary) [88], are claims to a class of compounds comprising Ring A.

Ring A is defined in the claim as an “optionally substituted heterocycle” [102]. The key issue — where the shoe pinches — is whether Ring A includes only fused and spiro rings, or also a bridged bicyclic ring, as is found in bictegravir.
Much of Manson J’s discussion concerned the proper approach to claim construction. As Manson J noted, the “[t]he law is clear that recourse to the disclosure is improper to vary the scope or ambit of the claims” [126], [136]. However, it is said that while recourse to the disclosure is “permissible to assist in understanding the terms used in the claims,” it is “unnecessary where the words of the claim are plain and unambiguous,” Dableh (1996) 68 CPR (3d) 129 (FCA) at 144 [126].

The tricky question is whether it is permissible to consult the specification as a whole only when the claims are ambiguous. What if the words of the claim appear to be clear when read in isolation, but when read in the context of the disclosure as a whole, it is apparent that they mean something different from what they “clearly” mean when read in isolation? Is it necessary to make a determination that the claims are ambiguous before recourse to the disclosure is permissible? A series of decisions have wrestled with this question.

I won’t go through Manson J’s review of the case law in detail, but I would highlight his conclusion:

[66] The common thread in all of these cases is that the court is to construe the claims through the eyes of the POSITA in light of their CGK at the relevant date. Apart from the patent specification, the only evidence the Court should consider to inform its analysis of the claims is evidence of how the POSITA would understand the claims in light of his or her relevant CGK in the context of the specification as a whole (Bombardier FCA [2018 FCA 172] at para 24).

In other words, the claims must be read in the context of the specification because the claims are part of the specification. This strikes me as clearly correct; I won’t say more as I’ve discussed the principles at length in other posts.

Manson J’s application of these principles to the facts is clear:

[128] While “optionally substituted heterocycle” as used in claim 1 appears on its face to be a clear and unambiguous term, I accept that recourse to the disclosure is necessary to understand the meaning given to these words by the inventors, and the intended scope of this claim language.

This is a clear holding, applied on the facts, that it is permissible to have recourse to the disclosure to understand the claims, even if the claims appear to be clear when read in isolation.

Essentiality
I’ll conclude with a brief comment on the essentiality analysis. ViiV argued that if Manson J construed Ring A as being limited to spiro and fused structures only, it was necessary for the Court to go on to consider whether the bridged ring was an obvious variant. Manson J rejected this, saying

[167] In light of ViiV’s admission that Ring A, as an “optionally substituted heterocycle,” is an essential feature of the invention, the Court does not accept that it should now look at a variant of this essential feature. The Free World Trust [2000 SCC 66]variant analysis focuses on a claimed element of an invention, not some sub-element or feature of the claimed element.

I’m not sure I agree with this. It is true that Free World Trust focused on what it described as “elements” but it’s not clear to me that the analysis turns on what particular aspect of the claim is identified as an “element.” The term “element” never even appears in earlier cases, such as JK Smit [1940] SCR 279 or Birmingham Sound [1956] RPC 232 (CA), that the SCC inWhirlpool 2000 SCC 67 [45], [47] identified as exemplifying the analysis. In any event, the point was not determinative, as Manson J went on to hold that in any event, ViiV had not met its burden of establishing that it would have been obvious to the POSITA at the publication date that bridged bicyclic Ring A structures would have no material effect on how the invention works” [168].

An Active Ingredient Is a Medicinal Ingredient

Glaxosmithkline Biologicals S.A. v. Canada (Health) 2020 FC 397 Barnes J
            2,600,905 / SHINGRIX

I believe this is the first decision interpreting the provisions of the Patent Act relating to the Certificate of Supplementary Protection (CSP) (s 104ff), which came into force in Sept of 2017 in order to meet Canada’s commitment under Art 20.27 of CETA [18]. Section s 106(c) of the Act, in combination with s 3(2) of the CSP Regulations, provides that a CSP may be only be granted for a patent that “contains a claim for the medicinal ingredient or combination of all the medicinal ingredients contained in a drug.” GSK sought a CSP in respect of the 905 Patent and the drug SHINGRIX. Claim 1 of the 905 patent is to a composition consisting of a truncated antigen and an adjuvant. The Minister refused the CSP on the basis that (i) an adjuvant is not a medicinal ingredient; and (ii) a CSP may only be granted for a patent directed solely to a medicinal ingredient or ingredients.

Both the Minister’s decision and that of Barnes J focused on the first point. Barnes J held that a medicinal ingredient means a biologically active ingredient; he considered the Minister’s position, that a medicinal ingredient must have some independent biological activity, even if only to a negligible extent, to be unreasonable. Because Barnes J held that an adjuvant is a medicinal ingredient, and because the 095 patent was directed solely to the antigen and an adjuvant, it was unnecessary for Barnes J to consider whether a CSP may only be granted for a patent directed solely to a medicinal ingredient. This issue will surely be raised in future cases, and Barnes J’s remarks on the point, though very brief, are worth noting.

Barnes J’s decision makes it clear that the Minister’s position on the definition of “medicinal ingredient” was entirely divorced from the text of the Act and CSP Regulations (as well as being unsupported by purposive considerations). I will suggest that the same appears to be true in respect of the second issue. I get the distinct impression that the Minister’s policy was developed by people who thought they already knew what the Act said, and so didn’t bother to actually read it, either before or after developing the policy.

The “Would Have” Branch of the Non-Infringing Alternative Analysis

Apotex Inc v ADIR 2020 FCA 60 Mactavish JA: Webb, Near JJA aff’g 2018 FC 346 Gagné J
            1,341,196 / perindopril / COVERSYL

In this decision the FCA affirmed Gagné J’s holding that Apotex had not established a non-infringing alternative defence in respect of an accounting of profits. I was very critical of Gagné J’s holding in my post on her decision, on the view that what I called “Dr Sherman’s idiosyncratic non-economic motivations,” should not have been taken into account, as doing so meant that the amount awarded as an accounting would not reflect the true economic value of the invention. On reading the FCA decision, I now see that my criticism was not entirely well-founded. On the one hand, the FCA decision reinforces the view that the “would have” branch of the NIA test is and should be focused on economic considerations; but on the other hand, I now see that the motivations taken into account by Gagné J actually were economic in nature.

The perindopril litigation started with 2008 FC 825 aff’d 2009 FCA 222, holding that ADIR’s 196 patent was valid and infringed by Apotex. ADIR elected an accounting, and the profits portion of the action has gone back and forth between the FC and FCA a couple of times. Gagné J’s initial decision refusing to consider the availability of a non-infringing alternative was decided just before the NIA defence was accepted by the FCA in Lovastatin Damages 2015 FCA 171 and Effexor / Venlafaxine 2016 FCA 161: see Perindopril Profits #1 2015 FC 721 rev’d in part and remanded by Perindopril Profits #1 Appeal 2017 FCA 23, discussed here. The remand gave rise to the decision under appeal, which we might as well call Perindopril Profits #2, making this FCA decision Perindopril Profits #2 Appeal.

Stay of Judgment Pending Appeal Granted

Evolution Technologies Inc v Human Care Canada Inc 2019 FCA 11 Webb JA granting motion for stay of judgment of 2018 FC 1304 Elliott J

At trial, Elliott J held that Human Care’s 392 patent was valid and infringed by Evolution Tech: see here. In this decision from January of 2019, only recently posted to the FCA website, Evolution sought a stay pending appeal. The applicable test is the same American Cyanamid test used in interlocutory injunctions, requiring a serious question to be tried on the merits, whether the applicant would suffer irreparable harm and and assessment of the balance of convenience [21]. The serious question threshold is low and was satisfied in this case [24].

Interlocutory injunctions are almost never granted by the FC in patent matters because of the very high threshold for establishing irreparable harm that is applied by the Federal Courts. However, irreparable harm was made out in the unusual circumstances of this stay application, for two reasons. First, Evolution established on the balance of probabilities it did not have enough money to pay the major part of the judgment and would be put out of business if required to pay [29]. This is well-recognized as perhaps the clearest type of irreparable harm: [29]. Second, normally a party seeking an interlocutory injunction will undertake to compensate the other party for any losses suffered as a result of the injunction if the injunction turned out to be ‘wrongly’ granted, in the sense that the other party ultimately prevailed on the merits. In this case, however, Human Care declined to give an undertaking to pay any amount to Evolution for any loss sustained by Evolution if the stay was not granted and Evolution was ultimately successful in its appeal [31]. Without such an undertaking, Evolution would be entirely uncompensated for its losses suffered as a result of being enjoined from selling the goods in question prior to the appeal decision, and that would clearly be a form of irreparable harm. The balance of convenience analysis followed largely from the irreparable harm issues. It is worth noting that Webb JA only stayed payment of the largest amount ordered, relating to the accounting of profits itself; the award of reasonable compensation, pre-judgment interest and costs were not stayed.

Human Care also raised two variants of an unclean hands argument, which, if successful would have meant that the stay would be denied without the need to consider the Cyanamid test. First, Human Care argued that Evolution had breached court orders by previously failing to disclose the financial documents which it has now tendered as part of its motion record [10], and so the documents should be inadmissible, following White v E B F Mfg 2005 NSCA 103 . Webb JA rejected this, and distinguished White, on the basis that a breach of the court orders had not been established [15]. Human Care also argued that Evolution had not fully disclosed its assets [16]. While Webb JA considered that Evolution had not been entirely forthcoming, this fault was not sufficiently related to the question of whether a stay should be granted [20].

In the end, Human Care’s refusal to give an undertaking was wise, as Evolution’s appeal was ultimately successful; see 2019 FCA 209, blogged here.

Market Share Expert Not Required for Market Share Damages Analysis

DNOW Canada ULC v Estate Grenke 2020 FCA 61 Dawson JA; Rennie, Rivoalen JJA var’g 2018 FC 564 Phelan J
            2,095,937 / stuffing box

It has been a decade now since Phelan J held Grenke’s 937 patent to be valid and infringed in Weatherford v Corlac 2010 FC 602 — so long that the parties or their names have almost all changed for one reason or another — and this is the fourth (dare I say final?) trip to the FCA. The decision now under appeal, 2018 FC 564 (here), is Phelan J’s award of $8 million in damages [9]-[10]. The defendants alleged a variety of errors by Phelan J in his assessment of the facts. While the FCA noted in couple of places that Phelan J’s reasons might have been more detailed [61], [113], the Court rejected most of these challenges on a deferential standard of review [19]-[20]. No new law was applied (the decision starts with a handy review of damages principles [18]), but there are a couple of points worth mentioning.

The 937 patent relates to an environmentally friendly stuffing box that prevents oil from spilling out of the top of a production oil well. During the relevant period, there were three main manufacturers in this market, including the plaintiffs and the defendants, along with some smaller players [35]. Total sales volume was on the order of a couple of thousand units annually [41]. Phelan J used historical market share as the basis (with adjustments) for assessing lost sales. The FCA affirmed that a market share analysis was appropriate on the facts; this is not a case, such as Alliedsignal 1998 CanLII 7464, with only nine customers in the market, in which a review of the evidence on a customer-by-customer basis would be necessary [68].

The plaintiffs relied on only one witness for the market share analysis [46], and the defendants objected to the witness’ qualifications on the basis that he not qualified as a “market share expert” [48]. (Presumably that means an accountant or economist with expertise in market assessment and modeling.) However, the witness in question was an expert on the industry and its purchasing preferences; he had personal knowledge of product offerings and the merits of available products, and of the market generally, from his long experience as a purchaser in the industry. The FCA held that it was not an error for Phelan J to have relied on this evidence in assessing the market share lost as a result of the infringement [76]-[78].

A final point of interest concerns loss of “convoyed” sales. “Convoyed” products are products that are not themselves protected by the patent, but that are typically sold with, or as a result of, the sale of a patented product [142]. The FCA reaffirmed that “An entity claiming under a patent is ‘entitled to damages assessed upon the sale of non-infringing components when there is a finding of fact that such sale arose from infringing the patented component’ [143] (quoting with approval Beloit v Valmet-Dominion Inc [1997] 3 FC 497 (FCA). However, the FCA stressed that the mere fact that the convoyed goods in question are commonly sold with the infringing goods is not sufficient to establish causation: [153-55]. What is required is “a specific finding based on evidence” that the loss of sales of the convoyed parts was caused by the loss of sales of the infringing products [154]: “‘[s]imply because a non-infringing product appears on the same invoice as a drive is not sufficient to establish causation’” [151] (quoting and agreeing with the appellants’ submission). The FCA was of the view that Phelan J had erred on this point [156], and, after assessing the evidence itself, held that no damages for lost convoyed sales should be awarded [169]. This was the sole point on which the FCA reversed Phelan J.

Blogging Hiatus

I'll be taking a blogging break for a week or two as I try to get my courses set up for online delivery. When I get back, I'll start by catching up with any decisions that I've missed.

Hearsay Evidence Not Enough to Ground Stay Pending Appeal

Western Oilfield Equipment Rentals Ltd v M-I LLC 2020 FCA 3 Nadon JA refusing to stay 2019 FC 1606 O'Reilly J
            2,664,173 / Shaker and Degasser Combination

In this decision, Nadon JA refused Western Oilfield’s motion for a stay pending appeal of 2019 FC 1606, in which O’Reilly J found that Western infringed the 173 patent and had consequently granted an injunction, as well as awarding damages and costs against Western in the vicinity of $5 million [2]. Western moved for a stay on the basis that its assets, covered by security interests, are insufficient to cover the monetary award and that unless a stay is granted, its creditors will enforce their security interests and it will become insolvent [4].

While being put out of business is normally considered a type of irreparable harm sufficient to establish the second branch of the RJR-MacDonald test, [1994] 1 SCR 311 at 341, Nadon JA emphasized that any such harm must be established on the evidence [11-12]. In this case, the main evidence was provided by Western’s controller [13]. She testified that Western did not itself have adequate funds to satisfy the award [16], but the crucial issue was the position of its financiers. She gave evidence that should Western inform its bank of the decision against the it, the likelihood is that the bank will execute its security interests over Western’s assets [17]. She also gave evidence that Western’s venture capital backers would cease funding Western if Western were prevented from earning revenue as a result of the injunction [21].

The difficulty is that all this evidence as to what Western’s financiers would do, was hearsay [22]. Nadon JA held that Western should have produced “an affidavit from their bank outlining its position following the rendering of the judgment and its position in the event that a stay was not granted” [18] and a similar statement from the managing director of the venture capital companies as to “the impact of the Decision on their funding decisions and whether or not a stay of the Decision would lead to a different position on their part” [19]. This information was crucial to his determination regarding irreparable harm [19], and in its absence he was not satisfied that the irreparable harm branch of the RJR-MacDonald test was satisfied [24].

It seems that as of the time of the hearing, Western had not yet informed its bank of the trial decision, apparently out of a concern that had the bank been informed of the Decision, it might, irrespective of the possibility of obtaining a stay, have called in Western’s advance and exercised its security interests [17]. If that concern is well-founded, then this decision puts Western between a rock and a hard place.

Correcting Inventorship Post-Grant

Inguran LLC dba STgenetics v. Canada (Commissioner of Patents) 2020 FC 338 Brown J

2,518,882 / 2,752,218 / 2,752,244 / 2,752,247

This decision concerned an uncontested application to remove six named inventors from several granted patents. Brown J followed Qualcomm 2016 FC 499 (here) in holding that an affidavit from remaining inventors to the effect that they are the sole inventors is not required, so long it is adequately established on the other evidence that the named inventors to be removed are not in fact inventors. The case also illustrates that the power of the FC to correct inventorship is post-grant pursuant to s 52 is broader than the power of the Commissioner to correct inventorship pre-grant pursuant to s 31.

In this case, the original application had twelve named inventors. After a unity of invention objection by CIPO, the application was divided into divisional applications relating separately to electro-mechanical subject-matter and biological subject-matter. All twelve inventors were left on the divisionals, even though the named inventors sought to be removed in this application had not contributed to electro-mechanical subject-matter claimed in the patents at issue. This application sought to remove those non-inventors.

Before a patent is granted, inventors can be removed by the Commissioner pursuant to s 31(3) and added by the Commissioner pursuant to s 31(4). The Commissioner does not have the authority to add or remove inventors after grant: Micromass 2006 FC 117. (The Commissioner can correct some essentially clerical errors under the Patent Rules, including a spelling error in the name of an inventor pursuant to Rule 109 (this was previously authorized by s 8, now repealed).)

Post-grant, grant, inventors may be added or removed on application to the FC pursuant to s 52, which gives the Court broad authority to “order that any entry in the records of the Patent Office relating to the title to a patent be varied or expunged.” A number of decisions by the FC have invoked the test under s 31 in a decision pursuant to s 52, notwithstanding that on its face s 31 applies only to the Commissioner in respect of applications (see here). Presumably this is because s 31 provides more specific guidance regarding changes in inventorship specifically.

There is a bit of a concern regarding this practice, as s 31 is more restrictive than the broad powers granted to the Court by s 52. In particular, s 31(3) regarding removal of non-inventors (ie named inventors who in fact did not contribute to the development of the claimed inventions), specifies that the application may be carried on by the remaining inventors “on satisfying the Commissioner by affidavit” that they are the true inventors. S 31(4), regarding addition, provides that inventors may be added on satisfying the Commissioner that (i) they should be so joined, and (ii) that the omission of the further applicant or applicants had been by inadvertence or mistake and (iii) was not for the purpose of delay. The question is whether these—in particular (ii) and (iii) are all required under s 52 as well.

Brown J agreed with the submission that in an application under s 52 the Court “may apply” the tests set out for the Commissioner of Patents in subsections 31(3) and 31(4) [35], citing various cases. I’d quibble a bit on this point, at least to the extent that “apply” suggests that the test under s 31 is also the strict test under s 52. Section 31 was certainly considered in the cases cited by Brown J, but I’m not sure it was actually adopted as the test under s 52, rather than as identifying relevant considerations. While the application to correct inventorship under s 52 will certainly be granted when the test under s 31 is satisfied, the question is whether it is necessary to satisfy the test under s 31 to correct inventorship under s 52. Brown J’s decision suggests that the answer is no.

First, Brown J noted at [37] that in Imperial Oil 2015 FC 1218 Leblanc J set out two criteria for the removal of named inventors set out by subsection 31(3):

[15] Subsection 31(3) of the Act sets out two criteria for the removal of named inventors:

i. does it appear that one or more of the named inventors have no part in the invention?; and

ii. has an affidavit been provided to satisfy the Court that the remaining inventors are the sole inventors?

However, in this case, two of the six remaining true inventors could not be located [29] and so they did not provide affidavits. There was plentiful evidence from the other named inventors, including both the true inventors and the non-inventors, that the non-inventors were indeed not inventors, and Brown J followed Qualcomm 2016 FC 499 (here) in holding this was a housekeeping requirement that is “not relevant when an issued patent is being considered by the Court under section 52 of the Act” (Qualcomm [10], quoted at [39]).

Thus, whether or not affidavits from all remaining applicants are required under s 31(3), there is no such requirement under s 52. This indicates that the test under s 52 is not the same as the test under s 31(3).

This makes sense functionally. It may be much more difficult to find the remaining inventors post-grant, as is illustrated on the facts of this case. Further, while it may make sense for the Commissioner to want to be satisfied that the remaining applicants are in fact the inventors before the patent is granted to them, it is not clear why the FC would need to be satisfied that the remaining inventors are in fact inventors, given that the Commissioner was already satisfied of this fact on granting the patent. Surely, post-grant, that can be presumed. The real question post-grant is simply whether the inventors sought to be removed were not in fact inventors, and it would seem that affidavits from those non-inventors to that effect would normally be sufficient evidence. I suppose the point will really be tested if one named inventor is to be removed, on the basis of satisfactory evidence that the named inventor not in fact an inventor, in circumstances in which none of the remaining named inventors can be located. It seems to me that it would be clearly appropriate for the FC to order the non-inventor to be removed in such circumstances.