Wednesday, August 5, 2020

Is Harm to Third Parties Taken into Account at the Second or Third Step of the RJR-MacDonald Test?

Arctic Cat, Inc v Bombardier Recreational Products Inc 2020 FCA 116 Rivoalen JA


Yesterday’s post provided an overview of the facts in Rivoalen JA’s decision to deny Arctic Cat’s application for a stay pending appeal. This posts focuses on a purely legal issue: is harm to third parties taken into account at the second or third step of the RJR-MacDonald test for an interlocutory injunction / stay? Why does it matter?

To recap the facts, AC and BRP are competitors in the snowmobile market. BRP sued AC for infringement of various patents and finally prevailed in a decision released in June: 2020 FC 691 (here). AC then sought a stay pending an appeal, which is the subject of this decision. The stay will determine whether AC can ship infringing machines for the upcoming winter season (summer-fall 2020 is the crucial window [13]). Since the patent expires next June, AC will be able to return to this design for the following season, regardless of the outcome of any appeal, which will affect only damages. The sleds that are affected have already been manufactured and are stored in US warehouses [9]. AC submitted that it would not be be possible to redesign them for the upcoming season [9] and Rivoalen JA’s decision proceeded on that basis [34], [35].

As usual in the FC approach to the RJR-MacDonald [1994] 1 SCR 311 test, whether AC would suffer irreparable harm was a key issue. In addition to the harm that AC argued it would suffer directly, AC argued that their dealers would suffer irreparable harm, especially because many are single-line dealers who may not be able to supply a competing product because of territorial exclusivity agreements [27].

On this issue, Rivoalen JA found that irreparable harm to the dealers had not been established on the facts [31], but:

[32] More importantly, whatever harm the dealers may suffer personally cannot be relied upon by the appellants to establish irreparable harm. Only harms suffered directly by the appellants can be considered in the second branch of the RJRMacDonald test. This Court has refused attempts to rely on third-party harms, other than by charities.

As authority, Rivoalen JA cited Glooscap 2012 FCA 255 at [29-30], [33-34]; Air Passenger Rights v Canada 2020 FCA 92 at [30], and Chinese Business Chamber of Canada 2006 FCA 178 at [6-7]. These decisions (none of which concern patents), do indeed state that the interests of third parties can only be considered at the third stage of the test, the balance of convenience, relying on RJR-MacDonald [1994] 1 SCR 311 at 341, in which the Court stated that the public interest, and by implication harm to third parties, “is more appropriately dealt with in the third part of the analysis.” (Metropolitan Stores [1987] 1 SCR 110 at 128 is also relied upon, but that statement is much more ambiguous.)

On the other hand, there are cases such as Marketing International (1977) 35 CPR(2d) 226 at 231 (FCA), Procter & Gamble Co v Bristol-Meyers Canada Ltd (1978), 39 CPR(2d) 171 at 177 (FCA) and, post-RJR-MacDonaldAstraZeneca Canada 2005 FCA 208 [20], holding that it is proper to take harm to the public into account at the irreparable harm stage.

Monday, August 3, 2020

Stay Pending Appeal Denied in the Absence of an Undertaking

Arctic Cat, Inc v Bombardier Recreational Products Inc 2020 FCA 116 Rivoalen JA


In this decision, Rivoalen JA denied Arctic Cat’s application for a stay pending appeal. That in itself is not so unusual, but what is odd is that there is no suggestion that the patentee, BRP, provided an undertaking in damages to address the issue of irreparable harm. From the complete absence of any discussion of the point, I have to suspect that an undertaking was not even requested by AC, or offered by BRP. In any event, the absence of an undertaking substantially affects the analysis, and accordingly, I will focus on that issue in this post.

As discussed here, the patents at issue related a “significant breakthrough” in snowmobile design made by BRP, that moved rider weight forward. BRP’s “Rider Position Patents” covered the forward position itself, and the 264 “Frame Construction Patent” relates to a frame assembly that facilitates the construction of sleds with the rider forward position. The litigation started when BRP filed its statement of claim in December of 2011 [43]. The trial started in 2015, with Roy J’s decision 2017 FC 207 following in 2017. Roy J held the Rider Position Patents to be invalid, and the Frame Construction Patent to be not infringed. On appeal, Roy J’s decision on the invalidity of the Rider Position Patents was upheld, but the FCA 2018 FCA 172 reversed on claim construction in respect of the Frame Construction Patent and remanded to Roy J to determine validity and infringement on the correct construction. Finally, on 15 June 2020, eight years after litigation started, and with less than a year left on the term of the 264 patent, BRP prevailed, with Roy J’s decision on remand, 2020 FC 691, holding the Frame Construction Patent to be valid and infringed. Roy J granted a permanent injunction, as is normal, over the objections of AC: see here.

Wednesday, July 29, 2020

Minister Intends Narrow Interpretation of CSP Regulations

ViiV Healthcare ULC v Canada (Health) 2020 FC 756 Fuhrer J

2,606,282 / JULUCA / dolutegravir and rilpivirine

In this judicial review of the Minister of Health’s decision denying ViiV’s application for a Certificate of Supplementary Protection (CSP) in respect of its 282 patent, Fuhrer J, applying reasonableness review [9], found the Minister’s approach to the interpretation of the relevant statutory provisions to be unreasonable. Fuhrer J’s legal analysis was straightforward: s 3 of the CETA Implementation Act provides that the regulations implementing the CSP regime must be interpreted harmoniously with CETA itself, but the Minister failed to consider CETA at all, relying instead on the RIAS for the CSP Regs and associated the Guidance Document, neither of which are law. This is the second decision relating to the new CSP regime, following Glaxosmithkline 2020 FC 397, and it is the second decision in which the Federal Court has found the Minister to have adopted an unreasonable interpretation of the relevant provisions: see here. Moreover, in this case the Minister has clearly signaled that she intends to interpret the CSP Regulations as restrictively as possible. Unfortunately, in light of these decisions, we cannot say that she intends to interpret them as restrictively as reasonably possible; it appears rather that the Minister intends to interpret the provisions as restrictively as the courts will allow. The CSP forecast is calling for a steady rain of judicial review applications.

Friday, July 24, 2020

Routine Correction of Inventorship

Alfasigma SPA v Canada (Attorney General) 2020 FC 561 Grammond J


This was a routine correction of inventorship under s 52. One inventor has been named on the Italian priority application, but his name had inadvertently been left off the PCT application [3]. The application was supported by affidavits of all the other inventors [4]. No interesting issues were raised and the application for correction was granted [5].

Monday, July 20, 2020

Summary Trial Instead of Markman Hearing in the US

IPKat has a post today about order made by Judge Alsup canceling a Markman hearing and effectively ordering a summary trial instead. This may be of interest in light of recent emergence of summary trial / judgment decisions we have seen here.

Wednesday, July 15, 2020

The underlying facts were NOT in fact disclosed

Apotex Inc v Wellcome Foundation Ltd / AZT 2002 SCC 77, aff’g [2001] 1 FC 495 (FCA), var’g T-3197-90, 79 CPR (3d) 193 (FC) Wetston J


The law of utility has become much quieter since AstraZeneca 2017 SCC 36, so I’ve been spending some time reviewing the case law to see where we have ended up. One issue that remains contentious relates to the enhanced disclosure requirement that arises when utility is established on the basis of a sound prediction. In Wellcome / AZT 2002 SCC 77 at paragraph 70 the SCC remarked that:

Normally, it is sufficient if the specification provides a full, clear and exact description of the nature of the invention and the manner in which it can be practised. It is generally not necessary for an inventor to provide a theory of why the invention works. Practical readers merely want to know that it does work and how to work it. 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.

This suggests that something other than the normal disclosure is required, though the SCC did not go on to explain what that might be. This passage has been interpreted as requiring a heightened disclosure requirement in the case of a sound prediction, such that the factual basis for the prediction must be disclosed, or at least referred to, in the patent itself: Raloxifene 2011 FCA 220 [46]-[47] aff’g 2010 FC 915 [116]-[17]. This enhanced disclosure requirement is substantively controversial: see Gauthier JA’s remarks in Clopidogrel 2013 FCA 186 [132] and Rennie J’s remarks in Nexium 2014 FC 638 [158-59]. Even parsing the SCC’s statement is not easy: see Rennie J’s careful discussion in Nexium [139-60] arguing that “this sort of case” refers to a new use, not sound prediction generally.

In this post, I am not going to tackle either the interpretation of paragraph 70 or the substantive merits of an enhanced disclosure requirement. Instead, I will focus on a purely factual point. The reason the SCC gave for not elaborating further is that the precise disclosure requirements “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” [70, my emphasis]. Similarly, the SCC said that “[t]he trial judge has found that the inventors possessed and disclosed in the patent both the factual data on which to base a prediction,” as well as the line of reasoning necessary to support a sound prediction [75, my emphasis]. In this post I will show that the SCC’s statement that the underlying facts supporting the sound prediction “were in fact disclosed,” is, in fact, false.

This is a purely factual point, involving a comparison between what was disclosed in the patent with the evidence that was found to support a sound prediction. The bulk of this post is devoted to supporting my claim that the factual basis was not disclosed by going through the decision and the patent in rather pedantic detail. It may seem at times that I am belabouring the obvious, but since I am arguing that the SCC made a factual error, I would like to be clear as to the basis for my assertion. I’ll finish by considering the doctrinal implications of this observation.

I should stress that I am not disagreeing with any of the key holdings in AZT. I am arguing that the SCC’s statement at [70] was based on a factually erroneous premise; but that statement was expressly obiter. Given that the remarks were obiter, it is understandable that the SCC was perhaps not as careful in dealing with the issue as it might have been. An obiter comment of this type is clearly not binding in any event: R v Henry 2005 SCC 76 [57]. My argument is that the underlying factual error is one more reason for not placing significant weight on this obiter comment in the future development of the law on this point.

Monday, June 22, 2020

Overbreadth in Canadian Law: Revised Version

A revised version of my paper “Overbreadth in Canadian Patent Law” is now available on SSRN. It is substantially revised from the previous version, though the underlying message is the same. Here is the abstract:

Under the overbreadth doctrine, a claim that exceeds the scope of the invention disclosed in the specification is invalid. While the doctrine is well established, it is redundant in the great majority of cases in which it is invoked, as an overbroad claim typically encompasses subject-matter which is not new, lacks utility, or is obvious. When overbreadth is not redundant, a puzzle arises: what is the principled justification for striking down a claim to an invention which is in fact new, useful, non-obvious and sufficiently disclosed? In such a case, how can it be said that the claim is broader than the invention? This article argues that overbreadth properly arises as an independent ground of invalidity in the context of the “roads to Brighton” problem, in which the question is whether the first inventor to achieve a result known to be desirable may claim the result itself or only their particular method of achieving it, but current Canadian law on this point does not require or invoke an independent overbreadth doctrine. Overbreadth was also applied as a truly independent ground of invalidity by the Federal Court of Appeal in Amfac Foods Inc. v Irving Pulp & Paper, Ltd. This article argues that Amfac was wrongly decided, both on its facts, and in its approach to overbreadth. The article warns that the Amfac approach, if widely adopted, risks invalidating patents for inventions which are new, useful and non-obvious, on the basis of an arbitrary parsing of the disclosure, in a manner reminiscent of the promise doctrine.

Wednesday, June 17, 2020

Display to the Public Not Enabling

Bombardier Recreational Products Inc v Arctic Cat, Inc 2020 FC 691 Roy J
This litigation originally concerned four patents, three rider position patents and one frame construction patent. In his initial trial decision, 2017 FC 207 Roy J held the rider position patents to be invalid for insufficiency (see here), and this was upheld by the FCA: 2018 FCA 172 (here). Roy J had held that the frame construction patent was not infringed, but the FCA reversed on a point of claim construction, held that the frame construction patent was infringed, and remanded to Roy J for determination of validity and remedies [3]. No new law was applied, but there are a few points of interest: Roy J was strongly disinclined to apply issue estoppel based on foreign litigation to a question of validity; he was inclined to view claim construction points that had not been appealed as res judicata; the prior art was not enabling because public display after races without opportunity for inspection was not disclosure to the public; and lost profits were refused because of the difficulty of establishing a causal link between the single infringed patent and the lost sales.

Foreign issue estoppel
An initial question arose because Arctic Cat sought to argue that the frame construction patent was anticipated as a matter of issue estoppel, which applies to preclude re-litigation of an issue which has been conclusively and finally decided in previous litigation between the same parties or their privies [23]. In particular, Arctic Cat argued that issue estoppel applied because of a jury verdict in US District Court in Minnesota, finding that the asserted claims were anticipated and obvious [23], [30]. After carefully reviewing the relevant cases on foreign issue estoppel, Roy J held that this argument had no reasonable prospect of success [71]. He noted that while some cases had suggested that issue estoppel based on a foreign decision might be potentially be applicable regarding purely factual findings [52], [64], no cases had actually gone so far as to apply foreign issue estoppel even on a factual issue. Further, the great weight of authorities is to the effect that determinations of validity of a patent in a foreign court are not helpful and cannot be the basis for an estoppel argument [51], [66]. In short, Arctic Cat “has not been able to refer to one patent case where the proposition it advances has had even a measure of success” [64]. Nonetheless, Roy J did not (quite) hold that foreign issue estoppel could never apply to a determination of validity, but rather that:

It would take, it seems to me, a very strong demonstration in order to accept that the issue has been conclusively decided by a jury in a foreign jurisdiction with its own law applied by its own courts, such that the verdict would bar litigation before a Canadian court, preventing it from considering the validity of a Canadian patent, using its own substantive and procedural laws, and hearing Canadian admissible evidence.

On the facts, there was not nearly enough evidence, in particular related to whether the US law of anticipation is the same as that in Canada, for the argument to have any prospect of success [68].

Reconsideration of claim construction on remand?
An interesting procedural issue was raised. The construction of several terms was at issue in the first trial [77], but only the term “engine cradle” was considered on appeal [FCA 13], and it was on the construction of that term that the FCA reversed. The question therefore arose as to whether the construction of other contentious terms should be reconsidered in light of the FCA’s construction of “engine cradle.” The issue was important because one element of prior art, the “T/S sled,” did not anticipate on the original construction of the key issues, but might if the construction of certain terms was reconsidered. Roy J was inclined to the view that the construction of the other terms was res judicata [79], but he did not need to decide as he concluded, after reconsideration of the other terms, that the outcome was the same [80], [103]. The argument that the T/S sled anticipated therefore failed in light of the claim construction [108].

Disclosure to the public
One interesting point arose in respect of anticipation. Roy J held that even if the T/S sled embodied the claimed invention (which it did not), it would not anticipate because the enablement branch of anticipation was not satisfied. This is because the evidence was that the T/S sled was only on display after races and the essential elements of the invention would not have been apparent to a skilled person on mere visual inspection [112]. This strikes me as correct; anticipation requires that the invention be made available “to the public,” and while it is enough that the public had opportunity to access the invention, in this case even that opportunity was not established. This case is quite similar to Bauer v Easton 2010 FC 361 aff’d 2011 FCA 83 in which hockey skates embodying the invention were worn in a public arena by skaters subject to an obligation of confidence; this was held not to anticipate as visual inspection at a distance was not sufficient to provide an enabling disclosure of the invention, and members of the public were not free in law and equity to carry out a close examination of the skates that would have disclosed the essential elements of the invention.

The obviousness attack failed on the facts [124]. Roy J therefore held the frame patent to be valid and infringed [125]. 

Turning to remedies, BRP sought lost profits for sales that it would have made but for the infringement and a reasonable royalty in respect of the remaining sale. 

The claim for lost profits failed, because BRP’s case on damages “was largely built on the four patents-in-suit having been infringed.” In light of the holding that only one patent was infringed, it was too difficult to make out the necessary causal link between the infringement of that single patent and the lost sales, as the rider position patents that had been held to be invalid, were a major driver of the lost sales [128], [136], [138], [144], [151].

The parties agreed that the hypothetical negotiation methodology was appropriate for establishing a reasonable royalty with a 50% split of the incremental profits attributable to the infringed patent [166], [174]. The key issue was therefore the assessment of the incremental profit. On this point Roy J preferred the evidence of BRP’s expert.

BRP sought the usual permanent injunction. Unsually, Arctic Cat resisted, not merely on the basis that there was no prospect of future infringement; on the contrary, it appears that it was Arctic Cat’s position that it should be permitted to continue to infringe: [183]. Arctic Cat advanced a variety of reasons why a permanent injunction should not be granted [183], all of which were rejected by Roy J [184]-[191], noting that “(a)n injunction normally will follow once the Court has found that a patent is valid and has been infringed” [185], quoting Abbvie 2014 FC 489 [35]. Roy J’s analysis was brief and I agree entirely, so I won’t recap it. I will plug the recent book I co-edited with Brad Biddle, Jorge Contreras, an d Brian Love, “Patent Remedies and Complex Products: Toward a Global Consensus” (open access) and especially Chapter 4 on Injunctive Relief, where we recommend that a permanent injunction be refused “if the negative effects of the injunction on enjoined parties would be disproportionate to the nature of the infringement and any noncompensable harm that the patentee will experience as a result of the absence of an injunction.”

Monday, June 8, 2020

"Foreign Prosecution History Is Inadmissible"

Gemak v Jempak 2020 FC 644 Lafrenière J
            2,276,428 / 2,337,069

After a decade in which it was almost unheard of for the Federal Court to grant a contested motion for summary trial or summary judgment in a patent case, it seems they are now raining down upon us, with Lafrenière J’s summary judgment decision in Gemak v Jempak following Manson J’s decisions in Viiv v Gilead 2020 FC 486 (here) and Canmar 2019 FC 1233 (here). Lafrenière J’s decision in this case is a good example of summary judgment being used to dispose expeditiously of a far-fetched claim construction argument. It is also notable for holding expressly that foreign prosecution history is not admissible under s 53.1. This is in tension with Manson J’s holding in Canmar that foreign prosecution history should be admissible, albeit only in “extraordinary circumstances” [73], [74], [77].

Gemak’s 428 patent at issue was to a dishwasher detergent pod. These pods commonly use percarbonate as a bleaching agent which is activated on exposure to water. Percarbonate is susceptible to degradation by contact with other detergent ingredients or by moisture. For that reason, the percarbonate must be coated to protect it prior to actual use of the pod. Claim 1 is representative [13]:

A detergent composition comprising a granulated percarbonate and a blend which encapsulates the percarbonate, the blend comprising . . . carboxymethyl cellulose [CMC]

Jempak’s detergent pods included percarbonate encapsulated in a protective coating. It was not really disputed that the use of CMC was an essential element of the claim [119]. It was also established that the protective coating used by Jempak did not comprise CMC. Gemak’s main argument was that CMC was present in the other detergent ingredients in Jempak’s pods, and that once the pod was assembled, the CMC in the other ingredients could adhere to the percarbonate coating, and that the resulting coating with CMC adhering to it would constitute “a blend” comprising CMC which encapsulates the percarbonate [121]. Lafrenière J rejected this on the view that “encapsulation refers to a protective coating (a blend) that is applied to the percarbonate during its manufacture to maintain the stability of the percarbonate and to prevent it from decomposing prematurely before use” [123]. Gemak’s position was not helped by its “evasive and defiant” expert witness [104].

It strikes me that this is an excellent example of the kind of argument that should not be allowed to proceed to a full trial. The patent system is rife with the potential for abuse, in large part due to the cost and complexity of patent litigation. The cost-effective disposition of weak claims is essential to ensuring that the patent system encourages innovation, rather than impeding it.

The other notable point is that Jampak sought to adduce evidence of the US prosecution history. Lafrenière J refused to allow this evidence, in part because it was introduced too late [77] and in part because it would not assist the court [78]. But he also held expressly that “foreign prosecution history is inadmissible” under the new s 53.1 of the Act: [86], and generally [82]-[86]. This holding was primarily based on a straightforward textual argument:

[83] Subsection 53.1(1) provides that the prosecution history may be admitted into evidence in an action to rebut any representation made by the patentee regarding claim construction, but only when specific conditions are met. In particular, subparagraph 53.1(1)(b)(ii) provides that the communication must be between the applicant and “the Commissioner, an officer or employee of the Patent Office or a member of a re-examination board.”

[84] The definition of “Commissioner” is set out in section 2 of the Patent Act as meaning the Commissioner of Patents, who is appointed by the Governor in Council and exercises the powers and performs the duties conferred and imposed on that officer by or pursuant to the Patent Act. The Patent Office described in section 3 as an office attached to the Department of Industry, or to such other department of the Government of Canada as may be determined by the Governor in Council.


[86] There is a further presumption against the legislature impliedly changing established law, particularly the common law. If Parliament had intended that communications prepared in respect of the prosecution of the application for a foreign patent could be admitted, clearer language would be required to effect that result. In the circumstances, I conclude that section 53.1 did not change the existing rule, as enunciated in Free World Trust, that foreign prosecution history is inadmissible.

I made some similar points in my blog post on Manson J’s decision in Canmar 2019 FC 1233 [77], which held that in “extraordinary” circumstances foreign prosecution history should be admissible to aid in construction of the Canadian claims.

On the other hand, “[t]he language of section 53.1 is limited to communications between the patentee and the Canadian Patent Office” [70]. In particular, per s 53.1(b)(ii), the communication must be between the applicant and “the Commissioner, an officer or employee of the Patent Office or a member of a re-examination board.”

Further, prior to the enactment of s 53.1, it was clear law that “statements made during prosecution of Canadian patent applications or corresponding foreign patent applications were neither relevant nor admissible with respect to construing terms used in issued Canadian patents” [58]; and Free World 2000 SCC 66 [66]. As a matter of statutory interpretation, “[i]t is presumed that the legislature does not intend to make any change in the existing law beyond that which is expressly stated in, or follows by necessary implication from, the language of the statute in question”: R v T (V) [1992] 1 SCR 749, quoting with approval Maxwell on the Interpretation of Statutes; and see also Parry Sound v OPSEU [2003] 2 SCR 157 [39]. This implies that s 53.1, in providing for admissibility of communications to the Canadian examiner, did not change the existing rule that foreign prosecution history is inadmissible.

I’d say that someone owes me a beer.

In any event, there is evidently some tension with Manson J’s holding in Canmar that foreign prosecution history should be admissible, albeit only in “extraordinary circumstances” [73], [74], [77]. Lafrenière J did not directly discuss Manson J’s holding on this point.

Friday, June 5, 2020

Restrained Approach to Patentability of Methods of Medical Treatment

Biogen Canada Inc v Taro Pharmaceuticals Inc 2020 FC 621 Manson J

            2,562,277 / fampidrine sustained release / FAMPYRA / NOC action

The claims at issue in the 277 patent were to the use of sustained release fampidrine for improving walking in a person with multiple sclerosis (MS) for a time period of at least two weeks at a unit dose of 10 mg twice daily” (Claim 17 is exemplary: [22]). These were attacked as being to an unpatentable method of medical treatment. The topic of the patentability of methods of medical treatment is incoherent, with authorities taking a variety of inconsistent positions, as I discuss here. The area is in need of thorough review, as the FCA has noted in Hospira 2020 FCA 30 [51-53], and Cobalt v Bayer 2015 FCA 116 [101]. In this case Manson J declined to follow some authorities that aggressively applied a rule against patenting of methods of medical treatment. This strongly suggests that Manson J favours a more moderate position.

In this case, the defendants drew analogies to Mylan 2010 FC 1123 and Novartis 2013 FC 985 aff’d 2014 FCA 17 in which similar claims had been held invalid. Manson J rejected these analogies, but without exactly distinguishing the cases. Dealing with Mylan, he effectively accepted the analogy — “I agree with the Defendants that the 277 Patent claims the use of a known compound for an established purpose using a known treatment methodology” [206] — but he noted that the claims at issue in Mylan would have been obvious, and he indicated that that was the more appropriate basis for the decision: “these general facts formed the basis of the obviousness finding, above. I do not agree that they also ground a separate finding of invalidity on the basis of unpatentable subject matter” [206]. Since Mylan itself was expressly decided on the basis that the claims at issue were directly to unpatentable methods of medical treatment, this seems to be a polite way of saying that he would not follow the holding in Mylan (which is of course not binding).

Dealing with Novartis, Manson J noted that “The Federal Court of Appeal summarily dismissed the appeal [in a four paragraph decision], finding that in order to allow the appeal, it would be necessary to conclude in the face of Tennessee Eastman that a method of medical treatment is patentable subject matter, or conclude that the Federal Court had misconstrued the patent” [208]. That is an entirely accurate description of the holding in Novartis FCA, but it is not clear how it distinguishes the case. Perhaps the suggestion is that the FCA did not fully consider the issue?

Manson J concluded that “I . . . do not accept the Defendants’ argument that Mylan and Novartis stand for a general proposition that any patent claim to ‘how and when’ a drug is administered covers unpatentable subject matter” [211]. That’s fair enough, but he didn’t explain what they do stand for.

I’m not faulting Manson J in this respect. The jurisprudence in this area is incoherent, and there are other authorities to the opposite effect that Manson J might have cited if he been inclined to delve more deeply into the issue. Because of the conflicting case law, there are a range of positions that might be justified, depending on which line of authority a judge chooses to follow. Overall, Manson J’s treatment of these cases strongly suggests that he favours a moderate position and is not inclined to be aggressive in invalidating patents on this basis.

Thursday, June 4, 2020

Making a Mosaic of Obscure Prior Art Is Permissible in Obviousness Attack under Hospira

Biogen Canada Inc v Taro Pharmaceuticals Inc 2020 FC 621 Manson J
            2,562,277 / fampidrine sustained release / FAMPYRA / NOC action

As outlined in my last post, the 277 patent, owned by Acorda and licenced to Biogen, relates to the use of sustained release fampidrine for improving walking in a person with multiple sclerosis (MS). In this decision Manson J held the 277 patent, to be anticipated and obvious, ultimately because the inventors had themselves disclosed the invention in a financial filing prior to the claim date. My last post dealt with anticipation. This post deals with obviousness. This case is the first clear application of the FCA’s holding in Hospira that the state of the art for the purpose of an obviousness attack includes all prior art, not just that which would be reasonably discoverable. For convenience, I’ll refer to prior art that is not part of the cgk or reasonably discoverable, as “obscure prior art.” Importantly, Manson J appears to have been of the view that it is permissible to mosaic various pieces of obscure prior art.

The prior art included a financial filing referred to as Acorda S-1, that disclosed results from a small clinical trial undertaken by Acorda, the MS-F201 trial, as well as the protocol for a second trial that was planned (the MS-F202 trial) [36, 122]. This was held to anticipate. It was also invoked in support of obviousness, along with the Goodman References (also disclosing the same trials), and a publication reporting the pharmacokinetic properties of fampridine SR (“Hayes”). Given the very small gap between this prior art and claimed invention, the holding that the claims were obvious in light of these references followed fairly directly [181-200].

The key issue on obviousness was not bridging the gap between the prior art and the claimed invention, but whether the prior art references were properly part of the state of the art. In particular, it was not established that any of these references would have been part of the common general knowledge or discoverable in a reasonably diligent search. As Manson J noted, prior to codification of the non-obviousness requirement in s 28.3, “citable prior art for obviousness was limited to that which would have been found by the POSITA in a reasonably diligent search” [152]. However, in Hospira 2020 FCA 30 the FCA held that “it is an error to exclude prior art from the obviousness analysis simply because it would not have been located in a reasonably diligent search” [153]. Biogen objected to this as being contrary to the intent of s 28.3, but as Manson J pointed out, “The Federal Court of Appeal’s decision in Hospira is both clear and binding on this Court. Prior art will not be excluded from the obviousness analysis solely because the POSITA would not have found it after a reasonably diligent search” [154]. Consequently, Manson J considered the prior art at issue to be part of the state of the art for an obviousness attack, without consideration of whether it would have been reasonably discoverable [163-64, 166].

That much follows directly from Hospira. But there was an important point left open in Hospira, where the FCA stated (my emphasis):

[86] The likelihood that a prior art reference would not have been located by a PSA may be relevant to consideration of step 4 of the obviousness analysis (whether differences between the state of the art and the inventive concept constitute steps which would have been obvious to the PSA) in that the uninventive PSA might not have thought to combine that prior art reference with other prior art to make the claimed invention.

In my post on Hospira, I said the following:

This indicates that there can be no mosaicing of prior art that is not available in a reasonably diligent search. Thus, obviousness can be assessed over the common general knowledge alone, or over one item of broader prior art plus cgk, but not over two items of broader public art plus cgk. I believe that this is essentially the UK position.

In other words, I read Hospira as saying that while one element of obscure prior art could be combined with the traditional state of the art (cgk or material reasonably discoverable), it was not necessarily permissible to combine two elements of obscure prior art, on the view that a POSITA who did not know about a piece of obscure prior art would not think to combine it with another piece of obscure prior art which she also did not know about.

However, Manson J did not read this paragraph the same way. He stated

[193] Following the Federal Court of Appeal’s guidance in Hospira that it may be relevant to consider the likelihood that a prior art reference would not have been located by the POSITA at this stage of the obviousness analysis, I am satisfied that the POSITA would have combined the pharmacokinetic parameters taught in Hayes 2003 with the fixed doses of 10 mg bid taught in the Acorda S-1. Both references report information on the Elan fampridine SR composition, and the Acorda S-1 states that the pharmacokinetic characteristics of fampridine SR in subjects with MS had been established in earlier trials sponsored by Elan.

There was no suggestion that either Hayes 2003 of Acorda S-1 were part of the cgk or were reasonably discoverable: in light of Manson J’s holding that it was wrong to exclude prior art from the obviousness analysis for that reason, he simply never addressed the question.

Consequently, in Biogen v Taro, Manson J did mosaic two elements of obscure prior art. He was evidently of the view that the only inquiry mandated by Hospira [86] is whether the POSITA, with both elements of prior art in hand, would find it obvious to combine them.

Manson J’s interpretation of Hospira [86] is certainly reasonable, but I like to think my interpretation is reasonable as well, so it’s not clear, at least to me, what the FCA intended. Presumably the point will be clarified by the FCA soon enough. If Manson J’s reading is correct, then the state of the art available for an obviousness attack in Canadian law now goes beyond what is available in either the US or the UK (at least as I understand the law in those jurisdictions.)

Tuesday, June 2, 2020

Anticipation by Speculation Redux

Biogen Canada Inc v Taro Pharmaceuticals Inc 2020 FC 621 Manson J

           2,562,277 / fampidrine sustained release / FAMPYRA / NOC action
In Biogen v Taro, Manson J held the 277 patent, owned by Acorda and licenced to Biogen, to be anticipated and obvious, ultimately because the inventors had themselves disclosed the invention in a publicly available financial filing prior to the claim date. The novelty analysis raised the issue of anticipation by speculation that was recently addressed by the FCA in Hospira 2020 FCA 30 (here), and the obviousness discussion is the first clear application of the FCA’s holding in Hospira that the state of the art for the purpose of an obviousness attack includes all prior art, not just that which would be reasonably discoverable. Manson J rejected the argument that the claims were directed to unpatentable methods of medical treatment. This post provides an overview and deals with anticipation.
MS is a chronic disease of the nervous system. Impaired walking is one of the most commonly reported MS symptoms [12], to the extent that a standard measure of the MS patient’s disability is scored in part on the patient’s ability to walk [13]. The 277 patent relates to the use of sustained release fampidrine for improving walking in a person with multiple sclerosis (MS) [109].
Acorda conceived the idea of developing fampidrine SR as a treatment for MS. It conducted a small (36 subjects) phase 2 clinical trial, referred to as MS-F201, using doses from 10-40 mg bid, with pre-established endpoints related to mobility, including a timed 25 foot walk. The study failed, in the sense that most of the pre-established endpoints did not show any statistically significant difference as compared to placebo [33]. After re-analysis (less politely, data mining), Acorda discovered that MS-F201 showed a nominally significant difference in walking speed (as opposed to the pre-established endpoint of walking time) [34]. Acorda therefore planned a further phase 2 study, MS-F202, to evaluate walking speed [34].
In an effort to garner public investment, Acorda filed a financial document, referred to as “Acorda S-1,” with the SEC [121]. Acorda S-1 was prior art against the 277 patent [121]. Acorda S-1 disclosed the results from the MS-F201 trial, as well as the protocol for the planned MS-F202 trial [36, 122], that had not yet been undertaken.
The key question is whether Acorda S-1 anticipated the 277 patent. This raised the same question of anticipation by speculation that was addressed by the FCA in Hospira 2020 FCA 30 (here):
[126] The main thrust of Biogen’s novelty argument is that use claims, such as those at issue in the 277 Patent, are inextricably linked with their utility such that they are inventive because they convey “new knowledge to effect a desired result”. In this case, the claimed invention is the knowledge that 10 mg bid of fampridine SR results in a statistically significant and clinically meaningful improvement in walking in MS patients with walking disability. Disclosure of the MS-F202 protocol alone, without disclosure of its results, does not satisfy the disclosure requirement of the anticipation analysis.
Manson J rejected this, holding that disclosure of MS-F202 study design was anticipatory even if it had not actually been performed as the relevant time (citations omitted):
[138] Despite the lack of results from the MS-F202 study, the disclosure requirement is satisfied if performing what is described in the prior art reference would necessarily result in infringement. Performing the MS-F202 study protocol would necessarily result in infringement of the 277 Patent, and hence the disclosure requirement is satisfied for claims 17, 18, 31, and 32.
In this respect, as Manson J noted, the reference to MS-F202 “is similar to the allegedly anticipatory art in Hospira [2020 FCA 30]” [133]. I agree with Manson J that the cases are similar on this point, and I think he was bound to follow Hospira. (My sense is that Manson J agreed with the Hospira holding, as he cited it as “similar” rather than binding.)
With that said, I had and continue to have considerable difficulty with the holding in Hospira, which I described as “anticipation by suggestion.” The general thrust of Biogen’s argument is that a patent can’t be granted for a new use for a known product unless the use is demonstrated or soundly predicted: “The public should not be expected to pay an elevated price in exchange for speculation” Wellcome / AZT 2002 SCC 77 [37], even if that speculation subsequently turns out to be correct. If the prior art was not enough to support a patent, then it should not be enough to anticipate. So, on “the ‘unquestionable authority’ of Lord Westbury in Hills v. Evans [(1862), 45 ER 1195]” (Sanofi 2008 SCC 61, [24]), applying the law to the facts,
[The prior art Heard specification] unquestionably, according to the rules which we have endeavoured to ascertain, is not such information as will vitiate a subsequent patent, for it is not such information as will be sufficient to support a patent.
If an experiment is necessary to support a patent, it is perfectly clear that the results are required; a proposal to carry out the experiment is not enough: Wellcome / AZT 2002 SCC 77 [72]. So, as the SCC noted in Wellcome / AZT at [64], in Beecham v Bristol Labs [1978] R.P.C. 521 (HL), “claims in respect of a semi-synthetic penicillin were invalidated as being little more than an announcement of a research project.” (p. 570).
The reason, as Lord Westbury explained at 1201, is that a proposal “adds nothing to the real stock of practical knowledge of mankind, and ought not to derogate from the validity and the benefit of a subsequent invention.” This all flows from the principle that an invention is information, and to anticipate, the information provided by the prior art must be equal to that provided by the patent. This is the point of the requirement of enabling disclosure. As Lord Hoffmann stated in Merrell Dow [1995] UKHL 14 [28]:
An invention is a piece of information. Making matter available to the public within the meaning of [the statutory novelty provision] therefore requires the communication of information.
Again, per Lord Westbury at 1200, “the information as to the alleged invention given by the prior publication must, for the purposes of practical utility, be equal to that given by the subsequent patent,” and “the prior knowledge of an invention to avoid a patent must be knowledge equal to that required to be given by a specification.” Statements to that effect are too numerous to cite in this post.
To the same effect, is the statement of Viscount Dunedin in Pope Appliance [1929] AC 269, 276: the general rule “may be expressed thus: Would a man who was grappling with the problem solved by the patent attacked, and having no knowledge of that patent, if he had had the alleged anticipation in his hand, have said, ‘That gives me what I wish?’”; and at 282 “Does the man attacking the problem find what he wants as a solution in the prior so-called anticipations?” When the prior art is a suggestion to carry out an experiment, the answer to these questions must be “no,” because the experiment remains to be carried out before the problem is solved.
Returning to the case at hand, if the patentee could not have been granted on the basis of the information disclosed in Acorda S-1, then Acorda S-1 should not anticipate, because Acorda S-1 does not put the public in possession of the invention. The rule is that infringement if after constitutes anticipation if before; but I don’t see that that rule is implies that Acorda S-1 anticipates: actually performing the MS-F202 protocol would infringe; but proposing the MS-F202 protocol would not.
With that said, I’ve consulted with some US colleagues and it looks like the US Fed Cir adopts much the same approach as Hospira: see Rasmusson v SmithKline Beecham Corp., 413 F.3d 1318 (Fed Cir 2005) and Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc. 246 F.3d 1368 (Fed Cir 2001). The US cases don’t make sense to me either, but there they are.
While Biogen v Taro illustrates and applies the Hospira principle of anticipation by speculation, it is not a particularly clear example because there are a number of problems with the prior art disclosure.
So, Acorda S-1 reported the results of MS-F201 as follows:
The clinical trial demonstrated that doses up to 25 mg twice a day were well tolerated, and were associated with statistically significant improvements in walking speed and leg muscle strength.
A key element from the claim was to the use of fampridine SR at a dose of 10mg bid in treating a patient with MS “for improving walking in a statistically significant way” [109], and Acorda S-1 on its face disclosed that element [128]. However, so far as I can tell, the MS-F201 trial didn’t really show a statistically significant improvement in walking speed — it just showed that if you parse a data set enough ways, you’ll eventually find some correlation with p<0.05. I expect that’s why Manson J referred to it as showing a “nominally” significant difference in walking speed [34]. In any event, Acorda S-1 expressly stated that the results were statistically significant, and it’s not clear to me whether the data mining behind that result was reported in Acorda S-1.
Further, the essential elements of the claim also included the use of fampridine SR for a time period of at least two weeks at a unit dose of 10 mg bid [109], and it seems that Biogen was trying “ a detailed parsing” of the claim elements in an effort to show that the two-week dosing period and the 10 mg bid dosage were not disclosed [129]. But the 10 mg bid dosage was disclosed by the MS-F201 trial, which also included a 10mb bid regime, so it was only the two-week time period that was not disclosed [131]. It is apparently at this point that the MS-F202 trial became relevant. But the MS-F202 trial also failed in terms of predefined endpoints [40] and “showed no meaningful difference in walking speed between the 10 mg, 15 mg and 20 mg bid doses” [43], so I’m not sure what Biogen’s basis was for arguing that MS-F202 revealed anything more than MS-F201.
Thus, while Biogen v Taro illustrates and applies the Hospira principle of anticipation by suggestion, it doesn’t really advance the law on this point. The facts don’t provide a particularly clean illustration of the issues because both the MS-F201 and MS-F202 studies were a fiesta of data-mining. I’d almost be inclined to say that they weren’t anticipatory because a skilled person wouldn’t believe anything that was said in either of them; but that’s not an issue that was raised in argument. I’ll end this post with one more quotation from Lord Westbury in Hill v Evans at 1201:
Now it is an admitted fact that that proposition [in the prior art] is untrue; it is a clear result, therefore, that the proposition would only mislead the individual who relied upon it.

Friday, May 29, 2020

Expediency of One Action Is Exclusive Purpose of Joinder Rules under PM(NOC) Regulations

Teva Canada Limited v Bayer et al 2020 FCA 86 Nadon JA: Pelletier, de Montigny JJA rev’g 2019 FC 1039 Pentney J
2,547,113 / 2,624,310 / 2,823,159 / 2,396,561/ rivaroxaban /XARELTO

This appeal clarifies several important procedural points under the new the PM(NOC) Regulations. In the main part of the decision, the FCA greatly clarified the meaning and implications of s 6.02, which provides that no action may be “joined” to a s 6(1) action during the period of the statutory stay. Two other points arose tangentially. The FCA also noted that procedural precedent under the former Regulations is not necessarily applicable under the new Regulations, given the change in purpose; and Nadon JA remarked that that disposing of cases brought under the Regulations within 24 months “remains a goal—not an obligation on the Court” [132].

This appeal concerns a motion to add defendants in a trial of common issues under the PM(NOC) Regulations. The issue of joining actions is important both for the usual procedural concerns of fairness and efficiency of adjudication, and also because it raises the issue of whether the first generic to serve an NOA can get a practical first-mover advantage over later generics. Under the US Hatch-Waxman patent linkage system, the first applicant to challenge a drug patent is entitled to 180 days of exclusivity against subsequent generic applicants (21 U.S.C. § 355(j)(5)), with the idea that this provides an incentive for the first generic to bear the cost of litigation. There is no equivalent statutory exclusivity period in the NOC Regulations, but the first generic to get its NOC will nonetheless get a practical head start.

In the underlying motion, Teva and Apotex resisted a motion to add Taro and Sandoz as additional defendants in the PM(NOC) action brought by Bayer against all four. Teva and Apotex argued, in part, that adding Taro and Sandoz would deprive Teva and Apotex of the potential first-mover advantage. As discussed here, in the decision under appeal Pentney J rejected this argument, and then went on to order Taro and Sandoz to be added, in light of a balancing of the usual considerations of balancing judicial economy against potential prejudice to the parties. While Pentney J did not provide the specific basis for his order, the FCA held that Rule 105 does give the discretion to make an order of that type [41].

The FCA also affirmed that the potential loss of the first-mover advantage should not be considered. While the procedural requirements under the PM(NOC) Regulations may result in a practical first-mover advantage, there is nothing in the Reuglations or the RIAS to suggest that this is the purpose: [53-54]. Indeed, the contrast with the US example where a first-mover advantage is explicitly provided for suggests that no such purpose was contemplated in the Canadian patent linkage system: [55].

The FCA nonetheless reversed. While Rule 105 permits an such an order to be made, it does not grant an unfettered discretion. In particular, the exercise of the discretion must not fall afoul of s 6.02 of the Regulations, which provides that no action may be “joined” to an action commenced under s 6(1) during the period of the statutory stay [81].

The FCA held that “joined” is not merely synonymous with “consolidated” [110]. This conclusion turned in part on the textual meaning of the two terms [99]-[121], where Nadon JA concluded that the words do not suggest that the meaning of “joining actions” is confined to consolidation: “Rather, they suggest that actions are joined whenever they are brought together, connected or brought into close association” [114].

The FCA’s conclusion turned primarily on the purpose of the Regulations. Nadon JA drew a very strong contrast between the purpose of s 6.02 and Rule 105:

[122] Having analyzed the wording of section 6.02 of the Regulations, I now turn to consider more closely the purpose of the prohibition. The entire raison d’être of the section 6.02 prohibition is to promote the expediency of one action, and one action only, instituted pursuant to subsection 6(1), in the context of the 24-month time period within which that action is meant to be determined. My meaning in saying that the prohibition is concerned with the expediency of one action only becomes clear when the purpose of the prohibition is contrasted with the purpose of Rule 105(a). The various forms of relief available under Rule 105(a) seek to promote the most expedient and least expensive determination of multiple proceedings before the Court that share similar issues. In other words, in making an order under Rule 105, a judge or a prothonotary seeks to achieve the most efficient and inexpensive way of dealing with two or more proceedings, both in the interest of the parties and of the Court. Not so with section 6.02 of the Regulations. Section 6.02 is exclusively concerned with the progress of a single action to ensure it is determined within the 24-month deadline that applies to it. The concerns that animate an order under Rule 105(a)—efficiencies and cost savings across multiple parties in multiple proceedings, and as they apply to the court—have no bearing on section 6.02 of the Regulations, the singular focus of which remains exclusively on determining that single action before its peculiar deadline. Thus, to make an order under Rule 105 for the arrangement of multiple proceedings that would result in time and cost savings for multiple parties and the court would still be contrary to the purpose of the section 6.02 prohibition if that arrangement made it at all less likely that any single action brought pursuant to subsection 6(1) would be determined within its 24-month deadline.

Further, the concern under s 6.02 “is whether the Rule 105 order could possibly result in the appellants’ actions exceeding their 24-month deadlines” [124] (emphasis added).
Nadon JA did not undertake a deep inquiry into exactly what would or would not be considered “joining” as the Court was satisfied that the practical effect of the order at issue was tantamount to a consolidation: [129], [131]. In coming to this conclusion, the FCA observed that while the discoveries that had taken place prior to the appeal were nominally conducted by all parties upon consent, the appellants were not “truly free to arrange their proceedings as they saw fit”: “I doubt very much that the Federal Court would have appreciated being advised by the appellants that they refused to cooperate with Taro and Sandoz in regard to the examinations on discovery or in regard to any motion arising from the common issues” [128].

Two other points deserve mention. Nadon JA noted that procedural precedent under the former Regulations would not necessarily be applicable under the new Regulations:

 [77] [I]t is not a foregone conclusion that the principles set out in Sanofi-Aventis [relating to abuse of process], which dealt with the former Regulations, will find identical application under the current Regulations, as the purpose of proceedings commenced under subsection 6(1) of the current Regulations differs from the purpose of proceedings commenced under the former Regulations.

Finally, Nadon JA also noted the 24-month period contemplated for the resolution of actions brought under the Regulations is a goal, not an obligation on the Court:

do not require the Federal Court to render judgment within 24 months. . . . Consequently, it is my view that, in case-managing these cases, judges should bear in mind that they are not positively duty-bound to decide them within the 24-month period. I wish to be clear that I am not suggesting that the 24-month guideline be dealt with flippantly. However, it should be recognized that disposing of cases within 24 months remains a goal—not an obligation on the Court. It bears recalling that even if, in a given case, judgment is rendered by the Federal Court in the 24-month period, appeals taken from such a judgment do not extend the stay period.

Wednesday, May 27, 2020

No Specific Prerequisites Before Having Recourse to Prosecution History in Claim Construction

Bauer Hockey Ltd. v. Sport Maska Inc. (CCM Hockey) 2020 FC 624 Grammond J

In this decision, Grammond J held that no valid claims of Bauer’s 748 patent were infringed. The decision turned largely on claim construction and Grammond J noted that if the parties had brought a motion for summary judgment or summary trial “a considerable amount of judicial resources would have been saved, and each party’s legal costs would have been substantially reduced” [29]. This indicates that Manson J is not alone among FC judges in seeing the need for increased use of summary proceedings: see Viiv Healthcare 2020 FC 486 (here) and Canmar 2019 FC 1233 (here). One noteworthy point is Grammond J’s holding that there are no specific requirements that must be triggered before reference to the prosecution history is permissible under s 53.1 [65].

The invention at issue relates to hockey skates. The uppers were traditionally made with two “quarters” that were sewn together. The 748 patent essentially claimed a one-piece quarter. It may seem obvious that the two pieces should be joined together, and this is exactly what Grammond J held [154-58] [184]. Grammond J addressed the “Beloit question” – 'If it was so easy, why was it not done before?' (my paraphrase of Beloit (1986), 8 CPR (3d) 289 (FCA) at 295, quoted at [146]), by noting that it had not been done before because of cost considerations and not because it was not technically feasible [162-65]. Bauer tried to rebut the prima facie obviousness case with arguments based on commercial success, but Grammond J rejected these, explaining that an adequate causal nexus between the commercial success and the invention specified by the claims had not been established [171-79].

On claim construction there has been an on-going debate as to whether recourse to the disclosure is always permissible, or is permissible only if the claim terms are ambiguous. Grammond J came down very firmly in favour of the former position:

[49] Legal interpretation is not an obscure practice governed by arcane rules. It is, as Lord Hoffmann once famously said, not very different from “the common sense principles by which any serious utterance would be interpreted in ordinary life.”

[55] The modern method [of interpretation] aims at helping the interpreter find clues about the meaning of a legal writing. There is no hierarchy of these clues, nor any predetermined order in which they are considered. In particular, the modern method rejects what is known as the “plain meaning rule,” or the idea that if one category of clues – the text – provides a “clear” answer, the other categories of clues are to be disregarded.

He noted that “Most recent decisions of the Federal Court of Appeal are in line with this approach,” [57], quoting Tetra Tech 2019 FCA 203 [86] and Tearlab 2019 FCA 179 [33] saying that “[c]laim construction requires that the disclosure and the claims be looked at as a whole.” I am entirely in agreement with Grammond J’s observations in this regard.

Without detracting from this general approach, Grammond J noted that patents have “certain distinctive characteristics” that need to be taken into account [51]. One in particular is reference to the prosecution history under s 53.1 which provides that communications between the patentee and the Patent Office “may be admitted into evidence to rebut any representation made by the patentee in the action or proceeding as to the construction of a claim in the patent.” In the specific of the modern approach to interpretation, Grammond J held that there are no specific requirements that must be triggered before reference to the prosecution history is permissible (emphasis added):

[65] Although the use of prosecution history is described in terms of estoppel in the United States, section 53.1 squarely makes this a matter of claims construction. When an issue of claims construction arises, the patentee is always making representations to the Court as to the proper construction of the claims and the defendant is always attempting to rebut those representations. Therefore, in my view, as long as the issue is one of claims construction, section 53.1 applies and the prosecution history is admissible. In other words, there is no need to identify a particular representation and rebuttal every time a reference is made to the prosecution history. It is simply integrated in the interpretive process.

Grammond J did have recourse to the prosecution history, but it served only to confirm the interpretation that was plain from the patent itself. This is not very surprising; the examiner made an obviousness objection, the applicant amended the claims to overcome it, and in litigation the patentee sought to reclaim the lost ground [103-06]. This illustrates why recourse to the prosecution history is often likely to be redundant: when the examiner accepts an amendment intended to restrict the scope of the claims, it will not be very surprising that the new language does indeed restrict the scope of the claims.

Monday, May 18, 2020

Direct Infringement of Product "For Use" Claim; No Inducement of Corresponding Use Claim

Janssen Inc v Teva Canada Ltd 2020 FC 593 Manson J
             2,655,335 / paliperidone palmitate / INVEGA SUSTENNA

Last Friday’s post gave an overview of this decision. As noted, the 335 patent relates to dosing regimens for long acting injectable paliperidone palmitate formulations for treatment of schizophrenia. The 335 patent has three sets of claims: product claims (to prefilled syringes adapted for administration according to the claimed dosing regimen; use claims (“use of a dosage form” etc); and Swiss claims (“use. . . for the manufacture of a medicament”). Yesterday’s post discussed induced infringement of the use claims. This post considers the direct infringement of the product and Swiss claims.

In respect of the product claims — the prefilled syringes — Teva argued that it could not directly infringe because they all require administration in accordance with the claimed dosing regimens; and alternatively, Teva submitted even if administration to patients was not required, Teva did not direct use in accordance with the claimed dosing regimens [234].

Manson J rejected these arguments after reviewing all the essential elements of product claim and finding they were all incorporated in Teva’s proposed product [252]. Claim 1 is to “Prefilled syringes containing a depot formulation of paliperidone . . . for administration by intramuscular injection to a psychiatric patient in need of treatment for schizophrenia.” As I see it, the key issue was the meaning of “for”. Teva’s argument seems to turn on the view that this means that the syringe had to actually be used for the specified purpose for the claim to be infringed. Manson J noted that the product was “capable, approved and intended” for the specified purpose, and that was enough to bring it within the claim. That makes sense as a matter ordinary grammar: I am boiling water “for tea” if I intend to use the water for tea, even if I get distracted and never actually make myself a cup of tea. The intended use was discerned primarily from Teva’s PM. I note that this approach to a claim “for” a purpose is essentially the same as that adopted by Lord Briggs (Lord Hodge concurring) and Arnold J (as he then was) in Warner-Lambert [2018] UKSC 56 var’g [2016] EWCA Civ 1006 var’g [2015] EWHC 2548 (Pat) Arnold J: see here.

Here is a key point (my emphasis):

[253] The Teva PM teaches that the prefilled syringes to be sold by Teva can be administered in combination according to the claimed dosing regimen. While this information may not rise to the level of “instructions to infringe” sufficient to induce practitioners to prescribe and use the syringes according to the claimed dosing regimen, it is sufficient to establish direct infringement of the product claims.

That is, claims to a product for a use are different from the corresponding use claims because the PM may establish intent to influence physicians to use the product in the specified manner, even if the PM does not in fact cause the physicians to use the product in the specified manner; the former is all that is necessary to establish direct infringement of a claim to a product “for” a specified purpose, while the latter is necessary to establish induced infringement of a use claim.

Turning to the Swiss-form claims, it is well known that Swiss claims were first developed as an end-run around the prohibition in European law on patenting methods of medical treatment. In form, they are a claim to a product, though they are intended to protect a use. As a result, in Novartis 2013 FC 985 Hughes J held that the court “should disregard the artificial nature of a Swiss claim and look at what is the real subject matter of the claim” [101]. In effect, Hughes J held that a Swiss claim should be construed as a use claim, even though, on its face, it is a product claim. Consequently, Hughes J held the claims at issue to be unpatentable methods of medical treatment [101]. In this case, Manson J took a different approach. He held that Swiss claims should be construed on the same principle as any other claim, namely as it would be understood by a skilled person [161], and consequently “The Swiss-type claims are capable of infringement if the medicament is adapted for administration to a psychiatric patient in need of treatment, according to the claimed dosing regimen” [163]. Consequently, the Swiss claims of the patent were directly infringed for the same reason that the product claims were directly infringed [256]. Manson J’s approach strikes as preferable. To the extent that Swiss form claims are objectionable as being an end-run around the prohibition on patenting methods of medical treatment, this should be addressed in the substantive law of subject-matter eligibility, rather than through a distorted construction of the claim itself.

With that in mind, there are two other minor points worth noting.

First, Manson J reiterated the need for clarification of the prohibition on patenting methods of medical treatment, though he noted that nothing turned on it in this case [143].

Second, Manson J admitted evidence of the prosecution history to rebut Janssen’s proposed claim construction on a particular point [140-42]. However, this had no effect on the result, as the plain meaning of the claim language supported the same construction as the prosecution history [140]. In effect, the claim on its face said X, during prosecution Janssen asserted that it meant X, the patent examiner evidently accepted that it meant X, but at trial Janssen asserted that it meant Y. This illustrates why the use of prosecution history can add needless complexity to a case; in establishing that a claim does indeed mean what it says on its face, it is not particularly helpful to go back and show that during prosecution the patentee agreed that it meant what it says on its face.