Monday, June 28, 2021

Direct Infringement and Swiss-Form Claims

Hoffmann-La Roche Limited v Sandoz Canada Inc 2021 FC 38 Manson J

2,667,654 / 2,709,997 / pirfenidone / ESBRIET / NOC

Roche’s 654 and 997 patents at issue in this NOC proceeding relate to the use of pirfenidone in the treatment of idiopathic pulmonary fibrosis [IPF]. As discussed in my last post, Manson J held that the asserted claims of both patents were invalid for obviousness and as being methods of medical treatment. This post will address Manson J’s construction of the Swiss-type claims.

The 654 patent claimed a dose escalation regimen, while the 997 patent claimed full dose treatment of a patient who had exhibited liver abnormality after initial treatment. The details of the claims don’t matter for present purposes. Both patents had three distinct claim types [95]–[96]:

            1) “German-style” — “Use of [drug] for treatment of [disorder]

2) “Swiss-style” — “Use of [drug] in the manufacture of a medicament for treatment of [disorder]

3) “Product for use style” — “[Drug] for use in the treatment of [disorder]

Sandoz argued that “Swiss-style claims do not apply in Canada and are properly construed as ‘use’ claims where the alleged invention resides in the use and not in the manufacture or composition of the medicine” [96]. Roche apparently argued that there is a substantive distinction between the claim types, such that Sandoz would be a direct infringer of the Swiss-style claims. (Manson J did not expressly state Roche’s argument.)

Manson J rejected Roche’s approach, saying it “seeks a finding of claim form over substance. In doing so, it obscures the proper approach to claims construction. As discussed above, the claims construction exercise emphasizes a purposive construction” [97] (original emphasis); and similarly, the case law “supports an approach to claims construction which values substance over form” [107].

With respect, it’s not quite right to say that a purposive approach focuses on substance over form—though in saying that, I have to admit that in a previous post on the UKSC decision in Warner-Lambert v Actavis [2018] UKSC 56, I made comments about Swiss-form claims that were very much along the same lines as those as Manson J in this case, so the extent that I am disagreeing with Manson J’s analysis, I am also disagreeing with myself. In any event, the principles of statutory interpretation apply to claim construction by virtue of the Interpretation Act: Whirlpool 2000 SCC 67 [49(e)]. Those principles require consideration of text, context and purpose: Canada Trustco 2005 SCC 54 [10]; Canada v Utah 2020 FCA 224 [9]. Purpose is one consideration, but primacy is given to the text, both in statutory interpretation generally—“When the words of a provision are precise and unequivocal, the ordinary meaning of the words play a dominant role in the interpretive process”: Canada Trustco 2005 SCC 54 [10]— and in claim construction in particular, where “The primacy of the language of the claims was emphatically affirmed in the celebrated case of Catnic Components Ltd. v. Hill & Smith Ltd., [1982] R.P.C. 183 (H.L.)”: Whirlpool 2000 SCC 67 [40]. Thus the purpose and context inform our understanding of the text, but the focus is on the text itself. A purposive analysis may in principle result in some part of the text effectively being read out of the claim, but this is rare in practice and is only done after an explicit essentiality analysis, which was not at issue here.

The main purposive consideration relied on by Manson J was to the effect that the inventive concept was the dose escalation regime: “there is nothing novel about the manufacture or composition of pirfenidone to treat IPF in this case, but only a new dosing regimen of pirfenidone for use in the treatment of IPF” [103]; “The alleged invention in this case resides in the use of pirfenidone, whether in the context of the 654 or 997 Patent, and not in the manufacture or composition of pirfenidone, a known compound” [97]. That’s true enough, but it doesn’t imply that the claim should be construed as a use claim. Manson J’s analysis almost seems to imply that a patentee is restricted to a claim form that directly reflects the inventive concept, and that has never been the law. A claim that does not encompass the inventive concept will normally be invalid for obviousness or anticipation, but there is no general prohibition on adding other elements that narrow the scope. For example, if an inventor discovers a new medical use for a known compound, the inventive concept lies in the discovery of the use. While the patentee will normally claim the use to treat the disorder, the patentee may also claim the product for use in various forms, such as a tablet, capsule, injectable form and a form for parenteral administration, even though none of the various forms involves an additional inventive step. Manson J also referred to the experts’ understanding of the claims expert understanding of the claims as relating to a dose escalation regimen [91], [97]. In effect, they understood the claim as being addressed to the inventive concept. But claim construction is for the court, not the experts, and the fact that a scientific expert ignored the text does not mean that the court should do so.

Why does it matter? Two substantive points are engaged. The Swiss-form claim was originally developed to avoid the European prohibition on patenting of methods of medical treatment. A Swiss claim is to the use of the drug “in the manufacture of a medicament,” and since the physician who prescribes a drug does not manufacture it, on its face, physicians are excluded from the scope of infringement. The rationale currently offered by Canadian courts for the prohibition on patenting methods of medical treatment is to ensure that the patent does not impede the physician in their treatment of their patients, so if Swiss-form claims were successful in excluding physicians from the scope of the claim, it would certainly be a point of substance. However, as the EWCA pointed out in Warner-Lambert v Actavis [2015] EWCA Civ 556 [54], the Swiss-form claim is probably not effective in excluding doctors from the scope of the claim: “As the claim is a process claim [under s 60 of the Patents Act 1977], its direct product, the medicine, is an infringement, and all those who use or dispose of the product will infringe.” The same appears to be true in Canadian law, in light of the Saccharine doctrine: see Hospira 2018 FC 259 [328]. The basic problem is that if a Swiss-form claim is infringed only by the actual manufacturer, then a generic could escape infringement of a Swiss claim by manufacturing abroad (as was argued, and rejected, in Hospira); but since Swiss claims are construed as encompassing the product of the patented process, it follows that the sale and use—including by physicians and patients—will also infringe. The lesson here seems to be that the problem of patentability of methods of medical treatment is not going to be solved by clever claim drafting.

But there is another aspect to Swiss claims. If construed as a claim to the process of manufacture and not solely as a use claim, then the manufacturer would be a direct infringer. This is entirely aside from the issue of whether those who use the product are infringers as well. In this case, the result of Manson J construing the Swiss claim—on its face a process claim—as a use claim, is that even though Sandoz evidently used the process, by manufacturing a medicament for the claimed purpose, it was not liable for direct infringement of the Swiss claim, “as it does not and will not use the Sandoz Products in the treatment of IPF” [108]. That is, the original purpose of Swiss claims was to exclude physicians from the scope of the claim, so that only the manufacturer would be a direct infringer. If Swiss claims are construed as use claims, the result is that the manufacturer is excluded from the scope of direct infringement, while physicians are encompassed—effectively the opposite of the original intent.

Roche therefore was confined to an argument in indirect infringement, which requires (i) direct infringement; (ii) inducement by Sandoz; (iii) knowledge by Sandoz. The direct infringement is that of the physicians and patients, and the knowledge requirement is only that Sandoz knows that its actions will result in direct infringement. The first and third elements will normally be readily established in any case in which the generic makes and sells a product with indications for the specified use, as happened in this case: [142], [123]. The real difference between direct and induced infringement lies in the second requirement. The main issue in this case, as is typical, is whether prescribing physicians read and are influenced by the Product Monograph which directs an infringing use [124]–[141]. If the Swiss claims were construed as process claims, then Sandoz would have been a direct infringer, and it would not have been necessary for Roche to establish that the physicians read and were influenced by the PM. Because the the Swiss claims were construed as use claims, Roche was required to prove that physicians do actually read the Sandoz PM. In this case, Roche was able to establish that at least some phyusicians would consult the Sandoz PM [140], so indirect infringement was established, albeit with an extra evidentiary hurdle.

So, construing the Swiss claims as use claims means that a generic that made and sold a drug intending it to be used for the patented purpose, and which was in fact used for the patented purpose, will not be liable unless the patentee can establish that the physicians read and were influenced by the generic PM. If the facts establish that physicians read the brand PM and rely on their knowledge that the generic product is equivalent, without actually being influenced by the generic PM, the generic will be able to make and sell the drug for the patented use.

As a practical matter, the patentee is usually able to prove that the physicians were influenced by the generic PM, so the result is only to add cost and complexity without changing the result. This would be acceptable if there were some good reason of policy or principle for enabling the generic to escape liability if the physicians rely on the brand PM instead of the generic PM; but I have considerable difficulty seeing any good reason for restricting the scope of infringement in that manner. The requirement of influence makes good sense when the product has a substantial non-infringing use, to ensure that the defendant is not prevented from selling the product for non-infringing uses: see generally Contributory Infringement in Canadian Law (2020) 35 CIPR 10. But why should a generic be permitted to sell a product which it specifically intends should be used to infringe, and which is in fact used to infringe, simply because the physician relies on the brand PM and equivalency, instead of reading the generic PM? In effect, construing the Swiss-type claim as a use claim introduces a substantive limitation on the scope of infringement. Perhaps there is some good policy reason for it, but if so, it should be directly articulated. I have a draft paper “Is 'But For' Causation Necessary to Establish Inducement?” arguing that the law of inducement should be clarified to avoid this result. Unless it is, the construction of Swiss-form claims will remain significant even if the confusion over patentability of methods of medical treatment is eventually resolved.

Friday, June 18, 2021

A New Twist on the Patentability of Method of Medical Treatment

Hoffmann-La Roche Limited v Sandoz Canada Inc 2021 FC 38 Manson J

2,667,654 / 2,709,997 / pirfenidone / ESBRIET / NOC

Roche’s 654 and 997 patents at issue in this NOC proceeding relate to the use of pirfenidone in the treatment of idiopathic pulmonary fibrosis [IPF], a rare, chronic and incurable lung disease [7], [12]. Manson J held that Sandoz would induce infringement of the asserted claims of the 654 patent by making and selling its generic product, but the asserted claims of both patents were invalid for obviousness and as methods of medical treatment. The asserted claim of the 997 patent was also invalid for obviousness-type double patenting. Various other invalidity attacks failed. The obviousness analysis was legally straightforward and turned on the facts. This post will provide background and focus on the patentability of methods of medical treatment, where Manson J has introduced a novel twist into a confusing area of law. Another interesting issue relates to the construction of Swiss form claims, which I’ll deal with in a subsequent post.

It was common general knowledge at the relevant date that pirfenidone was under investigation as a treatment for IPF, and preliminary results were promising though inconclusive [70]. Consequently, the use of pirfenidone for the treatment of IPF could not be claimed. Instead, the 654 patent claimed a dose escalation regimen, intended to minimize side effects [8], [158]. The 997 patent claimed full dose treatment of a patient who had exhibited liver abnormality after initial treatment [10], [182]. The prior art indicated that treatment should be stopped if a patient developed liver function abnormalities with the use of pirfenidone, and the 997 patent disclosed that such patients could still receive the full dose, with suitable monitoring of liver function.

The 654 patent was held to be invalid on a straightforward obvious-to-try analysis, given that it was common general knowledge that a dose escalation regime was one way of minimizing side effects and that there was no particular difficulty in arriving at the claimed regime [166]–[181]. The 997 patent was obvious because management of drug-induced liver toxicity was part of the cgk and continuing treatment while doing so would be an obvious alternative to discontinuing treatment entirely if the benefits outweighed the risks [66(ii)], [190]. The 997 patent was also found to be invalid for obviousness-type double patenting over the 654 patent [148]–[153]. I’m a bit puzzled as to why this argument was run on a double-patenting basis, as the publication date of the 654 patent was June 26, 2008 and the claim date of the 997 patent was November 10, 2008 [9], [11], [153], so the 654 patent was prior art over the 997 patent and so, on Hospira 2020 FCA 30, would have been part of the state of the art against the 997 patent. Perhaps Sandoz felt it was safer to use double patenting rather than to rely on the Hospira doctrine—presumably the 654 patent was not part of the common general knowledge and would not have been discoverable in a reasonably diligent search.

Both patents had three distinct claim types [95]–[96]:

            1) “German-style” — Use of pirfenidone for treatment of IPF

2) “Swiss-style” — Use of pirfenidone in the manufacture of a medicament for treatment of IPF

3) “Product for use style” — pirfenidone for use in the treatment of IPF

Manson J construed all the claims as “use claims” including the Swiss-type claims [107], and consequently did not distinguish between them in assessing whether they claimed unpatentable methods of medical treatment. In this post, I’ll focus on the German-style claims of the 654 patent, which are use claims on their face, so as to avoid any of the tricky claim construction issues that arise with the Swiss-type claims.

Manson J stated that “Patent claims to methods of medical treatment are prohibited in Canada and are not patentable under section 2 of the Patent Act” [195]. This is perhaps now in doubt—see Cobalt 2015 FCA 116 [55]; Hospira 2020 FCA 30 [53]—but it’s well established at the Federal Court level and I won’t pursue the point here. The main battle ground is over what constitutes an unpatentable method of medical treatment: for background see here and here.

Claim 1 of the 654 patent was of the following form (the full claim is reproduced below):

1. Use of X for treatment of disorder Y at a [dosage regimen with fixed dose and schedule]

Manson J held this to be an unpatentable method of medical treatment, essentially for the following reason:

[195] Patent claims are invalid where they prevent or restrict physicians from applying their skill and judgment. . . . . [T]he crucial question remains of whether the 654 and 997 Asserted Claims encroach on the skill and judgment of physicians.

The claimed regimen specified fixed doses and a fixed schedule, and, as Manson J noted, such a regimen will not normally be held to be a method of medical treatment [197]. However, picking up on an obiter comment in AbbVie 2014 FC 1251 [114], Manson J held that a fixed dosage regime is patentable “unless there is evidence to contradict the claimed dosage” [197]. He held that such evidence exists in this case:

[204] [T]he evidence has established that there is a continued need for a physician’s exercise of skill and judgement, as the default dose escalation regimen is not appropriate for all patients taking pirfenidone for the treatment of IPF. There are several anticipated adverse effects and individualized patient characteristics that require the attention of the prescribing physician.

In particular, the specified dose escalation regimen would not be tolerable for all patients [205]; pirfenidone is associated with adverse effects that require individualized assessment [206]; deviations from the regimen might be warranted due to “dietary habits, experienced nausea, a patient’s assessment of the adverse events and frailty” [207].

The main take-away is that whether the claim is to a method of medical treatment doesn’t turn just on the claim itself, but requires a fact-based analysis as to how the treatment is likely to be administered in practice. The question isn’t whether the claim specifies a fixed dosage, but whether a fixed dosage will actually be administered in all cases. This is a novel holding. I wouldn’t say it is a departure from prior law. Rather, the prior cases have implicitly assumed that patentability is determined by the nature of the claimed subject-matter. That is, a claim to “the use of X to treat disorder Y” was considered to be patentable subject-matter, even if the use might be discontinued in practice. That assumption has now been disrupted.

A few observations:

1) This means that you can’t tell by reading the patent whether it claims patentable subject-matter. The question, on Manson J’s analysis, is whether it interferes with the physician’s skill and judgment in fact, not in principle. I find this odd for an attack that turns ultimately on whether the claimed subject-matter falls within a category specified in s 2. In Harvard Mouse 2002 SCC 76 [172], the SCC held higher life forms to be unpatentable in part because of concerns that “innocent bystanders” might inadvertently infringe through adventitious entry (see Harvard Mouse 2002 SCC 76 [172]. Under a fact-oriented approach, we might say that higher life forms are unpatentable if and only if the particular claimed form is likely to escape from the owner adventitiously. Of course, other validity attacks, such as obviousness or anticipation, turn on the facts, so it’s not objectionable in principle that validity should turn on the facts of the case, but it nonetheless seems strange to me for that to be true for subject-matter, though I can’t put my finger on exactly why.

2) The factual inquiry as to whether individualized assessment is necessary either radically disrupts established law or relies on an arbitrary distinction. For example, it is well established that “X for treatment of disorder Y” is patentable subject-matter: Wellcome / AZT 2002 SCC 77 [50]. From the little I know, in fact even AZT requires individualized assessment, eg if tolerance develops. More generally, I suspect that there are very few if any drugs that are well tolerated by 100% of the population and do not require any individualized assessment. If Manson J’s fact-based analysis is generally applicable, as suggested by his statements at [195], claims of the form “X for treatment of disorder Y” are unpatentable if it can be established on the facts that individualized assessment is necessary, or that some patients cannot tolerate the drug at all. If accepted, that would be a revolution in the law, resulting in the invalidation of many valuable patents. I can't imagine it would be very difficult to establish the factual basis for this kind of attack on a use claim, so I expect we will see it in due course. It will be interesting to see what happens.

An alternative would be to say that the fact-based inquiry applies only to claims to a fixed dosage or fixed dosage schedule: Manson J’s remarks at [195] were general, but his statement at [197] was more specific to those types of claims. In that case, the “rule” would be that “X for treatment of disorder Y” is patentable subject-matter regardless of whether individual deviations might be required, but “X for treatment of disorder Y at a fixed dosage” is patentable only if individual deviations are never required. Such a distinction strikes me as entirely unprincipled—though admittedly not more unprincipled than most of the distinctions in this area.

3) Manson J’s basic point was that the claim is unpatentable if it “prevent[s] or restrict[s] physicians from applying their skill and judgment.” This is the usual rationale for the restrictions on methods of medical treatment in the Federal Court caselaw. The difficulty with this rationale is that it isn’t consistent with the patentability of claims of the type “X for treatment of disorder Y.” As I noted in a previous post, the claim at issue in Wellcome / AZT was to a formulation comprising “an effective amount” of AZT ('277 claim 22). In the context of a use claim without any specific dosage regime, that effective amount must be determined by the physician in the exercise of their skill and judgment. Indeed, the SCC expressly held that the claims at issue were not unpatentable methods of medical treatment on the basis that the physician was left free to exercise her skill and judgment: “How and when, if at all, AZT is employed is left to the professional skill and judgment of the medical profession” [50]. If claims of the form “X for treatment of disorder Y” don’t restrict physicians from applying their skill and judgment, then I don’t see how claims of the form “X for the treatment of disorder Y according to fixed dosage regimen” are any different. Adding Manson J’s point that an individualized assessment may be required to decide whether the claimed use is appropriate doesn’t make it any easier to reconcile this holding with Wellcome / AZT. To paraphrase, “How and when, if at all, [the claimed fixed dosage regimen] is employed is left to the professional skill and judgment of the medical profession.” That is precisely the reason given by the SCC in Wellcome / AZT for holding the claimed use was not a method of medical treatment and I can’t see how the point is any different when a fixed regimen is claimed instead of a use.

In making these observations I mean no criticism of Manson J, who had the unenviable task of applying incoherent principles in an inconsistent area of law. As the Court of Appeal has recognized, and as Manson J recognizes in this decision [195], the law relating to what constitutes an unpatentable method of medical treatment is confused and inconsistent at best. Manson J’s basic point that a claim is unpatentable if it encroaches on the skill and judgment of physicians strikes me as unpersuasive, but it is certainly not new: see eg Janssen / galantamine 2010 FC 1123 [55]. Indeed, it is the main justification for the rule against patentability of methods of medical treatment. With that said, the fact-based analysis undertaken by Manson J adds a new twist to an already twisted area of the law. It will be interesting to see what happens if someone tries to run this kind argument in respect of a more standard claim to “X for the treatment of Y.” I doubt that argument would succeed, but given the state of the law, anything is possible.

More broadly, this decision illustrates how incoherent this area of the law is. It also shows that the issue isn’t going to go away on its own. We will be facing incoherent and inconsistent decisions on this issue until the Court of Appeal takes it up. In Hospira, the FCA articulated a willingness to do so in the appropriate case. I rather doubt that this will be the case, given the holding on obviousness, but this will be worth keeping an eye on if it goes to the FCA.

Thursday, June 10, 2021

Second Person Not Strictly Bound by NOA

Sunovion Pharmaceuticals Canada Inc v Taro Pharmaceuticals Inc 2021 FCA 113 Locke JA: de Montigny, Rivoalen JJA affg 2021 FC 37 Furlanetto J

2,538,265 / 2,696,510 / 2,814,828 / lurasidone hydrochloride

In this decision the FCA has held that under the new NOC Regs a second person is not strictly limited to the infringement and invalidity allegations set out in its NOA, as was the case in the old proceedings. This holding was based in large part on an express statement in the RIAS accompanying the amendments that the requirement to set out the legal and factual allegations in the NOA “does not circumscribe or otherwise limit the issues and arguments that may be raised in a proceeding brought under the Regulations” [5].

Locke JA acknowledged the concern that this might make it difficult for a patentee to assess its risk when deciding whether to respond and might also lead to case splitting. The FCA agreed with Furlanetto J that there are two checks on this problem. First, the discretion afforded under s 8(6) of the Regs, permits the Court to consider whether the first person was improperly influenced to start an action because of an incomplete NOA as a factor in assessing s 8 compensation: [7]. The second check is the Court’s discretion to grant or dismiss a motion to amend a pleading. “If a Court is convinced that a proposed amendment seeks to introduce invalidity allegations of which the moving party was aware when its NOA was served, the Court may dismiss the motion on the basis that permitting the amendment would not serve the interests of justice” [8].

Monday, June 7, 2021

Potentially Conflicting Decisions of the Re-examination Board and the Federal Court

Teva Canada Innovation v Pharmascience Inc 2021 FC 367 Southcott J

2,760,802 / glatiramer acetate / GLATECT

The Patent Act s 48.1- 48.5 provide for the re-examination of granted patents by a Patent Office Re-examination Board. The Act does not, however, address the interaction between Board proceedings and parallel Federal Court litigation. As discussed here, two FC decisions, Prenbec 2010 FC 23 and Camso 2016 FC 1116, have granted a stay of re-examination proceedings pending a decision in parallel FC litigation. In the present decision Southcott J has again granted a stay of an ongoing re-examination proceeding in light of parallel FC litigation. Southcott J’s decision is entirely consistent with Prenbec and Camso, but clarifies some additional points while deliberately leaving open some other important questions. In particular, even while the re-examination proceeding is stayed, it is not terminated, and the Board will eventually render a decision [26]. What happens if the decision of the Board is inconsistent with that of the Federal Court? That is a very real prospect in this case.

A few preliminary points. The court in Prenbec held that the Federal Court has jurisdiction to order a stay of the Board’s re-examination proceedings using the standard RJR-MacDonald [1994] 1 SCR 311 test, and parties since have accepted this: [11], Camso [18]. This point therefore seems reasonably well established.

A second point is procedural. The Board in this case issued two “preliminary opinions,” the first on 17 June 2020 and the second on 22 February 2021. So far as I can tell, there is no express basis in the Act or Rules for such preliminary opinions. There is, however, an implicit basis. Section 48.3(2) allows the patentee to propose amendments as part of the procedure (so long as they do not enlarge the scope of the claims); but how can the patentee know to make an amendment unless it has some idea of what the Board thought about the original claims? So, the re-examination procedure is in effect a kind of limited re-prosecution, and the preliminary opinions were in the form of a letter to counsel for the patentee, inviting the patentee to propose new or amended claims in response.

Third, the Attorney General, on behalf of the Board, consented to the motion, and indeed made submissions in support. Evidently the AG is also concerned about the possibility of inconsistent decisions and is not seeking to prioritize the Board over the Federal Courts as a venue for patent adjudication.

On to the substantive issues. The 802 patent related to a particular dosage regimen for glatiramer acetate. Teva is the licensee of the 802 patent under the patentee, Yeda. Pharmascience is seeking to market a generic version and so served Teva with a notice of allegation [3]. While that action was underway, Pharmascience filed for re-examination. It was undisputed that the Re-examination Proceeding and the Federal Court litigation were largely duplicative, as the same issues and substantially the same prior art were at issue in both [22].

There is a twist on the facts in this case as compared with Prenbec and Camso. In those cases, there were parallel proceedings in the Board and Federal Court, but no final decision in either. In this case, a trial decision has been issued, upholding the validity of the asserted claims of the 802 patent: Teva v Pharmascience 2020 FC 1158 Kane J. That decision is under appeal, and what Teva sought was a stay of re-examination pending the outcome of the appeal.

Two main factors influenced Southcott J to grant the stay. First, he agreed with the reasoning in Camso and Prenbec that as between the two proceedings, the FC litigation should be favoured, on the basis that “Federal Court litigation generates a more comprehensive evidentiary record than does a re-examination proceeding” [35]. The main advantage of re-examination is speed and simplicity, but the more limited record means that in principle there is a trade-off with accuracy. Moreover, in this case, there has already been a FC decision, so there is not a choice as to which to stay in order to avoid inconsistent results, but only whether to stay the re-examination proceeding [36].

Pharmascience argued that the fact that the FC decision had been issued was a reason to refuse the stay, on the view that the purpose of the stay is to give the Board the benefit of the FC decision in coming to its own conclusion. Southcott J rejected this argument on the basis that to the extent the Board would be influenced by the parallel litigation, a final appellate decision would be important [37], [38].

Now, on the facts, it seems unlikely that the Board will be influenced by the FCA decision. The FC decision upholding the validity of the 802 patent was issued after the Board issued its first preliminary opinion indicating it intended to hold the patent invalid for obviousness. Kane J’s decision was released after that first preliminary decision, and Teva duly brought it to the attention of the Board. The Board then issued its second opinion, which began by expressly acknowledging that it had been notified of Kane J’s decision. The Board then said, in effect, that it would decide on the record before it, without reference to the FC decision, and it went on to again opine that the patent was invalid, without further reference to Kane J’s decision. The AG, who appeared on behalf of the Board, confirmed “the Board adjudicates matters based on the record before it, not by incorporating findings of fact by another decision-maker” [29]. Given that the Board was not influenced by the FC decision as a matter of principle, it seems very unlikely that it would be influenced by the FCA decision. This point of course did not escape Southcott J, who considered that a final appellate decision was desirable “to the extent the result in the litigation has any potential to influence the Board’s decision” [38].

So, it seems unlikely that the FCA decision will be considered by the Board, which suggests that providing the Board with the FCA decision is not a very compelling reason to grant a stay.

But there is another important factor considered by Southcott J [38]. If the Board is not inclined to take account of FC/FCA decisions, this means that there is a very real prospect of inconsistent decisions if the FCA affirms Kane J, which would be unsurprising given that her decision on the 802 patent turned largely on the facts. As just noted, it would appear that the problem of inconsistent decisions cannot be addressed by simply asking the Board to consider the FCA decision; it will have to be forced to do so, on the basis of issue estoppel, res judicata, or like principles [38]. But for issue estoppel to apply, the prior decision must be final [38]. (Apparently this includes any appeals, though I have not verified the jurisprudence on that point myself.) This was an additional reason why Southcott J decided to grant the stay [38].

Pharmascience argued that it would not be necessary to rely on issue estoppel to address the problem of inconsistent decisions, because Teva would have a right to appeal the Board decision under s 48.5 and the Board decision would be stayed pending appeal under s 48.4 [44]. However, Southcott J observed that an appeal “is not a hearing de novo and therefore does not necessarily represent a means of remedying inconsistencies resulting from the duplicative litigation” [46]. An appeal where issue estoppel cannot be argued would therefore not address the problem.

Southcott J accordingly granted the stay. Skipping over Southcott J’s careful consideration of the other aspects of the RJR-MacDonald test, this raises some interesting issues of remedy.

One relatively easy point is that Southcott J accepted the AG’s unopposed suggestion that the stay expire on discontinuance of the appeal or settlement by the parties, as well as on the appeal decision being granted [56].

The more difficult point is that the stay at best mitigates the risk of inconsistent results [36]. As noted above, the Board decision is stayed pending appeal, but not terminated [26]. If the FCA upholds Kane J’s decision, the Board will then render its decision, which will likely invalidate the claims. Apparently to address this, the AG also suggested that the Board, upon the stay being lifted, be directed to consider whether the doctrine of issue estoppel, or similar legal principle, applies to preclude the re-litigation of issues previously decided by the FC [57]. Southcott J declined to make such an order, noting that the question of the application of issue estoppel is already before the Board, having been raised by the parties, and as a matter of administrative law it would be inappropriate for the Court to weigh in on that question until it had a mandate to do so [58]. So, the real point of the stay is to ensure that when the Federal Court is faced with an appeal from a Board decision invalidating the patents, it will have the possibility of issue estoppel available in its toolkit to address the problem of inconsistent decisions. This is not to say that the Federal Court would necessarily choose to invoke issue estoppel, but it would be undesirable to foreclose that possibility.

The bottom line is that the stay was granted, but the problem of how to deal with inconsistent decisions between the Board and the Federal Court remains unresolved. The question might be answered in future installments of this litigation, if the FCA upholds Kane J’s decision in this case and the Board then issues an inconsistent decision.

Thursday, June 3, 2021

Can the Scope of the Claim Grow Over Time?

Merck Sharp & Dohme v Wyeth 2021 FC 317 Gagné ACJ

2,604,363 / 2,650,056 / 2,803,111 / pneumococcal polysaccharide protein conjugate vaccine / PREVNAR 13

Wyeth’s 363 patent relates to a pneumococcal polysaccharide protein conjugate vaccine that is effective against 13 serotypes. The 056 and 111 patents are related formulation patents. Merck was concerned that Wyeth would use its patents to block the Merck V114 vaccine, which is effective against 15 serotypes [5], and accordingly brought this impeachment action. A key issue was therefore whether the 363 patent, in particular Claim 1, was limited to 13 serotypes [49]. This turned on what strikes me as a tricky issue of claim construction.

As I understand it, capsular polysaccharides are the major components on the surface of bacteria. Different serotypes have different polysaccharide cell-surface antigens. A protein conjugate vaccine is a substance that is composed of a polysaccharide antigen fused (conjugated) to a protein carrier molecule. The protein carrier substantially enhances the immune response. It is desirable to have as many different serotypes as possible covered by a single vaccine, and since 2000, efforts have been underway by various parties to develop protein conjugate vaccines that are effective against multiple serotypes. The first, released by Wyeth in 2000, was effective against 7 serotypes [17]. This was subsequently bumped up to 9 by Wyeth, 11 by DSK and Aventis, then 13 by Wyeth and now 15 by Merck [18]–[21]. Wyeth’s favoured carrier is a protein known as CRM197.

Claim 1 of the 363 patent is as follows:

A multivalent immunogenic composition, comprising 13 distinct polysaccharide-protein conjugates, together with a physiologically acceptable vehicle, wherein each of the conjugates comprises a capsular polysaccharide from a different serotype of Streptococcus pneumonia conjugated to a carrier protein, and the capsular polysaccharides are prepared from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, wherein the carrier protein is CRM197

As you can see, the claim itself specifically lists 13 serotypes. Wyeth nonetheless argued that the claim extended to vaccines with more serotypes, on the basis that the word “comprising” means “included but not limited to” [54]. Substantively, Wyeth argued that it had invented a “platform” which could be used to add other serotypes [52].

As I understand it, Merck accepted this interpretation of the word “comprising” but argued that the claim was nonetheless limited to 13 serotypes by the “wherein” clauses [55]. Gagné ACJ accepted Merck’s construction, but without directly accepting the argument as to the limiting effect of the “wherein” clauses.

Gagné ACJ rejected Wyeth’s argument for a number of reasons. First, “In Purdue Pharma v Canada (Attorney General), 2011 FCA 132 at para 22 [Purdue Pharma] the Federal Court of Appeal held that even if the word “comprising” used in claim language could be regarded as open-ended, the inclusion of other elements requires some justification. The basis for such an inclusion must be found within the confines of the patent. No such basis existed in Purdue Pharma, and none can be found in the 363 Patent” [22]. I didn’t like that aspect of the Purdue Pharma when I blogged on it, and I still don’t like it in that context, in part because claim construction is more certain if we accept that “comprising” has a definite meaning. Moreover, “comprising” is and should be used to encompass the addition of elements that have no effect on the invention. It is therefore problematic to require that “There must be a basis for it within the confines of the patent” [Purdue Pharma 22], because elements that have no effect on the invention are unlikely to be mentioned or contemplated.

With that said, I find the point much more persuasive as Gagné ACJ used it in the context of this claim. It is really a stretch to argue that “comprising” encompasses additional serotypes, even though that is grammatically consistent with its normal meaning of “included but not limited to.” As just noted, “comprising” is normally used to encompass ancillary components, or at least unforeseen improvements. In this case, 90 other serotypes were known at the time, and 50 had a known structure [53], [60] and presumably these were in the contemplation of the drafter at the time. If the drafter had intended to claim a “platform” encompassing some of these other serotypes, that would have been very easy to do, for example by saying that the capsular polysaccharides are prepared from serotypes “including” the 13 listed.

Gagné ACJ also relied on the fact that the disclosure was specific about the 13 serotypes that were included: “There is no mention in the 363 Patent of a need, a desire, or a basis for adding any other serotype,” even though “some 90 serotypes were known at the time” [60]. Now, strictly these observations might be considered to be reading limitations from the specification into the claims, but if Wyeth had really intended to claim a platform, presumably it would have made some kind of explicit reference to the additional serotypes, even if only in broad language to the effect of “the compositions of the invention may also include other known serotypes.” So, the specification expressly stated that “The compositions of this invention may further include one or more additional antigens for use against otitis media caused by infection with other bacteria,” and went on to specify other suitable antigens by name (p16). If the drafters contemplated completely different antigens, they must have been contemplating other S pneumoniae serotypes. But there is no hint of that, apart from the consistent use of the word “comprising” in the disclosure. This again goes to the point that if the drafter had really intended to claim a platform, they would have thought of this, and it would have been very easy to do.

As noted, Gagné ACJ didn’t appear to rely on Merck’s argument that the “wherein” clauses have a limiting effect. I am inclined to agree. The real question is whether the list of 13 serotypes should be considered exhaustive, and I don’t really see how “wherein” addresses that, one way or the other. That is, if the claim stated that the capsular polysaccharides are prepared from serotypes “including” the 13 listed, we wouldn’t have any problem construing it as encompassing other serotypes, “wherein” notwithstanding.

So, while I don’t see any easy knockdown argument, I largely agree with Gagné ACJ’s analysis. My only real quibble is that Gagné ACJ also noted that if Wyeth’s construction were accepted “It would also mean that the ambit of Wyeth’s monopoly could grow over the life of the 363 Patent as new serotypes – or their structure – are discovered. This would be contrary to the fundamental principles of claims construction (Free World at para 57)” [66]. With respect to the SCC, this is not a fundamental principle of claims construction. I addressed this in my article “What does Actavis v Lilly Mean for Canadian Law? (Part II) (2019) 31 Intellectual Property Journal 267 at 289. I excerpt part here, without footnotes:

The difficulty with this logic is that it is exceedingly well established that a claim may indeed encompass after-arising technology, even if that new technology is a patentable improvement. As Bowen LJ remarked more than a century ago, in Wenham Gas Co Ltd v Champion Gas Lamp Co, “The superadding of ingenuity to a robbery does not make the operation justifiable.” This rule has since been applied in many cases, including the Supreme Court’s own decision in Grip Printing, in which the Court held that there was infringement, notwithstanding that the variants might have been improvements, in the face of the respondent’s argument that there is no infringement if the defendant uses an article that “was not known as an equivalent at the date of the patent.” The same rule was also recognized by Lord Hoffmann in Kirin-Amgen, who remarked that “[t]here is no difficulty in principle about construing general terms to include embodiments which were unknown at the time the document was written.” To my knowledge, the rule that after-arising technology may infringe has never been doubted.

The rationale is simply that it is an infringement to take the essential elements of the patented invention, and it does not matter whether other elements are added or subtracted. This is evidently true when the variants are trivial, but it is equally true when the variant is inferior, and it remains true if the variant happens to work better than the original, whether the improvement is minor, or so substantial as to merit its own patent.

Of course, that is a criticism of the SCC, not of Gagné ACJ, who is entitled to rely on SCC precedent, but nonetheless, that precedent is shaky.

Tuesday, June 1, 2021

“[I]t Is Not Obvious That [Windsurfing / Pozzoli] Has Been Useful”

Apotex Inc v Shire LLC 2021 FCA 52 Rennie JA: de Montigny, Gleason JJA affg 2018 FC 637 Fothergill J

            2,527,646 / lisdexamfetamine [LDX] / VYVANSE / NOC

 In Sanofi 2008 SCC 61 [67], the SCC endorsed the four-step Windsurfing / Pozzoli approach to the obviousness determination. In Bristol-Myers 2017 FCA 76 [64] Pelletier JA remarked that “It is true that the Windsurfing / Pozzoli framework does provide structure but it is not obvious that it has been useful.” In this post I will argue that the trouble lies with the Windsurfing / Pozzoli framework itself, which is unhelpful, confusing, wrong and rarely actually applied as it was originally framed.

In Bristol-Myers 2017 FCA 76 [65] Pelletier JA remarked that the obviousness analysis asks “whether the distance between two points in the development of the art” can be bridged by the skilled person. The problem addressed in Bristol-Myers, Ciba 2017 FCA 225 and Vyvanse, has been how to define this “second point.” The second and third steps of the Windsurfing / Pozzoli framework are aimed at defining this second point, and the question is whether it is a helpful way of doing so. I’ll argue that it is not. It works well enough in easy cases—where it is also unnecessary. In the more difficult cases, it is at best an unhelpful distraction and potentially misleading. For the most part, the FC/FCA have used a sound intuition borne of experience and sound intuition to define the end point of the obviousness inquiry, but the courts success in this respect has been despite the Windsurfing / Pozzoli framework, not because of it.