When can a range anticipate a point?

AbbVie Corporation v JAMP Pharma Corporation 2023 FC 1520 McVeigh J

2,504,868 / 2,801,917 / 2,904,458 / adalimumab / HUMIRA / SIMLANDI

The most important aspect of this case was McVeigh J’s refusal to grant a permanent injunction to the successful patentee. I will discuss that in a separate post. McVeigh J also had a brief discussion of double patenting, which I discussed in a previous post that focused on NCS v Kobold 2023 FC 1486. This post provides an overview and addresses some miscellaneous issues, including McVeigh J’s brief but helpful discussion of as to when prior art that discloses a range can anticipate a point within a range.

This case involved three patents related to adalimumab, which is well known under the brand name HUMIRA for treatment of rheumatoid arthritis, inflammatory bowel disease (IBD) and psoriasis. The 868 patent relates to a dosing regimen for a known use (the treatment of IBD). McVeigh held the 868 patent to be invalid as being obvious to try [303], though an attack based on patentable subject matter failed [339]. The 917 patent relates to a second medical use — the treatment of hidradenitis suppurativa (HS) — and a dosing regimen. It seems that the use of adalimumab to treat HS was known [400], so the key issue, as with the 868 patent, was whether the dosing regimen was obvious. McVeigh J held on the facts that it was [402]. An attack based on patentable subject matter failed [413]–[415]. There was also an unusual attack based on “Claim term not described” which I will come back to. The 458 patent related to an adalimumab formulation, which McVeigh J found on the facts to be not anticipated [559] and not obvious [591]. Attacks based on overbreadth [592]–[603] and double patenting [604]–[620], also failed.

Identical Witness Statements

As discussed here, in dTechs 2023 FCA 115 [32], [34], the FCA addressed the role of counsel in the preparation of expert reports. Gauthier JA noted that while it is not unusual for expert reports to be prepared “in close collaboration with counsel,” this is not normally a significant problem, so long as the Court is ultimately “presented with the substantive and objective opinion of the expert.” Gauther JA also noted that “While counsel may make mistakes and overstep the bounds of what is permissible involvement, this will normally be revealed on cross-examination at trial, and will be considered by trial courts in assessing the evidence” [34]. Something along those lines happened here, albeit with a fact witness:

[210] Dr. Noertersheuser suffered significant credibility issues. It became apparent during his cross-examination that much of his statement was nearly identical, or word-for-word the same, as a witness statement made by Dr. George Richard Granneman on December 18, 2017 in US litigation. While this is not, in and of itself, hugely problematic, his responses on cross-examination reduced his credibility. He attempted to explain that perhaps he and Dr. Granneman had written identical statements because of how closely they had worked together in the past. He said they worked side by side and discussed things back then, and that must have been the reason they wrote identical statements. He was asked several times and confirmed that he independently came up with the exact same words but that he never copied. This is clearly inaccurate, and he would have better served the Court by admitting the statements were copied, instead of trying to claim that it was sheer coincidence.

[212] Unlike in Rovi, Dr. Noertersheuser was not an expert witness. Nonetheless, the word-for-word copying of Dr. Granneman’s report raised significant concerns about Dr. Noertersheuser’s impartiality. His inability to accept or acknowledge the paragraphs were word-for-word the same greatly impugned his credibility and reliability.

[215] The similarity between Dr. Noertersheuser (fact witness) and Dr. Granneman’s expert report went well beyond the appropriate limits. I will assess Dr. Noertersheuser’s evidence with some caution when it is in disagreement with other witnesses.

Treating his evidence with “some caution” is a very measured response.

Blinding the Witness

Over the past decade there have been various attempts to enhance the credibility of an expert on issues such as claim construction or obviousness by not informing the expert of the party’s position when they write their report. While some earlier decisions supported this practice, the trend more recently has been to be skeptical, generally on the view that the substance of the report is more important than whether the witness was blinded. Another concern is that it may impossible to truly blind a person who is an expert keeping abreast of developments in a particular field: see eg Hospira 2018 FC 259 [203]. That problem arose in a particularly acute form in this case, when one of the experts who had been ‘blinded’, forgot that she had previously provided expert evidence in another matter involving the 868 patent [247]–[249], [252]. McVeigh J expressed skepticism of the worth of the blinding process, saying “I rely on Dr. Baughman’s evidence, not for the fact that it was blinded but for the reasoning it provides” [250]. McVeigh J did not fault Dr. Baughman, whom McVeigh J found to have sincerely failed to recall her prior involvement”; nonetheless, while she did accept the evidence as credible and reliable, she only assigned a moderate weight to it [252].

When can a range anticipate a point?

The parties disagreed “as to whether prior art that discloses a range can anticipate a point within a range or embodiment. For example, has disclosure occurred if the range is 0.2-400 mg in the prior art, and the subsequent patent claims about 10 mg or a narrower range such as 0.10-100 mg” [157]. JAMP relied on several recent cases in which “the Federal Court held a range or a broad disclosure can anticipate a point within a range or an embodiment” [158]. After reviewing those cases, and discussing several blog posts in which I have argued that these decisions were clearly wrong, McVeigh J concluded as follows:

[173] I find that the law has developed that, where the evidence presented at trial shows that the range is narrow enough, such that a flag can be planted based on the context and examples given, then it is anticipated. If the evidence shows a very broad range that the Judge, with the experts’ assistance (if needed), does not see it as a precise enough to plant the flag before proceeding to the enablement stage, then it fails at the disclosure stage.

This statement of the law strikes me as sound and helpful (though I’m not sure it actually explains the prior cases or whether McVeigh J intended it as doing so). It is consistent with the EPC Examination Guidelines G.VI.8, which also strike me as sound:

A sub-range selected from a broader numerical range of the prior art is considered novel if both of the following two criteria are satisfied (see T 261/15):

(a) the selected sub-range is narrow compared to the known range;

(b) the selected sub-range is sufficiently far removed from any specific examples disclosed in the prior art.

The meaning of "narrow" and "sufficiently far removed" has to be decided on a case by case basis.

McVeigh J also applied her analysis to the facts in two instances, both holding that there was no anticipation.

JAMP argued that the asserted claims of the 917 Patent were anticipated by the 868 application [383]. Recall that the 917 patent relates to the use of adalimumab, a TNFα inhibitor, to treat HS according to a specified dosing regimen. The 868 application disclosed the use of TNFα inhibitors as a means of treating 16 broad categories of disorders, including HS, and presenting a large class of dosing elements with numerous choices for the specific TNFα inhibitor, the number of loading doses, the amount for each loading dose, the interval between loading doses, the interval between loading and maintenance dose (one hour, one day, one week, two weeks) and the amount of maintenance dose [387]. So, “a skilled person reading the 868 Application would have a range of dose amounts, dosing intervals, and durations of treatment to choose from when creating a multiple variable dosing regimen to treat an inflammatory-related disorder” [388]. In contrast, the 917 Patent claimed a much more specific dosing regime [389]. McVeigh J invoked her para 173 analysis [385] and concluded:

[390] Given the number of dosing elements disclosed in the 868 Application, it is not clear that a POSITA would know to select adalimumab and to administer it using the specific dosing regimen claimed in the 917 Patent. If the POSITA reading the prior art reference must adopt a specific way forward in order to infringe, yet there are numerous other ways to perform the prior art without necessarily infringing, then there is no disclosure: Shire [2021 FCA 52] at para 50.

This strikes me as straightforwardly correct, and consistent both binding jurisprudence, such as Shire and with McVeigh J’s summary statement at [173].

JAMP also argued that the asserted claims of the 458 Patent, claiming a formulation of adalimumab, were anticipated by the 181 Application, titled “Self-Buffering Protein Formulations” [539]. The 181 Application listed adalimumab among the proteins:

[545] The most preferred protein concentration range in the 181 Application is 20-150 mg/mL. This is a very large range. For the four proteins tested whose test results appeared in the 181 Application, there were concentrations of 90 mg/mL and 110 mg/mL which proved to be self-buffering within pH ranges which included 5.2. But there were other ranges tested too, and none of these proteins were adalimumab. Moreover, in the claims section of the 181 Application, these proteins are not introduced in the same claim as adalimumab and there is no indication of dependency between the claims that introduce these proteins and the claim which refers to adalimumab.

[546] As mentioned above, a range does not always anticipate a point, but it could if dependant on the facts of the particular patent. This is even truer where the range is very large or broad. Accordingly, I do not see how a range of protein concentration from 20-150 mg/mL can plant a flag at the specific concentration of 100 mg/mL, especially where specific examples of formulations given do not include the relevant protein.

Accordingly, she held the 181 application did not anticipate. Again, this strikes me as straightforwardly correct, and consistent both the binding jurisprudence and with McViegh J’s summary statement at [173].

Methods of medical treatment

It is still black letter law that methods of medical treatment are not patentable subject matter, though the jurisprudential basis for that proposition is shaky: see Hospira 2020 FCA 30 [48]–[49] (discussed here). However, no one really knows what a “method of medical treatment” is. That’s because there is no clear principle underpinning the rule. The rule was originally set out by the SCC in Tennessee Eastman [1974] SCR 111, primarily on the very logical basis that allowing patentability of methods of medical treatment would allow an end-run around what was then s 41, which restricted patents for medicine to product-by-process claims. Section 41 has since been repealed, but Tennessee Eastman had a tantalizing dictum — “I do not think so” — suggesting there might be more to it than that. Subsequent decisions of the SCC suggested that the bar might turn on the “essentially non-economic” nature of the methods of medical treatment: see Hospira 2020 FCA 30 [49], discussing Shell Oil [1982] 2 SCR 536, 554 and Wellcome / AZT 2002 SCC 77 [49]. But no one really knows what it means to say that professional skills are essentially non-economic. (Try telling that to a lawyer.)

In any event, the best current theory is that a claim that encompasses the skill of a medical professional is unpatentable. To say it’s the best theory is not to say it’s a correct theory, or even a good theory — see Hospira [51]–[52] — but that’s more or less where we are now. The problem is that no one really knows what it means for a claim to encompass the skill of a medical professional. As a result, we are all flailing in trying to give some kind of content to the putative rule that methods of medical treatment are unpatentable.

In this case, JAMP argued that the claims of the 868 and 917 patents, both directed to dosage regimens, were invalid as being directed to a method of medical treatment that requires the exercise of professional skill or judgment [332] saying that:

[333] where there is evidence that the dose would be changed over time in response to a patient’s needs, then that regimen is vulnerable to an attack on the basis that is an unpatentable method of medical treatment. In JAMP’s view, the dosing regimen must be appropriate for all.

McVeigh J rejected this argument, quoting the decision of Manson J in Janssen 2022 FC 1218 [171] (discussed here) to the effect that if a physician departs from the claimed dosage regimen “they would no longer be practicing the claimed invention” [338]. She followed this reasoning, concluding that “to the extent a minority of physicians wish to deviate from the claimed regimens at some point, this does not render the claims unpatentable; rather, it takes their conduct outside the scope of the patents like in Janssen” [339]. See similarly [413]–[415] respecting the 917 patent.

More broadly, this suggests that the incoherent state of the law has made the Federal Court wary of striking down patents on the basis that they claim unpatentable methods of medical treatment. This wariness strikes me as being entirely appropriate. This bar on patentability has no basis in the Act. While the courts can and do read text into a statute, this is normally done only after a careful purposive interpretation shows that adhering to the text would lead to an absurd or otherwise unacceptable result. The courts are right to be reluctant to use a judge-made doctrine to strike down a patent for an invention which is otherwise new, useful and non-obvious, without some clear principled basis for doing so.

Doses not subject to discretionary adjustment

The 917 patent claimed a dosage regimen “wherein said multiple doses are not subject to any discretionary adjustment by a physician or medical practitioner” [380]. This phrase was added by AbbVie during prosecution to overcome an examiner objection that the claim was to a method of medical treatment because it limits the professional skill or judgment of a physician [441]. The issue came up as part of an added matter attack, which I will return to below. For now, I’ll just point out McVeigh J’s remark that “AbbVie’s addition did not change claim 1, nor does it broaden the claim. Claim 1 would have had the same effect, with or without the additional statement” [443]. This is a relief. I don’t want to get too far into the weeds of how this phrase might be construed. (Surely any dosage regimen is subject to discretionary adjustment in some cases, eg if the patient has an unexpected life-threatening reaction to the first dose—would that mean all claims with that phrase would be invalid?) The larger point is that McVeigh J’s statement suggests that the issue of patentability of methods of medical treatment will be decided on substantive grounds, not by trying to make the issue disappear with drafting slight of hand. When the law is settled, but unworkably, it may be necessary to allow the use of drafting methods to get around the black letter law, as was done with Swiss form claims. But that is a second best solution. It is better to get the substantive law right in the first place, and the law on patentability of methods of medical treatment is currently sufficiently unsettled to allow us to try to do that.

Added matter

JAMP attacked the 917 patent for failure to comply with s 38.2(2): see [192]–[197], reviewing the law, and [416]–[444], further reviewing the law and applying it to the facts. This attack was referred to as a “Claim Term Not Described,” but I’ll call it an “added matter” attack, as is this the conventional term for the parallel issue in UK law. The issue arises regularly in UK law, because claim amendments are permitted in litigation, and the question is whether the amended claim impermissibly adds new matter. There is limited Canadian caselaw on this provision, with the main authority being Western Oilfield 2021 FCA 24 (discussed here).

38.2(2) provides as follows:

The specification and drawings contained in an application, other than a divisional application, may not be amended to add matter that cannot reasonably be inferred from the specification or drawings contained in the application on its filing date.

One issue that was raised was whether this provision can be the basis for an invalidity attack, or whether it is purely procedural.

After reviewing the authorities, including Western Oilfield, McVeigh J concluded that “the law currently stands, it is unclear whether a patent is invalid when a party adds a claim term that cannot be reasonably inferred from the specification or drawings” [197]. Western Oilfield is perhaps a bit ambiguous. The main issue was the nature of the test for whether the new matter could be inferred, and specifically whether the Canadian courts should follow the “strict” UK test. One reason for wariness given by the FCA was that “the U.K. provision provides explicitly for patent revocation. Section 38.2 does not” [143]. McVeigh J took this as a hint that perhaps invalidity is not a remedy for failure to comply with s 38.2(2), as I did I in my post on that aspect of Western Oilfield, where I said that Locke JA’s statement “raises the question of whether added matter contrary to s 38.2 is a basis for invalidating a claim in a granted patent, or whether it is only ground for refusing an amendment during prosecution.”

On re-reading, I don’t think that is what Locke JA was suggesting. As noted, the discussion was in the context of whether the strict UK test for inferability should be followed. The full paragraph was:

[143] The third reason to be wary of the strict U.K. test is that the U.K. provision provides explicitly for patent revocation. Section 38.2 does not. On the contrary, subsection 38.2(1) provides that, subject to certain limitations, a patent application may be amended. The provision of particular interest in the present appeal, subsection 38.2(2), provides for one of the contemplated limitations.

I think Locke JA’s point is that because an amendment is explicitly permitted, we should be wary of being too restrictive in permitting such amendments. That does not imply that invalidity is not the remedy when the amendment is not permitted, even under a more relaxed test. The FCA in Western Oilfield went on to hold that the amendment was reasonably inferable [147], so the Court did not explicitly address the remedy for failure to comply with this provision.

I’d also note that s 72 of the UK Act exhaustively states the grounds for invalidity of a patent, including that the invention is not patentable (72(1)(a)), which includes anticipation or obviousness, as well as added matter (72(1)(d)). The Canadian Act has no equivalent. Section 60 simply provides that patent may be declared invalid or void, but without listing the specific grounds, and s 59 is the same. And s 28.2, for example, dealing with novelty, only says that subject matter “must not” have been disclosed, but does not say explicitly that a claim may be invalidated on that basis. So, given that there is no provision in the Canadian Act expressly stating that a patent may be held invalid for anticipation, obviousness, inutility or insufficiency, the fact that there is no provision expressly providing that a patent may be held invalid on the basis of 38.2 does mean much. This is another reason for thinking that this comment by Locke JA was not intended to question whether invalidity was the appropriate remedy for failure to comply with 38.2(2).

In any event, while McVeigh J did not consider the matter settled by Western Oilfield, she went on to hold that when an amendment is made in violation of 38.2(2), a claim is indeed invalid [434]. This seems to me to be clearly correct. Suppose I invent the wheel and file an application fully disclosing and claiming the wheel. Then, after I filed, but before my patent is granted, someone else publicly discloses how to make and use mRNA vaccines. I then amend my application to disclose and claim how to make and use mRNA vaccines. My claim can’t possibly be valid, even if it somehow slips through the patent office. There isn’t any other provision that would clearly prohibit this kind of amendment, since the mRNA vaccine is new and non-obvious as of my filing date. Section 38.2(2) provides a straightforward basis for invalidating such a patent.

The issue arose on the facts because of the addition of the phrase “wherein said multiple doses are not subject to any discretionary adjustment by a physician or medical practitioner” to the 917 patent during prosecution, as discussed above. McVeigh J held that amendment did not result in invalidity:

[443] In my view, AbbVie’s addition did not change claim 1, nor does it broaden the claim. Claim 1 would have had the same effect, with or without the additional statement.

[444] However, that is not the issue. The issue is whether the added claim term was reasonably inferable from the 917 Patent disclosure. I find that though it does conflict with the disclosure, AbbVie has not gained anything more than it originally had.

It’s not clear to me what McVeigh J meant when she said the added term “does conflict with the disclosure” but the main point seems to be that since the amendment did not change the claim scope, nothing at all was added, so it follows that nothing that was not reasonably inferable was added.

Claim construction

The only real dispute between the parties was the definition of “treating” in Claim 1

[296] I agree and adopt JAMP’s experts’ construction, as, even given its ordinary meaning, treating does not always achieve a meaningful result. Treating means attaining some therapeutic results but does not demand a particular duration or result.

[297] Treating does not mean achieving a meaningful clinical response and I do not accept Dr. Marshall’s definition that there must be a “certain therapeutic effect” (Dr. Marshall Report at para 91). “Treating” means a physician administering or prescribing adalimumab to an IBD patient according to the dosing regimen of the patent.

This seems right to me, not just on the text.

The question goes to utility. Generally, clinical efficacy does not have to be established at the time of filing. If the research has proceeded to the point where there is sufficient information to support a valid patent, the patent agent will want to draft a valid claim. The drafter will never specify “clinical efficacy” in the claim unless it is crucial to validity, because doing so needlessly raises the bar for utility. It seems to be consistent with a purposive interpretation to construe the claims on the presumption that the drafter did not intend to draft the claim in a way that would undermine its validity.

Fixed Dosage Regimen is Patentable Subject Matter

Janssen Inc v Pharmascience Inc 2022 FC 1218 Manson J

2,655,335 / paliperidone regimens / INVEGA SUSTENNA / NOC

In this action, Manson J found that Janssen’s 335 patent was not invalid for obviousness or as claiming an unpatentable method of medical treatment. The obviousness decision turned on the facts; the discussion of methods of medical treatment is of more general interest, though it does not break new ground.

This decision followed from Manson J’s prior decision in Janssen v Pharmascience 2022 FC 62, a motion for summary trial, in which he found that Pharmascience’s proposed paliperidone product would induce infringement of the 335 patent [48]: see here. The 335 patent has been the subject of a variety of other litigation, of which the most relevant is Teva Paliperidone 2020 FC 593, in which, as mentioned here, Manson J found that the 335 patent was not obvious, in a decision that turned on the facts.

Paliperidone is a second-generation anti-psychotic, known to be useful in treating schizophrenia. “[S]chizophrenia is incurable and requires life long management with antipsychotic medications. Adherence to a treatment regimen is critical. . . . A leading cause of relapse is non-adherence, where patients do no [sic] take their antipsychotic medication as prescribed, or at all” [11]. One strategy to improve adherence is the use of long-acting formulations. The 335 Patent relates to a long-acting formulation, in particular a dosing regimen for injectable paliperidone palmitate “depot” formulations, which releases from the injection site slowly [12].

Manson J’s analysis on obviousness followed similar lines to his decision in Teva Paliperidone 2020 FC 593: he found the same inventive concept [127] and his findings on the differences between the state of the art and the inventive concept were also consistent with Teva Paliperidone [134]. The key question was whether these differences were obvious. While Pharmascience argued that there were some crucial differences in the evidence on this point between this case and Teva Paliperidone [135], Manson J again concluded that the 335 patent was not obvious or obvious-to-try, in an analysis that turned on the facts [136]–[147]. The key point is that while there was a general motivation to develop a depot formulation of paliperidone to address compliance problems [155], there was not a specific motivation to develop the claimed dosing regimens [153]–[155]. Consequently, the claimed dosing regimens were not obvious [159].

The question of whether the 335 patent claimed unpatentable methods of medical treatment was of more general interest. Manson J noted that the Federal Court and FCA have acknowledged that the jurisprudence as to what constitutes an unpatentable method of medical treatment is inconsistent [161]. He noted, helpfully, “there appears to be no question in the case law that claims to a vendible product are patentable as not being methods of medical treatment” [163]. Many of the claims at issue were “product” claims, in particular claims to prefilled syringes (claims 1 to 16) and Swiss-type claims (claims 33 to 48), and consequently clearly do not constitute unpatentable methods of medical treatment [163]. It is worth noting that Manson J expressly stated that the Swiss-type claims are “product” claims [109]; his holding in Hoffmann-La Roche v Sandoz 2021 FC 384, [95]–[109], that the Swiss-type claims should be construed as use claims now appears to be an outlier: see also my recent post on Janssen v Apotex 2022 FC 996.

The question therefore only arose in respect of the “use” claims: [163]. The justification for the bar on patenting methods of medical treatment is that claims to a method of medical treatment should not constrain a medical professional in the exercise of their skill and judgment: [166], quoting Hospira 2020 FCA 30 [52]. Manson J summarized the law as being that use claims to dosing regimens that are “restricted to particular dosages and specific administration schedules” have been found to be patentable subject matter, “whereas claims to dosages or schedules with ranges within which the physician must exercise skill and judgment have been found to not be a vendible product and thus not patentable” [164]. This is a point Manson J has made before, in Hoffmann-La Roche v Sandoz 2021 FC 384. As discussed here, I’m not sure that distinction entirely reconciles the cases; and Manson J immediately went on to note that claims involving dosage ranges have been held unpatentable “at least in some cases” [165]. Moreover, Manson J evidently does not consider the distinction to be sound in principle, saying the distinction “seems to have a questionable underpinning in resulting judgments based on this dichotomy” but “nevertheless that is where we are under the current state of decisions up to and including decisions in the Federal Court of Appeal” [165]. In other words, we can all recognize that the current state of the jurisprudence is unsatisfactory, but it is what it is, at least for now.

Despite the very confused state of the law, this turned out to be a relatively easy case. The use claims were to a very specific dosing regimen, with “no choices in respect of possible ranges for the dosage amounts, which are fixed at loading doses of 150 mg-eq. on Day 1, 100 mg-eq. on Day 8, and 75 mg-eq thereafter as the maintenance dose” [168]. These are the types of claims that have consistently been held to be patentable subject-matter. Manson J noted that while there was some flexibility in dosing windows, “those choices do not have clinical implications,” as they were incorporated into the regimen to allow for a missed dose, or for convenience in the injection site [170].

Manson J made two observations of general interest. First, as the FCA pointed out in Hospira [52], quoted at [166], “It would seem that a medical professional will be constrained in their exercise of skill” whether the patent claims a fixed dosage or a range of dosages. That is, if a medical professional decides, in their professional judgment, that a certain dosage is required, and that dosage is claimed in a claim to a fixed dosage, their skill will be constrained as much as if it fell within a claimed range. Manson J noted that, in this case, the use claims “do not prevent physicians from practicing in a manner they had previously ‘because they weren’t doing anything before’ the 335 Patent with paliperidone palmitate to treat schizophrenia” [167]. Note the shift from asking whether the medical professional is constrained in the exercise of their skill and judgment, to asking whether they are constrained from practising in the manner they had previously. It seems to me that the medical professional will never be prevented from practising in the manner that they had previously in any case in which the claim is not invalid for anticipation. A valid patent does not constrain a physician’s choices as compared with what they were doing previously; on the contrary, it expands their choices by disclosing new information about how to best treat patients, which would not have been available but for the lure of the patent.

Manson J also noted that “A physician can choose to implement a claimed specific dosing regimen or not; however, skill and judgment are not required to implement the claimed dosing regimens” [171], and for that reason, the claimed subject-matter was not an unpatentable method of medical treatment. This observation also illustrates that the exercise of skill and judgment is always required in medical treatment, even in the administration of a fixed dosage regime. If the exercise of skill and judgment in deciding whether a particular regime is appropriate is not objectionable, I have difficulty seeing why it is any more objectionable if some skill and judgment must be exercised in deciding the exact dose within a claimed range.

A New Twist on the Patentability of Method of Medical Treatment

Hoffmann-La Roche Limited v Sandoz Canada Inc 2021 FC 384 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.

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.

Patentability of Methods of Medical Treatment “Deserves Deep Analysis”

Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research 2020 FCA 30 Locke JA: Rivoalen, Nadon JJA var’g 2018 FC 259 Phelan J
            2,261,630 / infliximab / INFLECTRA

Kennedy Trust’s 630 patent covers the adjunctive use of methotrexate [MTX] and infliximab for the treatment of rheumatoid arthritis [RA] in patients who do not respond fully to MTX alone. As discussed here, Phelan J at first instance held that Hospira’s infliximab product INFLECTRA, infringed several valid claims of the 630 patent. This appeal, reversing Phelan J on several points, raises a number of interesting (and mostly unrelated) issues, which I'll cover in a series of posts, starting, in this post, with the FCA's desire to reform the law related to patentability of methods of medical treatment.

As I argued in this blog post, the law related to patentability of methods of medical treatment is incoherent. In Cobalt v Bayer 2015 FCA 116 [101], the FCA agreed that the current law on the issue “calls for full consideration by this Court or the Supreme Court in a case where the issue is squarely raised on the facts.” However, the issue was moot in Cobalt because the patent was not infringed [100], and the FCA devoted only a single paragraph to the issue.

In this case, Hospira again raised arguments related to patentability of methods of medical treatment. Locke JA devoted several paragraphs to reviewing the state of the law. He summarized the Federal Court jurisprudence as holding that a claim to “a substance intended for the treatment of a medical condition, can be good subject matter for a patent claim, but not if the claim encompasses the skill of a medical professional such as a dosage range rather than a fixed dosage” [51]. He remarked that “it is not clear to me that the decisions of the Supreme Court of Canada that form the basis of the principle that methods of medical treatment are not patentable justify a distinction between a fixed dosage (or interval of administration) and a range of dosages (or intervals)” [52]. He then cited Cobalt (and also my blog post, I am pleased to say) and stated that “I agree that this issue deserves deep analysis” [53]. He concluded by saying that “[u]nfortunately, this does not appear to be the case for such an analysis,” because the claims at issue are of a type that are clearly patentable even in the current state of the law.

I read this as a clear signal that the FCA is willing, and even eager, to undertake a review of the law on this issue itself, rather than leaving the matter to the SCC. Locke JA considered it “unfortunate” that the case did not lend itself to treating the issue in depth, and he clearly stated that he does not consider the current law to be determined by the SCC jurisprudence, so leaving leeway for the FCA. Even the fact that Locke JA devoted almost four pages to the issue indicates the FCA wants to deal with the issue. Hospira raised so many issues on appeal that “it will not be practical to address each one specifically,” so Locke JA generally did not address those that were without merit [15]. He did, nonetheless, choose to address methods of medical treatment at some length, even though it was ultimately without merit. The panel in this case was differently constituted from that in Cobalt (Pelletier, Stratas and Webb JJA), so we now have six judges on two different panels indicating a willingness to review the law related to the patentability of methods of medical treatment.

US Solicitor General Calls for Reconsideration of Mayo v Prometheus

Hikma Pharmaceuticals v. Vanda Pharmaceuticals, 16-2707, 1887 F3d 1117 (Fed Cir 2018) petition for certiorari No 18-817
            US 8,586,610

The patentable subject-matter jurisprudence of the Supreme Court of the United States is a train wreck of historic proportions. In the brief of the United States recommending that the Supreme Court of the United States deny certiorari in Hikma Pharmaceuticals v. Vanda Pharmaceuticals, 16-2707, 1887 F3d 1117 (Fed Cir 2018). the US Solicitor General has joined the chorus of voices calling for reconsideration of SCOTUS’s framework for assessing patentable subject-matter, especially as set out in Mayo v Prometheus 566 US 66 (2012) (hat tip to Patent Docs).

The 610 patent relates to the use of iloperidone to treat schizophrenia. The drug was already known for that use, but the inventors had discovered that people with a specific genetic variant, the “CYP2D6 genotype,” did not tolerate it well. The representative claim 1, in effect claimed testing a patient for the CYP2D6 genotype and administering a reduced dose to those who did not tolerate the drug. As pointed out by Patently-O, the claim at issue in Hikma v Vanda is substantively very difficult to distinguish from the diagnostic method claim at issue in Mayo. However, in Hikma it was framed as a method of treatment claim—”A method for treating a patient” comprising testing and then administering iloperidone at a low or high dose according to the results—while in Mayo the claim was to “A method of optimizing therapeutic efficacy for treatment” of the disorder at issue, comprising a step of “determining the level” of the relevant analyte, such that the result “indicates a need” to increase or decrease the drug. In the Fed Cir, the majority in Hikma nonetheless held the claim to be patentable subject matter, distinguishing Mayo on the basis that in Hikma the claims include specific treatment steps rather than merely directing the physician to consider the test results. Prost CJ, in dissent, was of the view that Mayo was not distinguishable.

In its brief, the Solicitor General has now argued that cert should be denied, on the basis that the majority had gotten the right result on the facts (21). However, the Solicitor General (12-13, 15) acknowledged the force of Prost CJ’s logic. More importantly, the Solicitor General did not confine itself to the particular claim at hand. Throughout the brief, the Solicitor General emphasized that the logic of Mayo calling into question the patentability of many types of inventions that have long been considered to be unquestionably good subject matter:

Nevertheless, as evidenced by the dissenting opinion below, it is arguably unclear how the longstanding and entirely correct rule that method-of-treatment claims are patent-eligible can be reconciled with mechanical application of Mayo’s two-step framework. (10)

Indeed, it is arguably unclear whether even a method of treating disease with a newly created drug would be deemed patent-eligible under a mechanical application of Mayo’s two-part test. (14, original emphasis).

The brief as a whole is a sustained critique of Mayo. The question is not if Mayo should be reviewed, but when; the brief argues that this is not the right case to address the “confusion” caused by the recent SCOTUS jurisprudence: “instead should provide additional guidance in a case where the current confusion has a material effect on the outcome,” in particular a diagnostic method case such as several where the Fed Cir has indicated that it might have gone the other way but for Mayo.

I wonder if the Solicitor General has another motive in recommending that cert be denied in Hikma. While the Solicitor General is of the view that Mayo needs to be rolled back, it’s not evident that SCOTUS will agree. If they take a diagnostic methods case and affirm that diagnostic methods are unpatentable, this would be bad, but only in the same way that the status quo is bad. If they took Hikma and reversed it, holding Mayo really does apply, the situation would be even worse than it is already.

I won’t say more than that: Patent Docs provides a longer review, and the brief itself is well worth reading for those with a real interest. (I might quibble with the analysis a little bit; the brief suggests that the root of the problem is Bilski, which marked a sharp departure from prior SCOTUS jurisprudence when it added expressly non-statutory exceptions to patentability (4, 8). In my view, the roots of the problem go deeper, back to Funk Bros: see The Rule Against Abstract Claims: A Critical Perspective on US Jurisprudence, (2011) 27 CIPR 3. But this is a minor point: I do agree that Bilski was a turning point and turning the clock back that far would be an improvement.)

Unfortunately, this debate remains relevant in Canadian law. The modern SCOTUS approach is clearly inconsistent with Shell Oil [1982] 2 SCR 536, the leading SCC decision on patentable subject matter. Unfortunately, CIPO has gone its own way on the issue of patentable subject matter, and diagnostic methods in particular, apparently inspired by US case law. It seems inevitable that the issue will be litigated in Canada, and when it does, the Solicitor General’s brief should give Canadian courts fair warning that the SCOTUS jurisprudence should not be followed.

Professional Judgment and Subject Matter

Aux Sable Liquid Products LP v JL Energy Transportation Inc 2019 FC 581 Southcott J
            2,205,670

A final point raised by Aux Sable concerns patentable subject matter. Southcott J held Claims 9-10 to be invalid as being addressed to non-patentable subject matter, on the basis that “practice of claims 9-10 to a successful outcome within the ranges of compositions prescribed does depend on the exercise of professional judgment” [238]. In so holding, Southcott J relied on the dosage range cases such as Axcan 2006 FC 527 [232], [238]. I have criticized this line of cases at some length in this post, and I note that in Cobalt v Bayer [YAZ] 2015 FCA 116 [101] the FCA remarked that my posts had “forcefully advanced arguments of policy and logic against the current position.” Southcott J’s discussion was very brief — a single paragraph — and he remarked that “little turns on the outcome of this analysis,” as he had already held these claims invalid for other reasons [238]. Consequently, Aux Sable does not add any weight to the existing line of cases, particularly in light of the concerns expressed by the FCA.

UKSC decision in Warner-Lambert v Actavis – Infringement of Second Medical Use Claims

Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Anor [2018] UKSC 56 (UKSC) Lords Mance, Sumption, Reed, Hodge, Briggs var’g [2016] EWCA Civ 1006 Floyd LJ: Patten, Kitchin LLJ var’g [2015] EWHC 2548 (Pat) Arnold J
            EP(UK) 0934061 / pregabalin / LYRICA

The decision of the UKSC in Warner-Lambert v Actavis is important in UK law both for its discussion of the concept of “plausibility” and in respect of infringement in the context of a second medical use patent. This post provides an overview and discusses the issue of infringement, which raises a truly difficult problem, of how to balance the need for an incentive to develop new indications of a known drug, against the need to allow unfettered availability of the same drug for prior indication. I will argue that Warner-Lambert v Actavis does not provide a solution; and it is unlikely to have much impact in Canadian law, except, perhaps, as a cautionary tale about how the well-intentioned restriction on patentability of methods of medical treatment has gone badly awry.

Overview
Pregabalin is indicated and marketed by Warner-Lambert for the treatment of epilepsy, general anxiety disorder ("GAD") and neuropathic pain [Pat 2]. Warner-Lambert’s patent EP0641330 claimed pregabalin as such and for use in treating epilepsy and GAD. That patent expired in 2013. The key claims of Warner-Lambert’s 061 patent were Swiss-form claims to pregabalin for the treatment of pain, inflammatory pain and neuropathic pain (Claims 1-3) [5]. Claim 3 was the most important, as neuropathic pain is the most common type of pain for which pregabalin is indicated [7], [13]. Mylan and Actavis, seeking to launch a generic pregabalin product, brought separate actions for revocation of the 061 patent, which were consolidated [Pat 3]. After both revocation actions had been started, Actavis decided to launch with a skinny label; that is, with marketing authorization and corresponding product information targeting only the non-patented uses. Warner-Lambert brought an action against Actavis in respect of that skinny label launch [4]. The market at the time was something like 1/3 for unpatented uses, and 2/3 for patented uses [Pat 399-407,425-42]. (The exact numbers are not important, except to establish that both patented and unpatented uses were significant.) Note that Warner-Lambert is a company in the Pfizer group [4], and Warner-Lambert markets pregabalin, under the brand name Lyrica, but Pfizer holds the marketing authorization [Pat 2]. Nothing turns on this, but many of the facts refer to steps taken by Pfizer rather than Warner-Lambert.

More Support for Experimental Use Exception to Anticipation

Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research 2018 FC 259 Phelan J
            2,261,630 / infliximab / REMICADE / INFLECTRA

The 630 patent, held by Kennedy Trust, covers the adjunctive use of methotrexate [MTX] and infliximab for the treatment of rheumatoid arthritis [RA] in patients who do not respond fully to MTX alone. Infliximab is only approved for treatment of RA when used in combination with MTX [16]. Kennedy Trust’s licensee, Janssen, markets infliximab for use in combination with MTX under the name REMICADE [18]. Hospira’s infliximab product INFLECTRA, is a biosimilar of REMICADE, sold for the same purpose [18] (and see the product monograph). Hospira brought an action for a declaration that Kennedy’s 630 patent is invalid, and that INFLECTRA would not infringe, while Kennedy brought a counterclaim to the opposite effect [5].

MTX was a popular prior art treatment for severe RA [111], but for some patients — “incomplete responders” — MTX alone did not adequately control their RA. The efficacy of infliximab was also part of the cgk [113], but the duration of effect was limited [11]. It turned out that the combination of MTX and infliximab, as claimed in the 630 patent, exhibited enhanced efficacy over either drug alone as well as a sustained duration of effect [15]. On the facts, Phelan J concluded that this particular combination therapy was not obvious or obvious to try [230].

Hospira argued “an astonishing number and veritable panoply of patent law issues.” [24], including standing, ownership, improper priority, and double patenting plus along with the full range of the usual attacks, including anticipation, obviousness, sufficiency, utility, and overbreadth (and this list isn’t complete). As an academic, I hesitate to comment on litigation strategy, but I can’t help but feel that Hospira’s scattershot approach undermined the strength of its better arguments, particularly given that several of the arguments were thinly argued, occasionally without any supporting authority (see eg [159]). On overbreadth, Phelan J remarked that “Its submissions seem to have been made in the hope that something would “stick” – the patent law equivalent of the Hail Mary pass” [249]. At the end of the day, nothing stuck: Phelan J held the 630 patent to be valid and infringed. I won’t run through all of the arguments, but only those that raise a point of interest.

Experimental Use Exception to Anticipation

A couple of interesting points were raised by Hospira’s novelty attack. First, Phelan J endorsed the experimental use exception to anticipation, albeit in obiter [196]. Hospira argued that the patient consent forms used in Kennedy’s Phase II clinical trials were anticipatory. Phelan J rejected this primarily on the basis that confidentiality was established on the evidence (in part on the basis that the industry practice with clinical trials is to expect the maintenance of that confidence) [196i]. He also rejected it on public policy grounds, as it would effectively put an end to informed consent or to the patenting of medication [196i]. And he also suggested that “the experimental use exception is not as defunct as Hospira would have one conclude,” citing with approval Fothergill J’s decision in Bayer v Apotex 2016 FC 1013, discussed here (and see also Bayer v Apotex 2014 FC 436, Hughes J, discussed here). This experimental use defence to anticipation had some basis in the early case law, but it was not previously well-established; we now have three different Federal Court judges who have recently lent credence to the idea.

Speculative Anticipation

Hospira argued anticipation on the basis of a number of prior art documents which suggested trying infliximab or another anti-TNF-α antibody in combination with MTX, or referenced a trial in which that combination was being tried [196]. This is a bit of a twist on the usual anticipation attack, where the prior art says “We did X” and the question is whether X necessarily falls within the claims of the patent at issue. In this case (to oversimplify), the prior art says “Someone should try X” where X is exactly what the patent claims, namely combining MTX and infliximab to treat RA. (More precisely, the prior art references didn't all reference infliximab specifically.) Phelan J dismissed the prior art references as all being speculative [167], [191]. This calls to mind the case-law arising in the context of a conflict proceeding under the first-to-invent system, where in order to establish inventorship, it had to be shown that at the asserted date “the invention was no longer merely an idea that floated through the inventor's brain but had been reduced to a definite and practical shape” Ernest Scragg & Sons Ltd v Leesona Corp (1964), 45 CPR 1, 33. The allegedly anticipatory prior art in this case was really no more than “an idea that floated though the brain” of the proponents. It strikes me that just as a speculative idea cannot be an invention for the purposes of establishing priority over an inventor who had actually reduced the idea to practice, so it cannot be a disclosure sufficient to anticipate an invention that had actually reduced the idea to practice.

Blinding the Witness

Hospira’s experts were blinded. Phelan J gave little weight to this, saying “blinding alone is not a guarantee of reliability and it is not a sufficient reason to prefer the evidence of one witness over another” [203], consistently with 2016 FC 382 (discussed here). Phelan J also questioned whether blinding was even possible, at least on the facts of this case:

Further, given the involvement of the experts in this case in the development of RA treatments during the relevant time period, it is at least questionable whether blinding holds any value. It is impossible to believe that these experts were not aware of the development of Remicade prior to this trial.

Methods of Medical Treatment

Hospira argued that the 630 patent was invalid as being an unpatentable method of medical treatment [136]-55]. Phelan J recognized that “[t]he jurisprudence with respect to the unpatentability of methods of medical treatment is not entirely consistent” [141]. This is not very surprising, given that the FCA has also called for “full consideration [of the patentability of methods of medical treatment] by this Court or the Supreme Court in a case where the issue is squarely raised on the facts” 2015 FCA 116 [101]. Phelan J’s observation further emphasizes the need for reform in this area of the law.

On the facts, Phelan J held that the patent at issue was not a method of medical treatment, essentially because “the use of X in combination with Y to treat disorder Z” is no different in substance from “the use of X to treat disorder Z” and the latter is clearly patentable: [147]. A claim of that type was at issue in Wellcome / AZT, 2002 SCC 77; and see the discussion here.