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Patents - 'Unpatentable Subject Matter'. Pharmascience Inc. v. Janssen Inc. ['medical treatment']
In Pharmascience Inc. v. Janssen Inc. (Fed CA, 2023) the Federal Court of Appeal considered an appeal of "an action brought pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations" that "sought a declaration that the appellant, Pharmascience Inc. (Pharmascience), would infringe" another patent "if it were to make, use or sell its generic version of Janssen’s patented medicine".
Here, the court addresses whether the suspected infringing patents are invalid because they "comprise unpatentable subject matter, namely methods of medical treatment":V. Analysis
A. Jurisprudence concerning the prohibition on patenting methods of medical treatment
[17] The Patent Act, R.S.C. 1985, c. P-4, contains no explicit prohibition against claims for methods of medical treatment. Moreover, subsection 43(2) of the Patent Act provides that a patent is presumed valid. Claims are presumed not to concern methods of medical treatment, and the burden rests on the challenger (Pharmascience, in this case) to prove otherwise.
[18] As indicated above, the origin of this prohibition in Canada is the Supreme Court of Canada’s 1974 decision in Tennessee Eastman. That case involved an attempt to obtain a patent claiming a surgical method for joining or bonding the surfaces of incisions or wounds in living animal tissue by applying adhesive compounds described in the claims in a liquid state, directly to at least one of the tissue surfaces to be bonded. At the time, subsection 41(1) of the Patent Act generally prohibited claims to “substances prepared or produced by chemical processes and intended for food or medicine”. Therefore, the bonding compounds of the patent application in question could not be claimed as such.
[19] The Supreme Court maintained the rejection of the patent application by the Commissioner of Patents. Its analysis surrounded the definition of “invention” in the Patent Act. At page 118, the Court wrote:It is clear that a new substance that is useful in the medical or surgical treatment of humans or of animals is an “invention”. It is equally clear that a process for making such a substance also is an “invention”. In fact, the substance can be claimed as an invention only “when prepared or produced by” such a process. But what of the method of medical or surgical treatment using the new substance? Can it too be claimed as an invention? In order to establish the utility of the substance this has to be defined to a certain extent. In the case of a drug, the desirable effects must be ascertained as well as the undesirable side effects. The proper doses have to be found as well as methods of administration and any counter‑indications. May these therapeutic data be claimed in themselves as a separate invention consisting in a method of treatment embodying the use of the new drug? I do not think so, and it appears to me that s. 41 definitely indicates that it is not so. [20] At page 119, the Court added, “[h]aving come to the conclusion that methods of medical treatment are not contemplated in the definition of “invention” as a kind of “process”, the same must, on the same basis, be true of a method of surgical treatment.”
[21] The Supreme Court of Canada had occasion to comment on Tennessee Eastman in its later decision in Shell Oil Co. v. Commissioner of Patents, 1982 CanLII 207 (SCC), [1982] 2 S.C.R. 536, 142 D.L.R. (3d) 117 at 554 (Shell Oil):In Tennessee Eastman Co. v. Commissioner of Patents (1970), 62 C.P.R. 117 (Ex. Ct.), aff’d 1972 CanLII 167 (SCC), [1974] S.C.R. 111, the applicant sought a patent on a method of closing incisions following surgery by the use of an adhesive substance discovered to have a marked affinity for adhering to living tissue. The Commissioner refused the patent on the basis that this was not the kind of discovery (the adhesive itself not being new) which fell within the definition of “invention” in the Act. In particular, he found that it was not an “art” because it was useful only in the process of surgical or medical treatment and produced no result in relation to trade, commerce or industry. The applicant appealed to the Exchequer Court and the issue there was limited to the question whether this use of the adhesive fell within the meaning of new and useful “art” or “process” within the meaning of the Patent Act. It was held that it did not for the reasons given by the Commissioner. In effect, it was not patentable because it was essentially non-economic and unrelated to trade, industry or commerce. It was related rather to the area of professional skills. [22] The explicit prohibition in subsection 41(1) of the Patent Act against patent claims to “substances prepared or produced by chemical processes and intended for food or medicine” was later lifted by the repeal of this provision. However, that change did not have the effect of removing the prohibition on patenting methods of medical treatment. The Supreme Court of Canada effectively confirmed this in its comments on Tennessee Eastman in Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77, [2002] 4 S.C.R. 153 at para. 49 (Wellcome), where it cited the explanation in Shell Oil that a claim to a method of medical treatment is unpatentable because it is “essentially non-economic and unrelated to trade, industry, or commerce” and “related rather to the area of professional skills”.
[23] Wellcome concerned a patent on the use of AZT as a treatment for HIV. The Court found that the patent did not concern a method of medical treatment, stating as follows at paragraph 50:The AZT patent does not seek to “fence in” an area of medical treatment. It seeks the exclusive right to provide AZT as a commercial offering. How and when, if at all, AZT is employed is left to the professional skill and judgment of the medical profession. [24] Tennessee Eastman, Shell Oil, and Wellcome are Supreme Court of Canada decisions by which this Court is clearly bound. It is important to keep in mind what they say, and what they do not say. What they say is that a method of medical treatment is not patentable because it does not fall within the definition of “invention” as contemplated in the Patent Act. This is because a method of medical treatment is unrelated to trade, industry or commerce, and concerns professional skills that are non-economic. A patent should not seek to fence in the exercise of such skills (including how and when a drug is administered), but it may cover a commercial offering.
[25] The development of the jurisprudence beyond what is discussed in the foregoing Supreme Court decisions (what they do not say) is not equally binding on this Court, although this Court should follow its own decisions unless they are manifestly wrong: Miller v. Canada (Attorney General), 2002 FCA 370, 220 DLR (4th) 149 at para. 10. I will now explore that jurisprudence and discuss the principles that properly arise therefrom.
[26] The references to “trade, industry or commerce” and “commercial offering” by the Supreme Court appear to be the basis for the focus of many decisions on whether the invention concerns a “vendible product”: see Hospira at para. 53 as well as the Federal Court of Appeal’s decision in Wellcome (2000 CanLII 16270 (FCA), [2000] F.C.J. No. 1770, 10 C.P.R. (4th) 65 at para. 74). This focus is also discussed in the following Federal Court decisions: Merck & Co., Inc. v. Apotex Inc., 2005 FC 755, 41 C.P.R. (4th) 35 at paras. 136–37; Merck & Co., Inc. v. Pharmascience Inc., 2010 FC 510, 85 C.P.R. (4th) 179 at paras. 110, 114 (Merck 2010); Janssen Inc. v. Mylan Pharmaceuticals ULC, 2010 FC 1123, 88 C.P.R. (4th) 359 at para. 53 (Mylan); Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Company, 2013 FC 985 at paras. 78, 91, 98, aff’d 2014 FCA 17, 236 A.C.W.S. (3d) 1001 (Novartis); Bayer at para. 162; Abbvie Biotechnology Ltd. v. Canada (Attorney General), 2014 FC 1251, 248 A.C.W.S. (3d) at paras. 115, 125 (Abbvie); and Biogen Canada Inc. v. Taro Pharmaceuticals Inc., 2020 FC 621, [2020] F.C.J. No. 611 at para. 211. The idea, with which I agree, is that a vendible product has economic value and is distinguishable from the skilled work of a physician, and hence outside the realm of methods of medical treatment as contemplated by the Supreme Court of Canada.
[27] With regard to inventions relating to the administration of a drug, the jurisprudence at the Federal Court level has developed an approach whereby a claim may be found to be either patentable subject matter or an unpatentable method of medical treatment based on whether it defines a fixed dosage (or interval of administration) or a range of dosages (or intervals). This approach appears to have its origin in Axcan Pharma Inc. v. Pharmascience Inc., 2006 FC 527, 50 C.P.R. (4th) 321 at paragraphs 45–51 (Axcan), and was developed in Merck 2010 at paragraphs 111–14, and Novartis at paragraphs 82–99.
[28] As indicated in the passage from Hospira quoted at paragraph 10 above, the distinction between fixed and variable dosages (or schedules) has a questionable underpinning, since such a distinction would seem to make no difference to whether the drug in question is a vendible product. However, the distinction makes more sense if one bears in mind the guidance noted in paragraph 6 above from Bayer that what matters is what the claims say; the product that the patentee puts on the market is incidental. In my view, it is permissible to focus on whether the dosing regimen is fixed or variable provided that the analysis remains tied to the ultimate question of whether professional skill is applied in using the invention. This was reflected in Mylan, which noted the concern in Axcan and Merck 2010 about dosage ranges, and then stated as follows at paragraph 26:What I take from the above authorities is that a patent claim over a method of medical treatment that, by its nature, covers an area for which a physician’s skill or judgment is expected to be exercised is not patentable in Canada. This would include the administration of a drug whereby the physician, while relying upon the dosage advice of the patentee, would still be expected to be alert and responsive to a patient’s profile and to the patient’s reaction to the compound. [29] The Federal Court in Mylan at paragraph 4 noted that “the inventive concept of the [patent in suit] is limited to Janssen’s claimed discovery that the slow titration of galantamine improved patient tolerability for the drug, by reducing side-effects and resulted in the ability to use a lower maintenance dose than had previously been shown to be effective.” The Court found that the claims in issue concerned an unpatentable method of medical treatment because they defined a “titration regimen” (see paragraph 50) that required the ongoing exercise of a physician’s professional skill and judgment. The monopoly asserted by the claims would thereby interfere with the ability of a physician to exercise that skill and judgment.
[30] Despite this, I think it would go too far to say that any drug regimen that requires a physician to monitor a patient is unpatentable. Such a prohibition would cast too wide a net, potentially encompassing almost any drug.
[31] In Abbvie, the Federal Court provided a detailed review of the jurisprudence concerning methods of medical treatment. At paragraphs 110 and 121, the Court distinguished, properly in my view, between the exercise of skill and judgment in deciding whether to use a claimed invention (which does not indicate a method of medical treatment), and the exercise of skill and judgment in deciding how to use the invention (which is a prohibited method of medical treatment).
[32] As in Mylan, Abbvie cautioned against a simple distinction between fixed and variable dosages and schedules. Paragraphs 112 to 114 stated as follows:[112] The respondent cautioned against relying on catch phrases rather than principles. In my view, the jurisprudence reflects that approach – the principle has been applied regardless of the Courts’ references to “fencing in” or to “fixed dosages”. The issue in every case has been whether the patent claims a method of medical treatment. In applying the same principles, claims to fixed dosages and schedules which do not involve any professional decision-making have been accepted as patentable.
[113] However, just because the claims involve a fixed dosage and schedule does not mean that they are automatically patentable, nor does it mean that they constitute unpatentable subject matter. The fixed dosage and schedule may be a good signal or starting point, but the evidence about that claimed dosage regime and schedule may indicate that it is not exactly as it is claimed and that adjustments are needed which requires skill and judgment.
[114] The review of the relevant case law supports the appellants’ understanding of the principles from the jurisprudence and demonstrates that the Courts have consistently found that a claim directed to the exercise of professional skill or judgment is not patentable. However, a claim which does not restrict, or interfere with, or otherwise engage professional skill or judgment – including a claim for a fixed dosage and or a fixed dosage schedule or interval – is not impermissible subject matter where there is no evidence to contradict that claimed dosage. Contrary to the Commissioner’s decision and the respondent’s position, [Mylan] has not changed the law. [33] Pharmascience argues that the concern in Abbvie about evidence that could contradict a fixed claimed dosage or schedule is directed to cases in which the dosage or schedule in question may not be effective for all patients such that a physician would have to exercise skill and judgment in some cases in determining an appropriate dosage. Pharmascience argues that a claimed dosage regimen that will not be appropriate for all patients constitutes an unpatentable method of medical treatment. As support for this argument, Pharmascience notes the following passage from Abbvie at paragraph 121:In the present case, the physician’s skill is not expected to be exercised within the claim. The prescribing practices are not restricted. The physician must exercise skill and judgment to determine if the claimed use is appropriate for the patient. The physician decides to prescribe it as is or not at all. If prescribed, there would be no restriction on the exercise of skill or judgment. The evidence is that this dosage with the bi-weekly interval is appropriate for all those to whom it is administered. [34] I do not understand Abbvie to exclude as prohibited methods of medical treatment all patent claims to a dosing regimen that may not work for all patients. Such a rigid approach would be inconsistent with the jurisprudence. In practice, I would expect that few drug regimens could be anticipated to be effective for all patients at a particular dosage. In my view, Abbvie was properly focused on whether it was expected that professional skill and judgment would be required in using the patented invention. In that case, the Court found no evidence to that effect (see paragraph 111).
[35] The Federal Court reached the opposite result in Hoffmann-La Roche Limited v. Sandoz Canada Inc., 2021 FC 384, 185 C.P.R. (4th) 167 (Hoffmann). There, the Court found at paragraph 204 that “the evidence has established that there is a continued need for a physician’s exercise of skill and judgement”. Clearly, this issue is factually suffused; it depends on the evidence and it concerns how the patented invention is intended to be used.
[36] Another possible wrinkle seems to arise in Novartis. In finding the claims of the patent in suit invalid, the Federal Court there noted at paragraph 99 that the claims included “treatment by intermittent dosages with some claims specifying a dosage range and others specifying specific dosages; and some claims claiming more frequent intervals of dosing, and others less”. The Federal Court continued that the claims therefore included “that which lies within the skill of the medical practitioner”. This reasoning suggests that the Court in Novartis may have been concerned that, even though some individual claims provided a fixed dosage and schedule, the claims of the patent taken together covered a range of possible dosages or schedules, such that use of the patented invention as claimed effectively required the exercise of skill and judgment. Though preceding paragraphs of that decision discussed variability in the frequency of the intermittent doses (in the disclosure portion of the patent), such variability within any particular claim is not discussed in paragraph 99.
[37] To summarize, whether or not a patent claim to a dosing regimen relates to a method of medical treatment cannot be based exclusively on whether its dosing and schedule is fixed or not. The proper inquiry remains whether use of the invention (i.e., how to use it, not whether to use it) requires the exercise of skill and judgment, and the burden remains on the party challenging the patent. It is difficult to provide more detailed guidance than this for parties involved in future litigation and courts faced with allegations of invalidity of patent claims due to unpatentable subject matter, namely methods of medical treatment. Such allegations will generally turn on the particulars of the case and the evidence on the record.
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[41] In my view, the Federal Court did not err in law in finding that the other claims did not define methods of medical treatment because they were product claims. It is not in dispute that a vendible product is not a method of medical treatment. Therefore, the issue is really whether the Federal Court erred in finding that the other claims are for a vendible product. In my view, a claim may concern a vendible product even if it includes a dosing regimen as an essential element.
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