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Patents - Inducing Infringement. Apotex Inc. v. Janssen Inc.
In Apotex Inc. v. Janssen Inc. (Fed CA, 2023) the Federal Court of Appeal considered issues of patent infringement and inducing infringement:[13] Apotex focuses its argument on the high threshold for influence required by the second prong of the test for inducement: that the infringing act would not have occurred without the influence. This Court has equated this threshold to a sine qua non (without which not) test: MacLennan v. Produits Gilbert Inc., 2008 FCA 35, [2008] F.C.J. No. 128 at para. 38 (MacLennan). Apotex urges this Court to treat the threshold as a “but for” test, and it cites jurisprudence that calls this a causation test. I have no objection to Apotex’s characterization of the test, but I do not find it to be more helpful that the “would not have occurred without” and “sine qua non” characterizations provided in the jurisprudence of this Court. In my view, these are merely different ways of describing the same threshold.
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[23] I turn now to Apotex’s more substantive argument that the Federal Court erred in concluding that the high threshold for the second prong of the test for inducing infringement was met in this case. The main weakness of this argument is that it depends on there being a requirement that prescribing practices of physicians be altered because of Apotex’s activities. In fact, this is not necessary. What is required is that the ultimate act of direct infringement occur because of Apotex’s activities.
[24] It is important to bear in mind that the ultimate act of direct infringement in the present case could be either by a prescriber (e.g. a physician or a nurse practitioner) or by a patient: Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research, 2020 FCA 30, [2020] F.C.J. No. 179 at para. 40, citing AB Hassle v. Genpharm Inc., 2003 FC 1443, 243 F.T.R 6 at para. 127, aff’d 2004 FCA 413, [2004] F.C.J. No. 2079. The Federal Court recognized this at paragraphs 74 and 104 of its reasons. It is also important to understand that inducing patent infringement can occur even where there is no direct contact between the inducer and the direct infringer: MacLennan at para. 43, citing Procter & Gamble Co. v. Bristol-Myers Canada Ltd., [1978] F.C.J. No. 812, 39 C.P.R. (2d) 145 at 167. Accordingly, Apotex could be found to induce infringement by a patient even if they have no direct communication.
. Pharmascience Inc. v. Janssen Inc.
In Pharmascience Inc. v. Janssen Inc. (Fed CA, 2023) the Federal Court of Appeal considered an 'inducing infringement' patent appeal, here from a denied defence-brought summary judgment:[4] The legal test for a finding of inducing patent infringement was correctly stated by the Federal Court at paragraph 93 of its reasons:There is a three “prong” test for inducement: (1) direct infringement by a third party; (2) the inducer influenced the third party to the point that the infringing act would not have occurred without the influence; and (3) the defendant knew that its influence would bring about the infringing act [Corlac Inc. v. Weatherford Canada Ltd., 2011 FCA 228 [Corlac]]. . Apotex Inc. v. Janssen Inc.
In Apotex Inc. v. Janssen Inc. (Fed CA, 2023) the Federal Court of Appeal considered (and dismissed) an appeal from a successful action for 'inducing infringement' of a patent:[4] There is much on which the parties agree in this appeal. There is no argument that the Patent is invalid in any respect. The parties also agree that a party that does not directly infringe a patent may nevertheless be liable for patent infringement where it induces an act of direct infringement. They agree that the legal test for a finding of inducing infringement is as set out in Corlac Inc. v. Weatherford Canada Ltd., 2011 FCA 228, 95 C.P.R. (4th) 101 at para. 162:It is settled law that one who induces or procures another to infringe a patent is guilty of infringement of the patent. A determination of inducement requires the application of a three-prong test. First, the act of infringement must have been completed by the direct infringer. Second, the completion of the acts of infringement must be influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place. Third, the influence must knowingly be exercised by the inducer, that is, the inducer knows that this influence will result in the completion of the act of infringement: Dableh v. Ontario Hydro, 1996 CanLII 4068 (FCA), [1996] 3 F.C. 751, paras. 42, 43 (C.A.), leave to appeal refused, [1996] S.C.C.A. No. 441; AB Hassle v. Canada (Minister of National Health and Welfare), 2002 FCA 421, 22 C.P.R. (4th) 1, para. 17 (C.A.), leave to appeal refused, [2002] S.C.C.A. No. 531; MacLennan v. Les Produits Gilbert Inc., 2008 FCA 35, 67 C.P.R. (4th) 161, para. 13. The test is a difficult one to meet. [5] The Federal Court correctly summarized the three prongs of this legal test at paragraph 147 of its reasons:1. The acts of infringement must have been completed by the direct infringer;
2. The completion of the acts of infringement must be influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place; and
3. The influence must be knowingly exercised by the inducer; in other words, the inducer knows that this influence will result in the completion of the acts of infringement. [6] The parties also agree that the first prong of the test is met in this case. The dispute between the parties concerns the second and third prongs.
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[9] An important area of focus in this case is the product monograph (PM) related to Apo-Macitentan, which provides information to the public concerning the drug and its uses. The parties agree that a PM may be relevant on the question of whether the second prong of the test for inducing infringement is met, including with regard to the possible influence on prescribing physicians’ decisions. However, the parties disagree on whether sufficient influence is present in this case.
III. Second Prong: Influence
[10] As indicated above, the second prong of the test for inducing patent infringement requires that the acts of direct infringement be influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place.
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[13] An oft-quoted statement on the relevance of a PM to the issue of inducement is found in Novopharm Limited v. Sanofi-Aventis Canada Inc., 2007 FCA 167, 366 N.R. 231 at para. 11 (Novopharm):A generic drug manufacturer may be implicated in the infringement by others of a claim for a new use of a medicine if the generic drug manufacturer induces that infringement. Infringement by inducement may be established, for example, by inferences reasonably drawn from the contents of the product monograph for the generic drug product, or evidence relating to the dosage form of the generic product, or its labelling or marketing. However, an inducement to infringe generally cannot be inferred from a mere reference to the new use in the product monograph, for example, in the course of explaining contraindications or drug interactions, or as part of a list of scientific references. [14] This passage, which was recently quoted in Teva Canada Limited v. Janssen Inc., 2023 FCA 68 at para. 106, was considered at paragraph 163 of the Federal Court’s reasons in this case. No inducement was found in Novopharm. However, Novopharm is distinguishable from this case in that the previous approval of the drug in question there (Ramipril) was for an entirely different and non-infringing use: treating hypertension rather than the patented use (treatment of schizophrenia and related disorders, which remained off-label). Here, the difference between the infringing use and the non-infringing use is far less significant. Apotex seeks approval, based on marketing approval previously granted for Opsumit, to use macitentan to treat certain classes of PAH, which is the same indication as contemplated in the Patent. The distinction Apotex relies on is that Apo-Macitentan is to be used alone rather than in combination with a PDE5 inhibitor, as contemplated in the PM for Opsumit.
[15] Inducement has been found based on a PM: e.g. Genpharm Inc. v. AB Hassle, 2004 FCA 413, 329 N.R. 374, and Abbott Laboratories Limited. v. Canada (Ministry of National Health and Welfare), 2006 FC 1411, 55 C.P.R. (4th) 48, affirmed 2007 FCA 251, [2007] F.C.J. No. 935 (QL). The latter case, as here, involved an effort to cleanse a PM of references to a patented use.
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IV. Third Prong: Knowledge
[19] The third prong of the test for inducing patent infringement, as discussed above, requires that the inducer know that their influence will result in the completion of the acts of infringement. The parties agree that this prong refers to knowledge that the influence is being exercised, rather than knowledge that the resulting activity will be an infringement: Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research, 2020 FCA 30, 316 A.C.W.S. (3d) 537 at para. 45.
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