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Patents - Obviousness. Eli Lilly Canada Inc. v. Apotex Inc.
In Eli Lilly Canada Inc. v. Apotex Inc. (Fed CA, 2023) the Federal Court of Appeal considered the patent law of 'obviousness':[51] The statutory basis for the obviousness analysis is found in section 28.3 of the Patent Act, which provides:Invention must not be obvious
Objet non évident
28.3 The subject-matter defined by a claim in an application for a patent in Canada must be subject-matter that would not have been obvious on the claim date to a person skilled in the art or science to which it pertains, having regard to
28.3 L’objet que définit la revendication d’une demande de brevet ne doit pas, à la date de la revendication, être évident pour une personne versée dans l’art ou la science dont relève l’objet, eu égard à toute communication :
(a) information disclosed before the one-year period immediately preceding the filing date or, if the claim date is before that period, before the claim date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant in such a manner that the information became available to the public in Canada or elsewhere; and
a) qui a été faite, soit plus d’un an avant la date de dépôt de la demande, soit, si la date de la revendication est antérieure au début de cet an, avant la date de la revendication, par le demandeur ou un tiers ayant obtenu de lui l’information à cet égard de façon directe ou autrement, de manière telle qu’elle est devenue accessible au public au Canada ou ailleurs;
(b) information disclosed before the claim date by a person not mentioned in paragraph (a) in such a manner that the information became available to the public in Canada or elsewhere.
b) qui a été faite par toute autre personne avant la date de la revendication de manière telle qu’elle est devenue accessible au public au Canada ou ailleurs. [52] The question to be answered pursuant to section 28.3 of the Patent Act is whether the subject-matter defined by the asserted claims of the 684 Patent is obvious to a person skilled in the art with regard to the prior art as of the claim date of April 30, 1999. If the “invention” is obvious, the patent or its asserted claims are invalid.
[53] In Sanofi, the Supreme Court of Canada adopted the four-step approach to an obviousness inquiry first outlined in Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59 (C.A.):In the result I would restate the Windsurfing questions thus:
(1) (a) Identify the notional “person skilled in the art”;
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?
(Sanofi at para. 67, citing Pozzoli SPA v. BDMO SA, [2007] F.S.R. 37 (p. 872), [2007] EWCA Civ 588 at para. 23) [emphasis in original] [54] In Shire, this Court reminded us that obviousness is assessed on a claim-by-claim basis; each claim is evaluated against the four-part Sanofi test (Shire at para. 55).
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[71] As noted by this Court in Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research, 2020 FCA 30, 316 A.C.W.S. (3d) 537:It should be noted that, whereas being “more or less self-evident to try to obtain the invention” (per Sanofi at para. 66) is a requirement for obviousness to try, being “more or less self-evident that what is being tried ought to work” (per Sanofi at para. 69) is not a requirement but merely a factor to be considered. . Apotex Inc. v. Shire LLC
In Apotex Inc. v. Shire LLC (Fed CA, 2021) the Federal Court of Appeal considered the patent principle of obviousness:B. Obviousness
[55] As with anticipation, obviousness is assessed on a claim-by-claim basis (Zero Spill Systems at paras. 83, 85). Each claim is evaluated against the four-part Sanofi test (at para. 67):(1) (a) Identify the notional “person skilled in the art”;
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention? ....
[65] Section 28.3 of the Patent Act does not displace the common law test for obviousness. The inventive concept, properly construed and applied, remains the end point for the obviousness inquiry. Second, I do not see an error in the judge’s analysis of the inventive concept, nor in its application. Further, the arguments raised by Apotex, interesting as they may be, are of no consequence in light of the judge’s factual findings. I will elaborate on this later.
[66] I begin with three basic principles.
[67] First, on occasion, the inventive concept may be "“readily apparent”" where there is agreement on it. If not, the inventive concept needs to be construed. To do that, the judge is to first determine whether it can be identified from the previously completed claims construction exercise (Ciba at paras. 76-77). Second, where it is not possible to fully grasp the nature of the inventive concept solely from those claims, the judge may have regard to the patent specification to determine if it provides any insight or clarification into the inventive concept of the claim(s) in issue (Sanofi at para. 77; AstraZeneca Canada Inc. at para. 31). If this step is necessary, "“it is not permissible to read the specification in order to construe the [inventive concept of the] claims more narrowly or widely than the text will allow”" (Sanofi at para. 77).
[68] Second, insight from Sanofi shows that while an inventive concept is an attribute of the claims, it differs from claims construction (Joshua Sealy-Harrington, "“The Inventive Concept in Patent Law: Not so Obvious”", (2015) 27 I.P.J. 385). As such, though the process for the identification of an inventive concept bears a striking resemblance to that of claims construction, as seen in longstanding Supreme Court of Canada rulings (see, e.g., Free World at paras. 33-50; Whirlpool Corp. v. Camco Inc., 2000 SCC 67, [2000] 2 S.C.R. 1067 at paras. 43, 49), it is nonetheless a distinct, separate exercise.
[69] Third, the caution expressed in Unilever PLC. v. Chefaro Proprietaries Ltd., [1994] R.P.C. 567 (Eng. C.A.) at 580 (Unilever PLC) remains a governing legal principle: "“[i]t is the ‘inventive concept’ of the claim in question which must be considered, not some generalised concept to be derived from the specification as a whole.”" Thus, as required by section 28.3 as well as the wording of Sanofi, it is the inventive concept(s) of the claim(s) in issue that must be the focus of an obviousness inquiry, not the inventive concept of the patent (Ciba at para. 72; Bauer Hockey Corp. v. Easton Sports Canada Inc., 2010 FC 361 at para. 250, aff’d 2011 FCA 83; Pfizer Canada Inc. v. Apotex Inc., 2017 FC 774 at para. 247, aff’d 2019 FCA 16 (Pfizer Canada Inc.)).
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[103] Stage 4 of the obviousness inquiry asks whether the differences, in light of the prior art and viewed without any knowledge of the alleged invention as claimed, constitute steps which would have been obvious to the PSIA, or if they instead required any degree of invention (Sanofi at paras. 67, 70). Obviousness is assessed objectively and purposively, having regard to the problem addressed by the patent (Apotex Inc. v. Pfizer at paras. 32, 35 and 39).
[104] If a patent pertains to an area" “of endeavour where advances are often won by experimentation”", as here, "“an ‘obvious to try’ test might be appropriate”" (Sanofi at para. 68). However, an "“obvious to try”" analysis remains but one of many potentially relevant factors in the stage 4 analysis (Bristol-Myers at para. 38; Sanofi at paras. 64-65). As noted in Apotex Inc. v. Pfizer at para. 32:[…] while the Supreme Court introduced the “obvious to try” test, it favours “an expansive and flexible approach that would include 'any secondary considerations that [will] prove instructive'” (Atazanavir at para. 61, referring to Sanofi at para. 63). As a result, a categorical approach to the obviousness inquiry and the elaboration of a “hard and fast rule” was specifically deemed inappropriate and rejected […] (Atazanavir at para. 62). [105] For an invention to be "“obvious to try”", there must be evidence establishing, on a balance of probabilities, "“that it was more or less self-evident to try to obtain the invention”" (Sanofi at para. 66). As such, this analysis flows from the identification of the "“invention”" described by the claim’s inventive concept. For example in Sanofi, the focus on the properties of the isomers at the obvious to try stage was dictated by the fact that it was the special properties of the selection which made it inventive. The obvious to try test does not broaden the scope of the obviousness inquiry from a claim-by-claim analysis to an invention-overall analysis.
[106] To assess whether it is more or less self-evident to try to obtain an invention, as defined by a claim’s identified inventive concept, Sanofi enumerated three non-exhaustive factors that should be considered (at paras. 69, 83-92). While they must all be explicitly considered in order to answer the overall question of whether it is "“more or less self-evident to try to obtain the invention”," they need not all be met (Hospira at paras. 89-90):(1) Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified predictable solutions known to persons skilled in the art?
(2) What is the extent, nature and amount of effort required to achieve the invention? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine?
(3) Is there a motive provided in the prior art to find the solution the patent addresses? [107] Beyond the enumerated factors, there are contextual factors that should also be considered, depending on the facts of the case. These contextual factors include but are not limited to the history of the invention, how "“quickly, easily, directly and relatively inexpensively”" it was reached and any "“wild goose chases”" that were pursued before arriving at the invention, etc. (Sanofi at paras. 70-71; Apotex Inc. v. Pfizer at paras. 46-48). Although these additional contextual factors may not be, on their own, determinative (see, e.g., Tearlab at paras. 68-69), any that arise alongside the factors enumerated in Sanofi are to be considered and weighed before coming to a conclusion about whether the invention was obvious. . Western Oilfield Equipment Rentals Ltd. v. M-I LLC
In Western Oilfield Equipment Rentals Ltd. v. M-I LLC (Fed CA, 2021) the Federal Court of Appeal considered the patent issue of 'obviousness' in challenging a grant:[109] The four-step test set out in Sanofi-Synthelabo at para. 67 is one way to assess obviousness, but it is not mandatory. The Supreme Court of Canada warns in Sanofi-Synthelabo at para. 63 that one should avoid "“an overly rigid rule that limits the obviousness inquiry.”" The Court characterizes the four-step test as a useful approach. This Court has repeatedly commented that the framework provided in Sanofi-Synthelabo is not mandatory: Corlac Inc. v. Weatherford Canada Inc., 2011 FCA 228, 95 C.P.R. (4th) 101 at paras. 67-68; Wenzel Downhole Tools Ltd. v. National-Oilwell Canada Ltd., 2012 FCA 333, [2014] 2 F.C.R. 459 at para. 105; Teva Canada Limited v. Novartis Pharmaceuticals Canada inc., 2013 FCA 244, 451 N.R. 246 at para. 7. In my view, the only mandatory considerations are those laid out in section 28.3 of the Patent Act, which is concerned with obviousness to a person skilled in the art or science to which the invention pertains, having regard to "“information disclosed before the [relevant date] in such a manner that the information became available to the public in Canada or elsewhere.”"
[110] It is also helpful to observe that the four-step test set out in Sanofi-Synthelabo provides a framework for assessing obviousness (calling for the identification of the skilled person and that person’s common general knowledge, as well as the inventive concept and the differences, if any, from the state of the art), but it does not delve into the determination of whether those differences are obvious to the skilled person, except to say that it should be done without any knowledge of the alleged invention.
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