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Patents - 'Insufficiency'. Eli Lilly Canada Inc. v. Apotex Inc.
In Eli Lilly Canada Inc. v. Apotex Inc. (Fed CA, 2024) the Federal Court of Appeal considered patent 'insufficiency':B. Insufficiency
[41] Since the appellants’ argument on insufficiency depends on the success of its argument on claim construction, and since I have concluded that the Federal Court did not err on its claim construction, it is not necessary to review the question of invalidity for insufficiency.
[42] That said, I do wish to make a few comments about the Federal Court’s discussion of the fact that putting the invention of the 784 Patent into practice would require completion of a minor research project. The Federal Court suggested that this was the reason for concluding that the claims in issue are invalid for insufficiency. However, the need to conduct a minor research project is not the determinant factor for insufficiency of a patent disclosure in the present context.
[43] A finding of insufficiency is really a finding that the patent in question fails to meet the requirements of subsection 27(3) of the Patent Act, R.S.C. 1985, c. P-4. This provision requires that the specification "“correctly and fully describe the invention and its operation or use as contemplated by the inventor”" in order that, "“when the period of the monopoly has expired the public will be able, having only the specification, to make the same successful use of the invention as the inventor could at the time of his application”": Consolboard v. MacMillan Bloedel (Sask.) Ltd., 1981 CanLII 15 (SCC), [1981] 1 S.C.R. 504, 122 D.L.R. (3d) 203 at 520.
[44] The reference to a minor research project seems to come from Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60, [2012] 3 S.C.R. 625 (Teva) where the Supreme Court of Canada found a patent invalid for insufficiency because a skilled reader of the patent in issue would be unable, without undertaking a minor research project, to determine which of two compounds was favoured by the inventors. As the Court in Teva stated at paragraph 76, "“Pfizer had the information needed to disclose the useful compound and chose not to release it.”" In that sense, the patent specification in that case failed to meet the requirement to teach the public the same successful use of the invention as the inventor could at the time of the application.
[45] The present appeal is not about the patentee’s decision to withhold certain information, but rather a more general insufficiency of information in the patent specification. As this Court has stated several times in recent years, it remains the case that a patent specification may be sufficient even if some amount of non-inventive trial and error experimentation is required, so long as it is not undue: Teva Canada Limited v. Leo Pharma Inc., 2017 FCA 50, 145 C.P.R. (4th) 350 at para. 56; Bombardier Recreational Products Inc. v. Arctic Cat, Inc., 2018 FCA 172, 159 C.P.R. (4th) 319 at para. 78; Western Oilfield Equipment Rentals Ltd. v. M-I LLC, 2021 FCA 24, 331 A.C.W.S. (3d) 743 at para. 114; Seedlings Life Science Ventures, LLC v. Pfizer Canada ULC, 2021 FCA 154, 339 A.C.W.S. (3d) 69 at para. 68. Accordingly, a patent may be sufficient even if it requires a minor research project, provided no inventiveness or undue experimentation is involved.
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