Federal Court of Appeal Clarifies Misunderstanding: Factual Basis and Line of Reasoning Need not be Disclosed in the Patent
In a decision released on June 3, 2015 (2015 FCA 137), a unanimous Federal Court of Appeal (“FCA”) dismissed Apotex’s appeal of Justice O’Reilly’s order prohibiting the Minister of Health from issuing a NOC to Apotex to market its generic version of LUMIGAN RC® until the expiry of Canadian Patent No. 2,585,691 (the “‘691 Patent”).
Significantly, on the issue of sound prediction the FCA held that the elements of sound prediction need not be disclosed in a patent if they would be self-evident to the skilled person. The Federal Court of Appeal has previously stated this principle in obiter in relation to the requirement that there be a “line of reasoning” linking the factual basis for the prediction and the prediction itself. However, the issue was squarely before the Court on this appeal and the Court’s ruling is a ratio of the case. Further, the Federal Court of Appeal held that any element of the test for sound prediction that would be self-evident to the skilled person need not be disclosed in the patent.
Justice O’Reilly’s Decision (summarized here)
The ‘691 Patent claims, inter alia, a new formulation containing 0.01% bimatoprost for treating glaucoma comparably to the old formulation (containing 0.03% bimatoprost). While that specific formulation was never tested, Allergan’s experts testified that the line of reasoning, though not stated in the patent, was a “simple extrapolation” from the data in one of the examples. Based on that evidence, Justice O’Reilly found that “[t]he sound line of reasoning though not stated in the patent is implicit in the data itself and would be apparent to the skilled reader; it did not have to be explicitly laid out.”
FCA Decision (Dawson J.A., Webb J.A., Boivin J.A.)
On appeal, Apotex attacked this finding, alleging that under sound prediction law, the line of reasoning must be explicitly disclosed in the patent, and the FCA’s statements in Eurocopter to the contrary were obiter, applicable to mechanical patents, and inconsistent with other decisions relating to pharmaceutical patents.
Writing for a unanimous panel, Dawson J.A. citing to Eurocopter, held that the test for sound prediction is assessed as a function of both the knowledge that the skilled person would have to base that prediction on and what the skilled person would understand as a logical line of reasoning leading to the utility of the invention.
In the result, the FCA rejected Apotex’s assertion that the line of reasoning had to be explicitly disclosed in the patent:
Those elements of the doctrine of sound prediction that would be self-evident to the skilled person need not be explicitly disclosed in the patent.
The FCA’s approach is consistent with the fundamental principle in patent law that patents are addressed to persons skilled in the art to which the patent relates. It also avoids the absurd result of requiring patentees to write down every scientific principle and fact relevant to a prediction that would otherwise be self-evident to the skilled person. Finally, the FCA’s holding dispels any notion that its earlier decision in Eurocopter was limited only to mechanical patents.
Allergan was represented by Andrew Reddon, Steven Mason, Steven Tanner and Sanjaya Mendis of McCarthy Tétrault LLP.
FCA Patents sound prediction