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.
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
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.
McCartney & Lennon, Jobs & Wozniak, Watson & Crick. We are all looking for synergistic collaborations. In life sciences, some of those collaborations may be with your employees, independent contractors or corporate research partners.
A recent decision of the Federal Court of Canada has highlighted the difficulties in asserting trademark and copyright rights related to the appearance of functional products with unique design elements.
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