The Federal Court of Appeal (FCA) in Cobalt v.
Bayer1 has explicitly called into question two
central principles of Canadian patent law: the standard of review
for claim construction and the patentability of methods of medical
Cobalt v. Bayer is largely unremarkable in its outcome. It
concerned two appeals from a prohibition application made under the
PM(NOC) Regulations pertaining to two patents listed by Bayer on
the Patent Register for its YAZ® birth control product. As
between the parties, and based on Cobalt's allegations, at
first instance Justice Hughes found that Bayer's '426
Patent was infringed and valid while its '728 Patent was not
infringed and invalid.2 The FCA upheld Justice
Hughes's conclusions in these respects.
Standard of Review for Claim Construction
Claim construction was a central issue in Cobalt's appeal of
the decision with respect to the '426 Patent. Cobalt argued
that claim construction was to be reviewed on a correctness
standard as it is a question of law. The Court accepted this
proposition, with the caveat that any review of expert evidence was
to be performed pursuant to a standard of palpable and overriding
In obiter Justice Stratas's majority opinion questioned the
standard of review to be applied in cases where expert evidence
plays a significant role in the claim construction exercise. He
questioned whether the standard should be elevated to a more
deferential approach in such a situation. Discussing this, Justice
How are appellate judges supposed to cleave off those aspects of
claim construction that flow from the trial judge's
appreciation of expert evidence from the words of the claim per se?
Can appellate judges really second-guess the trial judge, who,
often over many days, has been educated in the relevant art and has
seen and evaluated the experts? Who are the appellate judges to
review on the basis of correctness, stepping into the shoes of the
trial judge and imposing their own views of the
Justice Stratas also noted that there is a growing acceptance in
the United States for deference to be accorded to the
interpretations of patents reached by experts, citing the US
Supreme Court's Teva v. Sandoz.5 Further, he
offered a practical work-around to what has been considered the
basis of the correctness standard: that a patent is a
"law" or "regulation" under the Interpretation
Act and thus that a correctness standard is mandated. In
particular, Justice Stratas noted that a distinction can be drawn
between "letters patent" – which includes only the
actual certificate bearing CIPO's seal – and the
specification of the patent. Applying this distinction, Justice
Stratas argued that the specification need not be termed a
"regulation" under the Interpretation Act.
In concurring reasons Justice Pelletier declined to endorse
Justice Stratas's position with respect to these obiter remarks
on construction as they were not necessary for the disposition of
Methods of Medical Treatment
Canadian Courts have held that claims to method of medical
treatments are not patentable, with the leading case being the
Supreme Court's decision in Tennessee Eastman v. Commissioner
of Patents.6 However, Tennessee Eastman justified
the prohibition on claiming methods of medical treatment through
reference to former section 41(1) of the Patent Act, which is now
repealed. Given the Supreme Court's repeated holding that
patent law is wholly statutory,7 the value of
Tennessee Eastman and the subsequent jurisprudence on the
patentability of methods of medical treatment is questionable.
In apparent recognition of this, and referencing Professor
Siebrasse's blog, the FCA noted that a full consideration of
the method of medical treatment doctrine is merited by the FCA or
Supreme Court in a future case where the issue is squarely raised
on the facts.
The full text of the FCA's decision can be accessed here.
1 2015 FCA 116 [Reasons]
2 2013 FC 1061
3 Reasons at ¶12-15
4 Reasons at ¶20
5 Reasons at ¶22, citing No. 13-854, 574 U.S. __
6  SCR 111
7 For example, see: Plavix SCC, 2008 SCC 61 at
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