Amgen Canada Inc v Apotex Inc (2015
FC 1261) is the first decision of the Federal Court under the
Patented Medicines (Notice of Compliance) Regulations
relating to a subsequent entry biologic. Justice Hughes dismissed
Amgen’s application for an order prohibiting the Minister of
Health from issuing to Apotex a Notice of Compliance for a generic
version of Amgen’s filgrastim product (NEUPOGEN®) until
after expiry of Canadian Patent 1,341,537.
The only claim at issue before the Court was construed by the
Court as covering a recombinant protein having an amino acid
sequence beginning with Met (i.e. methionine), with the remainder
of the sequence having some or all of the the sequence and some or
all of the biological properties of the natural protein.
The existence and biological properties of the natural protein
had been reported in a prior art publication (“Welte”),
but the amino acid sequence of this protein was not reported. The
Welte publication also noted the need for large-scale production of
the protein because of implications in the management of clinical
diseases including hematopoietic derangement or failure.
Apotex argued that the claimed invention was anticipated, since
the existence of the natural protein had been disclosed in Welte.
According to Apotex, Amgen could not receive a patent simply for
identifying its amino acid sequence, which was “an inherent
property” of the polypeptide. Apotex further argued that even
though the recombinant polypeptide was different from the natural
protein (since the former began with “Met”), this was
merely an artifact of the way the recombinant protein was produced
and did not confer novelty to the claim.
The Court rejected Apotex’s argument. Justice Hughes held
that Welte did not disclose the claimed recombinant protein as the
natural protein did not have “Met” at the beginning of
its amino acid sequence and becuase the rest of the sequence was
possibly, but not certainly, the same.
However, the Court did find that the claimed invention was
obvious in light of Welte. While the Court acknowledged the high
degree of skilled work and risk involved in developing the
recombinant protein, it found that this work was not
“‘creative work’ necessary to deserve patent
protection”. In so doing, the Court contrasted the claimed
invention with the work disclosed in the Welte publication, which
“may well be considered an invention”.
The Court went on to consider Apotex’s allegation of
inutility, which it held to be unjustified. In finding the claim in
question not to include a “promise” of therapeutic
utility, the Court noted that different claims can have different
utilities and that the claim in question was only directed to the
recombinant protein and not its uses. The Court concluded that the
“promised” utility relating to the claim in issue
(“to create a manufactured protein having some or all of the
amino acid structure, and some or all of the biological properties
of the natural protein”) had been demonstrated at the time
the patent was filed.
As a final note, the Court declined to order costs against
either party, as both parties had failed to make “matters
clear and efficient for each other or the Court”. The Court
noted in particular Apotex’s failure to drop arguments until
the eve of trial.
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