Federal Court issues first biologics decision under PM(NOC) regulations

4 minute read
01 November 2015

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 because 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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