Amgen Canada Inc. v Apotex Inc. et al, 2015 FC 1261 (Hughes J.)
November 10, 2015
Andrew Shaughnessy, Andrew Bernstein, Nicole Mantini, and Yael Bienenstock of Torys LLP, for Amgen Canada Inc. and Amgen Inc.. (Applicants)
Andrew Brodkin, Richard Naiberg, and Jordan Scopa of Goodmans LLP, for Apotex Inc. (Respondent)
Result: Application for a prohibition order under the Patented Medicines (Notice of Compliance) Regulations dismissed.
The Federal Court dismissed on November 10, 2015 the first prohibition application to go to a hearing relating to a subsequent entry biologic. Amgen Canada Inc. and Amgen Inc. sought to prohibit the Minister from issuing a Notice of Compliance to Apotex for its proposed generic version of filgrastim, marketed by Amgen as NEUPOGEN®. Amgen asserted Canadian Patent No. 1,341,537, a rare remaining patent issued under the old Patent Act. The Court found Apotex’s obviousness allegation justified, but rejected the allegations of anticipation and lack of sound prediction.
The Court began by refusing to make any findings in respect of the numerous attacks on the expert evidence. Having not seen any live witnesses, the Court found it unfair to make findings as to the propriety of their conduct or their candor. It added that that these proceedings have become anything but the summary proceedings they were intended to be, requiring the Court to consider complex scientific matters, address opposing views of sophisticated experts, and deal with complex issues of law within a limited timeframe. The Court posited that the system would break down completely if something did not change.
The Court then construed the only asserted claim as covering a recombinant protein having an amino acid sequence beginning with Met (i.e. methionine), with the remainder of the sequence largely replicating sequence and biological properties of the natural protein.
The Court rejected Apotex’s argument that the patent was anticipated by a prior art publication disclosing the existence and biological properties of the natural protein, but not its amino acid sequence. The Court held that the natural protein was not “identical” to the claimed recombinant protein because it did not have a “Met” at the beginning of its amino acid sequence, even though the rest of the sequence might be the same. The Court disagreed that Amgen merely identified this sequence, which Apotex argued was an inherent property of the protein. The Court also disagreed that the difference between the claimed recombinant protein and the natural protein (ie. the “Met” at the beginning of the former) merely resulted from how the recombinant protein was produced.
The Court did however find that the claimed recombinant protein was obvious in light of this same prior art publication. The Court found that the high degree of skilled work and risk involved in developing the recombinant protein was not “‘creative work’ necessary to deserve patent protection”, terminology unknown to patent law. The Court held that, while Amgen may well have developed an inventive process to produce the claimed recombinant protein, that end product itself, which was the subject of the only asserted claim, was not inventive.
The Court found Apotex’s allegation of inutility unjustified. The Court followed recent appellate jurisprudence confirming holding that different claims can have different utilities. On that basis, the Court disagreed that the asserted claim promised therapeutic utility, finding that it was directed only to the recombinant protein and not its uses. The Court concluded that, at the time the patent was filed, Amgen had demonstrated the utility of this claim, which was simply 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.
The Court concluded by noting that the parties did not make matters clear and efficient for each other or the Court, highlighting in particular Apotex’s failure to drop arguments until the eve of trial. As a result, the Court declined to order costs against either party.
By: Kiernan A. Murphy, Gowling Lafleur Henderson LLP