Amgen Canada Inc. et al. v. Apotex Inc. et al., 2015 FC 1261 (Filgrastim*)
Justice Hughes - 2015-11-10
Read full decision. Summary prepared by Alan Macek:
Amgen sought to prohibit the issuance of an NOC to Apotex for a biosimilar filgrastim product. The patent at issue, an old act patent issued in 2007 was directed to a 175 amino acid polypeptide consisting of "Met" followed by a likely naturally occurring sequence. The Court considered novelty, obviousness and inutility. The Court held that the claimed sequence was not identical to that of the 'naturally' occurring factor disclosed in the prior art, so was not anticipated. On obviousness, the Court found that the prior art asked the POSITA to go make it in quantity and such process was only 'skilled work', not inventive. On utility, the court found that claim met the promise to have a manufactured protein having some or all of the amino acid structure and properties of the natural protein. The asserted claim did not refer to any particular use. The application was therefore dismissed on the basis of obviousness. No costs were awarded because "the parties must accept that they have not made matters clear and efficient for each other or the Court."
Decision relates to:
- T-2072-12 - AMGEN CANADA INC. ET AL v. APOTEX INC.ET AL
- A-501-15(2016 FCA 121) - which is an appeal from this decision
- T-2072-12 - AMGEN CANADA INC. ET AL v. APOTEX INC.ET AL
- A-501-15(2016 FCA 196) - which is an appeal from this decision