Amgen Canada Inc. et al. v. Apotex Inc. et al., 2015 FC 1261

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: November 10, 2015
• Jurisdiction: Canada (Federal)
• Citations: 2015 FC 1261;[2015] F.T.R. TBEd. NO.066

Amgen Can. Inc. v. Apotex Inc., [2015] F.T.R. TBEd. NO.066

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Currently being edited for F.T.R. - judgment temporarily in rough form.

Temp. Cite: [2015] F.T.R. TBEd. NO.066

Amgen Canada Inc. and Amgen Inc. (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-2072-12; 2015 FC 1261)

Indexed As: Amgen Canada Inc. et al. v. Apotex Inc. et al.

Federal Court

Hughes, J.

November 10, 2015.

Summary:

Amgen Inc., was the owner of Canadian Letters Patent No. 1,341,537 ('537 patent). Amgen Canada Inc. listed the '537 patent under the provisions of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations). Amgen Canada (first person) secured a Notice of Compliance from the Minister in respect of a product it called Neupogen which was a sterile solution containing a drug known as filgrastim in 300 g/mL and 600 g/mL strength for subcutaneous or intravenous administration. Apotex Inc., a Canadian, generic drug manufacturer (second person), applied to the Minister for a Notice of Compliance to sell a generic version of the Amgen Neupogen product. Apotex served a Notice of Allegation on Amgen, alleging that it would not infringe that patent and, in any event, that the patent was invalid on the grounds of novelty, obviousness and inutility. Amgen applied to prohibit the Minister from issuing a NOC to Apotex.

The Federal Court dismissed the application for the prohibition order. Amgen satisfied the court that Apotex's allegations respecting novelty and utility were not justified but did not establish that Apotex's allegations concerning lack of invention (obviousness) were not justified.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - See paragraphs 81 to 107.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art - See paragraphs 81 to 107.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - See paragraphs 62 to 107.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - See paragraphs 62 to 80.

Patents of Invention - Topic 1675

Grounds of invalidity - Lack of novelty - Particular patents - See paragraphs 62 to 80.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. "promise of the patent") - See paragraphs 108 to 121.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - See paragraphs 108 to 121.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - See paragraphs 108 to 121.

Counsel:

Andrew Shaughnessy, Andrew Bernstein, Nicole Mantini and Yael Bienenstock, for the applicants;

Andrew Brodkin, Richard Naiberg and Jorden Scopa, for the respondent, Apotex Inc.;

No One, for the respondent, The Minister of Health.

Solicitors of Record:

Torys, LLP,, Toronto, Ontario, for the applicants;

Goodmans, LLP,, Toronto, Ontario, for the respondent, Apotex Inc.;

Department of Justice, Ontario Regional Office, Toronto, Ontario, for the respondent, The Minister of Health.

This application was heard in Toronto, Ontario, on October 26 to 30, 2015, before Hughes, J., of the Federal Court, who delivered the following decision in Toronto, Ontario, on November 10, 2015.