AstraZeneca Canada Inc. v. Pharmascience Inc.

AstraZeneca Canada Inc. v. Pharmascience Inc.

Pharmascience met its evidentiary threshold to put invalidity issues into play but AstraZeneca discharged the legal burden on the challenged grounds (not an invention, utility, sufficiency, obviousness). The specification and experimental data, read by a skilled person, provided a factual basis and enablement for selecting HPMC batches by cloud point to secure consistent omeprazole release; the invention was not obvious. Accordingly the NOA allegations were not justified and prohibition issued.

Citation
2012 FC 1189
Parties
Applicant: AstraZeneca Canada Inc.; Applicant: AstraZeneca AB; Respondent: Pharmascience Inc.; Respondent: The Minister of Health
Court
Federal Court
Jurisdiction
Canada
Judgment Date
11 October 2012
Procedural Posture
NOC Regulations Application (patent) / Judgment (application for Prohibition Under NOC Regulations)
Outcome
Prohibition order granted in favour of AstraZeneca; Minister prohibited from issuing NOC for Pharmascience until patent expiry
Legal Topics
Utility, Sufficiency of Disclosure, Obviousness, Claim Construction, Notice of Allegation (noc) Procedure
Source Language
English
Patent Law Regulatory Law Pharmaceutical Regulation Intellectual Property Litigation Utility Sufficiency of Disclosure Obviousness Claim Construction +1 more

Case Brief

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Parties

AstraZeneca Canada Inc.

Applicant

AstraZeneca AB

Applicant

Pharmascience Inc.

Respondent

The Minister of Health

Respondent

Procedural Posture

NOC Regulations Application (patent) / Judgment (application for Prohibition Under NOC Regulations)

Legal Issues

  1. 1 Whether the '531 Patent is not an invention under s.2 of the Patent Act because it merely ascertains properties of a known substance
  2. 2 Whether the '531 Patent meets the utility requirement
  3. 3 Whether the '531 Patent provides sufficient disclosure

Ratio Decidendi

Pharmascience met its evidentiary threshold to put invalidity issues into play but AstraZeneca discharged the legal burden on the challenged grounds (not an invention, utility, sufficiency, obviousness). The specification and experimental data, read by a skilled person, provided a factual basis and enablement for selecting HPMC batches by cloud point to secure consistent omeprazole release; the invention was not obvious. Accordingly the NOA allegations were not justified and prohibition issued.

Court Disposition

Prohibition order granted in favour of AstraZeneca; Minister prohibited from issuing NOC for Pharmascience until patent expiry

Orders

  • Minister of Health is prohibited from issuing a notice of compliance to Pharmascience for its 20 mg and 40 mg esomeprazole magnesium capsules until after the expiration of Canadian Patent No. 2,290,531 (May 18, 2018)
  • AstraZeneca shall have its costs of the application