Apotex Inc v. Shire LLC

Apotex Inc v. Shire LLC

Claims 1-5, 8, 10-12, 22, 24-30, 33-36 and 43 of the 646 Patent are valid because the prior art did not disclose or render obvious the specific compound LDX and its unexpected combination of sustained-release and abuse-resistant properties; Apotex’s manufacture and retention of capsules was exempt under the experimental and regulatory use exception, and therefore did not constitute infringement; accordingly a prohibition order under s 6(1) of the PM(NOC) Regulations was granted preventing the Minister from issuing a NOC to Apotex.

Citation
2018 FC 637
Parties
Plaintiff (defendant by Counterclaim) / Respondent: Apotex Inc.; Defendant (plaintiff by Counterclaim) / Respondent / Patentee: Shire LLC; Defendant (plaintiff by Counterclaim) / Applicant: Shire Pharma Canada ULC; Respondent (named, Did Not Participate): The Minister of Health
Court
Federal Court
Jurisdiction
Canada
Judgment Date
29 June 2018
Procedural Posture
Patent Validity, Infringement and Pm(noc) Prohibition Application / Judgment (federal Court Decision)
Outcome
Impeachment Action dismissed; Shire counterclaim dismissed; Prohibition application granted; Minister prohibited from issuing a NOC to Apotex for Apo-Lisdexamfetamine
Legal Topics
Obviousness, Anticipation, Infringement, Experimental and Regulatory Use Exception, Selection Patents, Prohibition Order Under Pm(noc) Regulations, Overbreadth, Insufficiency of Specification
Source Language
English
Patent Law Pharmaceutical Regulatory Law Intellectual Property Law Obviousness Anticipation Infringement Experimental and Regulatory Use Exception Selection Patents +3 more

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Parties

Apotex Inc.

Plaintiff (defendant by Counterclaim) / Respondent

Shire LLC

Defendant (plaintiff by Counterclaim) / Respondent / Patentee

Shire Pharma Canada ULC

Defendant (plaintiff by Counterclaim) / Applicant

The Minister of Health

Respondent (named, Did Not Participate)

Procedural Posture

Patent Validity, Infringement and Pm(noc) Prohibition Application / Judgment (federal Court Decision)

Legal Issues

  1. 1 Whether specified claims of Canadian Patent 2,527,646 are invalid for anticipation, obviousness, overbreadth or insufficiency of specification
  2. 2 Whether Apotex infringed the specified claims by manufacture and retention of generic product
  3. 3 Whether Minister of Health should be prohibited from issuing a Notice of Compliance to Apotex under PM(NOC) Regulations

Ratio Decidendi

Claims 1-5, 8, 10-12, 22, 24-30, 33-36 and 43 of the 646 Patent are valid because the prior art did not disclose or render obvious the specific compound LDX and its unexpected combination of sustained-release and abuse-resistant properties; Apotex’s manufacture and retention of capsules was exempt under the experimental and regulatory use exception, and therefore did not constitute infringement; accordingly a prohibition order under s 6(1) of the PM(NOC) Regulations was granted preventing the Minister from issuing a NOC to Apotex.

Court Disposition

Impeachment Action dismissed; Shire counterclaim dismissed; Prohibition application granted; Minister prohibited from issuing a NOC to Apotex for Apo-Lisdexamfetamine

Orders

  • Claims 1-5, 8, 10-12, 22, 24-30, 33-36 and 43 of Canadian Patent No. 2,527,646 upheld as valid
  • Impeachment Action (T-1056-16) dismissed