Case information
Conduct a refined search of the Supreme Court of Canada database to obtain details on the status of a matter before the Court.
39662
Apotex Inc. v. Shire LLC, et al.
(Federal) (Civil) (By Leave)
Docket
Judgments on applications for leave to appeal are rendered by the Court, but are not necessarily unanimous.
| Date | Proceeding | Filed By (if applicable) |
|---|---|---|
| 2021-10-08 | Close file on Leave | |
| 2021-10-07 | Copy of formal judgment sent to Registrar of the Court of Appeal and all parties | |
| 2021-10-07 | Judgment on leave sent to the parties | |
| 2021-10-07 |
Judgment of the Court on the application for leave to appeal, The motion to join two Federal Court of Appeal files in a single application for leave to appeal is granted. The application for leave to appeal from the judgment of the Federal Court of Appeal, Numbers A-282-18 and A-283-18, 2021 FCA 52, dated March 11, 2021, is dismissed with costs. Dismissed, with costs |
|
| 2021-10-07 |
Decision on the miscellaneous motion, See decision on application Granted |
|
| 2021-09-07 | All materials on application for leave submitted to the Judges, for consideration by the Court | |
| 2021-09-07 | Submission of miscellaneous motion, for consideration by the Court | |
| 2021-08-09 | Applicant's reply to respondent's argument, (Book Form), Completed on: 2021-09-03, (Printed version due on 2021-08-16) | Apotex Inc. |
| 2021-08-09 | Book of authorities, (Book Form), reply, Completed on: 2021-09-03, (Printed version due on 2021-08-16) | Apotex Inc. |
| 2021-08-04 | Correspondence received from, (Letter Form), Amended Memorandum filing | Apotex Inc. |
| 2021-06-28 | Certificate (on limitations to public access), (Letter Form), (Included in the certificate (on limitations to public access)), 23B, (Printed version due on 2021-07-06) | Shire LLC |
| 2021-06-28 | Certificate (on limitations to public access), (Letter Form), 23A, (Printed version due on 2021-07-06) | Shire LLC |
| 2021-06-28 | Notice of name, (Letter Form), (Printed version due on 2021-07-06) | Shire LLC |
| 2021-06-28 | Respondent's response on the application for leave to appeal, (Book Form), Completed on: 2021-07-15, (Printed version filed on 2021-06-28) | Shire LLC |
| 2021-06-03 | Notice of miscellaneous motion, (Book Form), Motion to join, Completed on: 2021-07-15, (Printed version filed on 2021-06-07) | Apotex Inc. |
| 2021-05-28 | Letter acknowledging receipt of an incomplete application for leave to appeal, FILE OPENED 05/28/21 | |
| 2021-05-25 | Certificate (on limitations to public access), (Letter Form), 23B, (Printed version due on 2021-06-01) | Apotex Inc. |
| 2021-05-25 | Certificate (on limitations to public access), (Letter Form), 23A, (Printed version due on 2021-06-01) | Apotex Inc. |
| 2021-05-25 | Notice of name, (Letter Form), (Printed version due on 2021-06-01) | Apotex Inc. |
| 2021-05-10 | Book of authorities, (Book Form), (3 volumes), Completed on: 2021-05-19, (Printed version filed on 2021-05-13) | Apotex Inc. |
| 2021-05-10 |
Application for leave to appeal, (Book Form), (3 volumes), Amended Memorandum of arguments received 2021-08-04 Missing: -Motion to Join (rec'd 2021-06-03) -Filing Fee (rec'd 2021-05-31) -Proof of Notification of the Notice of Application to the retired party (Ministry of Health) (rec'd 2021-05-31) -Form 23A & 23B (rec' 05/25/21) -Form 14 – Notice of Name (rec' 05/25/21), Completed on: 2021-09-03, (Printed version filed on 2021-05-13) |
Apotex Inc. |
Parties
Please note that in the case of closed files, the “Status” column reflects the status of the parties at the time of the proceedings. For more information about the proceedings and about the dates when the file was open, please consult the docket of the case in question.
Main parties
| Name | Role | Status |
|---|---|---|
| Apotex Inc. | Applicant | Active |
v.
| Name | Role | Status |
|---|---|---|
| Shire LLC | Respondent | Active |
| Shire Pharma Canada ULC | Respondent | Active |
Counsel
Party: Apotex Inc.
Counsel
Andrew Brodkin
Richard Naiberg
Sandon Shogilev
Bay Adelaide Centre
333 Bay Street, Suite 3400
Toronto, Ontario
M5H 2S7
Telephone: (416) 597-4142
Email: hradomski@goodmans.ca
Agent
66 Slater St
Suite 1900
Ottawa, Ontario
K1P 5H1
Telephone: (613) 231-8311
FAX: (613) 788-3667
Email: christopher.rootham@nelliganlaw.ca
Party: Shire LLC
Counsel
Alex Gloor
160 Elgin Street, Suite 2600
Ottawa, Ontario
K1P 1C3
Telephone: (613) 786-8806
FAX: (613) 563-9869
Email: jay.zakaib@gowlingwlg.com
Agent
160 Elgin Street, Suite 2600
Ottawa, Ontario
K1P 1C3
Telephone: (613) 786-0171
FAX: (613) 563-9869
Email: jeff.beedell@gowlingwlg.com
Party: Shire Pharma Canada ULC
Counsel
Alex Gloor
160 Elgin Street, Suite 2600
Ottawa, Ontario
K1P 1C3
Telephone: (613) 786-8806
FAX: (613) 563-9869
Email: jay.zakaib@gowlingwlg.com
Agent
160 Elgin Street, Suite 2600
Ottawa, Ontario
K1P 1C3
Telephone: (613) 786-0171
FAX: (613) 563-9869
Email: jeff.beedell@gowlingwlg.com
Summary
Keywords
Intellectual property — Patents — Medicines — Validity of respondents’ patent for a chemical compound used in the treatment ADHD that was resistant to abuse challenged by applicant on basis of, inter alia, obviousness — What is the proper approach to assessment of obviousness in Canadian patent law? — What is the proper end point for the obviousness analysis?
Summary
Case summaries are prepared by the Office of the Registrar of the Supreme Court of Canada (Law Branch). Please note that summaries are not provided to the Judges of the Court. They are placed on the Court file and website for information purposes only.
The Shire respondents (“Shire”) own the 646 Patent entitled “Abuse Resistant Amphetamine Compounds” related to the compound lisdexamfetamine (“LDX”), its compounds, methods of delivery and use in the treatment of Attention Deficit and Hyperactivity Disorder. An important drawback to both immediate and sustained release formulations of amphetamine is their potential for abuse. The 646 Patent addressed the need for an abuse-resistant dosage of amphetamine that was therapeutically effective. Apotex Inc., a generic drug manufacturer, served Notices of Allegation on Shire, seeking to obtain a Notice of Compliance from the Minister of Health to market its generic version of LDX under the Patented Medicines (Notice of Compliance Regulations, SOR/93 133. Shire responded by filing prohibition applications under s. 6(1) of the Regulations, to prevent the Minister from issuing a NOC to Apotex until after the expiry of its 646 Patent. Apotex also commenced an impeachment action under s. 60 of the Patent Act, R.S.C. 1985, c. P 4 for declarations that the 646 Patent was invalid on the grounds of anticipation, obviousness, overbreadth or insufficiency of specification. The Federal Court dismissed the impeachment action and granted the order of prohibition sought by Shire. These decisions were upheld on appeal.
Lower court rulings
Federal Court
2018 FC 637, T-1056-16, T-998-16
Claims of 646 Patent held not to be invalid; Minister prohibited from issuing a NOC to Apotex for its generic product
Federal Court of Appeal
2021 FCA 52, A-282-18, A-283-18
Apotex’s appeals dismissed
Filed documents
The memorandums of argument on an application for leave to appeal will be posted here 30 days after leave to appeal has been granted unless they contain personal information, information that is subject to a publication ban, or any other information that is not part of the public record. You may also obtain copies of the memorandum by filling out the Request for Court records form or by contacting the Court’s Records Centre either by email at records-dossiers@scc-csc.ca or by telephone at 613‑996‑7933 or at 1‑888‑551‑1185.
If you have questions about a memorandum of argument or want to use a memorandum of argument, please contact the author of the memorandum of argument directly. Their name appears at the end of the memorandum of argument. The contact information for counsel is found in the “Counsel” tab of this page.
Downloadable PDFs
Not available
Related links
The factums of the appellant, the respondent and the intervener will be posted here at least 2 weeks before the hearing unless they contain personal information, information that is subject to a publication ban, or any other information that is not part of the public record. You may also obtain copies of factums by filling out the Request for Court records form or by contacting the Court’s Records Centre either by email at records-dossiers@scc-csc.ca or by telephone at 613‑996‑7933 or at 1‑888‑551‑1185.
If you have questions about a factum or want permission to use a factum, please contact the author of the factum directly. Their contact information appears on the first page of each factum.
Downloadable PDFs
Not available
Related links
The condensed books of the appellant, the respondent and the intervener will be posted here upon receipt of the electronic version, 2 days prior to the scheduled appeal hearing. You may also obtain copies of condensed books by filling out the Request for Court records form or by contacting the Court’s Records Centre either by email at records-dossiers@scc-csc.ca or by telephone at 613‑996‑7933 or at 1‑888‑551‑1185.
If you have questions about a condensed book or want permission to use a condensed book, please contact the author of the condensed book directly. Their contact information appears on the first page of each condensed book.
Downloadable PDFs
Not available