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Case information

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41087

Apotex Inc. v. Janssen Inc. and Actelion Pharmaceuticals Ltd.

(Federal) (Civil) (By Leave)

(Sealing order) (Certain information not available to the public)

Docket

Judgments on applications for leave to appeal are rendered by the Court, but are not necessarily unanimous.

List of proceedings
Date Proceeding Filed By
(if applicable)
2024-06-07 Close file on Leave
2024-06-06 Copy of formal judgment sent to Registrar of the Court of Appeal and all parties
2024-06-06 Judgment on leave sent to the parties
2024-06-06 Judgment of the Court on the application for leave to appeal, The application for leave to appeal from the judgment of the Federal Court of Appeal, Number A-131-22, 2023 FCA 220, dated November 9, 2023, is dismissed with costs.
Dismissed, with costs
2024-05-16 Notice of change of solicitor, Change of firm to Tyr LLP Janssen Inc. and Actelion Pharmaceuticals Ltd.
2024-04-29 All materials on application for leave submitted to the Judges, for consideration by the Court
2024-02-22 Certificate (on limitations to public access), (Letter Form), 23B, (Printed version filed on 2024-02-27) Apotex Inc.
2024-02-22 Applicant's reply to respondent's argument, (Book Form), Completed on: 2024-02-22, (Printed version filed on 2024-02-27) Apotex Inc.
2024-02-12 Certificate (on limitations to public access), 23B, (Printed version filed on 2024-02-12) Janssen Inc. and Actelion Pharmaceuticals Ltd.
2024-02-12 Certificate (on limitations to public access), 23A, (Printed version filed on 2024-02-12) Janssen Inc. and Actelion Pharmaceuticals Ltd.
2024-02-12 Notice of name, (Printed version filed on 2024-02-12) Janssen Inc. and Actelion Pharmaceuticals Ltd.
2024-02-12 Respondent's response on the application for leave to appeal, (Book Form), CONFIDENTIAL

Missing:

- Proof of service (Rec'd 2024-02-13), Completed on: 2024-02-12, (Printed version filed on 2024-02-12)
Janssen Inc. and Actelion Pharmaceuticals Ltd.
2024-01-11 Letter acknowledging receipt of an incomplete application for leave to appeal, FILE OPENED

2024-01-11
2024-01-10 Notice of name Apotex Inc.
2024-01-10 Certificate (on limitations to public access), 23B
Apotex Inc.
2024-01-08 Certificate (on limitations to public access), 23A
Apotex Inc.
2024-01-08 Application for leave to appeal, (Book Form), CONFIDENTIALITY ORDER

Missing:

- Amended Notice of application (CA # quoted) (rec'd 2024-01-16)
- CA Orders
- Amended 23A (rec'd 2024-01-16)
- Amended 23B (Rec'd 2024-06-05)
- Filing Fee
, Completed on: 2024-04-30, (Printed version filed on 2024-01-11)
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

Main parties - Appellants
Name Role Status
Apotex Inc. Applicant Active

v.

Main parties - Respondents
Name Role Status
Janssen Inc. and Actelion Pharmaceuticals Ltd. Respondent Active

Counsel

Party: Apotex Inc.

Counsel
Names
Andrew Brodkin
Nando DeLuca
Sandon Shogilev
Contact information
Goodmans LLP
3400 - 333 Bay Street
Bay Adelaide Centre
Toronto, Ontario
M5H 2S7
Telephone: (416) 979-2211
FAX: (416) 979-1234
Email: abrodkin@goodmans.ca
Agent
Name
Andrew Montague-Reinholdt
Contact information
NELLIGAN O’BRIEN PAYNE LLP
50 O’Conner Piece
Suite 1500
Ottawa, Ontario
K1P 6L2
Telephone: (613) 231-8244
FAX: (613) 298-2098
Email: andrew.montague-reinholdt@nelliganlaw.ca

Party: Janssen Inc. and Actelion Pharmaceuticals Ltd.

Counsel
Names
Melanie Baird
Cole Meagher
Contact information
Tyr LLP
488 Wellington Street West
Suite 300-302
Toronto, Ontario
M5V 1E3
Telephone: (437) 873-9083
FAX: (416) 987-2370
Email: mbaird@tyrllp.com
Agent
Name
Jonathan Laxer
Contact information
Juristes Power
50, rue O'Connor
Bureau 1313
Ottawa, Ontario
K1P 6L2
Telephone: (613) 907-5652
Email: jlaxer@juristespower.ca

Summary

Keywords

Intellectual property — Patents — Medicines — Lower courts finding that if Apotex was granted a Notice of Compliance to market its generic form of macitentan, it would infringe the respondents’ 770 Patent by inducing physicians to infringe in their prescribing decisions — Does the proposed appeal raises one or more questions that, by reason of their public importance or the importance of issues of law warrant consideration and decision of this Court?

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.

(Certain information not available to the public)

The respondent Janssen Inc. markets a prescription medication in Canada, known as Opsumit, a tablet containing 10 mg of macitentan, to treat patients with pulmonary arterial hypertension (“PAH”). Left untreated, PAH could lead to heart failure and death. The respondent Actelion is the registered owner of the 770 Patent for macitentan. Opsumit may be prescribed alone or in combination with another class of drugs known as phosphodiesterase type-5 inhibitors (“PDE5-Is”) which affect blood pressure.

Apotex filed an Abbreviated New Drug Submission with Health Canada, seeking authorization to market its generic copy, Apo-macitentan, based upon its equivalent pharmaceutical and bioavailability characteristics, when compared to Opsumit. The respondents alleged that if Apotex were to sell Apo-macitentan, it would infringe certain of its claims in its 770 Patent. In particular, that patent related to a formula for the use of macitentan in combination with a PDE5-I to treat PAH.

The respondents alleged that Apotex would infringe the 770 Patent directly, or indirectly by making statements in the product monograph (“PM”) that would induce others to infringe, notably prescribing physicians.

The trial judge held that the respondents established indirect infringement of their 770 Patent. Apotex’s appeal from this decision was dismissed.

Lower court rulings

May 20, 2022
Federal Court

2022 CF 996 (French only)

Declaration that Apotex’s generic product would indirectly infringe the respondents’ 770 Patent by inducing infringement

November 9, 2023
Federal Court of Appeal

2023 FCA 220

Apotex’s appeal 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

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

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

Webcasts

Not available.

Date modified: 2025-05-21