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41209

Pharmascience Inc. v. Janssen Inc., et al.

(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)
2025-05-27 Correspondence received from, (Letter Form), from the appellant.
RE: Tentatively scheduled within the following timeframe: October 6-17, 2025, , (Printed version due on 2025-06-03)
Pharmascience Inc.
2025-05-20 Letter advising the parties of tentative hearing date and filing deadlines (Leave granted)
2025-05-20 Appeal hearing, Tentatively scheduled within the following timeframe: October 6 - 17, 2025
2025-04-25 Certificate (on limitations to public access), 23B Janssen Inc.
2025-04-25 Reply factum on appeal, (Book Form), Completed on: 2025-04-28, (Printed version filed on 2025-04-28) Janssen Inc.
2025-04-25 Certificate (on limitations to public access), 23B, (Printed version filed on 2025-04-28) Pharmascience Inc.
2025-04-25 Other book of authorities, (Book Form), Completed on: 2025-04-25, (Printed version filed on 2025-04-28) Pharmascience Inc.
2025-04-25 Reply factum on appeal, (Book Form), Completed on: 2025-04-25, (Printed version filed on 2025-05-06) Pharmascience Inc.
2025-04-11 Intervener's book of authorities, (Book Form), Completed on: 2025-04-11, (Printed version filed on 2025-04-14) Innovative Medicines Canada and BIOTECanada
2025-04-11 Intervener's factum, (Book Form), Completed on: 2025-04-15, (Printed version filed on 2025-04-14) Innovative Medicines Canada and BIOTECanada
2025-04-11 Intervener's book of authorities, (Book Form), Completed on: 2025-04-11, (Printed version filed on 2025-04-11) Canadian Generic Pharmaceutical Association
2025-04-11 Intervener's factum, (Book Form), Missing:

- Proof of service (Rec 04-15-2025), Completed on: 2025-04-15, (Printed version filed on 2025-04-11)
Canadian Generic Pharmaceutical Association
2025-04-11 Intervener's book of authorities, (Book Form), Completed on: 2025-04-11, (Printed version filed on 2025-04-14) International Federation of Intellectual Property Attorneys
2025-04-11 Intervener's factum, (Book Form), Completed on: 2025-04-11, (Printed version filed on 2025-04-14) International Federation of Intellectual Property Attorneys
2025-04-11 Intervener's book of authorities, (Book Form), Completed on: 2025-04-11, (Printed version filed on 2025-04-11) Canadian Organization for Rare Disorders
2025-04-11 Intervener's factum, (Book Form), Completed on: 2025-04-11, (Printed version filed on 2025-04-11) Canadian Organization for Rare Disorders
2025-04-11 Intervener's book of authorities, (Book Form), Completed on: 2025-04-11, (Printed version filed on 2025-04-11) David Homuth, Marco Solmi, and Pierre Bleau
2025-04-11 Intervener's factum, (Book Form), Completed on: 2025-04-11, (Printed version filed on 2025-04-11) David Homuth, Marco Solmi, and Pierre Bleau
2025-02-28 Order on motion for leave to intervene, By JUSTICE O'BONSAWIN
2025-02-28 Decision on the motion for leave to intervene, Ob, UPON APPLICATIONS by the Canadian Organization for Rare Disorders; International Federation of Intellectual Property Attorneys; Canadian Generic Pharmaceutical Association; David Homuth, Marco Solmi, and Pierre Bleau; Innovative Medicines Canada and BIOTECanada and Lazaridis Intellectual Property Lab and Norman Siebrasse for leave to intervene in the above appeal;


AND THE MATERIAL FILED having been read;

IT IS HEREBY ORDERED THAT:

Leave to intervene is denied to Lazaridis Intellectual Property Lab and Norman Siebrasse.

The motions for leave to intervene by the Canadian Organization for Rare Disorders, International Federation of Intellectual Property Attorneys, Canadian Generic Pharmaceutical Association, David Homuth, Marco Solmi, and Pierre Bleau, Innovative Medicines Canada and BIOTECanada are granted.

The five (5) interveners are each entitled to serve and file a single factum not to exceed ten (10) pages in length and a book of authorities, if any, on or before April 11, 2025.

The five (5) interveners are each granted permission to present oral argument not exceeding five (5) minutes at the hearing of the appeal.

The appellant is granted permission to serve and file a single factum in reply to all interventions not to exceed ten (10) pages in length on or before April 25, 2025.

The respondent is granted permission to serve and file a single factum in reply to all interventions not to exceed ten (10) pages in length on or before April 25, 2025.


The interveners are not entitled to raise new issues or to adduce further evidence or otherwise to supplement the record of the appellants and the respondents.

Pursuant to Rule 59(1)(a) of the Rules of the Supreme Court of Canada, the interveners shall pay to the appellants and the respondents any additional disbursements resulting from their interventions.

Judgment accordingly
2025-02-28 Submission of motion for leave to intervene, Ob
2025-02-24 Certificate (on limitations to public access), 23B Janssen Inc.
2025-02-24 Respondent's book of authorities, (Book Form), Completed on: 2025-02-24, (Printed version filed on 2025-02-25) Janssen Inc.
2025-02-24 Respondent's factum, (Book Form), Completed on: 2025-02-24, (Printed version filed on 2025-02-25) Janssen Inc.
2025-02-10 Reply to the motion for leave to intervene, (Book Form), Completed on: 2025-02-11, (Printed version filed on 2025-02-10) International Federation of Intellectual Property Attorneys
2025-02-10 Reply to the motion for leave to intervene, (Book Form), Completed on: 2025-02-11, (Printed version filed on 2025-02-10) Canadian Organization for Rare Disorders
2025-02-10 Reply to the motion for leave to intervene, Missing Proof of service (Rec'd on 2025-02-11), Completed on: 2025-02-13 Innovative Medicines Canada and BIOTECanada
2025-02-10 Reply to the motion for leave to intervene, Completed on: 2025-02-11 Canadian Generic Pharmaceutical Association
2025-02-06 Correspondence received from, To serve and file “reply” memorandum. Pharmascience Inc.
2025-02-04 Response to the motion for leave to intervene, (Letter Form), Completed on: 2025-03-06 Janssen Inc.
2025-02-03 Response to the motion for leave to intervene, (Book Form), Completed on: 2025-02-04, (Printed version due on 2025-02-10) Pharmascience Inc.
2025-02-03 Response to the motion for leave to intervene, (Letter Form), Completed on: 2025-02-04 Janssen Inc.
2025-01-29 Correspondence received from, (Letter Form), Letter regarding Counsel's availability for hearing Janssen Inc.
2025-01-27 Notice of name Innovative Medicines Canada and BIOTECanada
2025-01-27 Motion for leave to intervene, (Book Form), Completed on: 2025-01-29, (Electronic version filed on 2025-01-27) David Homuth, Marco Solmi, and Pierre Bleau
2025-01-27 Notice of name Canadian Organization for Rare Disorders
2025-01-27 Motion for leave to intervene, (Book Form), Completed on: 2025-01-29, (Electronic version filed on 2025-01-27) Canadian Organization for Rare Disorders
2025-01-27 Motion for leave to intervene, (Book Form), Completed on: 2025-01-29, (Electronic version filed on 2025-01-27) Innovative Medicines Canada and BIOTECanada
2025-01-27 Notice of name International Federation of Intellectual Property Attorneys
2025-01-27 Motion for leave to intervene, (Book Form), Completed on: 2025-01-29, (Electronic version filed on 2025-01-27) International Federation of Intellectual Property Attorneys
2025-01-24 Notice of name Lazaridis Intellectual Property Lab and Norman Siebrasse
2025-01-24 Motion for leave to intervene, (Book Form), Completed on: 2025-01-29, (Electronic version filed on 2025-01-29) Lazaridis Intellectual Property Lab and Norman Siebrasse
2025-01-23 Notice of name Canadian Generic Pharmaceutical Association
2025-01-23 Motion for leave to intervene, (Book Form), Completed on: 2025-01-29, (Electronic version filed on 2025-01-23) Canadian Generic Pharmaceutical Association
2024-12-17 Correspondence received from, (Letter Form), Letter regarding Counsel's availability for hearing Janssen Inc.
2024-12-16 Certificate of counsel (attesting to record), (Letter Form), 24A, (Printed version filed on 2024-12-23) Pharmascience Inc.
2024-12-16 Certificate (on limitations to public access), (Letter Form), 23B

Amended version received 1-23-2025, (Printed version filed on 2024-12-23)
Pharmascience Inc.
2024-12-16 Appellant's book of authorities, (Book Form), Completed on: 2024-12-16, (Printed version filed on 2025-01-07) Pharmascience Inc.
2024-12-16 Appellant's record, (Book Form), SEALED-CONFIDENTIAL and RESTRICTED

24 Volumes (Volumes 5 to 24 filed pursuant to rule 38.1)

, Completed on: 2024-12-17, (Printed version filed on 2024-12-23)
Pharmascience Inc.
2024-12-16 Appellant's factum, (Book Form), Completed on: 2024-12-16, (Printed version filed on 2024-12-20) Pharmascience Inc.
2024-11-28 Notice of change of counsel, (Printed version due on 2024-12-05) Janssen Inc.
2024-10-21 Certificate (on limitations to public access), Form 23B, (Printed version filed on 2024-10-22) Pharmascience Inc.
2024-10-21 Notice of appeal, Missing:
-Proof of service (rec'd 2024-10-21)
-Form 23B (rec'd 2024-10-21), Completed on: 2024-10-21, (Printed version filed on 2024-10-22)
Pharmascience Inc.
2024-09-19 Copy of formal judgment sent to Registrar of the Court of Appeal and all parties
2024-09-19 Judgment on leave sent to the parties
2024-09-19 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-205-22, 2024 FCA 23, dated February 1, 2024, is granted with costs in the cause.
Granted, with costs in the cause
2024-07-29 All materials on application for leave submitted to the Judges, for consideration by the Court
2024-05-21 Certificate (on limitations to public access), (Letter Form), 23B;, (Printed version filed on 2024-05-28) Pharmascience Inc.
2024-05-21 Applicant's reply to respondent's argument, (Book Form), Completed on: 2024-05-28, (Printed version filed on 2024-05-28) Pharmascience Inc.
2024-05-10 Notice of name, (Letter Form), (Printed version filed on 2024-05-10) Janssen Inc.
2024-05-10 Certificate (on limitations to public access), (Letter Form), 23B;, (Printed version filed on 2024-05-10) Janssen Inc.
2024-05-10 Certificate (on limitations to public access), (Letter Form), 23A;, (Printed version filed on 2024-05-10) Janssen Inc.
2024-05-10 Respondent's response on the application for leave to appeal, (Book Form), SEALED/RESTRICTED
Redacted copy filed 05/10/2024

Cover pages wrong colour, new covers requested (Rec'd 06-21-2024), Completed on: 2024-07-25, (Printed version due on 2024-05-17)
Janssen Inc.
2024-04-10 Letter acknowledging receipt of an incomplete application for leave to appeal, FILE OPENED 2024-04-10;
2024-04-02 Book of authorities, (Book Form), Completed on: 2024-06-14, (Printed version filed on 2024-04-08) Pharmascience Inc.
2024-04-02 Notice of name, (Letter Form), (Printed version filed on 2024-04-08) Pharmascience Inc.
2024-04-02 Certificate (on limitations to public access), (Letter Form), 23B;, (Printed version due on 2024-04-09) Pharmascience Inc.
2024-04-02 Certificate (on limitations to public access), (Book Form), 23A;, (Printed version due on 2024-04-09) Pharmascience Inc.
2024-04-02 Application for leave to appeal, (Book Form), SEALED/CONFIDENTIAL
Redacted copy filed 04/02/2024
Missing:
-Filing fees-rec'd 04/10/2024, Completed on: 2024-04-10, (Printed version filed on 2024-04-08)
Pharmascience 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
Pharmascience Inc. Appellant Active

v.

Main parties - Respondents
Name Role Status
Janssen Inc. Respondent Active
Janssen Pharmaceutica N.V. Respondent Active

Other parties

Other parties
Name Role Status
Canadian Generic Pharmaceutical Association Intervener Active
International Federation of Intellectual Property Attorneys Intervener Active
Innovative Medicines Canada and BIOTECanada Intervener Active
Canadian Organization for Rare Disorders Intervener Active
David Homuth, Marco Solmi, and Pierre Bleau Intervener Active

Counsel

Party: Pharmascience Inc.

Counsel
Harry B. Radomski
Andrew Brodkin
Sandon Shogilev
Daniel Cappe
Goodmans LLP
Bay Adelaide Centre
333 Bay Street, Suite 3400
Toronto, Ontario
M5H 2S7
Telephone: (416) 597-4142
Email: hradomski@goodmans.ca
Agent
Andrew Montague-Reinholdt
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.

Counsel
Marian Wolanski
Oleyna Strigul
Megan Pocalyuko
Catherine Beagan Flood
Fiona Legere
Belmore Neidrauer LLP
TD North Tower, 77 King Street West
Suite 4020, P.O. Box 16
Toronto, Ontario
M5K 1A1
Telephone: (416) 863-1771
FAX: (416) 863-9171
Email: mwolanski@belmorelaw.com
Agent
Marie-France Major
Supreme Advocacy s.r.l.
340, rue Gilmour, 100
Ottawa, Ontario
K2P 0R3
Telephone: (613) 695-8855
FAX: (613) 695-8580
Email: mfmajor@supremeadvocacy.ca

Party: Janssen Pharmaceutica N.V.

Counsel
Marian Wolanski
Marian Wolanski
Megan Pocalyuko
Oleyna Strigul
Catherine Beagan Flood
Belmore Neidrauer LLP
TD North Tower, 77 King Street West
Suite 4020, P.O. Box 16
Toronto, Ontario
M5K 1A1
Telephone: (416) 863-1771
FAX: (416) 863-9171
Email: mwolanski@belmorelaw.com
Agent
Marie-France Major
Supreme Advocacy s.r.l.
340, rue Gilmour, 100
Ottawa, Ontario
K2P 0R3
Telephone: (613) 695-8855
FAX: (613) 695-8580
Email: mfmajor@supremeadvocacy.ca

Party: Canadian Generic Pharmaceutical Association

Counsel
J. Bradley White
Nathaniel Lipkus
Osler, Hoskin & Harcourt LLP
340 Albert Street
Suite 1900
Ottawa, Ontario
K1R 7Y6
Telephone: (613) 787-1101
FAX: (613) 235-2867
Email: bwhite@osler.com
Agent
Daniel Hnatchuk
Osler, Hoskin & Harcourt LLP
Suite 320, 100 Queen Street
World Exchange Plaza
Ottawa,, Ontario
K1P 1J9
Telephone: (613) 787-1102
FAX: (416) 862-6666
Email: SCCAgent@osler.com

Party: International Federation of Intellectual Property Attorneys

Counsel
Andrew Skodyn
Sean Jackson
Eleanor Wilson
Cassels Brock & Blackwell LLP
Suite 3200, Bay Adelaide Centre - North Tower
40 Temperance Street
Toronto, Ontario
M5H 0B4
Telephone: (416) 350-6906
Email: askodyn@cassels.com
Agent
Darius Bossé
Juristes Power Law
50 O’Connor Street
Suite 1313
Ottawa, Ontario
K1P 6L2
Telephone: (613) 702-5566
Email: dbosse@powerlaw.ca

Party: Innovative Medicines Canada and BIOTECanada

Counsel
Orestes Pasparakis
Kristin Wall
Norton Rose Fulbright Canada LLP
222 Bay Street
Suite 3000, P.O. Box 53
Toronto, Ontario
M5K 1E7
Telephone: (416) 216-4000
FAX: (416) 216-3930
Email: orestes.pasparakis@nortonrosefulbright.com

Party: Canadian Organization for Rare Disorders

Counsel
Melanie Baird
Amy Grenon
Cole Meagher
Nick Morrow
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
Siobhan Morris
CONWAY BAXTER WILSON LLP/S.R.L.
400-411 Roosevelt Avenue
Ottawa, Ontario
K2A 3X9
Telephone: (613) 691-2000
Email: SMorris@conwaylitigation.ca

Party: David Homuth, Marco Solmi, and Pierre Bleau

Counsel
Christopher C. Van Barr
Erin Creber
Will Boyer
Mackenzie Jamieson
Veronica Van Dalen
Gowling WLG (Canada) LLP
160 Elgin Street, Suite 2600
Ottawa, Ontario
K1P 1C3
Telephone: (613) 786-8675
FAX: (613) 788-3603
Email: christopher.vanbarr@gowlingwlg.com
Agent
D. Lynne Watt
Gowling WLG (Canada) LLP
160 Elgin Street
Suite 2600
Ottawa, Ontario
K1P 1C3
Telephone: (613) 786-8695
FAX: (613) 788-3509
Email: lynne.watt@gowlingwlg.com

Summary

Keywords

Intellectual property — Patents — Validity — Lack of patentable subject matter — Method of medical treatment — Vendible product — Skill and judgment — Fixed or variable dosing regimen — Canadian Patent No. 2,655,335 teaches dosing regimen that includes first loading dose, second loading dose and monthly maintenance doses — Regimen incorporates dosing windows of +/- 2 days for the second loading dose and +/- 7 days for the maintenance doses — Whether patent is invalid in that it claims an unpatentable method of medical treatment.

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.

(SEALING ORDER) (CERTAIN INFORMATION NOT AVAILABLE TO THE PUBLIC)

Canadian Patent No. 2,655,335 (“’335 Patent”), which was issued to Janssen Pharmaceutica N.V. for INVEGA SUSTENNA, involves a suspension of paliperidone palmitate for the treatment of schizophrenia and related disorders. The ’335 Patent teaches a dosing regimen to achieve an optimum plasma concentration-time profile. Its claims have been construed in previous litigation and are not in issue: Janssen Inc. v. Teva Canada Ltd., 2020 FC 593,; Janssen Inc. v. Pharmascience Inc., 2022 FC 62, aff’d 2024 FCA 10 (“PMS Paliperidone”)). Its disclosure indicated that “[t]hose of ordinary skill in the art will understand that the maintenance dose may be [adjusted] up or down in view of patients condition (response to the medication and renal function)”.

Pharmascience Inc. has served two Notices of Allegation in respect of pms-PALIPERIDONE PALMITATE, its proposed generic version of INVEGA SUSTENNA. In 2020, Janssen’s infringement action related to Pharmascience’s Abbreviated New Drug Submission No. 236094 was discontinued on consent. Shortly thereafter, Pharmascience served a Notice of Allegation and Detailed Statement in respect of a different Abbreviated New Drug Submission — No. 244641 — seeking approval to market and sell doses of pms-PALIPERIDONE PALMITATE. Janssen again commenced an infringement action under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. In that proceeding, Pharmascience moved for summary trial. It was found that if Pharmascience’s pms-PALIPERIDONE PALMITATE was made, constructed, used or sold as set out in the Abbreviated New Drug Submission, it would influence prescribers to prescribe the dosing regimen claimed in the ’335 Patent, leading to direct infringement: PMS Paliperidone. The defence of invalidity went forward, with Janssen seeking a declaration that Pharmascience would infringe the ’335 Patent if it were to make, use or sell pms-PALIPERIDONE PALMITATE in 50, 75, 100 and 150 mg doses.

The Federal Court found that the Patent was not invalid based on obviousness or for lack of patentable subject matter. The claims provided specified dosing regimens meant to produce a concentration of the medication within the therapeutic range. If a physician chose to use a dose other than that claimed, to stop treatment or to change therapies, they would no longer be practicing the claimed invention. The Court of Appeal dismissed Pharmascience’s appeal, finding that the use of the invention did not require the exercise of skill and judgment.

Lower court rulings

August 23, 2022
Federal Court

2022 FC 1218

Claims of patent valid; making, constructing, using or selling pms-PALIPERIDONE PALMITATE in accordance with ANDS Nos. 244641 and 251767 would infringe patent; injunction granted until expiry of patent

February 1, 2024
Federal Court of Appeal

2024 FCA 23

Appeal dismissed

Memorandums of argument on application for leave to appeal

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 filing 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

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Factums on appeal

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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.

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Date modified: 2025-07-08