Abbvie Corporation v. Janssen Inc

Abbvie Corporation v. Janssen Inc

Having found claims of the '281 patent valid and infringed, the Court granted a permanent injunction effective immediately against Janssen Inc. and those acting in concert, with specified exceptions: continued supply to existing patients and access for new patients when their treating physician determines STELARA is medically necessary; prohibition on promotional detailing and marketing directed to psoriasis while permitting dissemination of medical and scientific information and compliance with Health Canada requests; prohibition on Phase IV trials in Canada relating to STELARA for psoriasis unless legally required; no stay of the injunction; costs awarded to Plaintiffs at the high end...

Citation
2014 FC 489
Parties
Plaintiff/defendant by Counterclaim: AbbVie Corporation; Plaintiff/defendant by Counterclaim: AbbVie Deutschland GmbH & Co. KG; Plaintiff/defendant by Counterclaim: AbbVie Biotechnology Ltd.; Defendant/plaintiff by Counterclaim: Janssen Inc.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
29 May 2014
Procedural Posture
Patent Infringement / Injunction Hearing (post Trial)
Outcome
Injunction granted with specified exceptions and terms; no stay; costs awarded to Plaintiffs at high end of Column V.
Legal Topics
Injunction, Validity and Infringement, Damages, Formulary Listing, Health Canada Regulatory Requests, Phase IV Clinical Trials, Stay Pending Appeal
Source Language
English
Patent Law Intellectual Property Remedies Pharmaceutical Regulation Injunction Validity and Infringement Damages Formulary Listing +3 more

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Parties

AbbVie Corporation

Plaintiff/defendant by Counterclaim

AbbVie Deutschland GmbH & Co. KG

Plaintiff/defendant by Counterclaim

AbbVie Biotechnology Ltd.

Plaintiff/defendant by Counterclaim

Janssen Inc.

Defendant/plaintiff by Counterclaim

Procedural Posture

Patent Infringement / Injunction Hearing (post Trial)

Legal Issues

  1. 1 Whether a permanent injunction should be granted following a finding of patent validity and infringement
  2. 2 What specific exceptions and terms should be attached to any injunction (existing patients, new patients, marketing/promotional restrictions)
  3. 3 Whether Janssen should be required to send a court-ordered letter to physicians

Ratio Decidendi

Having found claims of the '281 patent valid and infringed, the Court granted a permanent injunction effective immediately against Janssen Inc. and those acting in concert, with specified exceptions: continued supply to existing patients and access for new patients when their treating physician determines STELARA is medically necessary; prohibition on promotional detailing and marketing directed to psoriasis while permitting dissemination of medical and scientific information and compliance with Health Canada requests; prohibition on Phase IV trials in Canada relating to STELARA for psoriasis unless legally required; no stay of the injunction; costs awarded to Plaintiffs at the high end...

Court Disposition

Injunction granted with specified exceptions and terms; no stay; costs awarded to Plaintiffs at high end of Column V.

Orders

  • Permanent injunction granted against Janssen Inc. (and its officers, directors, servants, agents, employees, those acting in concert or under its control) restraining sale, promotion and use of STELARA in Canada to the extent it infringes the '281 patent, subject to terms below
  • Exception: continued supply and treatment for existing patients may continue