Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) [2011] FCA 846

Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) [2011] FCA 846

Apotex threatened to infringe Sanofi-Aventis's patent by proposing to supply leflunomide for psoriatic arthritis because such administration would almost always treat or prevent psoriasis in patients, engaging the method claimed in the patent. The patent was not anticipated or rendered invalid by the cited prior art, as those documents did not instruct or teach the method claimed. The Arava product information documents were original literary works made by joint authors and owned by Sanofi-Aventis; Apotex's copying constituted copyright infringement. There was no industry-wide implied licence permitting such copying. Apotex's conduct in supplying the PI without warning recipients of...

Parties
First Applicant: SANOFI-AVENTIS AUSTRALIA PTY LTD ACN 008 558 807; Second Applicant: SANOFI-AVENTIS DEUTSCHLAND GMBH; Third Applicant: AVENTISUB II INCORPORATED; Respondent: APOTEX PTY LTD ACN 096 916 148
Jurisdiction
Australia
Judgment Date
29 July 2011
Procedural Posture
Civil (intellectual Property) / Trial Judgment
Outcome
Applicants' claims for infringement and misleading conduct successful; patent upheld and copyright infringement established; matter stood over for final orders.
Legal Topics
Patent Validity, Patent Infringement, Joint Authorship, Copyright Subsistence, Implied Licence, Misleading or Deceptive Conduct, Therapeutic Product Regulation
Intellectual Property Patents Copyright Competition and Consumer Law Patent Validity Patent Infringement Joint Authorship Copyright Subsistence +3 more

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Parties

SANOFI-AVENTIS AUSTRALIA PTY LTD ACN 008 558 807

First Applicant

SANOFI-AVENTIS DEUTSCHLAND GMBH

Second Applicant

AVENTISUB II INCORPORATED

Third Applicant

APOTEX PTY LTD ACN 096 916 148

Respondent

Procedural Posture

Civil (intellectual Property) / Trial Judgment

Legal Issues

  1. 1 Whether Apotex threatened to infringe Australian Patent No. 670491 by supplying leflunomide for psoriatic arthritis
  2. 2 Whether the patent was invalid for lack of novelty, inventive step, utility, sufficiency, or fair basis
  3. 3 Whether Apotex infringed copyright in Sanofi-Aventis's Arava product information (PI) documents

Ratio Decidendi

Apotex threatened to infringe Sanofi-Aventis's patent by proposing to supply leflunomide for psoriatic arthritis because such administration would almost always treat or prevent psoriasis in patients, engaging the method claimed in the patent. The patent was not anticipated or rendered invalid by the cited prior art, as those documents did not instruct or teach the method claimed. The Arava product information documents were original literary works made by joint authors and owned by Sanofi-Aventis; Apotex's copying constituted copyright infringement. There was no industry-wide implied licence permitting such copying. Apotex's conduct in supplying the PI without warning recipients of...

Court Disposition

Applicants' claims for infringement and misleading conduct successful; patent upheld and copyright infringement established; matter stood over for final orders.

Orders

  • The parties confer and file agreed or competing proposed orders reflecting the reasons for judgment by 12 August 2011.
  • The proceeding be listed for directions and/or making of orders at 9.30 a.m. on 16 August 2011.