Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50

Methods of medical treatment of the human body, including the administration of pharmaceuticals for novel therapeutic purposes, are capable of being patentable inventions within the meaning of s 18(1)(a) of the Patents Act 1990 (Cth); the claim in question, directed to a method of preventing or treating psoriasis using leflunomide, is patentable as it meets the requirements of manner of manufacture. However, Apotex did not infringe the patent under s 117 in respect of the supply of leflunomide for PsA because the product information expressly excluded use for psoriasis, and Apotex did not instruct or have reason to believe it would be so used.

Parties
Applicant/appellant: Apotex Pty Ltd; Respondent: Sanofi-Aventis Australia Pty Ltd; Respondent: Sanofi-Aventis Deutschland GmbH; Respondent: Aventisub II Incorporated
Jurisdiction
Australia
Judgment Date
04 December 2013
Procedural Posture
Appeal and Cross Claim in Intellectual Property (patent) Infringement and Revocation Proceedings / Final Appellate Decision (high Court of Australia; Judgment and Orders)
Outcome
Appeal allowed in part; special leave to appeal on infringement issue granted; application for revocation of the patent dismissed; infringement not established; orders made for remission on costs.
Legal Topics
Patents, Patent Infringement, Medical Treatment Methods, Manner of Manufacture, Therapeutic Use Claims
Intellectual Property Law Patents Patent Infringement Medical Treatment Methods Manner of Manufacture Therapeutic Use Claims

Case Brief

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Parties

Apotex Pty Ltd

Applicant/appellant

Sanofi-Aventis Australia Pty Ltd

Respondent

Sanofi-Aventis Deutschland GmbH

Respondent

Aventisub II Incorporated

Respondent

Procedural Posture

Appeal and Cross Claim in Intellectual Property (patent) Infringement and Revocation Proceedings / Final Appellate Decision (high Court of Australia; Judgment and Orders)

Legal Issues

  1. 1 Whether methods of medical treatment of humans are patentable inventions within s 18(1)(a) of the Patents Act 1990 (Cth) ('manner of manufacture')
  2. 2 Whether a claim to the administration of a known pharmaceutical for a novel therapeutic use is patentable
  3. 3 Whether supply of a pharmaceutical for an unpatented indication infringes a patent under s 117(1) of the Patents Act 1990 (Cth)

Ratio Decidendi

Methods of medical treatment of the human body, including the administration of pharmaceuticals for novel therapeutic purposes, are capable of being patentable inventions within the meaning of s 18(1)(a) of the Patents Act 1990 (Cth); the claim in question, directed to a method of preventing or treating psoriasis using leflunomide, is patentable as it meets the requirements of manner of manufacture. However, Apotex did not infringe the patent under s 117 in respect of the supply of leflunomide for PsA because the product information expressly excluded use for psoriasis, and Apotex did not instruct or have reason to believe it would be so used.

Court Disposition

Appeal allowed in part; special leave to appeal on infringement issue granted; application for revocation of the patent dismissed; infringement not established; orders made for remission on costs.

Orders

  • Matter No S1 of 2013: Appeal dismissed with costs.
  • Matter No S219 of 2012: 1. Special leave to appeal on ground 3 of the Draft Notice of Appeal filed on 10 September 2012 granted.