Sandoz AG v Bayer Intellectual Property GmbH [2024] FCAFC 135

Sandoz AG v Bayer Intellectual Property GmbH [2024] FCAFC 135

The appeal was allowed because the evidence established that a skilled person could reasonably be expected to have ascertained WO 919, and that the subsequent drug development steps relating to rivaroxaban, as disclosed in WO 919 and claimed in both the 226 and 613 Patents, were routine with an ordinary expectation of success, rendering the inventions obvious and invalid under s 7(2)-(3) of the Patents Act 1990 (Cth). The primary judge erred by requiring a higher level of expectation of success than what is contemplated under Australian patent law.

Parties
First Appellant: Sandoz AG; Second Appellant: Sandoz Pty Ltd; First Respondent: Bayer Intellectual Property GmbH; Second Respondent: Bayer Australia Limited
Jurisdiction
Australia
Judgment Date
23 October 2024
Procedural Posture
Appeal / Judgment
Outcome
Appeal allowed
Legal Topics
Patents, Inventive Step, Obviousness, Pharmaceutical Patents
Intellectual Property Patents Inventive Step Obviousness Pharmaceutical Patents

Case Brief

Summary, issues, holding and outcome

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Parties

Sandoz AG

First Appellant

Sandoz Pty Ltd

Second Appellant

Bayer Intellectual Property GmbH

First Respondent

Bayer Australia Limited

Second Respondent

Procedural Posture

Appeal / Judgment

Legal Issues

  1. 1 Whether a skilled person could reasonably be expected to have ascertained WO 919 for the purposes of s 7(3) of the Patents Act 1990 (Cth)
  2. 2 Whether the inventions claimed in the 226 Patent and 613 Patent involved an inventive step in light of the common general knowledge together with WO 919
  3. 3 Whether the 613 Patent invention was obvious in light of the common general knowledge and the Blood Abstracts

Ratio Decidendi

The appeal was allowed because the evidence established that a skilled person could reasonably be expected to have ascertained WO 919, and that the subsequent drug development steps relating to rivaroxaban, as disclosed in WO 919 and claimed in both the 226 and 613 Patents, were routine with an ordinary expectation of success, rendering the inventions obvious and invalid under s 7(2)-(3) of the Patents Act 1990 (Cth). The primary judge erred by requiring a higher level of expectation of success than what is contemplated under Australian patent law.

Court Disposition

Appeal allowed

Orders

  • Within 10 days, the parties confer and supply draft short minutes of order giving effect to these reasons.
  • If the parties cannot agree on the terms of the draft short minutes of order, the areas of disagreement should be set out in mark-up.