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This is an informal case summary prepared for the purposes of facilitating exchange during the 2025 WIPO IP Judges Forum.

Session 4: Evidence

Federal Court of Australia [2024]: Sandoz AG v Bayer Intellectual Property GmbH, [2024] FCAFC 135

Date of judgment: October 23, 2024

Issuing authority: Federal Court of Australia (Full Court)

Level of the issuing authority: Appellate Instance

Type of procedure: Judicial (Civil)

Subject matter: Patents (Inventions)

Plaintiff: Sandoz AG

Defendant: Bayer Intellectual Property GmbH

Keywords: Patents, Whether skilled person could be reasonably expected to have ascertained international patent publication, Where patent database would have been one of the databases searched by person skilled in the art, Whether inventions involved an inventive step, Whether primary judge applied incorrect legal test

Basic facts: This is an appeal from the decision of the primary judge in Sandoz AG v Bayer Intellectual Property GmbH, [2023] FCA 1321.

The primary judge had found that, in relation to allegations of inventive step, the skilled person could not reasonably be expected to have ascertained a particular document. The test for when an invention would not be taken to involve an inventive step, set out under the Patents Act, was whether it represented a single piece of prior art information or a combination of any two or more pieces of prior art information, that the skilled person could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded as relevant and, in the case of two or more pieces of prior art information, to have combined.

The primary judge’s reasoning was as follows:

There are three requirements for purported prior art to qualify under s 7(3) (as in effect at the relevant time): that a person skilled in the art could be reasonably expected to have: 1) ascertained; 2) understood; and 3) regarded as relevant the information.

As to the meaning of “ascertained” in s 7(3), which is the focus of ground 1, the primary judge stated as follows at J [426]:

First, “ascertained” simply means “discovered” or “found out”. As explained in Sequenom Inc v Ariosa Diagnostics Inc, a “document could be ascertained if it was published in such a manner or form that it could reasonably have been expected to be found by a person skilled in the art”. It is essential to both inventive step cases that the s 7(3) document would be ascertained by the hypothetical person skilled in the art.

As to the meaning of “reasonably expected”, this does not assume an ascertainability by any and all skilled persons, of whatever description, of all publicly available prior art documents anywhere in the world. Nor does it assume that the skilled person has found the document in question, so that the only question is whether he or she has understood it and regarded it as relevant. Such a construction ignores the elements of expectation and reasonableness, as applied to the particular skilled person.

Further, the expectation as to what the skilled addressee “could” ascertain is a reasonable expectation, not a fanciful one. That reasonable expectation is to be assessed in light of the characteristics of the relevant hypothetical skilled person and the particular problem faced, the overcoming of which is said to involve an inventive step. The inquiry is hypothetical.

Evidence was provided of a series of tasks given to an expert, including by reference to search results obtained by another person. The expert was asked to assume that he was, at the relevant date, a member of a pharmaceutical product development team, seeking to develop a product for the relevant treatment and tasked with developing a formulation suitable to take forward through clinical trials. There, the formulation was to be for an immediate release solid oral dosage form.

Held: The Full Court determined that the appeal should be allowed.

The central issue was whether the primary judge applied the correct standard for the purpose of determining whether a person skilled in the art could be reasonably expected to have ascertained International Patent Publication No. WO 01/47919 (WO 919). The Full Court said: “The standard imposed does not require proof that the hypothetical skilled person would ascertain the document. Rather, it requires proof sufficient to demonstrate a reasonable expectation that the skilled person would do so, and that is on the balance of probabilities”. That is, a reasonable expectation requires more than a possibility and involves a prediction as to events which would have taken place and that must be sufficiently reliable for it to be regarded as reasonable. It depends on what the skilled person is likely to have done when faced with a problem similar to that claimed to have been solved with the claimed invention.

In this case, the evidence established that a search of the patent database would have returned results which included the document in question, and it was reasonable to expect that the skilled person would have reviewed the search result. The independent witness identified this document as a “top priority” result from the spreadsheet, as part of the hypothetical exercise. It was not necessary to establish that the skilled person would prefer, prioritize, or select the information in question over all other information. It is not relevant that additional searches might have been performed, or additional documents or information found.  It could have been reasonably expected to have been ascertained. 

As to the correct approach to the exercise of whether the skilled person would be directly led to the outcome, the relevant test is not knowing that steps will or would or even may well work, but merely expecting that the steps may well work. There is no need to prove that there was the requisite expectation at each stage of the drug development process. The evidence does not have to be that the skilled addressee knows that the steps will produce a useful result, only that the particular research path might well produce a useful result.

Relevant holdings in relation to evidence: Whether a prior art document in a database forms part of the prior art base as having been found by a person skilled in the art.

Relevant legislation: Patents Act 1990 (Cth) s 7