In Sandoz AG v Bayer Intellectual Property GmbH [2024] FCAFC 135, the Full Court has taken a markedly different approach to prior art ‘ascertainment’ than the primary judge (Rofe J in Sandoz AG v Bayer Intellectual Property GmbH [2023] FCA 1321). While acknowledging that whether prior art ‘could be reasonably expected to have been ascertained’ is a question of fact, the Court has effectively lowered the bar for the evidence required to establish this factual foundation. This raises a question of whether the practical difference between the old and new law is as great as previously assumed.
The primary judge took what might be called a ‘real world’ approach to ascertainment. Her Honour wanted to see evidence of the complete search process that would have been undertaken by the skilled person, without knowledge of the target document. This included evidence of searches across multiple databases using various relevant search terms, and – critically – how the skilled person would have identified the relevant document from among all the search results that would have been generated.
The Full Court rejected this approach as too demanding. Instead, the Court held that once it is established that a document would have been found in a relevant database search, it is not to the point that additional searches might have been performed or that other documents might also have been found.
This might seem like a practical approach – after all, if a document exists in a database that would have been searched, using search terms that would have been used, isn’t that enough to show it could have been found? But this reasoning potentially introduces precisely the kind of hindsight analysis that the ‘ascertainment’ requirement was – arguably – meant to guard against.
Form Over Substance?
Under the Full Court’s approach, it would seem that parties can now work backwards from knowledge of a relevant document to show that it could have been found through database searches. The evidence required is essentially reduced to showing that:
- the document existed in a database that would have been searched;
- it would have been returned by relevant search terms; and
- an expert can explain why it would have appeared relevant based on the search results.
What is missing is any requirement to show that the document would actually have been identified as relevant without the benefit of hindsight knowledge of the invention. The Full Court was explicit on this point, holding at [55] that ‘it is not necessary for evidence to be adduced that the skilled person would prefer, prioritise or select the information in question … over all other information which they could be reasonably expected to have discovered or found out, including other information which was not adduced into evidence’ (emphasis in original).
This represents a significant departure from the primary judge’s more demanding approach. As the Full Court observed at [57], her Honour had effectively required that a complete search be performed and that the expert select the relevant document from a broader array of results – an approach the Court found imposed too high a burden. Instead, the Court held at [58] that ‘once the primary judge accepted that the search results which were adduced into evidence are a subset of the searches which would have been taken by the skilled person, it is not to the point that additional searches might have been performed … or the skilled person could also be expected to have found additional documents or information, or the skilled person would have been required to review such additional documents or information.’
Aligning with International Approaches?
The Full Court’s more permissive approach to ascertainment brings Australian practice under the pre-RtB law closer to international norms. For example, in both the United States and Europe, the skilled person is effectively presumed to have knowledge of all relevant prior art information that was publicly available at the priority date. There is no requirement to prove that documents would actually have been found.
However, some important distinctions remain. The Full Court’s approach still requires evidence that a document would have been returned by relevant database searches, maintaining at least a minimal threshold that must be crossed. This contrasts with both the US and European approach of pure constructive knowledge, and with the current Australian post-RtB regime under which any single piece of prior art information is unconditionally available under s 7(3)(a). The question of what can ‘reasonably be expected’ only arises under the post-RtB law in relation to combinations of documents under s.7(3)(b).
The result is perhaps an awkward middle ground. While more permissive than the primary judge’s approach, the Full Court’s interpretation maintains a vestigial ‘ascertainment’ requirement that seems to serve little practical purpose beyond ensuring that prior art was at least theoretically accessible through conventional search methods.
Implications for the Old vs New Law
The Raising the Bar reforms removed the ‘ascertainment’ requirement entirely, thereby removing a hurdle to establishing obviousness of a claimed invention. But if proving ‘ascertainment’ under the old law requires little more than showing a document was accessible in relevant databases, how different are the two regimes in practice? The Full Court’s approach seems to reduce the old law’s ascertainment requirement to little more than a formal hurdle – one that can be cleared by working backwards from knowledge of relevant prior art to show that it could have been found, rather than requiring evidence of how it would have been found without that knowledge.
Practical Consequences
This interpretation has significant implications for both existing patents examined under the pre-RtB law and current litigation strategy. For patent owners, it suggests that defending against obviousness attacks may be harder than previously thought, as it will be more difficult to argue that prior art could not reasonably have been ascertained. For challengers, it provides a clearer roadmap for establishing that prior art meets the s 7(3) requirements – focus on demonstrating accessibility rather than likely discovery.
Has the Court Gone Too Far?
While the Full Court’s approach might be praised for its pragmatism, it arguably undermines an important policy objective of the pre-RTB regime. The ‘ascertainment’ requirement was presumably intended to ensure that combinations of prior art relied upon to challenge validity represented realistic starting points for development work, not just documents that could theoretically have been found with the benefit of hindsight. Of course, this is no longer the policy under the post-RtB regime, and some will no doubt welcome a little judicial levelling of the ground between the old and current law.
On the other hand, the Full Court’s interpretation may come as an unwelcome surprise to holders of pre-RtB patents – particularly those who rushed to file applications before the reforms commenced to take advantage of what was perceived to be a more forgiving regime. Many applicants went to considerable lengths to ensure examination of their applications would be completed under the old law, believing this would provide (among other benefits) greater protection against obviousness challenges based on prior art that might not have been ‘ascertained’ by the skilled person.
The Full Court’s approach also raises an interesting historical question: if the threshold for establishing that prior art could be ‘reasonably expected to be ascertained’ was actually so low under the old law, was the case for changing the law really as compelling as was argued at the time? The practical impact of removing the ‘ascertainment’ requirement may have been less significant than anticipated.