Australian law on inventive step (or “obviousness”) differed from that of many other jurisdictions in that, among other things, in order for a document to even qualify as prior art for the purposes of assessing the inventive step of a claimed invention, the document must have met the “threshold” requirements that a person skilled in the art could be reasonably expected to have: 1) ascertained; 2) understood; and 3) regarded as relevant the prior art document. This requirement was removed from the statute with the amendments made in 2013, but is still relevant to any patents to which the pre-amendment statute applies – and there are still a lot of these!
Proving that a prior art document fulfils these threshold requirements (or that it does not) requires, in the context of any invalidity patent proceedings, gathering evidence on what sort of literature searches a person skilled in the art would do, how they would do them, what the results of those searches would be, and how the results of the searches would be dealt with by the person skilled in the art.
In a recent decision[1] the Full Federal Court considered such evidence in the context of the “ascertained” requirement, and, in particular, whether a person skilled in the art could be reasonably expected to have ascertained a particular prior art document (“WO 919”). WO 919 was found, in addition to a large number of other documents, in patent literature searches conducted by an expert witness, and was identified by the expert as being a “top priority” result. However, as the expert was provided with a copy of only WO 919 (and not of any of the other documents found in the search), Bayer contended that the expert was not provided with all of the documents which he identified from the spreadsheet as being top priority (being 190 documents of a total of 218 documents). Therefore, in those circumstances, Bayer argued that WO 919 was not ascertained because it was not demonstrated that, had the expert reviewed all of those additional documents, the expert would have selected WO 919.
At first instance[2] it was indeed found that there was no evidence as to how the expert would prioritise between different peer-reviewed journal articles, how he would prioritise as between journal articles and patents, and whether he might prioritise other drugs over the specific class to which the relevant active belonged on the basis of the peer-reviewed articles he found. According to the primary judge, there also wasn’t sufficient evidence to conclude that the expert would have selected WO 919 if he was provided with the full suite of results from searches undertaken across all his suggested databases and with broader search terms. On this basis, it was decided that a person skilled in the art could not have been reasonably expected to have ascertained WO 919, and therefore WO 919 was not a prior art document that qualified as prior art for assessing the inventive step of the invention claimed in the patent in suit.
The Full Federal Court disagreed with the primary judge’s decision. The evidence established that the person skilled in the art would have conducted searches of, among other databases, the patent database using the relevant search terms, and it did not matter that the skilled person would have also conducted searches using additional search terms. The evidence also established that a search of the patent database would have returned results which included WO 919, and there was no evidence to suggest that a reasonable search of a patent database would not have found WO 919, or that WO 919 would not have been identified out of a broader search involving other databases or search terms. It was also concluded that it was reasonable to expect that the skilled person would have reviewed the search results, and as to the consequences of that review, the expert had in fact identified WO 919 as a “top priority” result. The Court also stated that:[3]
It is not necessary for evidence to be adduced that the skilled person would prefer, prioritise or select the information in question (here, WO 919) 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.
Further, it is not relevant that:[4]
- additional searches might have been performed (including by reference to additional search terms);
- that the skilled person could also be expected to have found additional documents or information, or
- that the skilled person would have been required to review such additional documents or information.
Therefore, the Court decided that, on the balance of probabilities, WO 919 could be reasonably expected to have been ascertained by the skilled person, and therefore WO 919 was a valid prior art document for the purposes of assessing the inventive step of the patent in suit.
This decision is a welcome step for those seeking to invalidate patents, as it may make the evidence-gathering process to meet the threshold requirements for re-examination and litigation proceedings less onerous. Conversely, patent owners may find their ability to have a prior art document discounted for not meeting the first of the three threshold requirements limited by this decision.
[1] Sandoz AG v Bayer Intellectual Property GmbH [2024] FCAFC 135.
[2] Sandoz AG v Bayer Intellectual Property GmbH [2023] FCA 1321.
[3] Ibid., [55].
[4] Ibid., [58].
