Reasons of the primary judge
26 By this ground, Sandoz asserts an error by the primary judge in finding that a person skilled in the relevant art could not be reasonably expected to have ascertained WO 919 within the meaning of s 7(3) of the Patents Act: J [496]. As to s 7(3), the primary judge identified at J [425] that:
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.
27 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": Lockwood No 2 at [132] (per Gummow, Hayne, Callinan, Heydon and Crennan JJ). As Beach J explained in Sequenom Inc v Ariosa Diagnostics Inc (2019) 143 IPR 24 at [598], 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.
(Emphasis original.)
28 As to the meaning of "reasonably expected" in s 7(3), the primary judge stated at J [429]-[430]:
Finally, with respect to the qualifying phrase "reasonably expected", Heerey, Kiefel and Bennett JJ observed in Commissioner of Patents v Emperor Sports Pty Ltd (2006) 67 IPR 488 at [31]:
Section 7(3) 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, Beach J observed in Sequenom at [599] that:
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.
29 Relevantly to this appeal, the primary judge described a series of tasks given to the expert retained by Sandoz (Professor Roberts) including by reference to search results obtained by another person retained by Sandoz (Mr Cruise), being evidence adduced by Sandoz at trial:
433 Professor Roberts (wearing his pharmaceutical scientist hat) was asked by Sandoz's instructors to undertake the following hypothetical task:
Ashurst asked me to assume:
(a) I am a member of a pharmaceutical product development team … at the Relevant Date;
(b) the product development team is seeking to develop a product for the treatment of thromboembolic diseases containing a Factor Xa inhibitor as the active pharmaceutical ingredient; and
(c) I am tasked with developing a formulation for an immediate release solid oral dosage form that is suitable to take forward through clinical trials ([First] Hypothetical Task).
(Italics added.)
434 Bayer took issue with the italicised parts of the First Hypothetical Task.
435 Early in his first affidavit, Professor Roberts described the literature searches he would undertake to find any information about a target drug in order to supplement the information in the product profile that he had been given by a research team. Typically, Professor Roberts would conduct searches for the target drug by its chemical name, code name and/or any other reference names. He would conduct his searches on a number of databases, including SciFinder (which includes Chemical Abstracts), which he described as the primary database he searched, the Merck Index, Martindale, the USPTO patent database, and search engines such as Google and Yahoo to identify any publicly available records including press releases or annual reports.
436 Professor Roberts considered that the First Hypothetical Task was directed towards a formulator with a pharmaceutical science skill set (like himself) rather than a straight formulator, such as Professor Poli.
437 Professor Roberts' evidence was that he would begin the First Hypothetical Task by conducting literature searches of the kind just described for a factor Xa inhibitor. He would also conduct broader searches using the terms "anti-thrombotic" and "anti-clotting" in case there were publications or documents about products in development where it had not been disclosed that the relevant product worked via factor Xa inhibition.
438 No search results in relation to the First Hypothetical Task were annexed to Professor Roberts' affidavit. After his description of his likely searches, he was provided with a copy of WO 919, and asked what information, if any, WO 919 disclosed that he considered relevant to the First Hypothetical Task. Professor Roberts then spent six pages of his affidavit discussing the disclosure of WO 919 and his choice of a preferred compound. Bayer submits that the irresistible inference to any reasonable person undertaking the First Hypothetical Task would be that they were given WO 919 because it was relevant to the task.
439 Following his discussion of WO 919, Professor Roberts was provided with a 71-page "redacted" spreadsheet of search results (containing limited bibliographic information) and asked to assume that the spreadsheet reflected the results of a Chemical Abstracts search for patent literature relating to factor Xa inhibitors. Professor Roberts' evidence was that he did not ask for the search to be limited in that manner, and that he would not normally limit a search to only patent literature. Professor Roberts was never given the results for the searches that he identified that he would have carried out across all the databases he identified. Even if his search was limited to the Chemical Abstracts database alone, his typical approach would include searching peer-reviewed literature, patents, citations and general search engines, not just patent literature. Professor Roberts agreed that he did not instruct Ashurst to limit the search to a single database (Chemical Abstracts) and to further limit the search on that database to patents only, thereby excluding these other resources which, in the normal course, he would examine. The obvious inference is that it was Ashurst, not Professor Roberts, that so limited the search results in this manner.
440 Mr Cruise conducted the search of Chemical Abstracts limited to only patents using the search term "factor Xa inhibitors", not the term "factor Xa inhibitor" proposed by Professor Roberts. Mr Cruise's search for "factor Xa inhibitors" produced about 177 results and 1,200 pages of results. Mr Cruise agreed that it was important to his search whether "factor Xa inhibitor" or "factor Xa inhibitors" was used, and that if the search was not limited to patent literature, the results would have been "significantly greater" than 177. Mr Cruise's 1,200 pages of results were reduced (presumably by the instructors) to a 71-page spreadsheet which was provided to Professor Roberts.
441 Professor Roberts only had a limited time (of about two hours) to review the spreadsheet of results. Following a "rapid scan" of the results, he classified the results as "top priority", "yes", "potentially relevant" and "no", which he explained reflected his "initial view". Professor Roberts marked WO 919 as a "top priority" document. Professor Roberts' evidence was that he would have proceeded to retrieve the full document for each of the results he identified as "top priority", "yes" or "potentially relevant" (151 documents). Professor Roberts observed that his initial ranking was just his initial view and not absolute and that he may change his mind having reviewed a paper "because sometimes abstracts don't tell you the full story". Professor Roberts was not provided with copies of any of the 151 documents, other than WO 919 which he had been given earlier. Before making a final selection, Professor Roberts said that he would have carried out further searching over additional databases, including a citation search.
(Emphasis original.)
30 The complaints by Bayer about the hypothetical task are described at J [443]-[444] and [447]. The submission by Bayer at trial was that Professor Roberts was given a starting point which included aspects of the invention, and that the formulation of the task amounted to leading Professor Roberts to the invention (which complaint it repeats in this appeal). However, the complaint by Bayer was not that factor Xa inhibitors were not known as at the priority dates or that the idea that a factor Xa inhibitor could be a solution was not part of the common general knowledge as at the priority dates.
31 After addressing the parties' submissions and certain authorities, the primary judge's reasons in relation to this issue appear at J [472]-[495].
32 Although the primary judge recognised at J [472] that the absence of evidence concerning the nature of any hypothetical literature search is not fatal to the correct application of s 7(3) and that each case depends on its facts (which statements we accept as being correct), her Honour then stated at J [473]:
Rather than rely on evidence as to each step of the search process, Sandoz seeks to take a short cut, relying on the absence of search evidence in [Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) (2020) 155 IPR 1; [2020] FCA 1477] and [Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd (No 4) (2015) 113 IPR 191; [2015] FCA 634], to jump straight to the assertion that the person skilled in the art would ascertain WO 919, without establishing the foundation for such an assertion via evidence of the search process the person skilled in the art would undertake
33 In forming the critical view that the skilled person could not be reasonably expected to have ascertained WO 919, the primary judge made the following findings:
(1) WO 919 is a patent specification, and the patent records database (within Chemical Abstracts) would have been one of the databases searched by the person skilled in the art: J [475], [484];
(2) the hypothetical task given to Professor Roberts was narrower than the problem found in the common general knowledge and skewed to finding the answer: J [478]; and
(3) while the evidence showed that factor Xa inhibitors were something that would have been focused on by a person skilled in the art, there was also another inhibitor of interest, being thrombin inhibitors, which would have been the subject of a search by a person skilled in the art: J [478]-[481].
34 It follows from these findings, and the references in the primary judge's reasons to the submissions made by Bayer at trial, that the submission that the hypothetical task was narrower than the problem found in the common general knowledge was directed to the fact that, while it was recognised as at both priority dates that a factor Xa inhibitor could be a solution to the problem and would be the subject of searches by a skilled person, there were other candidates that could also be a solution. On appeal, Bayer accepted that factor Xa inhibitors would be amongst the searches that would be carried out.
35 The primary judge also made the following observations and findings in respect of the literature search conducted by Mr Cruise:
(1) Mr Cruise's search was undertaken contrary to Professor Roberts' instructions as to his usual search practice. In short, instead of searching all the databases that Professor Roberts said he would typically search, using the terms Professor Roberts suggested, the search was run for "factor Xa inhibitors" across one database within Chemical Abstracts - the patent records: J [483];
(2) the patent records database (referred to above) would not have been the only database searched. Searches of the other databases would have produced peer-reviewed articles and review articles. In practical terms, seven other databases, and two other search terms ("anti-thrombotic" and "anti-clotting"), were not included: J [484];
(3) the limited search conducted by Mr Cruise produced 1,200 pages of results, but the raw results were not given to Professor Roberts. Instead, the results were "winnowed down" from 1,200 pages to a 71-page spreadsheet with no details provided as to the winnowing process: J [485];
(4) the omission of the other databases and sources of information from the search vastly reduced the volume of the search results that could be expected had the search contemplated by Professor Roberts been carried out. The volume of results was also likely further reduced to a significant, but unascertainable, extent by only focusing on factor Xa inhibitors: J [486].
36 Implicit in this last finding is acceptance by the primary judge that, had the typical search practice undertaken by Professor Roberts been carried out, the search results would have included WO 919 albeit as part of a larger volume of search results. Before proceeding to consider the search evidence put before the primary judge in more detail, and her Honour's reasons given by reference to that evidence, we take a small detour to consider two issues which were raised by Bayer on this appeal.
37 First, Bayer seeks to introduce the notion that ground one on appeal requires consideration of whether the skilled person could reasonably be expected to have ascertained and regarded as relevant WO 919 on the basis that the primary judge's conclusion at J [477] (first sentence) treated the requirements of ascertainment and relevance as related, and as such her Honour found that the document was neither ascertained nor regarded as relevant within the meaning of s 7(3). On that basis, Bayer submits that there was no evidence that, separately to being armed with it and asked directly as to its relevance, a person skilled in the art would regard WO 919 as relevant.
38 At J [477], the primary judge stated:
I do not consider that the evidence establishes that the person skilled in the art could reasonably be expected to have ascertained, understood and regarded WO 919 as relevant so as to satisfy the s 7(3) requirements. The evidence demonstrates that WO 919 could have been returned by a search of relevant patent databases but fails to demonstrate that it would have been reasonable to expect a person skilled in the art to have ascertained it.
39 We reject Bayer's submission as it is plain from the reasons as a whole that the primary judge decided that s 7(3) was not satisfied in relation to WO 919 because it had not been ascertained within the meaning of that section. We refer in particular to J [477] (second sentence), J [489] and J [496].
40 Second, Bayer sought to impugn the evidence of Professor Roberts.
41 That was because, at J [487], the primary judge noted that, prior to being given the patent results spreadsheet, a copy of WO 919 had been provided to Professor Roberts, and he was asked to describe what information, if any, it disclosed that he considered relevant to the First Hypothetical Task. At J [488], the primary judge stated that:
After his consideration of WO 919, Professor Roberts then reviewed the patent results spreadsheet and, perhaps unsurprisingly, he identified WO 919 as one of the nine documents which appeared to him most relevant and most likely to contain information of use for the First Hypothetical Task.
(Emphasis added.)
42 The emphasised words suggest that the primary judge considered that Professor Roberts' selection of WO 919 from the list in the spreadsheet was influenced by being given WO 919 prior to being given the spreadsheet. It is difficult to understand the emphasised words any other way. However, her Honour then went on to state in J [488] that, "[y]es, Professor Roberts was able to justify his selection of WO 919 as a 'top priority' document from the results in the spreadsheet". With respect, that statement is correct. When one has regard to the spreadsheet and to the transcript of the cross-examination of Professor Roberts at trial, it is apparent that there were no indicators in the spreadsheet itself that WO 919 had been included in the search results (as it was listed under a different title than that contained on the WO 919 document itself) or that Professor Roberts selected that entry in the spreadsheet as "top priority" because he knew that it was WO 919.
43 It follows that, as Sandoz submits, and taking into account the primary judge's acceptance that Professor Roberts was able to justify his selection of WO 919 from the spreadsheet, there is no finding by the primary judge that Professor Roberts acted with the benefit of hindsight (and Bayer did not submit otherwise).
44 Notwithstanding this, Bayer submits that, as Professor Roberts was provided with WO 919 prior to looking at the search results, this Court should apply the reasoning of the Full Court in Minnesota Mining & Manufacturing Company v Tyco Electronics Pty Ltd (2002) 56 IPR 248; [2002] FCAFC 315. In reliance on that decision, Bayer submits that to give WO 919 to Professor Roberts was hardly calculated to result in objective evidence as to what the hypothetical uninventive skilled addressee would have ascertained in the factual environment of the common general knowledge alone.
45 During the hearing of the appeal, Bayer also referred to an answer given by Professor Roberts during his cross-examination concerning his selection of the entry which was WO 919 in the spreadsheet:
MR SHAVIN: Right. Because I was suggesting to you that at least subconsciously, Professor, having looked very carefully at the 919 patent - - -
PROF ROBERTS: Yes.
MR SHAVIN: - - - and the compound identified on page 15 - - -
PROF ROBERTS: Yes.
MR SHAVIN: - - - you would have been familiar with the chemical structure of that compound, and you would recognise that when you saw it identified in the entry here?
PROF ROBERTS: I didn't at the time, but I should have. And I recognise there could have been some bias that's there intuitively. But I did not recognise it at the time.
46 Based on that evidence, Bayer submits that the evidence of Professor Roberts should therefore be "given very little weight". However, Bayer did not identify any submission made to the primary judge of this kind, and so it is not clear what Bayer proposes that the Full Court should make of this submission in circumstances where the primary judge did not find that Professor Roberts acted with the benefit of hindsight and Bayer does not assert an error by the primary judge through any notice of contention. We therefore propose to do nothing with it.
47 After canvassing the circumstances in which Professor Roberts selected WO 919 from the spreadsheet of results, her Honour found at J [488] that the question of whether Professor Roberts 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 than just "factor Xa inhibitors" could not be answered on the evidence before her. The primary judge identified that there was no evidence as to how Professor Roberts would prioritise between different peer-reviewed journal articles, how he would prioritise as between journal articles and patents, and whether he might prioritise other antithrombotics over factor Xa inhibitors on the basis of the peer-reviewed articles located: J [488]. At J [489], the primary judge reiterated that the evidence did not establish that it would be reasonable for the person skilled in the art undertaking a search of the kind described by Professor Roberts but not restricted to factor Xa inhibitors to have found WO 919.