University of Rochester v University of Queensland and CSL Limited - [2003] APO 4

OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 688759 in the name of University of Rochester

Title: Production of Human Papillomavirus Capsid Protein and Virus-Like Particles

Action: Opposition under s.59 of the Patents Act 1990; objection to a request for leave to serve further evidence by University of Queensland and CSL Limited

Decision: Issued 11 February 2003.
Abstract

Parts of the evidence were found to significantly add to the opponent's case and the admission of this evidence was likely to lead to a more correct or just result at the hearing. Further, the opportunity to provide focussed evidence was likely to assist at the substantive hearing in this case.
Leave was therefore granted to serve this material but not the remaining evidence. The public interest lies in determining the opposition on its merits. The importance in the public interest in considering the truncated material overrides the applicant's interest, especially given that it should not be onerous to the applicant to respond given that the issues are very specific and had already been canvassed in the US proceedings.

PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 688759 by University of Rochester; opposition under s.59 of the Patents Act 1990, by University of Queensland and CSL Limited; objection to a request for leave to serve further evidence.

BACKGROUND

University of Rochester (the applicant) filed patent application 688759 (64436/94) on 8 March 1994 through the provisions of the Patent Co-operation Treaty. The application claims priority from two US patent applications, the earliest of which was filed on 9 March 1993. Following examination, the application was advertised accepted on 19 March 1998.
University of Queensland and CSL Limited (the opponent) jointly opposed the application on 17 June 1998. The opponent served its statement under regulation 5.4 of the Patent Regulations on 16 September 1998. The opponent completed service of evidence in support on 16 August 1999. The applicant completed service of evidence in answer on 16 January 2001. Evidence in reply was formally completed on 17 December 2001. However, on 17 July 2001 (during evidence in reply), the opponent served a declaration by Ian Hector Frazer as further evidence which was objected to by the applicant. The matter was heard in Canberra on 7 August 2001. The decision ruled that the material was admissible and allowed the applicant 3 months to provide evidence in response to the further evidence.
The applicant filed their response on 2 May 2002, which included a declaration by Barbara Rose. The opponent filed a further application to serve further evidence on 27 June 2002 purportedly to respond to this material. It was accompanied by a declaration by Ian Hector Frazer dated 21 June 2002 with exhibits IHF-1-IHF-20. The applicant objected to this second application for leave to serve further evidence and the matter was heard in Canberra on Thursday 31 October 2002. Mr Bruce Caine of counsel assisted by Dr Steven Borovic, patent attorney of Phillips Ormonde & Fitzpatrick, represented the applicant. Mr David Yates SC assisted by Mr Robin Kelly, patent attorney of Fisher Adams Kelly, represented the opponent. Dr John Cox of CSL accompanied Mr Kelly.

I note that the opponent has made a similar request to serve further evidence in respect of an opposition involving patent application 683220. This application involves the same technology as the current application but has a different applicant (The Government of the United States of America as represented by the Secretary, Department of Health and Human Services). The applicant of 683220 has now also objected to the request for leave to serve further evidence (in their letter dated 11 December 2002). Consideration of this objection was deferred until the current objection was heard and will be followed up separately once this decision is issued.
SPECIFICATION
The specification is entitled "Production of Human Papillomavirus Capsid Protein and Virus-Like Particles". The described invention relates to a method of expressing the human papillomavirus (HPV) L1 major capsid protein coding sequence using the baculovirus expression system, production of HPV virus-like particles (VLPs) and use of these VLPs in production of antibodies which recognize epitopes on HPV, and for HPV vaccine development, and for development of serological tests for the detection of HPV infection. The main embodiments involved human papillomavirus type- 6 (HPV-6) and HPV-11 but the production of HPV-16 and HPV-18 VLPs was also disclosed.
The specification ends with 32 claims, including a number of independent claims. Claim 1 of the specification reads as follows:
"An isolated non-infectious human papillomavirus-like particle or capsomere comprising a human papillomavirus L1 capsid protein which is conformationally correct and is recognized by antibodies present in sera obtained from human patients infected with human papillomavirus."
HPV-6 and HPV-11 were specifically mentioned in the claims but not HPV-16 or HPV-18.
KEY AREAS OF DISPUTE
One of the key documents being relied on by the opponent as prior art is patent application WO 93/02184 (equivalent to Australian patent application 23666/92 now granted as Australian patent 651727) published on 23 February 1993 and referred hereafter as the Frazer application. This application discloses a generic method to make papillomavirus VLPs which contain the L1 protein.
The applicant argued that the Frazer application had not shown that their VLPs (from any papillomavirus) generated antibodies which could recognise the native virus and was therefore non-enabling. This was especially so for HPV-16 because the L1 protein from HPV-16 used in the Frazer application was prepared from a virus isolated by Dr L. Gissmann (the Gissmann clone). This clone had a mutation at amino acid position 202 (His to Asp) in the L1 protein. According to the applicant, this meant that VLPs could not be generated using L1 alone, and further, that VLPs produced from L1/L2 proteins were defective (relying in particular on the observations of Kirnbauer et al 1994).
The opponent conceded that (with respect to HPV-16), the Gissmann clone could not generate a VLP with L1 alone. However, they dispute the applicant's remaining points arguing:
a) the Frazer application produced VLPs from papillomaviruses containing L1 (including L1/L2 from HPV-16) which looked the same as the native virion and therefore were likely to be conformationally correct and inherently able to generate antibodies that recognized the native virion (the "look the same but may be different" argument) ; and
b) Even if the HPV-16 VLP containing L1/L2 produced using the Gissmann clone in the Frazer application was found to be different from the native virion VLPs, there was no evidence that they were not conformationally correct and inherently able to generate antibodies that recognized the native virion (the "may look different but are still the same" argument). The Kirnbauer et al 1994 results used by the applicant to prove otherwise were technically flawed.
Much of the evidence is somehow related to one or other of these points and my view is that these are the key issues of dispute between the parties. However, I have some concerns that the parties may not have fully appreciated the key issues under dispute as the evidence from both parties at times lacked focus. Part of the problem may have been caused by the applicant in evidence in answer when they concentrated on HPV-16 (and the Gissmann clone). This is somewhat narrow given that the specification as a whole does not seem to particularly relate to HPV-16. It is also at odds with the broader approach taken by the opponent in their evidence which tended to focus on papillomaviruses in general.
RELEVANT LAW
Sub-regulations 5.10(4) and (5) provide the statutory basis to allow further evidence to be served. Sub-regulation 5.10(4) reads as follows:
"(4) The Commissioner may:
(a) on the application of a party; and
(b) on such reasonable terms (if any) as the Commissioner specifies;
permit the party to serve further evidence on the other party."
Sub-regulation 5.10(5) provides inter alia that the Commissioner must not grant an application under sub-regulation (2) or (4) unless the Commissioner:

(i)gives the parties a reasonable opportunity to make representations concerning the application or proposed direction; and
(ii)is reasonably satisfied that a direction, an extension of time or the service of further evidence is appropriate in all the circumstances.
The Federal Court has considered the requirements of regulation 5.10(5) in Ferocem Pty Limited v. Commissioner of Patents (1994) 28 IPR 243, A Goninan and Co Ltd v Commissioner of Patents and other (1997) 38 IPR 213, and National Starch & Chemical Company v Commissioner of Patents 50 IPR 398. There have also been numerous decisions issued by the Patent Office in relation to regulation 5.10. Although Ferocem, Goninan, and National Starch all related to requests under regulation 5.10(2), a number of Patent Office decisions have considered the principles set out in these decisions to be generally applicable to regulation 5.10. For example, see Nalco Chemical Company v W.R. Grace & Co.-Conn [1998] APO 65 (23 November 1998) in relation to regulation 5.10(4), and Alvern Norway A/S v Trans Global Concepts Pty Ltd 38 IPR 158 in relation to regulation 5.10(1).
Burchett J set out some general guidance on the factors to be considered under regulation 5.10(5) in Ferocem at 247-248:
"The determination of an application for an extension of time under reg. 5. 10(2) involves a balancing exercise, in which competing considerations must be taken into account. There are interests of the persons directly concerned in the application and opposition in question. There are also public interests, which are not necessarily ranged on the same side. They include the expeditious disposal of matters in the Patents Office, and questions of costs, of efficiency, and of insistence upon proper professional standards being maintained by those who deal with the office. But they also include, as Kitto J pointed out in Kaiser Aluminium & Chemical Corporation v The Reynolds Metal Co (1969) 120 CLR 136 at 143, ' the public interest that a serious opposition by a person entitled in fact to oppose the grant of a patent should be dealt with on the merits, rather than it should be shut out in consequence of a failure of procedure, lamentable though the failure may be'. …"
These considerations were referred to in Goninan, where Sackville J adopted the position that the decision-maker was required to give proper, realistic and genuine consideration to the public interest generally and specifically to the opposition proceeding being determined on its merits. In respect of this point, he stated:
"In order for the Commissioner or his delegate to give proper, genuine and realistic consideration to the aspect of public interest I have identified, it is necessary to consider the nature of the evidence the opponent seeks to adduce and the significance of that evidence for the opposition proceedings. I do not mean to suggest that the evidence has to be scrutinised in the same way as would occur at a hearing on the merits. But unless the delegate forms a view as to the issues addressed by the proposed evidence, and whether that evidence is likely to be important in the opposition proceedings, it is difficult to see how proper consideration can be given to the public interest in having such proceedings being determined on its merits."
Both parties agreed that the relevance of the further evidence was a key factor in determining whether leave should be granted to serve further evidence. However, they disagreed as to how relevant the evidence needed to be. The opponent argued that the test was one of "adjectival relevance". In other words, the evidence is relevant and could have an important influence on the case. The applicant argued that given the evidence is adduced at such a late stage and that the opponent has already had an ample opportunity to present their case, the test for relevance has to be much higher and the evidence should be determinative of the opposition to be admissible.
I agree that all factors have to be balanced before making a decision whether the evidence is admissible. This is consistent with the principles of Goninan (and the statute itself) which require the evidence to be "appropriate in all the circumstances". However, I am not in the position of knowing what material the hearing officer at the substantive hearing will consider to be critical to his (or her) decision and therefore, I am not convinced the test is as high as "determinative" of the opposition as the applicant has argued. Instead, the appropriate test for relevance is whether the material being sought to be adduced significantly adds to a parties case such that it will likely lead to a more correct or just result at the hearing. The onus is, of course, on the party seeking leave to serve evidence to establish its significance. I note that this test is similar to those applied in Nalco Chemical Company v W.R Grace 1998 APO 65, Sonus Pharmaceutical Inc v Alliance Pharmaceutical Corp and Schering AG 2001 APO 13 and Transgene SA v Virax Holdings 2002 APO 14.
DECISION
The further evidence consists of a statutory declaration from Professor Frazer with 20 exhibits (IHF-1 - IHF-20) attached. Professor Frazer is the opponent's main expert witness and had provided evidence in both support and reply. His evidence purports to address criticisms of the Frazer application made by Barbara Rose in her evidence in response to the first round of further evidence. The problem with this new evidence is that there is a lot of material already served that deals with the Frazer application and it is not immediately apparent what, if anything, is being added to the opponent's case.
This is not helped by the way the further material has been presented. Complete depositions and transcripts from the US interference proceedings have been included which significantly add to the bulk of the evidence, although the opponent appears only to be relying on selected paragraphs in that material. Further, Professor Frazer declaration takes issue with most of the points raised by Rose, rather than focussing on the parts of Rose's declaration whether or not there was anything to add to the opponent's case by responding.
I also note that some parts of Frazer's declaration also appear to be submissions rather than evidence (see, for example, paragraphs 54, 56, 58, 73, 76) and other parts are either disparaging about the applicant's experts or argumentative (see, for example, paragraphs 28, 43, 65, 75). As a consequence, the "flavour" of the evidence was that the opponent was simply seeking to have the "last word" in the evidence proceedings and the real relevance of the material being sought to be added was obscured.
The opponent conceded that not all of the further evidence was critical to their case and they were prepared to truncate their further evidence to exclude the non-critical parts. At the hearing, I made a direction that the opponent provide a list of the paragraphs of Professor Frazer's further evidence which they consider important to their case within one month of the date of the hearing. At the same time, in order to assess the relevance of the paragraphs to the opponent's case, the opponent was to provide a statement of their substantive case. This latter direction had the added advantage of providing focus for the substantive hearing. For this reason, the applicant was also required to provide a statement of case (as per the timing requirements below).
I advised that the decision on further evidence would be issued shortly after the opponent provided their statement of case and list of critical paragraphs and directed that the process would then be as follows:
1.If the decision grants leave to serve new evidence, it will specify what evidence is allowable and the opponent will need to provide a truncated form of their current evidence. Further, the decision will also allow the opponent 1 month from the date of the decision to serve this truncated material. The applicant will be given 1 month to respond with the understanding that the opponent will not object to an extension of up to 2 months under regulation 5.10(2) if the applicant requires further time. At the same time as the applicant files any further evidence (or advises that they are not intending to file any), the applicant will provide a statement of case in the substantive matter.
2.If that decision refuses to grant leave to serve the new evidence, the applicant will have 1 month from the date of the decision to serve their statement of case in response to the opponent's statement.
The opponent filed both their statement of case on 2 December 2002 and the following list of paragraphs that they considered important:
paragraphs 1, 2(i)(ii) and (iii), 4, 5-6, 7-11, 15, 18, 19, 20-24, 32, 36-38, 41, 43, 47, 50, 61, 64, 66, 67, 70, 71, 73 and 74.
I will deal with those paragraphs individually and refer to the statement of case where relevant.
Paragraphs 1, 2, (i) (ii) and (iii)
These are simply introductory paragraphs identifying the witness and summarising the earlier Barbara Rose declaration. In my view, these paragraphs are admissible provided there is relevant material in the later (substantive) paragraphs.
Paragraph 4
This paragraph deals with the issue of whether the Frazer VLPs from HPV-16 have at least some conformationally correct epitopes and hence fall within the scope of the claims. However, this already appears to have been adequately covered in the evidence (see, for example Stanley 11 May 1999 paragraph 37). The extra material in paragraph 4 and the exhibits attached as they relate to that paragraph (paragraph 6 of IHF 1, paragraphs 23, 42 and 46 of IHF-2 and page 93, lines 7-10 of IHF-3) do not add substantially to that case and are inadmissible.
I also note that these arguments would only be relevant if the term "conformationally correct" (which appears in all of the claims) in the opposed application is construed to include "partly conformationally correct" as the opponent has argued in their statement of case (paragraphs 11-14). However, the applicant throughout the evidence appears to construe the term "conformationally correct" more narrowly as meaning "the structure of a VLP is the same as the native virus or presents the same epitopes as a native virion so that it is immunologically the same." Thus, for example, Barbara Rose, in evidence in answer, at paragraphs 151 and 152 interprets the claims narrowly and refers to the specification to support her interpretation:
The results described also demonstrate that the VLPs were obtained and characterized. Forming a VLP, which has the structure and exhibits the same antigenic structure and function of a virion, enables the viral protein to form conformationally correct epitopes. (my emphasis)
The transcript from Polly Roy's US deposition which has been proposed as further evidence (IHF-3) is even clearer at page 97:
"If you are making a particle, either you have the whole or you have none. It's not possible you have out of 180, 150 present correctly, other 30 is missing (sic). It's just not possible. Because the protein has to be folded correctly or they're misfolded. If they're misfolded, the conformational epitopes will be completely wrong."
Given this, the dispute between the parties is essentially one of clarity and fair basis rather than novelty and the extra evidence does not appear to be relevant.
Paragraphs 5 and 6

These paragraphs continue the "conformationally correct" debate. However, the points raised in these paragraphs have already been made in evidence in reply (see paragraphs 14-26 of Frazer's declaration) and figure 13A (IHF-4) was already been filed with the full specification of WO 93/02184 in previous evidence. I also note that even if there was something to add by these paragraphs, the arguments being raised can be presented by way of submissions. My view is that these paragraphs are inadmissible.
Paragraphs 7-11
These paragraphs concern the issue of whether the VLPs referred to in the Frazer applications and the Zhou et al (1991) citation had the same morphology and geometry compared with the native virion. The opponent argued that these paragraphs were important because they make key technical points and introduce particular paragraphs of Dr Stanley's US evidence.
I note that Professor Frazer's comments in paragraphs 7-11 merely refer to particular parts of Dr Stanley's US evidence (paragraphs 25, 43, 44 of IHF-2; and paragraphs 9 and 14 of IHF-5) and my view is that his statements add nothing over Dr Stanley's US evidence or back to Australian evidence already presented by Drs Stanley and Jansen and are not admissible. I also note that paragraph 8 attempts to add Dr Stanley's declaration in total from the US interference proceedings. As conceded by the opponent, they are not seeking to add the whole declaration into evidence. That paragraph is therefore not admissible as further evidence.
The opponent also argued in their letter of 2 December 2002 that paragraphs 13-28 of IHF-5 (Stanley's US disposition) were important and had been referred to in paragraphs 7-11 of Frazer's further evidence. This is the first mention of the importance of these particular Stanley paragraphs. However, while I think it is a "lamentable lack of procedure" to try to include these extra Stanley paragraphs at this stage, I do not see it as a deliberate attempt to "sneak in" key evidence but rather symptomatic of the opponent's poor focus on the key issues in Frazer's declaration. As a result, I will consider the admissibility of all the Dr Stanley's US paragraphs specifically identified by the opponent or Professor Frazer (ie: paragraphs 25, 43, 44 of IHF-2; and paragraphs 9 and 13-28 of IHF-5 of IHF-5).
Paragraph 25 of IHF-2 and paragraph 9 of IHF-5 merely summarise the disclosures in the Frazer applications (ie PK7322 and WO 93/02184). The Frazer applications have previously been tendered in evidence. A summary of them is apparent on the face of the documents and need not be presented by way of further evidence. In my view, the paragraphs are submissions and do not need to be adduced as further evidence. My view is that paragraphs 15-28 of IHF-5 are also inadmissible. These paragraphs provide general comments about whether Frazer's VLPs were likely to be conformationally correct and whether the teachings of PK 7322 apply broadly. However, this information seems to have already been adequately covered in evidence to date and in any event can be presented by submissions. Thus, these paragraphs do not add significantly to the opponent's case.
Paragraphs 43 and 44 of IHF-2 and paragraphs 13 and 14 of IHF-5, on the other hand, present Dr Stanley's view on whether the particles shown in the electron micrographs that appear as figures in Zhou et al Virology 185: 251-57 show particles which approximate the morphology and size of native papillomavirus. They present some data which actually measures the particles and explains why the sizes of the VLPs could be underestimated. All four paragraphs are likely to be relevant to the key areas of dispute.
I accept that this material is evidentiary in nature and highly relevant to the question of whether the L1/L2 HPV-16 particles are defective which has been identified as a key issue in the opposition. But the question still remains whether it adds anything significant to the evidence already in the opposition. The applicant submitted that the material was already presented in evidence referring, in particular, to paragraph 39 of Frazer's evidence in support and paragraph 7, 8, and 14 of his evidence in reply. In my view, these earlier paragraphs do not have the same level of detail supporting the opponent's conclusion as the new material.
While I cannot understand why Dr Stanley omitted to include the extra details in her Australian evidence in the first place, I believe that the extra supporting detail could be critical if the issue of whether the Frazer applications produced L1/L2 HPV-16 VLPs of the right size became contentious at the substantive hearing. I note that Barbara Rose in her declaration in evidence in response to further evidence (see paragraphs 20 and 34, for example) challenged the size of the VLPs, increasing the likelihood that the issue will be important at the substantive hearing. In such an event, the extra evidence could lead to a more just determination provided, of course, that the applicant has an opportunity to respond.
I accept therefore that the material should be in the evidence. However, to ensure that the applicant is not burdened with an onerous task in response, the material needs to be as succinct and highly specific as possible. The material also needs to be presented as proper evidence for the Australian proceedings. This means that the opponent needs to provide a separate declaration from Dr Stanley attesting to the view she presented in paragraphs 43 and 44 of IHF-2 and paragraph 13 and 14 of IHF-5. This must be provided within 1 month of the date of this decision for the material to be admitted as further evidence.
In contrast, paragraph 15-28 of Dr Stanley's evidence (IHF-5) contains general conclusions about whether VLPs produced by Frazer have a conformation which mimics the native virion and an analysis of material to show that the Frazer teachings would be broadly enabling to produce VLPs not based on HPV-16. My view is that this material is already adequately covered by previous evidence (see Dr Stanley's evidence in support paragraphs 10-18, 24, for example) and/or can be adequately dealt with by submissions. I do not believe those paragraphs add significantly to the opponent's case and my view is that they should not be admitted as further evidence.
Paragraph 15
This paragraph discusses paragraphs 38-42 of IHF-2 (Dr Stanley's evidence in the US proceedings). This material is directed to the issue of whether the VLP formation itself is an indicator of conformational correctness which was identified as a key issue above. The paragraphs refer to experiments performed in Dr Stanley's laboratory with HPV-16 L1 mutant proteins that lacked 5, 10 or 15 amino acids at one end. The one mutant which did not bind neutralising antibodies did not form VLPs leading the opponent to conclude that VLP formation reliably predicts the presence of conformational epitopes.
Even from a perfunctory consideration of this material, the experiments would clearly be insufficient to prove a general proposition that VLP formation is indicative of conformational correctness because they are only performed with a limited number of mutants. I therefore fail to see how the experiments are adding much, if anything, to the opponent's case. I find the paragraph inadmissible.
Paragraphs 18, 19
Professor Frazer refers to paragraphs 10-22 of the Jansen declaration in the US proceedings (IHF-1) apparently in support of a notion that VLPs of human papillomaviruses in general may have some variation in shape or size but still have conformational epitopes. Paragraphs 10-22 of the Jansen declaration are clearly in response to material not in the Australian proceedings. The opponent failed to demonstrate how this material was responsive to evidence before the Australian Office. In any case, it is difficult to see how this material is relevant to the key areas of dispute given that the applicant did not appear to argue that the VLPs from certain papillomaviruses (other than HPV-16 made of L1/L2 with the Gissmann clone) were defective as Frazer conceded in his opening sentence of the paragraph. None of the evidence adduced with this paragraph (exhibits IHF-6-10) relates to HPV-16 (IHF-7 and IHF-8 do not even concern papillomavirus). It follows that paragraph 18 and attached exhibits are inadmissible.
Similar considerations apply to paragraph 19 because none of the exhibits refer to L1/L2 particles from HPV-16. The opponent also argued that the papers by Rose et al 1998 (referred to earlier in the opposition) and Yuan et al (IHF-13) supported the contention that L1 proteins from papillomaviruses of HPV-11 were unable to further assemble into VLPs but still generated high titre neutralising antibodies. However, there does not appear to be a dispute with HPV-11. Therefore, it is not clear what, if anything, this paragraph adds to the opponent's case and the papers are not referred to by the opponent in their statement of case.
In any case, even if there were an important point to be made, the Rose paper is already in evidence and Frazer's comments on these papers can be made by submissions. The point can be made by the material on file already without needing to include the Yuan paper. It follows that paragraph 19 and exhibits IHF-11 to IHF-13 are inadmissible.
Paragraphs 20-24
These refer to paragraphs 30-36 of IHF-1 (the sixth Jansen declaration) and 4-7 of IHF-14 (the seventh Jansen declaration), which relate to Kirnbauer et al 1994. This reference had previously been used by the applicant in support of an argument that L1 from prototype HPV-16 did not demonstrate reactivity with a panel of patient sera. The opponent had previously argued that Kirnbauer was technically flawed (see evidence in reply paragraph 21) but wanted to put in more detailed arguments to that effect.
I note that the opponent has alleged that the applicant has conceded that there are technical problems with Kirnbauer (see paragraph 32 of the current Frazer declaration) which means that extra material from the opponent relating to Kirnbauer may be unnecessary. I also observe that if the substantive hearing officer concludes that L1/L2 VLP from the prototype HPV-16 (the Gissmann clone) is defective (ie the VLP looks different from the native virion), the onus of proof may lie with the opponent to show that the prototype L1/L2 VLP can generate conformationally correct antibodies rather than with the applicant to show that it can't. In that context, Kirnbauer may not be as critical as both parties currently seem to believe.
Having said that, I accept that both parties have referred to Kirnbauer extensively in their evidence and clearly consider Kirnbauer as highly relevant, including Rose in evidence in response at paragraph 38. It is also related to a key area of dispute. The further evidence adds more detail to the opponent's arguments about Kirnbauer. While the substance of the argument has not changed, the extra detail appears to clarify the opponent's arguments. My view is that, if Kirnbauer is found to be important at the hearing, the extra detail could be important in resolving the dispute and lead to a more just determination provided the applicant had an opportunity to respond. In this regard, I note that the issue is highly specific and it should not be onerous for the applicant to respond.
I accept therefore that the material should be in the evidence. However, as noted above for the Stanley material, Dr Jansen must present her views (ie: paragraphs 30-36 of IHF-1) in a separate declaration specific for the Australian proceedings from Dr Jansen. The opponent must provide this within 1 month of the date of this decision for the material to be admitted as further evidence. The summary provided by Frazer merely repeats Jansen's conclusions and I do not believe that it (by itself) adds any substance to the opponent's argument. However, it does provide some context for Dr Roy's apparent concessions (discussed in paragraph 32 below) and therefore I accept that it should be in Frazer's further evidence for clarity. As it does not add anything over Jansen's comments, it would not be onerous for the applicant to respond. Paragraphs 20-24 are therefore also admissible.
Paragraph 32
This paragraph referred to pages 192-198 of exhibit IHF-15 which the opponent argued were important because they contained a concession from the applicant's own witness, Dr Polly Roy apparently conceding paragraphs 20-24 of the (current) Frazer declaration. I am not convinced that Dr Roy has conceded to everything in paragraphs 20-24 as the opponent alleges but I accept that she may have made some relevant concessions regarding the Kirnbauer (1994) paper. Given that this may be a key area of dispute, and that Dr Roy is an expert witness for the applicant in the Australian proceedings, these concessions could be important. My view is that the relevant pages of IHF-15 (pages 192-198) are admissible but that there is no need to serve the complete (lengthy) deposition as the opponent has currently tendered as this is unnecessarily onerous for the applicant to respond. If the comments are taken out of context as the opponent has suggested, the applicant will be able to provide the proper context in their response.
Paragraphs 36-38
These paragraphs criticise the serological data presented in the Rochester application. The opponent argued that this was important new evidence in regard to a new section 40 point of invalidity. I find it difficult to believe that a major section 40 problem should be identified so late in proceedings or that having identified it, the points could not be dealt with by way of submissions. In any case, the applicant argued that the paragraphs were irrelevant because they relate to inutility. While in their statement of case, the opponent has approached the issue under insufficiency and fair basis [see paragraphs 31(d)-(h)], I agree with the applicant that the real argument appears to be a lack of inutility which is not a ground of opposition. Further, even if there were a valid section 40 argument, the matter can be dealt with by submissions based on material already in evidence (see Frazer's evidence in reply paragraphs 32 and 33, for example). As a result, paragraphs 36-38 are inadmissible.

I also observe that one of the opponent's key arguments in the opposition is that the production of VLPs itself is a key indicator of "conformational correctness". There is no argument that the current application failed to produce VLPs (as opposed to validly test VLPs) and the opponent's argument that the VLPs themselves are not then conformationally correct seems at odds with their key argument. My view is that the key question for the substantive opposition is whether there was any difference between the VLPs of the current application and the prior art and not whether serological tests have confirmed conformational correctness in the VLPs of either. Given that, the points being made in paragraphs 36-38 seem of little relevance and further, any debate on these paragraphs could detract from the key issues in dispute.

Paragraph 41

This paragraph relates to the point that isolated capsomeres which lack the ability to self-assemble into VLPs are nevertheless able to induce neutralising antibodies. The opponent argued that this is a new point not previously raised. I accept that capsomeres have not been discussed fully by either party in the evidence despite being encompassed by the claims and the point may well be highly relevant. However, in my view, the points in this paragraph can be made by submissions. The paragraph does not introduce any new evidence and is inadmissible.
Paragraph 43
The opponent argued that this was important new evidence containing scientific terms used in the PV art as well as rebuttal of the opponent's contention that VLPs from the Gissman clone contain linear denatured epitopes only. My view is that the paragraph states that the assembly of VLPs requires very strict conformation of the protein and reiterates Stanley's view that it is unlikely that the VLPs will not display the same epitopes as the native protein. This is a key argument but it has been covered more than adequately by the previous evidence. I do not see that this paragraph adds anything to the debate and, in my view, it is inadmissible.
Paragraph 47
The opponent argued that this was important as it rebuts paragraph 27 of Barbara Rose. In that paragraph, Barbara Rose had criticised Frazer's previous analysis of the Touze et al 1998 paper. I accept that it is appropriate for Frazer to answer that criticism in further evidence and consider the paragraph admissible.
Paragraph 50
This relates to the publication date of Kirnbauer et al 1992. This document is relied on by the opponent in their statement of case as a prior art document. Given this, I agree that it is reasonable for the opponent to have the opportunity to establish the publication date of this document if it has been challenged. The opponent therefore can serve this evidence. However, as indicated at the hearing, this is more appropriately done by a person who can properly attest to the publication date such as a librarian.
Paragraph 61
This paragraph criticises serological data presented in the Rochester application and in particular, the paragraph discusses the pEX215 antibody results and concludes that these results show that the L1 protein (when not in the form of a VLP) also reveals epitopes not present on the native virion surface. The paragraph was purportedly in response to paragraph 47 of Rose's evidence in response. However, as Rose did not appear to dispute the nature of the antibody, I do not see how this point is responsive to the points being made by her.

The opponent argued that the material was important for the same reasons as for paragraphs 36 -38. However, as noted above, the arguments appear to be a disguised inutility objection which is not a ground of opposition and the arguments seem of little relevance to the key issues in dispute. In any case, the point has already been made in paragraph 32 of Frazer's evidence in reply. The extra explanation adds nothing to the debate especially given that the applicant did not dispute the nature of the antibody. I find this paragraph inadmissible.
Paragraph 64
The paragraph alleges that Barbara Rose has not addressed an issue in her paragraph 50 and provides a restatement of facts about the reactivity of pEX215. The opponent argued that the paragraph was important as it refers to point of invalidity (c) under section 40 discussed in their statement of case. However, while I believe point (c) is an extremely serious issue for the substantive opposition to determine (and much more important than its position in the statement of case would seemingly indicate), I fail to see how paragraph 64 relates to the issue. In any case, my view is that the points being made in the paragraph have already been made in evidence in reply (Frazer's evidence in reply paragraphs 32 and 33) and paragraph 64 does not appear to add anything to the debate. I therefore find the paragraph inadmissible.
Paragraph 66
These paragraph relates to serological tests on the VLPs of Frazer application and why these were not performed. The opponent argued that the paragraph was important to rebut paragraph 53 of the evidence of Barbara Rose. I note that Barbara Rose contends in paragraph 32 that it is now well known that VLPs from the prototype are not recognized by antibodies in the sera obtained from patients infected with human papillomavirus. Given this statement, whether or not HPV-16 virions were readily available before the Rochester application is not really a key issue and I cannot see that it adds much to the debate. I therefore consider the paragraph inadmissible.
Paragraph 67
Paragraph 67 provides a response to Barbara Rose's criticism (in paragraph 55 of her evidence) of Frazer's analysis of serological data in a previous declaration. However the point being made in paragraph 67 already appears to have been conceded by the applicant (see paragraph 67 of Rose evidence in response) and I do not see any extra value in Frazer's comments. I therefore consider the paragraph inadmissible.
Paragraphs 70 and 71

These paragraphs contain a discussion of the Chen et al paper 1998 (BRR13), which is already in evidence and which had been referred to in paragraph 58 of evidence in response of Rose. Frazer provides some comments in rebuttal but mostly seeks to introduce paragraphs 8-10 of IHF-14 (a statutory declaration by Dr Jansen in the US proceedings).
The applicant had argued that Chen et al used a number of L1 proteins with small deletions at the end of the proteins with the HPV-16 prototype strains and showed that although some of these deletion proteins formed particles which appeared identical under the electron microscope to the native virion, these did not express conformationally correct epitopes. This was important to the one of the applicant's key arguments - that normal looking VLPs from papillomaviruses may not be able to generate antibodies that recognized the native virion.
Given Chen et al's is already in evidence and was important in Rose's declaration and to the applicant's case, I accept that a response by the opponent is likely to significantly add to the opponent's case. However, in my view Frazer's comments by themselves are not evidentiary in nature. His points can be made by submissions without the need for further evidence. In contrast, paragraphs 8-11 of IHF-14, which are referred to by Frazer, contain a more technical criticism of Chen et al's work and are therefore evidentiary in nature. Although the opponent has already addressed Chen et al in evidence in reply (Frazer's declaration paragraph 41), the Jansen material is more detailed and significantly adds to the debate. I accept therefore that the material should be in the evidence. However, it should be presented by a separate declaration specific for the Australian proceedings from Dr Jansen attesting to the view she presented in paragraphs 8-10 of IHF-14. The opponent must provide this within 1 month of the date of this decision for the material to be admitted as further evidence.
Paragraphs 73 and 74
These paragraphs discuss the Camvir 1 antibody work. The opponent argued that these paragraphs are important because they referred to technical issues which are evidentiary issues needed to rebut paragraphs 64, 65 and 68 of Barbara Rose's declaration.
Paragraphs 64, 65 and 68 of Rose relate to the key point whether VLPs produced from the L1 alone are conformationally correct and would be recognised by antibodies present in the sera from infected patients. Rose initially discusses some confusion with Stanley's declaration with regard to the properties of the Camvir 1 antibody and in paragraph 67 finally concludes that this antibody only reacts with the L1 protein of denatured VLPs as shown in the immunoblot or ELISA. Paragraph 73 of Frazer merely appears to agree with the statement and I cannot see that it adds anything to the debate. It is therefore inadmissible.
Paragraph 74 merely refers to data from Stanley to dispute the Chen et al results. This is reiterative argument that adds nothing to the opponent's case and is more than adequately covered by paragraphs 8-10 of IHF-14 which I have already concluded can be admitted. Paragraph 74 is therefore inadmissible.
Interests of the parties
I accept that the applicant is disadvantaged by the current request because serving extra evidence after the evidence in reply stage will inevitably delay the hearing and there are costs in responding to further evidence. I also note that most of the extra evidence is material from the US proceedings. Given that most of the US witnesses were also providing evidence in the Australian proceedings, there was no reason why this material could not have been prepared much earlier and the opponent's failure to do this suggests a serious lack of diligence in Australia.
Having said that, it is in the public interest to determine the opposition on its merits. As noted above, parts of the evidence are significant and likely to lead to a more correct or just result. Further, as I mentioned at the hearing, I have some concerns about the evidence filed to date from both parties which I found at times to lack focus on the key issues. Some of these problems may have arisen from the patent applicant's concentration on HPV-16 in evidence in answer despite the specification being drafted to generic HPVs with apparently little recognition of any special issues relating to HPV-16. As a result, the evidence in answer did not clearly separate the key issues in dispute and this may have led to the ensuing lack of focus in all the subsequent evidence. The opportunity to provide properly focussed further evidence will undoubtedly assist at the substantive hearing.
If the evidence is heavily truncated as directed above, I believe that it should not be onerous to the applicant given that the issues are very specific and already canvassed in the US proceedings. My view is therefore that the importance in the public interest in considering the truncated material overrides the applicant's interest and that the truncated material should be admitted.
CONCLUSION
Only the following parts of Frazer's declaration and attached exhibits are admissible as further evidence:
(a)Frazer's declaration:
·     Paragraphs 1, 2, (i) (ii) and (iii) (introductory material);
·     Paragraphs 20-24
·     Paragraph 32 with an attachment of pages 192-198 of exhibit IHF-15 (the transcript of Dr Polly Roy apparently conceding paragraphs 20-24 of the (current) Frazer declaration);
·     Paragraph 47.
(b)The publication date of Kirnbauer et al 1992 (see paragraph 50).
(c)Dr Stanley's US evidence at paragraphs 43 and 44 of IHF-2 and paragraph 13 and 14 of IHF-5.
(d)Dr Jansen's US evidence at paragraphs 30-36 of IHF-1 (and paragraphs 4-7 of IHF-14) and paragraphs 8-10 of IHF-14.
I therefore grant the opponent leave to serve this material but not the remaining parts of the declaration or attached exhibits. As mentioned at the hearing, this will need to be in a truncated form with fresh declarations drafted for the Australian proceedings from Professor Frazer, Drs Stanley and Jansen and a librarian (for point 2) attesting to the relevant material mentioned above. The opponent has 1 month from the date of this decision to serve this material.
The applicant then has 1 month from date of service of the truncated material to serve responding evidence. This is also on the understanding (as agreed at the hearing) that the opponent will not object to an extension of up to 2 months under regulation 5.10(2) if the applicant requires further time. As noted above, at the same time as the applicant files any further evidence (or advises that they are not intending to file any), the applicant will provide their statement of case in the substantive matter.
COSTS
Costs normally follow the event. In this case, the applicant was successful in arguing that most of the proposed evidence was inadmissible. I therefore consider it appropriate to award costs against the opponent, University of Queensland and CSL Limited.
Karen Ayers
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Phillips Ormonde & Fitzpatrick, Melbourne
Patent attorneys for the opponent : Fisher Adams Kelly, Brisbane