University of Rochester v University of Queensland and CSL Ltd

[2001] APO 50

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 an extension of time to serve evidence in reply; objection to a request for leave to serve further evidence; and objection to a request to amend the statement of grounds and particulars; by University of Queensland and CSL Limited

Decision:          Issued            .

Abstract

The evidence filed in reply to date was prima facie properly evidence in reply.  The evidence was also prima facie relevant to a correct determination of the matter.  The public interest in considering the opposition on its merits and the interests of the parties in having all significant matter relevant to their respective cases available at the substantive hearing weigh heavily in the circumstances under consideration.  Extension of time to 16 October 2001 in which to file evidence in reply allowed.

Opponent's application to serve further evidence on the applicant permitted.  The applicant allowed a period of three months to file evidence in response, commencing from the day on which evidence in reply is completed.

Opponent directed to provide further and better particulars in relation to particulars 3.1.15 to 3.1.31.  The further and better particulars should contain a summary of the material facts on which the opponent relies, including the relevance of the documents to the stated grounds and references directing the reader to the specific part of the document being relied upon.  Expectation that where particulars are amended at a late stage in proceedings, the opponent would be able to state their case with a considerable degree of precision.

Amendment to the statement of grounds and particulars dated 17 July 2001 allowed, on the condition that the direction for further and better particulars is complied with within one month of the date of this decision.

Costs awarded against the opponent.

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 an extension of time to serve evidence in reply; objection to a request for leave to serve further evidence; and objection to a request to amend the statement of grounds and particulars.

BACKGROUND

University of Rochester (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 (CSL, the opponent) jointly opposed the application on 17 June 1998.  The opponents served their 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 due to be served on 16 April 2001.  This was subsequently extended to 16 July 2001.  The opponent has requested a further extension of three months to 16 October 2001.  The applicant has objected to this request for an extension of time.

The opponent also filed on 16 July 2001 a request to amend the statement of grounds and particulars.  The applicant has also objected to this request.

The opponent served and filed a declaration by Ian Hector Frazer, together with exhibits IHF1 to IHF16 on 27 July 2001.  The opponent stated that this declaration formed part of the evidence in reply.  The opponent requested that the declaration and accompanying exhibits also be treated as further evidence under the provisions of regulation 5.10(4).  The applicant has objected to this request to serve further evidence.

The applicant has therefore objected to a request for an extension of time to serve evidence in reply, a request to serve further evidence, and a request to amend the statement of grounds and particulars.  I heard the parties on these matters in Canberra on 7 August 2001.  Raymond Evans, patent attorney of Phillips Ormonde & Fitzpatrick, represented Rochester.  Robin Kelly, patent attorney of Fisher Adams Kelly, represented CSL.  John Cox of CSL accompanied Mr Kelly.

At the hearing, I asked Mr Evans if the applicant was maintaining objection to the entire period requested in the extension of time application, or only that portion subsequent to the filing of the Frazer declaration.  He confirmed that the applicant objected to the entire period, as a result of which the Frazer declaration would be filed out of time.  Mr Evans referred me to A Goninan and Co Ltd v Commissioner of Patents and other (1997) 38 IPR 213, where Sackville J made it clear that the Commissioner was not under a duty to permit a party to rely on evidence already filed, regardless of other circumstances.

Mr Evans also said that in light of the amendments to the Patent Regulations, in which subregulation 5.9(2)(e) has been repealed, the applicant was not maintaining objection to the amendment to the particulars.  However, during the course of the hearing and following on from submissions presented at the hearing, Mr Evans contended that, depending on my findings, a direction that the opponent provide further and better particulars is appropriate.

The Frazer declaration and the amended statement referred to in the reasons for an extension of time to serve evidence in reply were filed prior to the hearing and were therefore available for me to consider at the hearing and in coming to my decision.  The opponent has not yet filed any evidence in reply from the other experts who executed declarations in the evidence in support.  Mr Kelly confirmed at the hearing that the opponent intended to file such evidence, but was waiting on my ruling as to the admissibility of the documents exhibited to the Frazer declaration, as the other experts would also be commenting on these documents.

The opponent has filed the Frazer declaration as evidence in reply and as further evidence.  However, Mr Kelly made it clear at the hearing that when the Frazer declaration was being drafted that it was considered to constitute evidence that was strictly in reply to points made in evidence in answer.  In view of the objections made by the applicant, the opponent proceeded with a request under regulation 5.10(4) so as to overcome any possible objections which may be made by the applicant and provide the applicant with a chance to respond to the evidence in reply.  I note here that it is often the practice of the Commissioner to allow the other party a period of time to file responding evidence as a term of granting a request under regulation 5.10(4).

I also heard a matter between The Government of the United States of America as represented by the Secretary, Department of Health and Human Services and University of Queensland and CSL Limited on 9 August 2001.  That matter was in relation to patent application 683220 and is the subject of a separate decision.  I mention it here because many of the issues arising in that case are similar to the issues considered herein.

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 type 6 (HPV-6) and type 11 (HPV-11) capsid protein coding sequence using the bacilovirus 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 serologic tests for the detection of HPV infection.  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."

REASONS FOR EXTENSION OF TIME

The reasons set out in the opponent's request for an extension of time to file evidence in reply on 16 July 2001are as follows:

"The Evidence-In-Answer has been considered by both Professor Ian Frazer and CSL Limited and a draft Statutory Declaration has been forwarded to CSL Limited which has included comments from Professor Ian Frazer.  The Statutory Declaration is now in an advanced stage of preparation and should be served on the Applicants within the next two weeks, after final consideration from CSL Limited and further consultation with Professor Ian Frazer.  It has also been necessary to amend the Statement of Grounds and Particulars which refer to a number of new particulars which are incorporated as 3.1.15 through 3.1.31 inclusive.  These particulars will be attached to the Statutory Declaration by Ian Frazer.  Once the Statutory Declaration has been settled in final form, copies will be forwarded to our other experts who executed declarations in the Evidence In Support."

RELEVANT LAW

Regulations 5.9 and 5.10 are the provisions relevant to amendment of the statement, extensions of time to serve evidence, service of further evidence, and directions by the Commissioner in the case of oppositions under section 59 of the Patents Act 1990.

Amendment of statement
5.9      (1) Subject to subregulation (2), the Commissioner, on the written request of an opponent and subject to such terms as the Commissioner may specify:

(a) …
(b) …
(c) must amend particulars relating to a ground set out in a statement that is served and filed under regulation 5.4.

(2) The Commissioner must not allow an amendment requested under subregulation (1), if:

…
(d) he or she does not reasonably believe that the applicant has been notified of the proposed amendment.
(e) [repealed]

(3) The Commissioner must give the parties an opportunity to make representations concerning the proposed amendment.
(4) If the Commissioner allows an amendment, he or she must give the applicant a copy of the statement as amended.

Conduct of proceedings to which this Chapter applies
5.10     (1) The Commissioner may, on his or her own motion or on the application of a party:

(a) give a direction that is not inconsistent with the Act or these regulations for the conduct of proceedings to which this Chapter applies; or
(b) determine that a period prescribed in this Chapter (except in regulation 5.3 or 5.3AA, paragraph 5.4 (a) or subparagraph 5.8 (1) (a) (i)) is to be extended by such further period as the Commissioner reasonably allows.

(2) The Commissioner may extend the time within which the party may take a step prescribed in this Chapter (not being a step that is taken under regulation 5.3 or 5.3AA, paragraph 5.4 (a) or subparagraph 5.8 (1) (a) (i)):

(a) on the application of a party in the approved form; and
(b) on such reasonable terms (if any) as the Commissioner specifies; and
(c) after the party has served the application on the other party.

(3) …
(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.
(5) The Commissioner must not give a direction under subregulation (1) or grant an application under subregulation (2) or (4) unless the Commissioner:

(a) if he or she proposes to grant an application by a party — is reasonably satisfied that the other party has been notified of the application; and
(b) if he or she proposes to act on his or her own motion — ensures that the parties are notified of the proposed action; and
(c) in either case:

(i) gives the parties a reasonable opportunity to make representations concerning the application or proposed action; and
(ii) is reasonably satisfied that a direction, an extension of time or the serving of further evidence is appropriate in all the circumstances.

Regulation 5.10 lays down the general requirement that, before granting the applications or giving a direction, I must be reasonably satisfied that it is appropriate in all the circumstances.

The Federal Court has considered the requirements of regulation 5.10 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."

DECISION

Before considering the evidence, I consider it appropriate to address some preliminary points made by Mr Kelly for the opponent.  Mr Kelly argued that the mere fact that the applicant had objected to the evidence shows that the applicant considers the new matters as damaging to their case.  Mr Kelly stated that if the particulars were irrelevant or did not damage the applicant's case then it would be safe to say that they would raise no objection.  I do not agree.  The applicant may have any number of valid reasons for objecting to the evidence.  I will consider the interests of the applicant in more detail later in my decision.  All that I need to say here is that the fact the applicant has objected tells me nothing about the relevance of the evidence.

Mr Kelly also said that any decision of the Commissioner on the substantive matters is appellable to the Federal Court, who will hear the case de novo.  Mr Kelly stated that there are no restrictions applicable to what evidence may be lodged on appeal, and that the hearing officer in a substantive opposition should have access to the same or similar evidence that may be cited in an appeal.  Mr Kelly argued that objections to admissibility of evidence should not be regarded as having any substance if they deal mainly with procedural matters and thus overshadow issues of relevance.  Mr Kelly said that it is only in regard to extreme circumstances such as overwhelming delay by an opponent in relation to giving notice of the new prior art that it may be ignored.

I believe Mr Kelly's argument here is incorrect.  It is clear from F Hoffman-La Roche AG v New England Biolabs Inc 50 IPR 305 that it was within the power of the court to constrain the evidence that may be considered on an appeal. In any case, Goldberg J stated in National Starch that it was not part of the delegate's task to speculate as to the issues which might arise on appeal.  Further, Sackville J rejected an argument in Goninan that the Commissioner has a duty to allow any evidence that is relevant to an opposition.  There, Sackville J said, "the public interest in having an opposition determined on its merits must be weighed with and against other considerations.  It is not the only factor to be considered."

The applicant attacked the evidence in the Frazer declaration on the basis that it was not strictly in reply and also that the evidence was not relevant to a correct determination of the matter.  On the issue of evidence being strictly in reply, a delegate of the Commissioner made the following comments in RGC Mineral Sands v Wimmera Industrial Minerals Pty Ltd [1999] APO 79 (16 December 1999):

"In my view, it is not practical or appropriate for the Commissioner to come to a concluded view on whether the evidence in reply is in fact properly in reply outside the substantive hearing.  I note that other Patent Office decisions have made similar observations (see Emory University v Biochem Pharma (1997) 39 IPR 603 (at 607) and Nippon Steel Corporation v BHP Steel (JLA) Pty Ltd 1999 APO 44). …"

In Sonus Pharmaceuticals, Inc v Alliance Pharmaceutical Corp and Schering Aktiengesellschaft [2001] APO 13 (16 March 2001), a delegate said:

"The only time that a final determination of whether the evidence is actually in reply is made is during the substantive hearing of the opposition.  However, that does not mean that I cannot form a view of the question, and indeed it is essential for me to do so in order to decide the matter before me.  However, it is only possible to form a preliminary view.  If there is a reasonable basis for believing that evidence fits the definition of evidence in reply, then I believe that I should treat that evidence as reply evidence at this time unless Sonus can satisfy me that that conclusion is not appropriate.  It may be that a different conclusion would be reached after detailed analysis of the declarations, such as during the substantive opposition.  It clearly would have been easier to determine these issues as a part of the substantive opposition, but that option is not available.  I am required to make a preliminary assessment, and to base my decision on that assessment."

In  Sonus Pharmaceuticals, the delegate discussed the purpose of evidence in reply, with reference to Ernest Scragg & Sons Ltd's Application [1972] FSR 219 at 223 and to a number of Patent Office decisions. I will not repeat the delegate's discussion here, though I bear in mind the principles set out in the cases discussed therein and the conclusions drawn by the delegate. However, I also note that in MacDonald Engineering Company Pty Ltd v Firebelt Pty Limited [2000]APO 37, a delegate considered the decision in Minister for Immigration and Ethnic Affairs v Pochi 31 ALR 666 and said:

"It is clear from this decision that the Commissioner is not restricted by the rules of evidence or procedure applicable in a court, and thus it is arguable whether the Commissioner is as a matter of law bound to exclude evidence which is not properly in reply."

Another decision of particular relevance here is Snap-On Technologies, Inc, v Beissbarth GMBH [2000] APO 52 (3 August 2000). In that case, the applicant had sought directions that the evidence in reply should not be admitted into proceedings as it was not strictly in reply. The opponent sought leave to serve as further evidence the material previously served as evidence in reply. The opponent indicated this action was taken as a precautionary measure, even though the opponent believed the evidence to be strictly in reply. Therefore the facts considered by the delegate in Snap-On Technologies are very similar to some of the issues before me.

The delegate in Snap-On Technologies did not believe it was appropriate for the Commissioner to decide prior to the hearing on the substantive matter whether the evidence is properly considered as evidence in reply or otherwise.  The delegate did not consider a debate about whether the evidence was strictly in reply to be useful in determining whether he should grant leave to serve further evidence.  The delegate also made the following comments:

"Moreover, I am concerned that long debates at the substantive hearing about whether evidence is admissible could detract from the substantive issues, and I believe it would be more administratively efficient if both parties come to the substantive opposition with all material. From the decision in RGC v Wimmera [1999] APO 79 (16 December 1999) I note that the Commissioner has an inquisitorial role in an opposition. While she must allow the parties natural justice to reply to evidence, she is not bound by the rules of evidence. Reflective of this, the Commissioner even has the power under regulation 5.11 to consider documents in an opposition that are not part of the evidence. In my view, the key question to consider is "how relevant is this material?" rather than "is it strictly in reply?"."

It is clear from the Federal Court decisions of Ferocem, Goninan  and National Starch, discussed above, that the nature of the evidence and the significance of that evidence for the opposition proceedings is an important consideration to take into account when considering the exercise of the discretionary power under regulation 5.10.  Of course, if the evidence is properly in reply, it will be prima facie relevant, on the assumption that the evidence in answer is relevant.  The Frazer declaration is available for me to consider and the parties have made submissions on whether or not the evidence is properly in reply.  Therefore I find it useful here to form a preliminary view on whether the material is properly in reply, in order to determine the relevance of the material and consider whether the exercise of the discretionary powers of the Commissioner sought by the parties are appropriate in all the circumstances.

Relevance of evidence

The evidence in reply filed to date includes a declaration by Ian Hector Frazer together with 16 exhibits.  The 16 exhibits are prior art documents that have all also been added to the statement of grounds and particulars under the grounds of novelty and inventive step.  However, it became apparent at the hearing, and on a more detailed reading of the Frazer declaration, that the opponent was not relying on these documents as anticipations in their own right.  Rather, the opponent is relying on the new documents for an understanding of the state of the art and particularly to assist in their interpretation of documents filed in the evidence in support.

The opponent filed a number of documents in its evidence in support relating to the grounds that the claims lack novelty and inventive step.  Patent application WO93/02184 appears to be particularly relevant for the present circumstances.  Ian Frazer is a co-inventor of the invention described in WO93/02184 (now Australian Patent 651727).  Other documents served in support that are of relevance here appear to be two documents referred to by the opponent as Kirnbauer (1992) and Hagensee.  According to the opponent, the applicant has argued in its evidence in answer that the VLPs described in these documents are not "conformationally correct", as is required by the claims of the opposed application.  For example, clause 53 of the Rose declaration says that the examples in the Frazer application do not give any indication of whether the proteins were conformationally correct or whether they could induce the production of neutralising antibodies or be utilised as a diagnostic agent.  Rose also suggests in this clause that "the reactivity with denatured particles indicates that the antibodies were reacting with non-conformational epitopes".  The opponent has argued that its evidence in reply addresses this point.  The other point of relevance to the matter before me is what Mr Kelly referred to as the "second ATG" point.  The opponent argued that without translation of the HPV16 L1 gene from the second ATG that HPV16 VLPs may not have been produced.  This is a factor that would be necessary to produce "conformationally correct" HPV16 VLPs.  Mr Kelly argued that all of the new exhibits are relevant to the issue of whether the prior art discloses proteins that are "conformationally correct" and to the related issue of translation at the second ATG point.  According to the opponent, this is directly responsive to issues raised in the evidence in answer.

Paragraphs 1 to 4 of the Frazer declaration summarise the conclusions drawn from the evidence in answer.  In paragraphs 5 to 7, Frazer briefly revisits the invention in his application WO93/02184 "to highlight the breakthrough in science that was achieved".  Mr Frazer asserts that "the invention has stood the test of time  … and has been copied by many workers without modification …".  Although Mr Evans submitted that the further evidence is here revisiting the evidence in support in an attempt to add further weight, in my view these paragraphs merely add context to the evidence in reply.

In paragraph 8, Frazer says that because of the close similarity between VLPs described in WO93/02184 and the infectious virion, the VLPs described will possess the same conformational epitopes as the native virion and will inherently generate neutralising antibodies in sera.  Frazer expands on this and other points from the evidence in answer in paragraphs 8 to 29, with reference to exhibits 1 to 12 to support his arguments.  Frazer also directly refers to the evidence in answer throughout his evidence.  In my opinion, paragraphs 1 to 29 and exhibits 1 to 12 are strictly evidence in reply.

Paragraphs 30 and 31 of the Frazer declaration deal more specifically with what Mr Kelly referred to as "the second ATG point".  Exhibits IHF13 to IHF 16 are also discussed in these paragraphs in support of Frazer's evidence.  The opponent argued that the significance of this issue is raised in the evidence in reply because it is not clear from the evidence in answer how Rochester obtained the HPV16 VLPs.  According to Mr Kelly, this point is also not discussed in the Rochester application.  In paragraph 30 Frazer discusses the necessity in the prior art for translation of the HPV16 L1 gene to be initiated at the second initiation codon.  Frazer then states: "It will also be appreciated that the same conclusions apply to AU688759, where regardless of which HPV16 clone was used … initiation must have been from the second ATG to achieve VLP formation.

Mr Kelly said that it may well be raised by the applicant that the relevance of the "second ATG" point was an issue that should have been raised in the evidence in support.  However, Mr Kelly submitted that when a detailed analysis between the relevant protocols of the Frazer application and Kirnbauer (1992) was made it was relevant to ask why this feature was not discussed in the Rochester application after detailed consideration of the evidence in answer.

As Mr Kelly has pointed out, the evidence in answer will sometimes bring up new issues that must be addressed in the evidence in reply.  For example, see RGC Mineral Sands v Wimmera Industrial Minerals Pty Ltd [1999] APO 79 (16 December 1999). The "second ATG" point appears to be relevant to the issue of whether or not the prior art particles were conformationally correct. While the point was not put in evidence in support, the opponent could not have reasonably seen it as relevant until the applicant's defence was put. Therefore, from a preliminary viewpoint, the evidence on this point appears to be in reply.

Paragraphs 32 to 41 of the Frazer declaration appear to be directly responsive to particular paragraphs of the declarations filed as evidence in answer, while paragraph 42 is a brief summary clause.  I am therefore satisfied that paragraphs 32 to 42 of the Frazer declaration are prima facie strictly evidence in reply.

Mr Evans argued that, in any case, the evidence is of low probative value and does not support either an extension of time or leave to adduce it as further evidence.  It now appears that the new documents were not being relied upon for novelty and inventive step, (despite the contrary indication in the statement of grounds and particulars), but are apparently being used to help in the interpretation of documents previously served in evidence.  Mr Evans put it that the disclosure of prior art documents relied on to support the grounds of opposition must be apparent on the face of the document as of its publication date, not as interpreted by subsequent documents.  A number of the exhibited documents are published well after the priority date of the claims and in some case are not published at all.  Mr Evans also submitted that none of the exhibited documents refer to the Frazer patent and are therefore of low relevance to deciding what the Frazer patent disclosed.

The applicant, in its evidence in answer, appears to have attacked the prior art put forward in the evidence in support on the basis that the alleged anticipations did not disclose conformationally correct epitopes.  According to Rose (paragraph 31), no-one had produced epitopes with the same characteristic structure or immunological function as epitopes on native virions prior to the work of Rochester.  Rose states that the formation of conformationally correct VLPs is of enormous practical and commercial significance in the detection and presentation of HPV infection (paragraph 33).  The applicant has put forward evidence that particles made in the Frazer application were not conformationally correct and cannot be used to produce neutralising antibodies.  It appears that this question is likely to be fundamental to a correct determination of the opposition.  It is well accepted that a disclosure must "for the purposes of practical utility" (Hill v Evans, (1862) 6 LT 90), be the same as the later claim. The applicant has attacked the opponent's evidence in support and the opponent is entitled to address that in its evidence in reply. In my view, the evidence filed by the opponent in reply is at least prima facie relevant.

In relation to Mr Evans' argument that many of the documents in the evidence in reply were published well after the priority date, I consider that there is a serious question to be answered and anything that would help decide the issue is relevant matter.  I note here that the applicant has also provided later publications in support of its argument that the particles made by Frazer et al were defective (paragraphs 53 to 61 of the Roy declaration).  In my view, the ultimate relevance and weight to be placed on such evidence is a matter that is best decided in the substantive opposition.

I am therefore of the view that the Frazer declaration and the exhibits thereto are properly evidence in reply.  My view, however, has only been formed on the basis of the type of limited analysis of the evidence necessary to form a preliminary view.  It has not been formed on the basis of the type of in-depth analysis of the evidence that would be given at the substantive hearing into the matter.  It is possible that the opponent has overstepped the mark as to what is strictly in reply in relation to some of the issues canvassed, and that the applicant is correct in that the evidence in reply involves some change to the case to be answered.  However, in my view, the evidence in the Frazer declaration is prima facie highly relevant to the issues to be determined in the substantive opposition.  It is therefore in the public interest for the evidence to be before the delegate at the substantive hearing.  My findings on the relevance of the evidence do not support the applicant's objections to the extension of time and the request to serve further evidence.  In my view, a more appropriate way of proceeding would be to provide the applicant an opportunity to serve evidence responding to any new matter.  However, before deciding this, I must balance the public interest in considering the opposition on its merits with all other relevant considerations.

Delay

The majority of Patent Office decisions relating to regulation 5.10 have considered any delay to the opposition proceedings that may be caused by the exercise of the Commissioner's discretion to be a relevant consideration when deciding whether to exercise that discretion.  As noted by Sackville J in Goninan, "it is a relevant factor for the commissioner to take into account that delays in determining opposition proceedings may unfairly disadvantage the applicant for a patent and may create difficulties for the efficient and orderly administration of the patents Office."

Relevant factors include the questions of whether the evidence could have been obtained with reasonable diligence at an earlier stage, and whether the exercise of the discretion under regulation 5.10 would cause unnecessary protraction of the opposition proceedings. These factors have been considered in a number of Patent Office decisions on applications to serve further evidence under the Patents Act 1990 that have adopted certain "criteria" in considering the exercise of the Commissioners discretion. For example, see Sandoz Ltd v Fujisawa Pharmaceutical Co Ltd (No 2) (1993) AIPC 91-013, and ICI v Mitsubishi Gas Chemical 29 IPR 285. In Nalco Chemical Company v W.R. Grace & Co - Conn [1998] APO 65 (23 November 1998), the delegate held that the criteria set out in these cases are in accord with the principles set out in Ferocem and Goninan.

Evidence in answer was served on 16 January 2001.  Evidence in reply was therefore due to be served on 16 April 2001.  The opponent has been granted a previous extension to 16 July 2001 and is now seeking a further extension to 16 October 2001.  The reasons extended by the opponent for the amendment refer principally to preparation of the evidence by Professor Frazer.  The reasons also refer to other experts, to who the opponent will forward copies of Professor Frazer's declaration once it is in final form.

Mr Evans submitted that the circumstances surrounding the application for an extension of time suggest that the only reason for the extension relates to searching for and providing evidence on new documents not previously particularised.  Mr Evans also submitted that the 16 new documents double the number of citations on novelty.  If the evidence is admitted this could radically change the case that the applicant has to answer and would lead to long delays in finalising evidence.

I believe that part of the applicant's problems here arise because of the way the new documents are cited in the amended particulars.  The documents are said in the particulars to disclose the invention as claimed in any claim.  I will address the statement of grounds and particulars in more detail below.  The applicant's problem with the new documents may have been exasperated by the opponent's request to serve further evidence.  However, as I have noted above, it became apparent at the hearing that the opponent was citing the new documents to aid in the interpretation of the prior art cited in the evidence in support, rather than as citations in their own right.  The documents appear to have been served to address issues raised by the evidence in answer.  I have found these documents to be at least prima facie relevant and, at least on a preliminary view, to be properly evidence in reply.  By its very nature the evidence could not have been served until after the evidence in answer was completed.  The opponent appears to have acted with reasonable diligence in preparing and serving the evidence from Professor Frazer, once the evidence in answer was completed.

Mr Evans also pointed out that the application for extension suggests that the preparation of evidence by other experts will not commence until they receive the Frazer declaration.  Moreover, Mr Evans said that the application to file further evidence suggests that no effort will be made to complete evidence in reply until the 16 newly cited documents have been ruled admissible or inadmissible.  Mr Evans further stated that the other experts have not apparently been provided with the evidence in answer, further demonstrating that the opponent is not properly pursuing evidence in reply.

It is not clear to me why the opponent has waited until Professor Frazer's evidence is completed before preparing evidence from the other experts.  The opponent should have been able to forward the evidence in answer to its other experts as soon as it was served, so that they could commence preparation of their declarations in reply to that evidence.  If the opponent wished the other experts to consider the documents to be included in the Frazer declaration, these documents could have been forwarded to the experts as soon as these documents were identified.  It is not generally appropriate, where a party intends relying on declaratory evidence from a number of people, to wait until preparation of one declaration is completed before commencing preparation of the next.

I note the opponent's desire to wait upon my ruling on the admissibility of certain evidence before preparing evidence from other experts on that material.  I observe here the general principle stated (in relation to an entirely different set of facts) in University of Georgia Research Foundation Inc v BioChem Pharma [2001] FCA 688 (8 June 2001), of "avoiding … the wastage of time and expense which may arise from the presentation and consideration of what may well prove to be irrelevant evidence or material". While this may provide some justification for the delay in the preparation of evidence since the objection by the applicant, it does not explain the delay prior to that objection.

At the hearing Mr Kelly referred me to a letter and comments from Margaret Stanley, who will apparently be preparing a declaration in reply.  It is not entirely clear if these comments apply to this opposition or the opposition to patent application 688759, though it appears that many of the issues are similar in each opposition.  It appears from this letter that at least Margaret Stanley has commenced consideration of the material, and is to file evidence of likely relevance to the opposition.  Mr Kelly also indicated that, once the issue of allowability of the evidence was settled, the opponent would be able to complete its evidence in reply with reasonably diligence.  Therefore the delay in preparing evidence by the other experts must be balanced against the likely relevance of that evidence.

Mr Evans directed me to Cooper Mechanical Joint Ld's Application [1958] RPC 295. This was a decision of an Assistant Comptroller under the UK Patents Act 1949. There, the Assistant Comptroller observed:

"A point must be reached where this uncertainty is more prejudicial to the general interest than would be the grant of a defective patent, which is in any case open to challenge in the Court if it improperly injures any interest."

I agree that, as a general principle, this also applies to applications under regulation 5.10.  It amounts to the same principle that Burchett J considered in Ferocem where he referred to a balancing exercise, in which competing considerations must be taken into account, and that the public interests are not necessarily all ranged on the same side.  However, in my view, the point referred to in Cooper Mechanical Joint Ld's Application has not yet been reached in the case before me.

Interests of the parties

The opponent's interests principally lie in having any material relevant to its case being considered at the substantive hearing into the matter.  I have dealt with the relevance of the material in some detail already.  The opponent did not alert me to any other considerations that are likely to impact on their interests in the matter.

The applicant's interests may be impacted by any delays in determining the opposition proceedings that may unfairly disadvantage the applicant.  I have dealt with the delay above.  Any new material introduced in evidence in reply or further evidence at this stage of the opposition procedure would also impact negatively on the applicant's interests.  It would be a denial of natural justice if new material was admitted and the applicant was not given an opportunity to respond to that material.

The opponent has indicated that they would be agreeable to the applicant being given a period of time in which to file responsive evidence.  While the opponent initially suggested a period of one month, I understood from Mr Kelly at the hearing that the opponent would be agreeable to a longer period, such as three months.  This would protect the applicant's interest in being able to mount a proper defence of its application.  In my view, any other interests of the applicant are outweighed by the public interest in determining the opposition on its merits.

I agree that a period of three months for the applicant to file evidence in response would be appropriate.  The opponent has indicated that it will be filing further evidence in reply based on the new documents exhibited to the Frazer declaration.  Therefore it would be appropriate for any period for the applicant to file evidence in response to commence from the day on which evidence in reply is completed.

It could be argued that, as I have found the Frazer declaration and attached exhibits to be properly in reply, then this closes the argument rather than opens it to further evidence.  However, the opponent has filed the evidence as further evidence as well as evidence in reply.  The opponent has also apparently conceded that the "second ATG" point, though necessary to produce conformationally correct particles and raised in response to the applicant's attack on the opponent's prior art, was not actually discussed in the evidence in answer or Rochester application.  I am also mindful that my findings on the evidence in reply are based only on a preliminary review and not on the type of full evaluation of the evidence that would occur at a substantive hearing.  In view of all these circumstances it would seem to me to be appropriate to allow the applicant an opportunity to address the "new" material in the Frazer declaration.

This in effect creates a fourth stage of evidence, whereas regulation 5.8 outlines three evidentiary stages.  However, I believe this is consistent with regulation 5.10(4), which allows for the Commissioner to permit a party to serve further evidence on such reasonable terms as the Commissioner specifies.  This course of action will necessarily extend the opposition proceedings.  However, in my view it will allow for the remainder of the evidence to be filed in an orderly and efficient manner and protect the interests of the parties in having all significant matter relevant to their respective cases available for consideration at the substantive hearing. The resulting protraction could not be considered to be an unnecessary protraction.

Statement of Grounds and Particulars

The amendments to the particulars introduce new particulars 3.1.15 to 3.1.31.  The applicant did not pursue their objection to the amendments under regulation 5.9 at the hearing but requested a direction for further and better particulars.

There have been a number of decisions where delegates of the Commissioner have given directions under regulation 5.10 in relation to the statement of grounds and particulars.  (For example, Mobay Corporation v Dow Chemical Company (1992) AIPC 90-895; Imperial Chemical Industries v Irenco 26 IPR 154; E I Dupont De Nemours & Co v Dowelanco 29 IPR 131). At the hearing, I invited submissions from the parties as to whether a direction for further and better particulars would be appropriate.

In ICI v Irenco the delegate said:

"…  The purpose of the statement is to expedite the opposition process and to this end, in the words of the Assistant Commissioner in the decision of Diamond Scientific Co. v. CSL Limited (supra), "the applicant has the right to know, at the time the statement of grounds and particulars is filed, the complete case that it has to answer in the opposition".

The suggestion that the relevance of a document needs to be disclosed only when the evidence-in-support is completed is therefore clearly incorrect.  The applicant must be made aware of the case to be answered at the time the statement of particulars is filed not after spending a great deal of effort analysing a large list of documents or when the evidence in support is finally filed.  …  In this regard, it is expected of the applicant that it make a reasonable effort to understanding the case made by the opponent but where the particulars require more than this, then further and better particulars are appropriate."

Similarly, in Dupont v Dowelanco, the delegate said:

"…, although evidence in support has already been served, a statement of grounds and particulars must be sufficiently informative, in itself, to enable the applicant to understand the case it has to defend …"

In my view, the statement here is not sufficiently informative.  The statement gives no indication of the relevance of new particulars 3.1.15 to 3.1.31 and does not identify what information in each of these documents is relied upon in relation to the particular ground of opposition.  Therefore I consider it appropriate to make a direction that the opponent provide further and better particulars.

What is required is further and better particulars that briefly include the relevance of the documents identified in particulars 3.1.15 to 3.1.31 to the ground, together with references to direct the reader to the specific part of the document that is to be relied upon.  The further and better particulars should only contain a summary of the material facts on which the opponent relies, but not the evidence by which those facts are proved.

Given the advanced stage of preparation of their case, I do not think such a direction will unduly burden the opponent.  In fact, in cases such as this where particulars are amended at a late stage in proceedings, I would expect that the opponent would be able to state their case with a considerable degree of precision.  On the other hand, without further and better particulars, the applicant will remain uncertain of the exact case to be answered.

This leaves the amended statement dated 16 July 2001.  Under regulation 5.9 the Commissioner must amend the particulars, despite any inadequacies.  However, the Commissioner may specify terms.  I consider it appropriate to specify as a term of that amendment that my direction for further and better particulars is complied with within a certain time.  I consider that one month would be an appropriate period for the opponent to comply with my direction.

CONCLUSION

I consider that the evidence filed in reply to date is prima facie properly evidence in reply.  I also consider that the evidence is prima facie relevant to a correct determination of the matter.  The public interest in considering the opposition on its merits and the interests of the parties in having all significant matter relevant to their respective cases available at the substantive hearing weigh heavily in the circumstances under consideration.  Therefore I allow the extension of time to 16 October 2001 in which to file evidence in reply.

I permit the opponent's application to serve the Frazer declaration dated 26 July 2001 as further evidence on the applicant.  I allow the applicant a period of three months to file evidence in response.  The period for the applicant to file evidence in response is to commence from the day on which evidence in reply is completed

I direct that the opponent provide further and better particulars in relation to particulars 3.1.15 to 3.1.31.  The further and better particulars should contain a summary of the material facts on which the opponent relies, including the relevance of the documents to the stated grounds and references directing the reader to the specific part of the document being relied upon.

I allow the amendment to the statement of grounds and particulars dated 17 July 2001, on the condition that my direction for further and better particulars is complied with within one month of the date of this decision.

COSTS

The applicant has been unsuccessful in its objections to the request for an extension of time and to the request to serve further evidence.  However, it has been successful in pointing out the inadequacies of the amended particulars.  I believe that the amendments to the particulars may have created some confusion for the applicant in establishing the case it has to defend.  This was possibly compounded by the opponent's request for certain evidence to be treated as both evidence in reply and as further evidence.  The true relevance of the 18 new documents only became apparent at the hearing.  In light of this, it was not unreasonable for the applicant to raise an objection to the new material.

In light of my findings on the statement of grounds and particulars and my subsequent directions, I consider it appropriate to award costs against the opponent, University of Queensland and CSL Limited.

Brendan Bourke
Delegate of the Commissioner of Patents

Patent attorneys for the applicant  :  Phillips Ormonde & Fitzpatrick, Melbourne

Patent attorneys for the opponent   :  Fisher Adams Kelly, Brisbane