University of Georgia Research Foundation, Inc. and Emory University v BioChem Pharma, Inc

[1997] APO 61

official notice

decision of a delegate of the commissioner of patents

Application  :          No. 670637 in the name of UNIVERSITY OF GEORGIA RESEARCH FOUNDATION, INC. and EMORY UNIVERSITY

Title:          Enantiomerically pure b-D-dioxolane-nucleosides

Action:          Opposition to the grant of a patent by BIOCHEM PHARMA, INC. and an objection to a request to amend the statement of grounds and particulars

Decision:          Issued            .

Abstract

Reg 5.9 does not provide the Commissioner with a discretionary power and therefore such considerations as the public interest and the significance of the proposed amendment to the opposition cannot be taken into account by the Commissioner when considering the request to amend.

Onus of proof lies with the person alleging undue prejudice.

Applicant did not establish that it would be unduly prejudiced by the inclusion of a new reference to one of its own earlier specifications.

Extra particulars in relation to articles supporting the extent of common general knowledge not considered to be unduly prejudicial to the applicant given the nature of the technology involved.

Extending the range of alleged common general knowledge found to be unduly prejudicial to the applicant because it would deprive the applicant with the time normally afforded to the applicant to consider the extent of the common general knowledge.

Amendment refused.  Opponent given an opportunity to provide a further statement of amendments.

patents act 1990

decision of a delegate of the commissioner of patents

Re:Patent Application No. 670637 by UNIVERSITY OF GEORGIA RESEARCH FOUNDATION, INC. and EMORY UNIVERSITY, opposition thereto by BIOCHEM PHARMA, INC. and an objection to a request to amend the statement of grounds and particulars

background

Patent application 670637 was filed on 25 August 1993 by University of Georgia Research Foundation, Inc. and Emory University and was advertised accepted on 25 July 1996.

BioChem Pharma, Inc. (BioChem) filed a notice of opposition on 25 October 1996 and served the statement of grounds and particulars on 28 January 1997.  On 17 February 1997, BioChem requested an amendment to the statement of particulars.  This was allowed, the applicant not having objected to such an amendment.  On 28 February 1997, the applicant requested the Commissioner to direct BioChem to provide further and better particulars.  In response to the Commissioner’s direction, BioChem requested further amendment to the statement of particulars on 24 March 1997.  This amendment was also allowed.

On 17 July 1997, BioChem filed a further request to amend the statement of particulars.  The applicant objected to the allowance of this amendment.

On 30 July 1997, BioChem completed serving evidence in support after receiving an extension of time within which to do so.

On 1 August 1997, BioChem filed a further request to amend the statement of particulars.

The request of 17 July 1997 to amend the statement of particulars was considered at a hearing in Canberra on 3 September 1997.  The applicant was represented by Dr Bill Pickering, patent attorney of F B Rice & Co, Sydney.  BioChem was represented by Dr Annabelle Bennett, SC of Counsel assisted by Ms Katrina Howard of Counsel and Dr Ken Finney of Cullen & Co, patent attorneys of Brisbane.

After the hearing, I gave both parties an opportunity to comment on the timing for the service of the evidence in answer.  On 1 October 1997, I issued a direction that the three month period for serving evidence in answer would not commence until the date of the present decision.

REQUEST TO AMEND THE STATEMENT OF GROUNDS AND PARTICULARS

The request dated 17 July 1997 includes proposed changes to each of the particulars.  Those changes which are of most concern to the applicant are:

• The inclusion of a further particular in support of the ground of lack of novelty with this further particular referring to a previously unparticularised patent document.

• The inclusion of 44 new references in support of the ground of lack of inventive step.

• The inclusion of a reference to the synthesis of the relevant enantiomers in support of the ground of lack of inventive step, the change being the underlined portion in the following: “The common general knowledge is the knowledge of a person of skill in Australia as of 25 August 1992, as to how to resolve enantiomers of racemic mixtures of nucleosides, or as how to synthesis (sic) those enantiomers asymmetrically.”

EVIDENCE

BioChem served a statutory declaration by Dr Ken Finney on 2 September 1997, the eve of the hearing.

This declaration categorises the proposed changes to the statement of particulars into four groups as follows:

• amendments arising from interpretation of the subject matter of the claims of the opposed application and BioChem’s earlier patent;

• amendments arising from the discovery of an earlier and highly relevant patent application by the present applicants;

• amendments arising from errors discovered in the claims of the opposed application, and

• amendments relating to the further particularisation of publications supporting common general knowledge.

I will refer to the detail of the statutory declaration in relation to these points where appropriate in my decision.

SUBMISSIONS

Both parties provided me with written summaries of the oral submissions they made at the hearing together with copies of relevant decisions.

Dr Bennett presented a list of what she termed “overriding propositions”.  I have summarised them as follows:

• An amendment to the particulars is being sought not an amendment to the grounds.

• It is strongly arguable, if not inevitable, that the Federal Court, the court of any appeal, would grant an equivalent request at this stage of proceedings.  If this is so, then the present request should be granted by the Patent Office.

• It is clear from State of Queensland v J L Holdings Pty Ltd (1997) 141 ALR 353, that case management cannot prevent a party from raising an arguable defence. A party should not be shut out from litigating an issue which is fairly arguable.

• Because the Commissioner must amend unless there is a reasonable belief that undue prejudice exists, the burden of proof of undue prejudice lies at all times with the patent applicant.

• The tests set out in Diamond Scientific Company v CSL Limited (1992) AIPC 90-927 should be construed in the light of Ferocem Pty Limited v Commissioner of Patents (1994) AIPC 91-057, A. Goninan & Co Ltd v Commissioner of Patents 38 IPR 213 and J L Holdings (supra).

• The evidence clearly establishes that there is an absence of undue prejudice.

• If the tests of Diamond Scientific (supra) are to be applied:

  Þ  Particulars have been discovered incidentally to the preparation of the evidence.

Þ  There has been no undue delay.

Þ  There has been no substantial change in the case to be answered.  The test is no higher than “fairly arguable” (J L Holdings (supra)).

Þ  The additional particular of novelty must be included in the public interest at least and its likely importance affects the degree of undue prejudice.

• Particulars of relevant publications in support of common general knowledge are not required.  If they provide assistance to the applicant, such particulars must be allowed.

Dr Bennett expanded on a number of these propositions and I will refer to the further explanations where necessary in my decision.

Dr Pickering made a number of points which I have summarised as follows:

• In Lubrizol v Exxon Chemical, unreported Patent Office decision on application no. 661038, the number of new particulars that might be inserted via amendment was particularly relevant.  In the present case, there are 44 new particularised references.

• Of the new particularised references, 33 were raised in evidence in reply (filed 20 January 1997) in the opposition to patent application 658136 in which both parties in the present opposition are also involved.  This was before the original statement of grounds and particulars was served in the present opposition.  It is clear from this that the opponent chose at that stage not to include the particulars now being sought to be included.

• There is no real justification for the delay in filing the request to amend.  The evidence of Dr Finney indicated that the opponent had not been diligent in filing the request to amend.  The Finney declaration discloses that  the opponent knew what some amendments needed to be well before the actual filing of the amendments.  This clearly represented an undue delay which established that the applicant would be unduly prejudiced.  It did not know even at the hearing what case it now had to answer.

• Allowance of the amendments would result in a further protraction of the case because the applicant would have to address a significant number of additional documents in its evidence in answer.

• There is no clear indication that the extra novelty citation was incidental to the preparation of the opponent’s case.

• The opponent had completed its evidence in support before amending the statement of particulars to bring it in line with the evidence in support.  This was reverse of what should be the correct procedure.

• Paragraph (c) (the reference to the synthesis of the enantiomers asymmetrically) in relation to the particulars in support of the ground of lack of inventive step had changed what was alleged to be part of the common general knowledge.

DECISION

A REVIEW OF THE RELEVANT LAW

The allowability of the present request to amend the statement of grounds and particulars is determined by regulation 5.9 of the Patent Regulations 1991.  The relevant portions of regulation 5.9 read as follows:

“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:

.

.

(c)       must amend particulars relating to a ground set out in a statement that is   served and filed under subregulation 5.4(1).

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

.

.

(e)       he or she reasonably believes that a person will be unduly prejudiced by the   amendment.”

Dr Bennett stressed that regulation 5.9(1)(c) indicates that the Commissioner must amend the particulars (and the present request is for an amendment to the particulars) unless he or she reasonably believes that a person will be unduly prejudiced by the amendment.  I would add that if the Commissioner reasonably believes that a person will be unduly prejudiced by the amendment, the Commissioner must not amend the particulars.  It is clear that the Commissioner has no discretion in the matter.  This is not a discretionary power.

Dr Bennett invited me to reconsider the approach taken to requests to amend the particulars in earlier office decisions such as Diamond Scientific (supra) in the light of recent court decisions such as Ferocem (supra), Goninan (supra) and J L Holdings (supra).  She contended that such court decisions clearly required the Commissioner to take into account the public interest when considering matters of the present nature.  Dr Bennett argued that a serious opposition should be dealt with on its merits rather than the opponent being shut out.  Further, she asserted that J L Holdings clearly indicated that case management should not prevail over the injustice of preventing a party from raising an arguable defence.

It is true that both Ferocem and Goninan consider that the public interest should be one of a number of considerations that the Commissioner should take into account when exercising certain powers.  Indeed, both court decisions overturned earlier decisions by the Commissioner because the court indicated that the public interest had not been properly taken into account by the Commissioner.  However, these decisions dealt with applications to the Commissioner for an extension of time to file evidence in opposition proceedings.  Subregulation 5.10 enables the Commissioner to extend the time within which a party may serve evidence but it allows the Commissioner a discretion on whether or not he or she exercises that power.  The courts in many cases have stipulated that, before any exercise of discretionary power occurs, all relevant circumstances should be taken into account.  Such relevant circumstances in industrial property matters include the relevant interests of the parties concerned, the public interest and even the interests of proper case management.  The person holding the discretionary power has to balance these often competing interests before deciding whether or not to exercise it.

However, as I have indicated earlier, the power provided to the Commissioner by subregulation 5.9 is not a discretionary one.  The Commissioner must amend unless the Commissioner has a reasonable belief that a person will be unduly prejudiced by the amendment in which case the Commissioner must not amend.

Is the public interest an issue in whether or not a person is unduly prejudiced?  Presumably the person with the most likelihood of being prejudiced by the amendment will be the patent applicant.  There may be instances where other parties may be potentially prejudiced by the allowance of an amendment but these would be rare.  Whether or not the public interest would be best served by the allowance of an amendment of the particulars seems to me in no way to affect the question of whether or not the applicant will be unduly prejudiced.  I do not believe that I am entitled to say that the degree of prejudice to the applicant would be reduced if the public interest would be better served by the making of the amendment.  I am unable to see how the degree of prejudice to the applicant would be reduced if the public interest is taken into account.  The legislation does not provide me as the delegate of the Commissioner with the discretion to take the public interest into account in any form other than if the public would be unduly prejudiced if the amendment was allowed.

If the amendment is not allowed, Dr Pickering indicated that the public interest would still be served by a bar to sealing action based on any unparticularised material in the evidence. This is not a very satisfactory means of serving the public interest but it is better than the complete disregard of such interest.

Therefore, I am of the opinion that the public interest is not a matter I am entitled to consider in exercising the power set out in subregulation 5.9 other than if the public would be unduly prejudiced if I allowed the amendment.  In this respect, I note the words of the delegate in S.D.S. Digger Tools Pty Ltd v Pasdonnay Pty Ltd, unreported Patent Office decision on patent application 638571, dated 1 February 1995, as follows:

“It was argued that the public interest was in favour of the opposition considering all available evidence, which would not be possible if the particulars are not amended.  I must now consider the relevance of the public interest to my decision making.

Regulation 5.9 requires me to answer the question whether I am reasonably satisfied that a person will be unduly prejudiced.  There is a difference between this consideration and that in, for instance, regulation 5.10(5)(c)(ii), where the question is whether the Commissioner “is reasonably satisfied that a direction, an extension of time or the serving of further evidence is appropriate in all the circumstances” [emphasis added].  Regulation 5.10 was considered by Burchett J in Ferocem Pty Ltd v Commissioner of Patents (1994) 28 IPR 243, who confirmed the relevance of public interest considerations to the broad discretion of that regulation (see pages 247 to 248).

However, regulation 5.9 is not a broad discretion.  I can only refuse an amendment if I am satisfied of a single fact (i.e. the undue prejudice of a person), and to take into account matters not relevant to determining that fact would be improper.  I cannot see that the public interest is a consideration over and above the issue of undue prejudice.  This seems to me to be the unavoidable meaning of the words of regulation 5.9.”

I note that some office decisions have considered the public interest in passing when considering whether or not to allow an amendment but as far as I am aware no decision has turned on this (e.g. Porter v Arbortech Investments Pty Ltd (1995) 31 IPR 169 and Colgate-Palmolive Company v Westone Products Ltd, unreported Patent Office decision on patent application 664182, 23 May 1997).

Turning to J L Holdings, I note that this also involved the exercise of a discretionary power by a Federal Court judge.  I do not believe that therefore it is appropriate to the present proceedings in relation to whether or not I should consider the public interest.

As an aside, I note that the Federal Court rules referred to by Dr Bennett clearly involve a discretionary power of the court.  While the explanatory text suggests that the Court would almost certainly grant any request to amend, the court has the discretion to take into account the interest of the person seeking the amendment, any public interest etc.  I believe that, under subregulation 5.9, I do not have that discretion.  I must not allow the amendment if I reasonably believe that a person will be unduly prejudiced.

Having decided that I am not entitled to take into account the public interest other than if the public would be unduly prejudiced if I allowed the amendment, I now turn to another of Dr Bennett’s submissions in which she contended that the importance of the amendment should also be considered in deciding on the degree of prejudice to the applicant.  In her written submissions Dr Bennett argued that there should be a balancing exercise between the public interest (which I have already dealt with) and the importance of the proposed amendment in the opposition against the degree of prejudice to the applicant.

For reasons similar to those I have discussed above in relation to the public interest, I do not believe that I have the discretion to balance the importance of the amendment against the degree of prejudice to the applicant.  The statute does not afford me this discretion.

I now turn to Dr Bennett’s submissions dealing with the question of burden of proof.

Dr Bennett spent some time dealing with the issue of burden of proof.  Her argument centred around the contention that, as the Commissioner must amend unless there is undue prejudice to another party, the onus of proof lies with the patent applicant to establish undue prejudice.  This approach has some support in Diamond Scientific (supra) where the delegate said:

“Furthermore, I note the opponent cannot be expected to have full knowledge of the prejudice to the other party - let alone any person as referred to in the regulation. Therefore, broadly speaking the onus of establishing undue prejudice rests with the applicant (or any other person alleging undue prejudice), rather than with the opponent having to establish that no person is unduly prejudiced.”

Dr Bennett dealt with the distinction between the legal burden of proof and the evidential burden of proof.  She contended that the legal burden of proof remained at all times with the patent applicant although the evidentiary burden of proof might shift to the person seeking the amendment if there was prima facie undue prejudice.  The evidentiary proof required from the opponent to shift this burden back to the applicant was not great, it being only required that the opponent raise a prima facie case to shift the evidential burden back to the patent applicant.  Dr Pickering referred me to Diamond Scientific (supra), which, he argued, demonstrated that any substantial changes to the case the applicant had to answer and any undue delay in filing the amendments resulted prima facie in undue prejudice and it was up to the opponent to prove differently.

It seems to me that the rules set out in Diamond Scientific (supra), support both viewpoints at least to some extent.  However, I take Dr Bennett’s point that if the evidentiary burden of proof can shift from the applicant to the opponent as a result of prima facie undue prejudice, it would seem equally appropriate that the evidentiary burden of proof should shift back to the applicant if the opponent establishes a prima facie case of lack of undue prejudice.  If this were not so, the applicant need only establish a prima facie case and the opponent is then imposed with a higher burden of proof in establishing lack of undue prejudice.  As Dr Bennett pointed out to me, it is the applicant who is asserting undue prejudice and therefore ultimately it is the applicant who has to establish that assertion.

There are two other issues I believe I need to review before considering the facts of the present case viz. the terms “reasonably believes” and “unduly prejudiced”.

Subregulation 5.9(2) requires the Commissioner to have a reasonable belief that undue prejudice exists.  Dr Bennett made the point that there must be reasonable grounds of cause for any belief I might have that the applicant is unduly prejudiced.  Her written submissions refer to a number of criminal cases in support of this.  There is no specific reference to any civil case although Dr Bennett’s written submissions refer to an unsourced quote from Lockhart J.

In Diamond Scientific (supra), the delegate set out a number of grounds which might provide the Commissioner with a reasonable belief of prima facie undue prejudice.  While the grounds themselves may be arguable, I think the point is that the Commissioner should have some grounds or reasons stemming from the case at hand to come to a belief which could be said to be reasonable.

I now turn to the question of undue prejudice.  In Diamond Scientific (supra), the delegate stated:

“In my view, a person will be unduly prejudiced by an amendment if:

i.the amendment is detrimental or disadvantageous to the person, and

ii.the circumstances surrounding the amendment cause the degree of that detriment      or disadvantage to be unwarranted, excessive, improper, inappropriate, or    unjustified.

In this context I note that any amendment that changes the case the applicant has to answer is potentially prejudicial to the applicant. I also note that an amendment to replace a particularised document with an equivalent document may involve a change of the case to be answered - for example by reason of different dates of publication.”

The delegate suggested some factors which might lead to a prima facie assumption of lack of undue prejudice as follows:

“In my view, extra particulars that arise incidental to the preparation of the case which:

i.do not result in any protraction of the preparation of the case, and

ii.        are included by way of amendment of the statement of grounds and particulars at              the earliest reasonable opportunity, and

iii.do not substantially change the case the applicant has to answer in the opposition

will not prima facie give rise to the applicant being unduly prejudiced by the relevant amendments.”

The delegate subsequently argued that prima facie undue prejudice existed:

“However, where:

-the applicant objects to an amendment, and

-          the amendment of the statement can reasonably be said to prejudice the applicant              (such as by the addition of extra particulars), and

-          the circumstances are such that there is a reasonable inference that the prejudice is   undue - such as by the time at which the amendment is sought, or the nature or                  extent of the amendment sought;

there is in my view a reasonable basis for the Commissioner to prima facie conclude that the applicant will be unduly prejudiced by the amendment. In this event, for the Commissioner to allow the amendment I consider the opponent has an onus of demonstrating that its activities have not been such as to have unduly prejudiced the applicant.”

In discussing “undue prejudice”, Dr Bennett argued that the delegate therefore appeared to be equating the degree of prejudice with the length of delay in filing the request to amend.  She contended that length of delay is not equivalent to undue prejudice.  The onus is on the applicant to establish that it has been unduly prejudiced because of the length of time taken to file the amendments.  I do not think that the delegate was saying that, as a general rule, any delay in filing a request to amend automatically means that the applicant will be unduly prejudiced.  I believe that the delegate qualified this by referring to the particular circumstances of the case.  In any event, I agree with Dr Bennett that any delay in filing the request to amend is not sufficient of itself to establish undue prejudice.

Any delay in the requesting of the amendments will result in a delay in the preparation of the patent applicant’s case.  This delay may prejudice the applicant because the applicant could conceivably have subsequently less time to prepare its case if it starts the preparation of its case on receiving the original statement of grounds and particulars.  Whether the applicant actually starts preparing its case after the filing of the statement of grounds and particulars and before the serving of the evidence in support is another matter.  Certainly it seems to me that the applicant would be unable to start preparing any adequate evidence in relation to the ground of lack of inventive step until the opponent has provided evidence from its experts.  It is more debatable about whether or not the applicant would be able to start preparing evidence in relation to the ground of lack of novelty.  Invariably expert evidence deals both with novelty and inventive step in the same statutory declarations so that it would seem counter-productive to prepare them separately  Nevertheless, it is likely that the applicant’s patent attorney, who is a legally and technically qualified person though not necessarily a person skilled in the art, would be able to come to some initial conclusions about the appropriateness of any novelty citations at least.  This may also be true of the particulars relating to the extent of the common general knowledge.

It seems to me that the applicant would be unduly prejudiced by undue delay if it was accorded less time then it is normally entitled to prepare its evidence in answer as a result of the amendment.  Thus, for instance, where the applicant has engaged expert witnesses on the basis of the statement of grounds and particulars and a subsequent amendment to those particulars required the applicant to discharge those witnesses and engage new witnesses then I would say that the applicant was unduly prejudiced because the time it has to prepare its case had been unfairly shortened.  The extra cost of engaging new witnesses may also be an issue.  The applicant may also be unduly prejudiced if, as a result of undue delay in filing the request to amend, it was afforded substantially less time to consider extra documents relating to the ground of novelty or extra pieces of common general knowledge.  Ultimately, however, the applicant needs to provide the Commissioner with reasonable grounds to believe that the delay has been such as to cause it to be unduly prejudiced.

In relation to the reference by the delegate in Diamond Scientific (supra) to the extent of the amendment sought, Dr Bennett argued that where the amendment sought to introduce more specific particulars in relation to common general knowledge, there was case law to suggest that this was entirely appropriate although not necessary.  She referred me to the delegate’s comments in Cooper Industries v Metal Manufactures Ltd (1994) 29 IPR 106 at 112:

“The relevance of these documents can only be to the establishing of the common general knowledge in the art.  If this is so, then there is no necessity to particularize these documents.  Ordinarily it is only necessary to particularize the actual common general knowledge being relied on, and the identification of any documentary evidence used to establish that common general knowledge is in the nature of evidence, not particulars (see, for example, my decisions in Borden v Elkem, (1992) AIPC 90-893, and Sterling Canada v Eka Nobel, an unreported Patent Office decision of 19 April 1993 concerning patent application 628254).  This should be sufficient to fulfill the purpose of the statement of grounds and particulars - to forewarn the applicant of the case against it - since the pervasiveness of common general knowledge is such that the applicant should be able to readily discern the strength or weakness of the opponent's case against it which relies upon the common general knowledge.”

Dr Pickering argued that the extent of any extra particulars including those dealing with common general knowledge had a great bearing on the degree of prejudice to the applicant.

It seems to me that the documents that purport to establish common general knowledge in so far as they are referred to in the evidence in relation to common general knowledge need not be specifically particularised.  I agree with the delegate’s comments above on the matter.  The opponent is accorded three months to gather evidence in support of the grounds of opposition.  The collecting of this evidence would include the engaging of expert witnesses to provide evidence of the alleged common general knowledge including the identification of various publications to support the proposition of what formed part of the common general knowledge which has been identified in the original statement of grounds and particulars.  It seems unreasonable that all of those documents in the mind of the expert should be known at the making of the statement of particulars.  Therefore I believe that, in the normal course of events, the applicant would not be unduly prejudiced by the inclusion of references in support of common general knowledge that have been referred to in the evidence in support.  To say otherwise would be to say that the applicant is unduly prejudiced by the serving of any evidence on the matter of common general knowledge.  I would say however that where the amendments seek to change the alleged nature of the common general knowledge then that is a different matter.  The applicant may indeed be able to argue that it would suffer undue prejudice if such an amendment were made.

Previous office decisions have considered the extent of the extra particularisation involved including, in some of the early office decisions in relation to amending the statement of particulars, the setting of some arbitrary number of new documents above which the applicant could be said to be unduly prejudiced.  However, in recent office decisions, that arbitrary number of new documents has been considered  to be only one of a number of factors.  Certainly the number of new documents sought to be included has generally been considered in the light of the ground of lack of novelty rather than establishing the common general knowledge in relation to lack of inventive step.  (See for example Colgate-Palmolive Company v Westone Products Ltd (supra).)

I am of the opinion that, in general, an amendment seeking to introduce new references to documents in support of common general knowledge, would not of itself cause the applicant undue prejudice provided that the documents are identified in the evidence in support.

The delegate in Diamond Scientific (supra) referred to any protraction of the preparation of the case in deciding whether or not there may be undue prejudice.  It seems to me that this concept overlaps with the concept of case management to some degree.  A protraction of the preparation of the case will result in a less speedy resolution of the opposition.

Dr Bennett stressed on me that the findings in J L Holdings (supra) clearly indicated that the present request to amend should not be disallowed.  In J L Holdings, the primary concern was whether or not pleadings could be changed which may result in consequential delay of the hearing which had already been set.  As the hearing date had been set some six months after leave to amend was sought, the High Court found that although efficient case management might be one consideration in deciding whether or not to grant leave to amend the pleadings, it should not automatically prevail over the allowing of a party to present an arguable defence.  I do not think that the High Court in JL Holdings is suggesting that case management should never be an issue.  In this respect, I note the comments of Sackville J in Goninan (supra):

“As Mason J said in Minister for Aboriginal Affairs v Peko-Wallsend Ltd (1986) 162 CLR 24, at 41, in general it is for the decision-maker and not the court to determine the appropriate weight to be given to the various matters which are to be taken into account in the exercise of a statutory power. The recent decision of the High Court in State of Queensland v J L Holdings Pty Ltd (1997) 141 ALR 353, indicates that there are circumstances in which a relevant factor (in that case, principles of case management) may be given such inappropriate weight, that other relevant factors (in that case, the attainment of justice) are in effect overlooked or supplanted (see at 356-357). But I do not read J L Holdings as detracting from the general principle stated in Peko-Wallsend.”

It seems to me that, in line with Sackville J’s comments above, the High Court in J L Holdings does not advocate that case management should be ignored completely rather it should not be given an inappropriate weight at the expense of other considerations.

I note also in Goninan (supra), Sackville J refers to the government response to the Industrial Property Advisory Committee 1984 report in relation to the report’s recommendation to abolish pre-grant opposition.  This response is as follows:

“Pre-grant opposition provides a relatively inexpensive mechanism for resolving third party disputes as to validity.  Opposition procedures will be made more stringent in order to expedite the determination of oppositions.” (my underlining)

The Patents Act 1990 introduced the concept of a statement of particulars into the opposition proceedings in order to assist this expedition. It seems to me, therefore, that the intent of the legislation is for the statement of particulars to be one means of speeding up the determination of the opposition and that this should be one factor which is taken into account when considering whether or not there has been undue prejudice. I am not saying that this should be the only consideration but in the light of the above comments I do not believe that I should ignore it. The issue of case management has been considered indirectly in earlier office decisions on requests to amend the particulars when consideration is given to the meaning of undue prejudice. Certainly, and I think not unreasonably, case management consideration has been one factor considered in decisions where such requests have been refused particularly where the requests have been filed late in the opposition proceedings e.g. after completion of the serving of all evidence. (See Porter v Arbortech Investments Pty Ltd (supra).)

APPLYING THE LAW TO THE PRESENT REQUEST

At the hearing, Dr Pickering indicated that the applicant was not objecting to those changes to particular 1(a) (where BioChem’s attorneys had subsequently realised that the claimed compound was a tautomer of the compound claimed in BioChem’s earlier patent application), (b)(i) and part II of the particulars (lack of compliance with section 40).  Dr Pickering also indicated that the applicant did not object to the additional explanation being proposed to clarify the existing references in relation to the state of the common general knowledge.

As I have indicated above, the applicant’s main concerns with the proposed amendment were the addition of a new reference in relation to novelty, the addition of 44 new references in support of the ground of lack of inventive step and the inclusion of the synthesis of the enantiomers asymmetrically as a further piece of common general knowledge.  These are the changes that I will consider in relation to the submissions provided by both parties in determining whether or not I should allow the amendment.  I would add that, if I find that any of the proposed changes would unduly prejudice the applicant if the amendment was allowed, I must not allow the amendment even though there may be parts of the amendment which would not unduly prejudice the applicant.

It is convenient for me to consider the present request by looking at the nature of the amendment sought and then reviewing the circumstances surrounding the filing of the amendment.

The nature of the amendment sought

As Dr Pickering pointed out, 44 new references are sought to be included into the particulars in relation to the ground of lack of inventive step.  However, I do not agree with Dr Pickering that this automatically means that the applicant will be unduly prejudiced.  As I have indicated above, I do not think that further references establishing the relevant common general knowledge provides undue prejudice.  Given that the  present patent application is directed at an antiviral agent for the treatment of human immunodeficiency virus (HIV), I would expect that there would be substantial literature available which could be used to support the assertion of relevant common general knowledge.  I do not think the number of new references to be unreasonable in the circumstances and given the nature of the technology.

In relation to the new novelty reference, the Finney declaration points out that this is an earlier patent application by the present applicant.  While Dr Pickering suggested that the applicant could not be expected to know which of any of its earlier patent applicants was going to be subsequently selected by the opponent for novelty purposes, I am not convinced that the applicant will be unduly prejudiced by the inclusion of such a reference.  I would assume that the applicant is well aware of the subject matter of this earlier application and therefore the amount of extra preparation it would have to carry out for its evidence in answer would be markedly less than if the document was one which it had never seen before let alone be familiar with its contents.

With respect to the extending of the common general knowledge to include synthesis of the enantiomers asymmetrically, I believe that this is extending the nature of the common general knowledge to be relied on rather than providing evidence on already identified common general knowledge.  As such, it certainly changes the case the applicant has to answer.  How much does this prejudice the applicant?  I think, prima facie, there are reasonable grounds for me to assume that the applicant will be unduly prejudiced by now discovering that the case it has to answer is extended to the synthesis of  the enantiomers asymmetrically.  While any experts the applicant may already have engaged may not yet have started to develop their evidence, I think that there would be a likelihood that they may have already considered the extent of the common general knowledge to be argued. There  is no response from the opponent in relation to the degree of prejudice that the applicant might suffer if this amendment were allowed.  Nor has the applicant specifically indicated why such a change might unduly prejudice it.  There is no indication of the extent of any preparation of evidence in answer, the number of expert witnesses already engaged or any other circumstances which might suggest that the inclusion of this extra particular would unduly prejudice the applicant.  If Dr Bennett is right that the applicant has the burden of establishing undue prejudice then the applicant has not done so.  However, the applicant presumably is entitled to start looking for expert witnesses particularly in relation to common general knowledge when it becomes aware of the extent of the alleged common general knowledge at the filing of the statement of grounds and particulars.  Therefore, despite the lack of any evidence, I am of the opinion that there are reasonable grounds for me to believe that the applicant would be prima facie unduly prejudiced if the amendment were allowed in relation to this piece of common general knowledge because the applicant would be deprived of the time normally accorded to it to consider the extent of the alleged common general knowledge.

The circumstances surrounding the filing of the request to amend

There are a number of  issues in relation to the filing of the amendment:

• The delay in filing of the request

• The relevance of the earlier opposition

• The location of the extra particulars

• The time of filing the request

The Finney declaration indicates that some of the proposed new particulars were known at an early stage some time before the request to amend was filed.  Some of the proposed changes were not finally acted upon until the completion of the statutory declarations comprising the evidence in support.  Dr Pickering argued that this clearly indicated that these had not been included via amendment at the earliest opportunity. Dr Bennett argued that it was entirely appropriate to collect the various amendments and file one statement rather than file a statement of amendments every time some change to the particulars was needed.  This would have meant that three or four statements would have had to be filed if Dr Picking’s argument were to be accepted.  Dr Pickering pointed out that two earlier requests to amend the particulars had been filed and allowed.

I note that at least one of the proposed changes to the particulars, which was known at an early stage and not acted upon for several months, resulted from the  re-interpretation of the claims of the present application.  This is one of the changes which Dr Pickering indicated the applicant was not concerned about. Therefore, I cannot say that this change would prejudice the applicant even though the request to amend was not included at the earliest opportunity.

In relation to the extra particulars which identify further documents in relation to common general knowledge, I think it is entirely appropriate to wait until the expert evidence is completed before establishing what references have been included in the evidence.  To do anything beforehand could be misleading as the actual references relied upon in the completed evidence could vary from those originally identified.

With respect to the additional citation to be included under the ground of novelty, the Finney declaration indicates that Dr Finney became aware of the new citation in late February or early March 1997.  One of the opponent’s expert witnesses made Dr Finney aware of an equivalent document.  Dr Finney indicates that he chose to show the document to another expert witness rather than request to have the particulars amended to include the document at that stage.  The other expert witness finished his evidence in April 1997.  Dr Finney waited until the first expert witness had completed his statutory declaration in July 1997 before requesting an amendment, which is part of the present request to amend the particulars.

It seems to me that the inclusion of a new particular in relation to novelty should be included as soon as possible so that the applicant can consider its relevance.  While common general knowledge is not something that the applicant can really deal with to any great degree until after the serving of the evidence in support, a novelty reference is something which the applicant’s professional advisers can start to consider even before the engagement of expert witnesses.  While evidence from expert witnesses on what the document actually discloses may be vital to the applicant’s defence, nevertheless the applicant’s patent attorney can form an initial impression of the particular relevance of the document and formulate a strategy for the gathering of evidence in answer accordingly.  In the present case the applicant has conceivably been deprived of some four months from when the opponent first became aware of the document to when the request to amend was filed within which time the applicant was entitled to be considering available material to assess relevance and formulate strategies in defence.  As I have indicated above in relation to the law, I believe that an applicant will be unduly prejudiced if any delay in filing the request to amend will result in the applicant having less time to prepare its case then it would otherwise be entitled to.  In the present case, I need to weigh up this undue delay against the fact that the new reference is one which is already familiar to the applicant, if not necessarily to the applicant’s attorney.

It seems to me that what has happened in the debate on this new particular is that the applicant has provided a prima facie case that there would be undue prejudice experienced by it because of the undue delay involved in the opponent making the applicant aware of the relevance of this document.  The opponent however has demonstrated that prima facie there is no undue prejudice because it is the applicant’s own document which is being referred to and the applicant therefore can’t be unduly prejudiced at this stage of the proceedings.  The applicant, to my mind, has not successfully countered this argument.  It has not provided any evidence that such a document would cause it undue prejudice.   Therefore I do not think that the applicant has successfully provided me with reasonable grounds to believe that it will suffer undue prejudice if the amendment was allowed in relation to this particular document.

In relation to the extra piece of common general knowledge (the synthesis of the enantiomers asymmetrically), I have no evidence before me as to when this particular was identified.  I have already mentioned that I believe that the inclusion of this new particular prima facie causes the applicant undue prejudice.  Without any explanation from the opponent as to when it was first discovered, I find that I have reasonable grounds to believe that the applicant will be unduly prejudiced if I allow the amendment to include this new particular.

Dr Pickering referred to another opposition to patent application 658136 involving the present parties.  Dr Pickering indicated that the opponent was aware of the references which were being sought to be introduced as early as January 1997.  This was before the present original statement of grounds and particulars was served.  Dr Pickering argued that this clearly indicated that the opponent chose at that stage not to include the particulars.  Dr Bennett argued that it was irrelevant that the particulars had been included in the earlier case.  The present case should be treated on its merits. The only possible significance of any earlier case would be if the claims were identical in scope and this was not the case here.  Therefore I should disregard the earlier opposition.  Dr Bennett suggested however that, in any case, the applicant was now not taken by surprise by these particular documents because it was already aware of them from the earlier opposition.

It seems to me that if these references were to be included as particulars in relation to the ground of lack of novelty then I would agree with Dr Pickering that there may be some reasonable argument that the applicant was being unduly prejudiced (given that the two patent applications were dealing with related subject matter).  However, as these references deal with the state of common general knowledge, I do not believe that the same argument applies.  The opponent is entitled to engage expert witnesses on a case by case basis.  It is appropriate to consult with such expert witnesses before including evidence on the common general knowledge in the form of documents or articles.  This is borne out by the fact that not all of the references now sought to be included were raised in evidence in the earlier opposition.  Therefore, I do not think that I should disregard the circumstances of the earlier opposition as Dr Bennett urged me to do but I find that these circumstances do not support the applicant’s argument of undue prejudice.

In respect of how the new particulars were located, Dr Pickering submitted that the opponent has not made it clear that the particulars were located incidentally to the preparation of the opponent’s case.  The delegate in Diamond Scientific (supra) stated that extra particulars that arise incidentally to the preparation of the opponent’s case is one of the factors which may indicate that there is no prima facie undue prejudice.  I am satisfied that, of those particulars which the applicant has indicated to be of concern to it, the new references in relation to the common general knowledge and the new novelty reference have been located incidentally to the preparation of the opponent’s case.  The Finney declaration sets out the circumstances of their location and I have no reason to believe that these references were located in circumstances other than the normal course of the establishing of evidence using expert witnesses.

However, in relation to the inclusion of the piece of common general knowledge dealing with the synthesis of the enantiomers asymmetrically, I am not aware of how or when this new particular was identified.   The Finney declaration is silent in this respect.  I think there is a basis for me to believe that the applicant would prima facie be unduly prejudiced by the inclusion of a new piece of common general knowledge, as opposed to evidence in support of the common general knowledge.  The opponent has not provided me with any evidence to suggest that this prejudice is not undue.  What the opponent has done is to submit that, because the amendment has been made at the same time as the completion of the evidence in support, the applicant will not be unduly prejudiced.  It now has the opportunity to consider all the evidence and prepare a defence.  While I have some sympathy for this argument, I have already mentioned that I believe that the applicant would be unduly prejudiced by the inclusion of new aspects of common general knowledge because it is entitled to consider at least at a broad level the extent of common general knowledge being argued by the opponent.  Therefore, I believe that I must come to the conclusion that the inclusion of this extra particular via amendment would be unduly prejudicial to the applicant.

I now turn to the time of filing of the request.  As I have already indicated, the request was filed about two weeks before the completion of the evidence in support.  As previously indicated, the period for serving of evidence in answer will not commence until the date of this decision.  Therefore, the applicant is not disadvantaged to the extent that any time is lost to gather the necessary evidence in answer.

In summary I believe that the applicant will be unduly prejudiced if the amendment were allowed to include the extra piece of common general knowledge because it would deprive the applicant of the time normally accorded to it to consider the extent of the alleged common general knowledge and because the opponent has not adequately explained how this extra piece of common general knowledge was arrived at.

However, I am of the opinion that the applicant would not be unduly prejudiced if the other changes to the particulars were allowed.

CONCLUSION

I have found that I must not allow the amendment because I have reasonable grounds to believe that the applicant would be unduly prejudiced as a result.

I do not believe that I am entitled to allow some only of the statement of amendments.  Therefore I allow the opponent an opportunity to file a further request to amend the statement of particulars incorporating only those that I have found would not unduly prejudice the applicant within one month of the date of this decision otherwise I will direct that the time for serving evidence in answer will commence.  If the opponent does not to file such a further request which is allowed, those further particulars included by way of the proposed amendment of 17 July 1997 would not be available to the opponent to argue at the substantive opposition.

I note also that the further request to amend the statement of particulars filed on 1 August 1997 is directed at the proposed amended statement of particulars filed on 17 July 1997.  Even though the applicant has not objected to this request of 1 August 1997, I do not believe that it is appropriate to allow this further request at the present time because it is directed at the proposed amended statement of particulars which I have not allowed.  If the opponent files a further statement of amendments, as indicated above, which is allowed, it may then be appropriate to allow the request to amend dated 1 August 1997.

I direct that the time for serving evidence in answer does not commence until the substitute amendment is allowed or one month from the date of this decision whichever is earlier.

COSTS

The applicant has been successful in that I have found that the amendment is not allowable in its present form.  I note also that the opponent filed its evidence in support of this request to amend the day before the hearing.  I relied on this evidence to some extent in reaching my conclusions on this matter.  Therefore I award costs against the opponent, BioChem Pharma, Inc.

R Hallett

Delegate of the Commissioner of Patents

Patent attorneys for the applicant  :  F B Rice & Co, Sydney

Patent attorneys for the opponent   :  Cullen & Co, Brisbane