Diamond Scientific Company v CSL Limited
[1992] APO 55
•29 September 1992
official notice
decision of a delegate of the commissioner of patents
Application : No. 614735 in the name of DIAMOND SCIENTIFIC COMPANY
Title : CANINE DISTEMPER VIRUS
Action: Opposition to grant by CSL Limited. Request to amend the statement of Grounds and Particulars
Decision: Issued . Amendment allowed in part.
It is the responsibility of the opponent to explicitly specify in the statement of grounds and particulars those documents on which it relies in the opposition.
Any amendment that changes the case the applicant has to answer is potentially prejudicial to the applicant.
An amendment of particulars will unduly prejudice a person 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.
Where an opponent actively pursues further particulars in the opposition after having filed its statement, the applicant will be unduly prejudiced by any resultant change to the case it has to answer if the statement is amended.
/cont
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.
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 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 the opponent has an onus of demonstrating that its activities have not been such as to have unduly prejudiced the applicant.
patents act 1990
decision of a delegate of the commissioner of patents
Re:Patent Application No. 614735 by DIAMOND SCIENTIFIC COMPANY, opposition thereto by CSL Limited, and a request to amend the statement of Grounds and Particulars.
background
Application 614735 was filed on 16 Feb. 1988 under application no. 11760/88. It was advertised accepted on 12 Sept. 1991, and a notice of opposition was filed by CSL Limited on 11 Dec. 1991.
The opponent served its statement of grounds and particulars on 11 Jan. 1992. It has not as yet served any evidence in support of the opposition.
On 19 June 1992, the opponent filed a request under regulation 5.9(1) to amend its Statement of Grounds and Particulars. The applicant objected to the amendments. A hearing in the matter was conducted by telephone on 8 Sept. 1992. The applicant was represented by Mr. John Slattery (patent attorney of Davies Collison Cave, Melbourne); the opponent was represented by Dr Vivian Santer (patent attorney of Griffith Hack & Co, Melbourne).
statement of grounds and particulars
The amendment of the statement of Grounds and Particulars being sought by the opponent is a substitution of a new statement for the old; to appreciate the nature of the actual amendments being sought, I here summarise the original statement, and the proposed amended statement. I also note that the amendment sought is of the particulars of the opposition only; there is no amendment to the grounds of the opposition.
Summary of the Original Statement of Grounds and Particulars
Statement of Grounds of opposition:-
(manner of manufacture, prior publication, obviousness, novelty, section 40)
Statement of Particulars of opposition:-
The invention claimed in any one of Claims 1 to 4, 6, 7 and 19 to 22 is not a patentable invention because ... fully disclosed in .. (2 documents).
The invention as defined in any one of claims 1 to 3 is not a patentable invention because:
a.... is not novel, or lacks an inventive step, having regard to the following publications which fully disclose inactivation of viruses by binary ethyleneimine ... (16 documents, one of which is repeated).
b.... is not novel, or lacks an inventive step, having regard to the following publications which fully disclose inactivation of viruses by furocumarins, and especially psoralens (6 documents)
The following references are also relevant:
List of "References cited" appearing on the title pages of:
US Patent No. 4990367
US Patent No. 4992272
US Patent No. 500367 (sic)
all assigned to the present applicant, and corresponding to the application in suit.
I note here that the positioning of the particulars above reproduces the positioning in the actual statement - that is, it is open to interpret the reference to the "References cited" as referring only to paragraph 2(b). However, I have treated the reference as applicable to both 2(a) and 2(b).
The specification does not comply with the requirements of section 40(2) (... 7 paragraphs setting out various issues).
The statement ends with:
"The opponent reserves the right to argue further grounds and particulars at a later stage.
Summary of the Proposed Amended Statement of Grounds and Particulars
To highlight the amendments sought, I here refer to documents listed in the original statement as `old' documents, and documents not listed in the original statement as `new' documents.
Statement of Grounds of opposition:-
(manner of manufacture, prior publication, obviousness, novelty, section 40)
Statement of Particulars of opposition:-
The invention claimed in any one of Claims 1 to 4, 6, 7 and 19 to 22 is not a patentable invention because ... fully disclosed in ....
(2 old documents, 5 new documents).
The invention as defined in any one of claims 1 to 3 is not a patentable invention because:
a.... is not novel, or lacks an inventive step, having regard to the following publications which fully disclose inactivation of viruses by binary ethyleneimine
(9 old documents maintained, 7 old documents deleted, 9 new documents - 5 of which were included in over 47 'References Cited' included on the three US patents referred to, and one of which was listed under heading 2b of the original statement).
b.(deleted)
(6 old documents deleted)
The specification does not comply with the requirements of section 40(2).
(3 old paragraphs maintained, 2 old paragraphs amended, 2 old paragraphs deleted.)
One of the paragraphs was changed by the addition of the underlined text in the following:
"... Although Fruend's complete adjuvant is disclosed at Page 10 lines 28 to 29, this is not generally regarded as a non-toxic, pharmaceutically acceptable adjuvant."
This statement of grounds and particulars also ends with:
"The opponent reserves the right to argue further grounds and particulars at a later stage."
In summary, the proposed statement of grounds and particulars:
maintains 11 of the 24 documents particularised in the original statement;
ii.particularises 14 new documents of which:
-8 are completely new;
-5 were included in over 47 'References Cited' included on the three US patents referred to.
-1 was particularised under a different heading
iii.has fewer section 40 particulars,
iv.two of the section 40 particulars are amended.
submissions
The essence of the opponent's submissions are that the amendments do not substantially change the case the applicant has to answer; that specifically identifying the documents in the reference to the `References Cited' given in the original statement did not change the case to be answered as the applicant was aware of those documents; the additional words included in one of the section 40 particulars was a narrowing of the scope of that particular, and did not adversely affect the case to be answered; there is a public interest in having all relevant documents considered by the Commissioner; and that if the amendment was not allowed the relevant documents would not be available for consideration in any subsequent bar-to-sealing action.
The essence of the applicant's submissions are that mere awareness of existence of documents was not relevant; the critical issue is the applicant's knowledge of the documents upon which the opponent relies; the deletion of a large number of documents from the statement, and the addition of a significant number of new documents, shows that the case to be answered has significantly changed; the transfer of a particular from one basis of opposition to another changes the case to be answered; the additional words included in one of the section 40 particulars substantially changes the case to be answered, that the statement of grounds and particulars sets out the basis of the opposition, and amendments to add new particulars (rather than qualify existing particulars) ought not be allowed; that as the opponent is seeking the indulgence of the Commissioner in making the amendment, the onus rests on the opponent to establish that there is no-one who is unduly prejudiced by the amendment.
At the hearing the applicant commented that written submission by the opponent indicated that they were now opposing only certain claims, but that was not apparent from the amended statement. The opponent indicated that there was an `obvious mistake' in the amended statement, and foreshadowed future corrections. Apart from noting this matter, I do not consider it relevant to the allowability of the present amendments.
Also at the hearing it transpired that the applicant was not in possession of an initial submission by the opponent. Dr. Santer indicated that a later submission (which the opponent had a copy of) was an expansion of the earlier submissions. On that basis, I suggested that the matter proceed with me taking no account of the earlier submission - to which both parties agreed. Subsequent to the hearing, Dr. Santer filed a declaration explaining certain circumstances surrounding the amendments, and Mr. Slattery filed submissions in response.
decision
An amendment of the statement of Grounds and Particulars is governed by regulation 5.9, which provides:
Amendment of statement
5.9 (1) The Commissioner, on the written request of an opponent and subject to such terms as the Commissioner may specify:
(a)if the Commissioner reasonably believes that an amendment of a statement referred to in subregulation 5.4 (1) ("filing of statement") corrects an error or omission by the opponent or by his or her agent-may amend the grounds of opposition set out in the statement; or
(b)if the Commissioner reasonably believes that an amendment of the grounds set out in a statement referred to in subregulation 5.4 (1) results from an amendment of a patent request or complete specification-must amend those grounds; or
(c)must amend particulars relating to a ground referred to in subregulation 5.4 (1).
(2)The Commissioner must not allow an amendment requested under subregulation (1), if:
(a)an application for dismissal of opposition is being considered; or
(b)an application for determination of opposition is being considered; or
(c)in the case of opposition under section 59 of the Act (" opposition to grant of standard patent") - a specification relating to the opposed application is being re-examined; or
(d)he or she does not reasonably believe that the applicant has been notified of the proposed amendment; or
(e)he or she reasonably believes that a person will be unduly prejudiced by the amendment.
(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.
In the present matter, the amendment is only of the particulars - that is, regulation 5.9(1)(c) applies; and under that sub-regulation the Commissioner MUST amend particulars relating to an existing ground of opposition.
However subregulation (2) makes clear that an amendment of the statement is subject to some fetters. In the present matter, there is no request for dismissal, and re-examination and determination of the opposition are not available (as the application was not made under the Patents Act 1990). I also note that the applicant has been notified of the amendment - and indeed has objected to its allowance.
Thus the only issue that I must determine to decide whether the amendment should be allowed is whether a person will be unduly prejudiced by the amendment.
Undue Prejudice
Essential to the present matter is a consideration of what circumstances would result in a person being unduly prejudiced.
As a preliminary point, I note that the regulation does not restrict the issue of prejudice to the parties to the action. If I reasonably believe that ANY person (including a notional member of the public who represents the public interest) will be unduly prejudiced by allowing the amendment, I cannot allow it.
The regulations specify that I cannot allow the amendment if a person is UNDULY prejudiced - not merely prejudiced. Clearly the regulations envisage that there will be some amendments that will prejudice a person, but not unduly. The basis of what gives rise to undue prejudice is therefore critical to these considerations.
Regarding the meaning of `unduly prejudiced', the Macquarie Dictionary provides the following relevant definitions:
undue
1. unwarranted; excessive; too great: undue haste
2. not proper, fitting, or right; unjustified: to exert undue influence
prejudice
3. disadvantage resulting from some ... action of another
7. to affect disadvantageously or detrimentally
In my view, a person will be unduly prejudiced by an amendment if:
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.
Although the determination of whether an amendment will unduly prejudice a person will generally depend upon the facts of each case, I consider that an understanding of the function of statement of grounds and particulars is essential to that determination.
In the recent decision of Kent-Moore Corporation v Environmental Products Amalgamated Pty Ltd (Patent application 613058, issued 28 Aug. 1992, as yet unreported) I stated:
The opponent is required to file a statement of grounds and particulars within 1 month of filing their notice of opposition. That statement, in setting out the grounds and particulars, sets out the basis of the opposition. It thus sets the environment for the future actions in the opposition of both the opponent and applicant. Having filed that statement of grounds and particulars, `all' that remains to be done by the opponent is to prove their opposition [such as by establishing publication dates, putting the material into evidentiary form, and (where needed) obtain declarations by appropriate experts in respect of material referred to in the statement]. There is no need, and certainly no expectation, for an opponent to be actively seeking further particulars subsequent to the filing of the statement of grounds and particulars. Statements in the statement of grounds and particulars to the effect that the opponent is still conducting searches, and will let the parties know about the results at some later time, do not in my view provide the opponent with any per se right to either amend the statement, or seek an extension of time to serve evidence in support.
In my view 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.
Where, for whatever reason, the statement is deficient and requires amendment to correct those deficiencies by adding particulars not specifically referred to in the original statement, the applicant will necessarily be prejudiced to some degree - in that the case they have to answer will be changed. Such prejudice is not necessarily undue. However, if there is any unnecessary delay in seeking a relevant amendment of the statement of grounds and particulars, the applicant will not timely know the case it has to answer - indeed they will not know until the opponent chooses to so inform them by seeking an appropriate amendment. Such delays are inconsistent with the function of the statement of grounds and particulars. Any delays in seeking a relevant amendment will unjustifiably hamper the preparation of the applicant's case in answer. It follows, generally speaking, that if there is any unnecessary delay in seeking amendment of the statement to include extra particulars, the applicant (at least) will be unduly prejudiced if the amendment is allowed.
Furthermore, as I said in the Kent-Moore decision supra:
There is no need, and certainly no expectation, for an opponent to be actively seeking further particulars subsequent to the filing of the statement of grounds and particulars
That is, the opponent should know the full basis of its case when it files the statement of grounds and particulars. It should not thereafter be actively endeavouring to find any further basis for its opposition. Furthermore, as I said above, 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. In my view, where an opponent actively pursues further particulars in the opposition after having filed its statement, the applicant will be unduly prejudiced by any resultant change to the case it has to answer if the statement is amended.
This is not to say, however, that all amendments to particulars will give rise to undue prejudice. Amendments to particulars may properly arise incidental to the preparation of the case - as distinct from efforts by the opponent to find a `better' basis for its opposition. In my view, extra particulars that arise incidental to the preparation of the case which:
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.
Onus of establishing undue prejudice.
The applicant submitted that as the opponent was seeking the indulgence of the Commissioner in allowing the amendment, they should bear the responsibility of establishing that no person will be unduly prejudiced.
Essentially I do not agree with this proposition. The requirements of the regulations are that the Commissioner must make the amendment UNLESS he is reasonably satisfied that a person will be unduly prejudiced. Thus, for example (and having regard to the applicant's awareness of the proposed amendment pursuant to regulation 5.9(2)(d)), I do not think the Commissioner can reasonably conclude that an applicant is unduly prejudiced by an amendment if the applicant does not object to the amendment.
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.
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.
Timeliness of the Amendments
Subsequent to the hearing, Dr. Santer filed a declaration which sets out the following circumstances relating to the amendments:
a.Instructions to oppose the application were received on 10 Dec. 1991. The notice was filed on 11 Dec. 1991, and the opponent was advised that the statement of grounds and particulars was due on 11 January 1992.
b.On 7 Jan 1992, CSL advised that their technical experts were all on leave until approximately 25 January; gave instructions to carry out any searches thought appropriate, and gave Dr. Santer a copy of a review article of which the list of references were said to be highly relevant.
c.Dr. Santer experienced great difficulty in obtaining copies of relevant documents; the statement was filed on 9 January on the basis of the material available to her at that time.
d.Dr. Santer had arranged leave, or was absent on travel, for the following periods:
13 January to 27 January 1992
4 to 13 February
24 to 28 March
20 April to 1 May - extended to 7 May
She also suffered a close family bereavement, which resulted in her not fully resuming her office responsibilities after 7 May, until 25 May 1992.
As a result, Dr. Santer was absent her office for about 2½ months - without there apparently being anyone in her firm of patent attorneys prosecuting the opposition in her absence.
e.By 16 March copies of the references had been obtained. It was necessary for the opponent's technical staff to review them.
f.On April 9 CSL provided several new references.
g.Shortly before 20 April Dr. Santer requested a European associate to carry out a further inspection of the corresponding file before the EPO, and prepared a draft amended statement which was forwarded to the opponent for comment on 22 April 1992.
h.The opponent's comments on the draft amended statement was received on 2 June 1992.
The applicant's submissions in response state, inter alia:
The statutory Declaration of Dr. Santer also adresses various delays arising from the attorney's absence from her office on annual leave, attending technical conferences, on overseas travel and her absence due to personal bereavement, however it is submitted that these delays really do not address the basic issue of why the opponent's Statement of Grounds and Particulars was not complete as originally filed, and why it took the opponent from January 1992 to June 1992 to seek the present amendment to this statement. ...
...it is suggested that the original Statement of Grounds and Particulars "was prepared under circumstances of considerable difficulty". Whilst this in fact may be the case, we should point out that any such difficulty was of the opponent's own making .... and apparently simply reflects a lack of preparedness of the opponent when the opposition was initially launched.
I consider the views expressed above by the applicant on this issue to be appropriate.
Furthermore, even having regard to the period between filing the notice of opposition and the due date for filing the statement of grounds and particulars including the Christmas - New Year period (thereby resulting in consequential difficulties that may result in the statement of grounds and particulars containing some recognised deficiencies that would require amendment), the opponent does not appear to have proceeded with a degree of urgency appropriate to the circumstances. For example,
-despite the notice of opposition being filed on Dec. 11, the relevant citations were not before Dr. Santer until at least 2 months after the statement was served; and another 3 months elapsed before the amended statement was filed.
-there does not appear to have been any arrangements in place within the firm of the attorney to take necessary actions during Dr. Santer's lengthy absences.
In my view, the period of 5 months to request the amendments to the statement of grounds and particulars is excessive in the circumstances.
As a result, in the present case I consider that any amendment which is prejudicial to the applicant will result in the applicant being unduly prejudiced by reason of the time taken to seek the amendment.
The Amendments Sought
I turn now to the specific amendments sought by the opponent. The amendments fall into six categories - elaboration of existing particulars, deletion of particulars, specifying certain documents from a referenced list, the listing of a particularised document under a different heading, the addition of particulars, and the amendment to the wording of a particular. For convenience I will consider each of these categories separately.
A first effect of the amendment is to elaborate the identification of certain particularised documents. Importantly, the amendment does not in any way change the identification, or the asserted relevance, of the documents. The applicant does not contend that they are unduly prejudiced by this part of the amendment. In my mind no person (including the 'public interest') is prejudiced by this part of the amendments, and this part of the amendment should be allowed.
A second effect of the amendment is to delete almost half of the particularised documents. At the hearing I enquired of the parties whether an amendment which merely deleted a particular would be prejudicial to a person. Both parties expressed the view that it would not be. In the present case, I accept this view of the parties - but I am not convinced that this view applies in all circumstances.
Additionally, I have no reason to believe that any other person (including the 'public interest') would be prejudiced by these amendments; this part of the amendment should also be allowed.
A third effect of the amendment is to enumerate selected documents which were 'foreshadowed' in the original statement.
The original statement included the following (as noted above):
The following references are also relevant:
List of "References cited" appearing on the title pages of:
US Patent No. 4990367
US Patent No. 4992272
US Patent No. 500367 (sic?)
The positioning of this paragraph in the original statement leaves it ambiguous as to whether it applies solely to particulars 2(b), or to particulars 2 in general. I here take it as applicable to particulars 2 in general.
The amended statement identifies five of the documents cited in these US patents. I note that the list of references in US 4990367 contains 41 references, and US 4992272 contains six references.
The opponent contends that, by the above reference, the applicant was made aware of the documents being relied upon by the opponent; therefore the amendment does no more than specifically state matters that the applicant was aware of. The applicant contends that it does not matter what documents the applicant is aware of; the critical factor is whether the opponent has informed the applicant of the documents being relied upon in the opposition.
In my view, it is the responsibility of the opponent to explicitly specify in the statement of grounds and particulars those documents on which it relies in the opposition. In so doing, it is not sufficient for an opponent to particularise the opposition by vague or indirect references to documents - such as by reference to a class of documents. An opponent should not provide a list of possible citations with an expectation that the applicant can identify those in the list that the opponent will ultimately rely upon. Correspondingly, where an amendment has the effect of specifically identifying documents which were only vaguely or indirectly referenced in the statement, the opponent cannot rely upon that reference to assert that the case the opponent has to answer is not changed by the amendment - unless the nature of the reference leaves no reasonable doubt as to the documents being relied upon.
For these reasons it is apparent that the originally filed statement, in referring to the `References cited' in three US patents, was deficient. (I also consider it likely that a particular which identifies documents by such a reference will not constitute an effective particular in an opposition). I do not think that the references are such that the applicant would reasonably know which of the many documents listed in the references the opponent would be relying upon. I am thus of the view that the amendment to specify particular documents in the referenced list of documents is prejudicial to the applicant.
As discussed previously, I consider that the period of 5 months to request the amendment is excessive in the present circumstances. As a result, I consider the applicant to be unduly prejudiced by these amendments. Therefore I refuse to allow these amendments.
The fourth effect of the amendment is one document (Hanson C.V. et al) which was particularised under one heading is proposed to be particularised under another heading.
In the original statement a document was particularised under a heading relating to `inactivation of viruses by furocumarins, and especially psoralens'; in the amended statement it appears under a heading relating to `inactivation of viruses by binary ethyleneimine'. These headings clearly relate to significantly different technical issues. If the amendment can be categorised as correcting an obvious mistake then it seems to me that no person can be unduly prejudiced by that amendment. Otherwise such an amendment must be equivalent to separate actions to delete a particular, and to add a completely new particular. In the present case there is nothing to suggest that this amendment is to correct an obvious mistake.
I do note that this amendment could properly fall in the category of an amendment that arises consequential upon the preparation of the case - in that in preparing the case the particularisation under the wrong heading might have become apparent. Nevertheless, the applicant is prejudiced by the amendment as the case it has to answer will be changed by the amendment.
As discussed previously, I consider that the period of 5 months from filing the statement, to request the amendment is excessive in the present circumstances. As a result, I consider the applicant to be unduly prejudiced by this amendment. Therefore I refuse to allow this amendment.
The fifth effect of the amendment is to introduce some 8 newly particularised documents.
The origin of these documents is not clearly stated, but from the available material would seem to be the several new references supplied to Dr. Santer on April 9. There is nothing to suggest that these documents arose consequential upon the preparation of the opponent's evidence. Rather the evidence before me is consistent with the proposition that these documents have arisen as the result of the opponent actively seeking further particulars for the opposition. As a result, I consider the applicant to be unduly prejudiced by this amendment. Therefore I refuse to allow this amendment.
The amendments to the particulars under section 40 involve deletion of two paragraphs, deletion of part of a paragraph, and additional words in one paragraph. I am satisfied that there is no prejudice involved in the amendments to delete the entire paragraphs, and the amendment that deletes a part of a paragraph.
At the hearing there was some debate over the addition of the words "generally regarded as" in one of the particulars (as noted earlier in this decision). The applicant argued that this was a significant broadening of the particular; the opponent argued that it was a subset of the particular, and therefore did not expand the case the applicant had to answer.
In my view it is inappropriate at this stage of the opposition proceedings to give a minutely detailed consideration of the change of case that the applicant has to answer as a result of the amendments sought; such detailed consideration may well preempt decisions that ought properly be made in the hearing of the substantive opposition.
What is readily apparent (and apparently agreed by the parties) is that the extra words added to the particular change the scope of that particular. (I additionally note that if this is not the case, there is no apparent reason for seeking this amendment). As a result, the case that the applicant has to answer has changed. Even though the change in the case to be answered might indeed be small, I consider any such change sufficient to prejudice the applicant.
However, in my view this amendment properly falls in the category of an amendment that arises consequential upon the preparation of the case - in that in preparing the case the significance of the absence of the words `generally regarded as' would become readily apparent. Consequently, if the amendment had been sought at the earliest reasonable opportunity, I would not consider that it would unduly prejudice the applicant. However there is nothing that indicates to me that the opponent has sought the amendment at the earliest reasonable opportunity. As a result, (and for this reason alone) I consider the applicant to be unduly prejudiced by this amendment. Therefore I refuse to allow it.
Conclusion
As a result of the above considerations, I find the following particulars of the proposed amended statement of grounds and particulars are not allowable as they would result in the applicant being unduly prejudiced:
-Paragraph 1 - all particularised documents other than the first two.
-Paragraph 2(a) - the first (Merck..), tenth (Hanson), and twelfth to eighteenth particulars.
-Paragraph 3 (c) - to the extent that it includes the words "generally regarded as".
The proposed amendment of the statement was by way of a substitute document. Having regard to the extent of the particulars for which I have refused to allow the amendment, I refuse to allow the amendment sought in its present form. Rather I invite the opponent to supply a new Statement of Grounds and Particulars consistent with this decision, within 21 days of the date of this decision.
costs
In actions before the Commissioner, costs normally follow the event. I see no reason for departing from this, and award costs of this action gainst the opponent.
D. HERALD
Assistant Commissioner of Patents
Patent attorneys for the applicant : Davies Collison Cave, Melbourne
Patent attorneys for the opponent : Griffith Hack & Co, Melbourne
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