Novo Nordisk A/S v Eli Lilly and Company
[2000] APO 14
•9 February 2000
OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 682061 in the name of NOVO NORDISK A/S
Title: Acylated Insulin
Action: Application for an extension of time by Eli Lilly and Company to serve evidence in reply, and an objection thereto by Novo Nordisk A/S
Decision: Issued .
Abstract
Extension of time from 16 December 1999 to 16 January 2000 allowed.
The reasons provided by the opponent, including the reasons set out in the declaration by Mark O’Donnell generally support the request for an extension of time. While there may have been a lack of detail in relation to some of the reasons why Dr Jeffrey could not complete his evidence in the required time, there was sufficient detail overall to support the request.
The public interest lies in favour of granting the extension so that all relevant materials are before the Commissioner in deciding the substantive issues. The evidence in reply is purported to include material relating to the enablement of certain patent documents filed as evidence in support that was disputed in the evidence in answer, as well as rebuttal of the results of certain experiments included in the evidence in answer.
On balance, the opponent will be disadvantaged more if I refuse the request than the applicant will be if I grant the request.
Costs awarded against the applicant, Novo Nordisk A/S.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 682061 by Novo Nordisk A/S; Application for an extension of time by Eli Lilly and Company to serve evidence in reply, and an objection thereto by Novo Nordisk A/S.
BACKGROUND
Novo Nordisk A/S (Novo Nordisk) filed patent application 682061 under the provisions of the PCT on 16 September 1994. The application was advertised accepted on 18 September 1997. Eli Lilly and Company filed a notice of opposition to the grant of a patent on 17 December 1997 and completed service of evidence in support of their opposition on 16 October 1998. Novo Nordisk A/S completed service of evidence in answer on 16 June 1999.
Eli Lilly and Company (Eli Lilly) filed a notice of intention to serve evidence in reply on 22 June 1999. Eli Lilly requested and was granted an extension of time in which to serve evidence in reply from 16 September 1999 to 16 December 1999. Eli Lilly then requested a further extension of one month from 16 December 1999 to 16 January 2000. Novo Nordisk objected to this further extension.
The request for the extension of time to file evidence in reply and the objection thereto was set for hearing in Canberra on 14 January 2000. Both parties requested to be heard by telephone. Dr W J Pickering, patent attorney of F B Rice & Co, appeared on behalf of Eli Lilly. Mr Chris Schlict, patent attorney of Phillips Ormonde & Fitzpatrick, appeared on behalf of Novo Nordisk .
THE APPLICATION FOR EXTENSION OF TIME
Eli Lilly set out the following circumstances in its application for an extension of time in which to serve evidence in reply:
“During the preceding period further meetings and discussions have been held with experts retained by the Opponent, namely Drs Jeffrey and Widmer. Dr Widmer is employed by CSIRO. Unfortunately due to demands on his time due to his employment Dr Widmer has only recently been able to provide us with his comments on the applicant’s Evidence-In-Answer. A Declaration for consideration by Dr Widmer is currently in preparation and we are hopeful that all the service of the opponent’s Evidence-In-Reply will be completed within the short extension sought.”
The opponent filed a statutory declaration by Mark Timothy O’Donnell, patent attorney of F B Rice & Co, on 11 January 2000 expanding on these circumstances. The declaration states that the opponent intends that the evidence in reply will consist of statutory declarations by Alfred Widmer, Peter Dalrymple Jeffrey, and Mark Timothy O’Donnell. The declaration filed on 11 January 2000 also states that the evidence in reply “will include, amongst other things, the following:
(i)Evidence rebutting statements included in the Evidence-In-Answer that an increase in “solubility” upon addition of zinc ions to LysB20-acylated human insulin is unexpected;
(ii)Evidence indicating that results of “solubility” measurements presented by Mr Markussen at paragraphs 6 and 9 in his Statutory Declaration dated 11 June 1999 are predictable and are consistent with well known “salting out effects”;
(iii)Evidence indicating that the abovementioned “solubility” measurement results were obtained from formulations which are not relevant to commercial products;
(iv)Evidence rebutting statements included in the Evidence-In-Answer, which attempt to dismiss the relevance of Japanese patent specification No. 1-254699; and
(v)Evidence rebutting statements included in the Evidence-in-Answer, which attempt to dismiss the relevance of International patent specification No. WO 92/01476.”
The O’Donnell declaration then elaborates on the circumstances relating to the request for extension and the progress to date. I will summarise these as follows:
The applicant served evidence in answer on 16 June 1999.
On 22 June 1999, a copy of the documents constituting the evidence in answer was sent to the opponent for review by their in-house patent attorneys.
Simultaneously, Mr O’Donnell undertook a review of the evidence in answer in conjunction with his partner, Dr W J Pickering.
During initial discussions with the opponent’s in-house patent attorneys on 3 August 1999, it was recognised that the validity of “solubility” measurements presented in the statutory declaration by Mr Markussen would need to be assessed by experimentation.
It was also recognised during those discussions that further assistance from the opponent’s expert, Dr Jeffrey, would be required. A copy of the evidence in answer was immediately prepared and sent to Dr Jeffrey for his review.
It was subsequently decided that advice from counsel should be sought in regard to the preparation of evidence in reply. On 12 August a copy of the evidence in answer was prepared and sent to Dr Anabelle C Bennett S.C.
The matter was discussed with Dr Bennett on 18 August 1999.
The opponent’s in-house chemists conducted the experimentation required to assess the validity of the “solubility” measurements. According to the O’Donnell declaration, “this was not a straightforward task since the methodology employed by Mr Markussen is not a typical solubility test and, accordingly, not one which was familiar to the inhouse chemists. Completion of the experimentation was therefore delayed until mid September 1999. A review of that experimentation by ourselves and the opponent’s inhouse patent attorneys was then commenced.”
With regard to the discussions held with Dr Bennett, it was agreed that assistance be sought from a further independent expert. Dr Widmer was engaged in late August 1999 to assist in rebutting certain statements made by the applicant’s experts in the evidence in answer.
Documentation relating to the opposition was sent to Dr Widmer on 31 August 1999.
Due to Dr Widmer’s work commitments, the first substantial discussions with him were delayed to 29 September 1999. Dr Widmer agreed to provide detailed comments and supporting references for his views. However, at the time, Dr Widmer was facing major milestone reviews of two projects being conducted by his employer CSIRO. This work had to receive priority and the time commitment was greater than originally expected.
Dr Widmer completed and forwarded his detailed comments on 10 December 1999. This left an inadequate amount of time to prepare and finalise a statutory declaration from Dr Widmer before the due date for service of evidence in reply.
The draft statutory declaration by Dr Jeffrey is a substantial document and this, in itself, has delayed its preparation and finalisation. The draft declaration also includes details of the abovementioned experimentation.
The reasons accompanying the request stated that the opponent was hopeful that the evidence in reply would be completed within the short extension sought. The O’Donnell declaration states that it is hoped that the statutory declaration “from Dr Widmer is close to finalisation and it is hoped that this will be executed and served within a week”. The declaration also states “It is expected that this Statutory Declaration (by Dr Jeffrey) will be executed and served within the near future”. At the hearing, Dr Pickering also said he was hopeful the evidence in reply would be served on Monday 17 January 2000, namely the last day of the extension sought. However I note that the opponent has subsequently requested a further extension of time in which to file the evidence. The evidence was finally served on 18 January 2000.
I note that a previous extension of time was granted from 16 September 1999 to 16 December 1999. The reasons accompanying the previous extension were as follows:
“Progress towards the preparation and service of Evidence-in-Reply during the prescribed period has been substantial. In particular, the Applicant’s Evidence-in-Answer, which we note is voluminous and complex, has been reviewed by our in-house counsel and by our primary expert, Dr Peter Jeffrey. On the basis of those reviews, a further Statutory Declaration for Dr Jeffrey is presently in preparation. In addition, assistance is being sought from a new expert, Dr Widmer and documents concerning matters upon which we seek his comment and opinion have been forwarded to him for his review. Dr Widmer has, however, been so far unable to complete his review of those documents.”
APPLICABLE LAW
The requirements for serving evidence in reply are set out in Patents regulation 5.8(4):
If an opponent intends to rely on evidence in reply to the evidence referred to in paragraph (2) (a) or (3) (a), the opponent must:
a). within 1 month of being served with a copy of the evidence under paragraph (2) (a) or (3) (a), serve on the applicant:
i)a copy of the evidence in reply; or
ii)if the opponent does not serve on the applicant a copy of the evidence in reply — a copy of a notice of intention to serve evidence in reply; and
b). if the opponent serves on the applicant a copy of a notice of intention to serve evidence in reply — serve on the applicant a copy of that evidence within 3 months of being served with a copy of the evidence under paragraph (2) (a) or (3) (a); and
c). file the evidence in reply and any notice of intention as soon as practicable after the copy of the evidence in reply or notice has been served on the applicant.
Regulation 5.10(2) allows for the time in regulation 5.8(4) to be extended:
(2) The Commissioner may:
(a) on the application of a party in the approved form; and
(b) on such reasonable terms (if any) as the Commissioner specifies;
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 paragraph 5.4 (1) (a).
Regulation 5.10(5) provides:
(5) The Commissioner must not … grant an application under subregulation (2) … 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.
The law on extension of time provisions, and more specifically the law on regulation 5.10 of the Patents regulations 1991, has been considered and summarised by Burchett J in Ferocem Pty Ltd v Commissioner of Patents (1994) 28 IPR 243 and more recently by Sackville J in A Goninan & Co Ltd v Commissioner Of Patents (1997) 38 IPR 213. In both of these decisions it was stated that regulation 5.10 confers a broad discretion, which cannot be reduced to an imperative compliance with particular requirements. On the contrary it is necessary to give proper, genuine and realistic consideration to all relevant aspects of the case. Relevant aspects include:
(a) Reasons provided on why an extension of time to lodge evidence-in-support is needed
Relevant reasons include explanations on any delays in filing evidence to date. The reasons why the evidence was not served in time are a relevant consideration, but a satisfactory explanation is not a mandatory requirement.
(b) The public interest
The public interest in determining a serious opposition on its merits is a relevant consideration. There is also the efficient and orderly administration of matters before the Patent Office to consider.
(c) The interests of the parties involved in the opposition
Disadvantages to either the applicant or the opponent are relevant considerations.
If I am to be reasonably satisfied that an extension of time is appropriate in all the circumstances, then I must take into account all relevant matters relating to the above aspects when deciding the issue.
DECISION
Reasons on why an extension of time to lodge evidence-in-support is needed
I have set out the reasons given by the opponent (Eli Lilly) for the extension of time above. Dr Pickering summarised the reasons, saying that one of the main reasons was the need to conduct experiments in response to the declaration by Dr Markussen. According to the opponent, these experiments were not standard. The opponent’s in-house chemists had to first make substituted insulin. Dr Pickering commented that there was no difficulty in this, but it was not an off-the-shelf product. Then, the chemists had to run a testing protocol on the insulin that was not straightforward.
Dr Pickering also stated that Drs Jeffrey and Widmer are not associated with the opponent. The opponent cannot demand that this matter take preference over other commitments. Dr Widmer has other commitments that have taken up much more time than estimated. While it was known that Dr Widmer had some major milestones approaching in his employment with CSIRO, he had believed that he could achieve these milestones and devote time to the opposition. However the milestones had taken an unexpected amount of time.
Mr Schlicht argued that the onus rests with the opponent, Eli Lilly. He said that the request should contain sufficient reasons to justify the extension. Mr Schlicht referred me to a Patent Office decision, Minproc Technology Pty Ltd v Commonwealth Scientific and Industrial Research Organisation 35 IPR 48 at 51, where a delegate of the Commissioner stated:
“Previous decisions recite the need for a full and frank disclosure of the facts which give rise to the need for an extension. …”
Dr Pickering pointed out that the Federal Court had twice downed the proposition that a full and frank disclosure was required, (see Ferocem and Goninan referred to above). Mr Schlicht conceded that there was no mandatory requirement for a full and frank disclosure, but the absence of sufficient reasons must weigh against the requestor. In my view the position is quite clear from the Ferocem and Goninan decisions. Although an explanation of delay would normally be expected, it was not imperative and is only one of a number of considerations to be taken into account.
The reasons provided by the opponent, particularly in the O’Donnell declaration, set out the sequence of events since the applicant served evidence in answer. The opponent has set out the dates on which certain actions occurred, albeit approximate dates in some circumstances (eg mid September 1999, late August 1999). Mr Schlicht argued that the O’Donnell declaration showed that there had been a lack of diligence on the part of the opponent in preparing its evidence in reply.
The evidence in answer was served on 16 June 1999. Initial discussions were held with the opponent’s in-house patent attorneys on 3 August 1999. It was recognised during these discussions that the validity of certain measurements would need to be assessed by experimentation. It was also recognised that assistance would be required from the opponent’s expert, Dr Jeffrey, and evidence in answer was sent to Dr Jeffrey for his review. Mr Schlicht pointed out that about 7 weeks, or half the statutory requirement, had elapsed by this stage and all that had occurred were “initial discussions”. Mr Schlicht stated that despite the opponent filing its intention to file evidence in reply on 22 June 1999, it took over one and a half months for the opponent to provide the evidence in answer to its expert.
Mr Schlicht noted that advice was first sought from Counsel on 12 August 1999. That is, around two months into the three-month period set out in the regulations. Mr Schlicht argued that this was an undue delay. While Mr Schlicht acknowledged that the opponent did not have to explain why they engaged Counsel, he said that it was up to the opponent to do so diligently.
I agree with Mr Schlicht that on the face of it the opponent appears to have been less than diligent in the initial months following service of evidence in answer. It is, of course, open to the opponent to seek advice from Counsel and to engage additional experts at the evidence in reply stage as the opponent sees fit. However it is not clear exactly why it took two months of a three-month period for the opponent to seek advice from Counsel and to engage its experts. This apparent lack of diligence appears to have caused an initial part of the overall delay in the opponent’s preparation of its evidence in reply.
The experiments referred to by the opponent were completed in mid September 1999. That is, after 3 months had elapsed from completion of evidence in answer. Mr Schlicht pointed out that a further three months had elapsed since the completion of those experiments. He said that the fact that the experiments may have been difficult to reproduce did not help to explain what has prevented the opponent from filing evidence by 16 December 1999. He argued that the experiments did not provide a reason for the current extension, as the experiments were concluded three months before the opponent applied for current extension.
I agree with Mr Schlicht that the experiments are less relevant to the current extension of time, although they are important in helping to explain the overall time required for filing the evidence in reply. This brings me to the reasons provided for the current request for an extension of time.
In regard to Dr Jeffrey, the reasons filed with the request state that further meetings and discussions have been held with Dr Jeffrey. The O’Donnell declaration states that the draft statutory declaration by Dr Jeffrey is a substantial document and this, in itself, has delayed its preparation and finalisation. The declaration also includes details of the above-mentioned experimentation.
Mr Schlicht submitted that the reasons provided in relation to Dr Jeffrey were inadequate. He said that as the case was a biochemical case it was to be expected that the evidence would be in detail. Mr Schlicht said that the parties had to bear this in mind when preparing their case. He referred me to Minproc v CSIRO at page 52:
“… In respect to the complexity of the technology and the nature of the evidence-in-answer the Kimberly-Clark Corp v The Proctor & Gamble Company decision (24 IPR 345) requires such issues to go beyond the realm of ‘routine’ complexity to justify an extension.”
Mr Schlicht pointed out that the evidence in support consists of declarations by Professor Hearn (30 pages), Professor Colagiuri (11 pages) and Mr Markussen (7 pages). He said that the complexity of the evidence in answer did not go beyond what would normally be expected in a biotechnology case. However I am inclined to agree with Dr Pickering that the number of pages is not necessarily a good indicator of the complexity of the evidence.
It is clear that the evidence from Dr Jeffreys was initially delayed because of the need to conduct experiments and for Dr Jeffreys to comment on these experiments. It is less clear from the reasons given what caused the subsequent delay in the preparation of Dr Jeffrey’s evidence. While the reference to a “substantial document” gives some indication of the reason, and there is also reference to “further meetings and discussions”, the steps taken in the period from mid September to 16 December 1999 to finalise Dr Jeffrey evidence are not fully explained.
The O’Donnell declaration states that Dr Widmer was facing major milestone reviews in December 1999 of two commercial projects being conducted by his employer, CSIRO. This work had to receive priority. The time commitment required to meet those milestones was greater than originally expected and, accordingly, the amount of his time remaining to devote to other matters such as this opposition was much less than had been anticipated.
Mr Schlicht said that it was not unusual for an expert to have other commitments. Mr Schlicht also said that if the witness is not available due to work commitments, then he is not a suitable witness. He again referred me to Minproc v CSIRO at page 51, where the delegate said:
“… I am also mindful of the ongoing work commitments of experts in other activities besides the need to provide commentary on evidence. However I do not think that these situations are different from the normal occurrences in opposition proceedings. Analysis of the evidence-in-answer, drafting declarations, forwarding them to experts in Australia and overseas, reviewing the evidence and declarations, awaiting replies, and prioritising other work commitments are routine activities in opposition proceedings. Normal timing provisions in the patent regulations make allowances for all these circumstances. I do not think these activities, alone, justify an extension of time.”
However the situation here is different to that in Minproc v CSIRO. In that case, the expert was an employee of the opponent CSIRO. In addition, the opponent did not rely on any unexpected work commitments for their expert, although he did have other work commitments that were known and expected. Rather, the opponent in that case asserted it was the nature and complexity of the evidence that required more than the predicted amount of time.
It is clear from the O’Donnell declaration that the amount of time required by Dr Widmer on his work commitments was unexpected. Dr Pickering explained that Dr Widmer had believed he could achieve milestone reviews and devote sufficient time to the opposition. However the time required in meeting those reviews was much greater than estimated. Further, neither Dr Widmer or Dr Jeffrey are associated with the opponent. The facts of the present application for extension are different to the facts in the Minproc decision.
While there is perhaps a lack of detail into the reasons why Dr Jeffrey could not complete his evidence in the required time, I am satisfied that overall the reasons support an extension of time.
The public interest
Sackville J considered the significance of public interest in cases where there has been a lapse in procedure at Page 222 in A Goninan & Co Ltd v Commissioner of Patents (above):
"The Commissioner must take into account the public interest in determining a serious opposition on its merits. The Commissioner must give consideration to that aspect of the public interest even where the party has failed to comply with the procedural requirements specified in the regulations. However as Burchett J made clear in Ferocem, the public interest must be weighed with and against other considerations. It is not the only factor considered."
This has been well summarised in the Office decision on Patent 675388, Nippon Steel Corp v.BHP Steel (JLA) Pty Ltd, [1998] APO 5 (26 February 1998). As the hearing officer put it:
"On the issue of the public interest I am guided by the reasons of Burchett J in the Ferocem case and reiterated by Sackville J in Goninan (supra). In short, the public interests are not all ranged on the same side. On the one hand are the expeditious disposal of matters in the Patent Office, and questions of costs, efficiency, and of insistence of standards maintained. On the other hand are the words of Kitto J in Kaiser Aluminium & Chemical v. The Reynolds Metal Company (1969) 120 CLR 136 at 143, viz a serious opposition should be dealt with on its merits rather than be shut out as a consequence of a failure of procedure."
Mr Schlicht again referred me to Minproc v CSIRO at page 53. Here the delegate stated:
“… While CSIRO may be undertaking a serious opposition, the public has a lesser interest with the evidence-in-reply compared to the evidence-in-support or evidence-in-answer. The provision for evidence-in-reply is simply to allow the opponent a right of reply. There is no provision to allow the serving of new evidence at this stage of proceedings. Accordingly the public interest is not so enhanced at the evidence-in-reply stage over that interest in the preceding evidentiary stages. The public, through the Commissioner of Patents, is already aware of the basis of the opposition through the statement of grounds and particulars and the evidence-in-support. …”
By “new evidence” I assume the delegate was referring to evidence that is not in reply to the evidence in answer. While the delegate’s comments regarding the public interest may be true as a general proposition, each case must be treated on its merits. There may be cases in which the evidence in reply is equally (if not more) relevant than the evidence in support to reaching a just result in a serious opposition. The Federal Court decision in Goninan, issued after the Minproc decision, warned against assuming that the public interest was already protected if some evidence had been filed, albeit only evidence in support was considered in that case.
In the present case the opponent says that the applicant has changed its case in the evidence in answer. According to Dr Pickering, the applicant’s evidence alleges that the invention has a surprising effect or surprising properties. There was no mention of any surprising properties in the patent application. Dr Pickering said that Dr Markussen raised this in relation to some experiments he had conducted and it was also picked up on by Professor Hearn in the evidence in answer. Dr Pickering argued that these experiments require expert analysis.
At the time of the hearing, the evidence in reply had not been filed, so its relevance could not be directly determined. There was considerable disagreement between the parties over what the experiments conducted by Dr Markussen did or did not show. Mr Schlicht stated that the results of the experiments were extreme. It was not a case where the results were close. Rather the experiment showed very clear results. On the other hand, Dr Pickering stated that while the experiments were conducted with and without zinc, there were no examples without salt. Therefore it was not clear if the results were due to the presence or absence of zinc or due to the presence of salt, which the opponent suggested would have caused a well-known “salting out effect”. Dr Pickering also questioned whether the experiments were directed to determining solubility at all. He suggested they showed stability rather than solubility.
Dr Pickering also said that two of the prime citations filed in evidence in support had been dismissed by the applicant as not enabled. According to Dr Pickering, the issue of enablement was the primary reason for engaging Dr Widmer as an additional expert. Dr Pickering said that the issue has been raised in the evidence in answer and has to be rebutted. He said that this was clearly within Dr Widmer’s expertise.
Mr Schlicht said that Professor Chisholm had discussed zinc in detail in the evidence in support and these comments were also picked up on by Dr Jeffrey. The evidence in answer included comments by Professor Hearn in answer to these comments. Therefore there is already commentary on zinc in the evidence in support. Mr Schlicht also said that the opponent had served extensive evidence in relation to the citations. He argued that the evidence in reply would not have great weight.
It appears that the evidence in reply is to be directed to matters of significant disagreement between the parties. These relate to matters that will be decided at the substantive opposition. In my view, the decision-maker will be in the best position to decide the matter if they have all the relevant evidence before them. These are strong arguments to giving considerable weight to the relevance of the evidence. Dr Pickering directed me to Cook Incorporated v Endo Vascular Technologies Inc, [1999] APO 14 (24 February 1999) where the delegate said:
“There are disputed matters of fact as between the evidence-in-support of the opposition and the evidence-in-answer. I believe the public interest, in so far as it relates to ensuring that invalid patents are not granted, weighs heavily towards the granting of the extension sought by the opponents. This is in order that the delegate of the Commissioner in hearing the substantive opposition, with appropriate evidence in reply, has a more legitimate basis upon which to decide the disputed matters of fact.”
I agree that these comments are equally relevant in the present case.
The public interest also concerns “the expeditious disposal of matters in the Patent Office, and questions of costs, efficiency, and of insistence of standards maintained”. Dr Pickering submitted that the public interest would not be affected by a delay of one month over the Christmas period. Mr Schlicht, on the other hand, said that a three-month extension had already been granted and the current request would extend the total time allowed for evidence in reply to 7 months. This was the same amount of time that had been required to file evidence in support. Mr Schlicht contended that producing evidence in reply should be a shorter task than evidence in support, and that the 3 months allowed in the regulations should be sufficient for routine preparation of evidence in reply.
I note that the regulations allow the same amount of time for filing the evidence in reply as for the evidence in answer, with provisions for extending the time in each case. Notwithstanding this, I agree with Mr Schlicht that, in general, preparation of evidence in reply should normally be quicker as the opponent is more fully aware of the issues involved and is restricted to replying to the evidence in answer. However circumstances in each case differ, for example the opponent’s need to conduct experiments in the present case. The present extension will bring the time allowed for evidence in reply to 7 months, the same as the evidence in support and similar to the 8 months for evidence in answer. While the delay in proceedings caused by granting an extension of time weighs against the opponent, I consider that the balance of the public interest in the present case weighs clearly in having the evidence before the Commissioner so that the case may be decided on its merits.
The interests of the parties involved in the opposition
The interests of the opponent are clearly in having the extension granted so that they may serve their evidence in reply. The opponent’s case would be disadvantaged if they were not allowed to file evidence in reply. As discussed above, the evidence in reply appears to go to matters not only of significant disagreement between the parties but also of considerable significance to the determination of the opposition.
In relation to the applicant’s interests, Dr Pickering referred me to the following comment in Cook Incorporated v Endo Vascular Technologies Inc:
“The interests of the applicant, Cook, are clearly in not having the opposition proceedings unduly delay the grant of the patent. I am unaware of any special circumstances which would specifically disadvantage the applicant if the present extension were granted.”
Dr Pickering said that there were no special circumstances in the present case. Apart from being forced to deal with the evidence, it was difficult to see how the applicant would be disadvantaged. Mr Schlicht, on the other hand, said the extension would take the total time for filing evidence in reply to seven months. Any further extensions would reduce the effective term of the patent.
I do not think the applicant’s interests can be dismissed altogether in the manner suggested by Dr Pickering. However I consider that in the circumstances of the present case the opponent would be disadvantaged more by not allowing the extension than the applicant would be if I were to allow the extension. In my view the balance of the parties interests weighs in favour of allowing the extension.
CONCLUSION
I have found that the reasons provided by the opponent, including the reasons set out in the declaration by Mark O’Donnell generally support the request for an extension of time. While there may have been a lack of detail in relation to some of the reasons why Dr Jeffrey could not complete his evidence in the required time, there was sufficient detail overall to support the request.
I have also found that the public interest lies in favour of granting the extension so that all relevant materials are before the Commissioner in deciding the substantive issues. The evidence in reply is purported to include material relating to the enablement of certain patent documents that was disputed in the evidence in answer, as well as rebuttal of the results of certain experiments included in the evidence in answer.
On balance, I have found that the opponent will be disadvantaged more if I refuse the request than the applicant will be if I grant the request.
Taking all these factors into consideration, I allow the extension of time from 16 December 1999 to 16 January 2000.
COSTS
Mr Schlicht said that even if I allowed the extension, I should award costs against the opponent, as the reasons given for the extension were inadequate. Dr Pickering submitted that the applicant could have withdrawn its objection following filing of the O’Donnell declaration. Mr Schlicht considered that the reasons in the O’Donnell declaration were also inadequate. I have already found that I consider that the reasons support the request for an extension of time. I therefore award costs against the applicant, Novo Nordisk A/S.
Brendan Bourke
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Phillips Ormonde & Fitzpatrick, Melbourne
Patent attorneys for the opponent : F B Rice & Co, Balmain
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