Les Laboratoires Servier v Lupin Limited (Corrected Version) - [2007] APO 4

ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 2001276418 in the name of Les Laboratoires Servier

Title: A crystalline form of perindopril tert-butylamine salt

Action: Request for an extension of time to serve evidence in support by Lupin Limited and an objection there to by Les Laboratoires Servier

Decision: Issued 17 January 2007 .
Abstract

Extension granted.
The public interest clearly supports granting an extension. The experimental data will be very important to the considerations of this opposition. Its inclusion would lead to a better and/or more just opposition outcome. It would allow a serious opposition to be treated on its merits.
On balance, the parties’ interests supported an extension of time. The interests of Lupin Limited clearly favour the allowance of further time so that they have a real opportunity to put their case to the Commissioner, and to ensure that all relevant evidence can be considered at the opposition. To not allow the extension would be to shut them out of presenting a full case. There was no practical disadvantage to Les Laboratoires Servier.
The explanation did not justify an extension of time. In particular there was no explanation as to why evidence from Dr Philip Marshall was delayed. The other explanations offered did not explain the delay.
Costs awarded against Lupin Limited.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 2001276418 by Les Laboratoires Servier and a request for an extension of time to serve evidence in support by Lupin Limited and an objection there to by Les Laboratoires Servier

BACKGROUND

Patent application 2001276418 in the name of Les Laboratoires Servier (hereafter referred to as Servier) was advertised accepted on 28 July 2005. A notice of opposition was filed by Lupin Limited (hereafter referred to as Lupin) on 28 October 2005. A statement of grounds and particulars was served on 30 January 2006 and evidence in support was due by 30 April 2006. On 1 May 2006 Lupin requested (and was granted) an extension to 30 July 2006 to serve evidence in support. Another three–month extension to file evidence in support until 30 October 2006 was requested by Lupin on 31 July 2006 and was granted. Partial evidence in support comprising a statutory declaration by patent attorney Helen Kyriacou (the “Kyriacou declaration”) with a number of exhibits was served on 3 August 2006. On 30 October 2006 Lupin filed partial evidence in support comprising a statutory declaration by Dr Philip Marshall with exhibits and another request for an extension of time to file evidence in support. Servier objected to this extension of time.
The matter was heard in Melbourne on 7 December 2006. Ms Elspeth Strong of counsel, assisted by Ms Carolyn Harris and Mr Mark Summerfield, patent attorneys of Watermark Patent & Trademark Attorneys, Melbourne, appeared for Servier. Mr Ben Fitzpatrick of counsel, assisted by Dr Helen Golias and Mr Paul Kilborn, patent attorneys of F B Rice & Co, Melbourne, represented Lupin.
The previous extensions
For the first extension the reason given was:
“Since filing the Statement of Grounds and Particulars, an expert witness has been located. Significant progress has been made in the preparation of the Evidence-in-Support and the expert witness has been interviewed. More time is required in which to finalise and file the Evidence-in-Support and we therefore request an extension of time of three months in which to finalise the Evidence-in-Support.”
The second extension was requested on the following reason:
“Further time is required to complete the Evidence-in-Support.
Further interviews with the expert witness have been conducted and a draft declaration has been prepared. A copy of the draft declaration has been forwarded to the expert for review.
The Opponent has also recently forwarded to us experimental data which is of relevance to this opposition. This data is currently under review and it is expected it will form part of the Evidence-in-Support. In the corresponding European patent opposition, the applicant has already been provided with similar experimental data.
We expect to be in a position to complete the Evidence-in-Support within the requested extended time period.”
The present extension
The reasons for the current (third) extension contain some more information on the progress of the opposition as follows:
“Further time is required to complete the Evidence-in-Support.
A Statutory Declaration by Helen Golias (formerly Kyriacou) has been served which forms part of the Opponent's Evidence-in-Support.
A Statutory Declaration by the expert witness, Dr Philip A. Marshall has been served today.
Further time is required to review and compile fully the experimental data forwarded to us by the Opponent referred to in the Application for Extension of Time filed on 31 July 2006. At that stage, it was believed that we would be in a position to complete our Evidence-in-Support by 30 October 2006.
The corresponding European opposition was heard on 27 July 2006 in light of which it has come [to] the Opponent's attention that certain aspects of that data filed in that matter require further consideration. We are presently in consultation with the Opponent regarding the experimental data, and depending on the outcome of the discussions, it is possible further experiments will need to be conducted in support of the Opponent's case.”
As is clear, Lupin is seeking an extension of time to file experimental data as part of the evidence in support.
RELEVANT LAW
The time for serving evidence in support of an opposition is 3 months from the date of serving the statement of grounds and particulars (regulation 5.8). This time can be extended under regulation 5.10(2):
(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).
This provision must be read in conjunction with regulation 5.10(5):
(5)The Commissioner must not give a direction under subregulation (1) or grant an application under subregulation (2) or (4) unless the Commissioner:
(a)if he or she proposes to grant an application by a party - is reasonably satisfied that the other party has been notified of the application; and
(b)if he or she proposes to act on his 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, and extension of time or the serving of evidence is appropriate in all the circumstances.
Consequently, it is a prerequisite to any decision that the Commissioner must ensure that the other party has been notified, and that both parties have had the opportunity to make representations. In the present case the opponent has been notified, and both parties have been given the opportunity to make representations.
An extension can only be granted if the Commissioner is reasonably satisfied that it is appropriate in all the circumstances. In exercising this discretion I am guided by the decisions of Burchett J in Ferocem Pty Ltd v Commissioner of Patents (1994) AIPC 91-057; 28 IPR 243, Sackville J in A Goninan & Co Ltd v Commissioner of Patents (1997) AIPC 91-330; 38 IPR 213 and Goldberg J in National Starch & Chemical Co v Commissioner of Patents (2001) AIPC 91-697, 50 IPR 398. The general principles that flow from these decisions are:
a)The power is discretionary:    Regulation 5.10 confers a broad discretion, which cannot be reduced to imperative compliance with particular requirements. It is necessary to give genuine and proper consideration to all relevant considerations. (Ferocem at AIPC 38,208; IPR 247-8, Goninan at AIPC 39,434; IPR 220)
b)Explanation of delay: The reasons why the evidence was not served earlier are a relevant consideration, but a satisfactory explanation is not a mandatory requirement. (Ferocem at AIPC 38,207-8; IPR 247). It is relevant to consider the disadvantage to the other party of delays in determining the opposition, and the effect of delays on the efficient and orderly administration of the Patents Office. (Ferocem at AIPC 38,208; IPR 247, Goninan at AIPC 39,436; IPR 222)
c)The public interest:     The public interest in determining a serious opposition on its merits is a relevant consideration. (Goninan at AIPC 39,435-6; IPR 222)
*         In order to do this, it is necessary for the Commissioner to form a view as to the nature of the evidence that it is sought to adduce, and the significance of that evidence for the opposition proceedings. (Goninan at AIPC 39,438; IPR 225-6)
*         The significance of the evidence is assessed having regard to any relevant material available, not just the evidence itself. (National Starch at [33])
*         The public interest is not protected merely because some evidence has already been served. (Goninan at AIPC 39,438; IPR 225)
d)The interests of the party seeking the exercise of discretion: The interests of the party seeking the exercise of discretion are a relevant consideration. (Ferocem at AIPC 38,208; IPR 247)
DECLARATIONS FILED BY THE PARTIES
Prior to the hearing Servier filed a declaration by Carolyn Harris (hereafter referred as the Harris declaration) which provided further information. The body of that declaration is as follows:
“1.I am a Principal of Watermark Patent and Trade Mark Attorneys. I am a registered patent and trade mark attorney and have care of this matter in Australia under instructions from Les Laboratoires Servier.
SERVICE OF EVIDENCE IN SUPPORT
2.The statutory declaration of Helen Kyriacou made on 28 July 2006 was served on Les Laboratoires Servier on 3 August 2006.
3.The statutory declaration of Phillip Andrew Marshall made on 27 October 2006 was served on Les Laboratoires Servier on 30 October 2006.
THE EUROPEAN OPPOSITION
4.The European equivalent of Australian patent application no. 2001276418 is European patent no. 1296947. They both claim priority from French application no. 00/08793 and are derived from PCT application no. PCT/FR01/02167.
5.I have reviewed the file history for European patent no. 1296947 available on the website of the European Patent Office.
6.The file history for European patent no. 1296947 shows that this patent was opposed and Lupin Limited was one of a number of opponents.
7.It also shows that the European opposition was heard on 27 July 2006. The patent status is granted, therefore the opposition was dismissed. A written decision was issued on 21 September 2006.
THREAT OF INFRINGEMENT
8.I am aware that Les Laboratoires Servier has sued Apotex Inc, (a Canadian generic pharmaceutical manufacturer) and other related companies in the United Kingdom for infringement of European patent no, 1296947 in Action No. HC 06 C 03050. I am also aware that Les Laboratoires Servier obtained an injunction in the United Kingdom on 8 August 2006 preventing Apotex Inc. and the related companies from importing and selling a generic perindopril product on the basis of European patent no. 1296947.
9.I am aware that GenRx Pty Ltd (a related company of Apotex Inc. based in Australia) has received TGA approval and PBS listing for a generic perindopril product to enter the Australian market with effect from 1 December 2006.
10.It is likely, therefore, that Les Laboratoires Servier will need to consider patent infringement proceedings against GenRx Pty Ltd and/or Apotex Inc. as soon as Australian application no. 2001276418 is granted.”
Following filing of the Harris declaration, on the day prior to the hearing Lupin filed a declaration by Helen Golias (hereafter referred to as the Golias declaration) which sets out further information as to why the evidence in support had not been completed and what the evidence was going to be directed to. The body of that declaration is as follows:
“1.I am an Attorney employed by FB Rice & Co ("my firm") and, subject to the supervision of my Partners, I have care and control in this matter.
2.On 30th October 2006, my firm filed, on behalf of Lupin Limited, an Application for Extension of Time in which to complete our Evidence-In-Support. In that Application it was stated:
"Further time is required to review and compile fully the experimental data forwarded to us by the Opponent referred to in the Application for Extension of Time, filed on 31 July 2006. At that stage, it was believed that we would be in a position to complete our Evidence-in- Support by 30 October 2006.
3.On 3 November 2006, my firm was advised by the Attorneys representing Les Laboratoires Servier that Les Laboratoires Servier had objected to our Application for Extension of Time. A hearing to settle the matter was subsequently set down for 7 December 2006.
4.At the time of filing the Extension of Time on 31 July 2006, I was in the process of reviewing various experimental data forwarded to me by Lupin Limited in support of this Opposition. The Experimental data was received by my firm in three lots - the first lot on 30 January 2006, the second lot on 26 May 2006 and the third lot in November 2006. The experimental data under review is quite complex in nature and is extremely relevant to the Opposition. In particular, the experimental data forms the basis for evidence that the relevantly skilled person performing the method described in Stage 3D at page 14 of Dl would produce the α-crystalline form of the compound claimed in claim 1 of the opposed specification. Furthermore, D1 is relevant to the assessment of inventive step as evidence will be adduced that Dl is a document that the relevantly skilled addressee would have ascertained, understood and regarded as relevant. The experimental data also relates to the issue of sufficiency and in particular the issue of whether the relevantly skilled person would be able to perform the invention without undue experimentation based on the disclosure of the opposed specification. The experimental data may also relate to the ground of inutility.
5.One of the reasons I did not forward the experimental data to our expert witness, Dr Philip Marshall, at the time of receiving the various lots of data was because at that time I was obtaining evidence from Dr Philip Marshall as to what constitutes the common general knowledge in Australia at the relevant priority date. Dr Marshall was first engaged on 11 October 2005. In order to avoid leading Dr Marshall, Dr Marshall was not supplied with a full copy of the opposed specification or any of the prior art documents. As Dr Marshall was in the process of providing this evidence, I did not consider that it was appropriate to forward any of the experimental data to Dr Marshall until after he had completed his evidence on the common general knowledge in Australia. This was particularly so given that the experimental data specifically referred to prior art document Dl and also explicitly discussed the reproducibility of the invention based on the disclosure in the opposed specification. Although it may have been theoretically possible to engage another expert to provide evidence on the experimental data, I did not consider that this was practically feasible as I had already identified Dr Marshall as the relevantly skilled person. Furthermore, I had anticipated that Dr Marshall's evidence on what constituted the common general knowledge would have been completed in sufficient time to forward to him the experimental data in order to obtain his further evidence in respect of the experimental data by 30 October 2006. However, the process of finalising the declaration took longer than expected.
6.Moreover, on further review of the first two lots of data, it became apparent to me that various technical issues required further instructions from Lupin Limited. To this end, I sent correspondence to Lupin Limited on 21 September 2006 outlining a number of questions of a technical nature requiring instructions. Exhibited hereto and marked as Exhibit HG-1 is a electronic mail from Lupin Limited acknowledging receipt of my correspondence dated 21 September 2006.
7.Lupin Limited replied to my correspondence of 21 September 2006 in a letter dated 21 October 2006. This letter was sent to me via electronic mail, however I only became aware on Thursday 9 November 2006 that I failed to receive this correspondence when I received further correspondence from Lupin Limited referring to the correspondence dated 21 October 2006. On Monday 13th November 2006, I wrote to Lupin Limited informing them that I had not received their correspondence dated 21 October 2006. Exhibited hereto and marked as Exhibits HC-2 is a copy of the correspondence dated 9 and 13 November 2006.
8.On 27 November 2006, as I was yet to receive the correspondence dated 21 October 2006 from Lupin Limited, I decided to call its offices. I spoke to Dr Roy, the person who has been providing me with instructions in this matter. From this telephone call, it became even more apparent that the electronic mail communication between our office and the offices of Lupin Limited in India was occasionally failing. As such, Lupin Limited decided to send the correspondence dated 21 October 2006 by courier. I received this correspondence on Friday 1 December 2006.
9.The experimental data forwarded to my firm by Lupin Limited has today been forwarded to our expert witness, Dr Philip Marshall, for his review and comment. Once Dr Marshall has had the opportunity to review this data, a statutory declaration will be obtained from Dr Marshall.
10.We expect to be in a position to complete our Evidence-in-Support by 30 January 2007
11.With respect to paragraphs 4 to 7 of the declaration of Carolyn Harris declared 5 December 2006, a search conducted on the Epoline database on 5 December 2006 indicates that the European Opposition decision issued on 21 September 2006 is subject to separate appeals by 6 of the Opponents in the European Opposition, including Lupin Limited. Now exhibited and marked as Exhibits HG-3 to 8 are copies of the Notices of Appeal extracted from the Epoline database.
DECISION
Explanation of the delay
It was conceded by Mr Fitzpatrick towards the end of his submissions that, “with the glare of hindsight”, it could always be said that more detailed reasons should have been given and that could be said of the first two applications for extension of time filed by Lupin. I believe that the same could be said of the explanation which accompanied the present application (hereafter referred to as the “written explanation”).
The written explanation on its own suggests a lack of diligence. It makes mention of reviewing data that had, according to the explanation accompanying the second request, been received over three months before. It is difficult to see from the explanation, why such data would still be under review after more than three months. There is no hint in previous explanations of any problems with the data. There is no sense of any great progress and no sense of anything important connected to the data.
The mention of the European opposition in the written explanation does not explain the present delay either. If anything it gives the impression put forward by Servier in their submissions at the hearing that the Australian opposition was delayed by Lupin. The hearing on the European opposition was held on 27 July 2006. This was before the second request for an extension of time was filed. Given that it was a result of this European hearing that it had “come [to] the Opponent's attention that certain aspects of that data filed in that matter require further consideration”, it would seem that such a reason should have appeared in the explanation for the second request for an extension of time explaining that Lupin needed another 3 months (to 30 October 2006) to review the data because of what had transpired at the European hearing. The inclusion of this detail in the third request for an extension of time simply does not explain any delay. It suggests that, in fact, no review of data had been carried out in the previous three months given that it was only now–some three months after the hearing and more than three months after receiving the data–that it had “come [to] the Opponent’s attention that certain aspects of that data filed in [the European opposition] require further consideration.” Problems with the data would have “come to the opponent’s attention” long before 30 October 2006 and should have been dealt with then. In other words, the impression is that the review of the data was stopped and, therefore, the delay in reviewing the data (which resulted in the need for more time) was one of the opponent’s own making.

However, it is the Commissioner’s practice to give due considerations to the explanation for the delay wherever and whenever the explanation is disclosed. That is, no lesser consideration is given to explanations just because they were disclosed “late” or not with the written explanation. Therefore, it entirely proper to consider the submissions made at the hearing regarding the reasons for the delay in filing the relevant evidence.
Mr Fitzpatrick pointed to the Golias declaration as providing sufficient information as to why the delay occurred.
His first point was that the data was “complex in nature”. I believe that the inference that I am supposed to draw from this is that this complexity slowed the review. However, there is nothing in the Golias declaration that details what the data consists of. Apart from saying that the data is “extremely relevant”, the Golias declaration takes the matter no further. The only reference as to what the data is appears in Mr Fitzpatrick’s written submissions, where he broadly refers to the data as “consisting of a range of different crystallisation experiments conducted under a variety of conditions”. This does not really advance my understanding. As Ms Strong submitted on behalf of Servier, in the present explanation there was still no explanation of what the data was. This lack of detail of the actual content of the data being reviewed does hamper any conclusion I may draw as to its complexity, and whether that is responsible for the delay. I cannot say that this point is a satisfactory explanation for the delay.
The next point that was raised was that the delay occurred because the data could not be sent to Dr Marshall until he had completed what Mr Fitzpatrick termed “black box evidence”. That is, evidence given without seeing the patent application. Such evidence was sought in light of a number of court decisions where it was indicated that providing the application to an expert before they gave evidence may bias them. See, for example, 3M v Tyco [2002] FCAFC 315 (at [45]–“The manner in which the evidence of some of the experts in the present case was bought into existence suggests that relatively little weight should be given to certain of that evidence. For example, witnesses were provided with a copy of the Patent. They were either provided with a large number of other documents or found them in response to the task that was set them. That is hardly calculated to result in objective evidence as to what the hypothetical uninventive but skilled worker would have done. To give the Patent to a prospective witness is tantamount to leading the witness”). Mr Fitzpatrick submitted that the provision of the experimental data to Dr Marshall before he completed his evidence on the common general knowledge would have tainted that evidence. Since Dr Marshall’s evidence took longer than expected to finalise, that delayed the sending of the data to Dr Marshall and, hence, delayed the service of evidence in support.
Mr Fitzpatrick pointed to the series of events that arose while Dr Golias sought instruction on a number of technical issues she had with the data. According to the Golias declaration a letter had been sent to Lupin in India on 21 September 2006 and a response had been sent from Lupin to Dr Golias on 21 October 2006. However, this response had not been received because of an occasionally failing electronic mail link. Dr Golias only became aware of her non-receipt of the response on 9 November 2006 and she then attempted to contact Lupin via e-mail on 13 November 2006 and again on 17 November 2006. She then rang Lupin on 27 November 2006 and received the missing correspondence via courier on 1 December 2006. It was submitted that this delayed the sending of the experimental data to Dr Marshall.
On this point Ms Strong directed my attention to the fact that, as stated in the Golias declaration, data had been with Lupin from 30 January 2006. Ms Strong also pointed out that the Golias declaration disclosed that further review had occurred and that further instructions were requested on 21 September 2006. Ms Strong indicated that it had been up to 8 months before this correspondence was sent. Ms Strong then pointed out that even with this “very urgent matter”, and knowing that they had delayed with the data, there was no urgency in following up on this communication. Dr Golias was only alerted to the fact of a missing communication on 9 November 2006 by another communication and through no action on her part. Ms Strong further indicated that the Golias declaration also showed that no action was taken to obtain this correspondence until 13 November 2006 and then, after waiting two weeks for a response, she made a phone call on 27 November 2006. Ms Strong also submitted that, even though the explanation of the present request discusses needing further time to review the experimental data, even this did not prompt Dr Golias to chase up any response from Lupin to her letter of 21 September 2006 requesting further instruction on the data.
Ms Strong submitted that this showed an “extraordinary lack of urgency” when dealing with the experimental data.
I do have some sympathy for Ms Strong’s submission. Furthermore, I do not see how such a series of events explain the delay in filing evidence. I cannot see how it explains why the service of evidence in support was not completed and further time is required. Even if the electronic mail link had been working perfectly, it is clear that the data was not going to be given to Dr Marshall until his evidence was complete. Dr Marshall did not complete his evidence until 30 October 2006. Even if the data had been given to Dr Marshall at that point, there was no possibility of any further evidence being filed within the time limit previously granted (which ended on 30 October 2006). It is the delay in the completion of Dr Marshall’s evidence that is crucial, and there is no explanation as to why that was delayed. It is this delay that requires explanation, not the delay in sending the data Dr Marshall. This does not support a request for extension.
Mr Fitzpatrick also made submissions as to why another expert could not have been engaged to review the data (I assume to compensate for the slowness of Dr Marshall). He submitted that, given the “quarantining” of Dr Marshall, it had been expected that Dr Marshall’s evidence would have been completed in time to allow the data to be sent to him for consideration. The delay in completion of Dr Marshall’s evidence postponed service of the data to him until 6 December 2006. He also pointed the complexity of the data slowing the review and the questions raised by that review that needed to be answered before an expert could review it.
I do not understand how these submissions answer the question as to why another expert could not have been engaged. They would appear to be directed at why Dr Marshall did not receive the evidence, not why another expert could be used. To paraphrase Ms Strong’s submissions on this point, surely Dr Marshall is not the only expert who could review the data?
In summary, the explanation of the delay is not satisfactory and does not support an extension of time. It gives very little detail as to the complexity of the data and why it is delaying service of evidence. The mention of the hearing of the European opposition does not explain any delay given that it occurred before the previous request for an extension of time. Lupin is effectively asking for an extension because of a situation that caused a delay that necessitated an earlier extension of time. This suggests a lack of diligence on the part of Lupin since they appear not to have addressed the situation in the previous three months that they were granted. Finally, the delay in the filing of Dr Marshall’s evidence has not been explained. To me it would appear that such an explanation was necessary.
Public Interest
The public interest in determining a serious opposition on its merits is a relevant consideration. In order to do this, it is necessary for the Commissioner to form a view as to the nature of the evidence that it is sought to adduce, and the significance of that evidence for the opposition proceedings [A Goninan & Co Ltd v Commissioner of Patent (supra)].
On the public interest, Mr Fitzpatrick submitted that, the overall delay was a relatively short time given the progress made so far and the length of time the patent can be in force. Furthermore, there was a clear interest in this particular case in ensuring the grant of a valid patent. As was acknowledged in the Harris declaration (above), Servier was likely to consider infringement proceedings against Australian companies as soon as the present application was granted. Mr Fitzpatrick submitted that this threat reinforced the public interest in ensuring only valid patents are granted and, therefore, the need to have all relevant material before the Commissioner. Not allowing this application would mean that relevant material (e.g. the experimental data) would not be supplied.
At the hearing, it was pointed out by Servier that there was no explanation in the application of what the data was and what it was to be used for. I agree. While, as Mr Fitzpatrick submitted, this action was not the substantive opposition, the nature of the evidence being sought is a relevant consideration. If the evidence is not going to contribute to a more just and correct decision, there is nothing to be gained by extending the time to receive it. As was said in Australian Lock Company Pty Ltd v Lockwood Security Products Pty Ltd [2005] APO 12:
“While it could be said with some confidence that expert evidence is accepted by [the Patent Office], it does not automatically follow that expert evidence must always be submitted.”
However, it is clear from the Golias declaration that the experimental data will be vital to the opponent’s grounds of novelty and sufficiency. It would appear that Lupin intends to use the data to show that when a particular method disclosed in AU 22362/88 (stage 3D) is carried out, it produces an α-crystalline form of a compound having all the features as defined in claim 1 of the present application. The experimental data will also be used to show that following the instructions of the present application will not produce a compound within the scope of the claims.
Ms Strong submitted that the data would be of no weight because it failed in Europe. However, as pointed out by Mr Fitzpatrick, there is divergence between Australian and European law and its dismissal in the European jurisdiction does not mean it will be similarly dismissed in the Australian jurisdiction (and vice versa). Ms Strong also submitted that Lupin already has substantial evidence filed in the form of Dr Marshall’s declaration. However, it is clear to me from reading Dr Marshall’s declaration (and, given the expertise of Servier, should have been clear to the applicant) that Lupin’s evidence is incomplete. Given the “quarantining” of Dr Marshall while he produced his evidence, it clearly does not address the claims of the specification in any way. It provides no discussion of features present in the claims and their novelty, inventiveness or clarity (or lack thereof). It also provides no opinion as to the sufficiency of the present application.
In my opinion, which is based on the Golias declaration and Lupin’s submissions at the hearing, the experimental data will be very important to the considerations of this opposition. I believe its inclusion would lead to a better and/or more just opposition outcome. It would allow a serious opposition to be treated on its merits. I am of the opinion that Lupin is undertaking a serious opposition.
The other arm of the public interest is the expeditious disposal of matters before the Patent Office. I am concerned with the apparent lack of action in obtaining the answers to questions about the data that had been sent to Lupin on 21 September 2006. While Mr Fitzpatrick submitted that, as a patent attorney, Dr Golias does have other things to do, it is worrying that no follow up was attempted until after requesting an extension of time, even though the request for an extension of time was there to “remind” Lupin’s attorneys that nothing had been received (as per the submissions of Ms Strong).
I am also concerned about the apparent lack of action to review the experimental data as it became available. It is clear from the Golias declaration that data had been available from as early as January 2006. However, there is no indication in the explanation for the first extension of time that any review of data had begun. Any review appears to have only started in July 2006. While it might be that the review of the January 2006 data could only be started when in possession of the data received in May 2006, the lack of detail on the data does not allow me to come to such a conclusion. One possible conclusion that could be drawn from this is that the review was deliberately delayed.
However, I note Mr Fitzpatrick’s submission regarding the intention of Servier to exercise its rights and begin actions on parties who would infringe any patent granted on the present application.
On balance, I believe the public interest in this case lies in ensuring that the opposition be determined on its merits so that Servier can be granted a valid patent to enforce their rights. I believe that this consideration outweighs any short delay in the overall opposition process. The public interest supports allowing the extension.
Parties’ Interest
With respect to the parties’ interests, Mr Fitzpatrick submitted that Servier asserted (via the Harris declaration) that a delay in the opposition process would delay any sealing and this was unduly prejudicing the interests of Servier given the intention to start infringement actions on the basis of a granted patent. He directed my attention to the decision of Kimberley–Clark Corporation v Proctor & Gamble Co (1990) 20 IPR 425 and submitted that a similar argument was not accepted. Mr Fitzpatrick submitted that, as the rights of Servier extend back to the date of publication of the application, there was no prejudice to the ability of the patentee to seek damages back to that date, and that right remains even if the sealing was delayed. Servier had given no evidence of any practical disadvantage that would arise if the extension was granted.
On the other hand, Mr Fitzpatrick submitted that Lupin would be severely disadvantaged if the extension was not granted. They would be left in the position of being unable to rely on experimental data which was critical to the grounds of novelty, inventive step and sufficiency. Given the intention of Servier to start infringement proceedings, it was essential that all relevant material be before the Commissioner to ensure that the patent granted to Servier was a valid patent.
On the interest of the parties, Ms Strong submitted that Lupin already had a tenable opposition from the substantive evidence of Dr Marshall that had already been filed. Servier’s interest was in resolving the opposition. It did wish to consider infringement actions and it would be undesirable for patients to have a generic version of the drug on the market for a short time and then, as a result of an interlocutory injunction, for example, have that drug taken off the market. Ms Strong submitted that Lupin wanted to delay the sealing of a patent on the application.
Ms Strong submitted that the decision of Kimberley–Clark Corporation v Proctor & Gamble Co (supra) did not support the position taken by Lupin that the fact of infringement proceedings was not a relevant consideration. She submitted that the decision clearly supported the position that the fact of future infringement actions is one factor that must be taken into account when deciding whether to grant the extension, and is not totally irrelevant.
On balance, the parties’ interests support the granting of the extension. The interests of Lupin clearly favour the allowance of further time so that all relevant evidence can be considered at the opposition and Lupin has a real opportunity to put their case to the Commissioner. To not allow the extension would be to shut Lupin out of presenting its full case.
As I noted above, it is clear that their evidence is not complete. Servier’s submission on this aspect do not point to any disadvantage. The submission made by Ms Strong that Kimberley–Clark Corporation v Proctor & Gamble Co (supra) meant that future infringement actions were a factor to be taken into account is more appropriate for considerations of the public interest. In addition, Ms Strong’s point about the removal of generic drugs affecting people taking them shows no disadvantage to Servier.
CONCLUSION
On balance, the extension should be granted. I note that there has been no satisfactory explanation for the delay. However, the parties’ interests and public interest in particular supports the granting of the extension.
I note that the experimental data has been forwarded to Dr Marshall, and I particularly note the submission by Mr Fitzpatrick that Lupin expects to complete its evidence in support within the period now being sought. Nevertheless, he did point out that the Christmas/New Year period did occur in the three months requested. It does concern me that this period may encourage further delays on the part of Lupin for the timely completion of their evidence in support. However, that is for future considerations if another request for an extension is filed.
COSTS
Mr Fitzpatrick submitted that costs should follow the event. Ms Strong submitted that, whether an extension was granted or not, costs should be awarded to Servier. She submitted that the original application for extension did not support granting an extension and the Golias declaration contained material that should have been included in earlier requests.
An extension of time has been granted. However, I share the view of Ms Strong that the written explanation given in the request for an extension of time did not support an extension. Furthermore, the explanation given at the hearing did not support an extension. It was clearly in the public interest to grant an extension, and it might be argued that Servier should have taken that into account when deciding whether to object to the request. However, it was only the further information in the Golias declaration, giving more detail as to the nature and relevance of the evidence, and the submissions of Mr Fitzpatrick at the hearing (which were based almost entirely on that declaration) that showed it was in the public interest at least to grant an extension. Faced with the written explanation only, Servier was entitled to object.
In light of this I award costs against Lupin.
GREG POWELL
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Watermark Patent & Trademark Attorneys, Melbourne
Patent attorneys for the opponent : F B Rice & Co, Melbourne