Wyeth v Sepracor, Inc - [2010] APO 5

ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 2005218047 in the name of Sepracor, Inc

Title: Derivatives of venlafaxine and methods of preparing and using the same

Action: Application for dismissal of an opposition under section 59 by Wyeth

Decision: Issued 29 April 2010
Abstract

The grounds relating to lack of sufficiency, lack of fair basis and lack of definition are dismissed. Wyeth cannot argue these grounds at the substantive opposition. All other grounds remain.
Wyeth argued that the methods of treatment claimed lack sufficiency. However, the specification clearly indicates where to get the “starting materials” for the methods – US patent 6673838 owned by Wyeth. It was clear from the submissions that Wyeth was not going to argue that their US patent did not show how to produce the succinate salt of ODMV. Consequently, this ground has no reasonable prospects of success.
For fair basis Wyeth’s argument was that there was no real and reasonably clear disclosure of any invention, but simply a reference to an invention already disclosed and claimed in Wyeth’s US patent. Wyeth’s arguments are not directed to fair basis. Wyeth is not doing a comparison between the claims and the description. The argument put forward by Wyeth has no reasonable prospects of success under the ground of fair basis.
Wyeth’s arguments for lack of definition were, firstly, that the claims lacked clarity and, therefore, did not define the invention and, secondly, for the reasons argued under fair basis and sufficiency. Lack of definition does not automatically follow a lack of clarity and, as already noted, Wyeth has no reasonable prospects of success under the grounds of fair basis and sufficiency. It follows that this ground has no reasonable prospect of success.
The particularisation of the remaining grounds in the Statement that was originally served was poor. It left out a lot of the detail which more particularly foreshadowed Wyeth’s case. A direction for further and better particulars was made. If this direction is not complied with, further direction(s) with respect to the non-complying ground(s) will be made.
An award of costs is not appropriate. Consequently, each party is to bear its own costs in this matter.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 2005218047 by Sepracor, Inc and an application for dismissal of an opposition under section 59 by Wyeth

BACKGROUND

Patent application 2005218047 was filed on 30 September 2005 by Sepracor, Inc (Sepracor). The application was advertised accepted on 9 July 2009 and a notice of opposition under section 59 was filed by Wyeth on 9 October 2009. On 24 December 2009 Wyeth served its Statement of Grounds and Particulars on Sepracor. On 25 January 2010 Sepracor filed a request under Regulation 5.5(1) for dismissal of the opposition.
The hearing took place in Canberra on 7 April 2010. Sepracor was represented by Mr Robert Finzi, assisted by Dr Vaughan Barlow, both patent attorneys of Pizzeys Patent and Trade Mark Attorneys, Canberra. Wyeth was represented by Mr Angus Lang of counsel, assisted by Mr John McCann and Mr Gavin Adkins, patent attorney and technical assistant respectively, of Spruson & Ferguson, Sydney. On the day of the hearing Wyeth filed a request to amend their Statement of Grounds and Particulars along with an amended Statement of Grounds and Particulars.
For the purpose of brevity, throughout this decision I will refer to the originally served Statement of Grounds and Particulars as the “Statement” and the Statement filed by Wyeth with their request to amend as the “amended Statement”.
THE LAW ON DISMISSAL
Dismissal of an opposition is provided for by regulation 5.5 of the Patents Regulations, which states:
5.5 (1)   An applicant may:
(a)within 1 month of being served with a copy of a statement by an opponent under paragraph 5.4(a); or
(b)if the complete specification in relation to an opposed application is re-examined under subsection 97(1) of the Act – within 1 month from the day when the re-examination is completed under regulation 9.5;
request the Commissioner in the approved form to dismiss the opposition.
(2)   As soon as practicable after a request is made, the Commissioner must inform the opponent of the request having been made.
(3)   The Commissioner may dismiss the opposition whether or not the applicant has requested dismissal of the opposition.
In the present case Sepracor requested for dismissal within one month of being served with a copy of the Statement by Wyeth (24 January 2010 being a Sunday). The Commissioner informed Wyeth of the request on 8 February 2010. Consequently the procedural prerequisites for dismissal have been satisfied.
Deciding Whether to Dismiss
The Commissioner developed an approach to dismissal based on the approach taken by the courts in exercising their powers to summarily determination. In this regard, the Commissioner took guidance from the approach laid down in General Steel Industries Inc v Commissioner for Railways (NSW) [1964] HCA 69; (1964) 112 CLR 125. The Federal Court approved this approach in Stack v Commissioner of Patents [1999] FCA 148 at [5 - 6]; (1999) 43 IPR 663 at 664 - 665:
“In resolving the matter, the delegate treated reg 5.5 as establishing a procedure for the summary dismissal of an opposition to applications of the kind referred to in reg 5.1; accordingly, he followed the approach that courts apply in determining whether or not to exercise their powers to summarily determine claims and defences. In this context, he referred to General Steel Industries Inc v Commissioner of Railways (NSW) [1964] HCA 69; (1964) 112 CLR 125 at 129. The delegate concluded:
‘... an opposition or a ground of opposition will be dismissed [under reg 5.5] only if it is clear that the opposition could not possibly succeed. In bringing this action the onus falls on [the applicant] to show that the opposition is clearly untenable.’
No complaint is made about, and there is no reason to doubt the correctness of the delegate's approach in this regard.”
Clearly it is expected that the Commissioner should interpret dismissal under regulation 5.5 in the same way as summary judgment by a court. The Federal Court’s approach is governed by section 31A of the Federal Court of Australia Act 1976 (“Federal Court Act”).
In Les Laboratoires Servier v Apotex Pty Ltd [2008] APO 11 the delegate noted that a change had been made to section 31A which meant that:
“the principles set out in General Steel (supra) are not given "canonical force" in summary dismissal proceedings (Batistatos v Roads and Traffic Authority of New South Wales (2006) 227 ALR 425 at 427). Rather, a proceeding may be dismissed where a party has "no reasonable prospect of successfully prosecuting the proceeding" (see for example Garrett v Macks [2006] FCA 601, White Industries Aust Ltd v Commissioner of Taxation [2007] FCA 511, Boston Commercial Services Pty Ltd v GE Capital Finance Australasia Pty Ltd [2006] FCA 1352, Rogers v Asset Loan Co Pty Ltd & Ors [2007] FCA 195, Vans, Inc. v Offprice.Com.Au Pty Ltd [2006] FCA 137, E. & J. Gallo Winery v Lion Nathan Australia Pty Limited [2008] FCA 136, and Alphapharm Pty Ltd v Merck & Co Inc [2006] FCA 1227).”
As noted in the Servier decision, a similar approach is also applied in England and Queensland. It seems clear that Parliament has decided that the approach to summary judgment in all federal courts should be the same, and that the same approach applies to all matters (not just to migration cases).
The delegate concluded in Servier that several key principles flowed through to patent oppositions from the changes to s 31A of the Federal Court Act and the guidance provided by the above decisions:
·An opposition need not be “clearly untenable” or “manifestly groundless” in order for it to be dismissed. An opposition may be dismissed if it is considered to have no reasonable prospects of success.
·In determining whether or not there is a reasonable prospect of success, consideration is given as to whether there is a real rather than fanciful issue to be decided. The onus will initially be on the applicant to show that the opposition has no reasonable prospects of success, but the onus may shift to the opponent to explain its case if a real issue is not self-evident. This will not involve an in-depth consideration of the substantive opposition, but may involve sufficient analysis to determine if a prima facie case has been established.
·A dismissal will generally be inappropriate where expert evidence is required to determine an issue. However, this does not preclude dismissal of an opposition where there is a clear deficiency in the case to be argued, such as a technical divergence of a citation and the application or where an opposition involves issues of construction and expert evidence is not necessary to clarify technical terms or other matters that are in doubt.
·Evidence of an “ambivalent character” will generally be sufficient to establish a reasonable prospect of success. However, if the evidence is only one-way, or can clearly lead only to a single conclusion, then a proceeding may be dismissed. If no particulars have been provided in relation to a ground of opposition then it may be considered to have no reasonable prospects of success.
·Care must be taken not to cause an injustice to a party by dismissing an opposition.
The Stack case was explicit in approving the adoption of court practices when considering dismissal. The practice of all federal courts has been altered by Parliament, and it would be strange indeed if Parliament intended that a different approach should apply in federal tribunals. I consider that it is undeniable that the Commissioner should follow the clear shift that applies in all federal courts, and apply the practice in section 31A of the Federal Court Act.
The effect of section 31A is that the previous test of whether an opposition is obviously or manifestly groundless or untenable has been relaxed slightly, and instead the question is whether there is no reasonable prospect of success (see the cases cited in the Servier decision). This is the approach that I will apply in the present case.
The specification
The present invention concerns the succinate salt of O-desmethylvenlafaxine (“ODMV”) and methods of treatment of a number of disorders using ODMV. Importantly for this matter, the specification was amended on 18 May 2009 to focus the invention to this salt. Prior to this amendment, the succinate salt was not explicitly exemplified. Inter alia, the amendments introduced the statement that ODMV “may be prepared according to the methods described in US Patent No. 6,673,838B2.” This patent belongs to Wyeth and was published on 6 January 2004, well after the claimed earliest priority date of 6 April 1999. The amendment also introduced statements as to why the succinate salt of ODMV is advantageous over the other possible salts. The statement added says that, in this regard, “reference is made to the results reported in US Patent No. 6,673,838B2 and in particular Example 13, where it was disclosed that the succinate salt from has a better adsorption in the small intestine and in the colon than did the fumaric salt form.”
Dismissal, or a Request for Further and Better Particulars?
At the outset Wyeth submitted that, while Sepracor had requested dismissal, Sepracor’s submission in support of dismissal was essentially a request for further and better particulars. Sepracor, in addressing some of the grounds of opposition, conceded (as set out below) that these grounds may not be able to be dismissed and, instead, provided submissions on inadequacies of the particulars for the grounds. Wyeth had the opportunity to respond to these submissions. Therefore, it seems to me that, should I be minded to issue a direction in relation to further and better particulars, I can proceed to do so without providing the parties a further opportunity to be heard on that direction. They have already been heard on the possibility of such a direction.
Wyeth’s Amendment Request
As noted above, Wyeth filed a request to amend their Statement on the day of the hearing. However, as noted by Sepracor, regulation 5.9(2)(a) states that the Commissioner “must not allow an amendment … if an application for dismissal of opposition is being considered”. Sepracor submitted that it was inappropriate to pay any attention to Wyeth’s amended Statement. I agree and Wyeth also conceded this point. Wyeth characterised its use of the amended Statement as being more of an aide memoir. Nevertheless, they did make mention to it and I will also refer to it where appropriate.
The Statement of Grounds and Particulars
The Statement itself states that “the Grounds of Opposition and the Particulars of the Grounds of Opposition are contained within this document.” However, it is difficult to ascertain what the grounds of opposition are. The Statement includes initial headings, a paragraph (or two) addressing in a broad way what requirement of the Patents Act in relation to the initial heading is not met and then another heading underneath which indicates that what follows are “Particulars”. The initial headings are:
(i)Not a Manner of Manufacture
(ii)Priority Date
(iii)Lack of Novelty
(iv)Lack of Inventive Step
(v)Lack of Utility
(vi)Lack of Sufficiency
(vii)Lack of Clarity
(viii)Lack of Fair Basis
(ix)Lack of Definition
While it would seem that the paragraph(s) following the initial headings are the grounds of opposition, Wyeth’s request to amend the Statement includes amendments to these paragraph(s) without identifying either (i) the error or omission that permits amendment to grounds under regulation 5.9(1)(a), or (ii) the amendment to the patent request or complete specification that permits amendment to grounds under regulation 5.9(1)(b). That is, it seems that the paragraph(s) may not set out the grounds of opposition. Indeed Wyeth’s conduct in attempting to amend them seems to lead away from a conclusion that these paragraph(s) are “grounds”. I am at somewhat of a loss in determining what grounds there are to for me to dismiss.
Looking at the headings themselves, nearly all of them relate to a section of the Patents Act under which the grant of a patent may be opposed. That is, they can all be used as grounds of opposition. However, as was pointed out by everyone at the hearing, it is not possible to for “Priority Date” to be a ground of opposition. While Sepracor submitted that this “ground” should be summarily dismissed, I questioned how I could dismiss something which cannot be a ground. It would seem to me that to dismiss this “ground” would mean that the opponent could not argue a lack of priority date at the hearing. Mr Finzi indicated that this would not be the case. He indicated that dismissal would mean that Wyeth could not rely on priority date “as a separate ground of argument”, but that Wyeth would be free to amend their particulars to include statements regarding priority date. Mr Finzi’s argument places form above substance. Sepracor state that Wyeth can argue lack of priority date as a component of a ground of opposition, but not as a separate ground in its own right. There is no real distinction between the two situations. Priority date can be argued. I am of the opinion that Wyeth have attempted to take a short cut to avoid repeating the same thing under other headings. While the short cut has created confusion, I cannot accept that heading (ii) is a “ground”. It is a particular.
For the present decision, I am prepared to accept that the grounds of the opposition are those set out headings (i) and (iii) to (xi) above. I am prepared to accept that under heading (ii) is a particular that is applicable to one or more of the “grounds” I have identified. However, as I have noted above, the Statement is not totally clear. It will be necessary for Wyeth to amend their Statement so that the Grounds they are relying upon are clearly identified as “Grounds”. It will also be necessary to indicate which ground(s) “particular” (ii) applies to. I note in passing that the amended Statement that Wyeth filed did not do this.
Priority Date
Notwithstanding that it is not being treated as a ground I will discuss the submissions made by the parties. These submissions, while possibly tainted by a view of priority date being a ground, are of use to my considerations.
Sepracor submitted that the particularisation of the priority date “ground” lacked any material facts supporting a prima facie case. In their submission (and this is the case), the Statement asserts that the application “is not fairly based on priority documents US 60/127938 and US 60/167906”. Sepracor noted the particulars do not set out what features of the present application are not present in the priority documents. In Sepracor’s opinion, given the apparent triviality of the exercise of identifying the missing features, not doing so indicated that lack of merit of this “ground”. Sepracor also drew my attention to the fact that, in interference proceedings in the US between these parties for related US patents and applications, Sepracor was found to be entitled to rely on US 60/127938 while Wyeth was not. Sepracor mentioned that, as the specification of this application and the US application were substantially identical, this decision is persuasive.
Wyeth submitted, assuming the priority date “ground” is effectively a particular, that unless the particularisation is misleading or confusing, “it does not create any difficulty for a statement of grounds and particulars for the purposes of dismissal”. I was referred to Euro-Celtique S.A. v F H Faulding and Co Ltd [1999] APO 25 where, when addressing a particular that had not much more information than Wyeth has included in their Statement, it was said:
“Paragraph 3.2.3 is not a matter for opposition. However, Mr Bartlett explained that it is an explanation of Faulding's argument that the application is not entitled to its earliest priority date (mentioned in connection with the Group 2 documents). Consequently, this goes beyond the nature of the case to be answered to the detail of how the case will be argued. Extra matter should not be included in particulars if it would mislead or distract from the real case to be answered (see Sumitomo Electric Industries Ltd v BICC Plc (1993) 26 IPR 613). I consider that this information does not causes (sic) any confusion as to the case to be answered. Consequently, I consider that the inclusion of this additional information does not causes (sic) a problem which requires rectification.”
To a certain extent, I am in agreement with this sentiment. It can be said that it is clear what Wyeth is arguing – the claims are not entitled to their earliest claimed priority date. While it is an assertion, there is no confusion here. However, I also have sympathy with Sepracor’s submission that there could have been so much more included without having to go into “how the case will be argued”. Wyeth also appears to agree with this in that they have filed an amended Statement with much more detail. Nevertheless, noting the detail that Wyeth supplied during the hearing as to their concerns about the priority date, there is certainly a point here that is much more than “merely arguable” (see White Industries Aust Ltd v Commissioner of Taxation [2007] FCA 511). It cannot be said that Wyeth’s argument that the claims are only entitled to a priority date of 18 May 2009 (the date they were amended) has no reasonable prospects of success. While interference proceedings exist in the US, as noted by Wyeth, I am unsure what effect a decision under US law for US patent applications may have on the present Australian opposition. The persuasiveness (or otherwise) of that decision is something for the substantive decision.
“Ground” (i) – Manner of Manufacture

Sepracor’s submissions in relation to this ground were that this ground had no reasonable prospects of success because the specification does not admit that the invention is not novel or lacks an inventive step. Wyeth’s argument was that, assuming that the claims are not entitled to the claimed earliest priority date of 6 April 1999, but are entitled to a priority date of 18 May 2009, the specification contains indications that the invention, at that point in time, was not new or inventive.
I have already noted that there is an issue to be argued in relation to the priority date of the specification. Assuming the priority date is as contended by Wyeth, it is also true that at this date it could be said that the specification contained indications that the compound being claimed was known. Sepracor sought to diminish these indications by characterising them as being “far from an admission, on the face of the specification, that the claimed invention is not a manner of manufacture”. While that may turn out to be true in the fullness of time, that is a matter for the substantive hearing. At present it cannot be said that this ground has no reasonable prospects of success. I will not dismiss it.
“Grounds” (iii) and (iv) – Lack of Novelty and Lack of Inventive Step
Sepracor conceded that these grounds admitted to arguments and expert evidence and, consequently, they were not pressing dismissal of these grounds. Instead they focussed on the lack of particularisation. Under novelty, Sepracor pointed to the lack of references to the parts of the documents that were relevant. They also raised issues with regard to possible combinations of documents not being exemplified and a lack of specificity when the Statement refers to “prior art information in … US 7,291,347.” Under inventive step, Sepracor pointed to the failure to provide the technological nature of the common general knowledge relied upon.
Wyeth recognised that particular portions of the documents which were referred to in the novelty ground were not provided, but submitted that this did not provide a basis for dismissal. For inventive step, Wyeth submitted that the detailed explanation of the common general knowledge is done by way of evidence.
It is clear that the particularisation in Wyeth’s Statement is inadequate. If nothing else, the phrase “prior art information in … US 7,291,347.” leaves it open as to whether this is US 7291347 itself, or the prior art documents which appear on the front page of the US publication. During the course of the hearing Wyeth clarified that this was a reference to US 7291347 itself. This is also shown in the amended Statement Wyeth filed (which also included references to the parts of the documents that were relevant). Clearly Wyeth also considers that better particulars are required.
However, it is also clear that these defects in particularisation do not provide a reason to dismiss these grounds. It cannot be said that they have no reasonable prospects of success, especially in light of the doubt surrounding the priority date. I will not dismiss these grounds.
“Grounds” (v) and (vii) – Lack of Utility and Lack of Clarity
I will address these issues together as Wyeth’s submissions made it quite clear that their case was based on what they saw as a close relationship between the grounds of lack of utility and lack of clarity.
Essentially, Wyeth submitted that the terms “affective disorder” and “cerebral function disorder” were not clear. As I understood the submissions, notwithstanding that the description gave examples of what were said to be affective disorders (e.g. ADD) and cerebral function disorders (e.g. senile dementia), the scope of these terms was indeterminate. Therefore, it was unclear what other possible disorders fell within their scope. As other disorders were not discussed, there was no evidence that the invention worked for these other disorders (i.e. possibly no utility).
For their part Sepracor submitted that, for lack of utility, it was impossible to see how a claim to a method for treating an “affective disorder” or a “cerebral function disorder” would include within its scope methods which would not result in a treatment of an “affective disorder” or a “cerebral function disorder”. For lack of clarity, Sepracor submitted that the Statement did not provide any information as to why the identified phrases were not clear.
To my mind, lack of utility is a question of evidence. The same applies, in this case, for the lack of clarity. The terms “affective disorder” and “cerebral function disorder” may well have a specific meaning in the art which is not inconsistent with the guidance provided in the specification. In that case the claims would be clear and it would be possible to obtain evidence as to whether the methods of treatment worked for disorders falling within the scope of the claim. On the other hand, the terms may not be clear and this may lead to a different decision regarding utility. However, evidence is required before such decisions can be made. Noting what was said in Servier (supra), I will not dismiss the grounds of lack of utility and lack of clarity.
Notwithstanding this conclusion, the particularisation for the ground of lack of utility is extremely inadequate. Given Wyeth’s actions in filing an amended Statement, it is clear they believe that to be the case as well.
“Ground” (vi) – Lack of Sufficiency
Sepracor submitted that, for lack of sufficiency, it was “a trifle specious” for Wyeth to argue that a claim which gave a series of steps to treat an “affective disorder” or a “cerebral function disorder” could not provide enough teaching the person skilled in the art to carry out the steps. They also submitted that it was “logically inconsistent” to say that there was a lack of sufficiency and a lack of inventive step.
Given the focus of the material fact of the ground on the “claimed methods” and the fact that the methods were methods of treatment, I questioned Wyeth at the hearing how such an invention could be insufficiently described. I noted that, by their very nature, claims to methods of treatment instruct the person skilled in the art to practise the claimed invention – you provide a particular compound to an appropriate patient. The ground was not indicating that the specification did not provide teaching as to how to produce the particular compound. Wyeth submitted that the material fact in the Statement was a general particularisation which embraced a variety of teachings which were lacking – one of which was how to produce the compound. They submitted that, if a person was going to lay claim to a compound, it would be expected that the specification would include the steps that you would go through. Wyeth’s contention was that the specification didn’t do this. Instead it referred the reader to Wyeth’s US patent.
Wyeth’s case is that the method of producing the compound is not disclosed and, therefore, the claimed invention cannot be practised. However, as noted above, the method of production is not claimed. Methods of treatment are. The specification clearly indicates where to get the “starting materials” for that method of treatment – in Wyeth’s US patent. For Wyeth’s case to have a reasonable prospect of success, Wyeth would have to argue that their US patent did not show how to produce the succinate salt of ODMV (so that it could be used in the methods of treatment claimed). They did not indicate that this was their argument at all. Indeed, as noted by Sepracor, the registration by Wyeth’s of PRISTIQ ® and ECENZE ®, both of which are succinate salts of ODMV, strongly indicates that Wyeth’s US patent does produce the “starting materials”.
As an alternative, it might be argued that the correct date for determining the sufficiency of the specification was the date of filing and, therefore, as the specification at that date did not disclose where to get the starting materials, it was insufficient. Such an argument would also have to be supported by the submission that the production of the succinate salt of ODMV was much more complex that the simple statement in the present application that salts “can be formed using reactions conditions well known in the art.” However, nothing along these lines was foreshadowed by Wyeth, both in the Statement and in their submissions.
On the case that they have outlined, Wyeth has no reasonable prospects of success under this ground. I dismiss this ground.
“Ground” (viii ) – Lack of Fair Basis
For this ground Sepracor submitted that the Statement provided nothing more than a statement of the law devoid of any material facts.
Wyeth submitted that the specification as amended selected the succinate salt of ODMV. Wyeth’s contention was that Sepracor did not select the salt or consider that it had special utility, but now laid claim to that selection and utility. Their argument was that there was no real and reasonably clear disclosure of any invention but simply a reference to an invention already disclosed and claimed in Wyeth’s US patent.
To my mind, Wyeth’s arguments are not directed to fair basis. As noted in Lockwood Security v Doric Products [2004] HCA 58; 217 CLR 274; 212 ALR 1; 79 ALJR 260:
“the language [of s40(3)] points to a comparison between the claims and what is described in the specification only”
By focussing on support for the selection of the succinate salt of ODMV, Wyeth is not doing a comparison between the claims and the description. Rather they are saying that the specification as originally filed did not support a claim of the succinate salt. This is not a fair basis argument. Instead, it is an argument more applicable to allowability of amendments and the priority date to be accorded to the claims following amendment.
The argument put forward by Wyeth has no reasonable prospects of success under the ground of fair basis and, as Wyeth did not indicate any other argument under this ground, it must be dismissed.
“Ground” (ix) – Lack of Definition
For lack of definition, Sepracor submitted that the claims defined the monopoly for which the application had been made and it could not be said that they bore no relationship to what was described in the specification. They also submitted that, as this ground relied solely on the particulars for the grounds of lack of sufficiency, clarity and fair basis, there were no particulars which were relevant to this ground.
Wyeth responded that:
(i)because the claims were not clear, it followed that there is no clear definition of the invention; and
(ii)because there was no invention disclosed, just a reference to the invention in Wyeth’s US Patent (and, therefore, the specification lacked sufficiency and fair basis), it followed that there was no invention made by Sepracor defined.
In regard to (i), Wyeth’s argument under this point is that the claims do not define the invention solely because they lack clarity. That is not the law. If it was true that a lack of clarity meant a lack of definition, section 40(2)(b) of the Patents Act would have no work to do. Clearly, a claim may said to be unclear, but it does not automatically follow that it does not define the invention.
Furthermore, for the reasons given above in relation to sufficiency and fair basis, point (ii) is not relevant. I would also note that “invention” in the Patents Act includes “alleged invention”. Claims can define alleged inventions. For example, if a company’s application claimed the exact same device which was being produced by another company, while such an application would have trouble in regard to novelty at least, it would not be said to not define an invention. At the very least, the claims of the present application define an alleged invention.
It follows that this ground has no reasonable prospect of success and I dismiss it.
Other Matters
On a final point, Sepracor drew my attention to the fact that the particulars for each “ground” concluded with a statement along the lines of:
“The opponent reserves the right to add further information.”
It was Sepracor’s submission that such statements clearly indicated that Wyeth had failed to state their complete case as was required. They contended that this left Sepracor “in a position of material prejudice, arising from the incapacity of the Applicant to determine with any clarity the nature of the case to be argued”. Sepracor urged me to dismiss of the opposition in this basis. I will not do so.
As noted by Wyeth, regulation 5.9 gives the opponent the right to add further particulars and the Commissioner has no discretion in deciding whether to allow the change. As such, even if Wyeth had not made the concluding statement quoted above, it would have always been inherent that they could add further information to the particulars. Sepracor is in no more of a position of “material prejudice” than they would be in any opposition.
CONCLUSION
I have dismissed the grounds relating to lack of sufficiency, lack of fair basis and lack of definition. Wyeth cannot argue these grounds at the substantive opposition. It is also clear that the particularisation of the remaining grounds in the Statement that was originally served is poor. It leaves out a lot of the detail that Wyeth put forward at the hearing which more particularly foreshadowed their case. While it might be possible to deal with this by allowing the amended Statement that Wyeth filed on the day of the hearing, as I have already noted, even this does not overcome all the deficiencies. In such circumstances a direction for further and better particulars is warranted.
Therefore, I direct:
1.That the opponent supplies further and better particulars by filing with the Patent Office, and serving on the applicant, an amended Statement of Grounds and Particulars which:
(i)clearly identifies the grounds of opposition – in this regard I note that the amended Statement must not make any reference to the grounds of insufficiency, lack of fair basis and lack of definition;
(ii)clearly identifies which grounds the particulars relating to priority date will apply to. I leave it to the opponent as to whether this is done by an explanatory statement being made under the heading of priority date or whether the priority date particulars are listed under one ground with cross‑references made to these listed particulars under the other relevant grounds. The priority date particulars should also identify the case that the opponent will put forward. I will observe that the way the case was identified in Wyeth’s amended Statement is acceptable;
(iii)identifies the relevant passage(s) of the documents listed in the particulars under the ground of lack of novelty. I will observe that the way this was done in Wyeth’s amended Statement is acceptable;
(iv)identifies the features that the opponent believes are common general knowledge in the particulars under the ground of lack of inventive step. I will observe that the way this was done in Wyeth’s amended Statement is acceptable; and
(v)identifies the case that the opponent will put forward under the ground of lack of utility. I will observe that the way this was done in Wyeth’s amended Statement is acceptable;
2.That the opponent has one (1) month from the date of this decision to comply with this direction. If this direction is not complied with, I will give further direction(s) that the non-complying ground will not be available for the opponent to argue at the hearing of the opposition.
COSTS
Wyeth submitted that, had Sepracor made a request for further and better particulars instead of requesting dismissal, the time and expense associated with a hearing would not have been incurred by either party. On that basis, Wyeth submitted that Sepracor should pay Wyeth’s costs or, in the alternative, each party should bear its own cost.
Sepracor submitted that costs should be awarded against Wyeth regardless of the outcome. They indicated that Sepracor had gone to considerable lengths reviewing the deficient Statement and highlighting its deficiencies. They submitted that the fact that Wyeth was seeking to file an amended Statement indicated even Wyeth’s belief that the original Statement was deficient. Mr Finzi also noted that, in addition to the request for dismissal, Sepracor made a request for further and better particulars. Mr Finzi further noted, in relation to having to appear at a hearing, that Wyeth paid their appearance fee to attend the hearing before Sepracor, effectively compelling Sepracor to the time and expense associated with a hearing.
It is usual for costs to follow the event. In the present case, Sepracor has been successful in that some grounds have been dismissed. However, Sepracor has also been unsuccessful in that other grounds have not been dismissed. Moreover, in my opinion, the remaining grounds are more “serious”. On the other hand the Statement originally served by Wyeth had serious deficiencies in the particularisation of the grounds and, indeed, was not totally clear as to the actual grounds of opposition. It may have been the case that, had Wyeth taken more care when initially drafting their Statement, this action may not have been necessary. While Sepracor did make a request for further and better particulars, they requested, and paid for, a request for dismissal. Ultimately it is Sepracor that is responsible for the hearing. In any event, Sepracor did not have to appear in person before me and it can be said that Wyeth’s payment of an appearance fee did not compel Sepracor to appear.
Taking into account all these factors, I believe that an award of costs is not appropriate. Consequently, each party is to bear its own costs in this matter.
GREG POWELL
Delegate of the Commissioner of Patents
29 April 2010
Patent attorneys for the applicant : Pizzeys Patent and Trade Mark Attorneys, Canberra
Patent attorneys for the opponent : Spruson & Ferguson, Sydney