Genelabs, Technologies Inc. v Murex Diagnostics Australia Pty Limited
[1996] APO 47
•2 October 1996
official notice
decision of a delegate of the commissioner of patents
Application : No. 660925 in the name of GENELABS TECHNOLOGIES, INC
Title: Hepatitis C Virus Epitopes
Action: Opposition to grant by MUREX DIAGNOSTICS AUSTRALIA LIMITED, requests to defer the opposition proceedings and for directions.
Decision: Issued .
Abstract: Request for deferral of proceedings refused.
I have given Directions for further and better particulars in regard to manner of manufacture and common general knowledge; and that particulars for manner of manufacture and common general knowledge that provide no material facts be unavailable to be argued at the opposition proceedings.
The question of whether it is appropriate to request further and better particulars could be resolved upon considering the comments of B.C.Cairns in Australian Civil Procedure 3rd Ed. (1992) at pages 120-122:
“A party is entitled to know every material fact on which the opponent relies. The nature and character of the charge must be known with such precision that the party can prepare a brief, and not be taken by surprise.
Two principles may be discerned from these broad statements. In the first place, the particulars inform the opponent of the case to be met at the hearing. Secondly, the particulars limit the generality of the pleadings, so as to more sharply define the issues.
When a pleading is properly particularised the party is bound by the particulars.
Two situations must, however, be distinguished. One is that a pleading may allege albeit inadequately all the material facts. In that case, it is proper for it to be supplemented by the separate delivery of particulars. The second situation is that of a pleading that does not allege the material facts at all. Where that occurs, the deficiency may not be cured by the delivery of particulars. Such pleadings, or at least the defective allegations, should be struck out. This is, it is submitted, the correct position in law, but a good deal of latitude is allowed by the courts in applying it."
Whether further and better particulars are appropriate will involve considering the circumstances surrounding the request.
There may be circumstances where the particulars do not provide any material facts. In these circumstances further and better particulars are inappropriate and the Commissioner may direct that the ground is to be dismissed, if there are no remaining particulars, or that the particular is not to be relied on at the substantive opposition hearing.
There may be circumstances where the particulars do provide material facts but do not clearly or adequately describe the case to be defended. In these circumstances further and better particulars are required.
There may be circumstances where the particulars do not clearly or adequately describe the case to be defended and they refer to unusually large numbers of complex documents. In these circumstances further and better particulars are required.
There may also be circumstances where the case to be defended is clearly stated but the particulars refer to unusually large numbers of complex documents; or circumstances where the opposed application is unusually complex. In these cases the remedy may lie, not in further and better particulars, but in a properly justified request for an extension of time. There may be clear justification for an extension of time where there are complex documents and applicant wishes to pursue complete or partial dismissal of the opposition under regulation 5.5(1)(a), which has a one month prescribed time. Otherwise, the allocation of sufficient resources to the task of understanding the case to be defended and serving evidence may be a relevant consideration in determining whether there is justification for an extension of time to meet the requirements of the regulations for serving evidence.
In the normal course of events, in a patent opposition, an applicant would have six (6) months, from service of the statement of grounds and particulars, in which to serve evidence in answer. This should normally be sufficient time for an applicant to understand the case to be defended and to serve evidence.
patents act 1990
decision of a delegate of the commissioner of patents
Re:Patent Application No. 660925 by Genelabs, Technologies Inc. and an opposition thereto by Murex Diagnostics Australia Pty Limited and a request by the opponent for deferral of opposition proceedings and by the applicant for directions.
background
Australian patent application number 77434/91 was filed as an application under the PCT on 6 April 1990 by Genelabs Incorporated. The applicant later changed its name to Genelabs Technologies, Inc (Genelabs). It claims priority from US applications 505611 (6 April 1990) and 594854 (9 October 1990).
The application was advertised accepted on 13 July 1995 and assigned the number 660925. Murex Diagnostics Australia Pty Limited (Murex) filed a notice of opposition on 13 October 1995 and served a statement of grounds and particulars on 15 January 1996. This opposition is yet to be heard.
On 18 January 1996 Murex filed a request to defer the s.59 opposition proceedings pending the outcome of a Federal Court action:
“The issues that have been raised in this opposition are the same or similar to issues which are presently before the Federal Court of Australia in the matter Murex Diagnostics Australia Pty Limited & Anor v Chiron Corporation & Anor Action No. 106 of 1994. The trial in the proceedings will commence on 24 June 1996. Substantial evidence has been prepared by the parties.
The patent applicant in this Opposition entered into various agreements with Chiron Corporation in march 1995. The effect of those agreements means that the Chiron Corporation has acquired the rights to this particular patent application.
So to avoid incurring unnecessary costs and given the proceedings before the Federal Court we ask on behalf of our client that the Commissioner defer the Opposition proceedings until after the Federal court hands down its judgement.
With respect to patent application no. 640920 we note that the Commissioner of Patents has held this application in deferral pending the outcome of the proceedings before the Federal Court.”
On 13 March 1996 Genelabs objected to the request for deferral of the opposition and requested the Commissioner to issue Directions for further and better particulars, under r.5(10), as follows
“(i) That the ground listed as item 1 in the regulation 5.4 statement may not be relied on at the hearing for the opposition.
(ii) That items 2.1, 3.1, and 4.1 should be amended to clearly indicate by page and line number the relevant passages in the prior art documents.
(iii) That particulars 5.1, 6.1 and 7.1 may not be relied upon at the hearing for the opposition.
(iv) That particulars 5.2, 6.2 and 7.2 may not be relied on at the hearing for the opposition.
(v) That items 5.3, 6.3 and 7.3 may not be relied upon at the hearing for the opposition.
Both matters were heard together in Canberra on 13 June 1996.
Genelabs was represented by Mr Ken Hamilton of Phillips Ormonde & Fitzpatrick patent attorneys, and Murex by Mr Luigi Palombi of Banki Palombi Haddock & Fiora solicitors and intellectual property attorneys, both of Sydney.
The invention relates to hepatitis C virus epitopes.
SUBMISSIONS
Deferral of proceedings
Murex
The significance of the case in the Federal Court is that it will be the first time in Australia that a court will be examining a series of legal issues concerning the patentability per se of gene sequences and the industrial application of those sequences in various forms such as diagnostic kits, vaccines.
This Federal Court action will no doubt result in a number of points of law that will indicate to the parties and the Patent Office how far one can go.
This will be relevant as to whether the opponent wants to continue with the opposition or to the extent and the nature of the evidence that is to be put on in furthering the opposition.
The evidence that has been put forth in this Federal Court case by both parties is extensive. Both parties have filed affidavits from no less than 14 experts who are permanent in their fields.
The present Genelabs application does not mirror the Chiron patent word for word but for all intents and purpose is directed to the same end.
The opposition in relation to patent application no. 640920 has been deferred pending the outcome of proceedings before the Federal Court.
It is therefore more cost effective and in the best interests of the Patent Office for this opposition to be deferred.
Genelabs
The Hearing Manual states that the Commissioner prefers not to hear and decide matters before him that are essentially before the Court. However, where a party wants the matter heard and decided by the Commissioner, and can demonstrate good reason why, ... the Commissioner may proceed to hear and decide the matter.
In the current matter, the opponent has not established any relevance of the pending Court proceedings.
We note that these proceedings relate to different parties, different patent specifications and, in our opinion, different alleged inventions. (This is prima facie supported by the opinion that the Examiner considered the claims of the present application novel in light of the patent the subject of the court proceedings.)
At best, the pending Court proceedings may be considered to relate to having a similar subject matter.
The applicant has already incurred a large cost in processing the patent application to this stage and it is in the applicant’s interest to obtain a granted patent as soon as possible.
The effect of not granting a deferral is that the following events would occur:
(a)the issue of the adequacy of the statement of grounds and Particulars would be decided, and
(b)a due date for the lodgement of the evidence in support would be set.
In the applicant’s opinion, both these issues are highly desirable as they would ensure that no undue delay would occur and the applicant would be in a position to know the case to be answered; in the event the opponent would still be able to argue any new effect of the law at the substantive hearing.
In the event that the pending Federal Court Proceedings changed the issues of fact, the opponent could claim exceptional circumstances and suitable reasons to adduce further evidence as allowed by the Regulations.
Thus, in the applicant's opinion, no undue prejudice is placed on the opponent by refusing the request for deferral.
The Commissioner must consider not only the interests of the applicants and opponents, but those of the public by ensuring
(a) that worthless patents are not granted, and
(b) that there are no unreasonable delays.
(see Vangedal-Neilson V. Smith (Commissioner of Patents) 33 ALR 144, Roussel-Uclaf v Shell International and Ciba-Geigy (1987) 9 IPR 475 and BASF Corp v ICI Australia Operations 13 IPR 458)
In the applicant's opinion, as the deferral requested at this time does not relate to the substantive hearing, a refusal of the deferral does not result in a potentially invalid patent being granted. Further, by refusing the deferral no unreasonable delays will be experienced.
Accordingly on the balance of interests the applicant believes that a deferral for filing evidence in support should not be granted.
Further and better particulars
Genelabs
The applicant is asking for an indication in the statement of grounds and particulars of which claims the grounds are being directed to.
The purpose of the Statement of grounds and particulars is for the applicant to have fair notice of the case it has to defend at the time the statement is filed.
It is established that mere enumeration of the requirements of the Act is not a sufficient statement of particulars. (24 IPR 77, CSIRO v CEM Corp 29 IPR 72)
In the present case the applicant submits that, in particulars 1.1 and 1.2, and in particulars 5.1, 6.1 and 7.1, the opponent has merely enumerated the requirements of the Act.
The adequacy of particulars and material facts to support grounds alleging that the invention does not relate to a manner of manufacture has been considered in L’Air Liquide v CIG 24 IPR 77 and Dupont v Dow Elanco 30 IPR 25.
In the current Statement, no material facts have been provided at all in particulars 1.1 and 1.2. In item 1.3 reference to the common general knowledge as material fact is noted. However, the applicant submits that the reference to eighty-nine documents implies that this particularises nothing.
In the present case, the opponent has referred to seven, nine and nine documents in particulars 2.1, 3.1 and 4.1. However, the documents are not simple or short documents - they range from sixty to two hundred and thirty pages each and under these circumstances, the applicant believes that further and better particulars of their relevance need to be provided.
In particulars number 5.2, 6.2 and 7.2 the opponent has referred to eighty-nine documents. Again, due to the length and large number of documents, the applicant submits that these references in fact particularise nothing.
By reference to the ambiguous term “The alleged invention”, the opponent has not identified which of the claims of the application have been objected to. Thus, the applicant has not been presented with a clear case to answer.
The particulars in the Chiron case are irrelevant in this case.
Murex
The Regulations require a simple straight forward document that alerts the applicant to what the issues are. It is not there to go into chapter and verse about where the material to be relied on is located. The document is simply there to set the parameters out of what the argument is going to be. It is for the evidence to set out the factual basis for what the ultimately substantive hearing will decide.
It is matter for the substantive hearing for the parties to put forward their submissions to tie the evidence up with the particulars at that hearing.
There is logic behind the filing of various documents and to go beyond that is to cause problems.
In relation to para 1.1 there are two points. Firstly, the statement that alleged invention is a mere discovery tells the applicant that the opponent does not know what the invention is. Is it the sequence, a process or what? Secondly in so far that there is an invention it does not comply with the Statute of Monopolies, that is it is not a manner of manufacture, it is a mere discovery. It is therefore for the evidence to set out how that issue is going to be expanded upon. To go any further than this is to get into argument about why there is no manner of manufacture. Consequently as the opponent does not know what is the invention it is impossible to provide further particulars.
All this will be described clearly when the evidence is in. It is not a matter for the opponent to go into chapter and verse at this stage.
Patent office decisions are not binding law. The hearing officer should look at the requirements of the Patent Regulations, look at the requirements of the Courts, all of which are set out in the Court Rules, and look at the particulars of invalidity in the Chiron case. There is no justification to provide further and better particulars.
Each party made submissions on costs.
DECISION
Deferral of proceedings
To defer opposition proceedings I will have to issue a Direction under regulation 5.10(1) that the time for serving evidence-in-support be deferred until an appropriate time after the Federal Court decision was handed down. This period of time would be, in my view, the unexpired time for serving evidence left after the letter requesting deferral by Murex.
Regulation 5.10(1) provides that:
(1)The Commissioner may, on his or her own motion or on the application of a party:
(a)give a direction that is not inconsistent with the Act or these Regulations for the conduct of proceedings to which this Chapter applies; or
(b)determine that a period prescribed in this Chapter is to be extended by such further period as the Commissioner reasonably allows.
Subregulation 5.10(5) sets out the conditions under which the Commissioner to gives a direction under regulation 5.10(1). This subregulation provides:
“(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 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.”
I note that, before I can issue a Direction in this matter, I must be reasonably satisfied that the Direction is appropriate in all the circumstances. If I am not so satisfied, I cannot give the Direction.
For administrative convenience, the Commissioner prefers not to hear and decide matters before him that are essentially before the court, pending the outcome of the court action - see Ferocem v Hightech Auto Tools (unreported decision on Petty Patent 621027, issued 1 October 1993). However where a party wants the matter heard and decided by the Commissioner, and can demonstrate good reason why the Commissioner ought not await the decision of the Court, the Commissioner may proceed to hear and decide the matter.
In the present circumstances, however, the opposition is not directly related to a matter that is before the court.
The relationship is in the sense that the court will be examining a series of legal issues concerning the patentability per se of gene sequences and the industrial application of those sequences in various forms. The findings of the court in this matter may or may not have an effect on the present opposition.
Murex has put forward submissions about the pending Federal Court decision and about the cost effectiveness of deferring the opposition until the Federal Court decision was handed down.
Genelabs, on the other hand, submits that Murex has not established any relevance of the Federal Court proceedings to the present proceedings beyond the similarity of the legal issues involved.
They also submit that they have incurred large costs in processing the application to date and that it is in their interests to obtain a granted patent as soon as possible.
They also submit that if I did not grant a deferral the following events would occur:
the issue of the adequacy of the Statement of grounds and Particulars would be decided;
a due date for service of evidence in support would be set; and
that there were avenues available to the opponent to adduce further evidence should the need arise.
I have looked at the deferral action in application no. 640920 referred to by Murex. In application no. 640920 both parties were agreeable to the opposition being deferred. This is not the case in the present proceedings.
In deciding whether to issue a Direction to defer proceedings I must consider the interests of the parties and the public interest.
The interests of the applicant for a patent are usually best served if the delay in proceeding to patent grant is minimised. The interests of the opponent are, of course, best realised on the basis of obtaining indefinitely extending periods of extension whereby to facilitate obtaining the maximum amount of evidence to demonstrate the invalidity of any patent that might be granted on the application. The public interest overrides the private interests only to the extent that it resides in the requirement for a balance between the state of uncertainty in which the application can exist given delay in the action, and the risk inherent in rapid, superficial or incomplete proceedings which might lead to the grant of an invalid patent. Unreasonable delays in the action will generally not be in the public interest in view of "the desirability of operating the [opposition] system efficiently".
I cannot defer opposition proceedings on the basis of the submission by Murex. That is, that the Federal Court might hand down a decision changing the law to significantly affect these proceedings. To defer on such a basis, would in my view, be unreasonable as there is an equal probability that the Court might not hand down such a decision or that the parties may settle out of Court.
Consequently, I will not issue a Direction under r.5.10(1) to defer proceedings.
Further and better particulars
Before addressing the specific issues in this action I will restate the function of and requirements of a statement of grounds and particulars in an opposition action. The current state of practice is, I believe, fairly set out in the Australian Patent Office Manual of Practice and Procedure, Volume 3.
“11.2.1 The Function and Consequence
The function of the statement of grounds and particulars is to give the applicant fair notice of the case to be met, and to define the issues of the opposition. The opponent is bound by the statement of grounds and particulars, and its case is confined to the issues raised in that statement, unless it is amended under reg 5.9.”“11.2.3 Requirements for the Statement of Particulars
The statement of particulars should be in summary form, and be as brief as the nature of the opposition permits; however, it is essential for the statement of particulars to set out the material facts on which each ground of opposition is based (but not the evidence by which those facts are proved).....
Where a ground of objection relates to deficiencies in the specification or other documents, the particulars should identify those deficiencies.....
Whatever the generality adopted in the statement of grounds and particulars, it must be consistent with the purpose of the statement of grounds and particulars; although a statement of particulars may bring in all the facts necessary to establish a ground of opposition, it will be defective if it is of such generality that it is insufficient to properly inform the applicant of the case it has to meet.....
Directions can also be made, in relation to grounds including particulars that provide no material facts, that these particulars be unavailable to the opponent to argue at an opposition hearing. A ground can be dismissed where none of the particulars provide material facts. (E.I. DuPont de Nemours and Company v DowElanco 30 IPR 25)
Each statement of ground of opposition must include at least one corresponding statement of particulars. A statement of grounds that is not supported by a statement of particulars is open to dismissal under reg 5.5.
Where the statement of grounds and particulars includes more than 10 particularised documents in respect of any one ground, the statement is required to briefly and generally identify what information in each of these documents is relied upon in relation to the particular ground of opposition.”
Murex have referred me to the Federal Court rules relating to statements of particulars and provided me with a copy of the amended statement of Particulars of Invalidity for their Federal Court action G106 of 1994 against the Chiron Corporation. The submission is that what is sufficient for the Federal Court should be sufficient for the Australian Patent Office.
I agree with the general principle that the Patent Office should follow the Court. However, the Federal Court proceedings in this instance are to do with the validity of a granted patent and the present proceedings involve a patent application that has not yet proceeded to grant. In this case I must consider not only the private interests of applicants for patents and opponents, but also the public interest. The public interest involves ensuring that invalid patents are not granted, and that proceedings are not unreasonably protracted. (Vangedal-Nielsen 33 ALR 144 and Ferocem Pty Ltd v Commissioner of Patents 28 IPR 243)
The Particulars of Invalidity submitted by Murex provide particulars drafted similarly to those listed in the present proceedings, including the details of document references (there are no references to page or line numbers). However, the Particulars of Invalidity provide a more detailed picture the nature of the case to be defended, including references to claims in some instances.
The adequacy of the statement of grounds and particulars in opposition proceedings before the Patent Office therefore appears, in my view, to relate to a question of whether or not the statement of grounds and particulars clearly and adequately describes the nature of the case to be defended. If it does clearly and adequately describe the nature of the case (and give material facts) then there is no need for further and better particulars.
A statement of grounds and particulars is required to be in summary form and as brief as the nature of the opposition permits. Borden v Elkem (1992) AIPC 90-893 stated that a purposive construction should be applied to the statement of grounds and particulars.
In Dupont v DowElanco (supra) there were finally 4-5 hundred references. This made the requirement for page and line references appropriate. In Trenton v Cotterill 28 IPR 629, and ICI v Irenco 26 IPR 154 only a brief identification of the information relied on in each document was required. In Mobay 24 IPR 379, it was stated that the particulars in that case went beyond the material facts to an arguing of evidence.
In her decision in Dominion Mining v Tech. Resources 31 IPR 609, the hearing officer made the following comment:
“The decisions in ICI v Irenco (supra) and DuPont v DowElanco (supra) state that a large number of documents provide no particulars at all and that more than 10 documents may be too many unless specific page and line references are given. However I do not believe that we can set down any rigid numerical limit. Each case must be treated on its merits taking all relevant factors into account. The overriding consideration must be whether the applicant can reasonably be expected to understand the case presented. Just because there are more than 10 documents does not necessarily mean that the applicant will be unable to understand the case against them. What it means is that there may be a need for further particularisation and this must be considered in the light of the specific facts of the case. Further, it would be only in very unusual circumstances that citing more than 20 documents could be adequate without further particularisation.” (my emphasis)
It seems to me that the change of practice brought about by ICI v Irenco (supra) has lead to some lack of clarity about what can be reasonably expected to be provided in a statement of grounds and particulars for an applicant to understand the case to be defended in a patent opposition. The practice needs to be clarified.
The question of whether it is appropriate to request further and better particulars could be resolved upon considering the comments of B.C.Cairns in Australian Civil Procedure 3rd Ed. (1992) at pages 120-122:
“A party is entitled to know every material fact on which the opponent relies. The nature and character of the charge must be known with such precision that the party can prepare a brief, and not be taken by surprise.
Two principles may be discerned from these broad statements. In the first place, the particulars inform the opponent of the case to be met at the hearing. Secondly, the particulars limit the generality of the pleadings, so as to more sharply define the issues.
Further particulars were ordered in Lemon & Co. Pty Ltd v Moran and Cato Pty Ltd [1921] V.L.R. 240. There the plaintiff sued because the defendant was alleged to be passing off the plaintiff’s product as its own. In the statement of claim, the plaintiff charged that the defendant was selling baking powder from its shops as having been manufactured by the plaintiff. The plaintiff had not manufactured the powder. Thirteen instances were alleged, but no further identification of the instances was given. The defendant operated a large number of shops in central and suburban Melbourne. But the pleadings did not allow it to isolate the transactions referred to, or to understand the circumstances surrounding the sales. To remedy that, the court ordered further and better particulars to enable the defendant to identify the sales complained of and the surrounding circumstances. Names and addresses of the purchasers were refused on the ground that evidence ought not, generally speaking, be made available under the guise of particulars...
When a pleading is properly particularised the party is bound by the particulars.
Two situations must, however, be distinguished. One is that a pleading may allege albeit inadequately all the material facts. In that case, it is proper for it to be supplemented by the separate delivery of particulars. The second situation is that of a pleading that does not allege the material facts at all. Where that occurs, the deficiency may not be cured by the delivery of particulars. Such pleadings, or at least the defective allegations, should be struck out. This is, it is submitted, the correct position in law, but a good deal of latitude is allowed by the courts in applying it."
Whether further and better particulars are appropriate will involve considering the circumstances surrounding the request.
There may be circumstances where the particulars do not provide any material facts. In these circumstances further and better particulars are inappropriate and the Commissioner may direct that the ground is to be dismissed, if there are no remaining particulars, or that the particular is not to be relied on at the substantive opposition hearing.
There may be circumstances where the particulars do provide material facts but do not clearly or adequately describe the case to be defended. In these circumstances further and better particulars are required.
There may be circumstances where the particulars do not clearly or adequately describe the case to be defended and they refer to unusually large numbers of complex documents. In these circumstances further and better particulars are required.
There may also be circumstances where the case to be defended is clearly stated but the particulars refer to unusually large numbers of complex documents; or circumstances where the opposed application is unusually complex. In these cases the remedy may lie, not in further and better particulars, but in a properly justified request for an extension of time. There may be clear justification for an extension of time where there are complex documents and applicant wishes to pursue complete or partial dismissal of the opposition under regulation 5.5(1)(a), which has a one month prescribed time. Otherwise, the allocation of sufficient resources to the task of understanding the case to be defended and serving evidence may be a relevant consideration in determining whether there is justification for an extension of time to meet the requirements of the regulations for serving evidence.
In the normal course of events, in a patent opposition, an applicant would have six (6) months, from service of the statement of grounds and particulars, in which to serve evidence in answer. This should normally be sufficient time for an applicant to understand the case to be defended and to serve evidence.
Genelabs submits that in particulars 1.1 1.2, and 1.3 and in particulars 5.1, 6.1 and 7.1, the opponent has merely enumerated the requirements of the Act and has provided no material facts. Section 1 of the statement of grounds and particulars deals with manner of manufacture and sections 5, 6 and 7 with inventive step.
Genelabs further submits that the opponent has referred to seven, nine and nine documents in particulars 2.1, 3.1 and 4.1 and that the documents are not simple or short documents - they range from sixty to two hundred and thirty pages each and under these circumstances, the applicant believes that further and better particulars of their relevance need to be provided. Sections 2, 3 and 4 of the statement of grounds and particulars deal with novelty.
In particulars numbers 5.2, 6.2 and 7.2 Murex has referred to eighty-nine documents. Again, due to the length and large number of documents, Genelabs submits that these references in fact particularise nothing.
Genelabs submits that particulars 5.3, 6.3 and 7.3 are irrelevant with regard to the lack of inventive step.
My findings are as follows:
In general.
Genlabs submits that the case to answer is not clear because the claims to which the grounds and particulars apply have not been identified. They also submit that the words “the alleged invention” are ambiguous and do not allow the applicant to identify the claims to which a ground applies.
Section 18 (1) (a) or (b) of the Act, to which section 59 refers, says that
“18. (1).... a patentable invention is an invention that, so far as claimed in any claim:
(a) ....
(b) when compared with the prior art base ....(1) is novel; and
(ii) involves an inventive step; and”
I interpret the words “so far as claimed in any claim” to refer to individual claims. In my view, this would mean that each claim must be dealt with individually. Consequently, for an applicant to clearly understand the case to be defended, an opponent should identify the claim or claims to which grounds and particulars apply.
I do not think the reference to “the alleged invention” causes any difficulty; after all allegations about patentability form the basis of statements of grounds and particulars. The reference to “each claim” means, in my view, that the particular ground and the relevant particulars apply to each and every claim of the specification. If this is found not to be the case in the substantive hearing it may be a factor to consider in awarding costs.
In particular.
Ground 1
The alleged invention is not a patentable invention in that, so far as claimed in each claim, it is not a manner of manufacture within the meaning of Section 6 of the Statute of monopolies.
Particulars
1.1 The alleged invention is a mere discovery.
1.2The alleged invention is the discovery of polypeptide sections of HCV, it is not a patentable invention as it had already been discovered at the earliest priority date.
1.3The complete application (the specification) does not disclose an inventive idea or step, having regard to any one or more of:
(a)the disclosure in the specification; and
(b) the common general knowledge in Australia before the priority date of each claim in the specification referred to in the particulars of the inventive step ground hereof.
I agree that particular 1.1 is neither clear nor adequate in the present circumstances. The reference to “mere discovery” does not clearly define the nature of the discovery or identify the circumstances surrounding the discovery. Consequently, the applicant is not in a position to understand the case to be defended...
Particular 1.2 clearly identifies the nature of the prior discovery but does not identify the earlier disclosure(s). That is, it does not allow the applicant to isolate the earlier instance(s) of the discovery or identify the circumstances surrounding the earlier instance(s) of the discovery. There is nothing to suggest that this particular was intended to be read in conjunction with the particulars of ground 2.
Particular 1.3 (a) provides a clear material fact, that is a reference to the entire patent specification. 1.3 (b) is inadequate in that it does not identify what common general knowledge is relied on, that is, it’s technological nature. It is also not clear whether this particular was intended to be read in conjunction with the references in ground 5.
There is also nothing to suggest that particulars 1.2 and 1.3(b) were intended to be read together in some way.
Ground 2
The alleged invention is not a patentable invention in that, so far as claimed in each claim, it was not novel as at the earliest priority date.
Particulars
2.1Hereunder the opponent relies upon the following prior art documents which fall under section 7(1) of the Patents Act 1990 (the Act) at the earliest priority date:
2.1.1AU 639560 (76510/91) Combinations of Hepatitis C Virus (HCV) Antigens for use in Immunoassays for Anti-HCV Antibodies CHIRON CORPORATION;
2.1.2AU 640920 (52783/90) Diagnosis and Vaccines CHIRON CORPORATION;
2.1.3AU 642942 (68175/90) Viral Agent THE WELLCOME FOUNDATION LIMITED;
2.1.4AU 638304 (68390/90) Hepatitis C Assay ABBOTT LABORATORIES.
2.1.5AU 624105 (27967/89) NANBV Diagnostics and Vaccines CHIRON CORPORATION;
2.1.6 Choo et al, Science 244 359 (1989)
2.1.7 Choo et al British Medical Bulletin 46 423 (1990)
Ground 3
Further, or in alternative, the alleged invention was not a patentable invention in that, so far as claimed in each claim it was not novel as at the second priority date.
Particulars
3.1The applicant refers to and repeats the particulars set out under paragraph 2.1 and in addition refers to the following prior art documents which falls under section 7(1) of the Patents Act 1990 (the Act) at the second priority date.
3.1.1AU 635124 (74399/91) peptides for the Detection Diagnosis and Prevention of hepatitis C UNITED BIOMEDICAL INC.;
3.1.2 Choo et al British Medical Bulletin 46 423 (1990)
Ground 4
Further, or in alternative, the alleged invention was not a patentable invention in that, so far as claimed in each claim it was not novel as at the second priority date.
Particulars
4.1The applicant refers to and repeats the particulars set out under paragraph 2.1 and 3.1.
Particulars 2.1, 3.1 and 4.1 are clearly adequate in that the applicant is left in no doubt about the case to be defended. The mere fact that there are lengthy documents in each particular does not of itself suggest the need for further particularisation.
Ground 5
The alleged invention is not a patentable invention in that, so far as claimed in each claim, it did not involve an inventive step as at the earliest priority date.
Particulars
5.1Hereunder the opponent relies upon common general knowledge in Australia as it existed before the earliest priority date.
5.2Without prejudice to the generality of 5.1 the opponent relies upon the matter set out hereunder which formed part of the common general knowledge in Australia before the earliest priority date.
5.2.1Mason et al (1987) Virology 156 348
5.2.2Huynh et al “Constructing and screening cDNA libraries in lambda gt 10 and lambda gt 11” DNA Cloning Vol 1 (Ed D.M. Glover) chapter 2 IRL Press (1985)
5.2.3Sanger PNAS 74, 5463, 1977
5.2.4Bradley et al “Post-transfusion non-A non-B hepatitis in chimpanzees. Physicochemical evidence that the tubule-forming agent is a small enveloped virus” Gastroenterology 88, 773 (1985)
5.2.24Maniatis Molecular Biology (1982 and 1987 ed)
There are 89 references listed under particulars paragraph 5.2. I have listed a few to give the flavour of the references. Apart from 5.2.24, which is a 3 volume laboratory manual, they all appear to be papers from journals or other publications.
5.3Further, without prejudice to the generality of 5.1 and 5.2 the opponent relies upon common general knowledge together with the documents set out in the particulars under paragraph 5.2 which constitutes prior art information referred to in paragraphs (a) and (b) of Subsection 7(3) of the Act.
Ground 6
Further, or in alternative, the alleged invention was not a patentable invention in that, so far as claimed in each claim it was not novel as at the second priority date.
Particulars
6.1Hereunder the opponent relies upon common general knowledge in Australia as it existed before the second priority date.
6.2Without prejudice to the generality of 6.1 the opponent relies upon the documents set out paragraph 5.2 which formed part of the common general knowledge in Australia before the second priority date.
6.3Further, without prejudice to the generality of 6.1 and 6.2 the opponent relies upon common general knowledge together with the documents set out in the particulars under paragraph 5.2 which constitutes prior art information referred to in paragraphs (a) and (b) of Subsection 7(3) of the Act.
Ground 7
Further, or in alternative, the alleged invention was not a patentable invention in that, so far as claimed in each claim it was not novel as at the second priority date.
Particulars
7.1Hereunder the opponent relies upon common general knowledge in Australia as it existed before the latest priority date.
7.2Without prejudice to the generality of 7.1 the opponent relies upon the documents set out paragraph 5.2 which formed part of the common general knowledge in Australia before the second priority date.
7.3Further, without prejudice to the generality of 7.1 and 7.2 the opponent relies upon common general knowledge together with the documents set out in the particulars under paragraph 5.2 which constitutes prior art information referred to in paragraphs (a) and (b) of Subsection 7(3) of the Act.
I agree that particulars 5.1, 6.1 and 7.1 are neither clear nor adequate in the present circumstances in that they do not identify the common general knowledge relied on. The reference to “common general knowledge as it existed in Australia” is not a material fact but a statement of the requirements of the Act. It presumably includes something, not identified, other than that included in the second and third particulars in each case. Each particular is also inadequate as in neither case is the technological nature of the common general knowledge clearly identified.
Particulars 5.2, 5.3, 6.2, 6.3, 7.2 and 7.3, in each case refer to “common general knowledge in Australia”.
In an unreported decision on application No 632857 published on 10 June 1994 (Hoffman-La Roche v Bresatec), the hearing officer said that for common general knowledge the references given are not the common general knowledge. Rather they are illustrations of the matters that are asserted to be common general knowledge. In this regard, they are evidence that the fact is correct, not that the fact is part of the common general knowledge. Therefore the references are merely illustrative and not essential to a clear understanding of the case to be defended.
It is different in the case of novelty where the references themselves are a material fact in the lack of novelty and are necessary to a clear understanding of the case to defended.
What is needed, in these particulars, is a clear statement of the aspect of common general knowledge relied on. The 89 references describe a variety of different aspects of technology. Consequently, it is unreasonable to expect the applicant to chose which aspect or aspects to base its case on. Consequently the applicant is not in a position to understand the case to be defended.
Consequently, I find that there is no need to further particularise the references listed in particular 5.2 and referred to in other particulars.
CONCLUSION
I have found that:
for an applicant to clearly understand the case to be defended, an opponent should identify the claim or claims to which grounds and particulars apply. The opponent does so in this case;
particular 1.1 is neither clear nor adequate in the present circumstances in that it does not identify the nature of the discovery or provide any material facts;
particular 1.2 clearly identifies the nature of the prior discovery but does not allow the applicant to isolate the earlier instance(s) of discovery or identify the circumstances surrounding the earlier instance(s) of discovery;
particular 1.3 (b) is inadequate in that it does not identify the common general knowledge relied on;
particulars 5.1, 6.1 and 7.1 do not provide any material facts; and
particulars 5.2, 5.3, 6.2, 6.3, 7.2 and 7.3 are not clear in that they do not identify the common general knowledge relied on.
Consequently, I direct that particulars 1.1, 5.1, 6.1 and 7.1 may not be relied on in the opposition hearing.
I also direct that within 4 weeks from the date of this decision further and better particulars be filed for particulars 1.2, 1.3(b), and for particulars 5.2, 5.3, 6.2, 6.3, 7.2 and 7.3. If a satisfactory response is not received within that time I will give a direction that the particulars, the subject of this direction, may not be relied on in the opposition hearing. If this results in a ground having no particulars left to support it I will then dismiss this ground.
I also direct that the further and better particulars be provided by amending the statement of grounds and particulars, and that a copy be served on the applicant.
The time for serving evidence in support ended on 13 July 1996. Murex has requested another extension to 13 October 1996. As Genelabs has indicated, in a letter dated 16 July that they will not oppose this extension, I grant the extension..
COSTS
I have not allowed Murex’s request for a deferral of the opposition proceedings and have directed them to provide further and better particulars for part of Genelab’s request. On balance, I award costs against Murex.
Bob Sawyer
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Phillips Ormonde & Fitzpatrick, Sydney
Solicitors and intellectual property: Banki Palombi Haddock & Fiora, Sydney
attorneys for the opponent
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