Emory University v Biochem Pharma Inc
[1998] APO 50
•14 September 1998
official notice
decision of a deputy commissioner of patents
Patent Application : 658136 in the name of Emory University
Title: Method and compositions for the synthesis of BCH-189 and related compounds
Action: Opposition by Biochem Pharma Inc, a notice under s.210(c) requiring Biochem Pharma Inc produce 17 documents, and in the matter of lawful excuse.
Decision: Issued .
Abstract
The Commissioner issued a notice requiring Biochem Pharma Inc to produce 17 documents. Biochem Pharma Inc claimed lawful excuse for not producing the documents. Those documents had been identified as a result of discovery proceedings in the USA, and Emory had obtained leave from a US Court to put them before the Commissioner, conditional upon the Commissioner considering the documents in confidence.
1. The opponent acceded to the jurisdiction of the Commissioner to require production of the documents (which were not located in Australia).
2. No-one at the hearing had constructive knowledge of the content of the documents. Hence relevance could only be assessed on an 'adjectival' basis.
3. While evidence of the notional person skilled in the art in Australia is paramount for a number of issues, the credibility of such evidence may properly be assessed by having regard to what happened elsewhere.
4. While Biochem Pharma Inc suggest that the 17 documents would be taken out of context, the mere reference to there having been 400,000 pages of documents discovered was insufficient to show that it would be onerous to provide context.
5. While the production will inevitably delay the proceedings, in the present case such delay was not counter to the public interest.
6. Where the Commissioner invoked Regulation 4.3(2)(b), both the documents produced, and any other copy of those documents filed (such as in evidence) are prescribed documents for the purpose of s.55 of the Patents Act.
§ Upon production of the documents, the Commissioner would invoke regulation 4.3(2)(b). As a result, the documents produced would be maintained confidential before the Commissioner.
§ If Biochem Pharma Inc is correct in asserting that documents produced are not thereby filed, then any copies of the documents filed in evidence would still be prescribed documents for the purpose of s.55 of the Act. In the present case, the copy produced to the Commissioner would be an exempt document under s.45 of the Freedom of Information Act 1982. Accordingly, both the produced copy, and any copies served in evidence, would be maintained confidential before the Commissioner.
7. Biochem Pharma Inc had not established any lawful excuse for not producing the documents, and was given 28 days to produce the documents. Since no-one at the hearing had constructive knowledge of the content of the documents, the Commissioner is prepared to reconsider the question of relevance based on the actual content of the documents.
patents act 1990
decision of a deputy commissioner of patents
Re:658136 in the name of Emory University, opposition by Biochem Pharma Inc, a notice under s.210(c) requiring Biochem Pharma Inc produce 17 documents, and in the matter of lawful excuse.
background
Emory University (Emory) applied for patent application 658136 on 31 Jan 1991 [ie. under the Patents Act 1952], claiming priority from a US application dated 1 Feb 1990. Biochem Pharma (Biochem) has opposed the grant of the application. Apparently a major ground of opposition is that the Emory application is prior claimed by claims in Biochem’s patent 630913. That patent was applied for on 8 Feb 1990, claiming priority from a US application dated 8 Feb 1989.
In corresponding proceedings in the USA, Emory obtained a large number of documents under court discovery. Emory consider that 17 of those documents are particularly relevant to the Australian opposition proceedings, and sought approval of the US court to file those documents in the Australian opposition proceedings. On 7 May 1997, Judge Tidwell of the US District Court granted a motion by Emory for permission to disclose the Documents upon the following conditions:
"(1) the Australian tribunal in which Emory seeks to disclose the seventeen documents it has identified will ACCEPT AND REVIEW them on a CONFIDENTIAL BASIS; and
(2) Emory will not oppose, either in this court or in the Australian tribunal, Biochem's efforts to rebut the information contained in the seventeen documents Emory has identified by disclosing to the Australian tribunal any confidential material, which Biochem has gained from Emory during discovery in this matter, that bears upon the patentability of Emory's application in Australia."
As discussed in Emory University v Commissioner of Patents 1998 AIPC ¶91-392, the attorney for Emory approached the Patent Office in mid-1997 to ascertain whether it would be possible for these documents to be introduced into the opposition proceedings on a confidential basis. The Patent Office expressed the view that this would not be possible without a relevant order of a court or tribunal. Emory then filed an action in the Federal Court seeking an order that would fall within reg.4.3(2) as it then existed. In his decision of 19 December 1997, Lindgren J found that the Court had no jurisdiction to make the order sought
In January 1998, regulation 4.3(2) was amended, to provide:
“For paragraphs 55(2)(a), (b), and (c) of the Act, the following documents are prescribed:
(a)a document that is subject to an order of a court or a tribunal that prohibits disclosure of the document or information in the document;
(b)a document required to be produced under paragraph 210(c) of the Act that the Commissioner has reasonable grounds for believing should not be open to public inspection.”
(Peripherally, I note my belief that the amendment to the regulations was for reasons unconnected with the decision of Lindgren J, or with the present opposition.)
Subsequently it appears that Emory recognised that this amendment to the regulations might facilitate their being able to put the 17 documents before the Commissioner within the constraints of Tidwell’s conditions. Thus Emory requested the Commissioner exercise his powers under s.210(c) to issue a notice requiring the production of those 17 documents. They also requested that in so doing, the Commissioner should apply reg 4.3(2) to those documents – to meet the requirements of Tidwell’s orders.
The Commissioner considered ex parte whether the adjectival test of relevance (G S Technology v Commissioner of Patents 39 IPR 583) was prima facie met. Being so satisfied, on 26 June 1998 he issued a notice under s.210(c) requiring Biochem to produce the 17 identified documents. In an accompanying letter, the Commissioner noted that having regard to Tidwell’s conditions, he was satisfied that there were reasonable grounds for believing any documents produced under the notice should not be open to public inspection pursuant to regulation 4.3(2)(b), and that he intended to so direct.
Biochem advised the Commissioner that they objected to the notice. A hearing was held in Canberra on 13 August 1998. Biochem was represented by Dr Annabelle Bennett (SC) and Ms Katrina Howard, instructed by Dr Ken Finney of Cullen & Co. Emory was represented by Mr David Catterns (QC), instructed by Dr Bill Pickering of FB Rice & Co.
The issues
Where a notice requiring production of documents has issued, a person must comply with the notice unless they have a lawful excuse to not comply. Biochem raised a number of issues that they assert constitute a lawful excuse:
The documents are not relevant to the opposition proceedings – or if they are relevant to some degree, their relevance is not significant
The documents are but a small selection from a large number of documents obtained through discovery. To avoid the documents being interpreted out of context, they would have to file a large number of other documents – which would be onerous, and result in significant delays in the opposition.
Documents produced pursuant to s.210(c) would not be ‘filed’ documents. As a result ss 55 and 56 do not apply – and r.4.3 (2) would have no effective application to the documents. That is, Tidwell’s requirements for confidentiality could not be met.
Additional matters that arose during the course of the hearing were:
If the documents were not encompassed by s.55, what power was there for the Commissioner able to maintain confidentiality? What was the impact of the Freedom of Information Act 1982?
Given the documents were not located in Australia, had Biochem acceded to the Commissioner’s jurisdiction to require the production of documents presently located outside of Australian territory?
Subsequent to the hearing, both parties provided written submissions on these additional issues.
It is appropriate to note here two points of concession and agreement that arose during the hearing:
Emory conceded that if the documents could not be given to the Commissioner in a manner whereby confidentiality was maintained, the documents should not be produced. That is, in the circumstances of this case an inability for the Commissioner to maintain confidentiality would be a lawful excuse for not producing the documents.
Tidwell’s orders relate to conditions for Emory to put the 17 documents before the Commissioner. However, the notice issued by the Commissioner requires Biochem to put the documents before the Commissioner, not Emory. Thus it might be suggested that Tidwell’s orders are not relevant to documents produced by Biochem. It might also be suggested that Emory’s actions in asking the Commissioner to require the production of documents is not strictly in accordance with Tidwell’s orders.
The Commissioner’s notice has come about solely as a result of a request by Emory. Emory conceded that if the documents were produced, they should be subject to the terms of Tidwell’s orders, especially para 2. In these circumstances I consider that Tidwell’s orders are relevant to any documents produced as a result of the present notice. There was also agreement between the parties that no issue arose vis-à-vis Tidwell’s orders as a result of Emory seeking the Commissioner issue a notice requiring production rather than itself disclosing the documents to the Commissioner.
It is also appropriate to observe that apparently no one at the hearing has seen the documents in question – or otherwise has constructive knowledge of the content of the documents. Consequently many of the issues debated at hearing (eg relevance of the documents) were necessarily argued on the basis of adjectival relevance rather than actual relevance.
Finally, Biochem suggested that they should have had an opportunity to be heard before the Commissioner issued the notice requiring production. On this issue I merely note that the Commissioner is proceeding on the basis that the proper approach for a recipient of a notice to raise issues concerning a notice requiring production, is by arguing for lawful excuse for not complying. For it is only at that time that the Commissioner can truly be said to be exercising discretionary powers requiring the production of documents.
Jurisdiction
The Patents Act 1990 applies to Australia and its territories (s.12). In the present case, the documents sought to be produced are not located in Australia or its territories, and neither party is (to my knowledge) an Australian company. An initial question is whether the Commissioner has power under s.210(c) to require the production by Biochem of documents located outside of Australia.
At the hearing, I sought confirmation from Biochem that I should take their absence of submissions on the question of jurisdiction as indicating they acceded to the Commissioner’s jurisdiction. Subsequent to the hearing, Biochem advised that they do “not raise any question of jurisdiction in respect of the fact that the documents are held out of the country.” Emory argued that “The opponent has submitted to the jurisdiction of the Commissioner of Patents by filing the opposition in accordance with the Regulations.”
I think there is a real question about whether the Commissioner has jurisdiction to require production of third party documents located outside Australia. On the other hand, it would be incongruous for a party seeking benefit from proceedings before the Commissioner to deny access to relevant material solely on the basis that the material was not located in Australia. For this reason, I think a person seeking to obtain the grant of a patent from the Commissioner has thereby submitted to the Commissioner’s jurisdiction. Similarly I think an opponent to the grant of a patent, by taking advantage of those proceedings, has thereby submitted to the Commissioner’s jurisdiction.
Accordingly I consider that the Commissioner has jurisdiction in the present case to require the production of the documents sought, and note Biochem’s explicit acquiescence to that jurisdiction.
Relevance
If the documents the subject of a notice requiring production are in fact not relevant to the proceedings, that lack of relevance constitutes a lawful excuse for not producing them. In the present case, assessment of the true relevance of the 17 documents is rendered difficult through the fact that no-one at the hearing had apparently sighted any of the documents, or had constructive knowledge of their content.
Emory argues that the documents sought are relevant to the present proceedings in the following way:
A ground of objection in the opposition is that the present application is prior claimed by a patent granted to Biochem;
The earliest priority document that the Biochem patent relies on is dated some 11¾ months prior to the earliest priority document that the Emory application relies upon;
If the Biochem patent is not entitled to its priority date, and the Emory patent is entitled to its priority date, the ground of prior claim by the Biochem patent will necessarily fail. Indeed, potentially the Emory patent (if granted) will prior claim the Biochem patent;
The Biochem priority document does not (it is alleged) disclose a key step of how to separate the enantiomers of a chemical substance;
Biochem is arguing in the opposition that the separation of the enantiomers is straightforward, and would have been readily capable of performance by skilled persons in the art without undue experimentation [and provide many declarations from Australian declarants in support of this position.] Accordingly Biochem argue that the absence of specific instructions in the priority document does not detract from its disclosure;
Emory asserts that the 17 documents show that Biochem had great difficulty in separating the enantiomers of the particular substance – contrary to the assertions of the Australian declarants – hence the priority document was not enabling, and the priority claim invalid.
Accordingly, the evidence in the 17 documents is relevant to determining the question of whether Biochem’s priority document is sufficient to provide a priority date for claims relied on to establish prior claim in the opposition.
Biochem argued that the issue of sufficiency of disclosure must be assessed against what the hypothetical skilled person in the art, in AUSTRALIA, would understand from the document at the relevant date. That is, evidence of what US researchers were doing was simply irrelevant to the issues to be determined in the Australian proceedings. What was required was evidence from Australian declarants, which they had provided. Additionally, if the 17 documents were in some manner relevant, they were insignificant in the totality of the other evidence. Emory argued that while evidence of difficulties experienced by workers located in the USA was not determinative, that evidence may be of assistance in assessing the relevance of the evidence as a whole. In support of their arguments, both parties referred me to various passages in The Wellcome Foundation v V.R. Laboratories 148 CLR 262.
At the hearing Emory handed up extracts from the evidence for Biochem, of Trost, Marcuccio, Kitching, de Jersey, O’Keefe, and McLeish. It would be quite inappropriate for me to assess at this time the relevancy or reliability of these declarations. However, I superficially observe that their evidence does not appear to be based on them having actually attempted to solve the problem at the relevant time. If such is the case, the credibility of their evidence vis-à-vis what they would have done at the relevant date if they were attempting to solve the problem, will need to be assessed in the opposition. I also observe that where there is conflicting evidence on a technological issue (which presumably is the case in the present opposition) it will be necessary to accept the evidence of some declarants over that of others.
To deal with these issues it seems particularly relevant to:
consider the difficulties that were in fact faced by those trying to solve the problem in question at the relevant time – irrespective of where in the world such persons were located;
consider whether the evidence showed those difficulties would have been faced by the hypothetical skilled person in Australia; and
if those difficulties would have been faced, consider whether the evidence showed whether the hypothetical skilled person in Australia using routine experiments, would have overcome the difficulties.
[See, for example, Kirin-Amgen v Genetics Institute, 33 IPR 357, (1996) AIPC ¶91-231]
That is, the evidence of the notional person skilled in the art in Australia may be paramount to the determination of certain issues. However, evidence from those actually trying to solve the problem at the relevant date – whether Australian or otherwise – is appropriate when assessing the credibility of the Australian evidence, and is of different import to such evidence.
In conclusion, if the 17 documents relate to difficulties encountered by Biochem with separating the enantiomers, I think they would be relevant to assessing the credibility of the evidence in the opposition proceedings – and therefore relevant. In the absence of any knowledge of the exact content of these documents, I consider it appropriate to conclude that these documents could be relevant. As a result, I do not believe there is any lawful excuse for not producing these 17 documents based on the relevance of these documents to the opposition proceedings.
Fairness
Biochem argued that the 17 documents were but part of a much larger number of documents that were discovered in the US proceedings – asserting that some 400,000 pages of documents had been discovered. They contend that requiring these documents be produced in isolation from other documents will take them out of context, and that they will have to file a large number of other documents to provide context. To do this, they say, will result in the present proceedings being protracted, with there being significant costs incurred to provide the material. On the other hand failing to do this may put them at a disadvantage.
It may well be that circumstances arise where the proper consideration of one document requires consideration of other documents to put that first document into proper context. There might then be a lawful excuse to not produce the one document, on the basis that it would be onerous to ensure that the document was put into proper context. However, I am not convinced that this is the case here. In the opposition Biochem is apparently alleging that separating the racemic mixture was routine, not requiring undue experimentation. Emory contends the documents refer to difficulties researchers within Biochem had with separating the racemic mixture. Superficially, and in ignorance of the content of those documents, it seems to me that those documents may have context on their own. But in any event, I do not accept Biochem’s inference that an unduly large number (if not all) of the discovered documents will need to be put into the proceedings to provide context. It seems to me that, in the absence of something more specific than has been provided to date, I have no basis to be reasonably satisfied that providing contextual evidence will be onerous. In addition, I understand that these 17 documents are being considered in the US proceedings – and I would therefore expect that the evidence required to provide relevant context is readily available (or at least under consideration) to Biochem.
Accordingly I do not believe there is any lawful excuse for not producing these 17 documents based on issues of fairness surrounding, or consequential upon, their production.
Delay
Biochem assert that the introduction of these documents will result in further delay in these proceedings. Unnecessary delay is always of concern to the Commissioner in proceedings such as the present. But I think the comments of Burchett J in Ferocem Pty. Ltd. v Commissioner of Patents 28 IPR 243 are apposite:
"The determination of an application for an extension of time under reg. 5.10(2) involves a balancing exercise, in which competing considerations must be taken into account. There are interests of the persons directly concerned in the application and opposition in question. There are also public interests, which are not necessarily ranged on the same side. They include the expeditious disposal of matters in the Patents Office, and questions of costs, of efficiency, and of insistence upon proper professional standards being maintained by those who deal with the office. But they also include, as Kitto J. pointed out in Kaiser Aluminum & Chemical Corporation v The Reynolds Metal Co (1969) 120 CLR 136 at 143, "the public interest that a serious opposition by a person entitled in fact to oppose the grant of a patent should be dealt with on the merits, rather than it should be shut out in consequence of a failure of procedure, lamentable though the failure may be". This proposition was cited by Bowen C.J. in Vangedal-Nielsen v Smith (Commissioner of Patents) (1980) 33 ALR 144 (at 150), where he also set out some of the considerations involved upon an application for an extension of time."
In the present case I am reasonably satisfied that, since these 17 documents came to Emory’s knowledge, Emory has proceeded with reasonable expedition to have the material put before the Commissioner within the confines of the various constraints that have existed. I note the prior claim objection implies that a patent has already been granted to Biochem in respect of relevant subject matter – which means that there is public certainty in the existence of a patent for the relevant subject matter, but not of ownership. There is a public interest in expeditiously resolving the competing claims to ownership, but I think there is an equal public interest in correctly determining those competing claims by having regard to all relevant evidence. It seems to me that, on balance, the public interest is not significantly adversely affected by the delay of some 2 to 6 months that would seem likely to occur in the present proceedings. Given Biochem has its patent granted, I do not think the delay significantly adversely affects its interests beyond the public interests. Finally, it is usually in the applicant’s interest for the application to proceed quickly; yet they do not complain about the resulting delays here. That is, I do not believe there is any lawful excuse for not producing these 17 documents based on issues of delay surrounding, or consequential upon, their production.
MAINTAINING Confidentiality
A major issue is whether any documents produced in response to the present notice of the Commissioner can be maintained confidential. Emory conceded at the hearing that if the conditions of Tidwell J could not be met, the documents should not be produced. I am satisfied that in the circumstances of this case, a lawful excuse for not producing the documents exists if the Commissioner cannot maintain confidentiality in the terms of Tidwell’s orders.
Biochem argued that documents produced under s.210(c) are not filed because the word 'file' is not used in the provision. As a result, Reg 4.3(2)(b) does not apply to the produced document, or any other copy of it; sections 55 and 56 therefore do not apply to that document; and there is no other mechanism to ensure confidentiality. This means, they argue, that the documents ought not be produced.
An initial point in this argument is the effect of regulation 4.3(2)(b). Biochem argues that Reg 4.3(2)(b) only applies to the copy of the document actually produced. In my view, this is incorrect. The provision prescribes a document by reference to the fact that the document was produced. I consider the prescription relates to the intellectual content of the document, not merely its physical entity. That is, it covers both the document actually produced, and to all filed copies of that document including (in particular) copies filed in evidence. [I observe here that if the regulation were in fact limited to the actual document filed, any internal copy of the document made by the Commissioner for his own use would not be covered by the regulation – a situation that seems manifestly inconsistent with the intent of the legislation.]
Thus, if the Commissioner invokes regulation 4.3(2)(b) with respect to the 17 documents, they are prescribed for the purpose of s.55 if they are later filed in evidence – which must occur if a party wishes to rely upon them – and are therefore confidential.
The main argument of Biochem is that a document that has been produced under s.210(c) has not been filed – relying on the absence of the word 'file' from that provision. I note that the definition of ‘file’ in the Dictionary to the Act [“File” means file with the Patent Office] is of no assistance, it being circular with respect to the word ‘file’. I also note IPAC recommendation 28, which was accepted by the Government:
"In the case of petty patents all documents lodged in respect of the application and all documents sent by the Office to the applicant become open to public inspection. We consider it desirable in the public interest to extend access to all information on the file of both standard and petty patents.
A broader right of access in more general terms is given by the Freedom of Information Act. We subscribe to the approach of that Act in relation to documents on patent files, while noting that it may not have been framed with a view to use by competitors wanting to obtain commercial information about patentees. The classes of exempt documents under the Freedom of Information Act are such as to adequately safeguard patentees' rights and the public interest, particularly those exemptions relating to national security and defence, and to trade secrets, business, commercial and financial affairs.
Prior to the date on which a specification becomes open to public inspection, however, the applicant is entitled to expect absolute confidentiality for his application, examiners' reports and any correspondence concerning it.
We Recommend that standard and petty patent application files be confidential until the date on which they become open to public inspection, but that after that date, public access be granted to all documents contained on patent files consistently with the principles and subject to the exemptions contained in the Freedom of Information Act.
Considering the Patents Act as a whole (and the regulations) I think that file as used in s.55 has a general meaning along the lines of ‘contained on a patent file’. In the context of a notice requiring production, I think ‘filing’ would occur on completion of the production – that is, after the Commissioner has determined any and all lawful excuses for not producing the documents, and has thereby ‘accepted’ them into the file – and I think the absence of the word 'file' in s.210(c) is not significant. That being the case, the publication of any documents produced to the Commissioner is subject to the operation of s.55 and 56 – and in the present case, if regulation 4.3(2)(b) is invoked, the documents produced to the Commissioner would not be publicly available.
If I am wrong, in that the absence of the word 'file' from s.210(c) is significant such that produced documents are not filed documents, the public availability of the produced documents would not be governed by s.55 of the Patents Act – but by the Freedom of Information Act 1982 [the FOI Act]. S.11 of the FOI Act grants a right of access to “a document of an agency, other than an exempt document”. The relevant question then is whether the documents produced to the Commissioner would be exempt documents under the FOI Act.
Exempt documents are specified in Part IV of the FOI Act. S.38(1), together with the Third Schedule, provides a specific exemption of all documents whose publication is dealt with by s.55 of the Patents Act. For documents whose publication is not dealt with by s.55 of the Patents Act, I think s.45 (FOI) is the provision most relevant to the circumstances of the present case. It provides:
45(1) A Document is an exempt document if its disclosure under this Act would found an action, by a person other than the Commonwealth, for breach of confidence.
This provision was considered by the Administrative Appeals Tribunal in Re: Gerald Gold v The Department Of The Prime Minister And Cabinet No. V92/632 AAT No. 8662, where it was stated:
20. The circumstances in which disclosure of a document would found an action for breach of confidence were discussed by Gummow J in his dissenting judgment in Corrs Pavey Whiting and Byrne v Collector of Customs (Vic) (1987) 74 ALR 428 at page 437. He said at lines 30 ff:-
"It is now settled that in order to make out a case for protection in equity of allegedly confidential information, a plaintiff must satisfy certain criteria. The plaintiff (i) must be able to identify with specificity, and not merely in global terms, that which is said to be the information in question, and must also be able to show that (ii) the information has the necessary quality of confidentiality (and is not, for example, common or public knowledge), (iii) the information was received by the defendant in such circumstances as to import an obligation of confidence, and (iv) there is actual or threatened misuse of that information: Saltman Engineering Co Ltd v Campbell Engineering Co (1948) 65 RPC 203 at 215; Commonwealth v John Fairfax and Sons Ltd (1980) 147 CLR 39 at 50-1; 32 ALR 485 at 491-2; O'Brien v Komesaroff (1982) 150 CLR 310 at 326-8; 41 ALR 255 at 266-8. It may also be necessary, as Megarry J thought probably was the case (Coco v Clark (AN) (Engineers) Ltd (1969) RPC 41 at 48), and as Mason J (as he then was) accepted in the Fairfax decision was the case (at least for confidences reposed within government), that unauthorised use would be to the detriment of the plaintiff."
21. That passage was adopted by the Tribunal in Re Kamminga and Australian National University (1992) 15 AAR 297 as an appropriate test to apply. With respect we similarly adopt it as the appropriate test to apply now that section 45 has been amended to predicate exemption on the fact that disclosure would found an action for breach of confidence.
I likewise adopt Gummow J's passage as the appropriate test to apply. If the Commissioner is to require the production of these 17 documents, in the knowledge of the orders of Tidwell J, the criteria identified by Gummow J are answered as:
the documents concerned are clearly well identified;
the necessary quality of confidentiality exists explicitly through the orders of Tidwell J. There is nothing to suggest that the documents are otherwise non-confidential;
in the process of requiring production of these documents, the Commissioner has been fully appraised of, and accepted, the claim of confidentiality in these documents;
given the orders of Tidwell J, I think any unauthorised use of the documents would necessarily be to the detriment of Emory, if not Biochem.
That is, if the 17 documents are produced to the Commissioner, those documents would meet the breach of confidence criteria specified by Gummow J. Consequently, the produced documents would be exempt documents under the FOI Act by reason of s.45 of that Act, and therefore not publicly available.
In conclusion, in the circumstances of the present case, the Commissioner will invoke regulation 4.3(2)(b) upon the production of the relevant documents. On the basis that the documents become ‘filed’ documents on completion of the production, they are prescribed documents for the purpose of s.55 and 56 (and therefore not publicly available), and are exempt documents under the FOI Act by reason of s.38 (1) of the FOI Act.
In the alternative – that the produced documents are not filed as a result of their production – the copy of the documents held by the Commissioner is exempt under the FOI Act by reason of s.45 of the FOI Act. Regulation 4.3(2)(b) has effect with respect to any copies of the documents filed in evidence, such that they are prescribed documents for the purpose of s.55 and 56 (and therefore not publicly available), and are exempt documents under the FOI Act by reason of s.38 (1) of the FOI Act.
In either event, I consider that if the 17 documents are produced to the Commissioner [with the Commissioner invoking reg 4.3(2)(b)] those documents will not be publicly available, and the documents will therefore be confidential before the Commissioner. That is, I do not believe there is any lawful excuse for not producing these 17 documents based on issues of maintaining confidentiality before the Commissioner.
Finally, I previously indicated that I consider that documents produced to the Commissioner are filed in the context of s.55 and 56 (in which event consideration of the FOI Act is not required.) In further support of this, it is appropriate to note here some of the anomalies that arise if one construes the Act such that a produced document is not a filed document – viz:
the incongruity of a document required to be produced in opposition proceedings being liable to FOI access, whereas a copy of the same document filed in evidence is exempt from FOI; and
the similar incongruity of a document required to be produced in opposition proceedings being liable to FOI access – but if the Commissioner intends to consider the document in those proceedings, and invokes reg 5.11 to send a copy of the document to (inter alia) the patent applicant, the copy of the document used in the proceedings is exempt from FOI {it having become a document referred to in s.55(2)(c)}.]
the denial of natural justice that results from the inability of a party to proceedings to gain access under the FOI Act to an exempt document that has been produced (and is therefore at least adjectivally relevant to the proceedings), as against the mechanism available under s.56(1)(b) of the Patents Act for filed documents that are not publicly available.
Conclusion
Biochem has raised a number of bases that they claim constitute a lawful excuse for not producing the documents. I have found that no lawful excuse has been established. Accordingly I direct Biochem Pharma Inc produce the 17 documents identified in the notice within 28 days of the date of this decision. Additionally, on production of the documents I shall make a determination under regulation 4.3(2)(b) to treat these documents as documents prescribed for the purpose of s.55.
At this time I have applied an adjectival test of relevance – given no one at the hearing had constructive knowledge of the content of the documents. In these circumstances I am prepared, on the request of Biochem Pharma Inc, to reconsider the question of relevance based on discussion of the actual content of the documents.
Finally, Emory will need to make an application to serve further evidence before these 17 documents can be considered in the opposition [unless the Commissioner invokes regulation 5.11, which is unlikely at this time.] I advise that the Commissioner expects Emory to make any such application with due expedition after the documents have been produced.
Costs
Both parties submitted that costs of this hearing should follow the event. I have found that Biochem have failed to establish any lawful excuse for not producing the documents. I award costs of this hearing against Biochem Pharma Inc.
D Herald
Deputy Commissioner of Patents
Patent attorneys for the applicant : F.B. Rice & Co, Sydney
Patent attorneys for the opponent : Cullen & Co, Brisbane
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