SmithKline Beecham plc v Alphapharm Pty Ltd - [2001] FCA 1324

FEDERAL COURT OF AUSTRALIA
SmithKline Beecham plc v Alphapharm Pty Ltd
[2001] FCA 1324
SMITHKLINE BEECHAM PLC, BEECHAM GROUP PLC, and SMITHKLINE BEECHAM (AUSTRALIA) PTY LIMITED v ALPHAPHARM PTY LTD and UNIVERSITY OF QUEENSLAND
V 935 of 2000
FINKELSTEIN J
18 APRIL 2001
MELBOURNE

IN THE FEDERAL COURT OF AUSTRALIA

VICTORIA DISTRICT REGISTRY

V 935 of 2000

BETWEEN:

SMITHKLINE BEECHAM PLC, BEECHAM GROUP PLC, and SMITHKLINE BEECHAM (AUSTRALIA) PTY LIMITED
Applicants

AND:

ALPHAPHARM PTY LTD and UNIVERSITY OF QUEENSLAND
Respondents

JUDGE:

FINKELSTEIN J

DATE OF ORDER:

19 APRIL 2001

WHERE MADE:

MELBOURNE

THE COURT ORDERS THAT:
1.The applicants be relieved of their Undertaking dated 18 December 2000 made in this proceeding.
2.The ‘confidential annexure’ to the first respondent’s Undertaking dated 18 December 2000 made in this proceeding be an open record in the court file in this proceeding.

Provision of Samples
3.By 4.00pm on 27 April 2001, the first respondent will provide to the applicants’ solicitors a sample of 50 grams of any paroxetine hydrochloride supplied to the first respondent by or on behalf of Sumika Fine Chemicals Co Limited used or proposed to be used in the formulation of PAXTINE tablets from each of the following lots:
(i)Lot No 811007;
(ii)Lot No 907010; and
(iii)Lot No 907011;

(collectively, the Samples).

4.The first respondent will draw the Samples from its stock as follows:
(a)the first respondent will permit the entry of the applicants’ nominated independent expert onto the premises on which the materials referred to in paragraph 3 above are stored, and will provide the facility for that independent expert to observe the drawing of each of the Samples from the first respondent’s stock;
(b)each of the Samples will be drawn by a representative of the first respondent qualified or experienced in drawing samples from powders;
(c)each of the Samples will be drawn, weighed and packaged in temperature and humidity conditions controlled in the same manner in which the first respondent formulates paroxetine hydrochloride;
(d)each of the Samples will be drawn from the approximate centre of the bulk of the materials from which the Sample is to be drawn;
(e)each of the Samples will be packaged by the representative of the first respondent in a container which intact will preserve the quality of the sample to be supplied to the applicants;
(f)the packaging of each of the Samples will be marked distinctively by the representative of the first respondent including identifying its source in the first respondent’s stock.

First respondent’s material
5.Tests may be undertaken on the Samples solely for the purpose of establishing whether any of the Australian Letters Patent Nos 593295, 697982 and 701518 (Patents) have been infringed.
6.(a) This paragraph 6 will apply to the following in this proceeding:
(i)paragraph 7 of and ‘Confidential Exhibit JAG‑1’ to the affidavit of Julian Andrew Grover dated 18 December 2000;
(ii)paragraphs numbered 12, 14 and 16 to 43 (inclusive) of and ‘Confidential Exhibit KML‑1’ to ‘Confidential Exhibit KML‑24’ (inclusive) to the affidavit of Katherine Mary Legge dated 25 January 2001;
(iii)paragraphs numbered 11, 12, 14 to 20 (inclusive) and 23 of and ‘Confidential Exhibit DBH‑1’ to ‘Confidential Exhibit DBH‑4’ (inclusive) to the affidavit of David Brynn Hibbert dated 25 January 2001; and
(iv)paragraphs numbered 13 and 21 of and ‘Confidential Exhibit KML‑30’, ‘Confidential Exhibit KML‑33’ and ‘Confidential Exhibit KML‑34’ to the Second Affidavit of Katherine Mary Legge dated 31 January 2001,

(collectively, the First Respondent’s Confidential Court Documents).
(b)The First Respondent’s Confidential Court Documents, the contents thereof and information contained therein or information derived from or notes taken or reports or other documents generated therefrom including copies of such documents as may be made by the persons referred to below in this sub-paragraph 6(b) (First Respondent’s Confidential Court Document Information) will be confidential in this proceeding and they and all and any information contained in them:
(i)will be disclosed only to:
(A)subject to paragraph 11 below, one nominated director of one of the applicants (Applicant Director);
(B)Australian based solicitors and Australian based counsel for the applicants;
(C)subject to paragraph 11 below, Australian based patent attorneys for the applicants;
(D)subject to paragraph 12 below, all or any Australian based independent expert or experts nominated on behalf of any of the applicants and as may be retained by or on behalf of the applicants (or any of them) for the purposes of this proceeding or any proceeding against the first respondent or the second respondent (or both of them) in Australia by the applicants (or any of them) for infringement of the Patents; and
(E)such other persons as the applicants and the first respondent may agree or as the court may order;

(ii)shall not be open to public inspection, or disclosed in open court whilst filed or used in this proceeding or any proceeding in Australia for infringement of the Patents; and
(iii)will be used only for the purposes of this proceeding or any proceeding in Australia by the applicants (or any of them) for infringement of the Patents.

7.(a) This paragraph 7 will apply to the Samples and information derived therefrom on behalf of the applicants or notes taken or reports or other documents generated therefrom or from the analysis or testing of the Samples on behalf of the applicants (Sample Information).
(b)The Samples and the Sample Information will be confidential in this proceeding and they and all and any information contained in them:
(i)will not, without the prior written consent of the first respondent, be disclosed to or inspected by any persons other than:
(A)subject to paragraph 11 below, the Applicant Director;
(B)Australian based solicitors and Australian based counsel for the applicants;
(C)subject to paragraph 11 below, Australian based patent attorneys for the applicants;
(D)subject to paragraph 12 below, all or any Australian based independent expert or experts nominated on behalf of the applicants and as may be retained by or on behalf of the applicants (or any of them) for the purposes of this proceeding or any proceeding against the first respondent or the second respondent (or both of them) in Australia by the applicants (or any of them) for infringement of the Patents; and
(E)such other persons as the applicants and the first respondent may agree or as the court may order;

(ii)shall not be open to public inspection, or disclosed in open court whilst filed or used in this proceeding or any proceeding in Australia for infringement of the Patents; and
(iii)will be used only for the purposes of this proceeding or any proceeding in Australia by the applicants (or any of them) for infringement of the Patents.

8.Any person to whom any of the First Respondent’s Confidential Court Documents, the First Respondent’s Confidential Court Document Information, Samples or Sample Information is disclosed under this Order will be bound by this Order.
9.No further court document filed by or on behalf of any party in this proceeding will contain any of the First Respondent’s Confidential Court Documents, the First Respondent’s Confidential Court Document Information or Sample Information save in exhibits or annexures to such document marked ‘Confidential’ and each such exhibit or annexure will be confidential in this proceeding and will not be used, inspected or disclosed except as provided in paragraphs 6 and 7 above of this Order.
10.The First Respondent’s Confidential Court Documents, Confidential Court Document Information, the Samples and the Sample Information will be used, handled, kept and stored in such a manner as will at all times preserve their confidentiality and may be disclosed only in accordance with paragraphs 6 and 7 above of this Order.
11.The First Respondent’s Confidential Court Documents, the First Respondent’s Confidential Court Document Information, the Samples and the Sample Information will not be disclosed to or inspected by:
(a)the Applicant Director; or
(b)any Australian based patent attorneys for the applicants,

unless the solicitors for the first respondent have been supplied in writing at least seven days before such disclosure or inspection:
(i)in the case of the Applicant Director, with a copy of an undertaking duly executed by that Applicant Director in the form of the Undertaking set out in Schedule 1 to these Orders; and
(ii)in the case of any Australian based patent attorney for the applicants, with a copy of an undertaking duly executed by that patent attorney in the form of the Undertaking set out in Schedule 2 to these Orders,

and the original of each such Undertaking shall have been filed in the Court.
12.The First Respondent’s Confidential Court Documents, the First Respondent’s Confidential Court Document Information, the Samples and the Sample Information will not be disclosed to or inspected by any independent expert or experts nominated by or on behalf of the applicants unless the solicitors for the first respondent have been supplied in writing at least seven days before such disclosure to that independent expert, with:
(a)the name;
(b)qualifications and business affiliations of that independent expert; and
(c)a copy of an undertaking duly executed by that independent expert in the form of the Undertaking set out in Schedule 3 to these Orders,

and the original of such Undertaking shall have been filed in the Court.
13.Within 28 days of the final determination of any proceeding in Australia against the first respondent or the second respondent (or both of them) for infringement of any of the Patents or any appeal therefrom (which ever is the later) or if by 2 August 2001 no applicant has commenced such a proceeding, then on 2 August 2001, the applicants’ solicitors will take all necessary steps to retrieve from the Applicant Director, and the applicants’ counsel, patent attorneys and independent experts, all the First Respondent’s Confidential Court Documents, the First Respondent’s Confidential Court Document Information, Samples and Sample Information in their possession, and will deliver up to the first respondents’ solicitors or the first respondent’s agents appointed for that purpose all of the First Respondent’s Confidential Court Documents, the First Respondent’s Confidential Court Document Information, Samples and Sample Information, save for such of those documents as constitute instructions to, or opinions, reports, notes or memorandum of counsel, solicitors, patent attorneys and independent experts.
14.Subject to paragraph 15, the costs of the parties to this proceeding will be costs in the cause of any proceeding taken on or prior to 1 August 2001 by the applicants (or any of them) against the first respondent or the second respondent (or both of them) in Australia for infringement of any one or more of the Patents.
15.If, by 2 August 2001 no applicant has commenced a proceeding against one or both of the first and second respondents for infringement of one or more of the Patents, the applicants will pay the reasonable costs, of, and incidental to, the application for preliminary discovery and the compliance with these orders, of any respondent against whom such patent infringement proceedings have not been commenced.
16.The parties will have liberty to apply, including in respect of paragraphs 6 and 7 of these Orders.

Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.
SCHEDULE 1

Undertaking (Applicant Director)
I, [Name] of [address], [position] of [Applicant company] do hereby acknowledge that I have read the Order dated 19 April 2001, made in respect of the First Respondent’s Confidential Court Documents, the First Respondent’s Confidential Court Document Information, the Samples and the Sample Information (collectively, the Confidential Material) in the action No V935 of 2000 before the Federal Court of Australia (this Proceeding) and I HEREBY UNDERTAKE to the Court with respect to the Confidential Material that:
(1)At the time of execution of this Undertaking I was not in possession of any of the Confidential Material.
(2)Each of the documents or samples comprising any of the Confidential Material which comes into my possession will be used only for the purposes of this Proceeding or any proceeding against the first respondent or the second respondent (or both of them) in Australia by the applicants (or any of them) for infringement of the Australian Letters Patent Nos 593295, 697982 and 701518 (Infringement Proceeding), will be kept confidential by me at all times, and will not be used by me or disclosed by me to the applicants, the applicants’ solicitors, counsel or patent attorneys, any independent experts retained on behalf of the applicants or any other person, except as provided in the following paragraph.
(3)As to each of the documents or samples comprising Confidential Material as comes into my possession, the same will be used, handled, kept and stored by me in such manner as will keep the same at all times safe from disclosure except as may be required for me to instruct:
(a) the applicants’ Australian based solicitors and Australian based counsel;
(b)the applicants’ Australian based patent attorneys who have provided an undertaking under the Order dated 19 April 2001;
(c)any Australian based independent experts retained on behalf of the applicants who have provided an undertaking under the Order dated 19 April 2001 in this Proceeding or any Infringement Proceeding; and
(d)such other person as the applicants and the first respondent may agree or as the court may order,

or as may be required (but subject to any order for protection of the confidentiality of the same) in my giving evidence in this Proceeding or any Infringement Proceeding.
(4)I will make no copy of such of the Confidential Material provided to me.
(5)I will not, directly or indirectly, be involved in any proceeding that may be taken against the first respondent or the second respondent or both for infringement of any patent that corresponds with, or claims the inventions that are claimed in, any of Australian Letters Patent Nos 593295, 697982 and 701518.
(6)Within seven days of receiving notice of the final determination of this Proceeding or any Infringement Proceeding (whichever is the later), I will deliver up to the applicants’ solicitors such of the Confidential Material as is in my possession.

Dated the day of .

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Signature
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Printed name of Person Giving Undertaking
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Signature of Witness
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Printed name of Witness
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Printed address of Witness
SCHEDULE 2
Undertaking (Patent Attorneys for the applicants)
I, [Name] of [address], [qualifications] do hereby acknowledge that I have read the Order dated 19 April 2001, made in respect of the First Respondent’s Confidential Court Documents, the First Respondent’s Confidential Court Document Information, the Samples and the Sample Information (collectively, the Confidential Material) in the action No V935 of 2000 before the Federal Court of Australia (this Proceeding) and I HEREBY UNDERTAKE to the Court with respect to the Confidential Material that:
(1)I have received none of the Confidential Material prior to the execution of this Undertaking.
(2)As to each of the documents or samples comprising any of the Confidential Material as comes into my possession, the same will be used only for the purposes of this Proceeding or any proceeding against the first respondent or the second respondent (or both of them) in Australia by the applicants (or any of them) for infringement of the Australian Letters Patent Nos 593295, 697982 and 701518 (Infringement Proceeding), will be kept confidential by me at all times, and will not be used by me or disclosed by me to the applicants, the applicants’ solicitors, counsel or other patent attorneys, any independent experts retained on behalf of the applicants or any other person, except as provided in the following paragraph.
(3)As to each of the documents or samples comprising Confidential Material as comes into my possession, the same will be used, handled, kept and stored by me in such manner as will keep the same at all times safe from disclosure except as may be required for me to advise:
(a)the Applicant Director (as defined in the Order dated 19 April 2001 in this Proceeding);
(b)the applicants’ Australian based solicitors and Australian based counsel;
(c)any other Australian based patent attorneys for the Applicants who have provided an undertaking under the Order dated 19 April 2001;
(d)any Australian based independent experts retained on behalf of the applicants who have provided an undertaking under the Order dated 19 April 2001 in this Proceeding (as applicable) or any Infringement Proceeding; and
(e)such other person as the applicants and first respondent may agree, or as the court may order,

or as may be required (but subject to any order for protection of the confidentiality of the same) in my giving evidence in this Proceeding or any Infringement Proceeding.
(4)I will make no copy of such of the Confidential Material provided to me.
(5)I will not, directly or indirectly, be involved in any proceeding that may be taken against the first respondent or the second respondent or both for infringement of any patent that corresponds with, or claims the inventions that are claimed in, any of Australian Letters Patent Nos 593295, 697982 and 701518.
(6)Within seven days of receiving notice of the final determination of this Proceeding or any Infringement Proceeding (whichever is the later), I will deliver up to the applicants’ solicitors such of the Confidential Material as is in my possession.

Dated the day of .

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Signature
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Printed name of Person Giving Undertaking
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Signature of Witness
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Printed name of Witness
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Printed address of Witness
SCHEDULE 3
Undertaking (Independent Experts)
I, [Name] of [address], [qualifications] do hereby acknowledge that I have read the Order dated 19 April 2001, made in respect of the First Respondent’s Confidential Court Documents, the First Respondent’s Confidential Court Document Information, the Samples and the Sample Information (collectively, the Confidential Material) in the action No V935 of 2000 before the Federal Court of Australia (this Proceeding) and I HEREBY UNDERTAKE to the Court with respect to the Confidential Material that:
(1)I have provided the solicitors acting for the applicants with a true and complete statement in writing of my qualifications as an expert and my business affiliations both past and present, and I have no affiliation and no connection with:
(a) any party to this proceeding;
(b)any person or company involved in the manufacture or sale of pharmaceutical products;
(c)the solicitors for the applicants,

other than is stated in my statement.
(2)I have received none of the Confidential Material prior to the execution of this Undertaking.
(3)As to each of the documents or samples comprising any of the Confidential Material as comes into my possession, the same will be used only for the purposes of this Proceeding or any proceeding against the first respondent or the second respondent (or both of them) in Australia by the Applicants (or any of them) for infringement of the Australian Letters Patent Nos 593295, 697982 and 701518 (Infringement Proceeding), will be kept confidential by me at all times, and will not be used by me or disclosed by me to the applicants, the applicants’ solicitors, counsel or patent attorneys, any other independent experts retained on behalf of the applicants or any other person, except as provided in the following paragraph.

(4)As to each of the documents or samples comprising Confidential Material as comes into my possession, the same will be used, handled, kept and stored by me in such manner as will keep the same at all times safe from disclosure except as may be required for me to advise:
(a)the Applicant Director (as defined in the Order dated 19 April 2001 in this Proceeding);
(b)the applicants’ Australian based solicitors and Australian based counsel;
(c)the applicants’ Australian based patent attorneys who have provided an undertaking under the Order dated 19 April 2001; and
(d)any other Australian based independent experts retained on behalf of the applicants who have provided an undertaking under the Order dated 19 April 2001 in this Proceeding or any Infringement Proceeding,

or as may be required (but subject to any order for protection of the confidentiality of the same) in my giving evidence in this Proceeding or any Infringement Proceeding.
(5)I will make no copy of such of the Confidential Material provided to me.
(6)I will not, directly or indirectly, be involved in any proceeding that may be taken against the first respondent or the second respondent or both for infringement of any patent that corresponds with, or claims the inventions that are claimed in, any of Australian Letters Patent Nos 593295, 697982 and 701518.
(7)Within seven days of receiving notice of the final determination of this Proceeding or any Infringement Proceeding (whichever is the later), I will deliver up to the Applicants’ solicitors such of the Confidential Material as is in my possession.

Dated the day of .

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Signature
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Printed name of Person Giving Undertaking
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Signature of Witness
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Printed name of Witness
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Printed address of Witness

IN THE FEDERAL COURT OF AUSTRALIA

VICTORIA DISTRICT REGISTRY

V 935 of 2000

BETWEEN:

SMITHKLINE BEECHAM PLC, BEECHAM GROUP PLC, and SMITHKLINE BEECHAM (AUSTRALIA) PTY LIMITED
Applicants

AND:

ALPHAPHARM PTY LTD and UNIVERSITY OF QUEENSLAND
Respondents

JUDGE:

FINKELSTEIN J

DATE:

18 APRIL 2001

WHERE MADE:

MELBOURNE

REASONS FOR JUDGMENT

On 19 March 2001, I handed down reasons why orders should be made pursuant to O 15A r 12 of the Federal Court Rules for the provision by the first respondent of a small sample of the raw material (paroxetine hydrochloride) that it used in the manufacture of Paxtine tablets. I directed the applicants to bring in minutes of the orders to be made. The parties have attempted to reach agreement on the form of the orders, with some success. It is necessary, however, for me to resolve the areas that are still in controversy. For this purpose, I received written submissions from the parties. I will consider the outstanding matters in the order in which they appear in those submissions.
First, the applicants seek an order that, in addition to the provision of a sample of raw material, the first respondent also produce tablet samples. As my reasons show, I had expressly declined to make such an order. In substance I said that the evidence of Professor Hibbert was to the effect that once the applicants had conducted tests on the sample of the raw material and had referred to the information in the documents that will be provided to them, the applicants will have sufficient information to decide whether to commence infringement proceedings. Hence, there was no need for them to have tablet samples.
The applicants say that I misread Professor Hibbert’s evidence and I should reconsider the matter. The applicants ask for tablet samples to determine whether, during the process of manufacturing the tablets, the anhydrate form of paroxetine hydrochloride converts to hemihydrate form. If this conversion occurs the tablet may infringe the hemihydrate patent, so it is alleged.
I have reread Professor Hibbert’s affidavit. I accept the possibility that I may have overstated his evidence. It may be, as the applicants say, that in the evidence to which I referred Professor Hibbert was commenting only on the quantity of tablets that should be provided and was not rejecting the need for the provision of any tablet samples. However, even if I have misread the evidence, that is not a sufficient reason to reopen the case.
The authorities establish that the power to rehear a matter should be exercised only in exceptional circumstances: State Rail Authority of New South Wales v Codelfa Construction Pty Ltd (No 2) (1982) 150 CLR 29, at 38 and 45. Normally the power will be exercised only to deal with technical or incidental changes to the formal contents of an order. It should not be used as a substitute for an appeal. However, in Autodesk Inc v Dyason (No 2) (1993) 176 CLR 300 Mason CJ said (at 303) that in some cases the court can exercise its jurisdiction to vacate orders and rehear a case if it has proceeded according to some misapprehension of the facts or the relevant law and this misapprehension cannot be attributed solely to the neglect or default of the party seeking the rehearing. Mason CJ affirmed that the purpose of the jurisdiction is not to provide a backdoor method by which an unsuccessful litigant can reargue a case.
As I say, I may have misinterpreted Professor Hibbert’s affidavit. On the other hand, his evidence is not so clear that it could be said that I overlooked an obvious point. Moreover, Professor Hibbert did direct his attention to the possibility of conversion. He said that detection of conversion in the tablet would be difficult. In addition, Professor Hibbert examined the IR spectra of the finished tablet and compared it with the IR spectra in the hemihydrate patent and of the raw material. Professor Hibbert said that his examination indicated that no conversion had taken place. Thus it is still not clear that any useful purpose would be served if tablet samples were provided.
In these circumstances, I am not persuaded that I should reconsider the matter. If the applicants are dissatisfied with the result, the proper step for them is to appeal.
The second outstanding matter concerns an issue raised by the first respondent. It seeks an order limiting the type of tests to be undertaken on the sample of raw material. The first respondent says that the applicants should be permitted to perform only NMR, DSC and melting point analyses. These were the tests that Professor Hibbert said would “be helpful… in determining whether the Raw Material is similar to any of the polymorphs described in the Anhydrate Patent”. It might not be necessary for any additional tests to be performed to determine whether infringement has taken place, but I will not limit the scope of the tests to be undertaken. First, at the hearing the respondents did not suggest that there should be any limits. Second, there is no injustice in permitting the applicants to conduct whatever tests they please to determine whether there has been infringement. Third, the applicants have expressed dissatisfaction with the accuracy of the tests, the results of which will be supplied to them, and they may wish to check their validity.
The next issue is the suggestion that there should be a limit on who may have access to the sample of raw material that will be provided. The first respondent says that neither the applicants’ patent attorneys nor the director who will receive the results of the tests performed on the sample should have access to the sample itself. The first respondent says that there is no need for the director or the patent attorneys to visually inspect the raw material. The first respondent is concerned that improper use may be made of the information, having regard to the fact that there are on foot proceedings commenced by members of the GlaxoSmithKline group for infringement of certain United States patents, that are the same as the anhydrate patent, the hemihydrate patent and the tablet patent.
I think that the risk of misuse of information obtained as a result of any inspection of the raw material is overstated. Without the results of the tests, an examination of the raw material will not assist the plaintiffs in the United States proceedings. Moreover, the director and the patent attorneys will give an undertaking that they will not make use of any information sought other than for the purposes of proceedings to be brought in this country. However, for reasons which will appear, the first respondent will not suffer any harm if the director or the patent attorneys are able to observe the sample.
The final matter in dispute concerns costs. I had indicated that if no infringement action is brought by 1 August 2001, the applicants should pay the respondents’ costs of the application for preliminary discovery. The respondents ask that those costs be paid on an indemnity basis. That submission was not made at the hearing. It is too late for it to be made now. But the order that I said I would make is too narrow. The respondents should also have their costs of complying with the orders that will be made.
This disposes of the dispute about the form of the orders. There is one other matter that is in issue. The respondents say that because of certain recent events, they should not be required to provide any samples and no orders should be made under O 15A.
The point arises in the following way. When the matter was argued, I was told of the existence of infringement proceedings in the United States. Those proceedings have been brought by members of the GlaxoSmithKline group (including the second applicant) against Geneva Pharmaceuticals Inc, in relation to United States patents that correspond with the anhydrate patent, the hemihydrate patent and the tablet patent. It now appears that further proceedings have been instituted in the United States. The second applicant is a plaintiff in those proceedings and the first respondent is the defendant. It is alleged that the first respondent has infringed four United States patents, including patents which correspond with the Australian anhydrate patent and hemihydrate patent.
The respondents argue that the existence of the new proceedings shows that there should be no order for the provision of any samples. The matter is put in two ways. First, it is said that if the GlaxoSmithKline group had sufficient information to bring an infringement action in the United States against the first respondent, it must have sufficient information to bring such a proceeding in this jurisdiction. Second, it is put that there is now a greater risk that confidential information will be used in relation to the various United States proceedings.
As to the first point, I decided that an order should be made under O 15A r 12 in reliance upon the sworn evidence of the applicants’ witnesses, which was to the effect that the applicants did not have sufficient information to enable them to decide whether to commence infringement proceedings in Australia. The fact that infringement proceedings have begun in the United States may call that evidence into question, but it does not undermine it. For one thing, in the United States proceeding, the plaintiffs rely on the fact that the defendant has submitted an Abbreviated New Drug Application (ADNA) to the Food and Drug Administration under § 505(j) of the Federal Food, Drug and Cosmetic Act (which corresponds with 21 USC § 355(j)). The submission of an ADNA in respect of a drug claimed in a patent is deemed to infringe the patent: 35 USC § 271(e)(2)(A). Such a proceeding can easily be commenced by a plaintiff who has limited information about the merits of his claim. Another matter to keep in mind is that often an action is commenced by a plaintiff who suspects, but at the time of commencement cannot prove, that his rights have been infringed. The United States proceedings might fall within that category.
As to the second matter, although I do not believe that in this case anyone who will give an undertaking to keep information confidential will breach that undertaking, it may be that the undertaking will be breached subconsciously. I do not think that this risk is fanciful. Nor do I think that the first respondent should suffer the risk. Accordingly, the director and the patent attorneys will be required to undertake that they will not be involved in infringement proceedings outside Australia. This will adequately “quarantine” the information gained on this application for preliminary discovery.
I will make orders that reflect my earlier reasons, and these reasons, and which will incorporate the form of orders that have otherwise been agreed.

I certify that the preceding seventeen (17) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Finkelstein.
Associate:
Dated: 18 April 2001

Counsel for the Applicants: Mr A Archibald QC

Dr J Emmerson QC

Mr B Caine

Solicitor for the Applicants: Arthur Robinson & Hedderwicks

Counsel for the Respondents: Mr D Shavin QC

Ms M Barker

Solicitor for the Respondent: Mallesons Stephen Jaques

Date of Hearing: Submissions filed in chambers

Date of Judgment: 18 April 2001

IN THE FEDERAL COURT OF AUSTRALIA
VICTORIA DISTRICT REGISTRY	V 935 of 2000

BETWEEN:	SMITHKLINE BEECHAM PLC, BEECHAM GROUP PLC, and SMITHKLINE BEECHAM (AUSTRALIA) PTY LIMITED Applicants
AND:	ALPHAPHARM PTY LTD and UNIVERSITY OF QUEENSLAND Respondents
JUDGE:	FINKELSTEIN J
DATE OF ORDER:	19 APRIL 2001
WHERE MADE:	MELBOURNE

Counsel for the Applicants:	Mr A Archibald QC
Dr J Emmerson QC
Mr B Caine
Solicitor for the Applicants:	Arthur Robinson & Hedderwicks
Counsel for the Respondents:	Mr D Shavin QC
Ms M Barker
Solicitor for the Respondent:	Mallesons Stephen Jaques
Date of Hearing:	Submissions filed in chambers
Date of Judgment:	18 April 2001