Aktiebolaget Hässle v Alphapharm Pty Ltd
[1999] FCA 1390
•12 OCTOBER 1999
FEDERAL COURT OF AUSTRALIA
Aktiebolaget Hässle v Alphapharm Pty Ltd
[1999] FCA 1390PRACTICE AND PROCEDURE – continuation in force of orders and undertakings as to confidentiality made before and during trial – whether information no longer confidential – whether restricted publication necessary to prevent prejudice to administration of justice
Federal Court of Australia Act 1976 (Cth) s 17(4) and s 50
Arnotts Ltd v Trade Practices Commission (1990) 24 FCR 313 cited
Australian Broadcasting Commission v Parish (1980) 29 ALR 228 citedAKTIEBOLAGET HÄSSLE AND ASTRA PHARMACEUTICALS PTY LIMITED v ALPHAPHARM PTY LIMITED
NG 884 OF 1998
LEHANE J
12 OCTOBER 1999
SYDNEY
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
NG 884 OF 1998
BETWEEN:
AKTIEBOLAGET HÄSSLE
First ApplicantASTRA PHARMACEUTICALS PTY LIMITED
(ACN 009 682 311)
Second ApplicantAND:
ALPHAPHARM PTY LIMITED
(ACN 002 359 739)
RespondentALPHAPHARM PTY LIMITED
(ACN 002 359 739)
Cross‑ClaimantAKTIEBOLAGET HÄSSLE
First Cross‑RespondentASTRA PHARMACEUTICALS PTY LIMITED
(ACN 009 682 311)
Second Cross‑Respondent
JUDGE:
LEHANE J
DATE:
12 OCTOBER 1999
PLACE:
SYDNEY
THE COURT ORDERS THAT:
1. The following orders as varied from time to time:
(a) orders 3 and 5 made on 23 October 1998;
(b) orders 6 and 7A made on 24 November 1998;
(c) order 1 made on 27 November 1998;
(d) order 5 made on 5 February 1999; and
(e)each other order made by the Court from time to time upon the application of the respondent in relation to information claimed by the respondent to be confidential to it (including, but not limited to, information claimed to be confidential and recorded in any transcript, affidavit or document referred to therein, exhibit, correspondence, written submissions or other written record of information)
be discharged (to the extent mentioned below), and that each of the following persons, namely:
AB Hässle
Astra Hässle AB
Astra Pharmaceuticals Pty Limited
Dr Rolf Oscar Jörgen Lindquist
Professor John Elvan Rees
Professor Kenneth Frederick Brown
Dr Karl Erik Karlsson
Professor Christopher Thomas Rhodes
Mr Carl Engholm
Mr Malcolm Royal
Mr Malcolm Bell
Professor Anthony Wedd
be released from its or his undertaking or undertakings given to the Court in pursuance of, or as a consequence of, the making of the said orders, to the extent that the orders referred to in subparagraphs (a) to (e) above and the undertakings relate to the following categories of information relating to the Alphapharm product (as that term is defined in the pleadings in these proceedings):
(a)the Sample (as defined in the orders made on 23 October 1998) and information arising from provision of the Sample including but not limited to:
(i)any information as to the nature, content, dosage form, formulation or structure of the Sample; and
(ii)the results of, or any other knowledge or information derived from testing, observing or analysing the Sample,
but excluding the Formulation and Manufacturing Details (as defined in the orders made on 23 October 1998);
(b) the country of origin of the product;
(c) the qualitative composition of the product;
(d)the process of manufacture of the product, to the extent disclosed in the version, published on 12 October 1999 (the “infringement reasons”), of the confidential reasons for judgment delivered on 12 May 1999;
(e)the Brisbane tests and their results, to the extent described in the infringement reasons.
2.Nothing in order 1 affects the operation of O 15 r 18 of the Federal Court Rules.
Note:Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
NG 884 OF 1998
BETWEEN:
AKTIEBOLAGET HÄSSLE
First ApplicantASTRA PHARMACEUTICALS PTY LIMITED
(ACN 009 682 311)
Second ApplicantAND:
ALPHAPHARM PTY LIMITED
(ACN 002 359 739)
RespondentALPHAPHARM PTY LIMITED
(ACN 002 359 739)
Cross‑ClaimantAKTIEBOLAGET HÄSSLE
First Cross‑RespondentASTRA PHARMACEUTICALS PTY LIMITED
(ACN 009 682 311)
Second Cross‑Respondent
JUDGE:
LEHANE J
DATE:
12 OCTOBER 1999
PLACE:
SYDNEY
REASONS FOR JUDGMENT
This was a proceeding in which the applicants sought to restrain the respondent from infringing an Australian patent. The respondent cross‑claimed for revocation on numerous grounds. On 12 May 1999 I delivered two judgments. In one of those judgments, published on that day, I held that the respondent succeeded in its cross‑claim for revocation. In the other which, in circumstances which I shall discuss later, has not been made available to the public, I held that if, contrary to my conclusions on the cross‑claim, the patent were valid, the applicants would succeed on the issue of infringement. I shall use in these reasons the same terminology as in the published reasons to refer to the parties, the Alphapharm product and other matters.
When the proceeding was commenced, the Alphapharm product was not publicly available. Astra could not obtain, except from Alphapharm, samples of the Alphapharm product for testing or information as to its ingredients or as to the way in which it was manufactured. Those matters were regarded by Alphapharm as highly confidential. Accordingly, in the interlocutory stages of the proceeding, I made orders which contemplated the provision by Alphapharm of samples of the Alphapharm product, for testing at Astra’s laboratories in Sweden, and of certain information the nature of which is evident from the description applied to it, the Formulation and Manufacturing Details. The orders, in broad terms, restricted the class of those who might participate in, or observe, the testing of the samples and who might receive the Formulation and Manufacturing Details. Those persons, in turn, were required to keep those matters confidential. Those to whom the information was to be made available, and who were required to keep it confidential, included Astra’s counsel, certain partners and employees of its solicitors, certain independent patent attorneys, independent expert witnesses and, as to certain of the information, two employees of Astra. Counsel and solicitors were bound directly by the orders; the other members of the class signed undertakings to the Court, in an approved form, by which they subjected themselves to a regime established by the orders. A somewhat similar regime was established, later in the interlocutory stages of the proceeding, in relation to certain tests conducted at Alphapharm’s laboratory in Brisbane. During the trial a number of orders were made under s 17(4) and s 50 of the Federal Court of Australia Act 1976 (Cth). The effect of those orders was to close the Court when evidence was given as to matters covered by the interlocutory orders and undertakings and as to certain other matters, relating to the Alphapharm product, claimed by Alphapharm to be confidential, and to forbid publication of evidence of those matters except to those bound by the orders or an undertaking. The reasons for judgment on infringement issues, because they referred to various of the matters subject to the orders, were not published but were made available to Alphapharm and, on Astra’s side, only to those bound by the orders and on the footing that the orders applied to any further disclosure of those reasons.
Alphapharm’s omeprazole formulation, a prescription drug known as Maxor, is now generally available in Australia. Alphapharm concedes that Maxor and the Alphapharm product are one and the same. Maxor capsules, accordingly, are now publicly available to be tested and in fact Astra has tested them. Information is publicly available as to the ingredients of the pellets contained in Maxor capsules, though not as to the quantity of each ingredient in a pellet or as to the source or precise grade or quality (beyond that which can be established by testing) of each ingredient. It is public knowledge – because it is stated on the containers – that Maxor capsules are made in Spain. But Alphapharm has not publicly disclosed the name of the manufacturer.
Astra now seeks the discharge of the various orders to which I have referred and the release from the undertakings of those who have given them, on the basis that the orders and undertakings would then be replaced by much more limited orders. It does so both on the basis that most of the information protected by the orders and undertakings is, Astra says, no longer confidential and because, it submits, the orders and undertakings are no longer necessary (except, perhaps, to a very limited extent) to prevent prejudice to the administration of justice. Alphapharm contends that a very much more limited release and discharge is appropriate. As a result of discussion during argument on Astra’s application, and further written submissions made subsequently, the gap between the positions taken by the parties has narrowed; but there remain significant matters in dispute between them.
Some matters, at least, are plain. Maxor is now publicly available; it is accepted that Maxor and the Alphapharm product are one and the same; it follows that the Alphapharm product itself is now in the public domain, as is that which can be discovered by testing and analysing it. It follows, in my view, that the results of the tests on the Alphapharm product, conducted in Sweden, can no longer be regarded as confidential. Secondly, the ingredients of Maxor (and thus of the Alphapharm product) are named in information made available generally to the public. That information is no longer confidential. Thirdly, Alphapharm publicly states, on the packaging of its product, that it is made in Spain. That is no longer confidential. Fourthly, in the course of argument and the later written submissions, Alphapharm’s resistance to publication of what I have said about the Brisbane tests in my unpublished judgment on infringement was, in the end, limited to references to certain precise measurements. As will appear, I propose now to publish a somewhat edited version of that judgment. What it says about the Brisbane tests will no longer be confidential.
Astra’s submission that other matters covered by the orders and undertakings should no longer be regarded as confidential was based on certain evidence which I shall describe using fairly general language. It concerned information publicly available in other countries concerning three other omeprazole formulations available overseas and evidence of Dr Lindquist (who conducted the tests in Sweden on the Alphapharm products) as to tests which he had conducted on Maxor pellets and each of the three other products. His conclusion was that the similarities which he observed made it extremely probable that all four products had the same origin.
But the information was disclosed by Alphapharm, in confidence, to a limited group of people. The group, for purposes relevant to this aspect of the matter, did not include Dr Lindquist. If the information had been disclosed outside the context of legal proceedings but in circumstances giving rise to an obligation of confidence, I do not think that the recipients of the information would have been free to disclose it simply because Dr Lindquist, or anyone else, was able, using publicly available material, to form a confident view of what the content of the information might be. The person who imparted the information would, I think, be entitled to require the recipient not to reveal that which had been disclosed in confidence and which would show that the confident view was either right or wrong. I can see no reason not to apply the same test where the question is whether information protected by orders or undertakings is still to be regarded as confidential.
In considering the second aspect of the matter, whether restricted publication is necessary to prevent prejudice to the administration of justice, it is necessary to bear in mind precisely what it is that, assuming the restrictions remain, may not be disclosed. What may not be disclosed, apart from the samples used in the tests in Sweden, comprises:
· The Formulation and Manufacturing Details. That phrase is defined as a particular document produced to Astra’s solicitor, the information contained in that document and any document referring to or including such information, “but not including information other than that which is derived directly or indirectly from” that document or the information contained in it.
· The Brisbane tests and information arising from them.
· Particular evidence given by several witnesses.
There can be no doubt that Astra is entitled to an “intelligible explanation” of the conclusion which I reached on the infringement issues: Arnotts Ltd v Trade Practices Commission (1990) 24 FCR 313 at 317. Equally, it is important that instructions can be given, in relation to an appeal, on an informed basis. Indeed it is unfortunate, having regard both to the interests of the parties and to the public interest, that no version of the reasons on infringement has yet been made public. This case is, however, rather different from Arnotts: it is possible, in my view, to publish a version of the reasons which omits certain precise details as to the method of manufacture of the Alphapharm product and as to the Brisbane tests (which are unnecessary to the reasoning and, in hindsight, might better have been omitted in the first place) and I propose to do so. But I cannot see why it should be necessary for Astra to know, in relation to any issue arising from the appeal, the detail of the process of manufacture of the Alphapharm product beyond that which will be given in the published version of the infringement reasons, the results of the Brisbane tests to an extent greater than disclosed in those reasons or the “quantitative formulation” of the Alphapharm product. I mention those matters particularly, because Astra, in submissions as to the form of order I should make, should I refuse the broad order which it claims, seeks disclosure to a somewhat wider class of recipients than those presently bound by the orders and undertakings of:
“… the following information concerning the product, namely:
(a) the process of manufacture of the product;
(b) the quantitative formulation of the product;
(c) the results of the Brisbane tests;
(d) the Formulation and Manufacturing Details.”
No argument was directed specifically to those matters and there was no evidence as to why disclosure to the wider class might be necessary to permit an appeal to be properly conducted. And information of the kinds in question is commonly regarded as information the protection of which, by restriction on disclosure, is necessary to prevent prejudice to the administration of justice: Australian Broadcasting Commission v Parish (1980) 29 ALR 228 at 233.
Astra sought, in its supplementary written submissions, inclusion in the class of information which might be disclosed of “such other information in the public domain at the date of these orders or which later enters the public domain otherwise than as a result of the breach of orders made in these proceedings”. In my view it is not necessary or appropriate to include that category. The orders protect particular information to the extent that it is derived from particular sources. They do not prevent the disclosure of information derived from other sources. Particularly, there is no restriction on disclosure of information which is truly in the public domain.
Astra’s application was heard on 27 September 1999 in closed court. That was because the evidence and argument concerned matters for which Alphapharm maintained a claim of confidentiality. An order was made, also, restricting the class of persons to whom the transcript of the proceedings on that day might be disclosed. It is appropriate, I think, that that order remain in force.
Finally, there is the question of costs. As well as Astra’s application, on 27 September I dealt with an application by Alphapharm for release, from the effect of orders and undertakings, of an exhibit tendered by Astra. That matter was uncontroversial. My conclusion on Astra’s application represents a point between the initial positions adopted by the parties and some distance from each of them. In the circumstances, I make no order as to the costs of either application heard on 27 September.
I propose, on publication of these reasons, also to publish the revised version of my reasons for judgment as to infringement and to make the orders a minute of which is attached to these reasons.
I certify that the preceding thirteen (13) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Lehane. Associate:
Dated: 12 October 1999
Counsel for the Applicant: Mr D M Yates SC with Ms K J Howard Solicitor for the Applicant: Minter Ellison Counsel for the Respondent: Dr A C Bennett SC with Mr S C G Burley Solicitor for the Respondent: Mallesons Stephen Jaques Date of Hearing: 27 September 1999 Date of Judgment: 12 October 1999
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