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.