Juno Pharmaceuticals Pty Ltd v Millennium Pharmaceuticals, Inc

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FEDERAL COURT OF AUSTRALIA

Juno Pharmaceuticals Pty Ltd v Millennium Pharmaceuticals, Inc

[2019] FCA 526

File number: VID 988 of 2018
Judge: BESANKO J
Date of judgment: 16 April 2019
Catchwords:

PRACTICE AND PROCEDURE — interlocutory application for leave to withdraw admissions — where the second respondent is registered as the owner of an Australian patent and as the exclusive licensee of an Australian patent — where the applicant supplies generic pharmaceutical products — where the applicant alleges that the second respondent’s patents are invalid on various grounds — where the second respondent cross-claims for patent infringement by the applicant’s generic products — where the applicant made certain admissions in its defence to the second respondent’s cross-claim — where the applicant now seeks to withdraw those admissions on the basis of an expert opinion

PRACTICE AND PROCEDURE — consideration of the principles relevant to whether to grant leave to withdraw an admission — consideration of the strength of the case now advanced that the admission is or may well be incorrect — whether the applicant has done all it could do to establish that the admission is incorrect — where the applicant could have, but has not yet, carried out an experiment which would or may well clarify whether the admission is incorrect — whether the applicant has acted in a transparent fashion — whether there has been a delay in making the application for leave to withdraw — whether the admission would have a significant impact on the respective cases of the parties if it is not withdrawn — consideration of case management principles and of the effect of the withdrawal of the admission on the trial date

Legislation:

Federal Court of Australia Act 1976 (Cth) ss 37M, 37N

Hague Convention on the Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial Matters 1965

Cases cited:

Ansell Healthcare Products LLC v Reckitt Benckiser (Australia) Pty Ltd (No 2) [2016] FCA 765

AON Risk Services Australia Ltd v Australian National University [2009] HCA 27; (2009) 239 CLR 175

Centrestate Exports Pty Ltd v Amarantos Shipping Co Ltd [2005] SASC 158

Jeans v Commonwealth Bank of Australia Ltd [2003] FCAFC 309; (2003) 204 ALR 327

Tamaya Resources Limited (in liq) v Deloitte Touche Tohmatsu (A Firm) [2016] FCAFC 2; (2016) 332 ALR 199

Date of hearing: 27 March 2019
Registry: Victoria
Division: General Division
National Practice Area: Intellectual Property
Sub-area: Patents and associated Statutes
Category: Catchwords
Number of paragraphs: 51
Counsel for the Applicant: Mr T Cordiner QC with Mr C Smith
Solicitor for the Applicant: Biopharmalex
Counsel for the First Respondent: The First Respondent is excused from further participation in the proceedings until further order
Counsel for the Second Respondent: Mr J S Cooke
Solicitor for the Second Respondent: Davies Collison Cave Law Pty Ltd

ORDERS

VID 988 of 2018
BETWEEN:

JUNO PHARMACEUTICALS PTY LTD

Applicant

AND:

THE GOVERNMENT OF THE UNITED STATES OF AMERICA AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN…

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Details
Case
[2019] FCA 526
Decision Date

CaseChat Overview and Summary

Juno Pharmaceuticals Pty Ltd sought leave to withdraw certain admissions made in its defence to cross-claims brought by Millennium Pharmaceuticals, Inc. The dispute involves patent validity and infringement concerning pharmaceutical products. The Federal Court of Australia was tasked with determining whether Juno could withdraw the admissions based on an expert opinion. The primary legal issues included whether Juno had established that the admissions were incorrect, whether the applicant had acted transparently, and the potential impact on the case and trial proceedings if the admissions were withdrawn.

The court considered the principles relevant to granting leave to withdraw an admission, focusing on the strength of Juno's case, the potential delay in the proceedings, and the transparency of Juno's actions. The court found that Juno had not yet conducted an experiment that could clarify the correctness of the admissions and had not acted transparently in delaying the application. Additionally, the court highlighted the importance of case management and the potential disruption to the trial date if the admissions were withdrawn. The expert opinion provided by Juno was deemed insufficient to warrant withdrawal of the admissions.

The Federal Court dismissed Juno's application for leave to withdraw the admissions. The reasoning underscored the need for a robust case demonstrating the incorrectness of the admissions, transparency in the proceedings, and consideration of the overall impact on the trial. The court emphasised the importance of adhering to case management principles and the potential disruption to the trial date.

The final orders of the court were that Juno's interlocutory application dated 5 March 2019 be dismissed.

Orders

Orders of the court

1. The applicant’s interlocutory application dated 5 March 2019 be dismissed.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Background

Background to the litigation

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Evidence

Evidence Before The Court

The trial date is 22 July 2019 with two weeks set aside. That trial date was fixed early in the proceeding. The proceeding was commenced on 10 August 2018 and the trial date was fixed on 24 September 2018.The Evidence on the Application Juno relied on three affidavits. First, Juno relied on an affidavit of Mr Paul William Jones sworn on 5 March 2019. Mr Jones is a patent attorney at Jones Tulloch. Jones Tulloch have been engaged by Juno to provide it with patent attorney advice in this proceeding, and to support Biopharmalex, the law firm retained by Juno in the proceeding. Second, Juno relied on an affidavit of Dr Alan Duncan Robertson affirmed on 17 January 2019. Dr Robertson is an expert who was engaged by Biopharmalex to provide his views on “certain matters relating to formulation chemistry and pharmaceutical science and to comment on certain documents”. Dr Robertson describes his field of technical expertise as medicinal chemistry. Third, Juno relied on an affidavit of Mr Wayne Maurice Condon sworn on 2019. Mr Condon is the owner and principal of Biopharmalex. In addition to the affidavits, counsel for Juno sought to tender letters which show (according to Juno) that earlier in the course of the proceeding Millennium “threatened” to perform experimental evidence. Millennium relied on two affidavits affirmed by Mr Paul Alexander Dewar who is a lawyer and a principal in the firm of Davies Collison Cave Law Pty Ltd. Mr Dewar has the care, conduct and control of the proceeding on behalf of Millennium and on behalf of two other cross-claimants, being Cilag GmbH International and Janssen-Cilag Pty Ltd. Mr Dewar’s first affidavit for the purposes of this application was affirmed on 23 March 2019 and his second affidavit was affirmed on 25 March 2019. Mr Dewar has affirmed a number of affidavits in this proceeding. The two affidavits relied on in this application were his fifth and sixth affidavits in this proceeding, and it is convenient if I (as the parties did) describe them in that way. Millennium also tendered a package leaflet for bortezomib 1 mg powder solution for injection. The package leaflet refers to Juno’s supplier as the marketing authorisation holder and manufacturer. The package leaflet states that the medicinal product referred to is authorised in the member States of the European Economic Area, being the Netherlands, Germany and France. The package leaflet provides an indication of the claimed therapeutic benefit of bortezomib. It states as follows:Bortezomib contains the active substance bortezomib, a so-called ‘proteasome inhibitor’. Proteasomes play an important role in controlling cell function and growth. By interfering with their function, bortezomib can kill cancer cells.Bortezomib is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years:…Bortezomib is used for the treatment of mantel cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with medicines …, for patients whose disease has not been previously treated or for whom blood stem cell transplantation is unsuitable.

Decision

Reasons for decision

Before concluding, I should address one other point made by Juno and that is that Millennium will have to address Dr Robertson’s opinion in any event. At this stage of the proceeding, I am not sufficiently informed of the issues in the case to reach a conclusion about that with any certainty. Millennium’s response was to say that this was not correct and that the issue with Dr Robertson was the state of common general knowledge in 2001. I am not persuaded on what I know to this point that Juno’s assertion is correct.Conclusion Juno’s interlocutory application dated 5 March 2019 is dismissed.

Ratio Decidendi

Legal Principle Established

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