Janssen Sciences Ireland UC v Alphapharm Pty Ltd

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FEDERAL COURT OF AUSTRALIA

Janssen Sciences Ireland UC v Alphapharm Pty Ltd [2017] FCA 1399

File number: NSD 1806 of 2017
Judge: YATES J
Date of judgment: 27 November 2017
Catchwords: PATENTS – threatened infringement –  threatened PBS listing of generic pharmaceutical products – whether interim injunction should be granted – whether applicant has established prima facie case for final relief – consideration of challenge to validity of claims in suit –  whether balance of convenience favours grant of interim relief – whether interim relief should be granted on terms    
Legislation:

National Health Act 1953 (Cth) s 85AD

Patents Act 1990 (Cth) s 18

Cases cited:

Apotex Pty Ltd v Warner-Lambert Co LLC [2016] FCA 1238; (2016) 122 IPR 17

Australian Broadcasting Corporation v Lenah Game Meats Pty Limited [2001] HCA 63; (2001) 208 CLR 199

Interpharma Pty Ltd v Commissioner of Patents [2008] FCA 1498; (2008) 79 IPR 261

Novartis AG v Hospira Pty Ltd (No 2) [2012] FCA 1113; (2012) 98 IPR 214

Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd [2012] FCA 239;  (2012) 291 ALR 763

Samsung Electronics Co Limited v Apple Inc [2011] FCAFC 156

The General Tire & Company v The Firestone Tyre & Rubber Company Limited [1972] R.P.C. 457

Tire & Company v The Firestone Tyre & Rubber Company Limited [1972] R.P.C. 457

Warner-Lambert Company LLC v Apotex Pty Limited [2017] FCAFC 58; (2017) 123 IPR 455
Date of hearing: 17 and 20 November 2017
Registry: New South Wales
Division: General Division
National Practice Area: Intellectual Property
Sub-area: Patents and associated Statutes
Category: Catchwords
Number of paragraphs: 185
Counsel for the Applicant: Mr C Dimitriadis SC with Mr J S Cooke
Solicitor for the Applicant: Davies Collison Cave Law Pty Ltd
Counsel for the Respondent: Mr T Cordiner QC with Mr C Burgess
Solicitor for the Respondent: Minter Ellison

ORDERS

NSD 1806 of 2017
BETWEEN:

JANSSEN SCIENCES IRELAND UC

Applicant
AND:

ALPHAPHARM PTY LTD (ACN 002 359 739) (TRADING AS MYLAN AUSTRALIA)

Respondent

JUDGE:

YATES J

DATE OF ORDER:

27 NOVEMBER 2017

In this order, the Mylan products means any product containing darunavir including those having the following registrations on the Australian Register of Therapeutic Goods (ARTG):

(a)ARTG registration No. 271132 entitled “DARUNAVIR MYLAN darunavir 600 mg tablet bottle” which was registered on the ARTG on 26 May 2017.

(b)ARTG registration No. 271133 entitled “DARUNAVIR MYLAN darunavir 800 mg tablet bottle” which was registered on the ARTG on 26 May 2017.

UPON THE APPLICANT AND JOHNSON & JOHNSON PTY LTD ACN 000 023 709 JOINTLY AND SEVERALLY UNDERTAKING TO THE COURT BY THEIR COUNSEL TO:

(a)submit to such order (if any) as the Court considers to be just for the payment of compensation, to be assessed by the Court or as it may direct, to any person, whether or not a party, adversely affected by the operation of these orders or any continuation (with or without variation) thereof; and

(b)pay the compensation referred to…

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Details
Case
[2017] FCA 1399
Decision Date

CaseChat Overview and Summary

Janssen Sciences Ireland UC filed a lawsuit against Alphapharm Pty Ltd in the Federal Court of Australia, seeking an interim injunction to prevent Alphapharm from listing its generic pharmaceutical products on the Pharmaceutical Benefits Scheme (PBS). The dispute centres on whether Alphapharm's products infringe on Janssen's patents, specifically claims 14 and 15 of the '562 patent. The urgency of the application stems from the anticipated PBS listing of Alphapharm's products on 1 December 2017, which Janssen claims would cause irreparable damage.

The court had to decide whether Janssen had established a prima facie case for final relief, and whether the balance of convenience favoured granting an interim injunction. Additionally, the court had to consider Alphapharm's challenge to the validity of the patent claims. The court found that the interpretation of claims 14 and 15, as proposed by Janssen, was arguable and could likely succeed at the final hearing. The court also noted that Alphapharm's challenge to the validity of the claims would be better addressed at the final hearing.

The court granted the interim injunction, restraining Alphapharm from various acts related to the sale and supply of its products, including providing assurance of supply for PBS listing purposes. The court ordered Alphapharm to notify the Department of Health and the Minister for Health of the interim injunction. The court also noted several undertakings provided by Janssen, including a commitment to prosecute the claim for final relief expeditiously and to notify Alphapharm of any other potential infringers.

In summary, the Federal Court of Australia granted an interim injunction in favour of Janssen Sciences Ireland UC, restraining Alphapharm Pty Ltd from listing its generic pharmaceutical products on the PBS, pending the outcome of the final hearing. The court found that Janssen had established a prima facie case for final relief and that the balance of convenience favoured granting the interim injunction. The court also noted that the challenge to the validity of the patent claims would be better addressed at the final hearing.

Orders

Orders of the court

1. Pending the determination of this proceeding or further order, the respondent, whether by itself, its directors, officers, servants, agents, related bodies corporate or otherwise, be restrained from engaging in any of the following acts within Australia, without the licence or authority of the applicant:

(a) making or importing any of the Mylan products;

(b) selling, supplying or otherwise disposing of any of the Mylan products;

(c) offering to sell, supply or otherwise dispose of any of the Mylan products;

(d) using or otherwise exploiting any of the Mylan products;

(e) keeping any of the Mylan products for the purpose of doing any of the acts referred to in sub-paragraphs (b) to (d) above;

(f) authorising any other person to do any act referred to in sub-paragraphs (a) to (e) above;

(g) procuring or inducing or joining in a common design with any other person to do any act referred to in sub-paragraphs (a) to (e) above; and

(h) continuing to provide any assurance of supply in relation to the Mylan products for the purpose of obtaining listing pursuant to the Pharmaceutical Benefits Scheme (PBS) maintained under the National Health Act 1953 (Cth).

2. The respondent forthwith notify the Department of Health (Director of the PBS Price Changes Section, Pricing and Policy Branch of the Technology Assessment and Access Division) and the Minister for Health:

(a) of the granting of the interim injunction in Order 1, and of its terms; and that

(b) for the purposes of seeking listing of the Mylan products on the PBS, the respondent is no longer able to continue to provide the assurance of supply it has given, pending the determination of this proceeding or further order of the Court.

3. The costs of and incidental to the applicant’s interlocutory application for interim injunctive relief be the applicant’s costs in the cause.

THE COURT NOTES THE FOLLOWING FURTHER UNDERTAKINGS:

4. The applicant undertakes to prosecute its claim for final relief as set out in its Amended Originating Application dated 23 October 2017 (or in any subsequently amended pleading) expeditiously.

5. The applicant undertakes to give 30 days’ written notice to the respondent prior to the applicant or any person authorised by the applicant making an application to obtain listing under the PBS of a pharmaceutical product which includes darunavir as the active ingredient and which would cause Janssen-Cilag Pty Ltd’s PREZISTA products to move from the F1 formulary to the F2 formulary.

6. The applicant undertakes that, should it be informed or become aware of any person other than Janssen-Cilag Pty Ltd seeking to exploit in Australia a pharmaceutical product which includes darunavir as the active ingredient, and which it believes infringes its patent rights, it will notify the respondent of that fact and take all reasonable steps to prevent that exploitation, including if necessary commencing proceedings seeking interim injunctive relief restraining that exploitation.

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 present application has been brought on as a matter of relative urgency given the likely listing of the Mylan products on the PBS on 1 December 2017 which, on the applicant’s case, will cause it irreparable damage in the sense discussed in the cases dealing with the grant of interim injunctive relief.The evidence The applicant read the following affidavits: ·David P. Geelan, affirmed 6 October 2017·Kerri-Ann Arnott, affirmed 10 October 2017;·Susanne Monica Hantos, affirmed 10 October 2017 and 10 November 2017;·Bradley Mitchell Yager, affirmed 10 October 2017 and 10 November 2017;·Brandon Rhodri Jones, affirmed 10 October 2017 and 10 November 2017;·Paul Alexander Dewar, affirmed 12 October 2017; and·Paul J. Reider, affirmed 9 November 2017. The respondent read the following affidavits: ·David William Lupton, affirmed 1 November 2017 and 15 November 2017;·Jonathan Leigh Kelp, sworn 3 November 2017; and·Mohit Gupta, affirmed 3 November 2017 and 15 November 2017. On 16 November 2017 orders were made preserving the confidentiality of certain annexures to the affidavits, as well as the confidentiality of the written outlines of submissions relied on by the parties, until further order. This order was amended on 20 November 2017. An electronic Court Book has been filed which contains the affidavits read, and the written submissions made, at the hearing. The documents in the electronic Court Book have been redacted so as to preserve the confidentiality of the material identified in Annexure A to the orders made on 20 November 2017.interlocutory injunctive relief In Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd [2012] FCA 239; (2012) 291 ALR 763 at [78]-[82], I summarised some of the principles relating to the granting of interim injunctive relief:78The principles relating to the grant of interlocutory injunctive relief have been recently discussed in Samsung Electronics Co Limited v Apple Inc [2011] FCAFC 156. It is not necessary to recite those principles in detail. It is sufficient to note that, when considering an application for an interlocutory injunction, the Court must address itself to two main inquiries, namely whether the applicant for relief has established a prima facie case in the sense explained in Beecham Group Ltd v Bristol Laboratories Pty Ltd (1968) 118 CLR 618 at 622-623, and whether the balance of convenience and justice favours the grant of an injunction or the refusal of that relief. 79In Australian Broadcasting Corporation v O’Neill (2006) 227 CLR 57 Gummow and Hayne JJ observed that the phrase “prima facie case” does not mean that the applicant for relief must show that it is more probable than not that at trial it will succeed. It is sufficient if the applicant shows a sufficient likelihood of success to justify, in the circumstances, the preservation of the status quo pending trial. How strong that probability needs to be depends upon the nature of the rights that are being asserted and the practical consequences likely to flow from the order that is sought.80In Samsung the Full Court (at [61]) discussed the requirement that, in order to obtain an interlocutory injunction, the applicant must demonstrate that, if no injunction is granted, it will suffer irreparable injury for which damages will not be adequate compensation: see in that regard Castlemaine Tooheys Ltd v South Australia (1986) 161 CLR 148 at 153. The Full Court went on to observe that, regardless of whether “irreparable harm” is properly to be considered as a matter to be addressed in the Court’s consideration of the balance of convenience and justice, rather than as a distinct and antecedent consideration, the assessment of prejudice or harm to the applicant, if there is no injunction, and the assessment of prejudice or harm to the defendant, if an injunction is granted, is at the heart of the basket of discretionary considerations which must be addressed and weighed. 81It is to be borne in mind that, in this discourse, “irreparable harm” does not mean harm that cannot be repaired but harm for which damages would not be adequate compensation: McCarty v The Council of the Municipality of North Sydney (1918) 18 SR (NSW) 210 at 215; R v MacFarlane; Ex Parte O’Flanagan and O’Kelly (1923) 32 CLR 518 at 550. In Samsung the Full Court (at [62]) said that the question of whether damages will be an adequate remedy for the alleged infringement of the applicant’s rights involves an assessment by the Court as to whether, absent an injunction, the applicant would, in all material respects, be in as good a position if confined to a remedy in damages. 82It is well recognised that the issue of whether the applicant has made out a prima facie case, and the question of the balance of convenience and justice, are related inquiries: Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth (2009) 81 IPR 339 at [15]; Samsung at [67]. In short, the apparent strength of the parties’ substantive cases will often be an important consideration to be weighed in the balance: Tidy Tea Ltd & Lyons Tetley Ltd v Unilever Australia Ltd (1995) 32 IPR 405 at 416; Aktiebolaget Hassle v Biochemie Australia Pty Ltd (2003) 57 IPR 1 at [31]; Hexal Australia Pty Ltd v Roche Therapeutics Inc (2005) 66 IPR 325 at [18].

Decision

Reasons for decision

Therefore, for present purposes, the debate is not a factual one. It is a debate concerning the proper construction of claims 14 and 15. The applicant submitted that it had a strong prima facie case of threatened infringement of those claims. The respondent submitted that the applicant had not established a prima facie case; if it had, that case was only a weak one. analysis and conclusion Given the nature of the present application, I do not propose to decide finally the question of the proper construction of claims 14 and 15. The proper construction of these claims will be an important question for the hearing for final relief. The answer to that question will be informed by all the evidence called at that time. That said, it seems to me that Interpretation 4 (if it differs from Interpretation 3) is plainly arguable and can be advanced on cogent bases. If the evidence remains as it is, there is a real probability that at the hearing for final relief, the applicant will be found to be entitled to the injunctive relief it seeks restraining the respondent from supplying the Mylan products and, if need be, from engaging in other acts of exploitation for which the Act provides. For that reason, I am satisfied that the applicant has established a prima facie case of threatened infringement of claims 14 and 15. Having regard to the specification’s description of the invention and its various aspects, and taking into account the claim set, I do not accept the respondent’s submission that the applicant’s case is a weak one. I acknowledge, however, that Interpretation 1 and Interpretation 2 are arguable.the respondent’s challenge on validityIntroduction For the purposes of the present application, the respondent has raised three asserted grounds of invalidity. The first is that the invention claimed in claims 14 and 15 is not novel in light of the publication of Ghosh et al, “A Stereoselective Anti-Aldol Route to (3R,3aS,6aR)-Hexahydrofuro[2,3-b] furan-3-ol: A Key Ligand for a New Generation of HIV Protease Inhibitors”, which was published on or about 2 August 2006 in the Journal “SYNTHESIS (No. 18)” (Ghosh 2006). The second is that the invention as claimed in claims 14 and 15 is not fairly based on the matter described in the specification. The respondent has particularised this ground as follows: Particulars(a) Claims 14 and 15 of the 562 Patent travel beyond the matter described in the specification.(b)There is no real and reasonably clear disclosure in the specification of any process for the preparation of a compound of formula (I) that does not involve the anterior process steps of:(i)reacting 2,3-dihydrofuran of formula (II) with a glyoxylate derivative of formula (III) in the presence of a titanium salt of formula Ti(Hal)n(OR)4-n in which Hal is a halogen radical, n is 0, 1, 2 or 3 and R is alkyl or arylalkyl, and subsequently reacting the resulting reaction product with an alcohol of formula (IV) to form a compound of formula (V); and(ii)further or alternatively, reducing the compound of formula (V) to form a compound of formula (VI).

Ratio Decidendi

Legal Principle Established

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