InterPharma Pty Ltd v Hospira, Inc (No 3)

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FEDERAL COURT OF AUSTRALIA

InterPharma Pty Ltd v Hospira, Inc (No 3) [2017] FCA 1536

File number: VID 885 of 2017
Judge: KENNY J
Date of judgment: 18 December 2017
Catchwords:

PATENTS – application for interlocutory injunction – prima facie case of patent infringement – alleged invalidity of patent on grounds of manner of manufacture, novelty, inventive step and lack of fair basis – triable issues – whether balance of convenience favoured grant of interlocutory injunction – interlocutory relief granted.

PRACTICE AND PROCEDURE - interlocutory application to set aside interim injunctive orders on the basis of non-disclosure or misrepresentation – interlocutory application dismissed.

Legislation:

Patents Act 1990 (Cth) ss 7, 18, 24, 40, 89, 117, 138 and Schedule 1

Therapeutic Goods Act 1989 (Cth)

Federal Court Rules 2011 (Cth), r 30.28

Patents Regulations 1991 (Cth) regs 2.2, 2.3
Cases cited:

AB Hassle v Pharmacia (Australia) Pty Ltd (1995) 33 IPR 63

Aktiebolaget Hässle v Alphapharm Pty Limited [2002] HCA 59; 212 CLR 411

Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162; 100 IPR 285

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50; 253 CLR 284

Apotex Pty Ltd v Sanofi-Aventis [2009] FCAFC 134; 82 IPR 416

AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99; 107 IPR 177; 226 FCR 324

AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30; 257 CLR 356

Australian Broadcasting Corporation v O’Neill [2006] HCA 46; 227 CLR 57

Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd [2017] FCA 250; 124 IPR 23

Beecham Group Ltd v Bristol Laboratories Pty Ltd (1968) 118 CLR 618

Bristol-Myers Squibb Co v Baker Norton Pharmaceuticals Inc [1999] RPC 253

Bristol-Myers Squibb Company v FH Faulding & Co Ltd [2000] FCA 316; 97 FCR 524

Bristol-Myers Squibb Company v Yew Tree Pharmaceuticals BV [2000] ENPR 26

British Acoustic Films Ltd v Nettlefold Productions (1936) 53 RPC 221

Chapman and Cook and Lectro Linx Ltd v Deltavis Ltd (1930) 47 RPC 163

Clough v Oil & Natural Gas Corporation Ltd [No 3] [2007] FCA 2082

D’Arcy v Myriad Genetics Inc [2015] HCA 35; 258 CLR 334

General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC 457

Generic Health Pty Ltd v Otsuka Pharmaceuticals Co Ltd [2013] FCAFC 17; 296 ALR 50; 100 IPR 240

H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 177 FCR 151

ICI Chemicals & Polymers Ltd v The Lubrizol Corporation Inc [2000] FCA 1349; 106 FCR 214

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

InterPharma Pty Ltd v Hospira, Inc [2017] FCA 1075

Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58; 217 CLR 274

Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [No 2] [2007] HCA 21; 235 CLR 173

Mack Innovations (Australia) Pty Ltd v Rotorco Pty Ltd [2010] QSC 138

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Details
Case
[2017] FCA 1536
Decision Date

CaseChat Overview and Summary

In the case of InterPharma Pty Ltd v Hospira, Inc (No 3), the Federal Court was asked to grant an interlocutory injunction against InterPharma to prevent it from infringing a patent held by Pfizer. The patent related to the use of dexmedetomidine for sedation in intensive care unit patients. InterPharma argued that the patent was invalid on several grounds, including that it did not involve an inventive step and that it lacked novelty. The court considered the strength of Pfizer’s prima facie case of patent infringement, the existence of triable issues in InterPharma’s invalidity case, and the balance of convenience in favour of granting the injunction.

The court found that Pfizer had shown a strong prima facie case of threatened patent infringement, but InterPharma had raised a clear triable issue under its manner of manufacture ground and under its novelty ground, with respect to the Precedex® Trials Consent Forms. The court considered that the strength of Pfizer’s prima facie case, the balance of convenience, and the fact that Pfizer, by its predecessors in title, had been the sole and continuous distributor of dexmedetomidine in Australia from around 2003 until the commencement of this proceeding, weighed in favour of the grant of interlocutory injunctive relief. The court rejected InterPharma’s contention that errors in Pfizer’s evidence were sufficiently egregious to warrant the discharge of the interim injunction. The court also found that the relative difficulty in assessing Pfizer’s damages on infringement compared with its damages on Pfizer’s undertaking did not justify a radical shift in the balance of convenience and the justice of the case.

The court granted the relief that Pfizer had sought and made several orders, including restraining InterPharma from engaging in certain acts within the patent area without the licence or authority of the Cross-claimants, dismissing InterPharma’s interlocutory application, and fixing the trial of the matter for 2 May 2018, commencing at 10:15 am, with an estimate of 5 days. The court also ordered that the parties each file and serve submissions on costs (limited to 2 pages) setting out the costs orders for which they contend and why, unless within that time they had filed proposed orders as to costs to which they each consent. Any orders as to costs were to be made on the papers and without another oral hearing.

Orders

Orders of the court

1. Until the hearing and determination of this proceeding or further order, the Cross-respondent, by itself, its directors, officers, servants, agents or howsoever otherwise, be restrained from engaging or threatening to engage in the following acts within the patent area (as that term is defined in the Patents Act 1990 (Cth)) without the licence or authority of the Cross‑claimants:

(a) making, marketing, selling, supplying or otherwise disposing of any medicament for use in intensive care unit sedation containing dexmedetomidine or a pharmaceutically acceptable salt thereof (Generic Dexmedetomidine Product);

(b) offering to make, sell, supply or otherwise dispose of any Generic Dexmedetomidine Product;

(c) using or importing any Generic Dexmedetomidine Product; or

(d) authorising, inducing, procuring or joining in a common design with any other person to do any of the acts referred to in sub-paragraphs (a) to (c) above.

2. The Cross-respondent’s interlocutory application dated 17 October 2017 be dismissed.

3. The Cross-respondent have liberty to apply, on reasonable notice, to vary the terms of Order 1 in accordance with the email dated 29 November 2017 from Stephens Lawyers & Consultants set out in [207] of the reasons for judgment published today.

4. If the Cross-respondent make such an application (as contemplated in Order 3), then the parties are to consult about further orders for the filing of affidavits and written submissions and such other orders as appear to them appropriate for the determination of that application and, having done so, notify the Court accordingly.

5. The proceeding be listed for a case management hearing on 2 February 2018 at 9:30 am.

6. The trial of the matter be fixed for 2 May 2018, commencing at 10:15 am, with an estimate of 5 days.

7. On or before 5 January 2018, the parties each file and serve submissions on costs (limited to 2 pages) setting out the costs orders for which they contend and why, unless within that time they have filed proposed orders as to costs to which they each consent.

8. Any orders as to costs be made on the papers and without another oral hearing.

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 Court in Lockwood continued (at [106]-[108]):Chapman may be understood as a case which exemplifies a specification showing “on its face” that an invention did not involve an inventive step. The expression derives from Commissioner of Patents v Microcell Ltd [(1958) 102 CLR 232], which stands for a narrow proposition that a Commissioner of Patents, or his or her delegate, may refuse an application for patent protection where a specification “on its face” shows the invention claimed is not a manner of new manufacture. This may arise, for example, from admissions concerning novelty. The decision in Microcell has not always been properly understood; it does not involve a separate ground of invalidity or a discrete “threshold” test.It is also possible to imagine, as Lord Hoffmann did in Biogen Inc v Medeva Plc [[1997] RPC 1] that there may be cases where the alleged subject matter is “so obviously not an invention that it is tempting to take an axe to the problem by dismissing the claim”. Such cases are likely to be rare.Although it is not usual for an express admission to be made in a specification that a crucial integer in a combination patent is common general knowledge, when such an admission is made, a court is entitled to treat the admission as part of the evidence to be considered on the issue of obviousness. An admission in a specification that some integers of a combination are common general knowledge can be considered together with witnesses’ evidence as to whether the remaining integers are also common general knowledge. However, admissions of mixed fact and law will not necessarily be conclusive on the issue of common general knowledge. Nor will they oust the trial judge’s function of weighing all the evidence.(Citations omitted; emphasis added) InterPharma’s argument as to invalidity on the manner of manufacture ground turned on the disclosure about United States Patent No. 4,910,214 dated 20 March 1990 (US 214) in the specification of the Patent. In discussing the background to the invention in the specification, the Patent “specifically incorporated by reference in their entirety” the US Patents to which it referred. This included US 214. The specification of the Patent stated a number of things about US 214, including that that “[d]exmedetomidine is described in [US 214] as an α2-receptor agonist for generation sedation/analgesia and the treatment of hypertension or anxiety”, and that US 214 discusses “parenteral, intravenous, and oral ways of administration”. InterPharma’s contention was that the Relevant Claims of the Patent, all of which concerned the use of dexmedetomidine for the sedation of patients receiving intensive care, were not for a previously unknown medical use of a known compound but for a previously claimed medical use (sedation) as applied to a sub-set of hospital patients defined by the setting in which they were cared for. In written submissions, InterPharma also said that its case on the manner of manufacture ground was consistent with:(a)the fact that the application made by Abbott Laboratories (Abbott) (NDA-21-038) to the United States Food and Drug Administration (FDA) for approval of Precedex® expressly referred to US 214; and(b)that an extension of the term of US 214 was obtained on the basis of delays in obtaining regulatory approval for Precedex®.This aspect of InterPharma’s argument was neither developed in writing nor at the hearing. I put it aside here. Amongst other things, the significance of the documents to which InterPharma referred in this context was unclear.

Decision

Reasons for decision

The matter of public interest does not, in this case, affect the balance of convenience.CONCLUSION Pfizer has shown a strong prima facie case of threatened Patent infringement. As stated, however, by its case of Patent invalidity, InterPharma has raised a clear triable issue under its manner of manufacture ground and under its novelty ground, with respect to the Precedex® Trials Consent Forms, although with respect to this latter matter a number of sub-issues also arise for determination. A decision in InterPharma’s favour on either ground would lead to a finding that the Relevant Claims of the Patent are invalid. Whilst this circumstance tends against the relief Pfizer seeks, the strength of Pfizer’s prima facie case of infringement and the balance of convenience weighs in favour of the grant of that relief. Apart from the strength of Pfizer’s prima facie case, the factors favouring the grant of interlocutory injunctive relief are:(1)The status quo from around 2003 until the commencement of this proceeding is that Pfizer, by its predecessors in title, has been the sole and continuous distributor of dexmedetomidine in Australia. (2)Pfizer will suffer significant harm if InterPharma enters the market for dexmedetomidine before the trial in May next year, for which damages will not be an adequate remedy. Further, it may be provisionally accepted that this harm would extend beyond the life of the Patent, although its precise nature and the quantum would appear to be unascertainable at this stage. (3)InterPharma proceeded with its “eyes wide open” to the existence of the Patent and the fact that, by its proposed conduct, it would, or that there was a significant risk that it would, infringe the Patent and was prepared to take the risk of being restrained, without taking any steps to try to “clear the way”. For the reasons stated, I have rejected InterPharma’s contention that errors in Pfizer’s evidence were sufficiently egregious to warrant the discharge of the interim injunction, or to justify considering the current application on the basis that the status quo should have been different from what it is in fact. As to InterPharma’s contention about the relative difficulty in assessing Pfizer’s damages on infringement compared with its damages on Pfizer’s undertaking, I am not satisfied that the difference in the level of difficulty in the potential assessment of InterPharma’s damages under Pfizer’s undertaking is so much greater than the potential assessment of Pfizer’s infringement damages to justify a radical shift in the balance of convenience and the justice of the case. Further, the significance of the relatively short remaining period of the Patent has been considered in the context of considering the adequacy of damages and the comparable difficulties of assessing potential claims for damages by Pfizer and InterPharma. Bearing in mind the strength of Pfizer’s prima facie case of Patent infringement, though tempered by the existence of triable issues in InterPharma’s invalidity case, and the other considerations mentioned above, I am of the opinion that the balance of convenience favours the grant of interlocutory injunctive relief. Having regard to the fact that Pfizer proffers the usual undertaking as to damages and that any loss to InterPharma (or a third party) arising from the interlocutory injunction can sound in an award of damages, I would grant the relief that Pfizer has sought.

Ratio Decidendi

Legal Principle Established

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