F. Hoffman-La Roche AG v Sandoz Pty Ltd

Link copied
Case Copied 79 min read

FEDERAL COURT OF AUSTRALIA

F. Hoffman-La Roche AG v Sandoz Pty Ltd [2018] FCA 874

File number:

NSD 2265 of 2017

Judge:

BURLEY J

Date of judgment:

12 June 2018

Catchwords:

PRACTICE AND PROCEDURE – patents – interlocutory application – injunction – prima facie case – validity of patents – inventive step – balance of convenience – application granted

Legislation:

National Health Act 1953 (Cth)

Patents Act 1990 (Cth) ss 7, 18, 40, 117

Cases cited:

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

AstraZeneca v Apotex [2014] FCAFC 99; 226 FCR 324

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] HCA 1; 118 CLR 618

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

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

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

Merck Sharp & Dohme Corp v Apotex Pty Ltd [2012] FCA 928; 97 IPR 414

Organic Marketing Australia Pty Ltd v Woolworths Ltd [2011] FCA 279

Samsung Electronics Co Ltd v Apple Inc [2011] FCAFC 146; 217 FCR 238

Tidy Tea Ltd v Unilever Australia Ltd [1995] FCA 1439; 32 IPR 405

Warner-Lambert Co LLC v Apotex Pty Ltd [2014] FCAFC 59; 311 ALR 632

Date of hearing:

15-16 May 2018

Registry:

New South Wales

Division:

General Division

National Practice Area:

Intellectual Property

Sub-area:

Patents and associated Statutes

Category:

Catchwords

Number of paragraphs:

236

Solicitor for the Applicants:

Spruson & Ferguson Lawyers Pty Ltd

Counsel for the Applicants:

Ms K Howard SC, Mr A Lang and Ms C Cunliffe

Counsel for the Respondent:

Mr B Caine QC, Mr N Murray and Mr L Merrick

Solicitor for the Respondent:

King & Wood Mallesons

ORDERS

NSD 2265 of 2017
BETWEEN:

F. HOFFMANN-LA ROCHE AG

First Applicant

ROCHE PRODUCTS PTY LTD ACN 000 132 865

Second Applicant
AND:

SANDOZ PTY LTD ACN 075 449 553

Respondent

JUDGE:

BURLEY J

DATE OF ORDER:

12 June 2018

UPON THE FIRST APPLICANT UNDERTAKING TO THE COURT BY ITS COUNSEL TO:

1.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

2.pay the compensation referred to in 1 above to the person or persons there referred to.

THE COURT ORDERS THAT:

1.Until 11 August 2019,  the final determination of these proceedings or further order, the Respondent, whether by itself, its servants, agents or otherwise howsoever, be restrained from infringing the Asserted Patent Claims and each of them, including, without the licence of the First Applicant:

(a)supplying for…

CaseChat AU logo

Keep reading for free

Create a free CaseChat account to read F. Hoffman-La Roche AG v Sandoz Pty Ltd and more:

  • Read every judgment in full
  • Ask AI and get answers linked to paragraphs
  • See how each paragraph was cited in later cases
  • Download judgments as PDF or Word
Continue with Google

One click creates your free account or signs you in.

By continuing you agree to the Terms and Privacy Policy.

Details
Case
[2018] FCA 874
Decision Date

CaseChat Overview and Summary

In the Federal Court of Australia, F. Hoffman-La Roche AG initiated proceedings against Sandoz Pty Ltd, asserting patent infringement concerning rituximab, a biologic therapy used in the treatment of various conditions. Roche sought interlocutory injunctive relief to prevent Sandoz from supplying rituximab without its authorisation. The primary legal issues revolved around establishing a prima facie case for patent infringement, assessing the strength of Sandoz’s challenge to the validity of the asserted patents, and determining the balance of convenience in favour of granting or denying the injunction.

The Court found that Roche had established a prima facie case for patent infringement based on admissions by Sandoz. The Court also acknowledged that Sandoz had an arguable case for invalidating the patents, primarily focusing on the lack of an inventive step. However, the Court concluded that Sandoz's evidence did not rise above the level of an arguable case and thus did not sufficiently counter Roche's infringement claims. Furthermore, the Court determined that the balance of convenience favoured Roche, given the imminent expiry of some of the patents and the significant impact of Sandoz’s actions on Roche’s market position and revenue.

Consequently, the Court granted Roche's application for interlocutory injunctive relief. The orders restrained Sandoz from supplying or offering to supply rituximab without Roche’s authorisation until the patents expired or the proceedings were finally determined. Additionally, Sandoz was required to notify relevant government departments of the injunction and its inability to provide assurance of supply for PBS listing purposes. The Court also set a timeline for the parties to confer on the pre-trial timetable and listed a case management hearing. The costs of the interlocutory application were awarded to Roche.

Orders

Orders of the court

1. Until 11 August 2019, the final determination of these proceedings or further order, the Respondent, whether by itself, its servants, agents or otherwise howsoever, be restrained from infringing the Asserted Patent Claims and each of them, including, without the licence of the First Applicant:

(a) supplying for use;

(b) offering for supply or sale;

(c) supplying;

(d) selling;

rituximab 500mg/mL concentrated injection vial or rituximab 100mg/10mL concentrated injection vial (together, the Sandoz Products).

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 interlocutory injunction set out above, and of its terms; and that

(b) for the purposes of seeking listing of the Sandoz Products on the PBS, the Respondent is no longer able to continue to provide the assurance of supply it has given, until further notice by the Respondent to the Department of Health.

3. If the respondent proposes to give further notice to the Department of Health pursuant to order 2(b) above, the Respondent shall give seven (7) days’ notice in writing to the Applicants of its intention to do so.

4. The costs of, and incidental to, the applicants’ interlocutory application for interim injunctive relief be the Applicants’ costs in the cause.

5. The parties are to confer and supply a draft short minutes of order to the Court within seven (7) days setting out the pre-trial timetable steps to bring the claim for final relief to trial with expedition.

6. Leave be granted to the Applicants to apply to the Court for the extension of Order 1, prior to 11 August 2019, having regard to the circumstances prevailing at that time.

7. These proceedings be listed for a case management hearing at 9:30am on 26 June 2018.

THE COURT NOTES THAT:

1. In this Order, Asserted Patent Claims means the claims of the patents that the First Applicant asserts, on an interlocutory basis, the Respondent threatens to infringe, being:

(a) Claims 18 and 21 of Australian Patent No. 2008207357;

(b) Claim 2 of Australian Patent No. 761844;

(c) Claim 35 of Australian Patent No. 2005211669; and

(d) Claim 3 of Australian Patent No. 2007242919.

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

Background

Background to the litigation

Faced with the same issue, Jagot J in Merck observed (at [6]-[7]) that the assessment of the strength of Apotex’s case for invalidity (an inventive step challenge) relied heavily on expert evidence. Were Apotex’s evidence to be the only evidence available, the assessment would have been straightforward. But as might be expected, Merck had also filed expert evidence, addressing the invalidity case. None of this evidence was, or could be, tested by cross-examination. All was prepared by apparently well-qualified experts and, on its face, appeared to be rational and persuasive. Yet the evidence of the experts would lead to different conclusions. Her Honour accordingly asked the parties for assistance in determining whether (and if so, how) she could prefer the evidence of one expert over another on a rational basis when there was no lack of persuasive force apparent from the face of the expert reports and none of the evidence had been tested. She proceeded to consider the evidence of the experts against the metric of whether there was a rational basis upon which the evidence of one could be preferred over another.3. BACKGROUND FACTS3.1 Introduction Before turning to apply the considerations relevant to the grant or refusal of the interlocutory orders sought, it is necessary to set out some background matters which have been addressed in considerable detail in expert and lay evidence. In many instances the experts disagree on matters of fact and opinion. The present hearing is not the place to make findings of fact, or to resolve disputes of opinion and I do not purport to do so here. This section addresses some matters of background that may facilitate a better understanding of the issues in dispute.3.2 Technical matters The immune system normally functions to protect the body from infections. There are various components and many different types of cells that make up the immune system. They include B-cells (or B lymphocytes) and T-cells (or T lymphocytes), which are sub-types of white blood cells. One function of B-cells is to produce antibodies as part of an immune response. Antibodies recognise, target and bind to specific proteins on the surface of foreign bodies (antigens) such as bacteria, viruses and some cancer cells, and cause cell destruction. T-cells are (inter alia) responsible for providing ‘help’ to B-cells and induce the release of chemicals called cytokines (predominantly by macrophages). Cytokines are small proteins that act as signals between different cells upon release. The release of cytokines can induce, exacerbate, or perpetuate inflammation. Tumour necrosis factor (TNFα) and interleukins are examples of cytokines, of which there are at least 30. As stated above, rituximab is a biologic therapy. Broadly, biologic therapies (also referred to as “biological medicines” or “biologics”) are large, complex molecules derived from a biological source, such as bacterium, yeast or blood. They are different to synthetic small molecule medicines in terms of production processes, the complexity of chemical structure, purity and immunogenicity (which is discussed further below). The manufacture of a biologic involves extensive research and development to select the most appropriate cell lines to be modified so that they can be made to reproduce in a manufacturing context.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

Celltrion’s products were not registered on the ARTG until after Sandoz had filed and served its balance of convenience evidence. As a consequence, there is no evidence from Sandoz which addresses these contentions. However, Sandoz submits that Roche’s evidence is largely speculative and is at odds with the clinical evidence as to the urgent need for less expensive rituximab. It also notes that Sandoz has already been approached by public authorities, private hospitals and healthcare providers to participate in tenders for rituximab (for supply in the second half of 2018). On the other hand, Mr Samwell’s own evidence is that there are a number of private and public hospital tenders for which Sandoz may not be in a position to participate in during 2018.6.2 Conclusions Roche has established a prima facie case for infringement of the asserted claims. Sandoz has by its evidence demonstrated that it has an arguable case for challenging the validity of those claims, however, for the reasons set out in section 5 above, the evidence does not permit a provisional view that rises above that level. This yields the conclusion that Roche has established a probability of success in the sense contemplated by Jessup J in Interpharma identified in paragraph [27] above. It is important to note that the prima facie case on infringement is based on admissions made by Sandoz with the result that the case advanced by Roche pursuant to s 117 of the Act is sufficiently established for present purposes. Tied up in the admission is the acceptance that by supplying RIXIMYO, Sandoz will be supplying to a person who it has reason to believe will use the product for the patented indications. Naturally each supply cannot be for each indication, but the admission made does not distinguish between patented indications. Each of Sandoz’s ARTG registrations for RIXIMYO is in respect of all of the patented indications. That is to say, the prima facie case established by Roche applies equally in respect of all of the patented indications. In the present case the expiry of the asserted patents is relevant. The NHL patent expires on 11 August 2019, the CLL patent expires on 9 November 2019, the DLBCL patent expires on 2 August 2020 and the RA patent expires on 6 April 2024. It is unlikely that the proceedings will be concluded before the expiry of the NHL or CLL patents. In its statement of claim, Roche alleges infringement of over 70 claims in respect of 5 patents. The cross-claim was only filed in April 2018 and a timetable for the filing of evidence and the trial has not yet been proposed. In the normal course of such cases there is also likely to be an appeal. This timing indicates that the outcome of the interlocutory application is likely to have the practical effect of determining the final question of injunctive relief at least for the asserted NHL and CLL claims, which enhances the need to have regard to the strength of the parties’ case when assessing the risk of doing an injustice by the grant or refusal of the interlocutory orders sought; Warner-Lambert at [70]. For the reasons that I have identified in section 5 above, this factor lies in favour of Roche.

Ratio Decidendi

Legal Principle Established

When read together, having regard to the dependencies, claim 3 is for a method of treating RA in a patient who experiences an inadequate response to a TNFα-inhibitor, comprising administering rituximab in 2 x intravenous doses of 1000mg, wherein the patient is further treated with concomitant methotrexate.5. CONSIDERATION OF THE QUESTION OF ARGUABLE CASE5.1 Introduction Sandoz challenges the validity of each of the patents on the basis that they lack an inventive step. As noted in Samsung at [67], the apparent strength of the parties’ substantive cases will often be an important consideration to be weighed in the balance of whether or not to grant interlocutory injunctive relief. Sandoz accepts, for the purposes of the present application, that its proposed conduct will infringe the asserted claims. That concession yields the result that, subject only to the invalidity challenge, Roche has established the strongest of arguable cases. The critical question then becomes; what is the strength of Sandoz’s invalidity challenge? A great deal of expert evidence has been filed by both sides concerning the cross-claim. The expert opinion evidence reflects numerous disagreements including; as to what the person skilled in the art knew at the priority dates; what research work they would undertake; and what expectation of success there would have been in relation to that work. Sandoz does not ask that the Court try to resolve the evidentiary conflicts reflected in the affidavit materials. Indeed it is not appropriate to do so. It is not the function of the Court to conduct a preliminary trial of the action or, in general, to resolve conflict between the parties’ evidence and grant or refuse the application on the basis of such findings; Warner-Lambert Co LLC v Apotex Pty Ltd [2014] FCAFC 59; 311 ALR 632 (Full Court) (Warner-Lambert) at [72], [91]. Nevertheless, Sandoz urges that the Court can conclude that there is a “very serious challenge” to the validity of the patents and that this weighs heavily against the grant of the orders sought. In this connection, Sandoz states that it does not invite the Court to make findings in respect of contested facts and opinions but it nevertheless asks the Court to conclude that it has a strong prima facie case. In response, Roche accepts for present purposes that the case advanced by Sandoz on the cross-claim is arguable, but no more. It submits that the overwhelming strength of its infringement case is not weakened by the existence of a merely arguable cross-claim and that this is a relevant factor in the consideration of the application.5.2 The Person skilled in the art It appears to be common ground between the parties that the personal skilled in the art for the cancer patents is a haematological malignancy specialist with both clinical and research experience, and the person skilled in the art for the RA patent is a rheumatology specialist with clinical and research experience. There is no dispute that the expert witnesses who have given evidence are suitably qualified.5.3 The relevant law on inventive step