FEDERAL COURT OF AUSTRALIA

Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2019] FCA 411

File number:

NSD 182 of 2019

Judge:

YATES J

Date of judgment:

25 March 2019

Catchwords:

PRACTICE AND PROCEDURE application to set aside notice to produce – whether notice to produce is oppressive – whether documents sought are adjectivally relevant to the proceeding – whether categories of documents sought are unduly broad, ambiguous or imprecise – whether appellants’ claim of privilege relevant – application dismissed

Date of hearing:

25 March 2019

Registry:

New South Wales

Division:

General Division

National Practice Area:

Intellectual Property

Sub-area:

Patents and associated Statutes

Category:

Catchwords

Number of paragraphs:

20

Counsel for the Appellants:

Mr T Cordiner QC and Mr J Cooke

Solicitor for the Appellants:

Minter Ellison

Counsel for the First Respondent:

Mr N Murray SC and Ms C Cunliffe

Solicitor for the First Respondent:

Ashurst

ORDERS

NSD 182 of 2019

BETWEEN:

MYLAN HEALTH PTY LTD

First Appellant

BGP PRODUCTS OPERATIONS GMBH

Second Appellant

AND:

SUN PHARMA ANZ PTY LTD

First Respondent

ALKERMES PHARMA IRELAND LIMITED

Second Respondent

JUDGE:

YATES J

DATE OF ORDER:

25 MARCH 2019

THE COURT ORDERS THAT:

1.    The interlocutory application dated 15 March 2019 be dismissed.

2.    Save in respect of documents for which a claim of privilege is made, in the first instance production of the documents sought in the notice to produce dated 11 March 2019 be made informally by producing copies of the same to the first respondent’s solicitors by no later than 9.00 am on 29 March 2019.

3.    The appellants pay the first respondents’ costs.

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

REASONS FOR JUDGMENT

(Revised from transcript)

YATES J:

1    This is an application to set aside a notice to produce.

2    The appellants, Mylan Health Pty Ltd (Mylan) and BGP Products Operations GmbH, have appealed from a judgment of the Court which, amongst other things, dismissed their claim against the first respondent, Sun Pharma ANZ Pty Ltd (Sun Pharma), for threatened infringement of Patent No. 2006313711, the complete specification of which is entitled Use of fenofibrate or a derivative thereof for preventing diabetic retinopathy. Sun Pharma proposes to market a number of fenofibrate products in Australia that were entered on the Australian Register of Therapeutic Goods on about 29 February 2019. The appellants seek interim injunctive relief against Sun Pharma pending the determination of the appeal restraining it from, amongst other things, importing and supplying its intended fenofibrate products.

3    The appellants have filed an affidavit of Sylvain Andre Vigneault, affirmed 5 March 2019. Mr Vigneault is the General Country Manager (Australia) and Head of ANZ Commercial of the first appellant. In his affidavit, Mr Vigneault has deposed that if the Court does not grant the interim injunction sought by Mylan against Sun Pharma, it is the first appellant’s intention to lodge an authorised generic fenofibrate product. He has deposed that an authorised generic fenofibrate product might be able to achieve a similar share of the generic market for fenofibrate anticipated for the products intended to be supplied by Sun Pharma, and separately by another supplier, Cipla Australia Pty Ltd (Cipla). Mr Vigneault has also deposed that in order to reach such a share of the volume of the market, the authorised generic product will need to be sold at a price that matches or is even slightly lower than the anticipated heavily discounted prices for fenofibrate to be offered by Sun Pharma and/or Cipla.

4    Sun Pharma has issued a notice to produce dated 11 March 2019 directed to the production by the appellants of the following documents for the purpose of the hearing of the application for interim injunctive relief:

    All documents recording or referring to the consideration by the appellants, or either of them, of launching an authorised generic fenofibrate product, as referred to in paragraph 8 of the affidavit of Sylvain Andre Vigneault, affirmed 5 March 2019 (the first category).

    All applications to the Pharmaceutical Evaluation Branch to list on the Pharmaceutical Benefits Scheme (PBS) a generic fenofibrate product authorised by or on behalf of one or both of the appellants (the second category).

    All communications to customers referring to the proposed supply of an authorised generic fenofibrate product, as referred to in paragraph 8(c) of the affidavit of Sylvain Andre Vigneault, affirmed 5 March 2019 (the third category).

5    Sun Pharma submits that the documents sought in the first category are likely to address the advantages of Mylan launching an authorised generic product. It submits that such documents are directly relevant to the balance of convenience to be considered in relation to the application for interim injunctive relief. Sun Pharma submits that these documents are also likely to give estimates of market share and price, thus providing important details which, it submits, are missing from Mr Vigneault’s affidavit.

6    Sun Pharma submits that if Mylan has filed an application to list its intended authorised generic product on the PBS, then this would enable that product to compete with Sun Pharma’s intended products, with the benefit of a subsidy. It submits that the documents in the second category will allow Sun Pharma to know with greater precision the manner in which Mylan would be able to compete, and to test Mylan’s evidence of alleged hardship which is intended to be adduced at the hearing for interim injunctive relief.

7    Sun Pharma submits that the documents in the third category are likely to provide details missing from Mylan’s intended evidence at the hearing of the application for interim injunctive relief, such as the price at which Mylan intends to offer its authorised generic product, and the time from which that product will be available. Sun Pharma submits that such information is directly relevant to Mylan’s ability to compete in the absence of an injunction and, once again, relevant to the Court’s consideration of the balance of convenience.

8    Mylan submits that the notice to produce should be set aside for a number of reasons.

9    First, it submits that the first category of documents is imprecise and ambiguous. It submits that the category does not describe the documents with adequate specificity, and is unconfined by date. Further, Mylan submits that because of its breadth, the category will capture documents that have no apparent relevance to the issues in the application for interim injunctive relief, and does not exclude documents that might be subject to a claim of privilege. Mylan also submits that it can be expected that the documents will be highly confidential.

10    In elucidation of its submissions that the first category will include documents that have no apparent relevance, Mylan submits that it is not in doubt that if an injunction is not granted, it will launch an authorised generic fenofibrate product. The advantages perceived by Mylan in launching that product are not likely to be relevant in considering its claim for interim injunctive relief. Further, Mylan submits that its estimates of market share and price are unlikely to add to the relevant evidence in the case. In all, Mylan submits that it would be unfairly prejudicial to it if it had to produce the documents sought in the first category.

11    Mylan submits that the second category of documents is unduly broad because it would cover historic PBS applications, which have nothing to do with its presently intended authorised generic fenofibrate product. It argues that, even if limited to any current application for PBS listing, there will be no documents to produce.

12    Mylan submits that the third category of documents is also unduly broad, and does not describe the documents that are sought with adequate specificity. It submits that the category refers to communications, not documents, and the category is not restricted by date. Further, the category is not confined to communications from Mylan, and will capture every single communication to a customer referring to an authorised generic fenofibrate product. Mylan submits that the third category will, therefore, capture documents that do not have any apparent relevance to the proceeding. It also submits, once again, that it can be expected that many documents falling within this category will be highly confidential.

13    In its submissions in relation to this category, Sun Pharma drew attention to the likely price which Mylan’s authorised generic fenofibrate product is to be offered, and the time from which that product will be available. Mylan submits that documents in respect of these matters are unlikely to add to the relevant evidence in the application for interim injunctive relief.

14    The fact that Mylan proposes to launch an authorised generic fenofibrate product, if the Court were to refuse to grant the interim injunctive relief it seeks, is likely to be an important matter affecting the Court’s consideration of the balance of convenience. I am satisfied that the first category seeks documents that are adjectivally relevant to the issues that will arise for the Court’s consideration. I do not accept that the category is imprecise or ambiguous. It is true that the category is not restricted by date but, in this case, I do not think that the lack of date restriction means that the category is too wide or that production under it would be oppressive. The category is directed to a particular event or set of circumstances. That is a sufficient description in the circumstances.

15    Further, the fact that the first category does not exclude documents that are privileged is, to my mind, neither here nor there. The category is not directed to documents that are necessarily privileged from production. If any of the documents are properly privileged from production, Mylan can make the appropriate claim at the time of production.

16    Similarly, it is not apparent to me that the documents sought are necessarily confidential. If there are documents falling within the call of the first category that are confidential, then Mylan can raise that matter at the time of production.

17    So far as the second category is concerned, I accept that applications for PBS listing in respect of products not referred to in Mr Vigneault’s affidavit are not adjectivally relevant. However, Sun Pharma has made clear in submissions that it does not seek the production of documents in relation to earlier applications in respect of PBS listing. The second category of documents should be read as limited to PBS listing for the authorised generic product referred to in Mr Vigneault’s affidavit. So limited, production under that category should be permitted.

18    So far as the third category is concerned, I think it is clear that the category is directed to the communications that are to be made in respect of the products referred to in Mr Vigneault’s affidavit. I do not accept that the category is unduly broad. The argument in Mylan’s written submissions that the category is directed to “communications” and not “documents” is without substance, because, in paragraph 8(c) of his affidavit, Mr Vigneault himself refers to communications, or at least the possibility of communications. He must know, and, therefore, Mylan must know, what those communications are or are likely to be.

19    I am satisfied that the call of the third category is for documents that will be adjectivally relevant to the Court’s consideration of the balance of convenience. It is not apparent to me that the documents sought are necessarily confidential, but, once again, this is a matter that Mylan can raise at the time of production.

20    For these reasons, the application to set aside the notice to produce should be dismissed with costs.

I certify that the preceding twenty (20) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Yates.

Associate:    

Dated:    26 March 2019