Abbey Laboratories Pty Ltd v Virbac

1. In these proceedings, the applicant (Abbey) seeks revocation of Australian Patent Number 2012227241 (the Patent) held by the respondent (Virbac) on the grounds of novelty and lack of inventive step. The Patent concerns formulations for the topical treatment of cattle for parasites. The priority date is 23 September 2011.
2. Abbey has filed six expert reports by Dr Fadil Alawi, a veterinary pharmaceutical formulator. The first of them is dated 21 August 2024 and was served on 15 October 2024. Dr Alawi details his practical experience in developing pharmaceutical formulations in the animal health industry. Since 2019, Dr Alawi has provided consulting services to animal health companies in relation to new product development and technology transfer through a company, Pharminnovation Ltd. In his first affidavit of 21 August 2024, Dr Alawi explains that in his role as a private consultant and trainer at Pharminnovation Ltd, he provides consulting services, including the development of formulations for new products and the reformulation of existing products, depending on his client's key objectives, This formulation work includes reviewing the results of literature and patent searches, conducting preliminary solubility studies, formulating prototypes that may meet the client's objectives and advising on stability trials. In paragraph [18] of his affidavit, Dr Alawi says the following:

Since April 2019, Pharminnovation Ltd has been retained by Abbey to consult on approximately 5 to 9 projects relating to the development of animal health products. The most recent project ended in June 2022.

1. On 21 August 2025, less than two weeks before the hearing, Virbac served a notice to produce on Abbey requiring the production of documents as follows:

In respect of each of the "5 to 9" projects related to the development of animal health products where "Abbey" has retained Pharminnovation Ltd (Pharminnovation), referred to in paragraph 18 of the Affidavit of Dr Fadil Alawi dated 21 August 2024 (Project(s)):

(a) sufficient documents to identify one or more of [amended in the course of oral argument to read "sufficient documents to identify"] the:

i. active ingredient(s);

ii. excipient, including solvent;

iii. method of administration; and/or

iv. target animal

The subject of each Project for which Pharminnovation was engaged by Abbey as referred to in that paragraph; and

(b) to the extent that any Project for which Pharminnovation was engaged by Abbey resulted in the registration of an animal health product, document(s) recording the name of the registered product.

1. The notice to produce is not confined to any projects which related to formulations for the topical treatment of cattle for parasites. The period in question is between eight and eleven years after the priority date of the patent, during which period common general knowledge as well as Dr Alawi's own views and practices may well have changed.
2. In Seven Network (Operations) Ltd v Fairfax Media Publication Pty Ltd [2023] FCAFC 185; (2023) 418 ALR 284, Wheelahan, Anderson JJ and I dealt with the concept of relevance applicable to subpoenas, which Virbac accepts are applicable also to notices to produce. At [36], we referred to the onus lying on the party issuing a subpoena to demonstrate that it has a legitimate forensic purpose in relation to the issues in the proceeding. At [37], we held that the fundamental principle is that the party issuing a subpoena must demonstrate that the subpoena has a legitimate forensic purpose, and it may be set aside if it is cast in terms which require the production of documents which do not have apparent relevance to the issues in the case. At [38], we cited with approval the reasoning of the New South Wales Court of Appeal in Secretary of the Department of Planning, Industry and Environment v Blacktown City Council [2021] NSWCA 145 to the following effect, omitting citations:

(a) the language of "tests" should be eschewed; whether a subpoena should be set aside depends on whether it involves an abuse of process, and it will be an abuse of process if it is not issued for a legitimate forensic purpose;

(b) it is not necessary to show that the documents subpoenaed will or will be likely to assist the case of the party that has issued the subpoena;

(c) it is sufficient to show that the subpoena can plausibly be seen to relate to an issue or issues in the proceedings or to cast light on such an issue, and the subpoena is not in other respects too vague or oppressive;

(d) put differently, it is sufficient to show that there is a reasonable basis for supposing that the material called for would likely add, in the end, in some way or another, to the relevant evidence in the case;

(e) it is sufficient to show that the documents sought are apparently relevant in the sense that it can be seen that the documents sought to be produced by way of subpoena will materially assist on an identified issue or that there is a reasonable basis beyond speculation that it is likely that the documents subpoenaed will so assist.

1. On the evidence currently before me, I am unable to see how the documents sought can plausibly be seen to relate to any issue in the proceedings or to cast light on such an issue, or that there is a reasonable basis for supposing that the material called for would likely add, in the end, in some way or another, to the relevant evidence in the case. It strikes me as a matter of speculation whether the document sought will materially assist on any issue in the proceedings. Accordingly, I regard the notice to produce as a fishing expedition.
2. Virbac also submits to the documents may be relevant to Dr Alawi's independence. I cannot at present, however, see that that is so beyond the information which is conveyed by paragraph [18] of Dr Alawi's first affidavit, which seems to me to contain sufficient disclosure for any submission to be put concerning that topic.
3. As to the form of order in relation to the notice to produce, the interlocutory application seeks an order that compliance with the notice to produce be dispensed with, whereas in oral address, Mr Ryan SC for Abbey submitted that the notice to produce should be set aside. Against the possibility that evidence of which I am currently unaware may throw further light on the legitimacy of the notice to produce, I regard the preferable form of order as being dispensing with compliance with the notice to produce rather than setting it aside.

I certify that the preceding eight (8) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Jackman.