Federal Court of Australia

AUPharma Pty Limited v Mundipharma Pty Limited [2023] FCA 330

ORDERS

THE COURT ORDERS THAT:

1.    The respondent produce to the applicant electronic copies of the following modules from the dossier provided to the Therapeutic Goods Administration in relation to each of the respondent’s TARGIN® products:

(a)    module 3.2.P.1 titled “Description and Composition of the Drug Product”;

(b)    section 3.2.P.2.1 titled “Components of the Drug Product”;

(c)    section 3.2.P.2.2 titled “Drug Product”;

(d)    section 3.2.P.2.3 titled “Manufacturing Process Development”; and

(e)    module 3.2.P.3.3 titled “Description of Manufacturing Process and Process Controls”.

2.    The respondent pay the applicant’s costs of the interlocutory application dated 23 March 2023.

3.    The interlocutory application dated 30 March 2023 be dismissed, with no order as to costs.

4.    The proceeding be listed for case management on 21 April 2023 at 9.30 am.

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

REASONS FOR JUDGMENT

YATES J:

Introduction

1    By an interlocutory application dated 23 March 2023, the applicant in the principal proceeding, AUPharma Pty Limited, seeks an order pursuant to r 1.32 of the Federal Court Rules 2011 (Cth) (the Rules) that the respondent, Mundipharma Pty Limited, produce electronic copies of the following modules from the dossier provided to the Therapeutic Goods Administration in relation to each of the respondent’s “Targin” modified release products (Targin):

(a)    module 3.2.P.1 titled “Description and Composition of the Drug Product”;

(b)    module 3.2.P.2 titled “Pharmaceutical Development”; and

(c)    module 3.2.P.3.3 titled “Description of Manufacturing Process and Process Controls”.

2    The applicant has also served a notice to produce seeking the production of these documents.

3    Shortly before the hearing of the interlocutory application, the applicant confined its application for production of module 3.2.P.2 to certain sections of that module.

4    The respondent opposes the application for production of the 3.2.P.2 module or any part of it, and has filed an interlocutory application dated 30 March 2023 seeking an order setting aside the applicant’s notice to produce insofar as it relates to module 3.2.P.2. It no longer resists the production of module 3.2.P.1 or module 3.2.P.3.3.

5    I should record at once my view that service of the notice to produce by the applicant pursuant to r 30.28(1) of the Rules was not only inappropriate as a matter of process, but also entirely unnecessary given that, independently of the notice to produce, the applicant was, at the same time, moving the Court for orders seeking production of the very same documents.

Background

6    The respondent is the patentee of the following patents:

(a)    Patent No. 2013270469 (the 469 patent);

(b)    Patent No. 2015210453 (the 453 patent);

(c)    Patent No. 2017200011 (the 011 patent);

(d)    Patent No. 2018206745 (the 745 patent);

(e)    Patent No. 2021245130 (the 130 patent);

(together, the Endo patents).

7    Each patent relates to an oral controlled-release pharmaceutical composition comprising oxycodone and naloxone, where the oxycodone and the naloxone are present in a ratio within the range of 5:1 to 1:1 (the 469 patent, the 453 patent, and the 011 patent), or within the range of 4:1 to 1:1 (the 745 patent and the 130 patent), and where the composition releases the oxycodone and the naloxone.

8    Except for the 130 patent, the term of each patent has been extended under s 70 of the Patents Act 1990 (Cth) (the Act). The respondent has also applied to extend the term of the 130 patent. The applicant initially opposed the extension being granted, but its opposition was withdrawn on 8 December 2022. It nevertheless contends that an extension of term of the 130 patent should not be granted because, as with the entries on the Register of Patents (the Register) for each of the other extensions of term, an extension of term of the 130 patent would be an entry made in the Register without sufficient cause, or an entry wrongly existing in the Register, or an error or defect in an entry in the Register.

9    A patentee’s entitlement to apply for an extension of term of a pharmaceutical patent is governed by s 70 of the Act, which relevantly provides:

    (1)     The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied.

(2)     Either or both of the following conditions must be satisfied:

(a)     one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;

(b)     one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.

(3)     Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances:

(a)     goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;

(b)     the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.

Note:    Section 65 sets out the date of a patent.

(4)     The term of the patent must not have been previously extended under this Part.

…

10    The applicant’s pleaded case is that the subject matter of each of the Endo patents is not a pharmaceutical substance per se within the meaning of s 70(2)(a) of the Act.

11    Further, the respondent’s applications for extension of term were based on the inclusion in the Australian Register of Therapeutic Goods of Targin. The applicant pleads that these goods do not contain or consist of a pharmaceutical substance within the meaning of Sch 1 to the Act.

12    The applicant pleads that, given these matters, the respondent’s applications to extend the terms of the Endo patents should have been refused and that, in respect of the 469 patent, the 453 patent, the 011 patent, and the 745 patent, the extensions of term were wrongly granted.

13    The applicant also seeks an order revoking the Endo patents on the ground that the complete specification of each patent does not comply with s 40(2)(aa) of the Act, which requires a complete specification to disclose the best method known to the patent applicant of performing the invention.

14    Taking the 469 patent as an example that is representative of all the Endo patents, the complete specification states:

The tablets may be made by any traditional method of manufacture of controlled release tablets. Two principal processes are wet process (including wet granulation) and dry process (including direct mixing and roller compaction process). Exemplary compositions for those processes are reproduced below.

15    The complete specification then gives three example compositions referred to as “Formula 1”, “Formula 2”, and “Formula 3”, each of which contains oxycodone hydrochloride and naloxone in a ratio of 1:1. These formulations are for 10 mg tablets. Tables 3, 4 and 5 in the complete specification set out the constituents of each composition. The tables show that the only excipients are lactose (spray-dried), hydroxypropyl methylcellulose K100M, silicone dioxide, and magnesium stearate.

16    The complete specification of the 469 patent also discloses “alternative compositions” being, preferably, tablets having the “following compositions”:

17    The applicant contends that no example is given of the manufacturing process for any of the disclosed compositions.

18    However, the complete specification of the 130 patent refers to the “commercially available product” Targin as a preferred embodiment of the invention. It also discloses that details of the product are available from the Product Information Sheet (product information) published by the Therapeutic Goods Administration.

19    The applicant’s pleaded case in this regard is that, at the time of filing each complete specification, or before the grant of each patent, the patent applicant at the relevant time (being Endo Pharmaceuticals Inc., Mundipharma International Corporation Limited, or the respondent) knew of at least one specific oral controlled-release composition comprising a controlled-release matrix containing oxycodone (as the hydrochloride salt) and naloxone (as the hydrochloride salt) in a ratio of 2:1, wherein the controlled-release matrix releases the naloxone and the oxycodone. This composition was the composition for Targin.

20    The applicant pleads that the complete specifications of the Endo patents do not disclose the formulation of Targin or any other specific oral controlled release composition comprising:

(a)    a 2:1 ratio of oxycodone to naloxone; or

(b)    a 2:1 ratio of oxycodone hydrochloride to a pharmaceutically acceptable salt of naloxone.

21    The applicant pleads, further, that the complete specifications of the Endo patents do not disclose any method of preparing Targin or any other specific oral controlled release composition comprising:

(a)    a 2:1 ratio of oxycodone to naloxone; or

(b)    a 2:1 ratio of oxycodone hydrochloride to a pharmaceutically acceptable salt of naloxone.

22    The applicant pleads that, for this reason, the complete specifications of the Endo patents do not comply with s 40(2)(aa) of the Act.

23    I note that the applicant does not plead (at least directly) that the composition of, and process for manufacturing, Targin was the best method of performing the invention claimed in each of the Endo patents that was known to the patent applicant at relevant times. It has nevertheless made clear in the course of oral submissions in the present application, and through an affidavit made by its solicitor Mr Miller, that that is its case on the failure to disclose the “best method”.

The submissions

24    The applicant relies on two bases to submit that the modules are sufficiently relevant to justify their production.

25    First, the applicant submits that the alleged invention in each of the Endo patents is an abuse-resistant, oral controlled-release pharmaceutical composition comprising a controlled-release matrix containing oxycodone and naloxone (or oxycodone hydrochloride and a pharmaceutically acceptable salt of naloxone) in a ratio of 5:1 to 1:1, where the controlled-release matrix releases the oxycodone and naloxone.

26    The applicant submits that, with the exception of the 130 patent, the complete specifications of the Endo patents do not refer to Targin, its formulation, or its process of manufacture.

27    The applicant submits that while the complete specification of the 130 patent does refer to (a) Targin as a “commercially available product”, and as the preferred embodiment of the invention that is claimed, and (b) the product information, neither the complete specification nor the product information discloses the formulation of Targin (except for some details regarding excipients) or the process for its manufacture.

28    In its defence, the respondent denies that the complete specifications of the Endo patents fail to disclose the formulation and the process for manufacturing Targin. It also pleads that, in any event, at relevant times, the common general knowledge included knowledge of the formulation of Targin and the “traditional methods of tablet manufacture, including wet and dry processes and the working of those processes”.

29    The applicant disputes that, at relevant times, the formulation of Targin was common general knowledge.

30    Given this state of affairs, the applicant submits that its challenge based on non-compliance with s 40(2)(aa) of the Act requires:

(a)    an understanding of the formulation of Targin and the process for its manufacture;

(b)    a determination of whether or not those matters formed part of the common general knowledge, or would have been available to the person skilled in the art by routine experimentation, at the relevant time; and

(c)    consideration of the burden imposed on the person skilled in the art who is left to rely upon routine experimentation, balanced against the practicality of disclosing information in the complete specifications.

31    The applicant submits that the modules are likely to provide information which is adjectivally relevant to these matters.

32    In this regard, the applicant says that the modules will contain information regarding:

(a)    the formulation of Targin, including the quantity of excipients, the function of each excipient, and detailed information regarding the identity of the excipients;

(b)    the process for manufacturing Targin; and

(c)    the development studies which led to the final formulation and final manufacturing process for Targin.

33    Amongst other things, the applicant says that this information will assist in enabling expert evidence to be adduced as to whether or not the formulation of Targin, and the processes for manufacturing Targin, form part of the common general knowledge, or could reasonably have been arrived at based upon routine experimentation and other information disclosed in the complete specifications, without the information in the modules. The information is also likely to assist in addressing the burden of the task in arriving at the formulation and manufacturing process for Targin.

34    With specific reference to the particular sections of the 3.2.P.2 module which the applicant now seeks, the applicant submits that they will:

… demonstrate whether, as a matter of fact, arriving at the final formulation and final manufacturing process for Targin was a matter of routine or involved difficulties and failures, blind alleys and pitfalls, dead-ends and the retracing of steps. It will also inform, as a matter of fact, the burden of overcoming these issues. It will identify where, as a matter of fact, the use of a particular excipient did not work, a particular formulation did not work or a particular manufacturing process did not work. The evidence of what was actually done and what choices were actually made (albeit by a highly skilled and inventive pharmaceutical company) in developing its commercial formulation and manufacturing process (i.e. its best method) is clearly of at least apparent relevance to the question of best method. The experience that [the respondent] had, as a matter of fact, will be highly informative as to whether the hypothetical [person skilled in the art], armed with the [common general knowledge] and the specification of each of the Endo Patents (at the relevant dates), could reasonably have arrived at the formulation of Targin and the process for manufacturing it based on routine experimentation, and the burden on the [person skilled in the art] in attempting to do so.

35    The second basis on which the applicant relies to justify production of the modules concerns its challenge to the extensions of term based on non-compliance with s 70(3)(a) of the Act. As I have noted, the applicant’s case is that Targin does not contain, or consist of, a “pharmaceutical substance” within the meaning of Sch 1 to the Act. This is because the oxycodone hydrochloride and naloxone hydrochloride in Targin is not a “mixture”, as that expression has been understood. In other words, as the applicant would have it, oxycodone hydrochloride and naloxone hydrochloride are not present in “an uncontrolled spatial configuration”: Re Application by LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12; 57 IPR 104 at [15]; Re LTS Lohmann Therapie Systeme AG & Schwartz Pharma Ltd and Commissioner of Patents [2010] AATA 809; 118 ALD 425 at [17] – [19]. The applicant submits that the information in the modules regarding the formulation and manufacturing processes for Targin will assist in addressing this question.

36    For practical reasons, the respondent has signified its preparedness to produce the 3.2.P.1 module and the 3.2.P.3.3 module, despite having resisted informal production in the past. As I have noted, it opposes the application to produce the 3.2.P.2 module or any part of it.

37    With respect to the applicant’s challenge to the extensions of term, the respondent submits that the applicant has not attempted to justify, in any detail, why the 3.2.P.2 module is necessary. It submits that this module “could not shed any additional light on the question of whether Targin was a mixture over and above Module 3.2.P.1 and Module 3.2.P.3.3”.

38    The respondent also disputes that the information in module 3.2.P.2 is relevant to the applicant’s “best method” challenge. It submits that module 3.2.P.2 is not reasonably likely to add, in the end, in some way or other, to the relevant evidence in this case. As the respondent puts it:

… evidence concerning the development process adopted by the patentee or its predecessor, many years before each filing date, in circumstances where the common general knowledge did not include knowledge of the existence of a controlled release formulation of oxycodone hydrochloride and naloxone hydrochloride cannot rationally bear on the question of whether a skilled person could reasonably have arrived at such a formulation based upon common general knowledge, routine experimentation and the matters disclosed in the Endo Patent many years later.

39    The respondent also submits that evidence of this kind will likely significantly expand the length of the trial since it will require evidence in answer, and a determination by the Court as to whether the common general knowledge has changed in the intervening period, and if so, how. The respondent submits that such evidence is likely to involve lengthy cross-examination and would, at best, be evidence of only “secondary significance”.

Consideration

40    The parties agree that module 3.2.P.1 and module 3.2.P.3.3 are short, specific descriptions of the composition of a drug product and its manufacturing process and process controls, as indicated by a flowchart and brief description of process steps. They agree that module 3.2.P.2 is usually much longer and provides a detailed historical account of the development of the drug, including details of studies conducted to establish the dosage form, the formulation, the manufacturing process, container closure system, microbiological attributes, and usage instructions that are appropriate for the purpose specific in the application.

41    As I have noted, the applicant originally sought production of the whole of module 3.2.P.2 as part of its application. However, following the exchange of affidavit evidence and submissions, it has now confined its application to the production of the following sections of the module:

(a)    section 3.2.P.2.1 titled “Components of the Drug Product”;

(b)    section 3.2.P.2.2 titled “Drug Product”; and

(c)    section 3.2.P.2.3 titled “Manufacturing Process Development”.

42    It appears to be accepted that, while module 3.2.P.1 and module 3.2.P.3.3 will give the final formulation and final manufacturing process for Targin, they will not give information on the development of the formulation or the manufacturing process.

43    On balance, I am persuaded that the sections of the 3.2.P.2 module that the applicant seeks should be produced by the respondent. I am satisfied that those sections are likely to provide information as to the formulation of Targin and the process of its manufacture that is adjectivally relevant to the “best method” case the applicant seeks to bring and will assist the applicant in the preparation and prosecution of that case.

44    The submissions advanced by the respondent do not persuade me that production of the sections of module 3.2.P.2 which the applicant seeks, should not be ordered.

45    First, while I accept that information as to the development of the Targin formulation and manufacturing process needs to be considered in a particular light, as the respondent’s submissions make clear, it does not follow that this information will not be relevant to the questions raised by the applicant with respect to whether the complete specifications comply with the requirement of s 40(2)(aa) of the Act.

46    Secondly, while the kind of evidence that the applicant envisages with respect to the information revealed by the particular sections of module 3.2.P.2 may significantly expand the issues for hearing, and the likely length of the trial, with all the consequences that the respondent’s submissions portend, this, alone, is not a sufficient reason to refuse the applicant’s application. What it does reveal, however, is that the trial of this proceeding is likely to be far more complex, and to take far greater hearing time, than the applicant has portrayed in earlier case management hearings.

47    I record that I have encouraged the parties to confine the issues in dispute between them so that this matter can proceed as efficiently, and with as little complexity and cost, as is possible. At the present time, this encouragement has not been fruitful.

Conclusion

48    I will order the respondent to produce, in electronic form, the documents sought by the applicant and, in respect of the interlocutory application dated 23 March 2023, order the respondent to pay the applicant’s costs.

49    I will order that the interlocutory application dated 30 March 2023 be dismissed, with no order as to costs.

50    I will list the proceeding for further case management on 21 April 2023 at 9.30 am.

Associate:

Dated:    13 April 2023