Pfizer Corp v Commissioner of Patents

the date from which extension of term is calculated

The statutory provisions 6 Part 3 of Ch 6 of the Act concerns extensions of term of patents relating to pharmaceutical substances. Section 70(1) of the Act provides that 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 subss (2), (3) and (4) are satisfied. The parties accept that those requirements have been satisfied. 7 Section 70(3) provides that, as a condition for extension, goods containing at least one of the claimed pharmaceutical substances must be included in the Australian Register of Therapeutic Goods ('the ARTG') and 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. Section 77 provides for the calculation of the term of extension by reference to the period beginning on the date of the Patent and ending on the earliest 'first regulatory approval date' as defined in s 70, reduced by 5 years. 8 The 'first regulatory approval date' in relation to a pharmaceutical substance is defined in s 70(5): 'For the purposes of this section, thefirst regulatory approval date,in relation to a pharmaceutical substance, is: (a) if no pre-TGA marketing approval was given in relation to the substance - the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or (b) if pre-TGA marketing approval was given in relation to the substance - the date of the first approval.'

Relevant factual matters 9 No Australian regulatory approval was granted for the pharmaceutical substances of the Pfizer patents prior to the establishment of the ARTG by the Therapeutic Goods Act 1989 (Cth) ('the TG Act'). The substances were first entered in the ARTG as "listed goods" for export only. They were later entered in the ARTG as "registered goods", that being the date of approval to market the substances in Australia. The dates by reference to which the extended terms of the patents were calculated pursuant to s 77 of the Act were those on which the goods had been included in the ARTG as "registered goods", the later date. When the Commissioner appreciated this, she decided that the extension of term should be calculated by reference to the earlier date, the date of entry in the ARTG as listed goods for export only. 10 The issue is whether, in the context of the Act, 'the first inclusion in [theARTG]' is the date of listing for export only or the date of registration enabling Pfizer to market the substances in Australia. Pfizer contends that the relevant date is that of registration, not of any listing in the ARTG. 11 This, in turn, raises the need to consider the meaning of the expressions: · "first inclusion in the ARTG"; · "first regulatory approval date"; and · "pre-TGA marketing approval".

The ARTG 12 Schedule 1 to the Act defines the ARTG to mean 'the register maintained under s 17 of [the TG Act]'. At the time of commencement of the current Pt 3 of Ch 6 of the Act in January 1999, s 17(3) of the TG Act provided that the ARTG contains two parts, one relating to goods to be known as registered goods and the other relating to goods to be known as listed goods. By Item 46 of the Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) ('the TG Amending Act'), despite the repeal of s 17, goods that were 'included in [theARTG]' prior to the TG Amending Act are taken to be included in the ARTG after its commencement. The distinction between listed goods and registered goods continues to apply in the TG Act, which now contains three parts - listed goods, registered goods and medical devices included in the ARTG under Ch 4 (s 9A of the TG Act, inserted by the TG Amending Act). The parties do not consider the difference between the old s 17 and the new s 9A to be material. 13 The Therapeutic Goods Regulations 1990 (Cth) ('the TG Regulations') provide for therapeutic goods of a certain kind to be included in the part of the ARTG for registered goods and therapeutic goods of a certain kind to be included in the part of the ARTG for listed goods (reg 10). The former encompasses goods which must be registered before they can be marketed in Australia while the latter encompasses goods manufactured in Australia for export only (Sch 4, Pt 1 of the TG Regulations). Section 17(4) provided and s 9A(4) of the TG Act provides that the regulations may prescribe the ways in which goods may be transferred from one part of the ARTG to the other part of the ARTG. Regulation 10B of the TG Regulations provides for such transfer. 14 It is apparent that, in the TG Act, "inclusion in the ARTG" relevantly refers to the inclusion of listed goods or registered goods. For example, s 6AAE(6) provides that, for the purposes of s 6AAE, where 'the Register' is the ARTG: 'A reference in this section to the inclusion of goods in the Register is a reference to the inclusion of the goods: (a) in the part of the Register for goods known as registered goods; or (b) in the part of the Register for goods known as listed goods; or (c) in the part of the Register for medical devices included under Chapter 4.'

Entry in the ARTG 15 It follows from the structure of the ARTG that the TG Act relevantly provides for two forms of regulatory approval of drugs. One permits export of goods, such goods being included in that part of the ARTG known as listed goods ('Listed Goods'). The other permits marketing in Australia of goods, such goods being included in that part of the ARTG known as registered goods ('Registered Goods'). 16 A patentee has a choice as to which regulatory approval to obtain to enable it to exploit the patented pharmaceutical substance. Subject to the requirements of the TG Act, inclusion in the ARTG as Listed Goods or inclusion in the ARTG as Registered Goods are each available to a patentee. 17 An export only listing of a pharmaceutical substance as Listed Goods does not permit marketing in Australia. Pfizer accepts that it does not only permit a product to be exported overseas but also permits manufacture in Australia for export. 18 The right to exploit an invention is not limited to the sale of a patented substance in Australia. For example, to manufacture a patented substance in Australia for sale in another country is to exploit an invention within the meaning of the Act (Sch 1 of the Act).

Dr Walter's Evidence 19 Spirit Pharmaceuticals Pty Limited is an Australian pharmaceutical company with a commercial interest in the expiry date of at least one of the Pfizer patents. Spirit was joined as a respondent to this proceeding on 1 March 2006 (Pfizer Corp v Commissioner of Patents (2006) 67 IPR 646). 20 Spirit seeks to adduce evidence of Dr Walters, a person experienced in matters relating to the ARTG, to establish the regulatory requirements of Listed Goods and the extent to which a patentee with an export only listing can exploit a patent. The evidence is said to answer Pfizer's contention that there is no requirement to lodge extensive data in support of an application for inclusion in the ARTG as Listed Goods, which is a requirement for goods to be Registered Goods. Spirit also wishes to respond to any suggestion that an export only listing does not allow exploitation of the patent which compensates for regulatory and product development delays. Such evidence was tendered by Pfizer before the Commissioner and was referred to in the decision. Pfizer now contends that the issue is one of statutory construction to which this evidence is not relevant. 21 Pfizer submits that all parties now accept that there can be different inclusions in the ARTG. Pfizer accepts that it is necessary to provide data in support of an application for Listed Goods and that an export only listing enables the patentee to exploit the invention, albeit on a less than "fully effective" basis. The point that Pfizer wishes to make is that the provision of data for Registered Goods is more onerous and extensive. This itself is said to result in regulatory delay before there can be marketing in Australia and full exploitation of the patent. 22 Pfizer relies on the distinction between the evaluation of Registered Goods and Listed Goods in ss 25 and 26 of the TG Act and stresses that it is not necessary to provide data of efficacy for an application for Listed Goods. Section 25 of the TG Act sets out the matters relevant to the evaluation of Registered Goods, which include a positive requirement that those goods are evaluated for quality, safety and efficacy (s 25(1)(d)). Section 26, which deals with matters relevant to Listed Goods, makes no express reference to efficacy and is couched in negative terms, in the sense that the Secretary is 'not to refuse' to list goods unless satisfied of certain matters (s 26(1)(c) to (n)). 23 This distinction alone does not establish the extent to which the provision of data for Registered Goods is more onerous and extensive in practice. For example, it is a prerequisite for Listed Goods that any requirements imposed by the Secretary under s 31 in relation to the goods are complied with (s 26(1)(b)). This may include requirements imposed by the Secretary to provide information or documents relating to, among other things, safety, quality and efficacy (ss 31(2)(f) and (h) of the TG Act; regs 16AA(a) and (b) of the TG Regulations). 24 Spirit tendered a sample application form for Listed Goods. Pfizer initially objected to the relevance of the form, but later submitted that the Court need only look at the face of it to see that the required data for Registered Goods are more onerous. Pfizer submits that 'for registration you send a pantechnicon full of paper to the Authority and they assess the material'. No evidence was adduced by Pfizer to support that submission. 25 Dr Walters was formerly Chief Scientist of the Pharmaceutical Chemistry Evaluation Section of the Drug Safety and Evaluation Branch of the Therapeutic Goods Administration ('TGA'). Although she did not review applications for Listed Goods, as part of her duties it was necessary for her to review and keep up to date with TGA policies, including policies in respect of applications for Listed Goods in comparison with the requirements for Registered Goods. 26 To the extent that Pfizer has submitted that it is a more onerous and extensive process to apply for Registered Goods, Dr Walters' evidence on that issue is relevant. Dr Walters' evidence is that the data that an applicant would need to hold in order to obtain an export only listing would be substantially the same quality, toxicological and clinical data as would be required for submission to the TGA in an application for Registered Goods. This contradicts Pfizer's submission. 27 Dr Walters' evidence is otherwise not relevant to the matters in issue. 28 I do not consider the extent to which the provision of data for Registered Goods is more onerous than Listed Goods to be determinative of the substantive issue in dispute, which is the construction of s 70 and 77 of the Act.

Use of the expression in s 70(5)(a) 29 Section 70(5)(a) uses the expression 'first inclusion in [the ARTG]' of goods that contain, or consist of, the substance. Section 70(3)(a) also uses the expression 'included in [theARTG]'. This is distinct from the references to 'first approval' (s 70(5)(b)), 'market the substance, or a product containing the substance, in Australia' (s 70(6)(a)) and 'import into Australia, for general marketing' (s 70(6)(b)). 30 Section 70(5)(a) also recognises that there may be more than one inclusion, which is consistent with the structure of the ARTG, where entries can be made in the parts for Listed Goods and Registered Goods. 31 I consider the meaning of the expression in s 70(5)(a), on its face, to be clear and unambiguous. The reference to "first inclusion in the ARTG" means what it says: the first entry in a part of the ARTG. 32 When the reference to "first inclusion in the ARTG" is informed by an understanding of the nature of the ARTG, the first inclusion means the entry, first in time, in a part of the ARTG. In the present case that is the first entry as Listed Goods. 33 Pfizer, however, contends that this is not the correct construction because of a 'unifying notion' of the "first regulatory approval date" which means that, because it is the date of the'first approval' in s 70(5)(b), it must also be the date that enables marketing in Australia, the first inclusion as a Registered Good in the ARTG, in s 70(5)(a).

First regulatory approval date 34 Section 77 refers to the 'earliest first regulatory approval date' (emphasis added). This recognises that the patent may cover more than one pharmaceutical substance and provides that the term of the extension is based on the earliest of the approval dates that apply to the patent. 35 Where there has been no "pre-TGA marketing approval", that date is 'the date of commencement of the first inclusion in [the ARTG]' (s 70(5)(a) of the Act). If "pre-TGA marketing approval" was given, that date is the date of the 'first approval' (s 70(5)(b) of the Act). 36 Pfizer's submissions can be summarised as follows: · "Pre-TGA marketing approval" is an approval to market a substance in Australia (s 70(6)). · If "pre-TGA marketing approval" was given, the first regulatory approval date (s 70(5)(b)) is the date of that approval. · The first regulatory approval date where there has been no pre-TGA marketing approval should be consistent with the meaning where there has been pre-TGA marketing approval. · Accordingly, where no pre-TGA marketing approval was given and the first regulatory approval date is determined by the date of commencement of the first inclusion in the ARTG, the inclusion must be an entry for the purpose of enabling marketing in Australia. That inclusion is the inclusion as Registered Goods, not as Listed Goods. · Such a construction is necessary for conformity with the purpose of the Act and applies for the purposes of s 70 and s 77 of the Act. · Section 77 provides a formula for calculating the term of the extension by reference to the period beginning on the date of the patent and ending on the "earliest first regulatory approval date" in relation to the relevant pharmaceutical substance. This embodies an assumption that both types of regulatory approval date are approvals for marketing in Australia. · Resort should be had to the history of the provision for extensions of term and extrinsic material with respect to Pt 3 of Ch 6 of the Act, and particularly s 70, in order to clarify the meaning of "first regulatory approval date". 37 Pfizer emphasises "pre-TGA" and the reference to "pre-TGA marketing approval was given" in s 70(5). Pfizer contends that "pre-TGA marketing approval" is a shorthand reference to approval for marketing in Australia prior to the commencement of the TG Act. It was the TG Act that established the ARTG in 1991 and the distinction between Listed Goods and Registered Goods. 38 Although Pfizer contends that "pre-TGA marketing approval" in s 70(5) means approval prior to the commencement of the TG Act, the expression is defined by s 70(6) to mean 'an approval (however described)'by a Minister or a Secretary to a Department to: '(a) market the substance, or a product containing the substance, in Australia; or (b) import into Australia, for general marketing, the substance or a product containing the substance.' 39 If there were approval by a Minister or a Secretary in the terms of s 70(6) prior to the commencement of the TG Act, there would be pre-TGA marketing approval. 40 In addition, the TG Act makes provision for the Secretary to grant approvals for the importation into Australia, or the supply in Australia, of specified therapeutic goods in certain circumstances and before the substance is included as Registered Goods in the ARTG (s 19A). That is, the definition recognises approval to import or supply in Australia outside entry in the ARTG. This is not approval prior to the commencement of the TG Act but allows the Secretary to make specific provision for certain goods. 41 Where the date of approval to market in Australia is the relevant date, that is specified. Where specific consideration was given to the date where pre-TGA approval was and was not given, provision was made for two different approaches. That is consistent with the application of two differently determined dates. If the intention were to define "first regulatory approval date" as the date of approval to market in Australia or the date of entry in the ARTG as Registered Goods, it would have been easy to have done so. It was not. There is no "unifying notion" that changes the meaning of "first inclusion in the ARTG" in s 70(5)(a).

Legislative history 42 The Act as enacted provided for a different mechanism for the extension of term of patents relating to pharmaceutical substances. A condition for an extension was that the patentee had requested the issue of a marketing approval certificate in respect of the pharmaceutical substance (s 70(1)(b)). Where such a request was made to the Secretary to the Department of Community Services and Health and the Secretary approved the marketing of that substance, or a product containing that substance, in Australia, the Secretary gave a marketing approval certificate to the patentee in respect of that substance (s 72 of the Act as enacted). A period of four years extension (s 75(2)) was available from the standard term of 16 years from the date of the patent (s 67). 43 Those provisions were repealed by the Patents (World Trade Organization Amendments) Act 1994 (Cth). It would seem, from the second reading speech to the Patents (World Trade Organization Amendments) Bill 1994 (Cth), that the provisions were repealed with the intention that they would be 'subsumed' by an accompanying amendment to increase the term of all standard patents from 16 to 20 years (Australia, House of Representatives, Debates (1994) Vol HR 197 at 2189). Despite repealing the pharmaceutical patent extension provisions, the speaker observed that the government was still committed to 'an effective 15-year term' for pharmaceutical patents.

The Industry Commission Report on the Pharmaceutical Industry (1996) ('the Report') 44 The Report notes that an intention to introduce a 15-year effective patent life for pharmaceutical patents had been announced in 1993 but was yet to be implemented (Industry Commission, The Pharmaceutical Industry, Report No 51 (AGPS, Melboune, 1996) at 437). The Report makes reference to 'extending the patent term to "restore" time lost in gaining marketing approval' and 'the period during which [patentees] can exploit their statutory monopoly', the latter defined by the Report as 'the effective patent life' (at 440). The then Government's 'preferred approach' was stated to be a commitment to extending the term of the patent to up to 25 years, 'depending on when the new drug was authorised for marketing in Australia' (at 442). Reference is then made to 'the day on which registration of the new drug in [the ARTG] commenced'. The Report refers to 'effective patent life' running from 'the date of Australian marketing approval' (at 443). 45 Thus, the view expressed in the Report was that 15 years protection would be provided 'from the date of marketing approval in Australia' (at 444). The approach was said to be more in line with that of the European Union ('EU'), which was described as providing for 15 years effective patent life in the country of first approval anywhere in the EU, with a lesser period of protection in other EU countries.

Final Government Response to the Report (1997) ('the Response') 46 The Response to the Report was issued on 22 April 1997 and accepts an extension of up to 5 years but makes no reference to marketing approval (Australia, The Pharmaceutical Industry: Final Government Response to the Industry Commission Report No 51 (1997)). The new extension of term scheme is said to be in recognition of the long development times and regulatory requirements that 'significantly erode the time available under patent to exploit the invention' (emphasis added).

The Intellectual Property Laws Amendment Act 1998 (Cth) ('IP Amendment Act'): Explanatory Memorandum and Second Reading Speech 47 The current regime for extensions of term of patents for pharmaceutical substances was enacted pursuant to the IP Amendment Act. 48 The Revised Explanatory Memorandum ('EM') to the Bill that became the IP Amendment Act refers to the Report and the Response. The EM states that an extension of up to five years will be available for a standard patent relating to a pharmaceutical substance that is the subject of 'first inclusion on [the ARTG]' (at 2). Further, the EM refers to the 'exceptionally long development time and regulatory requirements involved in developing and commercialising a new drug', with the aim of the Bill being to provide an '"effective patent life" or period after marketing approval is obtained, during which companies are earning a return on their investment' (at 3). The implementation of that objective is to provide an extension of term by reference to the 'first registration as a therapeutic good on [the TG Act]' of the substance. There is also reference to the time and work before which the product can 'enter the market' (at 3). 49 Much discussion in the Report and the EM concerns comparison with international competitors and allowance of spring-boarding. In that context, the EM considers the fact that spring-boarding at any time after an extension is granted would not reduce the period during which the originator company 'retains an exclusive right to sell its product on the Australian market' (at 8). This was said to be similar to the scheme in the United States, described as a maximum effective patent period of 14 years from marketing approval. 50 The notes on clauses section of the EM explains s 70(5) and s 70(6) as follows: 'Subsections 70(5) and 70(6) define the term "first regulatory approval date". For pharmaceutical substances that had not received marketing approval, or approval to be imported into Australia for general marketing, prior to being included in the Australian Register of Therapeutic Goods the first regulatory approval date is the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods. For pharmaceutical substances that had already received marketing approval, or approval to import into Australia for general marketing, prior to inclusion in the Australian Register of Therapeutic Goods the first regulatory approval date is the date of the first such approval.' 51 The second reading speech refers to the time taken 'to register and market a new product' (Australia, Senate, Debates (1997) Vol S189 at 1375). It notes that 'the development of a new drug is a long process' and '[t]he objective of this part of the bill is to provide an "effective patent life"'. The speaker then states that an extension will be available for a patent relating to a pharmaceutical substance 'that is the subject of first inclusion on [theARTG]' (at 1376).

The relevance of the extrinsic materials 52 The parties differ significantly as to the relevance, if any, of the extrinsic materials to the question of statutory construction. 53 Pfizer's submission is that a purposive approach to statutory construction should be adopted (s 15AA of the Acts Interpretation Act 1901 (Cth)). In so doing, Pfizer submits that the extrinsic materials evince a clear legislative policy of granting the patentee at least 15 years of 'unfettered exploitation rights'commencing on the date of approval enabling marketing in Australia. Such a policy is said to be apparent from the totality of the extrinsic materials and their use of the words 'marketing approval', 'marketing in Australia', 'right to sell…on the Australian market' and 'first registration as a therapeutic good'. 54 Spirit's primary submission, in contrast to Pfizer, is that the words of the Act are clear and the Court should not give any consideration to the extrinsic materials. As a fallback position, however, Spirit also submits that the extrinsic materials support a legislative intention that "first inclusion in the ARTG" means marketing approval in Australia or listing for export, whichever comes first. 55 The Commissioner, in contrast to Spirit, accepts that the Court is entitled to have regard to the extrinsic materials in order to identify the mischief intended to be remedied by the Act. However, she adopts a similar position to Spirit in respect of the legislative intention said to be apparent from the extrinsic materials. 56 Section 15AB of the Acts Interpretation Act and the common law each permit the Court to consider extrinsic materials in certain circumstances.

section 15ab of the acts interpretation act 57 Section 15AB(1) permits the Court, in interpreting a provision of an Act, to give consideration to 'any material not forming part of the Act' for the purposes set out in s 15AB(1)(a) and s 15AB(1)(b). 58 The words 'first inclusion in [the ARTG]' themselves are neither ambiguous nor obscure (see [31] above). This is acknowledged by Pfizer's submission that uncertainty arises 'not so much from the terms of s 70(5) itself but from the nature of the ARTG'. Accordingly, s 15AB(1)(b)(i) has no application (Newcastle City Council v GIO General Limited (1997) 191 CLR 85 at 112). Use of the extrinsic materials to confirm the ordinary meaning of the words does not assist Pfizer (s 15AB(1)(a)). Indeed, Pfizer did not rely on the extrinsic materials for this purpose. 59 Section 15AB(1)(b)(ii) is also not applicable. The ordinary meaning conveyed by the words 'first inclusion in [the ARTG]', taking into account their context and the purpose or object underlying the Act, does not lead to a 'manifestly absurd' or 'unreasonable' result ([65] below).

common law 60 Pfizer submits that, independent of s 15AB of the Acts Interpretation Act, the extrinsic materials are part of the legal and historical context of the Act. For this reason, it submits that it is appropriate to consider the extrinsic materials at the outset to ascertain and give effect to the purpose of the Act, or 'the mischief which the statute was intended to cure' (Newcastle City Council at 99, 112-3). 61 While no particular theory or rule of statutory interpretation obviates the need for close attention to the text and structure of the provision in question (Stevens v Kabushiki Kaisha Sony Computer Entertainment (2005) 221 ALR 448 at [30]), the extrinsic materials are part of the context of the Act and relevant in interpreting the meaning of 'first inclusion in [the ARTG]'. 62 In Newcastle City Council, the relevant Law Reform Commission Report on insurance contracts madethelegislative objectiveplain (at 102). In the present case, it is difficult to detect any clear legislative purpose or intention with respect to the relevant entry in the ARTG. Although Pfizer points to the use of the words 'marketing in Australia', 'the Australian market' and 'first registration as a therapeutic good',the extrinsic materials also refer to the time available to 'exploit' the invention, the period during which patentees can 'earn a return' and 'first inclusion in [the ARTG]'. To the extent that the policy of the IP Amendment Act is discussed, the discussion is equivocal as to whether the intention was to grant an extension from the date of an approval enabling marketing in Australia rather than the date of approval for a more limited form of exploitation such as manufacture for export. 63 The extrinsic materials, for whatever reason, do not give any clear indication of how the IP Amendment Act took its final form. That makes it difficult, if not impossible, to fix upon the references to 'marketing approval in Australia'and 'bend' the language of the Act to meet that purpose (Stevens at [34]). 64 What is clear from the Response, which is given effect in the IP Amendment Act, is that the extension of term scheme was introduced in recognition of the need to compensate for the time before which a patentee of a pharmaceutical substance can exploit the invention. 65 Pfizer's submission that the relevant approval must be one which allows marketing in Australia in order to give effect to the policy of the IP Amendment Act ignores the fact that inclusion in the ARTG as Listed Goods permits the patentee to exploit the patent. This may not extend to marketing in Australia but it does enable a commercial return to the patentee. The consequence that this is less than full exploitation of the product in Australia is not contrary to the policy of the Act or the purpose of an extension to extend the "effective life" of the patent. The patentee's decision to obtain an early export only listing and thereby a shorter extended term is its choice and may have sound commercial reasons. 66 As the Deputy Commissioner observed in his decision, citing the second reading speech to the IP Amendment Act, the "mischief" sought to be addressed by the IP Amendment Act is (at [31]): '"The long development time, combined with the considerable regulatory process to register and market a new product, means that companies usually have considerably fewer years under patent in which to gain a return for their investment." which leads to the need to provide a longer effective patent life. This seems to apply equally whether pharmaceutical products are subject to export listing or registration because, while the former may not require the same level of regulatory testing and scrutiny in Australia, the development costs will be the same and generally foreign regulatory requirements will need to be met. It is also the case that manufacturing or importing a product for export constitutes exploitation of the patent and would be expected to generate a financial return for the patentee once export listing is achieved. Consequently, the policy benefit of providing an additional "effective term" in which a return on the patented invention is achieved would appear to apply from the first regulatory approval date regardless of whether that is an export listing or registration. Therefore, I do not think it can be said that an interpretation of "inclusion" that encompasses export and other listings on the ARTG is a construction that clearly would not promote the purpose or object of the legislation or leads to a result that is manifestly absurd or is unreasonable. Rather, a construction that would calculate the term of an extension from a subsequent regulatory approval date rather than the first would appear to be inconsistent with the policy of providing an extension of term of only up to 5 years.' 67 This is not a case where a 'strained construction' is necessary to give effect to the legislative purpose (Newcastle City Council at 113). To the contrary, the extrinsic materials tend to confirm the clear, ordinary meaning of "first inclusion in the ARTG".

The undertaking as to damages 68 Pfizer applies for an order that the Commissioner of Patents be restrained from amending the Patents Register to reflect the shorter extended term of the Pfizer patents ('the stay order'). 69 The Commonwealth filed a motion on 16 November 2005 seeking to intervene in relation to the stay order. The Commonwealth submits that, unless Pfizer can establish that no person could potentially suffer damage by the stay in rectification of the Patents Register, an undertaking as to damages should be required before a stay is granted. The undertaking is only sought in respect of one of the Pfizer patents, Australian Patent No 540769 in respect of the product NORVASC. Such potential damage would include, but not be limited to, damage to generic pharmaceutical companies which may wish to market NORVASC and damage to the Commonwealth in respect of the costs of the Pharmaceutical Benefits Scheme. 70 Pfizer's concern is that, if the entry in the Patents Register is amended and Pfizer succeeds on any appeal, the Commissioner would have no power to re-amend the Register. Pfizer's concern arises because of potential problems once the Patents Register is rectified by amending the date of expiry of the patents to the earlier date. This was the subject of consideration by the Full Court in Woolworths Limited v BP plc (2006) 150 FCR 134 ('Woolworths No 1') and Woolworths Limited v BP plc [2006] FCAFC 132 ('Woolworths No 2') in the context of the Trade Marks Act 1995 (Cth). Sundberg and Bennett JJ in Woolworths No 1 at [52] and the Full Court in Woolworths No 2 at [149] were of the view that the Court has power to order the Register of Trade Marks to be rectified on appeal. No detailed submissions have been made as to the application of the Woolworths decisions in the context of the Act. Pfizer has not informed the Court whether it still seeks the stay order. 71 An undertaking as to damages in support of a stay is required when it is necessary to protect against a perceived risk of loss (Doric Products Pty Ltd v Lockwood Security Products Pty Ltd (2002) 54 IPR 495 at [8]; Atlantis Corporation Pty Ltd v Schindler [1997] FCA 455). Pfizer submits that the matters raised by the Commonwealth, such as a generic manufacturer who relies on the Patents Register and declines to take steps to be ready to enter the market in April 2007, are speculative and not sufficient reason to require the undertaking. 72 Pfizer points to the presence of Spirit as a generic manufacturer fully aware of the proceedings. Pfizer also emphasises that these proceedings are public and the decision of the Commissioner and of this Court are publicly available. Pfizer offers to cause a notice to be published in the Official Journal to the effect that the Commissioner has determined that the Patent Register ought to be amended to vary the expiry date of the NORVASC patent to 14 April 2007 as a condition of the stay. Pfizer also suggests a limited form of undertaking, limited to the NORVASC patent, to generic manufacturers and the timing of any damage suffered. 73 No submissions have been made by the Commonwealth or Spirit in response to Pfizer's written submissions on the undertaking, filed after the conclusion of the hearing. 74 In the circumstances, I will hear further from the parties on the application for the stay and the undertaking.

Conclusion 75 An inclusion in the ARTG, including an export only listing as Listed Goods, is an inclusion in the ARTG for the purposes of s 70 of the Act. Where that inclusion precedes registration that permits marketing in Australia and no "pre-TGA marketing approval"was given, it is the "first inclusion in the ARTG" and the "first regulatory approval date" for the purposes of calculating the period of extension pursuant to s 77 of the Act. 76 The application, being an appeal against the decision of the Commissioner, should be dismissed. The applicants should pay the costs of the Commissioner. Spirit informed the Court on 20 December 2005 that, as a condition of its joinder to this proceeding, it would not seek costs. I will hear from the parties as to Pfizer's application for the stay, the costs of that application and any undertaking as to damages. I certify that the preceding seventy-six (76) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Bennett.

Counsel for the Applicants: R Webb SC and K Howard

Solicitor for the Applicants: Spruson & Ferguson Lawyers

Counsel for the First Respondent: S Lloyd

Solicitor for the First Respondent: Australian Government Solicitor

Counsel for the Second Respondent: S C G Burley and C Dimitriadis

Solicitor for the Second Respondent: Blake Dawson Waldron

Solicitor for the Commonwealth of Australia: Australian Government Solicitor

Date of Hearing: 9 March 2006

Date of Final Submissions: 22 March 2006

Date of Judgment: 11 September 2006