Case: Newcastle City Council v GIO General Limited [1997] HCA 53 ; (1997) 191 CLR 85
Outcome: applied
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] HCA 53 ; (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. 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). 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). In Newcastle City Council , the relevant Law Reform Commission Report on insurance contracts made the legislative objective plain (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. 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". 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'). 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.