Discussion
27 By s 15 of the Acts Interpretation Act 1901 (Cth) (the Acts Interpretation Act):
Every Act amending another Act shall, unless the contrary intention appears, be construed with such other Act and as part thereof.
28 In other words, and as noted, the amendment Act is to be construed with and as part of the Copyright Act.
29 In interpreting the relevant provision, s 15AA of the Acts Interpretation Act requires that:
a construction that would promote the purpose or object underlying the Act (whether that purpose or object is expressly stated in the Act or not) shall be preferred to a construction that would not promote that purpose or object.
30 By s 15AB(1) of the Acts Interpretation Act extrinsic material, including the explanatory memorandum and second reading speech, may be considered:
(a) to confirm that the meaning of the provision is the ordinary meaning conveyed by the text of the provision taking into account its context in the Act and the purpose or object underlying the Act; or
(b) to determine the meaning of the provision when:
(i) the provision is ambiguous or obscure; or
(ii) the ordinary meaning conveyed by the text of the provision taking into account its context in the Act and the purpose or object underlying the Act leads to a result that is manifestly absurd or is unreasonable.
31 The relevant provisions, ss 44BA(1) and (2) of the Copyright Act, are ambiguous or obscure. The ambiguity or obscurity arises from the potential for tension between the definition of "product information" (which, by s 44AB(4), has the same meaning as in the Therapeutic Goods Act) and the reference in the provisions to "a work that is product information approved under" s 25AA of the Therapeutic Goods Act. In the scheme established by the Therapeutic Goods Act, as Apotex submitted, "product information" means the information itself, albeit information expressed in a particular form. This is apparent from the definition of "product information" in s 3(1) of the Therapeutic Goods Act (as "information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods"). The fact that the information must be reduced to a material form in order to accompany an application for registration of goods (s 23 of the Therapeutic Goods Act) and, in being so reduced, must accord with an approved form (s 7D of the Therapeutic Goods Act), does not transform the meaning of "product information". Nor is the meaning of "product information" transformed by the fact that, if the goods are registered, the Secretary must (if the goods are restricted medicine) notify the applicant of the product information that is approved in relation to the medicine (s 25(4)(d)(ia)), with the product information so notified being the product information for the medicine that is approved under s 25AA of the Therapeutic Goods Act. The approval is of the information "relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods". In this context, the words "product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine", as they appear in ss 44BA(1) and (2) of the Copyright Act, mean the information "relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods" which is the subject of the notice from the Secretary under s 25(4)(d)(ia) of the Therapeutic Goods Act. Those words, however, do not appear in isolation in ss 44BA(1) and (2) of the Copyright Act. They are preceded by the words "a work that is". The section operates so that there is no infringement of copyright subsisting in such a work ("a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine"). The tension, as the competing submissions disclose, arises from the operation of the Copyright Act in relation to a work (because copyright subsists in the expression of an idea or information and not the idea or information itself) and its relationship with the operation of the Therapeutic Goods Act on information (albeit information that has been reduced to writing and is required to follow a particular form).
32 This ambiguity or obscurity is to be resolved in the context in which the provisions operate and with regard to the purpose or object underlying the amendment Act and the Copyright Act. The amendment Act does not expressly state its purpose or object. Nevertheless its provisions, construed in context, and the extrinsic material assist in identifying the purpose or object.
33 Turning first to the extrinsic material, the explanatory memorandum (much of which is repeated in the second reading speech) states as follows:
It has been a long-standing practice in the Therapeutic Goods Administration (TGA) for delegates to approve the text of the PI of generic versions of a prescription medicine that is essentially the same as the approved PI of the "original" medicine. It is important for the safe and effective use of the medicine that doctors, pharmacists and other health professionals receive the same information about a medicine regardless of the brand, thus avoiding any perception that differences in the text of the PIs reflect clinical and/or pharmacological differences.
Recently a number of pharmaceutical companies that have prescription medicines on the Register ("originator companies") have taken, or threatened to take, legal action on the basis that they own the copyright in the approved PI for their medicines.
In 2008, the Federal Court granted an interlocutory injunction to a pharmaceutical company sponsor of a registered medicine partly on the basis of an argument that copyright in the approved PI for that medicine would be infringed by a competitor's use of the approved PI for a generic version of the medicine.
The Federal Court hearing in this matter is scheduled for March 2011 and the issue of copyright in the approved PI of a registered medicine will be considered by an Australian court for the first time.
The Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 (the Bill) provides an exemption to the infringement of copyright that may subsist under the Copyright Act 1968 where a person uses the relevant text for the purposes of applying to register a medicine, or for the purpose of varying the approved PI of a medicine, or any incidental or ancillary acts. The exemption applies to these acts irrespective of when the PI was approved. The exemption will also apply to third parties supplying, reproducing, publishing, communicating or adapting an approved PI for a medicine where such acts are for purposes related to the safe and effective use of the medicine.
The amendments are intended to prevent companies commencing legal action asserting copyright in the text of an approved PI where it is used in the PI of another version of the same medicine. They will enable the sound public health objectives underlying the TGA's practice in relation to the approval of the PIs of generic medicines to continue to be met.
34 These statements disclose that the purpose or object of the amendment Act is to ensure that the same product information may accompany all brands of the same medicine irrespective of copyright. To this end, the amendment Act is identified as providing an exemption from infringement where a person uses the "relevant text" (that is, the text of the product information document as approved) for the purpose of applying to register or to vary the approved product information for a medicine. On this basis, the construction proposed by Sanofi-Aventis is inconsistent with the object or purpose of the legislation as identified in the extrinsic material. The reason for this is that the text of the approved Arava PI (known as version 21, and which Apotex admitted copying) is in part derived from and thus contains much of the same text as appears in the SPC (as explained in the principal judgment at [291], [292] and [301]). This latter fact was the basis for my finding at [301] that the approved Apotex PI involved a reproduction of a substantial part of, amongst other works, the SPC. The consequence of the construction proposed by Sanofi-Aventis would be that, although each version of the Arava PI approved under s 25AA of the Therapeutic Goods Act would be within the scope of the exemption from copyright protection given by the amendment Act, the documents from which the Arava PI was derived would be outside the exemption. As a result, Sanofi-Aventis could (and, indeed, seeks to) restrain Apotex from infringing copyright in the SPC. In other words, by reason of the amendment Act Sanofi-Aventis would not be able to rely on copyright to prevent Apotex from copying (for the relevant purposes associated with the approved Apotex PI) the Arava PI approved under s 25AA of the Therapeutic Goods Act, but would be able to rely on copyright in the SPC to achieve the same outcome. Sanofi-Aventis's construction would thus enable Sanofi-Aventis to achieve indirectly that which it could not achieve directly.
35 These considerations weigh against acceptance of Sanofi-Aventis's proposed construction. They indicate that the phrase "a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine" should not be construed as meaning the document accompanying the application for registration and approved by the Secretary. If so construed, the amendment Act does not achieve its object or purpose.
36 With regard to the provisions of s 44BA, Sanofi-Aventis submitted that no meaning other than that for which it contended was open without doing violence to the statutory language. I do not accept this submission. The context of the provisions as a whole indicates to the contrary.
37 First, the provisions assume that, but for their operation, certain conduct will infringe copyright. Copyright, as Apotex stressed, subsists in works and is infringed by the doing of acts comprised in the copyright without the licence of the copyright owner (ss 13, 14, 31 and 36 of the Copyright Act). The expression of an idea or information in a particular form of words may or may not constitute a work in which copyright subsists (as explained in IceTV at [15], [22]-[29], [33]-[34], [45]-[48], [65]-[71] and [95]-[106]). If the relevant form of expression is not a work in which copyright subsists then there can be no infringement of copyright and, for that reason, the provisions of the amendment Act have no operation in respect of any such expression.
38 Second, the provisions recognise that the scheme in respect of product information in the Therapeutic Goods Act has nothing to do with copyright. That scheme does not concern itself in any way with the question whether product information might be a work in which copyright subsists. Moreover, and as discussed above, although the scheme requires product information to be in a particular form and to accompany an application for registration, the function of approval exercised by the Secretary under the Therapeutic Goods Act is approval of the information constituting the product information and not the document by which that information is conveyed.
39 By reason of the above, the provisions presuppose that acts have been or are proposed to be carried out which would infringe copyright subsisting in a work. This issue is to be determined by reference to the Copyright Act. In this case, for example, acts have been and are proposed to be carried out which would infringe copyright subsisting in the work that is the SPC. As set out in the principal judgment (at [304] and [349]-[360]), the SPC is a work in which copyright subsists. The issue which the legislation then raises is whether the SPC is "product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine". This issue is to be determined by reference to the Therapeutic Goods Act (as s 44BA(4) makes plain).
40 Sanofi-Aventis contended that Apotex's response to this issue - that the SPC contains or expresses such information - discloses that Apotex's construction is untenable on the ordinary meaning of the statutory language. Without citing any authority in support, Sanofi-Aventis contended that because the SPC contains some information which is the same as the "product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine" and some information which is not, the statutory definition is not satisfied. Sanofi-Aventis supported this contention by observing that notions of "substantial part" (critical to copyright by reason of s 14 of the Copyright Act) have no role to play in ss 44BA(1) and (2). This latter proposition may be accepted. But that does not mean that a work which is "product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine" ceases to be so merely because it is combined with other information. It is not apparent to me why the statutory language may be construed as changing a work which is product information as approved into a work which is not product information as approved, merely because it forms part of some larger work containing other material. The same observation applies where only some of the product information as approved forms part of a larger work. Provided that the part which is product information as approved is itself a work in which copyrights subsist (that is, it meets the definition of a "literary work" under the Copyright Act), it will attract the operation of ss 44BA(1) and (2), and the acts specified therein may be done in respect of it without infringement of copyright.
41 This conclusion is reinforced by the language of s 44BA(2) which refers (in each subsection) to doing an act in relation to "some or all of any product information that is approved under [s 25AA of the Therapeutic Goods Act] in relation to medicine". But for the operation of the section, these acts would constitute infringements of copyright. Section 44BA(2) thus contemplates that part ("some") of the product information as approved, as well as the whole, might constitute a work in which copyright subsists and in respect of which the exemptions from infringement provided for by the amendment Act might therefore apply. The result is that, as long as some or all of the product information as approved in relation to a particular good meets the definition of a "literary work", it will engage the provisions of s 44BA regardless of the context in which it appears.
42 This construction accords with the language and context of the statute as a whole and achieves precisely the object or purpose of the amendment Act identified in the extrinsic materials. By contrast, Sanofi-Aventis's proposed construction accords with one possible meaning of part of the statutory language (the preamble to each of ss 44BA(1) and (2), but not s 44BA(4)) but is at odds with both the overall context of the provisions (in that they relate to the different schemes embodied in the Copyright Act and the Therapeutic Goods Act respectively) and the object or purpose of the amendment Act. The conflict with the context is apparent from the fact that Sanofi-Aventis's construction transforms the concept of product information from the information itself into the document in which the information is embodied. The conflict with the object or purpose of the amendment Act is apparent from the example presented by the facts of the present case. It is manifestly absurd or is unreasonable for Sanofi-Aventis to achieve via the SPC the very result which the amendment Act is intended to ensure it cannot achieve through the approved Arava PI. Indeed, on Sanofi-Aventis's construction the provisions of the amendment Act would have no practical operation. An applicant seeking approval of product information may have brought into existence (or may bring into existence) any number of documents which are works in which copyright subsists and which contain part or the whole of the approved product information for a medicine. On Sanofi-Aventis's construction, if those works have not themselves been submitted to and approved by the Secretary under the Therapeutic Goods Act, they are outside the scope of the exemption in ss 44BA(1) and (2). The owner of copyright in those works may thus sue on any infringement and, on so doing, restrain the acts which would otherwise be authorised by the subsections of ss 44BA(1) and (2).
43 The construction which I prefer avoids this manifestly absurd and unreasonable outcome. It does so in a manner consistent with the ordinary meaning of the statutory language, albeit recognising the tension between one statutory scheme concerned with information and another concerned with works. It may be accepted that this construction implicitly involves reading the phrase "a work that is" either as contended for by Apotex (as a work that includes or expresses product information) or, as I prefer, as qualified by an unstated (but nevertheless obvious once the context is considered) assumption that the provisions are concerned with a "work that is product information" as approved. Product information as approved must include the whole or any part of such product information. To the extent that a work is product information as approved (whether it be the whole or part thereof) it is within the scope of the provision. To the extent that a work is not product information as approved it is outside the scope of the provision.
44 The SPC, in part, is product information as approved. The part of the SPC that is product information as approved is the part which enabled Sanofi-Aventis to contend that in reproducing the Arava PI version 21 (the most recently approved PI for Arava) Apotex also indirectly reproduced a substantial part of the SPC and thus infringed Sanofi-Aventis's copyright in the SPC (as found at [360] of the principal judgment). The fact that the SPC, in part, is product information as approved - and that I am satisfied that this part is itself a work in which copyright subsists - is sufficient to engage ss 44BA(1) and (2) of the Copyright Act. The acts proposed to be carried out in the future by Sanofi-Aventis are within the scope of the exemption created by those provisions. It follows that Sanofi-Aventis is not entitled to any relief in respect of infringement of copyright after the commencement of the amendment Act on 28 May 2011.