Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd

IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY GENERAL DIVISION NSD 1664 of 2008

BETWEEN: SANOFI-AVENTIS AUSTRALIA PTY LTD ACN 008 558 807

JUDGE: jagot j DATE: 18 november 2011 PLACE: SYDNEY

BACKGROUND 1 These reasons for judgment deal with the orders which should be made as a consequence of the publication of the principal judgment in this matter on 29 July 2011 (Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) (2011) 92 IPR 320; [2011] FCA 846, referred to below as the principal judgment). 2 Terms defined in the principal judgment have the same meaning in these reasons. 3 In the principal judgment I found as follows: (1) "Apotex has not established that the claim of the patent is invalid. Sanofi-Aventis has established that Apotex's proposed supply of Apotex's leflunomide product for the treatment of PsA will infringe the patent. Sanofi-Aventis is thus entitled to declarations and an injunction generally in accordance with paras 14 to 16 of the amended application" (at [274]). (2) In respect of the misleading and deceptive conduct claims, "Sanofi-Aventis has established a proper basis for the making of declarations and injunctions to the general effect of those in paras 19-21 of the amended application (albeit not by reference to all of the representations on which it relied)" (at [282]). (3) "Sanofi-Aventis has established that Apotex, without a licence to do so, infringed copyright in the Arava works on which Sanofi-Aventis relied (the SPC, the Arava PI version B and the Arava PI version 19) in contravention of s 36 of the [Copyright Act 1968 (Cth)]. The [Therapeutic Goods Legislation Amendment (Copyright) Act 2011 (Cth)], however, must be taken into account. The parties may wish to be heard on that issue" (at [384]). 4 The orders which should be made as a result of these findings are, in part, in dispute. The issue of costs is also outstanding, although the parties agree that consideration of the appropriate costs orders should be deferred pending the making of the substantive orders. 5 In these reasons, I deal with the disputed issues by reference to a document which the parties prepared identifying the orders each contends should be made.

Leave to re-open? 6 The copyright issue involves the operation of the Therapeutic Goods Legislation Amendment (Copyright) Act 2011 (Cth), referred to in the principal judgment as the amendment Act. The amendment Act commenced on 28 May 2011, after the hearing but before the publication of the principal judgment. The principal judgment at [283]-[285] discloses that, both during the hearing and when I made consent orders on 31 May 2011 setting aside the interlocutory injunction of 30 November 2008, the parties shared an assumption that the amendment Act, once commenced, would negate any breach of copyright in respect of any of the copyright works on which Sanofi-Aventis relied (that is, the works known as the SPC, the Arava PI version B and the Arava PI version 19). Sanofi-Aventis now contends that the amendment Act operates in respect of the Arava PI version B and the Arava PI version 19 but not the SPC, with the consequence that it is entitled to orders restraining any further breaches of its copyright in the SPC. Apotex contends that Sanofi-Aventis requires leave to re-open its case in respect of this issue and that, if leave is granted over Apotex's objection, Sanofi-Aventis should be found to have misconstrued the amendment Act or should be denied any relief in the exercise of discretion. 7 The principal judgment at [283]-[285] reflects the common position of the parties at the time. In this sense, the hearing was conducted on a certain basis as to the operation of the amendment Act - a fact which, as I understand it, in part founds Apotex's contention that leave to re-open is required. On analysis, however, this contention cannot be accepted. As noted, the amendment Act had not commenced during the hearing. Neither party expressly addressed the construction of the amendment Act. Their common position was based on nothing more than anticipation as to the effect of its commencement. It is this anticipation, rather than any finding or conclusion on my part, that founds [283]-[285] of the principal judgment. The anticipation is no longer shared. The construction of the amendment Act is within the scope of the further hearing contemplated at [384] of the principal judgment. This is not a case of "re-agitating arguments already considered by the Court" (Autodesk Inc v Dyason (No 2) (1993) 176 CLR 300; [1993] HCA 6 at 303). Nor is it a case of Sanofi-Aventis having failed to take the point during the hearing (as referred to in University of Wollongong v Metwally (No 2) (1985) 60 ALR 68; [1985] HCA 28 at 71 or Commonwealth v Verwayen (1990) 170 CLR 394 at 482). The amendment Act was not in issue during the hearing in any relevant sense. 8 For these reasons, and as foreshadowed at [384] of the principal judgment, Sanofi-Aventis is entitled to raise the construction of the amendment Act as a matter relevant to the relief which should be granted.

The dispute 9 The amendment Act amends the Copyright Act 1968 (Cth) (the Copyright Act) by inserting additional provisions after s 44B. Accordingly, it is those provisions as inserted into and within the context of the Copyright Act which must be construed. Section 44B is in Div 3 of Pt III of the Copyright Act, which provides for acts not constituting infringements of copyright works. The provisions inserted by the amendment Act are as follows: 44BA Acts done in relation to certain medicine (1) The following acts are not an infringement of any copyright subsisting under this Part in a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine: (a) an act that is done under that Act and that is in respect of product information in relation to: (i) restricted medicine; or (ii) medicine in respect of which the applicant for the registration of that medicine under that Act has been given a notice of the kind referred to in subparagraph 25(1)(da)(ii) of that Act; or (iii) medicine in respect of which subsection 25AA(2) or (3) of that Act applies; (b) an act that is ancillary or incidental to an act referred to in paragraph (a). (2) The following acts are not an infringement of any copyright subsisting under this Part in a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine: (a) supplying, in Australia, some or all of any product information that is approved under that section in relation to medicine; (b) reproducing, in Australia, some or all of the information referred to in paragraph (a); (c) publishing, in Australia, some or all of the information referred to in paragraph (a); (d) communicating, in Australia, some or all of the information referred to in paragraph (a); (e) adapting, in Australia, some or all of the information referred to in paragraph (a); to the extent that the supply, reproduction, publication, communication or adaptation is for a purpose related to the safe and effective use of the medicine referred to in paragraph (a). (3) An act done in Australia that is ancillary or incidental to a supply, reproduction, publication, communication or adaptation referred to in subsection (2) is not an infringement of any copyright subsisting under this Part in the work referred to in subsection (2). (4) For the purposes of this section, medicine, product information and restricted medicine have the same meanings as in the Therapeutic Goods Act 1989. 10 According to s 2 of Sch 1 to the amendment Act: Subsections 44BA(1), (2) and (3) of the Copyright Act 1968 , as inserted by this Act, apply in relation to acts done on or after the day on which this item commences (regardless of whether the product information referred to in subsection 44BA(1) or (2) of that Act was approved before, on or after that day). 11 The SPC, as identified in the principal judgment at [304], may be described as follows: SPC stands for "Summary of Product Characteristics" and is the European equivalent of a PI. Versions of the SPC for Arava were created in about 1997-98. These were generated from earlier documents that cannot now be located. Sanofi-Aventis Deutschland and Aventisub II are joint owners of any copyright subsisting in the Arava SPC, including in the version that is Exhibit ALF-12. That version is the last version of the Arava SPC before the Australian PIs were created. 12 It is common ground that, unlike the Arava PI version B and the Arava PI version 19, the SPC did not accompany any application for registration of Arava as a therapeutic good under the Therapeutic Goods Act 1989 (Cth) (the Therapeutic Goods Act). Sanofi-Aventis contends that the SPC (in contrast to the Arava PI version B and the Arava PI version 19) is not "a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine" within the meaning of ss 44BA(1) and (2) of the Copyright Act (as inserted by the amendment Act), with the consequence that the provisions do not apply to the SPC. 13 To understand this contention, it is necessary to identify the relevant provisions of the Therapeutic Goods Act (recognising that s 44BA of the Copyright Act refers to a number of provisions of the Therapeutic Goods Act and provides in subs (4) that "medicine, product information and restricted medicine have the same meanings as in" that Act). 14 "Product information" is defined in s 3(1) of the Therapeutic Goods Act in these terms: "product information", in relation to therapeutic goods, means information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods. 15 By s 7D(1) of the Therapeutic Goods Act: The Secretary may, by writing, approve a form for product information in relation to medicine. 16 As set out at [286] of the principal judgment, a form for product information has been approved by the Secretary and is contained in the Australian Regulatory Guidelines for Prescription Medicine (June 2004), referred to in the principal judgment as the Regulatory Guidelines. 17 Section 23 of the Therapeutic Goods Act regulates the making of applications for goods to be listed or registered as therapeutic goods. It provides: (1) An application for registration or listing of therapeutic goods must: (a) be made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary; and (b) be delivered to an office of the Department specified by the Secretary. (2) An application is not effective unless: (a) the prescribed application fee has been paid; and (b) the applicant has delivered to the office to which the application was made such information, in a form approved, in writing, by the Secretary, as will allow the determination of the application; and (ba) if the application is for the registration of restricted medicine - the application is accompanied by product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine; and (c) if the Secretary so requires - the applicant has delivered to the office to which the application was made a reasonable number of samples of the goods. 18 Arava's active compound, leflunomide, is a restricted medication. Accordingly, when Sanofi-Aventis applied for registration of Arava it provided product information in relation to the medicine in the form approved under s 7D of the Therapeutic Goods Act. As disclosed in the principal judgment at [305], the product information in relation to Arava was drawn from the SPC, the United States prescribing information for the drug, and other documents. 19 By s 25(1)(da)(i) of the Therapeutic Goods Act, the Secretary must evaluate the application for registration of therapeutic goods having regard to, relevantly, "the product information given by the applicant in relation to the medicine". Section 25(4)(d) applies if the Secretary decides to register the goods, in which event the Secretary must: (i) notify the applicant in writing that the goods will be included in the Register…; and (ia) if the goods are restricted medicine… notify the applicant in writing of the product information that is approved in relation to the medicine; and (ii) include the goods in the Register… 20 Section 25AA of the Therapeutic Goods Act is in these terms: (1) If: (a) the Secretary includes restricted medicine in the Register in relation to a person under subparagraph 25(4)(d)(ii); or (b) an applicant for the registration of medicine (other than restricted medicine) is given a notice of the kind referred to in subparagraph 25(1)(da)(ii) and the Secretary includes the medicine in the Register in relation to the applicant under subparagraph 25(4)(d)(ii); the product information that is approved under this section in relation to the medicine is the product information referred to in subparagraph 25(4)(d)(ia). 21 By ss 25AA (4) and (5) of the Therapeutic Goods Act product information may be varied and, if this occurs, the varied product information becomes the product information that is approved under s 25AA. 22 As noted, s 25AA of the Therapeutic Goods Act is referred to in ss 44BA(1) and (2) of the Copyright Act in the phrase "a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine". Taking into account the meaning of "product information" (which, by s 44BA(4), takes the same meaning in the Copyright Act as in the Therapeutic Goods Act), the condition qualifying the application of ss 44BA(1) and (2) may be expressed as follows: …any copyright subsisting under this Part in a work that is product information [that is, in relation to therapeutic goods, information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods] approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine… 23 The dispute between the parties is that Sanofi-Aventis contends that "a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine" in ss 44BA(1) and (2) of the Copyright Act means the document in the form approved under s 7D of the Therapeutic Goods Act, which has accompanied an application for approval under s 23 of that Act and the approval of which has been notified in accordance with s 25(4)(d), including a document as varied in accordance with s 25AA(4). Apotex contends that "a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine" in ss 44BA(1) and (2) of the Copyright Act means a document that contains or expresses, in relation to therapeutic goods, information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods, approved under s 25AA of the Therapeutic Goods Act in relation to medicine.

Submissions in support 24 Sanofi-Aventis supported its construction by emphasising the following points: (1) The reference in ss 44BA(1) and (2) of the Copyright Act is to a "work that is product information". A "work" is defined in s 10(1) of the Copyright Act to mean "a literary, dramatic, musical or artistic work". In context, the relevant work must be a "literary work". As s 44BA provides that certain acts are not infringements of copyright subsisting in the work as described, the work in question must be the specific literary work alleged to be infringed, being not merely information but information as expressed in a particular and ascertainable material form. (2) The language of ss 44BA(1) and (2) of the Copyright Act cannot accommodate Apotex's construction. This construction ignores the requirement that there be a "work that is product information" and substitutes instead the concept of a work that "contains or expresses" product information. (3) If it had been intended that copyright in documents other than the "work that is product information" not be infringed by the specified acts, then the language of the section could have achieved that object with no difficulty. Section 44B of the Copyright Act, the immediately preceding provision, provides that the "reproduction on a label on a container for a chemical product of any writing appearing on an approved label is not an infringement of any copyright subsisting under this Part in relation to that writing". Sections 47AB and 47B, in respect of computer programs, provide defences to infringement for certain acts not limited to reproductions of the computer program itself but including reproductions of any literary work "incorporated in, or associated with, a computer program" and "essential to the effective operation of a function of that computer program" (s 47AB). If ss 44BA(1) and (2) had been intended to achieve a similar outcome then a similar approach could have been taken in respect of any writing appearing in approved product information. (4) The extrinsic material relating to the amendment Act supports this approach. First, the second reading speech (Commonwealth, Parliamentary Debates, House of Representatives, 24 February 2011, 1363-1366 (Catherine King)) refers to the approach taken in s 44B of the Copyright Act in respect of labelling. Second, the explanatory memorandum (Therapeutic Goods Legislation (Copyright) Amendment Bill 2011 (Cth), Explanatory Memorandum) discloses that the amendments to the Copyright Act contained in the amendment Act were prompted, at least in part, by this proceeding. Despite this, the amendment Act does not provide a defence to infringement of copyright in a work such as the SPC which is not a product information document approved under s 25AA of the Therapeutic Goods Act. Third, the explanatory memorandum states that the amendments are "intended to prevent companies commencing legal action asserting copyright in the text of an approved PI" (emphasis added). 25 Even if the phrase "a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine" is construed as Apotex proposes, the SPC contains a variety of material, some of which is contained in the Arava PI approved under s 25AA of the Therapeutic Goods Act and some of which is not. It is not sufficient, for the purposes of ss 44BA(1) and (2), that the SPC expresses only part of the approved product information. 26 Apotex supported its construction by emphasising the following points: (1) There is a distinction in copyright law between "information" and a "work", expressed in the fundamental proposition that copyright protects the form of expression of an idea or information and not the idea or information itself (IceTV Pty Ltd v Nine Network Australia Pty Ltd (2009) 239 CLR 458; [2009] HCA 14 (IceTV) at [28]). (2) The scheme of the Therapeutic Goods Act discloses that it is information which is approved under s 25AA of that Act and not a work. The information, of necessity, is expressed in a work, but the statutory scheme makes clear that it is the information and not the work which is approved (see, in particular, the definition of "product information" in s 3(1)). This scheme is also apparent from the regime for "protected information" in s 25A of the Therapeutic Goods Act, which provides for a five-year period of data exclusivity for the use of information by the Secretary in evaluating therapeutic goods for registration. (3) The phrase "a work that is product information" reconciles the distinct concepts with which each statutory regime is dealing: information under the Therapeutic Goods Act, and the work in which the information is contained or expressed under the Copyright Act. This is different from the position in respect of approved labels under s 44B of the Copyright Act (where the label itself is approved) or computer programs under ss 47AB and 47B of the Copyright Act (where the provisions extend the scope of a literary work). (4) The construction proposed by Sanofi-Aventis would defeat the object of the amendment Act. As disclosed in the extrinsic materials, this was to ensure that health professionals could receive the same information about a medicine regardless of the brand. The exclusion of underlying works such as the SPC would frustrate this legislative intention.

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.

ADDITIONAL DECLARATIONS 45 Sanofi-Aventis claims that declarations should be made in respect of Apotex's threatened infringements of the patent and threatened misleading and deceptive conduct. Apotex opposes the making of those declarations on the basis that, by reason of the substantive orders, they are unnecessary. 46 As Sanofi-Aventis submitted, the declarations reflect the findings at [274] and [282] of the principal judgment as follows: [274] Apotex has not established that the claim of the patent is invalid. Sanofi-Aventis has established that Apotex's proposed supply of Apotex's leflunomide product for the treatment of PsA will infringe the patent. Sanofi-Aventis is thus entitled to declarations and an injunction generally in accordance with paras 14 to 16 of the amended application. […] [282] For these reasons Sanofi-Aventis has established a proper basis for the making of declarations and injunctions to the general effect of those in paras 19-21 of the amended application (albeit not by reference to all of the representations on which it relied). 47 The terms of the declarations are also in dispute. In respect of the declarations relating to threatened infringement of the patent, the same issues arise as in relation to the injunction. I deal with this aspect of the dispute below in the context of the injunction and on the basis that the declaration and injunction, insofar as possible, should be consistent. In respect of the declaration relating to the threatened misleading and deceptive conduct, I agree with Apotex's position that it is unnecessary to record the specific representations which I found would be made by the threatened conduct and would be misleading and deceptive if made. Otherwise, the identification of the relevant conduct in this declaration also should be consistent with the terms of the patent injunction.

RELEASE OF THE UNDERTAKING AS TO DAMAGES 48 Apotex opposed the release of Sanofi-Aventis from the undertaking as to damages given on 30 October 2008 in respect of the interlocutory injunction. As the undertaking relates to the interlocutory injunction (which will be discharged on the making of the final injunction in Sanofi-Aventis's favour), the undertaking must be released. Apotex's concern is that Sanofi-Aventis has not disavowed the possibility that it might argue that the effect of the release of the undertaking is to deprive Apotex of its benefit should Apotex succeed in its foreshadowed appeal. I am not aware of any authority suggesting that this might be the effect of the release of the undertaking (that is, that by releasing the undertaking it will be as if the undertaking had never been given). Nevertheless, Sanofi-Aventis did not disavow the potential argument that is of concern to Apotex. In these circumstances, and for abundant caution, the release of the undertaking should be qualified to make clear that the release operates with effect from the date of the release and not otherwise.

THE PATENT INJUNCTION 49 First, I agree with Apotex that the injunction should not encompass the act of applying to list on the schedule of pharmaceutical benefits. Despite Sanofi-Aventis's submissions to the contrary, this is not part of the relevant conduct of exploiting the patent. 50 Second, I agree with Sanofi-Aventis that the injunction should restrain conduct which would give rise to secondary liability on Apotex's part. Apotex should not be able to do indirectly that which it is the purpose of the principal injunction to restrain. 51 Third, although I accept Sanofi-Aventis's submission that there is the potential for ambiguity in Apotex's proposed description of the restrained conduct (that is, supplying etc the Apotex Products (as defined) "indicated" for the treatment of psoriatic arthritis), I also accept Apotex's concern that it should not be exposed to liability from any uncertainty in the scope of an injunction restraining Apotex from supplying (etc) the Apotex Products where it has "reason to believe" that the products will be administered for the treatment of psoriatic arthritis. 52 With respect to this third issue, the problem with Apotex's formulation - involving products "indicated" for the treatment of psoriatic arthritis - is that it is ambiguous. While it is true that Sanofi-Aventis particularised its claims by reference to the approved Apotex PI (which contained a clinical indication for the treatment of psoriatic arthritis), the claims themselves sought to restrain the supply (etc) of the Apotex Products "for the treatment of psoriatic arthritis". Moreover, a reference to "indicated for" in an injunction is not necessarily limited to a clinical indication in a product information document. The fact that Apotex was willing to proffer an undertaking not to seek to supply the Apotex Products without approved product information stating that the product is approved for rheumatoid arthritis only does not alter the potential for ambiguity in its formulation. However, this conclusion does not mean that the injunction Sanofi-Aventis sought should be made. 53 The principal problem with the form of injunction Sanofi-Aventis proposes is that it is in terms different from those sought in the amended application. Sanofi-Aventis seeks to include the words "for administration for" before the words "the treatment of psoriatic arthritis". I am not persuaded that this adds clarity to the injunction. If anything, it adds unnecessary complexity. Sanofi-Aventis also seeks an additional injunction to restrain Apotex from supplying (etc) the Apotex Products where it has "reason to believe" the Apotex Products will be administered for the treatment of psoriatic arthritis. An injunction in these terms was not sought in the amended application. Moreover, the basis upon which Sanofi-Aventis seeks this injunction is unpersuasive. The fact that Apotex conducted its case on a particular basis as to the relationship between psoriatic arthritis and rheumatoid arthritis as disclosed in the prior art is beside the point, given that I did not accept Apotex's argument in this regard. The practical result is that on and from the publication of the principal judgment it cannot be said that, merely by reason of supplying the Apotex Products for the treatment of rheumatoid arthritis, Apotex would have reason to believe that it was supplying products for the treatment of psoriatic arthritis (in contravention of the patent). To assert otherwise would be contrary to the basis upon which Sanofi-Aventis (at least) conducted this proceeding and to the rationale underpinning the outcome of the proceeding in favour of Sanofi-Aventis. Accordingly, Sanofi-Aventis should not have the benefit of any proposed additional injunction in the terms proposed.

CONCLUSIONS 54 Excluding the issue of costs (on which the parties wish to be heard), I make orders reflecting the conclusions set out above. I certify that the preceding fifty-four (54) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Jagot.