FEDERAL COURT OF AUSTRALIA

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2012] FCAFC 62

THE COURT ORDERS THAT:

1.    The application be dismissed.

2.    The applicant pay the first respondent’s costs of the application to be taxed.

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

REASONS FOR JUDGMENT

(REVISED FROM TRANSCRIPT)

REPRODUCTION OF THE Product information documentation

1    The Generic Medicines Industry Association Pty Ltd (the GMIA) applies, pursuant to r 36.32 of the Federal Court Rules 2011, for an order that it be allowed to intervene in this appeal, to make oral submissions, to the effect that the primary judge erred in finding copyright infringement by the appellant’s reproduction of the first respondent’s product information documentation (PID) because:

(a)    the relevant acts of reproduction were done pursuant to a licence implied by law; and alternatively

(b)    section 183(1) of the Copyright Act 1968 (Cth) (the Copyright Act) applied to exempt the relevant acts of reproduction, that is, the relevant acts were authorised in writing by the Commonwealth or were done for the services of the Commonwealth.

2    Rule 36.32 requires an intervener’s contribution to be “useful and different” from the contribution of the parties to the appeal. Although the GMIA’s arguments are different from those proffered by the appellant, we are unable to see how the GMIA’s intervention could be “useful” because there is no prospect that findings not sought or made below, which are essential steps in these arguments, would be made on the appeal. We will deal first with the argument advanced on the basis of s 183 of the Copyright Act.

Section 183 of the Copyright Act

3    Section 183 of the Copyright Act is relevantly in the following terms:

The copyright in a literary … work … is not infringed by … a person authorized in writing by the Commonwealth … doing any acts comprised in the copyright if the acts are done for the services of the Commonwealth …

4    The GMIA’s argument based on s 183 of the Copyright Act is certainly “different” from that urged by the appellant. No reference is made to this provision in the appellant’s grounds of appeal or submissions. The GMIA’s argument raises factual issues that were not agitated or in contest before the primary judge. The potential operation of s 183 of the Copyright Act was not raised in argument before the learned primary judge. The contentions that the appellant was acting pursuant to written authorisation from the Commonwealth or that its reproduction of the first respondent’s PID was done for the services of the Commonwealth would be raised for the first time in this Court. No findings of fact necessary for these contentions were sought by the appellant or put in contest below. Accordingly, it cannot be said that the primary judge, in deciding the case tendered by the parties, erred in failing to make those findings. This circumstance casts doubt on whether the application is of a kind contemplated by r 36.32, which is concerned with intervention in a pending appeal, not the raising of a new controversy.

5    The GMIA would seek now to argue that, in terms of s 183 of the Copyright Act, the Therapeutic Goods Administration (TGA) authorised in writing the reproduction by the appellant of the first respondent’s PID for use by the TGA in carrying out its duties under the Therapeutic Goods Act 1989 (Cth), including the evaluation and registration of the appellant’s leflunomide product and providing for the quality, safety, efficacy and current availability of therapeutic goods pursuant to s 4(1)(a) of that Act. It follows, so the GMIA would contend, that the appellant’s reproduction of the PID was for the services of the Commonwealth and therefore exempt from infringement under s 183 of the Copyright Act.

6    The GMIA’s argument, in broad terms, is that the TGA’s requirement that the first respondent’s PID contain information apt to ensure the safe and effective use of its medicine meant that the TGA necessarily obtained the right to use the first respondent’s PID for its statutory purposes, and that this right extends to authorising others to reproduce that material for that purpose. That authority is said to have been exercised by the TGA’s practice of approving PIDs for generic medicines that contained similar information to that in the PID for the originator medicine.

7    One may say immediately that the argument adumbrated by the GMIA is not without its difficulties. Even if one were to accept that the TGA’s practice authorised the reproduction of the same product information, the assumption that the TGA should be taken to have authorised the reproduction of a substantial part of the first respondent’s expression of the first respondent’s PID, as distinct from the substantive information contained in it, would require clear proof of the fact, after a fair contest. More importantly for present purposes, no finding of fact was sought or made before the primary judge that the TGA purported to give such an authorisation to the appellant by reason of its practices in relation to approving PIDs.

Implied licence

8    The GMIA seeks to urge a determination of whether the reproduction by the appellant of the first respondent’s PID was authorised by the TGA which was itself licensed to reproduce the first respondent’s PID in order to carry out its statutory functions.

9    The GMIA submits that the first respondent created the PID and provided it to the TGA for a particular purpose in which the first respondent and the TGA were associated, with the expectation of a reward being so much of the net profit expected to eventually flow from the registration of its leflunomide product. The GMIA submits that there should be a licence implied by law in favour of the TGA to use the first respondent’s PID to carry out the purpose for which it was created and provided.

10    The purpose is said to be the TGA-imposed requirement that the first respondent’s PID contain information aimed at ensuring the safe and effective use of its medicine. The GMIA asserts that it must therefore inevitably be implied that the TGA obtained the right to use the first respondent’s PID in the public interest for the safety and efficacious purposes for which it was provided and created. This extends to the right to authorise others to reproduce that material in carrying out that purpose.

11    The reproduction by the appellant was, so the GMIA contends, authorised by the TGA by virtue of its practice to approve PIDs for generic medicines that contained similar information to the PIDs for the originator medicine. The GMIA asserts that the appellant was therefore properly authorised by the TGA under its implied licence and does not infringe copyright.

12    Once again the GMIA’s argument has its difficulties. First, the TGA is not the person using the PID contrary to the wishes of the first respondent; the appellant is. The first respondent might be taken to have consented to the use of the PID by the TGA for its statutory purposes, but there is a distinct stretch in the argument that the TGA’s right to use the PID for its governmental purposes includes a right to authorise others to reproduce the PID for their private commercial purposes even where those commercial purposes are adverse to the originator’s commercial interests. Secondly, the argument that the TGA’s licence included a right to license others and that this right was exercised is not compelling.

13    More important for present purposes, though, is the circumstance that no finding of fact was sought or made at first instance which would support the GMIA’s contentions that the TGA was itself entitled to authorise others to reproduce the first respondent’s PID and that it purported to do so by approving the appellant’s reproduction of the first respondent’s PID.

CONCLUSION

14    There could be utility in granting the GMIA’s application to intervene only if there were a real prospect that findings not sought or made below would be made on the appeal. To countenance a course whereby that might occur would be unfair to the first respondent who was not afforded the opportunity to meet such a case at trial. The position is further complicated by the absence of the Commonwealth and the TGA which are clearly affected by the arguments that the GMIA wishes to agitate. The TGA’s attitude is unknown, a difficulty which could be met only by delaying the hearing of the appeal. That delay would not be convenient to the parties or to the Court. There is, in addition, a further consideration which goes beyond considerations of convenience.

15    To countenance the course involved in granting leave to the GMIA to intervene would go beyond any question of “intervention” in a pending appeal from the trial judge’s resolution of the controversy tendered by the parties. That is because it would allow the presentation of a controversy outside the scope of the appeal by a person not party to the appeal. To allow the GMIA to pursue its point, having regard to the circumstance that the primary judge cannot be said to have made any error in failing to deal with the point that the GMIA now seeks to agitate, would be to allow it to present and pursue an argument which is not part of the appeal brought to correct error below.

16    We doubt whether that state of affairs is contemplated by r 36.32. Whether or not that is strictly the case, it is not a state of affairs which we would be disposed to bring about by the exercise of the discretion conferred by the rule to grant leave to intervene. The scope of the appeal has been circumscribed by the issues tendered for determination by the parties and the findings made, or not made, as to those issues by the primary judge. It is true that the rule expressly contemplates the making of submissions that are different from those to be advanced by the parties, but that does not mean that the Court should entertain submissions which are alien to the controversy resolved at first instance so as to facilitate a departure from the fundamental presupposition of r 36.32, namely, that the submissions by the intervener are to be germane to the appeal.

17    For these reasons, we would dismiss the GMIA’s application.

Associate:

Dated:    16 May 2012