Testing the boundaries of “product information” exemptions to copyright infringement in Australia
Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 4)  FCA 1307
Therapeutic Goods Legislation Amendment (Copyright) Act 2011 (Cth)
In the first decision to substantively examine recent amendments to the Copyright Act which now allow generic pharmaceutical companies to copy product information documents in prescribed circumstances, Justice Jagot of the Federal Court of Australia determined that the amendments apply to works which are “product information” as approved by the Therapeutic Goods Administration (regardless of whether the work accompanies an application for registration of a medicine under the Therapeutic Goods Act (TG Act)). The decision:
- indicates that the Courts are willing to purposively interpret the new amendments to ensure that the same product information may accompany all brands of the same medicine irrespective of copyright; and
- confirms that originator pharmaceutical companies will have difficulty stopping generic pharmaceutical companies from copying and using original product information they may create.
Justice Jagot’s copyright infringement findings
As previously reported, in July this year, Jagot J found that, amongst other things, Apotex had infringed the copyright in certain product information produced by Sanofi-Aventis for its “Arava” leflunomide product. The information (referred to collectively as the “Arava Works”) related to the quality, safety and efficacy of Arava and included:
- Arava product information version B;
- Arava product information version 19; and
- A Summary of Product Characteristics (“SPC”).
Unlike works 1 and 2, work 3 (which was the European equivalent of a product information document) did not accompany Sanofi’s application for registration of Arava as a therapeutic good under the TG Act.
In Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 4)1, Jagot J proceeded to consider the orders that should be made as a result of his previous substantive copyright infringement findings, having regard to the application of the Therapeutic Goods Legislation Amendment (Copyright) Act 2011 (Cth), which came into force on 28 May 2011.
The amendments to the Copyright Act
As explained in a previous legal update, section 44BA of the Copyright Act now sets out a number of prescribed acts which do not constitute an infringement of copyright subsisting 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.
The product information dispute
Sanofi-Aventis contended that having regard to the scope of s. 44BA as defined by the emphasised passage above, only works that accompanied an application for registration as a therapeutic good under the TG Act fell within the protections afforded by the amendments. Under this approach, the amendments would not apply to its SPC.
On the other hand, Apotex relied upon the scheme of the TG Act, and the object of the amendments as expressed in extrinsic legislative materials to assert that the amendments were not so confined, and applied to any document that contained or expressed information in relation to the safe and effective use of therapeutic goods, approved under s 25AA of the TG Act in relation to medicine, such as the SPC.
The scope of the Copyright Act amendments
Jagot J acknowledged that the relevant provisions of the amendments were “ambiguous or obscure”,2 and that such ambiguity “is to be resolved in the context in which the provisions operate and with regard to the purpose or object underlying the [amendments] and the Copyright Act.“3
In this regard:
- the explanatory memorandum for the amendments disclosed that the purpose of the amendments was to “ensure that the same product information may accompany all brands of the same medicine irrespective of copyright”.4 Sanofi’s interpretation was inconsistent with this expressed intention as, whilst Apotex would be protected against copyright infringement claims arising from reproductions of product information documents supplied to the TGA for approval (such as the Arava product information versions B and 19), they would be exposed to infringement claims based upon direct and indirect reproduction of documents from which such material was derived (in this case, the SPC); and
- whilst the Therapeutic Goods Administration’s scheme required product information to be in a particular approved form and to accompany an application for registration of a therapeutic good, the TG Act was concerned with approval of the information constituting the product information, rather than the particular document in which the relevant product information is conveyed.
For these reasons, Jagot J accepted Apotex’s construction of section 44BA and held:
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 [amendments]. To the extent that a work is not product information as approved it is outside the scope of the [amendments].5
Justice Jagot’s conclusions
Jagot J concluded that the amendments applied to the SPC, as it was, in part, product information as approved, and that the product information part of the SPC was itself a literary work for the purposes of the Copyright Act.
Accordingly, Sanofi was not entitled to any relief in respect of the infringement of its copyright after the commencement on the amendments on 28 May 2011.
Implications for originator pharmaceutical companies
The decision has confirmed that generic pharmaceutical companies are now able to use product information that has been approved by the Therapeutic Goods Administration, without infringing copyright in a range of prescribed circumstances.
As a result, originator pharmaceutical companies will have difficulty stopping generic pharmaceutical companies from copying and using original product information they may create.
-  FCA 1307 (Sanofi (No. 4)).
- Sanofi (No. 4) at 
- Sanofi (No 4) at 
- Sanofi (No 4) at 
- Sanofi (No 4) at