On 18 November 2011 the Federal Court delivered a further judgment in the long running dispute between Sanofi-Aventis and Apotex relating to generic Arava® (leflunomide) (Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 4) [2011] FCA). The dispute included an interesting application of the vexed dichotomy in copyright law between information and its embodiment, encapsulated in the maxim that copyright protects the form of expression of an idea or information and not the idea or information itself.
At key issue in dispute was the effect of the Therapeutic Good Legislation Amendment (Copyright) Act 2011 (Cth) (Amendment Act), which commenced May 2011. Jagot J had previously found that Apotex had infringed copyright in Sanofi-Aventis' product information document (PI) by reproducing it in its PI for generic leflunomide-containing products: Sanofi-Aventis Australia Pty Ltd & Ors v Apotex Pty Ltd (2011) 92 IPR 320.
'Product information' is defined in the Therapeutic Goods Act 1989 (Cth) (TG Act) to mean 'information relating to the safe and effective use of goods, including information regarding the usefulness and limitations of goods'. Generally, a PI must be submitted to the Therapeutic Goods Administration (TGA) before a new drug, or generic version thereof, is approved or can be lawfully marketed or supplied in Australia.
The Amendment Act relevantly created section 44BA of the Copyright Act 1968 (Cth) (Copyright Act). Subsection 44BA(1) provided that:
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).
Under subsection (4), 'product information' was defined as having the same meaning as in the TG Act.
At the time of the previous court hearing, the Amendment Act had not commenced. The parties proceeded on the basis that upon commencement, it would defeat Sanofi's copyright claim. Following the commencement of the Amendment Act, Sanofi resiled from that position.
Sanofi now contended that one of the copyright works allegedly infringed by Apotex was the Arava 'Summary of Product Characteristics' (SPC), being the European equivalent of a PI. While the SPC contained information that was included in Sanofi's PI, it was a different document containing additional information.
Sanofi's position was that the immunity grated in section 44BA was limited to PI documents submitted to and approved under the TG Act. The SPC did not accompany any application for the approval of Arava under that Act. Therefore (so Sanofi's argument went) the immunity in section 44BA did not apply and it could restrain Apotex from reproducing it and thereby impede the approval and supply of the generic product.
Her Honour observed that the relevant provisions of subsections 44BA of the Copyright Act were ambiguous or obscure: 'The ambiguity or obscurity arises from the potential for tension between the definition of 'product information' (which, by section 44AB(4) [sic], has the same meaning as in the [TG Act]) and the reference in the provisions to 'a work that is product information approved under' section 25AA of the [TG Act].' (at [31])
Given this ambiguity, her Honour referred to the Explanatory Memorandum, which included the following statement:
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.
Her Honour concluded that the construction proposed by Sanofi was inconsistent with the object or purpose or the legislation as defined in the extrinsic material. The difficulty was that the broad intention expressed in the Explanatory Memorandum was not clearly reflected in the statutory provision, which on their face were tied to 'a work... approved under [the TG Act]'.
Jagot J resolved this tension by reference to the distinction between 'information' and copyright 'works'. Her Honour expressed the view that, under the TG Act, it is the information that is approved and not a particular work. Therefore, the SPC fell within the section 44BA immunity because it contained information that was included in Sanofi's PI, which in turn had been approved under the TG Act. That 'information' did not lose its characteristic of being 'approved' information merely because it forms part of some larger work containing other material.
In terms of linking that 'information' to a 'work', her Honour stated that '[p]rovided 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... 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.' (at [40-41])
Consequently the phrase 'a work that is' in section 44BA of the Copyright Act is not to be read as a particular document that was submitted as part of the approval process under the TG Act. Rather:
- it refers to any document that includes or expresses product information as approved; or
- (as her Honour preferred) it refers to the whole or parts of the product information as approved that is a work in which copyrights subsist (see [43]).
In relation to Jagot J's preferred construction, the application of section 44BA seems to depend on a finding that the embodiment of the product information itself constitutes a copyright work:
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. (at [44], our emphasis)
As Drummond J pointed out Coogi Australia Pty Ltd v Hysport International Pty Ltd (1998) 157 ALR 247, this concept of dividing out a copyright work from a larger work is unusual:
... the fundamental principle enshrined in s 32 [is] that copyright can only subsist in a work considered as a whole, not in elements or component parts of the work. Cf Powerflex Services Pty Ltd v Data Access Corporation (1997) 37 IPR 436 at 455.
What that entity the subject of copyright is in any given case cannot be governed by what the copyright claimant chooses to say it is. It must be a matter for objective determination by the court. Otherwise a person suing for infringement of copyright could, by narrowing the subject matter of his claim, deprive a defendant of what might be a good defence that what the defendant took did not involve the taking of a substantial part of the true object of the claimant's expenditure of skill and effort...
It may be possible in some circumstances to claim copyright in what might be said to be only an element or part of a larger entity. But, in my opinion, that can be so only if the part can fairly be regarded as so separable from the material with which it is collocated as itself to constitute an “original … work” for the purposes of s 32 of the Act. (at 263-4)
It is possible that the product information approved under the TG Act would not be a copyright work in and of itself, but rather would form part of or have been extracted from a larger copyright work. Her Honour's preferred construction would leave open the possibility of an originator relying on that larger copyright work to avoid the immunity given to generics in section 44BA.
Nonetheless, the Federal Government's provisions that were intended to protect the generic pharmaceutical companies have held up to the scrutiny of the court notwithstanding some reservations as to their drafting. Sanofi was not entitled to relief in respect of the copyright claim after the commencement of the Amendment Act.
Although not dealt with in this note, Apotex was nonetheless restrained from selling its generic product on the basis of patent infringement.
Partner: John Fairbairn
Partner: John Fairbairn
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