In the recent case between Sanofi-Aventis Australia Pty Ltd and
Apotex Pty Ltd  FCA 846, the Federal Court of Australia
addressed for the first time the issues of copyright subsistence
and infringement in relation to product information documents
(PI) for pharmaceutical products.
The Court held that the PIs for Sanofi's leflunomide product
were works of joint authorship entitled to copyright protection, as
their creation involved considerable skill and judgment on the part
of Sanofi's employees who worked collaboratively in their
The Court further held that the PI for Apotex's leflunomide
product infringed the copyright in Sanofi's PIs as it
reproduced the whole or a substantial part of those PIs, and a
licence for Apotex to copy Sanofi's PI could not be implied in
However, the Court itself acknowledged that these complex issues
have been rendered moot insofar as the future is concerned by the
Therapeutic Goods Legislation Amendment (Copyright) Act
That Act amended the Copyright Act 1968 to insert a new
section 44BA which provides that certain acts are not a breach of
copyright "in a work that is product information approved
under section 25AA of the Therapeutic Goods Act 1989 in
relation to medicine".
The acts which do not constitute breach include acts of
supplying, reproducing, publishing, communicating or adapting done
under the Therapeutic Goods Act in respect of "some
or all" of "product information approved under section
25AA of the Therapeutic Goods Act in relation to
Clayton Utz communications are intended to provide
commentary and general information. They should not be relied upon
as legal advice. Formal legal advice should be sought in particular
transactions or on matters of interest arising from this bulletin.
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