20 July, 2012


Sanofi Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) 2011 FCA 846


In brief


  • On 29 July 2011, Jagot J of the Federal Court of Australia held that Sanofi-Aventis Australia Pty Ltd ("Sanofi") could rely on its patent over a method of using leflunomide to treat the skin disorder psoriasis, to prevent Apotex Pty Ltd ("Apotex") from selling leflunomide for the treatment of the rheumatic condition psoriatic arthritis.
  • Jagot J held that, in selling leflunomide for the PsA indication, Apotex had engaged in patent infringement, misleading and deceptive conduct and copyright infringement.
  • While, (as confirmed by a further judgment on 18 November 2011) the copyright infringement ground is no longer available due to the Therapeutic Goods Legislation Amendment (Copyright) Act 2011 (Cth), the case remains notable for the patent infringement and misleading and deceptive conduct grounds successfully relied upon by Sanofi at first instance.




Sanofi obtained Australian Patent No. 670491 (the "Patent") for a method of preventing or treating the skin disorder psoriasis by administering a pharmaceutical composition containing leflunomide. The Patent has a priority date of 31 March 1993 and an expiry date of 29 March 2014. The compound leflunomide was itself the subject of a prior patent, which expired in 2004.


In 2008, Apotex registered its generic leflunomide products on the Australian Register of Therapeutic Goods for the treatment of the rheumatic conditions PsA and rheumatoid arthritis ("RA").


Sanofi commenced infringement proceedings based on the PsA indication. Sanofi argued that Apotex's supply of leflunomide to treat PsA infringed the Patent, because the use of leflunomide to treat psoriasis ("PsA") also involved the treatment of the skin disease psoriasis.


Construction and infringement


Jagot J construed the Patent based on the effect of the administration of leflunomide to patients, not the purpose for which leflunomide was being administered. In other words, Jagot J held that the Patent was infringed if the administration of leflunomide for any purpose, including the treatment of PsA, would result in the prevention or treatment of psoriasis.


The expert evidence firmly established that almost all patients with PsA also had, or would develop, the skin disease psoriasis. The administration of leflunomide to patients to treat PsA would, therefore, prevent or treat their psoriasis as well (albeit with varying degrees of success). Because the use of leflunomide by patients with PsA infringed the Patent, Apotex's supply of leflunomide constituted indirect or secondary infringement under section 117 of the Patents Act 1990 (Cth). The approved product information gave instructions to use the product for treatment of PsA, for the purposes of section 117(2)(c).


Patent validity


Jagot J considered and rejected Apotex's attack on the validity of the patent based on the grounds of lack of novelty, lack of inventive step, not a manner of manufacture, lack of utility, insufficiency and lack of fair basis.


One notable feature of the case is that Jagot J rejected Apotex's argument based on "the starting point for assessing obviousness" (see Apotex Pty Ltd v Sanofi-Aventis (2009) 82 IPR 416, 441-4). Jagot J rejected Apotex's submission that the correct starting point for the inventive step enquiry was that, at the priority date, leflunomide was a drug known to be useful in the treatment of RA and PsA. Jagot J held that this information, which was not part of common general knowledge, could not be taken into account.


Another notable feature of the case is Jagot J's construction of the relevant prior art documents, being the "341 Patent", the "Bartlett Article" and the "Rozman Abstract". Although each reported the investigation of leflunomide in patients with RA, and indicated that administering leflunomide might have a positive role to play in the prevention and treatment of RA, her Honour held that they did not contain a clear direction, recommendation or suggestion to administer it to humans "for that purpose". Thus there appears to be inconsistency between her Honour's constructions of the claim in the context of infringement and in the context of novelty.


Misleading and deceptive conduct


Jagot J upheld Sanofi's claim that Apotex's supply of leflunomide to treat PsA would result in Apotex falsely representing to medical practitioners, pharmacists and patients that they were entitled to prescribe, dispense and use the product. Such representations were false and likely to mislead or deceive because the respective recipients are not entitled to prescribe, dispense and use leflunomide: as discussed above, such conduct would infringe the Patent.


Copyright infringement


Sanofi also relied on Apotex's infringement of Sanofi's copyright in product information documents that were approved by the Therapeutic Goods Administration for use in relation to Sanofi's leflunomide products.


Apotex fought the copyright infringement claim largely on the questions of the originality and authorship of the product information documents.


In rejecting Apotex's submissions, Jagot J distinguished the High Court's decision in IceTV Pty Ltd v Nine Network Australia Pty Ltd (2009) 239 CLR 458 and the Full Federal Court's decision in Telstra Corp Ltd v Phone Directories Co Pty Ltd (2010) 273 ALR 725. Jagot J held that the works in those cases bore no resemblance to Sanofi's product information documents. The evidence in this case established that the product information documents were the product of significant skill, knowledge and effort exercised by identifiable Sanofi employees.


On 28 May 2011 (between the trial and the publication of her Honour's principal judgment), new provisions of the Copyright Act 1968 (Cth) inserted by the Therapeutic Goods Legislation Amendment (Copyright) Act 2011 (Cth), commenced. Under those amendments, the use of product information that has previously been approved by the Therapeutic Goods Administration does not infringe copyright in certain circumstances.


In a further judgment delivered on 18 November 2011, Jagot J ruled that:


(a) Apotex did not infringe Sanofi's copyright in product information documents under the new provisions of the Copyright Act 1968 (Cth); and

(b) Sanofi did not require leave to re-open the issue of copyright infringement because this was not a case where:

(i) Sanofi sought to "re-agitate arguments already considered by the Court", as discussed in Autodesk Inc v Dyason (No 2) (1993) 176 CLR 300; or

(ii) Sanofi having failed to take the point during the hearing (as discussed in Commonwealth v Verwayen (1990) 170 CLR 392 at 482).


Jagot J noted there was a tension between the scheme of the Therapeutic Goods Act 1989 (Cth), which relates to the approval of product information, and the new provisions of the Copyright Act 1968 (Cth), which relate to the infringement of works containing product information. Jagot J interpreted the new provisions of the Copyright Act 1968 (Cth) broadly, to exempt from infringement all works that contain approved product information, in whole or in part. This meant that Apotex did not infringe copyright in documents from which Sanofi's approved Australian product information leaflet was derived.


Appeal to the Full Court


Apotex appealed to the Full Court from Jagot J's judgment. The appeal was heard on 30 April 2012 and judgment is reserved.




  • The facts of this case enabled Sanofi to rely on a method of treatment patent to prevent Apotex's sale of leflunomide for a non-patented indication. Jagot J's construction of the patent is a reminder that under Australian law, claims to second medical uses of known compounds are not narrowed by notions of purpose or intention of the user. Indeed state of mind is irrelevant to the construction of such claims and, therefore, to questions of both direct infringement and novelty. Claims to uses or methods of treatment are infringed if the use or method is in fact performed, irrespective of the user's intention.
  • Pending the Full Court's judgment, Jagot J's broad interpretation of the Therapeutic Goods Legislation Amendment (Copyright) Act 2011 (Cth) should give some comfort to generics seeking to reproduce some or all of an originator's approved product information.




For further information, please contact:
Ben Miller, Partner, Ashurst 
Claire Roberts, Ashurst 
Stuart D'Aloisio, Ashurst 
Melissa McGrath, Ashurst 


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