When Justice Jagot handed down her judgment in Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) in August this year (read our Alert here, her Honour found that Apotex’s proposed supply of a generic leflunomide product would infringe Sanofi’s patent. Her Honour also found that Apotex had infringed the copyright in Sanofi’s leflunomide product information (“PI”). Unable to agree on final orders and the effect of the Therapeutic Goods Legislation Amendment (Copyright) Act 2011 (the “Amendment Act”), Justice Jagot was called in to adjudicate. Her Honour’s decision, handed down on 18 November, is a useful bedtime read for anyone interested in the effect of the Amendment Act.
The Amendment Act, which was introduced in response to the Sanofi-Aventis v Apotex proceedings, inserted a new section 44BA into the Copyright Act to provide a specific exemption that the reproduction of an originator’s product information by other (generic) companies was not an infringement of the originator’s copyright on and from the day the Amending Act commenced (something you’re probably sick of us blogging about!)
During the hearing Apotex and Sanofi assumed that the Amendment Act, once it commenced, would negate any breach of copyright in respect of any of the copyright works relied on by Sanofi (namely, two versions of the leflunomide PI and the SPC (“Summary of Product Characteristics”), which is the European equivalent of our PI). However, following her Honour’s primary judgment, Sanofi changed its view, saying the Amendment Act only operated in respect of the leflunomide PI documents and not the SPC (thereby entitling them to relief for copyright infringement after the Amendment Act had commenced).
While her Honour granted Sanofi leave to reopen their case, Sanofi were unsuccessful in convincing her Honour that the changes brought about by the Amendment Act should be limited to PI documents. Her Honour described Sanofi’s preferred construction as ‘manifestly absurd and unreasonable outcome’ stating that it was inconsistent with the purpose of the Amendment Act (being to ensure that the same PI accompanies all brands of the same medicine irrespective of copyright): ‘the phrase “a work that is product information approved under section 25AA of the Therapeutic Goods Act in relation to medicine” should not be construed as meaning the document accompanying the application for registration and approved by the Secretary’. The take-away is that PI means the information itself (ie, the information relating to the safe and effective use of the medicine) and that section 44BA will protect any document that contains or expresses, in relation to a medicine, information relating to the safe and effective use of that medicine.
The parties were also in dispute about the final form of the patent injunction. Justice Jagot concluded that Apotex should (only) be prevented from supplying its leflunomide product ‘for the treatment of psoriatic arthritis’. Her Honour refused to order an injunction in wider terms proposed by Sanofi (namely, that Apotex be prevented from dealing in its leflunomide product where it would have ‘reason to believe‘ its leflunomide product would be administered for the treatment of psoriatic arthritis). In making this decision, her Honour stated that it was incorrect to say that ‘merely by reason of supplying the Apotex Products for the treatment of rheumatoid arthritis, Apotex would have reason to believe that it was supplying products for the treatment of psoriatic arthritis (in contravention of the patent)’ and that ‘[t]o assert otherwise would be contrary to the basis upon which Sanofi-Aventis conducted this proceeding and to the rationale underpinning the outcome of the proceeding in favour of Sanofi-Aventis’. The consequence of this decision means that Apotex is now entitled to supply its leflunomide product for rheumatoid arthritis but not psoriatic arthritis.
The decision, Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 4)  FCA 1307, can be found here.