Under the Patents Act 1990, only the patentee and an exclusive licensee have standing to sue for infringement: s 120. For this purpose, the licensee must be the exclusive licensee of all the rights to exploit the patent.
In its initial licence, Orion had reserved to itself the right to manufacture the relevant drugs; granting Novartis the exclusive rights to import, use, offer to sell and sell the drugs. Orion also had rights to introduce its own generic product if a generic producer entered the market.
Following the Full Court’s ruling in BMS v Apotex (Aripiprazole), those terms meant that Novatis was not an “exclusive licensee” as (at the least) the grant did not include also the exclusive right to make the drugs.
Following Aripiprazole, however, Orion and Novartis amended the terms of the licence. Under the terms of the new licence, Orion simply granted Novartis the exclusive licence to exploit the patent in Australia “to the exclusion of all other persons”. In clause 2, however, Novartis undertook to buy all its requirements for the licensed products from Orion. There was also a side agreement that Novartis’ exclusive licence terminated if its rights under another, umbrella agreement terminated.
As Actavis did not contend that the new arrangements were a sham, the Full Court affirmed Rares J’s conclusion that the new arrangements superseded the previous arrangements in which Orion had reserved rights of manufacture. Further, the agreement to buy all its requirements for the patented products did not undercut that exclusivity.
There were textual arguments to support that conclusion, such as recognition that Novartis could apply to IP Australia to register its status as exclusive licensee. Perhaps, the key point is that an exclusive licensee could, if it so wished, contract with some other person for that person to make the products for it. The fact that the “other person” was the patentee did not undermine that proposition.
We are persuaded that the primary judge’s analysis of the relationship between clause 1 and clause 2 is correct. Although it is true to say that the two clauses are connected, we think that the primary judge was correct to conclude that they represent separate promises in the sense that clause 1 creates the plenary rights of an exclusive licensee and clause 2 reflects the agreement between the parties as to how Novartis will exercise its rights. We do not think that clause 2 acts as some exclusion clause or limitation clause in the way in which the appellants contend, such as to cut down the legal effect of the rights granted by clause 1.
Novartis itself had granted an exclusive sub-licence of its rights under the exclusive licence to Novartis Australia.
The Full Court rejected the argument (and Novartis itself did not try to defend it) that there had been an assignment of its rights to Novartis Australia.
The Full Court ruled that s 120 is mandatory and not permissive only. That is, only a patentee or an exclusive licensee had standing to sue for infringement. As Novartis Australia was only a sub-licensee, therefore, it had no standing to sue for infringement.
As a sub-licensee, however, Novartis Australia had sufficient interest to have standing as a proper party to the cross-claim for invalidity under s 139.
It is difficult to imagine that in this case this delicate footwork will have much reflection in who pays whose costs. One point where it could have a real impact, however, could be on what damages, if any, were payable. It might well not be possible to claim damages for sales lost by Novartis Australia, if it did in fact lose any sales, as Novartis Australia did not have standing to sue for infringement.
Actavis Pty Ltd v Orion Corporation  FCAFC 121 (Allsop CJ, Nicholas and Yates JJ)
- There are 193 paragraphs before the discussion of this issue, dealing with questions of validity and infringement (which seem to turn mainly on points of construction). ?
- From the Dictionary: “exclusive licensee ” means a licensee under a licence granted by the patentee and conferring on the licensee, or on the licensee and persons authorised by the licensee, the right to exploit the patented invention throughout the patent area to the exclusion of the patentee and all other persons. ?
- A so-called Rest of the World Agreement, setting out arrangements between the parties except for the USA and the European Union. ?
- In Insight SRC v ACER, however, a Full Court held that a copyright owner could recover damages for sales lost non-exclusive licensees who did not have standing to sue for infringement. ?