The Full Court has upheld Nicholas J’s ruling that Apotex infringed the Swiss claims in Warner-Lambert’s (Pfizer’s) pregabalin patent by making the product outside Australia and then threatening to import it into Australia for sale.
Claims 16 to 30 of the pregabalin patent were Swiss claims. For example, claim 16 was for “use of a compound of Formula 1 or a pharmaceutically acceptable salt diastereomer or an enantiomer thereof … in the manufacture of a medicament for the treatment of pain.”
Apotex’ plan was to have its product made overseas by a third party, then import the product and offer it for sale.
As you know, infringement requires the infringer to “exploit” the claim said to be infringed in the patent area. For this purpose, the Dictionary defines exploit to mean:
“exploit ”, in relation to an invention, includes:
(a) where the invention is a product—make, hire, sell or otherwise dispose of the product, offer to make, sell, hire or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; or
(b) where the invention is a method or process—use the method or process or do any act mentioned in paragraph (a) in respect of a product resulting from such use.
Apotex argued that it was not going to infringe because Swiss claims are method claims and so, according to Apotex, could be infringed only by practising the method in Australia. Therefore, according to Apotex, paragraph (b) of the definition of “exploit” should be limited to products made by practising the method in Australia only.
In Lundbeck at  – , Lindgren J had found infringement in similar circumstances, but through some rather convoluted reasoning. At , while rejecting Apotex’ criticisms of Lundbeck, the Full Court upheld the trial Judge’s finding of infringement on the basis of his Honour’s reasoning in preference to Lindgren J’s reasoning. Nicholas J found at - :
296 The definition of “exploit” makes no reference to the patent area. As I have said, the express territorial limitation upon the patentee’s exclusive rights is found in s 12 and s 13. In my respectful view, there is therefore no reason to read down the words of either para (a) or para (b) of the definition of “exploit” to found any territorial limitation. This is because the Act expressly provides that a patent only has effect in the patent area: see also s 70 of the Patents Act 1952 (Cth).
297 Paragraph (b) of the definition of “exploit” refers to the doing of an act referred to in para (a) which includes to make or import a product. The patentee’s exclusive rights are infringed (subject to available defences) if another person does any such act within the patent area. The fact that the patented method is performed outside the patent area does not avoid infringement of a method claim (including a Swiss claim) if the product imported and sold in Australia was made using the patented method because the acts of importation and sale occur within the patent area. The relevant act of infringement is not the use of the method outside the patent area but the exploitation (by importation and sale) in Australia of a product made using the patented method.
298 In my respectful opinion, contrary to the approach taken by Lindgren J, the relevant territorial limitation is reflected in the language of s 12 and s 13(3) and there is therefore no justification for importing words of territorial limitation into the definition of “exploit”. It follows that I take a somewhat different approach to the construction of the definition of “exploit” to that taken by Lindgren J in Alphapharm, though I do not think the difference has any impact on whether or not Apotex threatens to infringe the Swiss claims in this case.
So the question now appears to be “Is the respondent exploiting in Australia a product which was made by a method as claimed in the patent?” It does not matter whether the method was performed in or outside Australia.
If Apotex imported its product as planned, therefore, Apotex would infringe because it would be importing into Australia and then offering for sale a product which had been made by one of the claimed methods. Any other result, of course, would have seriously compromised the utility of method patents.
The Full Court also dismissed Apotex’ appeal against the findings that the Patent was fairly based and not invalidated by a false suggestion. That may be a topic for another day.
Warner-Lambert Company LLC v Apotex Pty Ltd (No 2)  FCAFC 26 (Jagot, Yates and Burley JJ)