Case against Pharmacem
10 In the proposed pleading, Servier seeks injunctive and pecuniary relief against Pharmacem. Servier's case against Pharmacem is for indirect infringement of the AC Patent, on the bases that:
Pharmacem has infringed and continues to infringe and/or threaten to infringe the AC Patent by causing, authorising, directing, procuring or inducing Apotex to import and sell perindopril erbumine products in Australia; and
Pharmacem is jointly liable for any infringement of the AC Patent committed by Apotex on the basis of having acted pursuant to a common design with Apotex to import and sell perindopril erbumine products in Australia.
11 Servier contends that this sets out a clear prima facie case against Pharmacem. It relies on a number of matters in support of this contention:
There is evidence, in correspondence from Apotex's solicitors to Pharmacem, on the Pharmacem website and in an affidavit sworn by a solicitor for Apotex, that Pharmacem manufactures in Canada the perindopril erbumine products sold by Apotex in Australia (the Australian product).
The active pharmaceutical ingredient of the Australian product (API) is manufactured by Pharmacem.
Both the API and the Australian product fall within the scope of the claims of the AC Patent.
Pharmacem played an active role in obtaining and maintaining approval for the Australian product under the Therapeutic Goods Act 1989 (Cth) (TGA). As the manufacturer of the API, Pharmacem completed documents and supplied information as requested by the Australian regulatory authorities in order for Apotex to obtain TGA approval.
Pharmacem manufactures the API in circumstances where it knows about the AC Patent and, by its involvement in obtaining TGA approval, knows that the API will form part of the Australian product.
Apotex is a wholly owned subsidiary of Apotex Inc. Apotex Inc and Pharmacem are related companies, being subsidiaries of the same parent companies, Sherfam Inc and Apotex Holdings Inc. There is evidence that the Apotex group of companies (of which Apotex, Apotex Inc and Pharmacem form part) operates as a vertically integrated group of companies or as a single worldwide organisation.
The Apotex group of companies operates a single worldwide research and development program in Canada.
The Apotex group of companies has sold the relevant perindopril erbumine products throughout the world. For example, the products page of the Apotex group of companies' worldwide website contains links to the local Apotex company website for each of Australia, Belgium, Canada, Czech Republic, Netherlands, Spain, United Kingdom and United States. Perindopril erbumine products are listed, inter alia, on the Australian website.
On 1 August 2006 proceedings were initiated in the United Kingdom against parties from the Apotex group of companies including Pharmacem and Apotex Inc in relation to infringement of Servier's UK equivalent of the AC Patent. It follows that, at all material times, Pharmacem has been aware of the AC Patent and is not in the position of an innocent third party supplier.
Pharmacem has instructed Apotex's solicitors with respect to discovery sought by Servier from Apotex.
The joinder of Pharmacem is necessary in order to obtain discovery of documents not in the possession of Apotex and likely to be in the possession of Pharmacem, given Pharmacem's role in the manufacturing of the product and its involvement in the corresponding UK proceedings.
Joinder rather than the commencement of fresh proceedings against Pharmacem is preferable and consistent with the overarching purpose of s 37M of the FC Act.
As the proceedings are at an early stage and awaiting the determination of the Full Court on proposed amendments to the claims of the AC Patent, Apotex will not suffer any prejudice, nor will there be an unreasonable delay in the proceedings.