Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (Part 2) – Contributory infringement

The scope of what conduct constitutes contributory infringement in Australia remains unclear but is now potentially broader as a result of this decision. Contributory infringement will always depend closely upon the facts, and, in this case, the Federal Court of Appeal in Australia had interpreted method of treatment claims as having an element of intention.¹  In Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd – Claiming intent we dealt with the construction and novelty of the relevant claim. The focus of this article is the way the Federal Court of Appeal analysed the issue of contributory infringement under Australian law. This is particularly topical given the recent Federal Circuit decision in the US regarding inducement of patent infringement.

In this case, the issue was whether the sale of a generic leflunomide product by Apotex Pty Ltd for the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) would infringe the single claim of Sanofi-Aventis Deutschland GmbH’s Australian patent number 670491. The claim is:

A method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of a pharmaceutical composition containing as an active ingredient a compound of formula I or II…

The compound of formula I is the active leflunomide. As discussed in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd – Claiming intent, the trial judge found as facts that:

(i) a person suffering from RA may have or develop psoriasis;
(ii) a person suffering from PsA will almost always have psoriasis; and
(iii) by administering leflunomide to a person with RA and/or PsA (as taught in the prior art), any psoriasis that the patient may have or may develop would inevitably be prevented or treated.

The appeal judges construed the claim as being limited to the administration of leflunomide for the objective of preventing or treating psoriasis, regardless of whether other conditions (such as RA and/or PsA) may also be treated, or were sought to be treated, by its administration. In light of this claim construction, Apotex itself was found not to directly infringe the claim.

However, Apotex was still held to infringe the claim by way of contributory infringement by supplying leflunomide with a Product Information (PI) leaflet, which included a statement that this leflunomide product “is not indicated for the treatment of psoriasis when it is not associated with manifestations of arthritic disease”.

Contributory infringement

The legislative provision governing contributory infringement in Australia is s 117(1), which states:²

If the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent.

In cases such as Rescare Ltd v Anaesthetic Supplies Pty Ltd,³  this provision has been interpreted as being limited to only those situations where it is a product that is the subject of a patent claim (or a product resulting from the use of a patented method or process), and therefore it does not apply where the subject of a patent claim is a method or process of using a product. That is, where the patent involves a method or process claim, there must be a product resulting from an infringing use of the method or process for there to be contributory infringement under s 117(1). Other decisions have taken a less restrictive view (for example, Bristol-Myers Squibb Co v FH Faulding).⁴

Two questions in the present case were whether the supply of an input (ie Apotex’s generic leflunomide product) for use in a patented method of treatment was capable of attracting the operation of s 117(1), and, if so, whether the statement in the PI affected that operation.

In the present case, s 117(1) was considered to have a broader application – that is, it extended to method of treatment patents. The Court therefore concluded that, because psoriasis would inevitably be treated when Apotex’s generic leflunomide product was administered to a patient, Apotex, through its PI (which, as mentioned above, indicated use of the generic leflunomide product for the treatment of arthritic disease) was held to contravene s 117(2)(c).  In addition, it was held that Apotex had reason to believe that its generic leflunomide product would be used in a method of preventing or treating psoriasis (in contravention of s 117(2)(b)).⁵  Therefore, Apotex, by supplying pharmacists (who would then supply a patient) with its generic leflunomide product, was held to infringe the method of treatment claim by contributory infringement.

This decision highlights some of the vagaries of s 117 contributory infringement. It re-enforces the need to be aware of any rights that competitors may have in methods of using products (even in the absence of any patent rights to the products themselves) and that method claims may be infringed even when it is not intended that a claimed method be carried out.