The recent Federal Court decision in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd  FCA 28 deals with fascinating issues for patentees seeking to enforce Swiss-style claims against makers of bioequivalent products. Senior Associate Lauren John and Lawyer Amelia van der Rijt explain.
Mylan Health (Mylan) owned three patents covering formulations of fenofibrate products, or methods of treating diabetic retinopathy (a complication associated with diabetes, which can lead to severe and long-term vision loss) using fenofibrate products. Sun Pharma ANZ, formerly known as Ranbaxy Australia (Ranbaxy), proposed to market a number of fenofibrate products in Australia (Ranbaxy Products). Mylan argued Ranbaxy threatened to infringe its patents because:
- the Product Information (PI) for Mylan's fenofibrate products (Lipidil) states they are indicated for diabetic retinopathy; and
- the PI for the Ranbaxy Products states they are 'bioequivalent to Lipidil', and does not state they are not indicated for diabetic retinopathy or bioequivalent for that purpose (PI Evidence).
Ranbaxy denied infringement and cross-claimed, challenging the validity of the patents. Two interesting issues arise from the court's decision in this matter.
As noted in the Patent Manual of Practice and Procedure, Swiss-styles claims generally appear in the format: 'The use of (substance X) for the manufacture of a medicament for the therapeutic and/or prophylactic treatment of (medical condition Y).' Such claims essentially define a new medical use for a particular substance, rather than a new substance.
In considering whether the Ranbaxy Products infringed the Swiss-style claims of the Mylan patents, the court said the crucial question to be asked is whether the manufacturer has the intention that the medicament be used to treat the designated condition – mere knowledge that the relevant medicament is suitable for use in the claimed treatment is insufficient.
The intention is to be ascertained objectively, and relevant factors include the PI for the product, any product labelling and the nature, size and other characteristics of the market for the product.
In this case, the court held the PI Evidence did not provide a sufficient basis to find the Ranbaxy Products would be manufactured with the intention of being used for the treatment of diabetic retinopathy.
The Saccharin doctrine, named after a century-old case in the UK concerning the artificial sweetener, establishes that the importation of a non-infringing product may still infringe a patented method or product if that patented method or product was used as an intermediary in the manufacture of the non-infringing product overseas. The doctrine is no longer in use in the UK under the current legislative regime.
Seeking to invoke the Saccharin doctrine, Mylan alleged certain product claims would be infringed by the importation and sale of the Ranbaxy Products. The Ranbaxy Products are not, and do not include, any product within the scope of these product claims, but Ranbaxy uses products falling within their scope in the course of manufacturing the Ranbaxy Products. Mylan argued that, as the doing of certain acts, in Australia, in respect of a product made using a patented method overseas, constitutes infringement, it should likewise be an infringement to use a patented product overseas to produce another, non-infringing product that is subsequently imported.
The court rejected this argument. An incongruity arises because the Patents Act defines the concept of exploitation for product claims and method claims differently. The definition of 'exploit' in the Act is silent as to situations where a patented product is used overseas to make another product, which is then imported into Australia. There was no infringement of the product claims.
The decision leaves open the question of whether a person infringes a patented method for producing Product A, by performing that process overseas and using resulting Product A to manufacture Product B, which is then imported into Australia.