Full Court rejects “mental element” test in construction of Swiss-style claims
A five-judge bench of the Full Federal Court of Australia has unanimously overturned the “mental element” test for infringement of Swiss-style claims in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd  FCAFC 116 (Mylan v Sun Pharma). Rather, the relevant question when assessing infringement of Swiss-style claims is whether the medicament is for the specified therapeutic purpose, the answer to which involves consideration of a variety of factors, which may include (but is not limited to) the manufacturer’s objective intention. The Full Court also confirmed that these factors differ from those to be taken into account when assessing infringement of method of treatment claims, highlighting the importance of including both claim types in patent applications in Australia.
A Swiss-style claim typically takes the form “Use of [substance X] in the manufacture of a medicament for the treatment of [condition Y]”, the patentability of which frequently arises from the discovery of a new therapeutic use for a known substance. The use of the medicament as it emerges as a product of the manufacturing process for this therapeutic indication, and this indication alone, defines the monopoly of a Swiss-style claim.
While Swiss-style claims emerged in Europe to address specific patentability requirements under a previous iteration of the European Patent Convention, they have been widely embraced in Australia as providing an avenue for recourse against manufacturers of a competing pharmaceutical products, including products manufactured overseas and imported into Australia. This contrasts with the method of medical treatment claims, which are directly infringed by administration of the relevant pharmaceutical product (e.g., by a medical practitioner).
The alleged infringement
The Swiss-style claim ultimately at issue before the Full Court in Mylan v Sun Pharma related to the use of fenofibrate for the manufacture of a medicament for the prevention and/or treatment of retinopathy, in particular diabetic retinopathy, in specific dosages (claim 5 of AU 2006313711). The patentee, Mylan, markets its fenofibrate products as Lipidil®, which is listed on the Australian Register of Therapeutic Goods (ARTG). The indications listed in the Product Information (PI) for Lipidil® include diabetic retinopathy.
Mylan alleged that Sun Pharma ANZ (formerly Ranbaxy Australia) threatened to infringe the Swiss-style claim by listing its own fenofibrate products on the ARTG (the Ranbaxy Products), the PI for which stated that they are bioequivalent to Lipidil®. However, diabetic retinopathy was not included among the indications listed in the PI for the Ranbaxy Products, which was amended during the course of proceedings to specify hypercholesterolaemia, various types of dyslipidaemia and dyslipidaemia associated with type 2 diabetes, as the only indications.
The “mental element” test
At first instance, the primary judge found that a Swiss-style claim imports a “mental element” with respect to the manufacturer’s intention. Thus, the relevant question in determining whether the Ranbaxy Products infringed the relevant Swiss-style claims (including claim 5 of AU 2006313711) was whether the manufacturer of the Ranbaxy Products objectively intended them to be used for the treatment of retinopathy (particularly diabetic retinopathy).
According to the primary judge, the relevant factors to be taken into consideration in ascertaining the manufacturer’s objective intention include the PI and any product labelling, as well as the nature, size and other pertinent characteristics of the market into which the product is to be sold. However, the primary judge held that there was no threatened infringement of Mylan’s Swiss-style claims because insufficient evidence was provided to establish the objective intention of the manufacturer of the Ranbaxy Products.
In contrast, the primary judge found that the corresponding method of treatment claims were indirectly infringed because it was “reasonably foreseeable” that the Ranbaxy Products would be used by medical practitioners for treating the same indications as Lipidil®.
The Full Court decision
Mylan appealed the first instance decision on the basis that, inter alia, the primary judge erred in finding that Swiss-style claims import a “mental element” on the part of the manufacturer of the relevant medicament. Mylan also contended that the primary judge’s finding of non-infringement of the Swiss-style claims was inconsistent with the finding of infringement in relation to the method of treatment claims.
The Full Court agreed that the proper construction of Swiss-style claims does not involve the addition of a further essential feature, namely, the manufacturer’s objective intention. Rather, infringement of Swiss-style claims is concerned with whether the medicament is for the specified therapeutic purpose.
The Full Court considered that the question of infringement of Swiss-style involves consideration of a number of factors depending on the specific circumstances of the case, no single one of which is determinative of infringement. The factors that may be taken into account include:
(a) the manufacturer’s intention in producing the medicament;
(b) the physical characteristics of the medicament (e.g., its formulation and dosage);
(c) the packaging, labelling and PI for the medicament; and
(d) the reasonably foreseeable use(s) to which the medicament would be put after its manufacture.
In Mylan, although the PI for the Ranbaxy Products specified that it is bioequivalent to Lipidil®, the evidence established that there was a substantial therapeutic use for the Ranbaxy Products in the treatment of the various disorders listed in the amended PI. Further, while the PI for the Ranbaxy Products did not disclaim their use in the treatment of diabetic retinopathy, this was not considered proof that the medicament is for that use.
The Full Court did not consider that the facts pointed persuasively to a conclusion that the Ranbaxy Products are medicaments for the treatment of retinopathy (particularly diabetic retinopathy). Further, the Full Court rejected Mylan’s submission that the primary judge’s findings in relation to Swiss-style and method of treatment claims were inconsistent, stating that different considerations inform the question of infringement in each case.
This decision highlights some important considerations for originators and generics alike:
- the relevant question in assessing infringement of Swiss-style claims is whether the medicament is for the recited therapeutic use;
- the manufacturer’s objective intention is but one of many factors to be taken into account in determining whether the medicament is for the recited therapeutic use;
- different considerations inform the question of infringement of Swiss-style and method of treatment claims; and
- corresponding Swiss-style and method of treatment claims should always be included in tandem to provide the broadest scope of protection against potential infringers.