What you need to know
- A unanimous decision of an expanded five judge bench of the Full Federal Court has clarified the law in Australia regarding infringement of Swiss-style patent claims.
- The Court held that it is not necessary to show that a manufacturer has made the relevant product with the intention that it be used for the therapeutic purpose specified in the claim for a finding of infringement. Instead, the critical question is whether the product is in fact manufactured for the therapeutic purpose specified in the claim.
- The Court will look at the physical characteristics of the product, including the packaging, labelling, product information, formulation and dosage to assess whether the product was manufactured for the therapeutic purpose in the claim. While intention of the manufacturer may be taken into account, it is not determinative.
What are Swiss-style claims?
Swiss-style claims are directed to the use of a substance in the manufacture of a medicament to be administered for a specified therapeutic purpose. In Australia, Swiss-style claims are interpreted as method (or process) claims. However, the therapeutic use defined in the claim qualifies, and therefore confines, the scope of the monopoly.
The independent Swiss-style claim in suit was:
"Use of fenofibrate or a derivative thereof for the manufacture of a medicament for the prevention and/or treatment of retinopathy, in particular diabetic retinopathy."
Sun Pharma's fenofibrate product
Sun Pharma's product had originally been approved for the same indications as Mylan's fenofibrate product (Lipidil), which included an indication for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. The product information for Sun Pharma's product was subsequently amended to remove the references to diabetic retinopathy.
Sun Pharma also applied to the Therapeutic Goods Administration to amend the product information to include an express disclaimer that its products were not indicated for the prevention or treatment of diabetic retinopathy. However, the Therapeutic Goods Administration refused that request. Accordingly, there was no express statement in the product information that Sun Pharma's product should not be used for the treatment or prevention of diabetic retinopathy.
Finding at first instance
Two issues were raised at first instance regarding infringement of the Swiss-style claims:
- whether a Swiss-style claim can be infringed by the importation and supply in Australia of a medicament that is manufactured outside Australia; and
- whether a Swiss-style claim can be infringed if the manufacturer has prepared the relevant medicament knowing that it is suitable for use in the treatment of the specified claim.
Regarding the first issue, the primary judge, having regard to the definition of "exploit" in s 13(1) of the Patents Act, held that a Swiss-style claim can be infringed in circumstances where the medicament is manufactured outside Australia. There was no appeal from this finding.
Regarding the second issue, the primary judge concluded that mere suitability for use is not sufficient for infringement of a Swiss-style claim. Rather, the crucial question is whether the manufacturer has made (or will make) the relevant product with the intention that it be used in the treatment of the specified condition.
Full Court's findings
The Court disagreed that the crucial question for infringement of Swiss-style claims is one of intention. The Court held that the critical question is whether the product is in fact manufactured for the therapeutic purpose specified in the claim. Put simply, the Court stated:
"infringement of a Swiss type claim is concerned with what the allegedly infringing manufacturer has done, not what it intended to do."
To determine this, the Court will consider "the physical characteristics of the medicament as it emerges as a product of the manufacturing process, including its formulation and dosage, packaging and labelling, and its patient information". While the Court found that intention of the manufacturer is not determinative, it maintained that intention is a relevant factor to be taken into account with all the other circumstances of the case.
In this case, no evidence of intention from the manufacturer of Sun Pharma's product was available. The Court considered Sun Pharma's product information, including: (i) the absence of an indication for diabetic retinopathy, (ii) the fact that it referred to the Sun Pharma products as bioequivalent to Lipidil, which are indicated for the reduction in the progression of diabetic retinopathy; and (iii) the fact that it did not expressly disclaim use for diabetic retinopathy.
Having regard to all of the facts, the Full Court was not persuaded that the evidence established that, as manufactured, the Sun Pharma products are medicaments for the treatment of diabetic retinopathy. Accordingly, the Full Court upheld the primary judge's finding that the Swiss-style claims were not infringed.
Swiss-style claims are purpose limited
At first instance, the primary judge was satisfied that the method of treatment claims in suit, which related to the prevention and/or treatment of retinopathy by administering fenofibrate, would be indirectly infringed by Sun Pharma supplying its fenofibrate products in Australia. This was because Sun Pharma was found to have reason to believe that a significant portion of its products would be used in a manner that would infringe the method of treatment claims. The primary judge concluded that Sun Pharma had this reason to believe because doctors prescribing fenofibrate would not specify on the prescription the purpose for the administration of the drug and pharmacists would therefore, potentially dispense Sun Pharma's fenofibrate product when it was intended to treat retinopathy.
On appeal, Mylan argued that the primary judge acted inconsistently in rejecting the case on infringement of the Swiss-style claims whilst nevertheless finding indirect infringement under s 117 of the Patents Act on the basis of Sun Pharma's reason to believe.
This argument was rejected by the Court, which held that Swiss-style claims are purpose limited in scope with the relevant question of infringement being whether the product was manufactured for the therapeutic purpose specified in the claim. Conversely, uses to which a product may be put is relevant for indirect infringement under s 117 of the Patents Act. The Court held:
"where a medicament would be used extensively for purposes that fall outside the monopoly of a Swiss type claim, the fact that it is reasonably foreseeable, or indeed likely, that a substantial portion of the manufactured medicament would also be used for the claimed therapeutic purpose will not be determinative of infringement: it might be reasonably foreseeable that a product might be put to a particular use, but it does not necessarily follow that the product, as manufactured, is for that use."
These findings demonstrate the utility of patenting and enforcing both method of treatment claims and Swiss-style claims in Australia.
Conclusion
While Mylan has applied for special leave to appeal the Full Federal Court's decision, Mylan has not sought to appeal the findings in relation to Swiss-style claims. Accordingly, this decision will remain as the authority on the infringement of Swiss-style claims in Australia.
Ashurst acted for Sun Pharma in the proceedings.
Authors: Anna Glen, Lawyer; Stevie Gough, Senior Associate; and Nina Fitzgerald, Partner
