Manufacturer’s Intention Not Necessarily Relevant to Infringement of Swiss-Style Claims
In Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd the unanimous decision of the Full Court of the Federal Court (FCAFC) held that when assessing whether a Swiss-style patent claim has been infringed the intention of the accused infringer is not a necessary factor to take into consideration...
The case considered whether Sun Pharma had infringed three patents, where Mylan is the exclusive licensee in respect of two and a licensee in respect of the third. Each of the patents involves Fenofibrate, which is a fibric acid derivative that is used to regulate lipoproteins and triglycerides in blood and more recently to treat diabetic retinopathy. Swiss-style claims were only in issue in respect of the first patent (2006313711), which contained claims to the 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. For the purposes of considering infringement claim 5 was in issue, which involved specific dosages of fenofibrate.
The trial Judge held the claims in issue for the 2006313711 patent to be invalid on account of both lack of novelty and lack of inventive step in light of prior art – the ACCORD Eye Study Protocol – which contained an untested hypothesis that fibrate therapy would be effective in reducing the risk of diabetic retinopathy. In addition to that finding, the trial Judge also held that validity issues aside threatened infringement had not been established due to a lack of proof regarding the manufacturer’s intention when making the medicament – given that fenofibrate had other medical uses.
On appeal, the FCAFC found the trial Judge had erred in how he arrived at the conclusion that the relevant claims of the 2006313711 patent lack an inventive step, but that on their reassessment the conclusion that there is a lack of inventive step was upheld. The FCAFC also upheld the lack of novelty determination, finding from applying the reverse infringement test that the hypothesis prior published the invention on account of disclosing its essential features with sufficient specificity, and that it did not matter that the skilled addressee would not have used the untested hypothesis.
Mylan’s other point of appeal in respect of the 2006313711 patent took issue with the trial Judge’s contention that a manufacturer’s intention when making a medicament is required for making an infringement determination. In making that statement the trial Judge sought to distinguish the case from precedent that Merck sought to apply. In Otsuka Pharmaceutical Co. Ltd v Generic Health Pty Ltd (No 4) it was held that infringement determinations in respect of Swiss-style claims should be made on the basis of suitability for use rather than the way the product is marketed. Mylan sought to use that to argue that the intention of the manufacturer is irrelevant as the primary consideration is whether it is suitable for an infringing use. However, the primary Judge held that the Otsuka case was not addressing the question of the manufacturer’s purpose or intention and that suitability for use on its own is not sufficient for making an infringement determination for Swiss-style claims as there will be valid non-infringing uses. Citing the UK Supreme Court case Generics (UK) v Warner-Lambert the trial Judge held that, in addition to suitability for use, the other factor is whether the manufacturer has or will make the product with the (objectively determined) intention that it will be used to treat the condition that is the subject of the Swiss-style claims.
In its appeal Merck argued that the trial Judge mis-applied the UK Supreme Court case, and claimed that the UK Supreme Court had used an outward presentation test – whether the manufactured product was presented as suitable for the use specified in the Swiss-style claims - which involves no mental element. In the alternative, Merck argued that if the objective intention test was used that infringement should be determined by reasonable foreseeability.
The FCAFC noted that Swiss-style claims are purpose limited process claims. It also noted that the UK Supreme Court case was not decided unanimously. Two of the Judges advocated the outward presentation test on the basis that infringement is solely determined by the suitability for use of the end product (including labelling and pamphlets). Another two Judges advocated the subjective intention test on the basis that a mental element is an essential feature of claims that are limited by purpose. In doing so they noted that while subjective intention is routinely proved by objective evidence of conduct, the purpose for which something is manufactured is not always obtainable from such objective evidence. The fifth Judge advocated an objective appearance and characteristics test that in some circumstances would hold a manufacturer to infringe unless they positively exclude the use specified in the Swiss-style claims.
The FCAFC took from this that the UKSC rejected an objective test for purpose satisfied by the reasonable foreseeability test. The FCAFC also found that the remaining differences between the UKSC Judges stemmed from their respective attempts to satisfy the Protocol on Interpretation of Article 69 of the EPC, which requires the extent of protection to combine fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties. It was noted that in Australia claims are not construed by such a policy objective, but rather are guided by context dependent common law principles. The FCAFC held that for Swiss-style claims the manufacturer’s intention is not an essential feature of the invention, and as such infringement is not concerned with what the manufacturer intends to do, rather it is concerned with what they have done – whether the medicament as manufactured is for the alleged therapeutic use. Nonetheless, the FCAFC held that where direct evidence of the manufacturer’s intention is available it can form part of the matrix of considerations in an infringement determination. In further contrast to the UKSC the FCAFC also held that reasonable foreseeability can be useful, but is not determinative in an infringement determination - 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. The FCAFC agreed with the trial Judge’s holding that suitability for use is an insufficient test for infringement of a Swiss-style claim. Hence, while holding that the manufacturer’s intention is not necessary for making an infringement determination in respect of a Swiss-style claim, the FCAFC left open several factors that in a given case can assist in determining whether a generic medicament as manufactured is for the Swiss-style claimed therapeutic use.
On the facts of the case the FCAFC held that Sun Pharma’s manufactured product (including labelling, information given to patients and product information lodged with the Therapeutic Goods Administration (TGA)) was clear in what it was to be used for and involved substantial therapeutic uses. On account of that and despite the product information lodged with the TGA stating that it is bioequivalent to Merck’s product a statement excluding the use specified in Merck’s Swiss-style claim (had it been valid) was not required. Nor was Sun Pharma obliged to write to medical practitioners and pharmacists instructing them not to prescribe or dispense it for the use specified in Merck’s Swiss-style claim. The FCAFC indicated that this last consideration concerns downstream activity and is more relevant to defending a claim to contributory infringement of a method of treatment claim than to defending a claim to infringement of a Swiss-style claim. The FCAFC also noted that the differences between Swiss-style claims and method of treatment claims mean that infringement of one does not necessarily imply infringement of the other. In this respect they found that the trial Judge was not acting inconsistently in finding the Swiss-style claim not infringed and the method of treatment claims to be infringed, given that reasonable foreseeability could be found to be established for the latter, but not the former.