The enlarged Full Court of the Federal Court decision of Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd  FCAFC 116 has confirmed that a reasonable but untested hypothesis can be sufficient to render a patent invalid.
As the Full Court recognised, this is a departure from the position in Europe and other key jurisdictions. When deciding on the timing for filing patent applications, originators will be in the invidious position of having to weigh up the need to file patent applications early in Australia on the one hand, against the need to satisfy more onerous patent support requirements in other major jurisdictions on the other.
The Full Court has also clarified the test for infringement of Swiss style claims. The decision makes it easier to avoid infringement by excluding patented indications from a product’s approval (or ‘skinny labelling’) and reinforces the need for method of treatment claims. This approach is, in practical effect, consistent with the ‘outward presentation’ test which has been applied in the UK.
An untested hypothesis is sufficient to destroy novelty
The trial judge, Nicholas J, held that the hypothesis published in a clinical trial protocol (the Protocol) was a prior disclosure of Mylan’s method of treatment and Swiss type claims (discussed further below) and therefore deprived the invention of novelty. The expanded five-judge Full Court (the Court) unanimously upheld this finding on appeal.
The Court was clear in its judgment that the test for a prior (or anticipatory) disclosure of a claimed invention was well established. The Court therefore applied the ‘reverse infringement test’ and determined that the hypothesis published in the Protocol was sufficient to ‘teach’ the invention and was therefore an anticipation. The hypothesis was that:
“[i]n the context of good glycaemic control, a therapeutic strategy that uses a fibrate to lower triglyceride levels and raise HDL cholesterol levels in patients already receiving a statin drug for treatment of LDL cholesterol levels, will reduce the rate of development or progression of [diabetic retinopathy] compared to a strategy that only uses a statin drug for treatment of LDL cholesterol levels.”
Although the hypothesis had not been tested, Nicholas J found, and the Court agreed, that use of the claimed doses of fenofibrate in accordance with the method would clearly infringe the relevant method of treatment and Swiss type claims. Mylan was unable to persuade the Court that the Protocol did not anticipate as the hypothesis had not been evaluated for therapeutic efficacy and that the person skilled in the art (being a doctor treating diabetic retinopathy) would therefore not use it. Expert evidence was submitted to this effect, but the Court said it was not relevant. The Court confirmed that the question is simply whether the invention had been published, not whether the skilled addressee would be persuaded to use it. Here, regardless of whether the skilled addressee thought it was a good idea from a clinical perspective, the fact of the matter was that if they were to carry out the method disclosed in the hypothesis with the claimed doses of fenofibrate, they would carry out the claimed invention.
Mylan relied on previous decisions in which clinical trial data was pleaded as an anticipatory disclosure. In Bristol-Myers Squibb Company v FH Faulding & Company Limited  97 FCR 524 (BMS), the Court found that five reports of clinical trials on dosage safety were not anticipatory disclosures of the claimed method of treatment. Despite the fact that the reports strictly disclosed use of the claimed method to treat patients with cancer, the Court found that they did not contain the requisite specificity regarding the patients’ clinical response to the drug that was necessary to teach the invention. However, the Court in the present case found that a person skilled in the art who carried out the hypothesis in the Protocol using the claimed doses of fenofibrate would indeed be performing a method of treatment for diabetic retinopathy.
The Court acknowledged that the decision of a single judge in InterPharma Pty Ltd v Hospira, Inc (No 5) (2019) 149 IPR 182 found a failure to establish lack of novelty based on a ‘proposal for a trial to evaluate an hypothesis, namely whether use of dexmedetomidine in ICU sedation was safe, effective and dose titratable’. However, the Court observed that the judge in that case found that the disclosure was factually distinct and, perhaps more importantly, that ‘[t]he correctness of that factual conclusion is not before us’.
The UK and EU position
Lastly, Mylan sought to rely on two UK authorities which support the submission that in relation to a pharmaceutical compound, novelty cannot be destroyed unless the claimed therapeutic effect is established. The Court swiftly dismissed this submission, pointing to the fact that those authorities were subject to precedent from Boards of Appeal of the European Patent Office, which import a requirement of established therapeutic effect into the claim. That is, in Europe and the UK the claim is read as successfully achieving the claimed therapeutic effect, a requirement not read into Australian method of treatment claims.
Upshot for originators and generic / biosimilar pharmaceutical companies
The upshot for originators is that the documents created when embarking on the exercise of conducting a clinical trial may well render a later-filed method of treatment patent invalid.
Originators will need to carefully consider the timing of patent applications, having regard to:
- the risk that delay will lead to invalidity in Australia; and
- the risk that having insufficient data will lead to invalidity in Europe and other jurisdictions.
While the 12 month grace period applicable in Australia may assist in delaying patent filing a little, it may not provide sufficient time to obtain data and does not apply universally.
Infringement of Swiss style claims depends on what has been done, not what one intends to do
Swiss style claims (as their name suggests) originated in Europe and usually have the following general structure:
Use of compound X in the manufacture of a formulation for the treatment of medical condition Y.
It is common for patents directed to new medical uses to include conventional method of treatment claims (Use of X to treat condition Y) as well as Swiss style claims.
The Court’s findings
In this case, the relevant Swiss style claims related to the use of Lipidil to treat diabetic retinopathy. The Court upheld the primary judge’s finding that the claims were invalid for lack of novelty and / or inventive step. However, the Court held that the primary judge erred in reaching his findings on infringement (though the result was upheld in any event).
At first instance, the primary judge held that the critical question to ask on the question of infringement was ‘whether the manufacturer has made (or will make) the relevant medicament with the intention that it be used in the treatment of the designated condition’, and that this question should be determined objectively.
However, the Court disagreed and found that, since infringement arises from the taking of the essential features of the invention as claimed, ‘infringement of a Swiss type claim is concerned with what the allegedly infringing manufacturer has done, not what it intended to do’. In other words, it would be incorrect to address the question of infringement ‘by fixing on the manufacturer’s intention’ whether assessed objectively or subjectively. Instead, the only question that should be asked, directed to the characteristics of the manufactured product and having regard to all the circumstances, is:
“as the product of the claimed method or process, is the medicament for the specified therapeutic use?” (original emphasis)
Although no single consideration would be determinative of infringement, the Court found that the most important consideration lies in ‘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’.
The Court stressed that the mere evidence of suitability of a medicament for a claimed purpose cannot be determinative of infringement where the medicament is known to have multiple uses.
Having regard to the product in question and the product information (which did not expressly include the patented use), the Court held that the product in question did not infringe the Swiss style claims:
“In the present case, the product information for the Ranbaxy Products states the indications for which they are registered and thus, inferentially, the therapeutic purpose they serve as medicaments.”
The UK ‘outward presentation’ test
In the United Kingdom Supreme Court decision in Generics (UK) v Warner-Lambert Company LLC  UKSC 56 (Warner-Lambert), which the primary judge also cited, their Lordships considered the infringement of Swiss style claims for a second medical use of pregabalin (which were also found to be invalid). Although their Lordships held that the Respondent would not have infringed the claims had they been valid, they differed as to their reasons.
The majority (Lords Sumpton, Reed and Mance) adopted an ‘outward presentation test’, where the sole criterion of infringement was whether the final product, including the label and instruction leaflet as it emerged from the manufacturing process, is presented as being suitable for the patented uses.
While the Court reinforced that it does not construe Swiss style claims as including any requirement of ‘intention’, the test applied is similar to that developed in Warner-Lambert.
Upshot for originators and generic / biosimilar pharmaceutical companies
Swiss style claims appear to have limited utility in Australia. Enforcing standard method of treatment claims is likely to be far more effective. It is likely to be more difficult for alleged infringers to avoid infringement when faced with a claim that they have ‘reason to believe’ a product will be put to an infringing use under the infringement by supply provisions (s117(2)(b) of the Act).
In this case, Sun Pharma would have indirectly infringed Mylan’s method of treatment claims by virtue of section 117 had those claims been valid. That said, the primary judge found that he would, in those circumstances, have refused Mylan a permanent injunction. While the Court did not have cause to consider that aspect of the primary judge’s decision, patentees should carefully consider the impact of that finding.
NOTE: Mylan made an application for special leave to appeal to the High Court, which was rejected.
 Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd  FCAFC 116, , citing Bristol-Myers Squibb Company v FH Faulding & Company Limited 97 FCR 52 and Merck & Co Inc v Arrow Pharmaceuticals Ltd (2006) 154 FCR 31.
 Ibid, .
 Regeneron Pharmaceuticals Inc v Genentech inc  EWHC 657 (Pat) and Hospira UK Ltd v Genentech Inc  EWHC 1796 (Pat).
 Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd  FCA 28, .
 Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd  FCAFC 116, .
 Ibid, .
 Ibid, .
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