Clinical trial roulette: Patenting pharmaceuticals in Australia is now a game of chance

• Published date: 06 September 2021
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Spruson & Ferguson
• Author: Dr. James Beckett, Brendan Nugent and Doug Horton

While the case of Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd¹ ('Mylan v Sun Pharma') was decided a little over a year ago, some of the repercussions of the decision are only starting to become apparent. We have become aware of Examiners raising objections, based on Mylan v Sun Pharma, that entries in websites reporting clinical trial activity are novelty destroying. Of most concern is the situation where the patent applicant's proposal for clinical trials is cited against their own patent application. This means that inventors of pharmaceutical products and methods must very carefully consider and balance the need to publish details of their own research proposal, which often must be made public for reasons discussed in this article, with the ability to validly seek patent applications in Australia and internationally. For inventors that cannot file for patent protection prior to commencing clinical trials, this results in a game of chance, where they gamble on whether an Examiner will find the publication of their clinical trial protocol and consider it to be relevant during examination.

Mylan v Sun Pharma case summary

Mylan v Sun Pharma is well known for the finding that Swiss-style claims require 'objective intention' on the part of the manufacturer in order to establish infringement (as reported in our previous article). However, to date, little attention has been given to invalidity in the light of a publication of a report of a clinical trial.

In the first instance,² Mylan sued Sun Pharma over the marketing of a number of fenofibrate drugs, which Mylan alleged infringed three of their existing patents (AU 731964, AU 2003301807 and AU 2006313711, 'the 711 Patent'). As part of the proceedings, the trial judge held that the method of treatment claims in suit in the 711 patent were not novel in light of the publication of The Accord Eye Study Protocol (the ACCORD protocol). The ACCORD protocol hypothesised that daily doses of 160mg of fenofibrate could be used to treat diabetic retinopathy, a regimen which later became the subject of method of treatment claims in the 711 patent.

On appeal, Mylan argued that this amounted to nothing more than a reasoned hypothesis for a possible treatment. However, the Full Federal Court upheld the decision, stating:

'We do not accept that a documentary disclosure containing an hypothesis cannot be an anticipatory disclosure that deprives an invention of novelty. In such a case the question, simply put, remains: what does the prior document disclose?' [I]f, as a matter of interpretation, the document nonetheless discloses that which is later claimed as an invention, that disclosure will anticipate the invention and deprive it of novelty.'

The Court remained unconvinced by Mylan's submissions that a prior art document must show that the therapeutic effect is achieved in order to be anticipatory. These submissions were based on two UK decisions (Regeneron Pharmaceuticals Inc v Genentech Inc [2012] EWHC 657 (Pat) and Hospira UK Limited v Genentech Inc [2015] EWHC 1796 (Pat); [2016] RPC 1). However, this argument was dismissed on the grounds that the UK cases proceeded on the case law of the Boards of Appeal of the European Patent Office, and that in contrast, the principles developed under Australian case law impart no requirement of therapeutic success.

The problem with publication

The difficulty with the position reached in Mylan v Sun Pharma is that...