IP SPOTLIGHT 20 APRIL 2020

LITIGATION – AUSTRALIAN IP COURTS, ARE FIGHTING ON.

DOSAGE REGIMENS IN AUSTRALIA … STILL PATENTABLE!

While Courts around the world are closing because of COVID-19, Australian Courts are finding new ways to assist practitioners in virtual hearings. On 2 April 2020, the Federal Court of Australia published a guide to its view of virtual court proceedings and how they will operate.

Dosage regimen patent claims are very much alive in Australia, and given their potential value, they should still form part of any IP strategy for a pharmaceutical product. Patents to approved dosage regimen are a valuable method for capturing infringement, and such patents often provide valuable extended franchise life. The advantages of having a patent to the approved dosage regimen are obvious in terms of demonstrating infringement, and such patents often provide valuable extended franchise life. According to some reporting, the approach of the UK Supreme Court in Lilly v Actavis [2017] UKSC 48 (which concerned the dose of the erectile dysfunction drug CIALIS® (tadalafil)) has thrown the inventiveness of dosage regimen patents per se into doubt in the UK. Of course, that decision needs to be read in the context of the invention at issue, which was directed to one of the first approved doses. For example, in our view, the Court’s reasoning would not

encompass an invention directed to a dosage regimen developed after the initial marketed dose, such as a lower dose that showed acceptable efficacy with lower side effects, or perhaps a less frequent dosage regimen. Further, in Australia at least, the patentability of the first marketed dose will turn on the facts. The High Court in the CRESTOR® (rosuvastatin) case ( AstraZeneca v Apotex [2015] HCA 30) invalidated a dosage patent where the claimed dose was the same as other statins already on the market. However, in the Australian equivalent of the CIALIS® case mentioned above ( Apotex v ICOS (No 3) [2018] FCA 1204), dosage claims broader than those invalidated by the UK Supreme Court were found to be inventive based on evidence regarding the design of the necessary dose ranging study. Dosage regimen claims are very much alive in Australia, and given their potential value, they should still form part of any IP strategy for a pharmaceutical product.

In particular, the Courts have set up virtual hearings by sharing a video link provided by the Court through Microsoft Teams. At first, we were sceptical about this approach, but having now been part of this process, it is not hard to see that the new norm may well reshape many aspects of appearing in court. When you join a virtual hearing you will see that while the parties might be in different places, the Court process does not really change. Participants register in advance with the Judges’ Associate. and the Associate will generally test the system well in advance of the hearing. Participants are prohibited from making a record or a transcript of the hearing and are expected to dress appropriately, be in a quiet and secure location, and have good Internet. In short, it is business as usual.

GARY COX Chairman & Principal

TODD SHAND Principal

2 | wrays.com.au

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