Clinical Trial Disclosures A Significant Risk To Patent Validity In Australia

• Published date: 09 August 2022
• Subject Matter: Intellectual Property, Patent
• Law Firm: Davies Collison Cave
• Author: Ms Claire Gregg and Alex Tzanidis

We recently published in Australasian Biotechnology (and on our website) on the nexus between IP and clinical trials in Australia, in which we highlighted the importance of balancing the timing and content of a patent application with the potential for novelty-destroying clinical trial disclosures and the need for supporting data. The recent Patent Office decision in Astellas Pharma Inc. v Aragon Pharmaceuticals, Inc. [2022] APO 36 (Astellas) further emphasises the importance of filing a patent application before publishing clinical trial information in Australia, where even untested hypotheses can put method of treatment and Swiss-style claims at risk of invalidity.

Background

The claims at issue in Astellas were directed to methods of treating non-metastatic castration-resistant prostate cancer (nmCRPC) by administering either apalutamide (ARN-509) or enzalutamide (MDV3100) in combination with a gonadotropin releasing hormone agonist or orchiectomy (collectively referred to as androgen deprivation therapy or ADT). The specification included the results of a phase II clinical trial in which men with nmCRPC were administered apalutamide. Relevantly, the specification did not explicitly state that those trial participants were also receiving ADT.

Several prior art documents were cited relating to apalutamide and enzalutamide clinical trials in patients with nmCRPC. The applicant argued that those documents also did not...