Astellas Pharma Inc. v Aragon Pharmaceuticals, Inc

In the matter of Astellas Pharma Inc. v Aragon Pharmaceuticals, Inc, the Australian Federal Court considered the validity of several patent claims relating to the treatment of non-metastatic castration resistant prostate cancer with second generation anti-androgens. The primary issue was whether the claims were novel, given the prior art, and if they were clear and supported by the specification. The opposition argued that the claims lacked novelty and were not clear or supported, while the applicant, Astellas Pharma Inc., defended the validity of the claims.

The court found that the claims for apalutamide and enzalutamide were not novel, as they were implicitly disclosed in the prior art. The court noted that the prior art described the use of second generation anti-androgens in treating castration resistant prostate cancer, which included non-metastatic forms. The opposition successfully demonstrated that the skilled reader would have understood the use of these drugs for non-metastatic castration resistant prostate cancer based on the prior art. Additionally, the court determined that all claims were clear and adequately supported by the specification.

As a result of the findings, the opposition succeeded on the grounds of lack of novelty for claims 1-16, 22-31, and 33-35. The court granted Aragon Pharmaceuticals, Inc. one month to file amendments to the patent claims under subsection 60(3B) of the relevant legislation. The court also awarded costs to Aragon Pharmaceuticals, Inc. in accordance with Schedule 8.