H. Lundbeck A-s & Anor v Sandoz Pty Ltd; CNS Pharma Pty Ltd v Sandoz Pty Ltd

The Full Federal Court of Australia heard appeals in two related proceedings: *H. Lundbeck A-s & Anor v Sandoz Pty Ltd* and *CNS Pharma Pty Ltd v Sandoz Pty Ltd*. The dispute concerned allegations of patent infringement and invalidity relating to pharmaceutical products. Lundbeck and CNS Pharma (the appellants) alleged that Sandoz Pty Ltd (the respondent) had infringed their patents by manufacturing and supplying generic versions of vortioxetine, an antidepressant medication. Sandoz denied infringement and sought to invalidate the patents.

The central legal issues before the Full Federal Court were whether Sandoz had infringed the asserted claims of the Lundbeck patents, and if so, whether those claims were valid. Specifically, the court had to consider the scope of the patent claims, the doctrine of equivalents, and the requirements for inventive step and novelty in relation to the pharmaceutical compounds and their uses. The appeals also involved questions regarding the proper construction of patent specifications and the assessment of evidence in patent litigation.

The Full Federal Court's reasoning focused on a detailed analysis of the patent claims and the prior art. The court applied established principles of patent law, including the approach to claim construction as set out in cases such as *Improver Corp v Remington Consumer Products Ltd* and the requirements for inventive step under the *Patents Act 1990* (Cth). The court found that Sandoz's products did not fall within the literal scope of the asserted claims, nor did they infringe under the doctrine of equivalents. Furthermore, the court considered arguments regarding the validity of the patents, including whether the inventions were obvious in light of the prior art.

The Full Federal Court allowed the appeals in part, setting aside the primary judge's findings of infringement and upholding the validity of the patents in question. The court's orders reflected its findings on the infringement and validity issues, ultimately determining the rights of the parties in relation to the vortioxetine patents.