Novartis AG v Pharmacor Pty Limited (No 3)

Novartis AG sought to enforce a patent against Pharmacor Pty Limited for alleged infringement. The central dispute involved the interpretation and validity of the claims in a standard patent concerning a pharmaceutical composition with specific active pharmaceutical ingredients. The Federal Court of Australia was tasked with determining whether the patent claims covered certain pharmaceutical compositions and if they were valid and infringed. The court had to construe the claims to ascertain their scope, determine whether the claimed invention was properly disclosed in the patent specification, and assess the validity of the patent by examining the inventive step and sufficiency of disclosure.

The legal issues encompassed the proper construction of the patent claims, particularly whether they extended to pharmaceutical compositions where the active pharmaceutical ingredients were in the form of a complex with ions associated by non-covalent bonds. The court also had to identify the relevant person skilled in the art, considering whether this person should be viewed as an individual or a team, and evaluate whether the skilled person could reasonably have identified and considered relevant prior art. The court further needed to decide if the invention lacked an inventive step and if the patent term extension was validly granted, warranting rectification of the Register of Patents.

In its reasoning, the court determined that the claims were properly construed and did not cover the specific pharmaceutical compositions at issue. The court held that the person skilled in the art should be understood as a team, incorporating collective knowledge and expertise. It found that the prior art was not sufficiently identified and considered by the skilled person, which did not establish a lack of inventive step. The court also concluded that the patent term extension was validly granted, and there was no basis for rectifying the Register of Patents. Consequently, the patent was found to be valid, and no infringement occurred.

The final orders required the parties to submit agreed or competing draft orders by a specified deadline to implement the court's decision.