Pharmacia LLC v Juno Pharmaceuticals Pty Ltd

Pharmacia LLC sued Juno Pharmaceuticals Pty Ltd for patent infringement, validity, and relief in the Federal Court of Australia. The dispute centred on a standard patent for a reconstitutable powder composition containing a cyclooxygenase-2 inhibitor intended for parenteral administration. Juno Pharmaceuticals manufactured and sold a competitor product, leading to the infringement claim. The validity of the patent was challenged on several grounds, including lack of inventive step and clarity. The court had to determine whether Juno Pharmaceuticals' products infringed the patent claims and whether the patent was valid.

The court addressed several legal issues, including the interpretation of terms such as "about," "therapeutic agent," and "essentially" in the patent claims. It also considered whether the claims included or excluded residual water from the composition and whether the omnibus claim was infringed. Regarding validity, the court assessed whether there was a lack of inventive step and clarity in the patent claims. The hypothetical skilled team's approach to formulating the composition was also examined.

The court found that three batches of Juno Pharmaceuticals' products fell within the scope of the asserted claims, while the other three did not. It rejected the challenges to the validity of the claims, including the lack of inventive step and clarity. The court determined that Pharmacia LLC was entitled to injunctive relief to restrain infringement, considering the patent's impending expiration.

The court's detailed analysis included the examination of expert evidence, the hypothetical skilled team's approach, and the properties of the active pharmaceutical ingredient (API) and excipients. It concluded that the claims were clear and that the hypothetical skilled team would have reasonably arrived at the claimed invention. The injunctive relief was deemed appropriate to prevent prejudice to the proper administration of justice.