Aktibolaget Astra v Biogen Inc

The dispute before the Full Federal Court of Australia concerned the validity of Australian Patent No 730000 (the patent) held by Aktibolaget Astra (Astra) and its alleged infringement by Biogen Inc (Biogen). Astra alleged that Biogen's product, a biosimilar of natalizumab, infringed its patent. Biogen counterclaimed for revocation of the patent on the grounds of lack of novelty and inventive step.

The primary legal issues before the Full Federal Court were whether the patent was valid, specifically whether it possessed novelty and an inventive step over the prior art, and if valid, whether Biogen's biosimilar product infringed the patent claims. The court was required to consider the scope of the patent claims and compare them with the prior art and Biogen's product.

The Full Federal Court upheld the primary judge's finding that the patent was invalid for lack of inventive step. The court found that the prior art disclosed a genus of antibodies that encompassed the antibody claimed in the patent. While the patent claimed a specific antibody within that genus, the court determined that the selection of this particular antibody was obvious to a person skilled in the art, given the disclosures in the prior art and the predictable nature of antibody development. Consequently, the patent was found to be invalid, and therefore, no infringement could occur.