Generic Health Pty Ltd v Otsuka Pharmaceutical Co., Ltd & Ors

Generic Health Pty Ltd (Generic Health) sought to introduce a generic version of Otsuka Pharmaceutical Co., Ltd's (Otsuka) drug, Abilify, which is used to treat schizophrenia and bipolar disorder. Otsuka held Australian Patent No. 2003203432 (the patent) for the active ingredient aripiprazole, and also held a registration for Abilify as a registered medicinal product. Generic Health commenced proceedings in the Federal Court of Australia seeking declarations that its proposed generic product did not infringe the patent and that the patent was invalid. Otsuka counterclaimed for infringement.

The primary legal issues before the Full Federal Court were whether Generic Health's proposed product infringed Otsuka's patent, and if so, whether the patent was invalid on the grounds of lack of novelty or obviousness. Specifically, the court had to consider whether the claims of the patent, as construed, covered the active ingredient in Generic Health's proposed pharmaceutical product.

The Full Federal Court, in allowing Otsuka's appeal from the primary judge's decision, found that Generic Health's proposed product did infringe the patent. The court construed the relevant patent claims in a manner that encompassed the active ingredient of Generic Health's product. The reasoning focused on the interpretation of the patent claims and the scope of protection afforded by them, applying established principles of patent claim construction. The court determined that the primary judge had erred in their construction of the patent claims.

Consequently, the Full Federal Court set aside the primary judge's orders and declared that Generic Health's proposed product infringed Otsuka's patent. The court also dismissed Generic Health's cross-claim for a declaration of invalidity.