Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4)

In the Federal Court, Otsuka Pharmaceutical Co., Ltd. sought a declaration of non-infringement of a patent against Generic Health Pty Ltd. The patent related to a carbostyril compound, specifically aripiprazole, and its use in treating disorders of the central nervous system, including cognitive impairment in schizophrenia. The case involved a complex discussion of the interpretation and application of Swiss-type patent claims, whether these should be considered methods or processes, and the implications for infringement and validity.

The court had to determine several critical legal issues, including the interpretation of Swiss-type claims, the constitution of the person skilled in the art, and the applicability of the Saccharin doctrine to Swiss-type claims. It also needed to assess whether the patent met the requirements of novelty, inventive step, utility, and sufficiency, as well as whether the person skilled in the art could reasonably be expected to have combined certain prior art documents. Additionally, the court examined whether the second applicant had standing to sue for infringement, given their status as an exclusive licensee.

The court found that the patent claims were not properly characterised as Swiss-type claims and were instead method claims. It held that the team of the person skilled in the art should not be differently constituted based on the specific patent question. The court also determined that the Swiss-type claim could not be infringed by exploiting a medicament manufactured outside the patent area, consistent with the Saccharin doctrine. Regarding validity, the court found that the patent met the requirements of novelty, inventive step, utility, and sufficiency. The court concluded that the second applicant had standing to sue for infringement as an exclusive licensee.

The court ordered the parties to bring in draft orders by a specified date, and if they could not agree on costs, to provide written submissions and a draft order for the court’s consideration.