Ono Pharmaceutical Co, Ltd v Commissioner of Patents

In the case of Ono Pharmaceutical Co, Ltd v Commissioner of Patents, the central dispute involved an application for an extension of the term of a patent held by Ono Pharmaceutical Co, Ltd. The Commissioner of Patents had refused the application, leading to a judicial review under the Administrative Decisions (Judicial Review) Act 1977 (Cth). The Federal Court of Australia was tasked with determining the correct interpretation of sections 70 and 71 of the Patents Act 1990 (Cth), which govern the extension of patent terms. Specifically, the court had to decide whether the term extension should commence upon the approval of a third-party product containing the patented substance or if it should commence upon the approval of the patentee's own product.

The primary legal issues centered around the interpretation of the statutory provisions and whether the literal construction of the text led to an absurd or unreasonable outcome. The Commissioner argued that the term should start with the approval of any product containing the patented substance, which would be a third-party product in this instance. Conversely, the applicant contended that the term should only begin upon the approval of their own product. The court considered whether the literal interpretation of the statutes led to unreasonable outcomes and whether a more beneficial and remedial construction was possible. The court also examined whether the term extension regime was intended to be restricted to new and inventive substances and whether the patented substance, nivolumab, qualified as such.

The court found that the Commissioner's interpretation, which hinged on the approval of a third-party product, led to absurd and unreasonable consequences. It was concluded that the ordinary meaning of the statutory text did not support this interpretation and that the applicants' construction avoided such outcomes. The court acknowledged that while the delegate's interpretation was understandable given the statutory text and existing precedents, it was not the preferable one. The decision to set aside the Commissioner's refusal of the term extension application was based on the court's finding that the statutory interpretation adopted by the Commissioner was not supported by the text and led to manifest absurdity or unreasonableness. The court granted the application for an extension of the patent term.

The court issued orders setting aside the decision of the delegate, granting the application for an extension of the term of the patent, and outlining a process for the parties to submit further submissions on consequential orders and costs. The applicants were given seven days to file and serve their submissions, followed by the Commissioner's response within seven days of receiving the applicants' submissions. The court also granted liberty to apply for further orders as necessary.