Merck Sharp & Dohme Corp. v Sandoz Pty Ltd

Merck Sharp & Dohme Corp. (MSD) appealed against the decision of the Full Court of the Federal Court of Australia (Full Court) in respect of the extension of the term of a patent. MSD argued that the Full Court had erred in its construction of sections 71(2)(b) and 77 of the Patents Act 1990 (Cth) (Patents Act). The dispute arose from the patent for the pharmaceutical substance sitagliptin/metformin, which MSD claimed was validly extended under the Patents Act. Sandoz Pty Ltd (Sandoz) and the Commissioner of Patents contested the validity of the extension, arguing that the term of the patent should not be extended beyond the original expiry date of 5 July 2022.

The central legal issue was the correct interpretation of sections 71(2)(b) and 77 of the Patents Act in relation to the extension of the term of the patent. MSD contended that the term of the patent should be extended based on the inclusion of sitagliptin/metformin in the Australian Register of Therapeutic Goods (ARTG), while Sandoz argued that the term should instead be calculated based on the earlier inclusion of sitagliptin in the ARTG. The court had to determine which interpretation of the statutory provisions was correct.

The court examined the language and purpose of the relevant provisions of the Patents Act. It considered the history and context of the legislation, including the reasoning in Pfizer Corp, to understand the legislative intent. The court found that the primary judge correctly interpreted the provisions to mean that the term of the extension should be calculated based on the earliest first regulatory approval date of any pharmaceutical substance satisfying the conditions in section 70(3) of the Patents Act. This led to the conclusion that the patent term was validly extended until 27 November 2023. The appeal was dismissed, and MSD was ordered to pay Sandoz’s costs of the appeal, subject to potential variation on further written submissions.