Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd [2013] FCA 658

FEDERAL COURT OF AUSTRALIA

Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd [2013] FCA 658 Citation: Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd [2013] FCA 658

Parties: SPIRIT PHARMACEUTICALS PTY LIMITED (ACN 109 225 747) v MUNDIPHARMA PTY LIMITED (ACN 081 322 509), PURDUE PHARMA LP, MUNDIPHARMA LABORATORIES GMBH SPIRIT PHARMACEUTICALS PTY LIMITED (ACN 109 225 747) v COMMISSIONER OF PATENTS, MUNDIPHARMA PTY LTD (ACN 081 322 509), PURDUE PHARMA LP, MUNDIPHARMA LABORATORIES GMBH

File numbers: NSD 721 of 2010 NSD 1054 of 2010

Judge: RARES J

Date of judgment: 5 July 2013

Catchwords: PATENTS – validity of extension of patent under s 76 of Patents Act 1990 (Cth) – statutory construction – whether patented formulation was a "pharmaceutical substance per se" within the meaning of s 70(2)(a) of the Act – construction of patent – where patent claimed controlled release formulation containing one active pharmaceutical ingredient – meaning of "therapeutic use" – where two potential chemical interactions – whether only "therapeutic use" of invention achieved by active pharmaceutical ingredient or also by controlled release formulation – whether "drug" as used in s 76A of the Act affects the meaning of "pharmaceutical substance per se". PATENTS – validity of application for extension of term of patent under s 70(1) of the Patents Act 1990 (Cth) – where application for extension made by registered patentee having no beneficial interest in the patent – where applicant for extension had made unregistered assignment of patent to related company. JUDICIAL REVIEW – application for extension of time under s 11 of Administrative Decisions (Judicial Review) Act 1977 (Cth) – where decisions made by the Commissioner of Patents to accept application for extension of patent and many years later to refuse the application for rectification of the Register by removal of the extension – where person seeking rectification had previously had opportunity to oppose extension under s 75(1) of Patents Act 1990 (Cth) – where significant, unexplained delay in bringing challenge to Commissioner's decision to accept application for extension of patent. ADMINISTRATIVE LAW – Constitutional writ relief – discretion to grant where other appropriate relief available. Held: (1) formulation claimed in patent was a "pharmaceutical substance per se"; (2) registered patentee having no beneficial interest in patent entitled to apply for extension of patent; (3) extension of patent validly granted.