Federal Court of Australia
Federal Court of Australia
Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 Review of: Ono Pharmaceutical Co, Ltd et al [2020] APO 43
File number: VID 673 of 2020
Judgment of: BEACH J
Date of judgment: 11 June 2021
Catchwords: PATENTS – pharmaceutical substance per se – nivolumab – human anti-PD-1 monoclonal antibody – substance contained in goods being OPDIVO – application for extension of term of patent – ss 70, 71, 74 and 77 of Patents Act 1990 (Cth) – refusal of application by delegate of Commissioner of Patents – judicial review – s 5 of Administrative Decisions (Judicial Review) Act 1977 (Cth) – construction of ss 70 and 71 – literal construction – approval of third party product triggering start of clock for extension – absurd and unreasonable consequences – beneficial and remedial construction – approval of patentee product triggering start of clock – decision set aside
Legislation: Patents Act 1990 (Cth) ss 2A, 65, 70, 71, 74, 76A, 77, 191A, 223, sch 1, ch 6 pt 3 Patent Regulations 1991 (Cth) reg 6.8 Patents (World Trade Organization Amendments) Act 1994 (Cth) s 5 Intellectual Property Laws Amendment Act 1998 (Cth) s 3 Intellectual Property Laws Amendment Bill 1997 (Cth) Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Act 2018 (Cth) sch 1 pt 4 item 47 Intellectual Property Laws Amendment (Productivity Commission Response Part 2 and Other Measures) Act 2020 (Cth) sch 1 pt 1 item 4 35 US Code §156 Commonwealth, Parliamentary Debates, House of Representatives, 26 November 1997, 11274 to 11275 Commonwealth, Parliamentary Debates, Senate, 9 July 1998, 5330 to 5331 Explanatory Memorandum, Intellectual Property Laws Amendment Bill 1997 (Cth) Explanatory Memorandum, Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Bill 2018 (Cth) Final Government Response to the Industry Commission Report No. 51, The Pharmaceutical Industry (9 April 1997) Industry Commission Report No. 51, The Pharmaceutical Industry (3 May 1996) Productivity Commission Inquiry Report No. 78, Intellectual Property Arrangements (23 September 2016)
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