AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99

FEDERAL COURT OF AUSTRALIA

AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 Citation: AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99

Appeal from: Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162

Parties: ASTRAZENECA AB and ASTRAZENECA PTY LTD (ABN 54 009 682 311) v APOTEX PTY LTD (ACN 096 916 148) ASTRAZENECA AB and ASTRAZENECA PTY LTD (ABN 54 009 682 311) v WATSON PHARMA PTY LTD (ACN 147 695 225) ASTRAZENECA AB and ASTRAZENECA PTY LTD (ACN 009 682 311) v ASCENT PHARMA PTY LTD (ACN 118 734 795)

File numbers: NSD 603 of 2013 NSD 604 of 2013 NSD 605 of 2013

Judges: BESANKO, JESSUP, FOSTER, NICHOLAS AND YATES JJ

Date of judgment: 12 August 2014

Catchwords: PATENTS – entitlement – whether appellants solely entitled to patent – where a person other than the patentee discovers compound – where that person conducts Phase I and early Phase II clinical trials which showed beneficial results in terms of reduction of lipid levels and tolerance by humans – where that person licenses compound to patentee which then conducts further clinical trials – whether phrase "[a] method of treating" implies a particular level of efficacy and safety achieved by the claimed invention. PATENTS – inventive step – "starting point" issue – whether valid patent may be obtained for invention compromising solution to problem where solution is obvious but problem is neither common general knowledge nor s 7(3) information – whether permissible to attribute knowledge of problem to hypothetical person skilled in the art on the basis of the inventor's "starting point" as identified in complete specification – Patents Act 1990 (Cth) ss 7(2), 7(3) and 18(1)(b)(ii). PATENTS – inventive step – whether inventive step to be tested against any information made publicly available in a single document in or out of the patent area irrespective of whether the information is common general knowledge or s 7(3) information – construction of s 7(2) – Patents Act 1990 (Cth) ss 7(2), 7(3) and 18(1)(b)(ii). PATENTS – priority date – amendment – whether patent date deferred by subsequent amendment – whether unamended specification contains real or reasonably clear disclosure of what was claimed as a result of amendments – where amendment said to narrow scope of claims – separate claims – whether specification defines more than one form of the invention – where a number of variants within the scope of invention as defined – Patents Act 1990 (Cth) ss 43(3), 114(1) – Patent Regulations 1991 (Cth) reg 3.14. PATENTS – novelty – anticipatory disclosure – whether prior art disclosures sufficient to disclose invention claimed in disputed patent – application of reverse infringement test – distinction between prior art information and common general knowledge – permissible use of common general knowledge in determining anticipation – whether implicit disclosure may constitute sufficient prior disclosure – Patents Act 1990 (Cth) ss 7(1), 18(1)(b)(i). PATENTS – manner of manufacture – method of treatment – whether method of treatment of human body is a manner of manufacture – inventiveness – whether manner of manufacture exhibits requisite quality of inventiveness – whether inventiveness of method of manufacture to be assessed by reference only to what is disclosed on the face of the specification – whether findings on obviousness or inventive step relevant to inventiveness in method of manufacture – Patents Act 1990 (Cth) s 18(1)(a). PATENTS – fair basis – whether claimed invention fairly based on disclosure in specification – Patents Act 1990 (Cth) s 40(3). PATENTS – infringement – whether consumers induced to engage in infringing use – whether respondents had reason to believe consumers would engage in infringing use – relevance of number of consumers who may engage in infringing use – whether compound the subject of the invention a "staple commercial product" – Patents Act 1990 (Cth) s 117. PRACTICE AND PROCEDURE – application to amend notices of appeal – discretion to refuse application – where application to incorporate ground of appeal based on amendments to Patents Act 1990 (Cth) relating to revocation of a patent granted to a person not entitled to it – introduction of s 22A – whether any useful purpose served by allowing amendment of notices of appeal where patent invalid on other grounds. STATUTORY INTERPRETATION – amendment to Patents Act 1990 (Cth) – transitional provision – where amendment to introduce s 138(4) applies relevantly to an application for revocation order on or after specified date – whether an appeal against decision at first instance includes an application for revocation order – Patents Act 1990 (Cth) s 138(4) – Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) Sch 6, Item 133(14).