Astrazeneca AB v Apotex Pty Ltd; Astrazeneca AB v Watson Pharma Pty Ltd; Astrazeneca AB v Ascent Pharma Pty Ltd

The High Court has unanimously dismissed an appeal from a decision of the Full Federal Court relating to novelty and the inventive step in s 7 of the Patents Act 1990 (Cth). Astrazeneca holds the patent relating to a method of treating high blood cholesterol using a compound called rosuvastatin, marketed under the drug name Crestor. The respondent drug companies produce and sell generic rosuvastatin products that have low dosages of the drug, combined with an inorganic salt, to treat generic cholesterol conditions. The FCAFC upheld the first instance judge’s conclusion that Astrazeneca’s patent was invalid on the basis that it was invented by another company, the manner of manufacture was not disclosed, and that it did not involve an inventive step (that is, that rosusvastatin had already been invented).

In four separate judgments (French CJ, Kiefel J, Gageler and Keane JJ, and Nettle J), the Court unanimously dismissed the appeal, holding that the invention as claimed lacked an inventive step because it did not pass the obviousness test. Astrazeneca’s failure on this first ground of appeal meant it was not necessary for the Court to rule on the other grounds of appeal. Section 7(2) states that

an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed … before the priority date of the relevant claim, whether that knowledge is considered separately or together with the [prior art] information mentioned in subsection (3).

French CJ held that no error could be found in Jessup J’s reasoning (with whom the rest of the FCAFC agree on the ‘obviousness’ point) supporting the conclusion that the invention in the patent would have been obvious to a skilled person in light of the common general knowledge and the relevant scientific literature (see at [40][47]). Kiefel J likewise dismissed Astrazeneca’s arguments on obviousness, holding that those contentions elided the separation in ss 7(2) and 7(3) between the test of obviousness and the documents relevant for that test (at [82][85]), and rejecting the argument that the expert evidence must show which of the alternative routes to the invention the hypothetical skilled person must take (see at [86][95]). Gageler and Keane JJ agreed with the reasons of French CJ and Kiefel J, making additional comments on the ‘lack of merit’ in the appellants’ challenges throughout the appeals. Nettle J likewise agreed with the reasoning of French CJ and Kiefel J adding brief remarks on the meaning of ss 7(2) and 7(3).

High Court Judgment [2015] HCA 30 2 September 2015
Result Appeal dismissed
High Court Documents Astrazeneca
Full Court Hearings [2015] HCATrans 107 14 May 2015
[2015] HCATrans 106  13 May 2015
Special Leave Hearing [2015] HCATrans 58 13 March 2015
Appeal from FCAFC [2014] FCAFC 99 12 August 2014
Trial Judgment, FCA
[2013] FCA 162 5 March 2013
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About Martin Clark

Martin Clark is a PhD Candidate and Judge Dame Rosalyn Higgins Scholar at the London School of Economics and Political Science and Research Fellow at Melbourne Law School. He holds honours degrees in law, history and philosophy from the University of Melbourne, and an MPhil in Law from MLS. While at MLS, he worked as a researcher for several senior faculty members, was a 2012 Editor of the Melbourne Journal of International Law, tutor at MLS and various colleges, a Jessie Legatt Scholar, and attended the Center for Transnational Legal Studies Program.