Astrazeneca AB v Apotex Pty Ltd [2015] HCA 30: Patents: Lack of Inventive Step
Wednesday 2 September 2015 @ 12.04 p.m. | IP & Media | Trade & Commerce
In Astrazeneca AB & Anor v Apotex Pty Ltd; Astrazeneca AB & Anor v Watson Pharma Pty Ltd; Astrazeneca AB & Anor v Ascent Pharma Pty Ltd [2015] HCA 30 handed down today (2 September 2015), the High Court of Australia has, in a unanimous decision, found that a patent which disclosed a method of treatment for hypercholesterolemia was invalid because it lacked an inventive step within the meaning of subsections 7(2) and 7(3) of the Patents Act 1990 (Cth) (the Patents Act).
Background
In each appeal, the first appellant is the registered proprietor of the Australian patent numbered AU200023051 (the relevant patent) and the second appellant is the exclusive licensee of the relevant patent. The relevant patent disclosed as a method for the treatment of hypercholesterolemia through the administration of rosuvastatin and its pharmaceutically acceptable salts at a starting dosage range of 5-10 milligrams daily. The respondents in the case supplied generic compounds using rosuvastatin at like dosages.
The Legislation
Section 18(1)(b)(ii) of the Patents Act provided as a requirement for a patentable invention that the invention must involve an inventive step:
(1) Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:
(b) when compared with the prior art base as it existed before the priority date of
that claim:
(i) . . .
(ii) involves an inventive step; and
(c) . . .
Subsections 7(2) and 7(3) of the Patents Act provide a definition of the conditions which if satisfied mean that an invention would not be taken to involve an inventive step:
(2) Inventive step: For the purposes of this Act, 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 (whether in or out of the patent area) before the priority date of the
relevant claim, whether that knowledge is considered separately or together with the
information mentioned in subsection (3).
(3) The information for the purposes of subsection (2) is:
(a) any single piece of prior art information; or
(b) a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.
Relevant to the current matter was the condition in subsection 7(2) that an invention would have been obvious to a person skilled in the relevant art in light of the common general knowledge considered separately or together with prior art information publicly available in a single document before the priority date of the patent. Such a single document had to contain prior art information which could reasonably be expected to have been ascertained, understood and regarded by the skilled person, before the priority date, as relevant to work in the relevant art in the patent area.
Initial Trial and Appeals
The appellants commenced proceedings in the Federal Court of Australia (see Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162 (5 March 2013)) claiming an infringement of the relevant patent resulting from the supply of generic compounds using rosuvastatin as indicated above, and obtained interlocutory injunctions while the respondents sought revocation of the relevant patent.
Justice Jagot found the relevant patent to be invalid on the following three grounds:
- that the appellants were not entitled to the relevant patent;
- that the invention disclosed in the relevant patent was not novel in light of two prior art publications; and
- that the invention disclosed in the relevant patent did not involve an inventive step and was obvious within the meaning of subsection 7(2) of the Patents Act.
On appeal to the Full Court of the Federal Court of Australia (see AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 (12 August 2014)) the decision of Justice Jagot was only overturned with respect to the finding of a lack of novelty and dismissed the appeal from the primary judge's decision.
The appellants appealed to the High Court of Australia, seeking to argue all grounds of invalidity which had been upheld by the Full Court of the Federal Court and the respondents raised other issues by notice of contention.
The High Court Decision
A good summary of the application of the relevant statutes is at paragraph [61] in
Justice Kiefel’s judgment:
“Section 18(1)(b) of the Patents Act 1990 provides that an invention is patentable
if, so far as claimed in any claim, it is novel and involves an inventive step when
it is compared with the prior art base existing before the priority date of the claim.
In relation to deciding whether an inventive step was involved, "prior art base" is
defined in the Dictionary to the Act to mean information in a document that is publicly
available and information made publicly available through doing an act. However, section
7(2) makes plain that, subject to the effect of the provisions of section 7(3), what
is spoken of as the prior art base in the assessment of an inventive step is the common
general knowledge, which is to say, the general body of knowledge and experience which
is available to all those who might consider making a new product or improving existing
products in order to meet an identified need.”
The High Court unanimously dismissed the appeals on the basis that the invention claimed lacked an inventive step and was obvious in light of the common general knowledge together with either of the two prior art publications considered separately; and having so found, held that it was unnecessary to consider the other ground of invalidity and issues raised in the notice of contention.
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Sources:
AstraZeneca AB v Apotex Pty Ltd; AstraZeneca AB v Watson Pharma Pty Ltd; AstraZeneca AB v Ascent Pharma Pty Ltd [2015] HCA 30 2 September 2015 (Judgment and Summary)
AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 (12 August 2014)
Apotex Pty Ltd v AstraZeneca AB (No 4) (includes Corrigendum dated 8 March 2013) [2013] FCA 162 (5 March 2013)
