On 2 September 2015, the High Court handed down a decision in the long-running AstraZeneca v Apotex battle, dismissing AstraZeneca’s appeal and finding the patent claims of its Australian CRESTOR (rosuvastatin) patent invalid for lack of inventive step.
The decision is consistent with the appealed Full Federal Court decision and has been described as a “conventional” decision. However, it is also significant in that, to date, invalidating a patent for lack of inventive step has been very difficult due to the somewhat convoluted requirements of the inventive step provisions under the Australian Patents Act (the Act). This has applied to both opposition process and litigation in the courts.
What does this decision mean for patent applicants in Australia?
In summary, on a practical level, the decision clarifies that the inventive step of an Australian patent will be considered in reference to “relevant prior art information”, as it existed at the priority date, in light of the “common general knowledge” of the person skilled in the art. The decision clearly highlights that it is not permissible for an Examiner or the Court to use information from the body of the patent specification to determine inventive step when that information does not form part of the common general knowledge of a skilled person and is not disclosed in the prior art information. The information in the body of the specification may be used in considering the inventive step of a patent if it is, in fact, disclosed in a prior art document or part of common general knowledge of a skilled person in the field.
The High Court Decision
The High Court decision confirmed that:
(i) Different prior art documents may be considered separately as long as they meet the threshold requirement (“ascertained, understood and regarded as relevant”)(for patent applications filed before the Raising the Bar Amendments came into force in 2013).
(ii) “The skilled person may well sort through all manner of information with a view to finding something that is regarded as relevant” and section 7(3) “places no embargo on the skilled person using combinations of sources of information”.
(iii) It is not permissible to use information from the body of the specification to determine inventive step when that information does not form part of the CGK and is not disclosed in any prior art document falling within the scope of section 7(3) of the Act.
This decision is considered a “sensible” and “conventional” decision from the High Court regarding the interpretation of sections 7(2) and 7(3) of the Act. Although the “ascertained, understood and regarded as relevant” restriction on prior art documents has now been removed from the Patents Act, there are still a considerable number of patents prosecuted and granted under the previous Act to which these interpretations will apply.
See the link to our full article for a more detailed discussion of the case.
by Sarah Herbert
