This is a guest post from Hazel Moir. Hazel’s submission can be viewed here.
I am concerned to read that the absymally low height of the inventive step will not be a primary focus of this review.
It is the very low “inventiveness” requirement for a patent that allows so many evergreening patents to accumulate.
Indeed outside the patent world, the inventiveness standard would be labelled ‘trivial difference” not inventiveness.
Governments have agreed generous monopoly arrangements for the inventors of new pharmaceuticals. Companies should not be allowed to seek unapproved extensions to this by adding a thicket of trivial variations around their core molecule. A proper height to the inventive step would prevent the grant of this thicket of trivial variation patents and thus ensure speedier access of generics to the market once the monopoly period has expired.
I urge the committee to consider recommending the adoption of the standard – a significant advance over what is known – as the standard for the height of the inventive step.
Hazel Moir
“… the abysmally low height of the inventive step will not be a primary focus of this review”
“… the very low “inventiveness” requirement for a patent that allows so many evergreening patents to accumulate”
“… outside the patent world, the inventiveness standard would be labelled ‘trivial difference” not inventiveness”
“Companies should not ...
... be allowed to seek unapproved extensions to this by adding a thicket of trivial variations around their core molecule”
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Dear me, somebody doesn’t like patents very much. It would be helpful if these assertions were supported by some empirical evidence.
Innovation in pharmaceuticals does not stop with the identification of a “core molecule”. That is the start. Because patent applications have to be filed before disclosure or exploitation begins, later inventions will almost inevitably occur in drug storage or delivery, new indications to be treated and target patient populations. To dismiss incremental innovation as “trivial differences” without considering each one on its own merits is to dismiss ongoing pharma research as meritless. Is IP Australia to determine which invention is worthy? Is IP Australia to pick winners?
The expression “evergreening patents” assumes only one model of pharmaceutical innovation – that a pharma patent holder is the only entity to carry out continuing research on new patented drugs. It ignores the discoveries in genomics, proteomics and all the other emerging “-omics” being made by outside researchers (including Australian researchers) that are finding new receptor sites that are specific to patients or to known molecules. These are as deserving of patents as the original core molecule.
The concept of open innovation is one that is being forced onto big pharma – whether they like it or not. And appropriability of new inventions for acquisition by companies able to develop and market them is a necessary step in open innovation. If patent eligibility is to stop at the “core molecule” then open innovation could mean giving big pharma a free lunch.
“Dear me, somebody doesn’t like patents very much. It would be helpful if these assertions were supported by some empirical evidence.”
Please read my submission to the committee where these “assertions” are fully documented using both case law and empirical data on granted standard patents.