One of the issues in the terms of reference concerns the extension of a pharmaceutical patent for up to 5 years. There appear to be a number of matters of interest in this part of the review. The first is whether or not pharmaceutical patents ought to be able to be extended. This right does not apply in all countries. It derives from the length of time it takes to get government regulatory approval for pharmaceuticals, a process which is not applicable to the commercialisation of other patents. Another matter is the length of the extension. In some jurisdictions it is longer, in others it is shorter.
Another issue is the conditions or protections attached to the extension. The rights during the extended term are not identical to the rights of the standard 20 year patent term. During the term of extension, the patent owner’s rights are limited to therapeutic use of the patented pharmaceuticals in humans. Using the pharmaceutical for a non-therapeutic purpose does not infringe the patent owner’s rights during that part of the term which has been extended. For example, making and selling a substance for veterinary use during the extended term is not an infringement. Using the pharmaceutical solely for regulatory approval is also not an infringement. So should the rights be as wide as the original patent or even narrower than is currently allowed in Australia?
The terms of reference also require some analysis of the extension facility and the review is looking for evidence which it can use to inform the government on the implications of the policy.
In short, is the current policy the right one? The issues paper provides further information regarding extension of term provisions.
Tony Harris
Isn’t it a question of why there was delayed marketing approval. If it was caused by the patent-holding company (through provision of inadequate adat to the regulator) why should it be rewarded with five extra years. The extension period should be restricted with respect to 1) compulsory licences–should be easier ...
... and the amount of reimbursement less 2) stricter supervision of anti-competitive practices 3) facilitation of export under patent during this period (allow generic mfg in Australia for sale overseas where patent has expired). Need for company to bear the onus of proof in establishing it did not contribute to the excessive regulatory delay
Thanks Thomas,
I’ll look forward to what beneficiaries of the current patent extensions say to your proposal regarding inadequate submissions to the regulator.
On your comment that the patent extension should come with “stricter supervision of anti-competitive practices”, can you be more specific? Patents are inherently anti-competitive – that’s their ...
... point. They are (time-limited) monopolies. So how would you propose to restrict ‘anti-competitive practices’ during the patent protection period?
Should any term extension exclude the right to prevent production for export to markets where the patent has already expired? There doesn’t seem any good reason why delayed relugatory approval for sale in Australia should apply to production for sales overseas.