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.