Springboarding allowed for all pharmaceutical patents!
It is no longer an infringement of a pharmaceutical patent to exploit a pharmaceutical solely for purposes connected with obtaining inclusion in the Australian Register of Therapeutic Goods of goods that are intended for therapeutic use; or for obtaining similar regulatory approval under a law of a foreign country or of a part of a foreign country.
A pharmaceutical patent is one that claims a pharmaceutical substance, a method, use or product relating to a pharmaceutical substance. This includes a method for producing a raw material needed to produce the substance, a product that is a raw material needed to produce the substance; and a product that is a pro-drug, metabolite or derivative of the substance. It does not apply to patents for medical or therapeutic devices.
Proposed single drug registration body for Australia and New Zealand
The Australian and New Zealand Governments have agreed to establish a harmonised model for the scheduling of medicines for Australia and New Zealand. The joint regulatory scheme will be administered in both countries by a single, binational authority, the Australia New Zealand Products Authority (ANZTPA). ANZTPA will replace the Therapeutics Goods Authority (TGA) in Australia and the Medicines and Medical Devices Safety Authority (Medsafe) in New Zealand and will be accountable to both the Australian and New Zealand Governments.
Under the new scheme, there will be only one licence per product in contrast to the current requirement for separate registration in each country, which raises questions as to who should apply for and hold the ANZTPA licence.
Extended infringement remedy for patentees
For the first time, the Patents Act provides for exemplary damages whereby the court may include an additional amount in an assessment of damages for an infringement of a patent.
In deciding the quantum of the additional damages, the court will have regard to the flagrancy of the infringement; the need to deter similar infringement of patents; the conduct of the infringing party after the infringing act or after the party was informed that it was infringing; and/or any benefit accrued to the party because of the infringement.
For further information concerning the above, please contact Jenny Petering email@example.com, Paul Kilborn firstname.lastname@example.org or any of the other practitioners of FB Rice & Co via our website at www.fbrice.com.au.
The information contained in this email is provided for informational purposes only and does not represent legal advice. Neither the APLF nor the author intends to create an attorney client relationship by providing this information to you through this message.
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