In October this year, the Parliamentary Secretary for Industry and Innovation announced a Review Panel to evaluate whether the system for pharmaceutical patents effectively balances the objectives of securing timely access to competitively priced pharmaceuticals, while fostering innovation and supporting research.
The Pharmaceutical Patents Review Panel Issues Paper which was released on 20 November, presents 11 questions which form the framework of the review. Of key interest is the review of the current extension of pharmaceutical term regime and whether this adequately serves the interests of both originators and generic manufacturers.
The Panel will also review issues related to data exclusivity provisions and copyright issues as they relate to Product Information (PI) documents. Data protection and copyright protection for PI documents has been the subject of judicial consideration in the past few years.
Question 1: Is the breadth of pharmaceutical patents eligible for an extension of term appropriate?
Question 2: Is the length of the extension of term provided for appropriate?
Question 3: Are the recent amendments to increase the thresholds for the grant of an Australia patent appropriate in the context of pharmaceuticals? If not, why not and what further changes are necessary?
Question 4: Do the systems for opposition and re-examination provide appropriate avenues for challenging the granting and validity of a pharmaceutical patent?
Question 5: Do interlocutory injunctions, as the law is currently applied, provide appropriate relief in cases involving pharmaceuticals?
Question 6: Is Australian law on contributory infringement appropriate in relation to pharmaceuticals?
Question 7: Are the current timeframes in which infringement proceedings must commence appropriate for pharmaceutical patents?
Question 8: Are follow-on patents being used to inappropriately extend protection for pharmaceuticals? If so, how? And, if they are, is this sound policy and what changes, if any, are needed?
Question 9: Is the law on data exclusivity appropriate?
Question 10: Are the laws on patent certificates appropriate?
Question 11: Are the laws on copyright of product information appropriate?
The public are invited to contribute to the review by commenting on the Pharmaceutical Patents Review's blog. Formal submissions are due by 21 January 2013, with the final report to be submitted to Government by 21 April 2013.
We will update you on progress and outcomes of the review.