Pharma Patents Review Releases Issues Paper, Launches Blog

On 21 November 2012 the Australian Government’s Pharmaceutical Patents Review panel released a ‘Background and Suggested Issues Paper’ [PDF, 609kB], which outlines the panel’s initial impressions of the key issues for the review.  This review was originally announced by the Parliamentary Secretary for Industry and Innovation, Mark Dreyfus QC, on 15 October 2012 (see Yet Another Patent System Review – Pharmaceutical Patents).

According to the panel’s announcement, the paper seeks to ‘begin engaging with anyone who has an interest in this area [i.e. pharmaceutical patents] and to provide a stimulus for written submissions.’

The paper includes a number of specific questions, however it is said said that these are intended only to provide ideas for developing submissions.  The panel is seeking a broad spectrum of views, and does not want anyone to feel constrained by its suggested questions!

There are two aspects of the announcement which we find quite interesting, at least from our own personal perspective.  Firstly, the review does not merely have a web page – as is now absolutely standard – but has set it up as a blog at pharmapatentsreview.govspace.gov.au.  The panel intends to use the blog to explore the relevant issues with stakeholders, and interested parties will be able to interact directly with the panel throughout the review process by commenting on individual posts (including the announcement of the issues paper itself).

Secondly, Patentology’s article Pharmaceutical Extensions of Term: Is It Time for a Fix? is cited in the issues paper (footnote 20), which came as a pleasant surprise!

Written submissions are due by 5pm on 21 January 2013.  This is actually quite a tight deadline, considering that the month between Christmas and the end of January is the main summer vacation period for many Australian stakeholders.

TERMS OF REFERENCE

The review has a particular focus on whether the provisions enabling the term of a pharmaceutical patent to be extended for up to five years, as compensation for time lost in obtaining regulatory approval, are striking an appropriate balance.  The current extension of term regime was introduced in 1998, with the intention that it be reviewed after periods of five and ten years.  It has now been 14 years, so this aspect of the current review is long overdue!

Additionally, the panel has been charged with considering a wide range of issues relating to the role of patents in the pharmaceutical and healthcare industries, including:

1. issues that impact on competition in the pharmaceutical industry, for example, the ability of generic medicines to enter the market;
2. issues around fostering innovation and bringing new pharmaceuticals to market;
3. the importance of the patent system in providing employment and investment in research and industry;
4. the impact of pharmaceutical patent provisions on Government health expenditure;
5. international approaches to extensions of term for pharmaceutical patents;
6. Australia's obligations under international agreements (including free trade agreements and World Trade Organisation agreements); and
7. Australia's position as a net importer of patents and medicines.

The review panel is chaired by Mr Tony Harris (former NSW Auditor-General and Parliamentary Budget Officer) with members Dr Nicholas Gruen (CEO of Lateral Economics) and Professor Dianne Nicol (Associate Dean, Research, of the University of Tasmania).

TIMETABLE

A timetable for the review process has also now been established, with the key dates being as follows:

1. 15 Oct 2012: Announcement of Review
2. 21 Nov 2012: Release of Issues Paper
3. 21 Jan 2013: Submissions Due 5pm
4. Feb 2013: Hearings
5. March 2013: Draft Report
6. April 2013: Final Report

We note that public hearings will be held in February.  Contributors of written submissions who are interested to attend these hearings and discuss their views in person should make this clear in their submissions.

SUGGESTED QUESTIONS

The issues paper identifies 11 questions as a suggested starting point for submissions:

1. Question 1: Is the breadth of pharmaceutical patents eligible for an extension of term appropriate?
2. Question 2: Is the length of the extension of term provided for appropriate?
3. 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?
4. Question 4: Do the systems for opposition and re-examination provide appropriate avenues for challenging the granting and validity of a pharmaceutical patent?
5. Question 5: Do interlocutory injunctions, as the law is currently applied, provide appropriate relief in cases involving pharmaceuticals?
6. Question 6: Is Australian law on contributory infringement appropriate in relation to pharmaceuticals?
7. Question 7: Are the current timeframes in which infringement proceedings must commence appropriate for pharmaceutical patents?
8. 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?
9. Question 9: Is the law on data exclusivity appropriate?
10. Question 10: Are the laws on patent certificates appropriate?
11. Question 11: Are the laws on copyright of product information appropriate?

Further information on the background to each of these questions can be found in the paper, which is written in a very accessible form that does not presume a great depth of existing knowledge on the part of the reader.  A number of useful real-life examples (‘case studies’) are provided to illustrate the points at issue.

THE BLOG

It is a positive sign that the Pharmaceutical Patents Review has chosen to establish a blog to facilitate interaction with the community.

The Pharmaceutical Patents Review blog is hosted on the Australian government’s govspace platform, which was set up in 2010 to enable Australian Government agencies to create public blogs and websites.  The sites are hosted by the Department of Finance and Deregulation.

There are now 52 public sites hosted on govspace, however to our knowledge this is the first time an IP review of this kind has made use of a social media platform to engage with the community on an ongoing basis.  And while a blog, by itself, is hardly an extensive social media engagement program, it is definitely a step in a positive direction.  We therefore hope that it works, and encourages similar initiatives in future reviews and consultations.  (For more of our views on these issues, see Patent Office, Professionals, Must Get With the Social Media Program.)

CONCLUSION

Once again: submissions are due by 5pm on 21 January 2013.  They should be sent as an attachment to pharmapatents@ipaustralia.gov.au.  For accessibility reasons, Word or RTF format are preferred, however an additional PDF version may also be submitted.

Submissions may also be made by post to:

Terry Moore
IP Australia
PO Box 200
WODEN ACT 2606

Submissions may be in the form of short letter to the panel or a more substantial document.  The person/organisation making the submission should be clearly identified.

We also encourage interested readers to follow the Review’s blog, and engage via the comments should a suitable opportunity arise.
Image: Copyright (c) 123RF Stock Photos

Tags: Australia, Extension of patent term, Law reform, Pharmaceuticals