Agenda

CONFERENCE DAY ONE
Monday 25th July 2011

DAY ONE | DAY TWO

8:30 Registration and Coffee

9:00 Opening Remarks from the Chair
Ric Morgan, Senior Associate, Allens Arthur Robinson

9:10 Social Networking - A New Era in the Pharmaceutical Industry?

• To what extent can pharmaceutical companies communicate with healthcare professionals and patients via facebook, You Tube and Twitter?
• Examining legal implications and recent cases

Lisa Kurian, Legal Adviser, Pfizer Australia Pty Limited

9:50 Privacy - Where Pharmaceutical Companies Get it Wrong and What They Can Do to Get it Right

Compliance with obligations in relation to privacy is a significant issue for all corporations, but particularly for those dealing with health information. The ramifications from a significant privacy breach could be material for pharmaceutical companies, especially in relation to reputation and corporate brand. Based on knowledge acquired through advising many pharmaceutical companies on privacy compliance, including undertaking numerous privacy audits, this presentation will outline and discuss the key areas where pharmaceutical companies tend to have issues with privacy compliance and how these areas can be identified and addressed.

Paris Petranis, Partner, Middletons

10:30 Morning Tea

11:00 Reprocessing of Single-Use Medical Devices

The FDA has permitted reprocessed medical devices to be marketed and supplied in the United States for close to a decade now. In Australia, the TGA has said that an application for marketing approval of a reprocessed single use device is treated like any other marketing approval application and has a number of applications before it. This presentation looks at the range of complex issues that arise including:

• Third party standing to obtain information and to seek review of regulator action
• Originator brand protection and misrepresentation risk
• Healthcare professional ethical issues and patient consent
• Patent infringement – do US exhaustion doctrines apply?
• Product liability implications

Odette Gourley, Partner, Corrs Chambers Westgarth

11:40 Dual Presentation: Recent Developments in International Anti-Corruption Enforcement

• Update on enforcement of US Foreign Corrupt Practices Act – FBI involvement, more investigations and some much needed clarity on the meaning of 'foreign official'
• UK Bribery Act – key issues for the industry including prohibition of facilitation payments, bribery in the private sector and what is required for the 'adequate procedures' defence to the new offence of failing to prevent bribery
• Foreign corruption enforcement in Australia – increased penalties and the relevance of foreign regulatory activity

Sana Rasool, Associate Legal Director and Lead Counsel – Pfizer Worldwide BioPharmaceutical Businesses, Pfizer Australia and New Zealand
Tim Robinson, Senior Associate, Allens Arthur Robinson

12:20 Lunch

1:20 The 'Gene Patent' Controversy

• A consideration of the current version of the Human Genes and Biological Materials Bill
• A review of the criticisms of the Bill and consideration of the supporting submissions
• Consideration of the ACIP Report on patentable subject matter and its relevance to the 'gene patenting' debate
• What does the future hold for the patenting of biotech innovation in Australia

Wayne Condon, Principal, National Practice Group Leader - Law, Griffith Hack

2:00 Interlocutory Injunctions: Current Trends

• A review of the case law and recent decisions on interlocutory injunctions in patent matters in Australia
• A look at how to prepare for and resist an application for an interlocutory injunction

Peter Chalk, Partner, Blake Dawson

2:40 Afternoon Tea

3:10 Recent Developments in Patent Law

In the past 12 months there have been a handful of significant cases in the Federal Court:

• Sigma Pharmaceuticals vs Wyeth; Alphapharm vs Wyeth (heard together)
• Albany Molecular Research vs Alphapharm
• Kimberly-Clark vs Multigate Medical Products
• Abbott vs Apotex

This session will give insights and commentary on recent developments and where the law on novelty and obviousness is headed.

Kim O'Connell, Partner, Mallesons Stephen Jaques

3:50 Panel Discussion: Towards an Efficient Resolution of Patent Disputes - A Proposal for Reform
The present state of patent litigation over the launch of generic medicines in Australia is broken. The first an innovator knows of a generic product is often its ARTG listing and there is no guarantee of an interlocutory injunction to restrain at-risk launch. Generic companies who take on the heavy lifting of attacking a patent often get no benefit if they win as other generics swoop in to the now open market. Further, they are sometimes surprised by patents not found in their searches.

All this adds up to cost and uncertainty for all parties. In this session, an external patent litigation expert will outline a proposal for reform to address these and other concerns with the current state of pharma patent litigation in Australia.
This model will then be tested by critique from both innovators and generics.

Dr Alan Robertson, CEO, Pharmaxis
James Sharkey, Head - Business Development and Licensing (Asia Pacific Region), Sandoz Pty Ltd
Matthew Swinn, Partner, Corrs Chambers Westgarth
Kate Lynch, CEO, Generics Medicines Industry Association Pty Ltd
Innovator pharma representative to be confirmed

4:30 Close of the Day From the Chair

4:40 Networking Drinks

6:30 Speakers and delegates are welcome to join us for a complimentary networking dinner.

CONFERENCE DAY TWO
Tuesday 26th July 2011

DAY ONE | DAY TWO

9:00 Opening Remarks from the Chair
Dr Teresa Schafer, Partner, Piper Alderman

9:10 Originators vs Generics - Which Way is Justice Leaning?

• A cooks guide to recent Australian decisions concerning injunctions against the launch of generics
• What factors are influencing the courts in granting/denying injunctive relief and how can parties be best prepared for battle?
• Review of the changes to the Patent Act in "Raising the Bar" proposed amendments - how will they affect evergreening patents/pharma patent litigation?
• The role FOIs can or may play in gathering of information pre patent challenge (consideration of iNova vs DOHA) and use of prelitigation discovery

Jane Owen, Partner – Intellectual Property, Middletons

9:50 Price Disclosure - the Policy Objectives & the Legal Disclosure Requirements

• The policy objectives of price disclosure and whether the current system really meets those objectives
• The disclosure requirements including what must be reported and when across the pharmaceutical supply chain
• Are these requirements clear or are we comparing apples and oranges to set the new price
• What is not disclosed and is it possible to implement pricing structures that do not need to be disclosed
• Who loses most when price disclosure based price cuts are implemented?

Ric Morgan, Senior Associate, Allens Arthur Robinson

10:30 Morning Tea

11:00 Trademarks and Copyright: The Law & Recent Cases Affecting the Pharma Sector

• Refresher on trade marks issues affecting pharma
• Copyright in PIs – recent litigation and legislative reform

Neil Murray, Barrister, Tenth Floor Selborne/Wentworth Chambers

11:40 Getting Up Early: Dealing with Regulators

• The roles and powers of the TGA, DoHA, ACCC, ATO and ASIC
• Policies you should have
• What do you do when the regulator comes knocking?
• Legal professional privilege
• Lessons from the Pan Pharmaceuticals litigation

Ross McInnes, Senior Associate, Clayton Utz
Alexandra Rose, Senior Associate, Clayton Utz

12:20 Lunch

1:30 AAT Appeals/Review of Administrative Decisions

• Reviewable decisions: What are they?
  - Understanding merits review
  - The role of the AAT
  • What action can a party take if a decision is not 'reviewable'?
  - Understanding judicial review options
• Who has standing to seek a review?
• Informal remedies:
  - Challenging procedure and enforcing your rights
  - Accessing information about the decision-making process
• Case examples:
  - Merits review: Ego Pharmaceuticals vs Minister for Health and Ageing
  - Judicial review: Boehringer Ingelheim vs Dept of Health and Ageing; AstraZeneca vs Minister for Health and Ors (undecided)
  - Due process: Analysis of various decisions of the Complaints Resolution Panel
  - Standing to seek review: SmithKline Beecham vs Chipman

Dr Teresa Schafer, Partner, Piper Alderman

2:10 Protecting your Confidential Information

The recent review seeking to improve the transparency of the TGA has focused on what information should be made publicly available by the TGA. This session will look at the protection of pharmaceutical companies’ valuable intellectual property and consider the measures that can be taken to protect the confidentiality of information submitted to the TGA. Areas to be covered will include:

• When will information be protected information that cannot be used by the TGA in evaluating other medicines?
• Data exclusivity periods and international trends
• New Commonwealth freedom of information regime which commended November 2010
• What information is exempt from freedom of information disclosure?

Mary Saywell, Senior Associate, Baker & McKenzie

2:50 Close of Conference from chair

3:00 Afternoon Tea

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