Agenda

Conference Day One: Thursday 20th August 2009

Day One | Day Two

8:30 Registration & Coffee

9:00 Opening Remarks from the Chair
Andrew Wiseman, Partner, Allens Arthur Robinson

Opening Address

9:10 MA Code & Related Developments for 2009

> Current Code views and status
> Current compliance and consequences
> The who, what, how and when of the Code Review
> Longer term - changing landscape and Code
> International developments and influences

Tim James, Manager, Corporate & Government Affairs, Janssen-Cilag Australia

9:50 All that Glitters is Not Gold: Advertising in the Pharmaceutical Industry

> Key legislation and industry codes, including proposed changes to the Medicines Australia Code of Conduct
> Interactions with healthcare professionals and consumers
> Recent cases - legal obligations when promoting pharmaceutical products

Lisa Kurian, Compliance Counsel, Wyeth Australia Pty Ltd

10:30 Morning Tea

11:00 Competition Issues for the Pharmaceutical Industry

This session will provide an overview of "hot topics" in Australia and overseas: competition issues arising [from Part IV of the Trade Practices Act 1974 including misuse of market power, anti-competitive arrangements, price fixing, boycotts, etc.] in the context of:

• Registration and listing
• Pricing and reimbursement strategies, including bundling and rebates
• Supply and distribution arrangements
• Protection of intellectual property
• Competition between originator and generic Companies

Carolyn Oddie, Partner, Allens Arthur Robinson

Intellectual Property

11:40 Exploring Intellectual Property Issues

• An overview of the IP landscape in the pharma sector and the practical implications of recent and current cases
• Tips and traps in patent enforcement and market defence
• Reconsideration of the options for action and defence in relation to less familiar IP and other rights including copyright, confidential information, data exclusivity, brands and trade marks, license performance obligations, misleading product claims etc and how these are playing out in current cases
• Constitutional law issues around IP rights in pharma?

Odette Gourley, Partner, Corrs Chambers Westgarth

12:20 Lunch

Patents Part I

1:20 Hot Topics in Patent Law for 08/09: A Global Analysis

• Brief overview of the Federal Courts approach to Patent term extensions and adjustments
• Recent developments in the law of obviousness/infringement
• Biogenerics - do they need special patent law treatment?

Naomi Pearce, IP Director & Counsel, Lawyer & Patent Attorney, Hospira Global Pharma R&D

2:00 Pharma Patents - Its Not all About Maximum Scope
The trick is to get the right balance right between:

• Maintaining flexibility of coverage vs. patentability of future inventions
• Attracting undue prior art rejections vs. easy avenues for competitors to design around
• File wrapper estoppel problems vs. early disclosure of lead compound
• Adequate disclosure for desired claims in US, EP vs. disclosure required in Japan, China
• The cost of ineffective protection vs. the cost of divisionals and a complex examination process

Mark Roberts, Partner, Davies Collinson Cave

2:40 Afternoon Tea

3:10 Practical Implications of Recent Patent Cases

• Summary of key recent decisions (assuming UWA vs. Gray, Sanofi vs. Apotex and Lundbeck vs. Alphapharm may all be decided by the Full Federal Court)
• Patenting of Emantiomers and Pro-Drugs
• Implications for the employment relationship - tips and pitfalls
• What is enabling disclosure? How to read prior art according to the Full Federal Court
• Any other key points arising from 2009 cases

Kim O'Connell, Partner, Mallesons Stephen Jacques

3:50 Panel Discussion :
The Licensing of New In-License Products

> Performance obligations on the licensee, including obligations to commercialise
> Payment terms - license fees, milestone payments, royalties
> Protection, maintenance and enforcement of IP rights
> Risk issues - warranties, indemnities, exclusions of liability, liability caps, insurance
> Termination and dispute resolution - what happens when it all goes sour?

Jonathan Barlow, Legal Director - Asia Pacific, Hospira
Dr Chris Sotiropoulos, Manager, Business Development, Orphan Australia
Wayne Condon, Partner, Griffith Hack

4:30 Closing Remarks from the Chair

4:40 Networking Drinks

6:30 Speakers and delegates are welcome to join us for a complimentary networking dinner at Nicks Bar & Grill, King Street Wharf Darling Harbour. For more information visit our website www.iir.com.au/pharmalaw

Conference Day Two: Friday 21st August 2009

Day One | Day Two

8:30 Morning Coffee

9:00 Opening Remarks from the Chair

The Law & the Pharmaceutical Benefits Scheme

9:10 PBS Reform & Unintended Consequences of the Legislation

> Review of the implementation of PBS Reform
> Brief discussion on relevant sections of the legislation
> Identification of 'holes' and unintended consequences of the legislation
> Discussion around the ways in which these can be rectified - or cannot be rectified as the case may be
> Theoretical case examples

Tara Eaton, Senior Corporate Lawyer - Australia & New Zealand, Merck Sharp & Dohme

9:50 Review of Adverse PBS Outcomes

• When can you have decision reviewed?
• What legal processes do you adopt?
• What are the guidelines?
• How to decide whether to take on government

Greg Williams, Partner, Clayton Utz

10:30 Morning Tea

11:00 The Availability of Information about Pharmaceuticals

• Trends in data protection
• Confidentiality
• Information available online

Dr Janice Hirshorn, Legal Counsel, Eli Lilly Australia

11:40 In-House Role in Promoting Business Practice Compliance

> Key principles of business practice in pharmaceutical suppliers
> Getting buy-in from your commercial colleagues
> Juggling overlapping policies - Medicines Australia, Medical Technologies Association of Australia and global company policies
> Managing expectations with customers and healthcare professionals
> Making life easier - use of technology and templates

Jeremy Levy, Corporate Counsel, Australia & New Zealand, Associate Director, Baxter Healthcare Pty Ltd

12:20 Lunch

Patents Part II

1:30 Senate Gene Patent Inquiry - Downstream Implications for Genetic Testing

• What does the inquiry mean for genetic diagnostic testing?
• Relationship between gene patents and genetic diagnostic testing
• Implications for patient access
• Gene patents and research availability

Anne Trimmer, Chief Executive Officer, Medical Technology Association of Australia

2:10 Interlocutory Applications in Patent Cases & Processes for Obtaining Information Prior to Commencing Proceedings

• Brief overview of the Federal Courts approach to interlocutory applications in patent cases and the evidence required to support such applications
• Access to information via the Freedom of Information regime
• Preliminary discovery under the Federal Court Rules
• What are reasonable inquiries?
  - What is the level knowledge required as to the alleged infringing conduct?
  - Other avenues for obtaining discovery from the Court
• Issues arising from discovery of information from government bodies

Lisa Taliadoros, Partner, Gilbert & Tobin

2:50 Regulatory Approaches to Biosimilars/Bioequivalents

• How can extrapolation of efficacy and safety data to other indications of the reference product be supported?
• Can a biosimilar claim another route of administration than the originator?
• Extrapolation of indications
• Interchangeability/substitution
• Relative developmental costs and size of clinical trials - still need to demonstrate efficacy and adequate lack of immunogenicity?

Mark Worsman, Senior Associate, DLA Phillips Fox

3:30 Closing Remarks from the Chair

3:40 Close of Conference & Afternoon Tea