DAY 1 | Thursday, November 4, 2010
8:00 Registration Opens and Coffee Served
8:45 Opening Remarks from the Co-Chairs
Dr. John Norman, PhD
Gowlings LLP
Jamie Mills
Partner
Borden Ladner Gervais LLP
9:00 Exploiting New Opportunities in Biologics
and Subsequent Entry Biologics
Moderator
Tim Gilbert
Partner
Gilbert's LLP
Panel
Beverley Moore
Borden Ladner Gervais LLP
Dr. Philip Schwab, Ph.D.
Vice President, Industry Relations
BIOTECanada
Rasmus Rojkjaer
Vice President, Head of Global Biologics R&D
David K. Lee
Director, Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate (PPIAD)
Health Products and Food Branch, Health Canada
Brian R. Dorn, Ph.D.
Attorney
Merchant & Gould, P.C. (U.S.)
• Overview of recent regulatory developments
• Patenting biotechnology
- How do biologics fit into the existing pharma patent framework?
• Understanding the new terminology
• Reviewing the Final Guidance Document (Sponsors:Information and Submission Requirements for Subsequent Entry Biologics (SEBs))
• Identifying key principles outlined in the Guidance Document and its implications for aspects of the drug approval process relating to intellectual property
protection in Canada
- How do these Guidelines apply on a practical level?
- How do these Guidelines impact on patenting strategies?
• Discussing the pros and cons of Guidelines versus Regulations
- Is the government contemplating legislative changes?
• Critiquing the Guidelines: what is working and what is not working?
• Analyzing updates to the PM(NOC) Guidelines and their impact on biologics
• Identifying listing issues and how they are being overcome
• Adjusting the law to accommodate different molecules: what should be done?
• Status update on SEB opportunities: are there generic companies interested in SEBs on previously patented pharmaceuticals?
• Overview of the different approval pathway systems in Canada, U.S and E.U.
Panel sponsored by: 
10:30 Networking Refreshment Break
Sponsored by: 
10:45 Reviewing Significant Cases in Canada and the United States and Their Impact on Patent Prosecution and Litigation
Steven Mason
Partner
McCarthy Tétrault LLP
Mark Edward Davis
Partner
Heenan Blaikie LLP
Brian R. Dorn, Ph.D.
Attorney
Merchant & Gould, P.C. (U.S.)
In this session, leading practitioners will examine some of this
year’s top cases that are contributing to the changing landscape
of pharma patents in Canada and the U.S. including:
• Update on critical cases and strategies under NOC Regulations,patent infringement and impeachment actions
• Getting patent approval and avoiding invalidity by meeting the anticipation and obviousness standard
- Update on cases following Sanofi-Synthelabo Canada Inc. v. Apotex Inc.
- How is the law evolving in Canada?
- What is the standard in Canada and how does it compare to other jurisdictions?
• Key U.S. cases and their implications for Canada
• Meeting the written description and enablement requirements as interpreted in the U.S case of Ariad Pharmaceuticals Inc. v. Eli Lilly & Co.
- What are the implications of this case for pharma patents in Canada?
12:00 Networking Luncheon
1:15 View from the Bench: Getting Direction from
the Court for Tactical Planning Purposes
The Honourable Justice Roger T. Hughes
Federal Court Trial Division
In this session, participants will hear from the bench regarding
recent developments in pharmaceutical patent litigation and have
the opportunity to ask their most pressing questions.
2:00 Networking Refreshment Break
Sponsored by:
2:15 Minimizing the Risk of Section 8 Damages
Gunars A. Gaikis
Partner
Smart & Biggar/ Fetherstonhaugh
Dr. John R. Rudolph
General Counsel & Corporate Secretary
Eli Lilly Canada, Inc.
• Update on cases under s.8 following the decision in Apotex v. Merck Frosst
• Determining whether a generic has a s.8 claim if it fails under the NOC Regulations
• Clarifying the scope of s.8 damages and how they are being pursued in pending actions
• Strategies for multiple s.8 claimants and actions for same medicine
• Can an NOC case be converted into an action with s.8 protection for the generic?
• Practical strategies to minimize financial risk: generic v.innovator/brand name approaches
3:15 Gaining Effective Courtroom Advocacy Skills:
Lessons Learned from Recent Patent Litigation Trials
The Honourable Justice Johanne Gauthier
Federal Court Trial Division
Anthony G. Creber
Partner
Gowlings LLP
David Aitken
Partner
Osler, Hoskin & Harcourt LLP
Patent litigation raises complex factual and legal issues and
involves considerable expenditures. Since the validity of issued
patents will almost always be an issue, patent litigation requires
an in depth knowledge of the courts that most frequently handle
these issues. In this session, Justice Gauthier and leading private
practitioners, representing both brand and generic companies,
will discuss winning trial strategies and provide lessons learned.
4:30 Remarks from the Co-Chairs: Conference Adjourns
DAY 2 | Friday, November 5, 2010
8:00 Coffee Served
9:00 Opening Remarks from the Co-Chairs
9:15 Utility, Sound Prediction and Selection Patents:
Clarifying Canadian Standards and their Impact
on Patent Drafting, Prosecution and Litigation
Judith Robinson
Partner, Ogilvy Renault LLP
• Reviewing changes to the Manual of Patent Office Practice
- How do these changes impact on clients from the U.S and E.U. bringing patent applications in Canada?
• Utility and Sound Prediction
- What are the standards in Canada and the U.S and how do they compare?
- When does a prediction become patentable?
- What are the disclosure requirements?
• Selection patents: exploring the landscape and best practices subsequent to Sanofi-Aventis
10:15 Networking Refreshment Break
10:30 Eliminating Excessive Pricing Allegations by
Staying on Top of the Canadian Pharmaceutical Price Review Regime
Dr. Gregory Bell, Ph.D.
Vice-President
Charles River Associates
Wayne Critchley
Senior Associate
Global Public Affairs’ Health & Life Sciences Practice
Former Executive Director, PMPRB
• Patented Medicine Prices Review Board (PMPRB): recent cases and developments
• Examining the recently implemented Excessive Price Guidelines
• Analyzing the application of the Guidelines and trends in PMPRB enforcement activities
- Will authorized generics become more prominent?
• Clarifying the jurisdiction of the PMPRB when marketing products in Canada
- Update on Celgene Corporation v. Canada (Attorney General)
• Analyzing other recent decisions and their implications for patented medicines, including:
- Pfizer Canada Inc. v. Canada (Attorney General)
- Teva Neuroscience G.P.-S.E.NC. v. Canada (Attorney General)
11:30 How to Successfully Protect Exclusivity in the Patent/Regulatory Framework
Eileen McMahon
Partner
Torys LLP
• Mastering life cycle management
• Assessing the strengths and weaknesses of a patent portfolio
- Identifying “weak” and “strong” patents
• Top 10 tips for obtaining “strong” patents
• Developing an effective worldwide patent strategy
• Learning what to avoid in prosecution
• Best practices for strengthening a patent in prosecution
• Understanding the interface between patents and regulatory/data exclusivities
• Reviewing agreements (supply, license, co-marketing and co-promotion) and their role in life cycle management
• Looking at pre and post patent issuance strategies
• Leveraging the patents
12:15 Networking Luncheon
1:30 Avoiding Drug Patent Invalidity by Meeting
the Duty of Good Faith Patent Prosecution
Post Lundbeck Canada Inc. v. Ratiopharm Inc.
Steven Garland
Partner
Smart & Biggar/Fetherstonhaugh
Barbara Murchie
Partner
Bennett Jones LLP
• Clarifying the applicant duty of candour when communicating with the Patent Office pursuant to s. 73(1)(a) of the Patent Act
- What is the extent of the good faith requirement in Canadian patent prosecution?
• Analyzing the Lundbeck decision and its impact on patent prosecution and enforcement
• Comparing the Canadian and U.S. good faith standards
- Is the standard higher in Canada than the U.S.?
• Complying with the duty of good faith: best practices
2:30 How and When to Use Expert Witnesses to Bolster Your Case
Douglas Deeth
Founding Partner
Deeth Williams Wall LLP
Ronald E. Dimock
Partner
Dimock Stratton LLP
• Best practices for using expert witnesses at NOC proceedings and patent infringement trials
• Clarifying the rules around expert witnesses
• Update on the proposed Federal Court rule changes regarding expert witnesses
• Hot tubbing: where are we now?
• Qualifying the expert: tips and traps
• Making and meeting objections
3:30 Networking Refreshment Break
3:45 Using Access to Information Requests to Advance the Interests of Your Clients
Caroline Jacques
Senior Counsel Canada
International Legal Operations
Abbott
• Best practices for getting information to advance the interests of your clients
- What information can you get?
- How can you use it?
• Interpreting the obligation to divulge
• Analyzing recent cases
• Examining the Access to Information Act and its impact on market exclusivity
• Clarifying who owns the information being requested
• Understanding what is covered by confidentiality
4:30 Closing Remarks from the Co-Chairs:
Conference Concludes
Conference Details
