DRUG PATENTS IN CANADA

This year’s distinguished faculty of legal and industry experts from Canada and the U.S. will provide you with current, in-depth information on the latest legal developments and regulatory changes in pharmaceutical and biotechnology patents.

Session highlights include:

• Case law on selection patents sound prediction: what is required?
• File histories: alive and well in PM(NOC) litigation?
• Canada’s pharmaceutical price review regime and trends
• Settling pharma patent cases: when to, how to and obstacles to
• Improving access to medicines with a pharmaceutical patent pool: legal/business and antitrust considerations
• South of the border: the year in review
• Strategies in pharma patent litigation
• Ground breaking decisions: how the landscape has changed for 2010
• Canadian duty of good faith vs. the U.S.: where the law is headed

PROGRAM CO-CHAIRS

J. Sheldon Hamilton
Partner
Smart & Biggar/Fetherstonhaugh

Barbara Murchie
Partner
Bennett Jones LLP

SPECIAL PRESENTATION:

Protecting Innovations in Nanomedicine – A U.S. Practitioner’s Perspective

Raj Bawa, M.S., Ph.D.
Patent Agent
Bawa Biotechnology Consulting LLC, Ashburn (Virginia, USA)

This program has been accredited by the Law Society of Upper Canada towards the professional development requirement for certification. Intellectual Property Law – 9 hours

SPONSOR

MARKETING PARTNERS

• In-house Counsel from Pharmaceutical
  and Biotech companies
• VPs, Directors and Managers of:
  • Legal, Regulatory and Corporate Affairs
  • Strategic Partnerships
  • Research and Development
  • Intellectual Property and Scientific Affairs
  • Business Development
  • Strategic Pricing
  • Health Care Strategies
  • Therapeutic Products
  • Compliance

• Patent Agents and Examiners
• Patent and IP Consultants and Litigators
• Pharmaceutical and Biotech Consultants
• Representatives from:
  • Patented Medicine Prices Review Board
  • Health Canada
  • Industry Canada

Dear Colleague,

The legal landscape in pharmaceutical litigation continued to evolve during the past 12 months. Significant decisions in patent trials and PM(NOC) cases are shaping and perhaps shifting the legal landscape. Paradigm-shifting technologies – including developments in biosimilars and nanomedicines – make it even more challenging to stay on the leading edge.

In such a busy environment, it can be difficult to keep up to date on all of these legal and regulatory changes. This Insight Information conference assembles skilled practitioners in all of these fields to provide the insight on the latest issues in Canada and the U.S. and from the innovator and generic perspectives.

Don’t miss Insight’s line-up of outstanding speakers, carefully chosen to give you a range of different and sometimes competing perspectives. They will bring you up to date on the latest developments and maybe even challenge your thinking on these difficult issues.

We look forward to seeing you on May 6-7, 2010!

J. Sheldon Hamilton
Partner
Smart & Biggar/Fetherstonhaugh

Barbara Murchie
Partner
Bennett Jones LLP

Thursday, May 6, 2010

8:30

Conference Registration and Continental Breakfast

9:00

Welcome and Opening Remarks from the Co-Chair

J. Sheldon Hamilton
Partner
Smart & Biggar/Fetherstonhaugh

9:10

Ground Breaking Decisions: How the Landscape Has Changed for 2010

Brand Perspective:
Jason C. Markwell 
Partner
Ogilvy Renault LLP

Generic Perspective:
Mark Edward Davis
Partner
Heenan Blaikie LLP

• The fall out from the Ramipril, Olanzapine and Amlodipine trials
  • The importance of the “promise” in the patent
  • Ramipril – Sanofi-Aventis Canada Inc. et al. v. Apotex Inc. et al., 2009 FC 676
  • Olanzapine – Eli Lilly v. Novopharm, 2009 FC 1018
  • Amlodipine – Ratiopharm Inc. v. Pfizer Ltd., [2009] F.C.J. No. 967
  • Sufficiency of the disclosure and the selection and presentation of supporting data in a patent
  • False material allegations wilfully made for the purpose of misleading
  • The importance of direct evidence from the inventors
  • The criteria for selection patents
  • Utility and sound prediction
• The Federal Court’s reaction to the Sanofi-Synthelabo decision on anticipation and obviousness
  • Has the law really changed? Apotex v. Pfizer Canada, [2009] F.C.J. No. 66

10:15

Networking Coffee Break

10:30

Selection Patents Sound Prediction: What is Required?

David Reive
Partner
Dimock Stratton LLP

• Latest case law on sound prediction
• Is there a different test for selection patents (and what is a selection patent anyway?)
• New vs. old compounds
• Animal testing vs. human testing
• Disclosure requirements

11:15

File Histories – Alive and Well in PM(NOC) Litigation?

Barbara Murchie
Partner
Bennett Jones LLP

This presentation will focus on how file histories are best utilized in the following areas:

• s. 73 arguments
• s. 53 arguments
• Other invalidity arguments
• Canadian file history vs. U.S. file history

12:00

Networking Luncheon

1:30

Protecting Innovations in Nanomedicine – A U.S. Practitioner’s Perspective

Raj Bawa, M.S., Ph.D.
Patent Agent, Bawa Biotechnology Consulting LLC, Ashburn (Virginia, USA)
Adjunct Associate Professor, Rensselaer Polytechnic Institute, Troy (New York, USA)
Senior Scientist, SynerGene Therapeutics Inc., Potomac (Maryland, USA)

In today’s global economy, pharmaceutical companies are under enormous pressure to maintain profitability in light of numerous challenges ranging from revenue losses due to patent expirations on blockbusters to enhanced regulatory oversight to an ever-increasing challenge from generic manufacturers. Clearly, new ground rules and competitive business strategies are needed in the post-blockbuster world. As a result, they are turning to miniaturization and nanotechnology to enhance or supplement drug target discovery and drug development. With this backdrop, this presentation will highlight:

• Commercial activity in the nanodrug delivery space – size-driven innovations in the pharmaceutical drug industry (FDA-approved or in clinical testing)
• Patenting Nanomedicine inventions in light of the current “patent gold rush” and emerging “patent thickets”
• Impact and interplay of federal bodies (U.S. FDA, U.S. Patent Office, U.S. Congress) on commercialization efforts
• Overcoming “obviousness” when patenting nanomedicine inventions – the issue of size
• Patent activity in different sectors of nanomedicine
• Outstanding challenges, trends and opportunities arising from nanomedicine inventions
• Examining the viability of patent pools to the growing patent thicket – navigating the patent labyrinth
• Nanomedicine patent trends in the U.S. Patent Office
• U.S. patent reform and the future of nanopatents

2:30

Networking Refreshment Break

2:45

Canada’s Pharmaceutical Price Review Regime and Trends

Barbara Ouellet
Executive Director
Patented Medicine Prices Review Board

• 2010 sees the implementation of the Board’s revised Excessive Pricing Guidelines – what lies beyond the new Guidelines: application and effect on future pricing of patented drug products
• Key elements of the latest Federal Court decisions
• Price review in Canada compared to trends in other countries
• Evolving pharmaceutical environment and potential implications

3:30

Settling Pharma Patent Cases: When To, How To and Obstacles To

Andrew Bernstein
Partner
Torys LLP

• Which types of cases might be amenable to a settlement?
• What are brands and generics looking for in a settlement?
• What are the pitfalls of a settlement? Should you be worried about competition law?
• When can mediation help you reach a settlement?

4:15

Conference Adjourns for the Day

Friday, May 7, 2010

8:30

Continental Breakfast

9:00

Opening Remarks from the Co-Chair

Barbara Murchie
Partner
Bennett Jones LLP

9:10

Improving Access to Medicines with a Pharmaceutical Patent Pool: Legal/Business and Antitrust Considerations

Karen Durell
Associate Lawyer, Patent Agent, Trade-mark Agent
Miller Thomson LLP

Stacey Ivanchuk, MSc, PhD
Director, Commercialization & Business Development
MaRS Innovation

Patent Pool: One beast in a menagerie of collective schemes for managing IP

• Summary of ways to collectively manage IP and the reasons for doing so
• A brief history of the patent pool concept – U.S. has the most experience
  • • Mid-1850’s to mid-1950’s: pools primarily, but not exclusively, for price fixing and anti-competitive purposes
    • Starting in about 1990, a series of “pro-competitive” pools were created in the IT sector – certain ‘rules’ for their formation were promulgated based on industry IT standards
  • Pools relating to the biomedical industry – can you have an “industry” standard in biomedicine?
  • The UNITAID patent pool
    • Function: “upstream” or “downstream” pools?
    • Structure
    • Business considerations
    • Update on implementation of UNITAID pool as of May 2010

10:15

Networking Coffee Break

10:30

Regulatory and Industry Update: Biosimilars/SEBs and Pharma Drug Patents

Adrienne Blanchard
Partner
Gowlings LLP

Veera Rastogi
Vice President, Law
Janssen-Ortho Inc.

• Report on the latest developments from the BGTD
• Regulatory developments and commentary
• Industry perspective and update
• Application of IP rules
• What is on the horizon?

11:30

South of the Border: A Year in Review

Janet I. Cord, Esq.
Partner
Ladas & Parry LLP

This presentation will review decisions that practitioners need to know about, including decisions impacting
the pharmaceutical industry, such as:

• Bilski – is a method for diagnosis patentable subject matter?
• Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co (written description and enablement)
• Wyeth and Elan Pharma International Limited (patent term adjustment)
• Abbott Laboratories v. Sandoz (product by process claims)
• Forest Group v. Bon Tool (patent marking requirements)

2:30

Networking Refreshment Break

2:45

Canada’s Pharmaceutical Price Review Regime and Trends

Barbara Ouellet
Executive Director
Patented Medicine Prices Review Board

• 2010 sees the implementation of the Board’s revised Excessive Pricing Guidelines – what lies beyond the new Guidelines: application and effect on future pricing of patented drug products
• Key elements of the latest Federal Court decisions
• Price review in Canada compared to trends in other countries
• Evolving pharmaceutical environment and potential implications

12:15

Networking Luncheon

1:45

Strategies in Pharma Patent Litigation

Gunars A. Gaikis
Partner
Smart & Biggar/Fetherstonhaugh

• NOC case vs. action
• Dealing with multiple generics/allegations
• Settlement considerations on both sides
• Experts
• Maximizing case management benefits

2:30

Networking Refreshment Break

2:45

Canadian Duty of Good Faith vs. the U.S.: Where the Law is Headed

Brand Perspective:
Michael E. Charles
Partner
Bereskin & Parr LLP

Generic Perspective:
Angela Furlanetto
Partner
Dimock Stratton LLP

U.S. Perspective:
Daniel P. DiNapoli
Partner
Kaye Scholer LLP

The duty of good faith is now moving towards the U.S. style inequitable conduct doctrine. This panel discussion will focus on the latest developments including:

• The duty of candour to the Patent Office and the Impact of the recent Lundbeck decision
• The potential impact of disclosure on drafting/prosecution and enforcement of pharmaceutical patents

4:15

Register 3 delegates for the main conference at regular price at the same time and you’re entitled to register a fourth person from your organization at no charge. For other group discounts, please call 1-888-777-1707. All discounts must be redeemed when booking, discounts will not be valid or applied after this time.