Maximizing Pharmaceutical Patent Lifecycles

The definitive Hatch-Waxman event for brand names and generics

Wednesday, October 07, 2009

About

The Pharmaceutical Patent Endgame is in the midst of a radical metamorphoses being shaped by forces here and abroad.

A new pharmaceutical patent paradigm is emerging.

Be part of the one event which for nearly a decade has shaped industry policies and patent strategies for both brand name and generic drug companies.

The rules of the pharmaceutical patent endgame are being re-written through several pending and potentially iconoclastic measures in Congress, groundbreaking decisions in the courts and the aggressive actions of various agencies including the PTO, FDA and FTC – all of which may drastically alter the Hatch-Waxman rubric and related patent life cycle strategies. This collective activity is causing drug makers – for both brand name and generic pharmaceutical companies – added anxiety as they frantically re-work current strategies to accommodate the potential changes of this emerging patent paradigm and prepare for patent losses which will exceed $40 billion by 2012 alone1. Moreover, with the proposed introduction of follow-on biologics and the findings of the EC pharmaceutical sector inquiry, the industry must now think globally – in terms of both product portfolio and international reach.

Now is the time to come to the one and only event that has consistently allowed brand name
and generic drug makers to benchmark their companies’ current Hatch-Waxman strategies
and tactics against competitors in both camps.

This 10th American Conference Institute event on Maximizing Pharmaceutical Patent Life Cycles will bring you the thoughtful and targeted commentary and in-depth analysis that you have come to expect from this industry leading conference. This year’s conference will help you prepare for the sweeping changes currently underway by providing you with:

  • Focused panels on the pending Follow-On Biologics and Patent Reform legislation that will allow you to assess how both legislative proposals will impact pharmaceutical patent life cycle management
  • Access to key officials from the FTC’s Bureau of Competition’s Health Care Division and the EC’s DG Competition’s Pharmaceuticals Task Force who will provide you with direct insights into the logic of these agencies on some of the most pressing antitrust matters currently affecting the industry
  • An in-depth review of new FDA determinations regarding exclusivity, forfeitures, patent listing and delistings and strategies for incorporating these guidelines into your initial life cycle management plan
  • Analyses of key cases that have affected patent life cycle strategies and tips for using these rulings to your advantage

Also, this year, in response to your requests, we have added the following specialized class:

  • Hatch-Waxman Boot Camp – A Primer on IP Basics and Regulatory Fundamentals

This Boot Camp, together with our in-depth Master Classes for brand names and generics on:

  • New Strategies for Obtaining Pharmaceutical Patent Extensions in a Post-KSR World
  • Updated Drafting Guidelines for Paragraph IV Certifications and Notice Letters

will offer hands-on practical advice on core Hatch-Waxman principles as well as some of the most critical day–to–day concerns for both sides of the pharmaceutical industry.

Nearly 2,000 pharmaceutical patent professionals – for both brand names and generics – have made this conference their source of information for the legal issues surrounding life cycle management for nearly the last ten years. This updated event will bring you the latest legal strategies and tactics for successful maneuvering in the evolving patent endgame.

Contents & Contributors

About

The Pharmaceutical Patent Endgame is in the midst of a radical metamorphoses being shaped by forces here and abroad.

A new pharmaceutical patent paradigm is emerging.

Be part of the one event which for nearly a decade has shaped industry policies and patent strategies for both brand name and generic drug companies.

The rules of the pharmaceutical patent endgame are being re-written through several pending and potentially iconoclastic measures in Congress, groundbreaking decisions in the courts and the aggressive actions of various agencies including the PTO, FDA and FTC – all of which may drastically alter the Hatch-Waxman rubric and related patent life cycle strategies. This collective activity is causing drug makers – for both brand name and generic pharmaceutical companies – added anxiety as they frantically re-work current strategies to accommodate the potential changes of this emerging patent paradigm and prepare for patent losses which will exceed $40 billion by 2012 alone1. Moreover, with the proposed introduction of follow-on biologics and the findings of the EC pharmaceutical sector inquiry, the industry must now think globally – in terms of both product portfolio and international reach.

Now is the time to come to the one and only event that has consistently allowed brand name
and generic drug makers to benchmark their companies’ current Hatch-Waxman strategies
and tactics against competitors in both camps.

This 10th American Conference Institute event on Maximizing Pharmaceutical Patent Life Cycles will bring you the thoughtful and targeted commentary and in-depth analysis that you have come to expect from this industry leading conference. This year’s conference will help you prepare for the sweeping changes currently underway by providing you with:

  • Focused panels on the pending Follow-On Biologics and Patent Reform legislation that will allow you to assess how both legislative proposals will impact pharmaceutical patent life cycle management
  • Access to key officials from the FTC’s Bureau of Competition’s Health Care Division and the EC’s DG Competition’s Pharmaceuticals Task Force who will provide you with direct insights into the logic of these agencies on some of the most pressing antitrust matters currently affecting the industry
  • An in-depth review of new FDA determinations regarding exclusivity, forfeitures, patent listing and delistings and strategies for incorporating these guidelines into your initial life cycle management plan
  • Analyses of key cases that have affected patent life cycle strategies and tips for using these rulings to your advantage

Also, this year, in response to your requests, we have added the following specialized class:

  • Hatch-Waxman Boot Camp – A Primer on IP Basics and Regulatory Fundamentals

This Boot Camp, together with our in-depth Master Classes for brand names and generics on:

  • New Strategies for Obtaining Pharmaceutical Patent Extensions in a Post-KSR World
  • Updated Drafting Guidelines for Paragraph IV Certifications and Notice Letters

will offer hands-on practical advice on core Hatch-Waxman principles as well as some of the most critical day–to–day concerns for both sides of the pharmaceutical industry.

Nearly 2,000 pharmaceutical patent professionals – for both brand names and generics – have made this conference their source of information for the legal issues surrounding life cycle management for nearly the last ten years. This updated event will bring you the latest legal strategies and tactics for successful maneuvering in the evolving patent endgame.

Contents & Contributors

The Endgame Re-Invented: Preparing for An Emerging Pharmaceutical Patent Paradigm
George W. Johnston, Vice President & Chief Patent Counsel, Hoffmann-La Roche (Nutley, NJ)
John C. Vassil, Patent Attorney, (formerly Of Counsel to Morgan & Finnegan LLP)  (New York)

Patent Reform and the Pharmaceutical Industry: Anticipating and Adapting to Change
Guy Donatiello, Vice President, Intellectual Property Endo Pharmaceuticals (Chadds Ford, PA)
Hans Sauer, Associate General Counsel for Intellectual Property, Biotechnology Industry Organization (Washington, DC)
Moderator:
Teresa Stanek Rea
, Partner, Crowell & Moring LLP (Washington, DC), President, American Intellectual Property Law Association

Follow–On Biologics: Understanding the Role of Patents in Health Care Reform and Related Consequences for Life Cycle Strategies
Michael P. Dougherty, Special Counsel, Cadwalader, Wickersham & Taft LLP (New York)

Overcoming Obviousness: An Analysis of the Post-KSR Treatment of Primary and Secondary Patents and Finding New Ways to Extend Patent Life

Amy H. Fix, Of Counsel, Womble Carlyle Sandridge & Rice, PLLC (Research Triangle Park, NC)
Steven J. Lee, Partner, Kenyon & Kenyon LLP (New York)
Margaret “Peg” M. Buck, MLS, JD, Patent Attorney, Lundbeck Research USA, Inc (Paramus, NJ)
Moderator:
Brian P. Murphy
, Partner & Deputy Practice Group Leader, Patent Litigation Group, Morgan Lewis & Bockius LLP (New York)

In Re Bilski: Exploring Its Implications for Pharmaceutical Method Claims
Denise L. Loring, Partner, Ropes & Gray (New York)

Eye on the Federal Circuit and District Courts: Life Cycle Lessons Derived from Paragraph IV Litigation
Edward T. Lentz, Patent Attorney, (New Lisbon, NY)
James K. Stronski, Parter, Frommer Lawrence & Haug LLP (New York)
Shashank Upadhye, Vice President & Global Head of IP, Apotex, Inc. (Toronto, ON)
Moderator:
Brian V. Slater
, Partner, Fitzpatrick, Cella, Harper & Scinto (New York)

Promoting Competition in the Pharmaceutical Industry
Pete Levitas, Deputy Director, Bureau of Competition, Federal Trade Commission (Washington, DC)

The European Commission Pharmaceutical Sector Inquiry - Main Findings and Policy Recommendations
Monica Alfaro Murcia, European Commission, DG Competition, Pharmaceuticals Task Force (Brussels, Belgium)

Rethinking Life Cycle Strategies for Established and Emerging International Markets: Focus on Europe and Asia
Bert Oosting, Partner, Lovells (Amsterdam, NE)

Wyeth v. Dudas: Revisiting Patent Term Adjustment Calculations
Patricia Carson, Partner, Kaye Scholer LLP (New York)

A New Look At Orange Book Listings, Delistings and Related Challenges
Bruce A. Pokras, Senior Corporate Counsel, Pfizer Inc. (New York)
Brian J. Malkin, Partner, Frommer Lawrence & Haug LLP (New York)
Martin A. Voet, Consultant in Intellectual Property and Pharmaceutical, Product Exclusivity, (Mission Viejo, CA/ Amsterdam, NE) (former Senior Vice President, Chief IP Counsel, Allergan)

Exclusivity: Modes, Methods and New Interpretations
Thomas D. Hoffman, Patent Counsel – Consultant, Sandoz Inc. (Princeton, NJ)
Michael S. Labson, Partner, Covington & Burling LLP (Washington, DC)

Re-Exploring the Safe Harbor: Learning to Navigate the Potential Limits and Boundaries of Proveris
Brian D. Coggio, Senior Principal, Fish & Richardson, P.C. (New York)



DOCUMENT TYPES: PPT PPTX ZIP PDF PRESENTATIONS AVAILABLE: 24

7:30
Continental Breakfast
8:15
Co-Chairs' Welcoming Remarks
Mr. George W. Johnston
Patent Attorney
John C. Vassil
Of Counsel
Morgan & Finnegan LLP
8:30
The Endgame Re-Invented: Preparing for An Emerging Pharmaceutical Patent Paradigm
Mr. George W. Johnston
Patent Attorney
1 file
Observations on Receiving a Paragraph IV Notice Letter
69.6 KB 8 pages Presentation
PPTX - Observations on Receiving a Paragraph IV Notice Letter
John C. Vassil
Of Counsel
Morgan & Finnegan LLP
1 file
THE EVOLVING LIFECYCLE LANDSCAPE
563.5 KB 15 pages Presentation
PPT - THE EVOLVING   LIFECYCLE LANDSCAPE
9:30
Patent Reform and the Pharmaceutical Industry: Anticipating and Adapting to Change
- Guy T. Donatiello
Vice President‚ Intellectual Property
Endo Pharmaceuticals‚ Inc.
1 file
Patent Reform Act of 2009
129.1 KB 24 pages Presentation
PPTX - Patent Reform Act of 2009
Hans Sauer, M.D., J.D.
Associate General Counsel for Intellectual Property
Biotechnology Industry Organization
1 file
The Patent Reform Act of 2009: A Brief Overview
2.2 MB 12 pages Presentation
PPTX - The Patent Reform Act of 2009:A Brief Overview
Dr. Bob Filippone, Ph.D.
Vice President‚ Federal Affairs
PhRMA
-Teresa Stanek Rea, Esq.
Partner
Crowell & Moring LLP
1 file
THE PTO RULES TAFAS V. KAPPOS
267.5 KB 14 pages Presentation
PPT - THE PTO RULESTAFAS V. KAPPOS
10:45
Morning Coffee Break
11:00
Follow-On Biologics: Understanding the Role of Patents in Health Care Reform and Related Consequences for Life Cycle Strategies
Mr. MichaeL P. Dougherty
Partner
King & Spalding
1 file
Patent Litigation Involving Follow-On Biologics: What We Can Expect Under The Current Bills
120.8 KB 30 pages Presentation
ZIP - Patent Litigation Involving Follow-On Biologics: What We Can Expect Under The Current Bills
Gregory J. Glover, M.D., J.D.
Principal
Pharmaceutical Law Group, P.C.
David Korn
Vice President, Intellectual Property and Law
Pharmaceutical Research and Manufacturers of America
Mr. Mark Bowditch
Executive Director, Head, US Product Support
Sandoz‚ Inc.
Mr. Steven E. Irizarry, Esq.
Senior Vice President
Capitol Hill Consulting Group‚
1 file
Understanding the Role of Patents in Health Care Reform and Related Consequences for Life Cycle Strategies
502.5 KB 8 pages Presentation
PPT - Understanding the Role of Patentsin Health Care Reform and Related Consequences for Life Cycle Strategies
12:15
Networking Lunch
13:30
Overcoming Obviousness: An Analysis of the Post-KSR Treatment of Primary and Secondary Patents and Finding New Ways to Extend Patent Life
Ms. Amy H. Fix, Esq.
Of Counsel
Womble Carlyle Sandridge & Rice‚ PLLC
1 file
In re Kubin: Lessons and Implications
458.5 KB 13 pages Presentation
PPT - In re Kubin: Lessons and Implications
- Steven J. Lee
Partner
Kenyon & Kenyon‚ LLP
1 file
Minimizing Pharmaceutical Patent Life Cycles
365.5 KB 25 pages Presentation
PPT - Minimizing Pharmaceutical Patent Life Cycles
Margaret (Peg) M. Buck, MLS, JD
Patent Attorney
Lundbeck Research USA‚ Inc.
1 file
Overcoming Obviousness: An Analysis of the Post-KSR Treatment of...Secondary Patents...”
180.3 KB 30 pages Presentation
PDF - Overcoming Obviousness: An Analysis of the Post-KSR Treatment of...Secondary Patents...”
Brian Murphy, Esq.
Partner
Edwards Angell Palmer and Dodge LLP
1 file
ACI’s Maximizing Pharmaceutical Patent Life Cycles Conference
267 KB 5 pages Presentation
PPT - ACI’s Maximizing Pharmaceutical Patent Life Cycles Conference
14:45
Afternoon Refreshment Break
15:00
In Re Bilski: Exploring Its Implications for Pharmaceutical Method Claims
Jonathan A. Harris
Partner
Axinn Veltrop & Harkrider LLP
Denise L. Loring
Partner
Ropes & Gray LLP
1 file
RE BILSKI -- EXPLORING ITS IMPLICATIONS FOR PHARMACEUTICAL METHOD CLAIMS
257.5 KB 22 pages Presentation
PPT - RE BILSKI --  EXPLORING ITS IMPLICATIONS FOR PHARMACEUTICAL METHOD CLAIMS
15:45
Eye on the Federal Circuit and District Courts: Life Cycle Lessons Derived from Paragraph IV Litigation
Edward T. Lentz
Patent Attorney
1 file
Eye on the Federal Circuit & District Courts - Life Cycle Lessons
79 KB 25 pages Presentation
PPT - Eye on the Federal Circuit & District Courts - Life Cycle Lessons
-Mr. James K. Stronski, Esq.
Partner
Frommer Lawrence & Haug LLP
1 file
Eye on the Federal Circuit and District Court: Life Cycle Lessons Derived from Para IV Litigation --
394 KB 29 pages Presentation
PPT - Eye on the Federal Circuit and District Court: Life Cycle Lessons Derived from Para IV Litigation --
Mr. Shashank Upadhye
Lawyer & Pharma Executive
1 file
10th Annual Maximizing Life Cycle Pharma Patents Conference
642 KB 14 pages Presentation
PPT - 10th Annual Maximizing Life Cycle Pharma Patents Conference
Brian V. Slater
Partner
Fitzpatrick‚ Cella‚ Harper & Scinto (New York, NY)
1 file
Recent Developments In Parties’ Obligations In Hatch-Waxman Act Litigation
1.1 MB 14 pages Presentation
PPT - Recent Developments In  Parties’ Obligations In   Hatch-Waxman Act Litigation
17:00
Cocktail Reception
7:30
Continental Breakfast
8:30
Co-Chair's Remarks and Recap of Day One
8:45
Promoting Competition in the Pharmaceutical Industry
Mr. Pete Levitas, Esq.
Deputy Director‚ Bureau of Competition
Federal Trade Commission
1 file
Promoting Competition in the Pharmaceutical Industry
941.5 KB 36 pages Presentation
PPT - Promoting Competition in thePharmaceutical Industry
9:45
The European Commission Pharmaceutical Sector Inquiry - Main Findings and Policy Recommendations
Ms. Monica Alfaro Murcia

European Commission‚ DG Competition‚ Pharmaceuticals Task Force
1 file
Pharmaceutical Sector Inquiry : Final Report
1.4 MB 26 pages Presentation
PPT - Pharmaceutical Sector Inquiry : Final Report
10:45
Morning Coffee Break
11:00
Rethinking Life Cycle Strategies for Established and Emerging International Markets: Focus on Europe and Asia
-Mr. Bert Oosting
Partner
Hogan Lovells, L.L.P.
1 file
Rethinking Life Cycle Strategies for Established and Emerging Markets Focus on Europe and Asia
212 KB 24 pages Presentation
PPT - Rethinking Life Cycle Strategies for Established and Emerging MarketsFocus on Europe and Asia
Mr. Michel Brodbeck
European Patent Attorney
Roche Palo Alto LLC
12:00
Wyeth v. Dudas: Revisiting Patent Term Adjustment Calculations
Ms. Patricia A. Carson
Partner
Kirkland & Ellis, LLP
1 file
Maximizing Patent Term Adjustment
579.5 KB 22 pages Presentation
PPT - Maximizing Patent Term Adjustment
Ms. Kimberly Prior
Senior Patent Counsel
Hoffmann-La Roche, Inc.
12:30
Networking Lunch
13:45
A New Look At Orange Book Listings‚ Delistings and Related Challenges
Bruce A. Pokras
Senior Corporate Counsel
Pfizer Inc. (Peapack, NJ)
1 file
Applying the Orange Book Rules
1.1 MB 32 pages Presentation
PPT -  Applying theOrange Book Rules
Mr. Brian J. Malkin
Partner
Frommer Lawrence & Haug LLP (Washington, DC)
Mr. Martin A. Voet, Esq.
Consultant in Intellectual Property and Pharmaceutical Product Exclusivity
14:45
Update on FDA Activities Relative to Pharmaceutical Patent Life Cycles
Ms. Elizabeth H. Dickinson
Associate Chief Counsel for Drugs
U.S. Food and Drug Administration
15:45
Afternoon Refreshment Break
16:00
Exclusivity: Modes‚ Methods and New Interpretations
Thomas D. Hoffman, Ph.D., J.D.
Consultant‚ Patent Counsel
Sandoz, Inc.
1 file
Hatch-Waxman Forfeiture Cases 2003 MMA Amendments
347.5 KB 26 pages Presentation
PPT -  Hatch-Waxman Forfeiture Cases  2003 MMA Amendments
Michael S. Labson
Partner
Covington & Burling LLP
1 file
Non-Patent Exclusivity
443.5 KB 29 pages Presentation
PPT - Non-Patent Exclusivity
17:00
Re-Exploring the Safe Harbor: Learning to Navigate the Potential Limits and Boundaries of Proveris
-Brian Coggio
Senior Principal
Fish & Richardson‚ P.C.
1 file
SUMMARY OF THE SAFE HARBOR EXEMPTION OF THE HATCH-WAXMAN ACT (INCLUDING RESEARCH TOOL PATENTS) AND CONSEQUENCES IF THE EXEMPTION DOES NOT APPLY
645 KB 41 pages Presentation
PPT - SUMMARY OF THE SAFE HARBOR EXEMPTION OF THE HATCH-WAXMAN  ACT (INCLUDING RESEARCH TOOL PATENTS)  AND CONSEQUENCES IF THE EXEMPTIONDOES NOT APPLY
17:45
Conference Concludes