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.
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)
Publication Details