9th Annual Maximizing Pharmaceutical Patent Lifecycles

Wednesday, October 15, 2008

About

Branded and generic pharmaceutical companies are in a mission critical phase where every decision has terrific consequences.

What kind of language should the parties include in a settlement agreement to avoid FTC rejection? How can pharma companies prepare a viable covenant not to sue in a post-Medimmune world? What actions will set off forfeiture of 180-day generic market exclusivity?

Increasing competition requires innovators to constantly reevaluate strategies for fully realizing a patented drug’s value during the life cycle. In turn, generics trigger formidable competition upon patent expiration.

The tasks on both sides of this complex equation are easy to identify, intricate to analyze, and difficult to execute.

FTC enforcement, FDA rulings, and differing court decisions add to the innovators’ already extensive demands of competition in the pharmaceutical industry. Pharmaceutical patent counsel at innovators are entrusted with the massive obligation of looking beyond the patent term and mastering these other complex factors in defining, strengthening, and extending a pharmaceutical patent’s life cycle. Generic pharma must incorporate the same factors in measuring their risk, developing a business plan, and mounting a competitive campaign against a patented drug already emboldened with years of exclusivity, name recognition, and success.

Branded and generic pharma companies must continually sharpen, refine, and evolve their patent life cycle strategies in the wake of constant, challenging, and sometimes volatile change – economic, political, and legal.

ACI is proud to present this timely publication from the hallmark event for the pharmaceutical industry – 9th Annual Maximizing Pharmaceutical Patent Life Cycles Conference. This definitive Hatch-Waxman event provided the crucial information for pharmaceutical patent counsel to cultivate, modify, and enhance a foundation for their life cycle strategies. Industry leaders offer insight on analyzing the complex issues, evaluating options, and benchmarking strategies against competitors on either side of the progressively heated branded-generic battle.

Contents & Contributors

About

Branded and generic pharmaceutical companies are in a mission critical phase where every decision has terrific consequences.

What kind of language should the parties include in a settlement agreement to avoid FTC rejection? How can pharma companies prepare a viable covenant not to sue in a post-Medimmune world? What actions will set off forfeiture of 180-day generic market exclusivity?

Increasing competition requires innovators to constantly reevaluate strategies for fully realizing a patented drug’s value during the life cycle. In turn, generics trigger formidable competition upon patent expiration.

The tasks on both sides of this complex equation are easy to identify, intricate to analyze, and difficult to execute.

FTC enforcement, FDA rulings, and differing court decisions add to the innovators’ already extensive demands of competition in the pharmaceutical industry. Pharmaceutical patent counsel at innovators are entrusted with the massive obligation of looking beyond the patent term and mastering these other complex factors in defining, strengthening, and extending a pharmaceutical patent’s life cycle. Generic pharma must incorporate the same factors in measuring their risk, developing a business plan, and mounting a competitive campaign against a patented drug already emboldened with years of exclusivity, name recognition, and success.

Branded and generic pharma companies must continually sharpen, refine, and evolve their patent life cycle strategies in the wake of constant, challenging, and sometimes volatile change – economic, political, and legal.

ACI is proud to present this timely publication from the hallmark event for the pharmaceutical industry – 9th Annual Maximizing Pharmaceutical Patent Life Cycles Conference. This definitive Hatch-Waxman event provided the crucial information for pharmaceutical patent counsel to cultivate, modify, and enhance a foundation for their life cycle strategies. Industry leaders offer insight on analyzing the complex issues, evaluating options, and benchmarking strategies against competitors on either side of the progressively heated branded-generic battle.

Contents & Contributors

EVOLVING LIFECYCLE GAME PLAN: WHAT ARE THE DRIVERS? WHAT’S THE STRATEGY?
John C. Vassil, Morgan & Finnegan LLP (New York, NY)

PATENT FILING STRATEGIES FOR THE PHARMASEUTICAL INDUSTRY: WHAT, WHEN AND WHERE?
Philip Datlow, Boehringer Ingelheim Pharmaceuticals, Inc. (Ridgefield, CT)

GUARDING AGAINST THE DANGER OF JUDGES MISREADING PATENTS
Renee Kosslak, Ph.D., PDL BioPharma, Inc. (Redwood City, CA)

ENSURING AN INTERNATIONAL PATENT PROSECUTION STRATEGY IS IN PLACE
Andrew A. Paul, Procter & Gamble Company (Cincinnati, OH)

VIEW FROM THE FTC: PHARMACEUTICALS, PATENTS AND PROMOTING COMPETITION
Saralisa Brau, Federal Trade Commission (Washington, DC)

NAVIGATING THE COMPLEXITY OF STRUCTURING PATENT SETTLEMENT OPTIONS BETWEEN BRAND NAME AND GENERIC PHARMACEUTICAL COMPANIES
Stephana E. Patton, Ph.D., Salix Pharmaceuticals, Inc. (Palo Alto, CA)

NAVIGATING PATENT SETTLEMENTS: REVIEW OF FTC COMPLAINT IN RE CEPHALON
Shashank Upadhye, Apotex, Inc. (Toronto, Canada)

BRAND NAME AND GENERIC PHARMACEUTICAL PATENT SETTLEMENTS
Mark E. Waddell, Loeb & Loeb LLP (New York, NY)

DECLARATORY JUDGMENT ACTIONS AND COVENANTS NOT TO SUE IN A POST-MEDIMMUNE WORLD
Denise L. Loring, Ropes & Gray LLP (New York, NY)

EYE ON THE BENCH: IDENTIFYING JUDICIAL TRENDS IN PHARMACEUTICAL PATENT CASES
Hollie L. Baker, Wilmer Hale LLP (Boston, MA)

KSR 18 MONTHS LATER: RETHINKING PARAGRAPH IV CHALLENGES IN VIEW OF SHIFTING OBVIOUSNESS STANDARDS
Duane-David Hough, Fish & Richardson P.C. (New York, NY)

THE 180-DAY EXCLUSIVITY: WAIVER AND RELINQUISHMENT
Mark I. Bowditch, Sandoz Inc. (Princeton, NJ)

MASTERING THE INTRICACIES OF THE 180-DAY GENERIC MARKET EXCLUSIVITY
William D. Hare, Concentrx BioSciences, Inc. (Princton, NJ)

HATCH-WAXMAN FORFEITURE CASES 2003 MMA AMENDMENTS
Thomas D. Hoffman, Sandoz Inc. (East Hanover, NJ)

FDA EXCLUSIVITIES
Charles J. Raubicheck, Frommer Lawrence & Haug LLP (New York, NY)

RESEARCH TOOL PATENTS AND THEHATCH-WAXMAN SAFE HARBOR
Brian D. Coggio, Fish & Richarson P.C. (New York, NY)

INJUNCTIONS RELATED TO ACTIVITIES NOT WITHIN “SAFE HARBOR
” Eric Fischer, Schering-Plough Corporation (Kenilworth, NJ)

271(E)1 SAFE HARBOR, PROVERIS, AND ME?
Thomas S. Kim, VGX Pharmaceuticals, Inc. (Blue Bell, PA)

VIEW FROM THE FDA: PATENTS AND THE EXCLUSIVITY PROVISIONS OF THE MMA
Elizabeth Dickinson U.S. Food and Drug Administration (Rockville, MD)

RECENT DEVELOPMENTS IN THE LAW OF DECLARATORY JUDGMENTS IN PATENT CASES
Michael P. Dougherty, Cadawalder, Wickersham & Taft LLP (New York, NY)

SLICING THROUGH THE COMPLEX SPECTRUM OF DECLARATORY JUDGMENT ACTIONS IN PHARMACEUTICAL PATENT CASES
Steven J. Lee, Ph.D., Kenyon & Kenyon LLP (New York, NY)

SLICING THROUGH THE COMPLEX SPECTRUM OF DECLARATORY JUDGMENT ACTIONS IN PHARMACEUTICAL PATENT CASES
James P. Leeds, Eli Lilly and Company (Indianapolis, IN)

FACTORING THE ROLE, CHALLENGES, AND IMPACT OF ORANGE BOOK LISTINGS AND DE-LISTINGS IN PATENT PORTFOLIO MANAGEMENT
Ann M. Caviani Pease, Ph.D., Dechert LLP (Silicon Valley, CA)

MINING THE ORANGE BOOK AND PATENT DELISTING: EFFECT ON 180-DAY GENERIC EXCLUSIVITY
Bruce A. Pokras, Pfizer Inc. (New York, NY)



DOCUMENT TYPES: PPT PDF PRESENTATIONS AVAILABLE: 26

8:00
Registration and Continental Breakfast
9:00
Co-Chairs' Opening Remarks
-Mr. George W. Johnston, Esq.
Vice President & Chief Patent Counsel
Hoffmann LaRoche
John C. Vassil
Of Counsel
Morgan & Finnegan LLP
9:15
Clarifying the Evolving Meaning of 'Patent Life Cycle' for the Pharmaceutical Business
-Mr. George W. Johnston, Esq.
Vice President & Chief Patent Counsel
Hoffmann LaRoche
1 file
EVOLVING LIFECYCLE GAME PLAN
577.5 KB 15 pages Presentation
PPT - EVOLVING LIFECYCLE GAME PLAN
John C. Vassil
Of Counsel
Morgan & Finnegan LLP
1 file
EVOLVING LIFECYCLE GAME PLAN
577.5 KB 15 pages Presentation
PPT - EVOLVING LIFECYCLE GAME PLAN
10:15
Morning Coffee Break
10:30
Constructing‚ Adjusting‚ and Executing a Pharmaceutical Patent Life Cycle Management Plan
Steven J. Moore
Partner
Kelley Drye & Warren LLP
Mr. Philip Datlow
Senior Associate Director and Senior Counsel‚ Intellectual Property
Boehringer Ingelheim Pharmaceuticals‚ Inc.
1 file
Patent Filing Strategies for the Pharmaceutical Industry: What, When and Where
227.3 KB 18 pages Presentation
PDF - Patent Filing Strategies for the Pharmaceutical Industry: What, When and Where
Dr. Renee Kosslak
Senior Counsel
Abbott Laboratories
1 file
Guarding Against the Danger of Judges Misreading Patents
1.5 MB 43 pages Presentation
PPT - Guarding Against the Danger of Judges Misreading Patents
Andrew Paul
Senior Counsel
Procter & Gamble Company
2 files
Ensuring An International Patent Prosecution Strategy is in Place
241.5 KB 12 pages Presentation
PPT - Ensuring An International Patent Prosecution Strategy is in Place
Ensuring Patent Applications are Filed with Supporting Information
247.5 KB 17 pages Presentation
PPT - Ensuring Patent Applications are Filed with Supporting Information
12:30
Networking Luncheon
13:15
View from the FTC
Ms. Saralisa Brau
Attorney‚ Health Care Services and Products Division‚ Bureau of Competition
Federal Trade Commission
2 files
View From The FTC: Pharmaceuticals, Patents and Promoting Competition
914 KB 31 pages Presentation
PPT - View From The FTC: Pharmaceuticals, Patents and Promoting Competition
View from the FTC: Case
961.5 KB 28 pages Presentation
PDF - View from the FTC: Case
14:15
Navigating the Complexity of Structuring Patent Settlement Options Between Brand Name and Generic Pharmaceutical Companies
Dr. Stephana E. Patton
Senior Attorney‚ Intellectual Property and Licensing
Salix Pharmaceuticals‚ Inc.
1 file
“Navigating the Complexity of Structuring Patent Settlement Options Between Brand Name and Generic Pharmaceutical Companies”
347.5 KB 18 pages Presentation
PPT - “Navigating the Complexity of Structuring Patent Settlement Options Between Brand Name and Generic Pharmaceutical Companies”
Mr. Shashank Upadhye
Lawyer & Pharma Executive
1 file
Navigating Patent Settlements
248.5 KB 15 pages Presentation
PPT - Navigating Patent Settlements
-Mark E. Waddell
Partner
Loeb & Loeb LLP
1 file
Brand Name and Generic Pharmaceutical Patent Settlements
262 KB 11 pages Presentation
PPT - Brand Name and Generic Pharmaceutical Patent Settlements
Mr. William J. Golden, Jr.
Chair‚ IP and Technology Litigation
Kelley Drye & Warren LLP
15:30
Refreshment Break
15:45
Eye on the Bench: Identifying Judicial Trends in Pharmaceutical Patent Cases
Moderator: Ms. Denise L. Loring
Partner
Ropes & Gray LLP
1 file
Declaratory Judgment Actions And Covenants Not To Sue In A Post-MedImmune World
307.5 KB 27 pages Presentation
PPT - Declaratory Judgment Actions And Covenants Not To Sue In A Post-MedImmune World
Ms. Hollie L. Baker
Partner
Wilmer Hale LLP
1 file
Eye on the Bench: Identifying Judicial Trends in Pharmaceutical Patent Cases
426.5 KB 21 pages Presentation
PPT - Eye on the Bench: Identifying Judicial Trends in Pharmaceutical Patent Cases
Dr. Michael Davitz
Partner
Fahmi, Sellers, Embert & Davitz LLP
Mr. Duane-David Hough
Principal
Fish & Richarson P.C.
1 file
KSR 18 Months Later: Rethinking Paragraph IV Challenges in View of Shifting Obviousness Standards
979.5 KB 41 pages Presentation
PPT - KSR 18 Months Later: Rethinking Paragraph IV Challenges in View of Shifting Obviousness Standards
17:25
Conference Adjourns to Day Two
17:30
Cocktail Reception Hosted by Fish & Richardson
7:45
Continental Breakfast
8:30
Co-Chairs' Opening Remarks
8:45
Mastering the Intricacies of the 180-Day Generic Market Exclusivity
Mr. Richard J. Berman
Partner
Arent Fox LLP
Mr. Mark Bowditch
Executive Director, Head, US Product Support
Sandoz‚ Inc.
1 file
The 180-Day Exclusivity: Waiver and Relinquishment
306 KB 9 pages Presentation
PPT - The 180-Day Exclusivity:  Waiver and Relinquishment
Mr. William Hare
Legal Director
Concentrx BioSciences‚ Inc.
1 file
Mastering The Intricacies Of The 180-Day Generic Market Exclusivity
1.2 MB 16 pages Presentation
PPT - Mastering The Intricacies Of The 180-Day Generic Market Exclusivity
Thomas D. Hoffman, Ph.D., J.D.
Consultant‚ Patent Counsel
Sandoz, Inc.
1 file
Hatch-Waxman Forfeiture Cases 2003 MMA Amendments
308 KB 9 pages Presentation
PPT - Hatch-Waxman Forfeiture Cases  2003 MMA Amendments
10:00
Morning Coffee Break
10:15
Penetrating the Complexities of Non-Patent/FDA Exclusivities
Mr. Stuart Kim
Senior Regulatory Counsel‚ Pharmaceuticals
Covidien PLC
Mr. Charles Raubicheck
Partner
Frommer Lawrence & Haug LLP
1 file
FDA EXCLUSIVITIES
196.5 KB 12 pages Presentation
PPT - FDA EXCLUSIVITIES
11:15
Plotting a Course into Safe Harbor for Branded Pharma
-Brian Coggio
Senior Principal
Fish & Richardson‚ P.C.
1 file
Research Tool Patents and theHatch-Waxman Safe Harbor
258.9 KB 27 pages Presentation
PDF - Research Tool Patents and theHatch-Waxman Safe Harbor
Mr. Eric Fischer
Senior Counsel
Schering-Plough Corporation
1 file
Injunctions Related To Activities Not Within “Safe Harbor”
163 KB 7 pages Presentation
PPT - Injunctions Related To Activities Not Within  “Safe Harbor”
Mr. Thomas S. Kim
Senior Director of Intellectual Property
VGX Pharmaceuticals‚ Inc.
1 file
271(e)1 Safe Harbor, Proveris, and ME?
297 KB 10 pages Presentation
PPT - 271(e)1 Safe Harbor, Proveris, and ME?
12:15
Networking Luncheon
13:30
View from the FDA
Ms. Elizabeth H. Dickinson
Associate Chief Counsel for Drugs
U.S. Food and Drug Administration
1 file
The View from FDA: Patents and the Exclusivity Provisions of the MMA
139.5 KB 29 pages Presentation
PPT - The View from FDA: Patents and the Exclusivity Provisions of the MMA
14:30
Slicing Through the Complex Spectrum of Declaratory Judgment Actions in Pharmaceutical Patent Cases
- Michael P. Dougherty
Special Counsel
Cadwalader‚ Wickersham & Taft LLP
1 file
Recent Developments In The Law Of Declaratory Judgments In Patent Cases
228.5 KB 15 pages Presentation
PPT - Recent Developments In The Law Of Declaratory Judgments In Patent Cases
Dr. Steven J. Lee, Ph.D.
Partner
Kenyon & Kenyon, LLP
1 file
Minimizing Pharmaceutical Patent Life Cycles
413.5 KB 19 pages Presentation
PPT - Minimizing Pharmaceutical Patent Life Cycles
Mr. James P. Leeds
Associate General Patent Counsel
Eli Lilly and Company
1 file
Slicing Through the Complex Spectrum of Declaratory Judgment Actions in Pharmaceutical Patent Cases
189 KB 20 pages Presentation
PPT - Slicing Through the Complex Spectrum of Declaratory Judgment Actions in Pharmaceutical Patent Cases
15:45
Refreshment Break
16:00
Factoring the Role‚ Challenges‚ and Impact of Orange Book Listings and De-Listings in Patent Portfolio Management
Ms. Ann M. Caviani Pease
Partner
Dechert LLP
1 file
Application Drafting Strategies In Light of Orange Book Listings and Assessing the Import of Antitrust Considerations in Listings
651 KB 37 pages Presentation
PPT - Application Drafting Strategies In Light of Orange Book Listings and Assessing the Import of Antitrust Considerations in Listings
Bruce A. Pokras
Senior Corporate Counsel
Pfizer Inc.
1 file
Mining the Orange Book and Patent Delisting
523 KB 18 pages Presentation
PPT - Mining the Orange Book and Patent Delisting
17:00
Conference Ends