4th Advanced Forum on

Biotech Patents

The Tactical and Practical Guide to Today's Most Complex Issues

Monday, December 06, 2004

About

In the ongoing quest to develop new, effective and profitable biological products and therapies, the biotech and pharmaceutical industries are constantly and aggressively fighting to preserve and enforce their patent rights to the existing tools and processes which continue to enable them to unlock the secrets of genetic defects and disease.

However, innovator biotech companies are now about to face a whole new set of patent challenges. The patent life cycles of many of their most lucrative biological products are on the verge of expiration. Generic competitors are seeking to put biogenerics on the market in a manner similar to that of small molecule generic drugs. Although it is anyone's guess as to what the final outcome of these latest patent challenges will be, one thing is certain: based on the number of infringement suits filed in the last year alone, these companies will hold no bars to protect the patents on their biotech inventions.

With millions in future revenue at stake, it is imperative that counsel to biotech and pharmaceutical companies and their advisors have an up-to-the-minute and complete understanding of the latest legal developments affecting biotech patents. This American Conference Institute publication will give you in-depth analysis from an outstanding faculty of leading in-house biotech and pharmaceutical counsel and expert attorneys.

Contents & Contributors

About

In the ongoing quest to develop new, effective and profitable biological products and therapies, the biotech and pharmaceutical industries are constantly and aggressively fighting to preserve and enforce their patent rights to the existing tools and processes which continue to enable them to unlock the secrets of genetic defects and disease.

However, innovator biotech companies are now about to face a whole new set of patent challenges. The patent life cycles of many of their most lucrative biological products are on the verge of expiration. Generic competitors are seeking to put biogenerics on the market in a manner similar to that of small molecule generic drugs. Although it is anyone's guess as to what the final outcome of these latest patent challenges will be, one thing is certain: based on the number of infringement suits filed in the last year alone, these companies will hold no bars to protect the patents on their biotech inventions.

With millions in future revenue at stake, it is imperative that counsel to biotech and pharmaceutical companies and their advisors have an up-to-the-minute and complete understanding of the latest legal developments affecting biotech patents. This American Conference Institute publication will give you in-depth analysis from an outstanding faculty of leading in-house biotech and pharmaceutical counsel and expert attorneys.

Contents & Contributors

THE SCOPE OF PROTECTION UNDER THE "SAFE HARBOR" PROVISION OF THE HATCH-WAXMAN ACT AND THAT OF FOREIGN COUNTERPARTS; APPLICABILITY OF THE "SAFE HARBOR" PROVISION TO RESEARCH TOOL PATENTS; AND SECTION 271(g) AND THE IMPORTATION OF DATA
Brian D. Coggio, Orrick, Herrington & Sutcliffe LLP

STRATEGIES FOR ENHANCING THE LIKELY ENFORCEABILITY OF PHARMACEUTICAL PATENTS IN VIEW OF RECENT FEDERAL CIRCUIT DECISIONS
David J. Weitz, Syrrx, Inc.
Elizabeth A. Howard, Orrick, Herrington & Sutcliffe LLP
Rachel D. Albright, Orrick, Herrington & Sutcliffe LLP

PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT IN VIEW OF RECENT FEDERAL CIRCUIT DECISIONS
Rachel D. Albright, Orrick, Herrington & Sutcliffe LLP

PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT IN VIEW OF RECENT FEDERAL CIRCUIT DECISIONS
David J. Weitz, Syrrx, Inc.

FESTO IN LIGHT OF THE FEDERAL CIRCUIT'S EN BANC RULING: WHERE ARE WE NOW AND WHERE ARE WE GOING?
Scott B. Familant, Orrick, Herrington & Sutcliffe LLP

FOLLOW-ON BIOLOGICS: THE LEGAL AND REGULATORY LANDSCAPE
Michael S. Labson, Covington & Burling

ANTIBODY PATENTABILITY
Jane T. Gunnison, Fish & Neave

RESEARCH TOOL PATENTS: DEFENSES TO INFRINGEMENT
Richard J. Berman, Arent Fox PLLC

REACH-THROUGH CLAIMS
Frank P. Grassler, GlaxoSmithKline

JUDICIAL REMEDIES FOR INFRINGEMENT OF RESEARCH TOOL PATENTS
Donald R. Ware, Foley Hoag LLP

TACKLING WRITTEN DESCRIPTION ISSUES
Gerard F. Diebner, Greenberg Traurig LLP

CURRENT WRITEN DESCRIPTION REQUIREMENTS FOR PATENTABILITY IN BIOTECH
Vernon M. Winters, Weil, Gotshal & Manges LLP

CLAIM CONSTRUCTION TRENDS
Sandra A. Bresnick, Weil Gotshal & Manges, LLP

THE ACCIDENTAL AND INHERENT ANTICIPATION DOCTRINE: WHERE DO WE STAND AND WHERE ARE WE GOING?
Anne Brown, Athersys Inc.
Mark Polyakov, Athersys Inc.

DOUBLE PATENTING: HANDLING DIFFICULT PROSECUTION AND LITIGATION ISSUES
Emily A. Evans, Morrison & Foerster
Jill A. Jacobson, Morrison & Foerster

THE FINE ART OF INTERFERENCE PRACTICE: STRUCTURE, CONCEPTS AND PITFALLS
Samuel B. Abrams, Jones Day LLP
Muna Abu-Shaar, Jones Day LLP
Christine B. Chua, Jones Day LLP

THE ENABLEMENT REQUIREMENT AND FUTURE DEVELOPMENTS
Kevin L. Bastian, Townsend Townsend & Crew LLP

THE UTILITY REQUIREMENT AND THE GENOMICS INDUSTRY: A STUDY IN THE RELATIONSHIP BETWEEN COMMERCE AND LAW
John Storella, Ciphergen

3D STRUCTURES & THE TRILATERAL REPORT
Lisa A. Dixon, Vertex Pharmaceuticals Incorporated

LICENSING STRATEGIES
Judith Ann Hasko, Cooley Godward

RECENT INTERNATIONAL AND DOMESTIC DEVELOPMENTS IN ANTITRUST, PATENT MISUSE AND COMPETITION LAW AFFECTING BIOTECH PATENT LICENSING
Stephen P. Johnson, Kirkland & Ellis

FREEDOM TO OPERATE AND OPINION LETTERS: KEY CONSIDERATIONS IN AN EVOLVING BIOTECH PATENT LANDSCAPE
Joyce Morrison, Xencor
Robin M. Silva, Dorsey & Whitney

DRAFTING SUCCESSFUL BIOTECHNOLOGY RELATED PATENT APPLICATIONS MASTER CLASS
Mark A. Kassel, Foley Lardner
Kenneth H. Sonnenfeld, Ph.D., J.D., Morgan & Finnegan
Carol Stratford, Ph.D., J.D., Stratford Law



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