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