5th Advanced Forum on

Biotech Patents

Analysis, Insights and Strategies for New Challenges In Biotech Patent Practice

Monday, September 19, 2005

About

Are You Prepared For The Next Wave of Challenges Affecting Biotech Patent Practice?

The biotech and pharmaceutical industries are at a crossroad in their efforts to preserve and enforce the patent rights to their most effective and profitable biological products and therapies. Their present endeavors in this pursuit are plagued with many challenges and uncertainties. For example, as these industries anxiously await the Supreme Court's decision in Integra, there are questions concerning research tool patents and whether one company can successfully block a competitor from using its research tools to develop products that will affect its market share. There is also a question surrounding claim construction and the role of extrinsic evidence and expert witnesses in influencing the trial court's findings.

If these dilemmas were not enough, innovator companies are about to face a whole new set of patent challenges. Patents on many of the most lucrative biological products are now on the verge of expiration. Generic companies are seeking to put "biogenerics" on the market in a manner similar to that of small molecule generic drugs. As Hatch Waxman does not apply to biological products, it is anyone's guess as to what the final outcome of these latest patent challenges will be.

However, despite these challenges and uncertainties old and new one thing is still perfectly clear: based on the number of infringement suits filed in the last year alone not to mention vast sums of money spent on lobbying biotech companies will hold no bars to protect the patents on their 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 provide you with practical, comprehensive information and insights on:
  • The industry debate for and against follow-on biologics
  • How the CREATE Act and proposed patent reforms will shape the future of biotech patent practice
  • The continuing impact of Festo
  • 35 USC 112 Update: how key decisions on written description, enablement and utility will influence biotech patenting li> The repercussions of the Trilateral Report on 3D Crystal Structure on protein crystallography
  • International and domestic biotech licensing strategies: tips and traps

Contents & Contributors

About

Are You Prepared For The Next Wave of Challenges Affecting Biotech Patent Practice?

The biotech and pharmaceutical industries are at a crossroad in their efforts to preserve and enforce the patent rights to their most effective and profitable biological products and therapies. Their present endeavors in this pursuit are plagued with many challenges and uncertainties. For example, as these industries anxiously await the Supreme Court's decision in Integra, there are questions concerning research tool patents and whether one company can successfully block a competitor from using its research tools to develop products that will affect its market share. There is also a question surrounding claim construction and the role of extrinsic evidence and expert witnesses in influencing the trial court's findings.

If these dilemmas were not enough, innovator companies are about to face a whole new set of patent challenges. Patents on many of the most lucrative biological products are now on the verge of expiration. Generic companies are seeking to put "biogenerics" on the market in a manner similar to that of small molecule generic drugs. As Hatch Waxman does not apply to biological products, it is anyone's guess as to what the final outcome of these latest patent challenges will be.

However, despite these challenges and uncertainties old and new one thing is still perfectly clear: based on the number of infringement suits filed in the last year alone not to mention vast sums of money spent on lobbying biotech companies will hold no bars to protect the patents on their 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 provide you with practical, comprehensive information and insights on:
  • The industry debate for and against follow-on biologics
  • How the CREATE Act and proposed patent reforms will shape the future of biotech patent practice
  • The continuing impact of Festo
  • 35 USC 112 Update: how key decisions on written description, enablement and utility will influence biotech patenting li> The repercussions of the Trilateral Report on 3D Crystal Structure on protein crystallography
  • International and domestic biotech licensing strategies: tips and traps

Contents & Contributors


FOLLOW ON BIOLOGICS
Michael S. Labson, Covington & Burling

DEVELOPMENTS IN GENERIC BIOLOGICS
Charles J. Raubicheck, Esq., Frommer, Laurence, & Haug LLP

THE CREATE ACT OF 2004
Jeffrey P. Kushan, Sidley Austin Brown and Wood LLP

FESTO IN LIGHT OF THE FEDERAL CIRCUIT'S EN BANC RULING
Scott Familant, Sidley Austin Brown & Wood LLP

BIOTECHNOLOGY PATENTS AND THE WRITTEN DESCRIPTION REQUIREMENT
Paul Fehlner, Ph.D., Darby & Darby PC

ENABLING BIOTECH PATENTS: IS IT COLD FUSION IN DISGUISE?
M. Lisa Wilson, Ph.D., Duane Morris

THE UTILITY REQUIREMENT AND THE GENOMICS INDUSTRY
John Storella, Ciphergen

MERCK V. INTEGRA: AN ANALYSIS
James Haley, J.D., Ph.D., Ropes & Gray

EUROPEAN BOLAR PROVISIONS AND CLINICAL TRIALS AND RESEARCH EXEMPTIONS
Bert Oosting, Lovells

REACH-THROUGH CLAIMS AND RESEARCH TOOLS
Richard Berman, Arent Fox PLLC

THE REACH-THROUGH ROYALTIES RISK
Donald Ware, Foley Hoag LLP

THE ACCIDENTAL & INHERENT ANTICIPATION DOCTRINES
Anne Brown, Athersys Inc.

ANTIBODY PATENTABILITY
Jane T. Gunnison, Fish & Neave IP Group of Ropes & Gray

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

THE WRITTEN DESCRIPTION REQUIREMENT AND THE PATENTING OF ANTIBODIES
Amy Hamilton, Eli Lilly



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