9th Advanced Forum on

Biotech Patents

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

Thursday, September 27, 2007

About

Biotechnology inventions are only as valuable as their patents, and every facet of patenting-from qualifying criteria, to the scope of rights a patent bestows, to the length of a patent's duration-is becoming increasingly complex. This is especially true of patents covering biotechnology inventions.

Learn to incorporate evolving legal and regulatory standards into biotech patent practices

Several bills have been introduced in Congress that would specifically impact patents in the biotech industry, including proposals surrounding follow-on biologics and genes. Also, recent Supreme Court cases such as MedImmune v. Genentech and KSR v. Teleflex may have a significant effect on patents and licensing as well as the obviousness standard. Many courts are also reassessing the standard for inequitable conduct and basic claim construction principles. In addition to case law and legislative efforts, PTO reforms are still looming on the horizon.

Develop strategies for managing your biotech patent portfolio

With patent standards constantly in flux, you need to decide whether it is beneficial to file for patents in the first place. To make this determination, you need to know how to conduct the most effective and cost-efficient freedom to operate analysis to ensure that you are even able to seek the desired patent. If you are free to seek a patent, you must develop practical strategies for working with the examiners to achieve the best results possible.

In short, anyone drafting biotech patent applications needs to be able to incorporate current standards-while making allowances for potential reforms-and scientific realities into their claims to ensure that their patents are ironclad, both in the United States and abroad.

With all of this in mind, the American Conference Institute has developed this publication from our 9th Advanced Forum on BIOTECH PATENTS: Analysis, Insights and Strategies for New Challenges in Biotech Patent Practice to provide you with the most up-to-date and complete information on current legal developments impacting your biotech patent practice.

Contents & Contributors

About

Biotechnology inventions are only as valuable as their patents, and every facet of patenting-from qualifying criteria, to the scope of rights a patent bestows, to the length of a patent's duration-is becoming increasingly complex. This is especially true of patents covering biotechnology inventions.

Learn to incorporate evolving legal and regulatory standards into biotech patent practices

Several bills have been introduced in Congress that would specifically impact patents in the biotech industry, including proposals surrounding follow-on biologics and genes. Also, recent Supreme Court cases such as MedImmune v. Genentech and KSR v. Teleflex may have a significant effect on patents and licensing as well as the obviousness standard. Many courts are also reassessing the standard for inequitable conduct and basic claim construction principles. In addition to case law and legislative efforts, PTO reforms are still looming on the horizon.

Develop strategies for managing your biotech patent portfolio

With patent standards constantly in flux, you need to decide whether it is beneficial to file for patents in the first place. To make this determination, you need to know how to conduct the most effective and cost-efficient freedom to operate analysis to ensure that you are even able to seek the desired patent. If you are free to seek a patent, you must develop practical strategies for working with the examiners to achieve the best results possible.

In short, anyone drafting biotech patent applications needs to be able to incorporate current standards-while making allowances for potential reforms-and scientific realities into their claims to ensure that their patents are ironclad, both in the United States and abroad.

With all of this in mind, the American Conference Institute has developed this publication from our 9th Advanced Forum on BIOTECH PATENTS: Analysis, Insights and Strategies for New Challenges in Biotech Patent Practice to provide you with the most up-to-date and complete information on current legal developments impacting your biotech patent practice.

Contents & Contributors

Protein Therapeutics and “Biogeneric” Competition
Kathleen Madden Williams, Edwards, Angell, Palmer & Dodge LLP

Follow-On Biologics: The New Regulatory Frontier [?]
Michael Labson, Covington & Burling LLP

The Patenting Of Biotechnology Inventions: Ethical and Practical Considerations
Arie M. Michelsohn, PhD, Millbank, Tweed, Hadley & McCloy LLP

Patenting of Life – Biotechnology Innovation: How Other Countries Consider the Ethical and Practical Concerns
Lesley Rapaport, Borden Ladner Gervais

Freedom to Operate Assessments in Biotechnology: Analysis, Opinions and More
Thomas M. Saunders, Seyfarth Shaw LLP
John C. Serio, Seyfarth Shaw LLP

Obviousness After Ksr V. Teleflex
Kevin E. Noonan, PhD, McDonnell Boehnen Hulbert & Berghoff LLP

Protecting Proprietary Information – Biological Materials
Suzannah K. Sundby, Smith Gambrell & Russell LLP

Maximizing Your Success With the Examiner: How to Prepare and Prosecute High Quality Biotechnology Patent Applications
Stephen G. Kunin, Spivak, McCelland Maier & Neustadt P.C.

Working Effectively With Examiners When Filing & Drafting Biotech Patent Claims
Robert Smyth, PhD, Morgan, Lewis & Bockius LLP

Final Rulemakings: Continuation and Examination Practice
Michele A. Cimbala, PhD, Sterne, Kessler, Goldstein & Fox P.L.L.C.

Continuation, Claims, Co-Pending New Rules
Denise M. Kettelberger, PhD, Merchant & Gould P.C.

Evolving Best Practices for Claim Construction in Biotech Patent Applications
Jerry Cohen, Burns & Levinson LLP
Janine M. Susan, Burns & Levinson LLP
Yakov Korkhin, PhD, Burns & Levinson LLP

Dissecting the Impact of Medimmune
Gregory Castanias, Jones Day Cultivating Biotechnology Patent Strategies in Europe and Asia: Identifying Differences and Assessing Impact on US Practices
Andreas von Falck, Lovells

The China Patent System and Current Issues
Michael J. Wise, Perkins Coie LLP

Maximizing Patent Term Extensions and Adjustment
Scott E. Kamholz, M.D., PhD, Foley Hoag LLP

Patenting Antibodies
Eric K. Steffe, Sterne, Kessler, Goldstein & Fox P.L.L.C

Inequitable Conduct – The “Plague” Continues
Vineet Kohli, Merck & Co, Inc.



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