Developments in Pharmaceutical and Biotech Patent Law 2009

Overview

Why You Should Attend

This year’s program is totally new! Pharmaceutical and biotech patent law is an important and rapidly changing practice area and the program is designed to give you the information you need to maintain your practice edge.

Technological innovation, Federal Circuit appellate oversight, Congressional action and Supreme Court decisions have all driven significant changes in the law. Several different perspectives on many of the most pressing issues will be offered from experienced in-house and outside counsel.

Do not miss this opportunity to fully understand the impact of appellate decisions and the pending patent legislation on your pharmaceutical and biotechnology patent practice.

What You Will Learn

• The patentability of pharmaceutical products post-KSR v. Teleflex from the Federal Circuit and District Court perspectives
• Inequitable conduct in biotechnology and pharmaceutical patent cases; recent Supreme Court and Federal Circuit developments
• Section 112 developments regarding enablement and written description requirements: the impact of  U.S. Patent and Trademark Office (USPTO) Written Description Guidelines
• Cutting-edge issues impacting your pharma and biotech patent prosecution practice
• Patent misuse and other issues in pharma and biotech licensing
• At the intersection of antitrust and pharma and biotech patent cases: unique issues that can arise and strategies to avoid antitrust liability

Who Should Attend

The program will cover many aspects of pharmaceutical and biotech patent law, including many of the most recent developments relevant to anyone who practices in this area. Attorneys, whether in-house counsel or practicing at law firms, who are responsible for pharmaceutical and biotech patent prosecution, patent litigation and patent transactions and strategies, will benefit from attending this program.

Special Features

Live Webcast - Simultaneous live webcast of the New York session is available for individual viewing. Webcast participants will receive streaming audio and/or video of the program, view and print the Course Handbook, and have the ability to submit questions electronically.

For more information click on the Live Webcast link in the Related Items box.

Special Bonus to all Registrants

All attendees will receive a complimentary copy of PLI's comprehensive Course Handbook. This softcover, bound volume was written to augment the program and to stand alone as a permanent reference. PLI's Course Handbooks represent the definitive thinking of the nation's finest legal minds, and are often the standard reference in the field.

Please Note: Webcast attendees will receive a downloadable version of the Handbook one business day prior to the program.

PLI Group Discounts

Groups of 4-14 from the same organization, all registering at the same time, for a PLI program scheduled for presentation at the same site, are entitled to receive a group discount.  For further discount information, please contact membership@pli.edu or call (800) 260-4PLI.

PLI Can Arrange Group Viewing to Your Firm

Contact the Groupcasts Department via email at groupcasts@pli.edu for more details.

Cancellations

All cancellations received 3 business days prior to the program will be refunded 100%. If you do not cancel within the allotted time period, payment is due in full. You may substitute another individual to attend the program at any time.

Schedule

Please plan to arrive with enough time to register before the conference begins. A networking breakfast will be available upon your arrival.

Morning Session: 9:00 a.m. - 12:30 p.m.

9:00  Program Overview

David K. Barr, Daniel L. Reisner

9:15  Patentability of Pharmaceutical Products in View of KSR

How has KSR impacted the patentability of pharmaceutical products at the Federal Circuit? How have the federal district courts reacted to KSR? Learn about the effect of KSR on pharma inventions, including:

• The development of the “lead compound” analysis for determining obviousness of drug compounds
• Patentability issues affecting chemical compounds, stereoisomers, and pharmaceutical salts
• Review the significant post-KSR Federal Circuit pharma cases, including: Takeda v. AlphaPharm (Actos®), Ortho-McNeill v. Mylan (Topomax®), Eisai v. Dr. Reddy’s (AcipHex®), and Sanofi v. Apotex (Plavix®)
   

David K. Barr

10:15  Inequitable Conduct in Biotechnology and Pharmaceutical Patent Cases

Are biotechnology and pharmaceutical patents more prone to inequitable conduct challenges because they tend to have lengthier, more arduous prosecution histories and claim inventions that are based on complex laboratory and clinical experimentation? 

Learn the common evils - or pitfalls, as the case may be - that can render biotechnology and pharmaceutical patents unenforceable for inequitable conduct and the potential downstream consequences of such a holding

• Find out whether the “plague” rages on or is becoming more contained
• Recent developments at the Federal Circuit and the Supreme Court, along with Patent Reform Legislation, will be discussed

Jennifer Gordon

11:15  Networking Break

11:30  Developments in Section 112 Law: The Enablement and Written Description Requirements As Applied to Pharma and Biotech Patents

Learn how the ever-evolving Section 112 requirements have been affecting pharma and biotech patents. 

• How have the USPTO’s Written Description Guidelines developed and what has been their impact on pharma and biotech patents in litigation? 
• Are there special rules that apply to patents directed to nucleic acid sequences? 
• Explore the relationship between written description and the utility requirement for biotech patents

Karen I. Boyd, Prof. Timothy R. Holbrook, Lisa A. Schneider

12:30  Lunch Break

Afternoon Session: 1:45 p.m. - 5:00 p.m.

1:45  Cutting Edge Issues Impacting Pharma and Biotech Prosecution

• What has been the impact of KSR on the examination of pharmaceutical and biotech patent applications in the USPTO? 
• How have the revised Written Description Guidelines affected prosecution in the pharmaceutical and biotech arts? 
• How has the USPTO been dealing with nucleotide and amino acid sequence claims in terms of written description and utility? 
• What rule changes are being considered that may impact pharma and biotech practice before the USPTO?

Sharon Fujita, Cynthia H. Zhang

2:45  Networking Break

3:00  Patent Misuse and Other Issues in Pharmaceutical and Biotech Licensing

• What is patent misuse: when does it matter and why?
• Can patent misuse be cured and what does that mean when analyzing the potential for patent misuse?
• When and how does monetizing research tool patents risk patent misuse? 
• Arbitration and Most Favored Nation clauses in patent licenses
• Effect of corporate transactions on existing patent licenses

Daniel L. Reisner

4:00  Antitrust Issues Impacting Pharma and Biotech Patent Cases

• What kinds of unique antitrust issues arise in litigation over pharma and biotech patents? 
• What strategies should be used to avoid antitrust liability in bringing and maintaining Hatch-Waxman litigation? 
• What constraints affect settlement? 
• What issues do authorized generics raise? 
• How have recent decisions by the courts and actions by the FTC altered the landscape?

Stephen J. Elliott

5:00  Adjourn

Faculty

Co-Chair(s)

David K. Barr, Kaye Scholer LLP
Daniel L. Reisner, Kaye Scholer LLP

Speaker(s)

Karen I. Boyd, Turner Boyd LLP
Stephen J. Elliott, Kaye Scholer LLP
Sharon Fujita, Attorney-at-Law
Jennifer Gordon, Baker Botts L.L.P.
Timothy R. Holbrook, Professor of Law, Emory University School of Law
Lisa A. Schneider, Sidley Austin LLP
Cynthia H. Zhang, Ph.D., Director, Intellectual Property, Gilead Sciences, Inc.

Program Attorney(s)

John M. Mola, Practising Law Institute

CLE Credit

Travel Information

San Francisco Seminar Location

PLI California Center, 685 Market Street, San Francisco, California 94105. (415) 498-2800.

San Francisco Hotel Accommodations

The Palace Hotel, 2 New Montgomery Street, San Francisco, California 94105. Call (800) 917-7456 seven days a week from 6:00 am to 12:00 am (PDT) and mention you are attending this program at Practising Law Institute to receive the preferred rate. For online reservations, go to www.sfpalace.com/pli to receive the preferred rate.

Due to high demand we recommend reserving hotel rooms as early as possible.