Law Seminars International Presents

Running the Race with

Running the Race with Biotechnology

From start to finish for all lawyers and industry executives

March 8 & 9, 2004
Hyatt Regency La Jolla in San Diego, CA
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Who Should Order Homestudy

Attorneys, industry executives, industry representatives, consultants, government and university officials

Why Order

"Biotechnology is racing ahead with advancements in gene therapies, stem cell research, pharmaceutical drug developments, biologics and devices. To get pioneering biotechnology and pharmaceutical innovations to market, they must pass through a complex maze of intellectual property, contract, licensing, regulatory and financing issues, often interspersed with litigation and dispute management. Industry leaders and practitioners need a holistic approach to biotechnology and pharmaceutical development which takes into account all of these challenges. This two-day conference is an advanced level interactive session with national level experts on leading issues of the day. It is an opportunity to meet with peers, to engage in thoughtful discussion, and to update and expand your understanding in all of these areas." ~ Kate Murashige, Esq., Ph.D. and Lynn H. Pasahow, Esq.

What You Will Learn

Emerging business and legal issues in biotechnology, including: Legal Protections, FDA Regulations, Key Licensing Alliances, Financing, Antitrust Issues, Dispute Resolution, Hot Topics in the Press

What Attendees Said

"Overall very good." "Excellent overview for non-FDA lawyer." " I learned a lot of new things!"

Agenda

Monday, March 08, 2004
8:30 am At the Starting Line
  Kate H. Murashige, Ph.D., Esq, Program Co-Chair
 Morrison & Foerster LLP / San Diego, CA
  Lynn H. Pasahow, Esq., Program Co-Chair
 Fenwick & West LLP / Palo Alto, CA
8:45 am Out of the Blocks: What is Biotechnology?
  Making sense of the jargon; reading materials and training resources for non-science professionals; survey of current science
  Cathryn Campbell, Esq., Ph.D.
 McDermott, Will & Emery / San Diego, CA
9:30 am First Hurdle: The Unique Nature of Bio-technology as a Business
  Understanding the strategic interaction of food & drug administration regulations, intellectual property law, and technology licensing
  Mark S. Brown, Esq.
 King & Spalding / Washington, DC
  Biotechnology from the device patent perspective: Biotech outside pharmaceuticals
  Andrew P. Rasdal, President & CEO
 DexCom, Inc. / San Diego, CA
10:45 am Break
11:00 am Second Hurdle: Legal Protections for Biotech
  Patent Basics: patenting genes, living organisms and treatment methods; utility, enablement, best mode, written description, novelty & non-obviousness; understanding the structure of patent claims; strategies for patent portfolios
  Jorge A. Goldstein, Esq., Ph.D.
 Sterne Kessler Goldstein & Fox PLLC / Washington, DC
  Trade secrets, CDAs, MTAs, DMF/BMFs and other non-patent protections
  Alan J. Morrison, Esq.
 Cooper & Dunham LLP / New York, NY
12:00 pm Lunch (on your own)
1:15 pm Third Hurdle: FDA Regulation of Drugs and Devices
  Medicare Prescription Drug, Improvement and Modernization Act 2003
  Brian Slater, Esq.
 Fitzpatrick, Cella, Harper & Scinto / New York, NY
  The FDA, biologics and combination drug/devices.
  Edward L. Korwek, Esq., Ph.D.
 Hogan & Hartson LLP / Washington, DC
2:15 pm Fourth Hurdle: Alliances
  Business Development: Why and when to partner; finding partners; valuing technologies and deals; M&A as a tool for growing a business
  Kevin F. Kelly, Esq.
 Heller Ehrman White & McAuliffe LLP / Seattle, WA
  University/Industry partnerships
  Alan S. Paau, MBA, Ph.D., Assistant Vice Chancellor
 University of California San Diego / La Jolla, CA
3:15 pm Break
3:30 pm Fifth Hurdle: Documenting and Administering Deals
  Biotech Licensing Basics: exclusivity and retained rights; royalty provisions; hybrid licenses; field of use definitions; licensing for troubled companies
  Roger M. Tolbert, Esq.
 Orrick Herrington & Sutcliffe, LLP / Seattle, WA
  Auditing provisions, control of patent prosecution and infringement actions
  Kirke M. Hasson, Esq.
 Pillsbury Winthrop / San Francisco, CA
  Joseph M. Reisman, Esq., Ph.D.
 Knobbe Martens Olson & Bear LLP / San Diego, CA
5:15 pm Reception
  Sponsored by Fenwick & West LLP and Morrison & Foerster LLP

Tuesday, March 09, 2004
8:30 am Special Address: "Special Problems in Protecting Pharmaceuticals in Biotechnology"
  Kate H. Murashige, Ph.D., Esq, Program Co-Chair
 Morrison & Foerster LLP / San Diego, CA
9:30 am Sixth Hurdle: Who’s Going to Pay for All This?
  Industry investment outlook, by sector
  Robert E. Patterson, Esq.
 Squire, Sanders & Dempsey LLP / Palo Alto, CA
  Coming consolidation? M&A activity and prospects; practical aspects of mergers and acquisitions
  Douglas N. Cogen, Esq.
 Fenwick & West LLP / San Francisco, CA
  M&A agreements; securities reporting and disclosure issues
  Mark Hofer, Esq.
 Brown Rudnick Berlack Israels LLP. / Boston, MA
10:15 am Break
11:15 am Seventh Hurdle: Advanced Patent and Licensing Issues
  Doctrine of equivalents; international patenting; reach-through royalties; research tool patents, etc.
  Debra D. Nye, Esq.
 Foley & Lardner LLP / San Diego, CA
  Market exclusitivity for biopharmaceuticals: extending patents and other means for getting or prolonging exclusitivity
  Gregory P. Einhorn, Esq., Ph.D..
 Morrison & Foerster LLP / San Diego, CA
12:15 pm Lunch (on your own)
1:30 pm Eighth Hurdle: Avoiding Antitrust Problems
  Antitrust issues in alliances and M&A; also in delaying introduction of generics
  Scott Andrew Sher, Esq.
 Wilson Sonsini Goodrich & Rosati / Palo Alto, CA
2:15 pm Ninth Hurdle: Staying on Top
  Gathering good Business Intelligence about your competition and protecting your own competitive advantage
  R. Mark Halligan, Esq.
 Welsh & Katz, Ltd. / Chicago, IL
3:00 pm Break
3:15 pm Tenth Hurdle: Dispute Resolution
  Lessons from recent cases; arbitration vs. litigation
  John Allcock, Esq.
 Gray Cary Ware & Freidenrich LLP / San Diego, CA
  David C. Doyle, Esq.
 Morrison & Foerster LLP / San Diego, CA
  IP rights litigation in the biotech industry: patent and patent license litigation
  Lynn H. Pasahow, Esq.
 Fenwick & West LLP / Palo Alto, CA
4:15 pm The Finish Line: Hot Topics from the Press
  GMO’s; stem cells; cloning; regulation and disclosure issues in clinical trials; bioterrorism; regional development of biotech industry
  Donald R. Johnston, VP & Group Publisher
 Bioworld Online / Atlanta, GA
5:00 pm Adjourn

Cancellation

There is a $25 cancellation fee for Course Materials orders and $50 for Homestudy orders

Continuing Education Credits

Law Seminars International self-certifies CLE credits for Washington, California, and Alaska. For other locations, we automatically seek CLE credit approval for the state in which a seminar is held. On request, we will apply for credits from other bar associations or the accrediting bodies for other professions. The current credits status for this program is CA MCLE 13.75 | AZ CLE 13.75 | CO CLE 17 | IA CLE 13.5 (#23502) | NY CLE 16.5 (no ethics non-transitional) | OH CLE 13.5 (#000139432) | OR CLE 14.5 (#2104*192) | TX CLE 12.75 (#000059985) | UT CLE 16.5 | WA CLE 13.75 (#116154)

Cost

Our complete Homestudy Course, consisting of a VHS or DVD recording and the written course materials, is available for $905. The course materials alone are available for $100. We will ship your homestudy order via UPS ground within two weeks after the seminar or the date we receive payment (which ever is later).
Order Homestudy

Faculty Bios

Kate H. Murashige, Program Co-Chair, a partner at Morrison & Foerster LLP and co-chair of the firm’s Patent Group, focuses her practice on the pharmaceutical and healthcare industries.

Lynn H. Pasahow, Program Co-Chair, is a partner in the Litigation and Intellectual Property Groups of Fenwick & West LLP. His practice focuses on patent and other intellectual property counseling, litigation, and mediation principally related to software and Internet technologies.

John Allcock, a partner at Gray Cary Ware & Freidenrich, LLP, is the Chair of the Patent, Copyright, and Trademark Litigation Division. His practice focuses largely on handling patent cases through trial and appeal to the Federal Circuit.

Mark S. Brown is a partner with King & Spalding LLP’s FDA Practice Group. He has also served as an Associate Chief Counsel for Enforcement in the Office of General Counsel for the Food and Drug Administration.

Cathryn Campbell is a partner in the San Diego office of McDermott, Will & Emery. Dr. Campbell serves as head of the firm’s Life Sciences Intellectual Property practice where she concentrates her practice on biotechnology patent law.

Doug N. Cogen is a partner with the San Francisco offices of Fenwick & West LLP and is Co-Chair of the Mergers and Acquisitions Group. His practice focuses on mergers and acquisitions, strategic and commercial transactions, corporate counseling and financing.

Mr. Doyle is a partner with the San Diego office of Morrison & Foerster LLP. He is Co-Chair of the Firm's intellectual property group.Mr. Doyle specializes in patent litigation and patent licensing disputes. He has extensive experience in all facets of intellectual property and licensing litigation for pharmaceutical, biotechnology, telecommunication and other technology companies. He was recognized as one of San Diego’s leading intellectual property attorneys by San Diego Magazine.

Gregory P. Einhorn is a partner with Morrison & Foerster, LLP in San Diego. Dr.Einhorn’s practice emphasizes intellectual property and life sciences and health care, particularly patent prosecution in the field of biotechnology, immunology, cell biology, molecular biology and genetics.

Jorge A. Goldstein is a Director in the Biotechnology/Chemical Group at Sterne, Kessler, Goldstein & Fox P.L.L.C. Dr. Goldstein’s intellectual property experience has been principally in areas such as genomics, molecular and cell biology, and recombinant DNA technology.

Mark R. Halligan is a principal with Welsh & Katz, Ltd. He is a recognized expert in trade secrets law and teaches Advanced Trade Secrets Law and Trade Secrets Litigation at John Marshall Law School.

Kirke M. Hasson is Co-chair of Pillsbury Winthrop LLP’s Life Sciences and Technology Group. His practice includes a range of litigation, with special focus on disputes in the biotechnology and life sciences fields.

Mark A. Hofer is a partner in the Boston office of Brown Rudnick Berlack Israels LLP. Mr. Hofer’s expertise and experience is greatest in analyzing, identifying and developing pathways for strategic business development particularly in the biotech environment.

Donald R. Johnston is Vice President and Group Publisher of BioWorld Today, BioWorld International and all of the other BioWorld publications, including BioWorld Online (www.bioworld.com). His group, a division of Thomson Healthcare, also publishes Medical Device Daily.

Kevin F. Kelly, a shareholder in the law firm of Heller Ehrman White & McAuliffe LLP, practices commercial law and is a member of Heller Ehrman’s National Life Sciences Practice Group.

Edward L. Korwek is a partner in the Washington, D.C. office of Hogan & Hartson L.L.P. Dr. Korwek’s practice is primarily in the areas of food, drug, medical device and environmental law. He also concentrates on biotechnology issues pertaining to these practice areas.

Alan J. Morrison is a member of Cooper & Dunham LLP based in New York. He specializes in biotechnology patent and transactional law, and has lectured internationally on various topics in U.S. patent law.

Alan S. Paau is Assistant Vice Chancellor for University of California, San Diego, and holds a Ph.D. degree in Biological Sciences and a Master of Business Administration degree. He is the inventor to 8 US patents and has contributed thirty peer-reviewed research articles to scientific journals and six invited reviews/chapters to technical books.

Robert E. Patterson is a partner in the Palo Alto offices of Squire Sanders & Dempsey LLP and was named as one of Silicon Valley’s top corporate lawyers in May 2003 by San Jose Magazine.

Andrew P. Rasdal is President and CEO of DexCom, Inc., a development-stage company focused on commercializing the first long-term implantable sensor for the continuous measurement of glucose in people with diabetes.

Joseph M. Reisman is a partner in Knobbe Martens Olson & Bear LLP’s San Diego office. Dr. Reisman’s practice involves patent prosecution and strategic counseling, chiefly for clients in the pharmaceutical industry, as well as patent litigation and appellate work involving various technologies.

Scott Sher is an associate in WSGR's Palo Alto office, where he focuses on antitrust and trade regulation matters, with a particular emphasis on government investigations and counseling matters. He assists clients with antitrust issues that arise throughout the merger and acquisition process, from pre-merger counseling through investigations conducted by the Department of Justice, the Federal Trade Commission, and foreign regulatory agencies. He also counsels clients on a wide range of antitrust issues, including distribution, pricing and standard-setting matters. Scott Andrew Sher Scott Sher is an associate in WSGR's Palo Alto office, where he focuses on antitrust and trade regulation matters, with a particular emphasis on government investigations and counseling matters.  He assists clients with antitrust issues that arise throughout the merger and acquisition process, from pre-merger counseling through investigations conducted by the Department of Justice, the Federal Trade Commission, and foreign regulatory agencies.  He also counsels clients on a wide range of antitrust issues, including distribution, pricing and standard-setting matters. Scott has written several antitrust related articles, including a discussion of the antitrust implications for the peer-to-peer networking industry, which appeared in the July 2001 Antitrust Report, and was featured in the FTC: Watch newsletter.  Scott has also written articles for the Santa Clara Computer and High Technology Law Journal, Mergers & Acquisitions Advisor, Competition, The Journal of the Antitrust and Unfair Competition Law Section of the State Bar of California and the Transportation Antitrust Update.  Scott has spoken on recent developments in merger-antitrust law at the 12th Annual Seattle Conference on Computer Law and at the 2001 Mergers & Acquisitions Advisor Conference. 

Brian Slater is a partner in the New York office of Fitzpatrick, Cella, Harper & Scinto. He specializes in patent and trade secret litigation, as well as opinions and the intellectual property aspects of transactions.

Roger M. Tolbert leads the intellectual property contracting and licensing practice in Orrick Herrington & Sutcliffe LLP’s Pacific Northwest office. He represents clients from the biotechnology, pharmaceuticals and e-commerce industries. Mr. Tolbert is listed in The Best Lawyers in America and by Seattle Magazine as one of Seattle’s Top Lawyers.