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Issue 5 : September/October 2002


Update 2002, Issue 5: Intellectual Property

 

 

Intellectual Property

September/October 2002

Subscription Information
FDLI members receive Update as part of membership.
Additional copies or back issues are available at $15 each.

 

 

 

Feature Articles


Bringing Reason to Pharmaceutical Patent Settlements

by Robert D. Paul, Partner and Co-Chair of the Global Antitrust Group in the law firm of White & Case LLP, Washington, D.C. and formerly General Counsel of the Federal Trade Commission.

Hatch-Waxman: Will the Playing Field Be Leveled?
by Richard J. Berman, Member in the law firm of Arent Fox Kintner Plotkin and Kahn PLLC, Washington, D.C.
and Ashley A. Weaver, Law Clerk in the law firm of Arent Fox Kintner Plotkin and Kahn PLLC, Washington, D.C.

Controversy Surrounding FDA's Same Labeling Requirement for Generic Drugs
by Clark G. Sullivan, Associate in the law firm of King & Spalding, Atlanta, GA

Trademark Implications of Repairing and Altering Branded Products
by Raymond A. Kurz, Partner in the law firm of Hogan & Hartson LLP,
Washington, D.C.
and Celine Jimenez Crowson, Partner in the law firm of Hogan & Hartson LLP, Washington, D.C.
and Shelly L. McGee, Associate in the law firm of Hogan & Hartson LLP, Washington, D.C.

FDA's Office of Postmarketing Drug Risk Assessment Trademark Approval Process
by Gabrielle A. Holley, Associate with the law firm of Pillsbury Winthrop LLP, San Diego, CA

 

Also In This Issue


FDA Finalizes Rule That Could Expand OTC Drug Marketplace

by Suzan Onel, Partner in the law office of Kirkpatrick & Lockhart, L.L.P., Washington, D.C.

Impact of New OTC TEA Rule
by Scott Bass, head of the Food and Drug practice at Sidley Austin Brown & Wood LLP in Washington D.C.
and Emily Marden, Associate in the Food and Drug practice at Sidley Austin Brown & Wood LLP in New York

FDA in the Dock: The Supreme Court's Western States Decision
by Jonathan S. Kahan, Partner in the law firm of Hogan & Hartson, L.L.P., Washington, D.C.
and Jeffrey K. Shapiro, Partner in the law firm of Hogan & Hartson, L.L.P., Washington, D.C.

The European Food Safety Authority
by Roger Chadwick, Advisor with the Liberal/ELDR Group in the European Parliament, Brussels, Belgium

Fraud and Abuse Enforcement: Medical Device Manufacturers Beware!
by Howard J. Young, Partner in the law firm of Arent Fox Kintner Plotkin and Kahn PLLC, Washington, D.C. and formerly with the DHHS Office of Inspector General

 

Columns


From the President's Desk

Regulatory Trade-Offs
by Jerome A. Halperin, President and Chief Executive Officer of the Food and Drug Law Institute, Washington, D.C.

Making History
A History Primer on Bioterrorism: Part II
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
Disgorgement and the Schering Case—What Are the Rules?
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd, LLC, Chicago, IL

Global Corner
Intellectual Property Concerns in the EU
by Matthew Weinberg, Chief Executive Officer of THE WEINBERG GROUP, INC., Washington, D.C.

Associates' Corner
A Rose Is a Rose Is a Rose, or Is It? Hatch-Waxman Protection of Patents for Polymorphs and Hydrates
by John Barlow Weiner, Associate in the law firm of Ropes & Gray, Washington, D.C.

Note: All author affiliations are current as of the date of publication of the issue.

 

 

(Note: All author affiliations are current as of the date of publication of the issue.)

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