UPDATE: The German Plavix Case: Loopholes In European Data Protection?

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UPDATE: The German Plavix Case: Loopholes In European Data Protection?

Originators beware: The marketing authorization granted by the

German authority for a generic formulation of Plavix and the

subsequent decisions of the competent courts in preliminary

proceedings to allow the marketing of the drug raise questions

about the protection of data under the European regulatory

framework. Business plans will have to allow for generic

competition earlier than previously expected, and particular

attention should be paid to the publication of preclinical and

clinical data.

This is an update to our Commentary from September

2008, incorporating the decision of the court of appeals. Added

sections are marked "UPDATE."

Introduction

In 2006, sales of Plavix, the blockbuster anticoagulant of the

French pharmaceutical company Sanofi-Aventis, suffered a blow in

the U.S., where it is distributed by Bristol-Myers Squibb, when the

Canadian generics company Apotex launched a generic form of the

drug. An injunction, upheld on appeal, subsequently barred Apotex

from distributing the drug during the...

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