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home > epc > summer 2003 > data exclusivity under review - striking the balance between originator and generic medicines

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European Pharmaceutical Contractor Data Exclusivity Under Review - Striking the Balance Between Originator and Generic Medicines
The first part of this article, The Current Legal Framework of Regulatory Data Protection (Data Exclusivity) Within The EU, addressed the concept of "essential similarity" as developed by the European Court of Justice (ECJ) in its 'Generics' judgment of 1998 (1). The scope of protection for variations and line extensions has been discussed, as well as the question of whether a generic product can be authorised after the marketing of the originator product has been discontinued. Both subjects are currently at issue in pending proceedings at the ECJ. In his recent opinion in the Novartis case, Advocate General Jacobs held that a generics manufacturer may, under the abridged procedure, refer to product A and cross-refer to product B if B is a line extension of A, provided that the generic product is either bioequivalent to A or to B (2). In another opinion delivered on the same day in the AstraZeneca case, Advocate General Jacobs took the view that a generic product could be authorised even after the marketing of the originator product had been discontinued, provided that the generic application was filed at a time where the marketing authorisation of the originator product was still in force (3). While the decisions of the ECJ are pending in both cases, the discussion about the Commission's and the European Parliament's recent proposals for reform of the provisions on data exclusivity is still going on. The Proposals for Amending the Data Exclusivity Provisions The Commission's Proposals In its proposal for a directive amending Directive 2001/83/EC adopted on 26th November 2001, the Commission suggested the following modifications of the provisions relating to data exclusivity:
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By Dr Manja Epping, Lawyer at Ashurst Morris Crisp, Germany

Dr Manja Epping is a qualified lawyer working in the Munich office of international law firm Ashurst Morris Crisp. In 1990 she took a French degree (Maоtrise en droit) in international and European law. After having qualified in Germany in 1995, Manja wrote her doctoral thesis on German and international arbitration law.

Since then, she has specialised in German and European intellectual property law including regulatory issues, with a particular focus on the pharmaceutical and nutraceutical industries. She is an experienced litigator and a regular speaker at conferences.