European Union

Genentech Inc. v Hoechst GmbH and Sanofi-Aventis Deutschland GmbH (Court of Justice of the European Union, Case C-567/14, 2016)

The Court of Justice of the European Union confirmed its position that a contractual obligation to pay royalties for a licensed intellectual property (IP) right does not depend on the validity of the licensed IP right. Such contractual obligation in the Court’s view is compatible with competition law provided the licensee has the right to terminate the licensing agreement.

Sanofi-Aventis/Zentiva (Commission of the European Communities, Case No COMP/M.5253, February 2009)

In early 2009, the Commission of the European Communities cleared the proposed acquisition of the generic drug maker Zentiva N.V. by Sanofi-Aventis Europe, subject to conditions. In light of Sanofi-Aventis’ commitment to divest fifteen drugs in Eastern Europe, the Commission concluded that the proposed acquisition would not harm competition in the internal market.

Teva/Barr (Commission of the European Communities, Case No COMP/M.5295, December 2008)

This case concerned a concentration involving two generic producers. The Commission of the European Communities approved the proposed acquisition of Barr Pharmaceuticals, Inc., by Teva Pharmaceutical Industries Limited, subject to conditions. In its decision, the Commission recognized that the third level of the anatomical therapeutic chemical (ATC) classification system, known by the abbreviation ATC3, is not always the most appropriate level for the purposes of market definition. It adopted inter alia a narrower market definition, i.e.

Generics (UK) limited, The Wellcome Foundation Limited and Glaxo Operations UK limited and Others, 3 December 1998 (Court of Justice of the European Union Case C-368/96)

This case concerned the protection of pharmaceutical test data under European Union (EU) legislation. The Court of Justice of the European Union (CJEU) interpreted EU law as authorizing generic producers to rely on the test data submitted by an originator firm once the original product has been in the market for at least six or ten years (depending on national law), as long as the generic product is essentially similar to the original product.

Case Summary

IMS Health GmbH v NDC Health GmbH (Court of Justice of the European Union Case C-418/01, 29 April 2004)

In the IMS Health case, the Court of Justice of the European Union (hereinafter “CJEU”) clarified the ‘exceptional circumstances’ test used to determine whether a refusal to license an intellectual property right (hereinafter “IPR”) constitutes an abuse of a dominant position under Art. 102 of the Treaty on the Functioning of the European Union.

Case Summary

Établissements Consten S.à.R.L. and Grundig-Verkaufs-GmbH v Commission of the European Economic Community, 1966 Case 56/64

The Court of Justice of the European Communities (CJEC), known today as the Court of Justice of the European Union, examined the application of most aspects of Article 101 of the Treaty on the Functioning of the European Union (TFEU), which prohibits agreements restricting competition. It held inter alia that the prohibition of Article 101 TFEU applies not only to horizontal agreements but also to vertical agreements.

AstraZeneca AB & AstraZeneca plc v European Commission, 6 December 2012 (Court of Justice of the European Union)

The Court of Justice of the European Union (CJEU) upheld the General Court’s decision that AstraZeneca abused its dominant position by excluding from the market competing manufacturers of generic products. The CJEU concluded that AstraZeneca’s attempt to mislead the patent offices amounted to an abuse of a dominant position and that the deregistration of the marketing authorizations (MAs) for its anti-ulcer medicine with the principal intention of preventing generic market entry was inconsistent with European competition law.

Genentech Inc. v Hoechst GmbH and Sanofi-Aventis Deutschland GmbH (Court of Justice, Case C-567/14, 2016)

The Court of Justice of the European Union confirmed its position that a contractual obligation to pay royalties for a licensed intellectual property (IP) right does not depend on the validity of the licensed IP right. Such contractual obligation in the Court’s view is compatible with competition law provided the licensee has the right to terminate the licensing agreement.

Copolymers/Dupont, T124/87, OJ 1989 (1988) (European Patent Office Boards of Appeal)

In this case, the European Patent Office Boards of Appeal decided on the patentability of a class of compounds defined by parameters within numerical ranges. It denied the grant of a patent, finding that the invention lacked novelty and an inventive step.