Pharmaceutical Innovation, Competition and Patent Law
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Pharmaceutical Innovation, Competition and Patent Law

A Trilateral Perspective

Edited by Josef Drexl and Nari Lee

Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care.
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Chapter 7: Recent UK case law on supplementary protection certificates

A Trilateral Perspective

Richard Arnold


Recently there have been quite a number of cases in the UK involving requests for supplementary protection certificates. Many of these have raised issues of interpretation of Council Regulation 1768/92/EEC of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, now codified as European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (‘the Regulation’), and as a result several questions have been referred to the Court of Justice for the European Union. Article 1 of the Regulation contains four key definitions, including the following definition of ‘product’ in paragraph (b): ‘product’ means the active ingredient or combination of active ingredients of a medicinal product. In Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd [2009] EWCA Civ 646, [2009] RPC 23 Daiichi was the proprietor of EP 0 047 005 applied for in 1981 and granted in 1984 which covered ofloxacin, a racemic mixture of enantiomers. Marketing authorizations were granted for ofloxacin in Germany in 1985 and in the UK in 1990. Daiichi was also the proprietor of EP 0 206 283 applied for in 1986 and granted in 1993 for levofloxacin, one of the two enantiomers contained in the racemate. Levofloxacin is much more active, much more soluble and less toxic than the other enantiomer. GUK unsuccessfully attacked the validity of EP 283, Kitchin J and the Court of Appeal holding that levofloxacin was novel and inventive over the prior art. A UK marketing authorization for levofloxacin was granted in 1997.

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