ARTICLES
PROTECTION FOR ORPHAN MEDICINAL PRODUCTS IN THE EU AND CONTROVERSIES THAT HAVE ARISEN UNDER THE EU REGIME
TREVOR COOK
Bird & Bird LLP, London

The orphan medicinal products regime in the EU supplements that as to regulatory data protection but differs from it in offering true exclusivity and not just exclusivity over the use of data. Moreover, and in contrast to regulatory data protection, it not only provides scope to secure exclusivity for a new indication of an old product because the protection that it confers is not limited only to the same but also “similar” products for the same indication where the expression “similar products,” is given a broad interpretation. This article reviews the scope ofsuch exclusivity and the legal disputes that have taken place under the orphan medicinal product regime.

THE UNIFIED PATENT COURT – SHIFTING TO A NEW PARADIGM
DAVID SANT
Solicitor-advocate, London

After decades of negotiation Europe has taken an historical step forward in radically overhauling the patent system. In the most important European development in patents since the European Patent Convention in 1977, ministers from EU member states met on 19 February to sign a treaty creating the Unified Patent Court – if the agreement is ratified Europe will have not only a new patent litigation system, but also a unitary patent covering the relevant member states. The move promises to create a very different world for those involved with patents in Europe, although its full effect of the treaty will remain unclear for some years to come. This article considers how the Unified Patent Court will work, what impact it may eventually have and speculates about how patent litigation may be conducted in the new regime.

CASE COMMENTS
COURT OF APPEAL UPHOLDS THE VALIDITY OF GENENTECH PATENT
(1) REGENERON PHARMACEUTICALS INC (2) BAYER PHARMA AG VGENENTECH INC
NINA O'SULLIVAN
S J Berwin LLP, London

The Court of Appeal has upheld Floyd J’s March 2012 decision that Genentech’s European Patent (UK) 1 238 986 relating to the use of human vascular endothelial growth factor (hVEGF) antagonists for the treatment of non-neoplastic diseases characterised by excessive angiogenesis was valid. It rejected a broad range of validity attacks by the appellants based on arguments of lack of novelty, obviousness and insufficiency, with a particular focus on the several strands to the arguments relating to sufficiency. The Court also upheld Floyd J’s finding of infringement in respect of the appellants’ product VEGF Trap-Eye (Eylea) which they intended to launch on the UK market for the treatment of neovascular age-related macular degeneration (ARMD), a leading cause of premature blindness. The patent in fact expired in October 2012 but the analysis in the judgment relating to sufficiency is of particular interest.

NEURAL PRECURSOR CELLS II: DECISION OF THE GERMAN SUPREME COURT
(BUNDESGERICHTSHOF) X ZR 58/07 (BRÜSTLE/GREENPEACE)
DR GABOR MESTER, 
DR STACEY FARMER AND
DR MARTIN GRUND
Grund IP Group Munich, Germany

The German Supreme Court applies for the first time the CJEU decision C-34/10, concerning the definition of human embryos and the patentability of their use. The use of human embryos for industrial and commercial purposes is considered not to beexcluded from patentability if the embryos are not destroyed in the process. Furthermore, stem cells obtained from a human blastocyst are not to be regarded as embryos themselves.

UK IPO CONSULTATION ON EXEMPTIONS TO PATENT INFRINGEMENT FOR CLINICAL TRIALS
LUKE KEMPTON
Partner, Wragge & Co LLP

NEWS
AUSTRALIA Patents – Cancer Voices Australia v Myriad Genetics Inc UNITED KINGDOM Regulation – Falsified Medicines Directive Tax – New CFC Rules – the Patent Box and Tax Credits for R&D

BOOK REVIEW
PHARMACEUTICAL, BIOTECHNOLOGY AND CHEMICAL INVENTIONS – WORLD PROTECTION AND EXPLOITATION Duncan Bucknell (ed.)