Abstract
Lundbeck’s patents protecting their blockbuster Cipralex® have been subject to invalidation actions around the globe for already many years. Cipralex® is an antidepressant drug which contains as the active substance escitalopram, the (S)-enantiomer of the racemic mixture citalopram marketed amongst others as Cipramil®. Outside Europe, these actions have mainly been finalised. However, patent litigation is still continuing in Europe.
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References
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7.The term “stereoselective” means that a given starting material yields one enantiomer or diastereomer in larger amount than the other. The term “stereospecific” means that the given starting material yields this enantiomer or diastereomer exclusively; Klumpp GW. Reactivity in organic chemistry J. Wiley & Sons, 1982, p.16 .
8.Kitchin J., Generics (UK) vs. H Lundbeck A/S, Chancery Division, High Court of Justice, [2007] RPC 32, 4 May 2007 .
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12.Dutch Patents Court, 312468/HA ZA 08-1827 of April 8, 2009; according to T 1046/97, an enantiomer of compound X and a racemate of compound X must be regarded as different compounds so that the enantiomer is novel over the racemate .
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15.Dutch Court of Appeal, case numbers 200.444.332/01, 200.081.980/01 and 200.081.996/01, 24 January 2012; the hearing was held on 11 February 2011 .
16.The problem-solution approach adapted by the European Patent Office has similarities with the approach taken by the USPTO (Graham vs. John Deere Co., 383 U.S. 1 (1966)) and the “Windsurfing/Pozzoli” approach known from the UK .
17.Based on inter alia C-392/97, C-258/99, C-630/10 and C-322/10 of the ECJ (currently CJEU) .
18.Belgian Court of Commerce, Lundbeck vs. Ratiopharm (Teva) and Tiefenbacher, 3 October 2011 .
19.C-431/04 and C-202/05 of the ECJ (currently CJEU) .
20.Belgian Court of Appeal, A.R. no. 2011/AR/2821, 14 February 2012 .
21.http://thespcblog.blogspot.com (accessed 8 March 2012) .
22.French Court of Appeal, case 10-25495, SPC No 02C0020 directed to a mixture of Benoxacor and (S)-metolachlor31 January 2012 .
23.http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/index.html (accessed 8 March 2012) .
24.http://www.epo.org/law-practice/legislative-initiatives/epla.html (accessed 8 March 2012) .
