Dr Reddy’s Laboratories (UK) Ltd and Dr Reddy’s Laboratories Ltd v Warner-Lambert Company LLC, 20 December 2012, Patents Court, UK, Case No. HC 11C03027
This is a UK decision clarifying certain provisions of Regulation (EC) 1901/2006 (the “Paediatric Regulation”) which applies in relation to the grant of a six month extension to Supplementary Protection Certificates (SPCs), and of Regulation (EC) 469/2009 (the “SPC Regulation”). The Court held that deferrals under the Paediatric Regulation can be requested on the ground where the safety of the product was a concern, or the paediatric study would have caused the delay in the authorisation for adults. Further, Article 45(3) of the Paediatric Regulation is transitional in nature and has no application in cases where all the studies included in a paediatric investigation plan were initiated after the regulation came into force on 26 January 2007.
The Court also clarified that Article 16 of the SPC Regulation grants discretion to national bodies whether or not to revoke an extension if the conditions of Article 36 of the Paediatric Regulation are not met.
H. Lundbeck A/S v. Pharma Change ApS, bailiff's court (enforcement court) Elsinore, Denmark, 16 April 2010, Docket no. 9921/2009
A Danish bailiff's court granted Lundbeck's application for an interim injunction against the wholesaler Pharma Change ApS, selling and distributing a generic escitalopram product manufactured by Dr. Reddy's Laboratories in India.
Having obtained in the summer of 2009 an interlocutory injunction against the largest Danish wholesaler, Nomeco A/S, H. Lundbeck A/S filed an application for an interlocutory injunction against the new and independent wholesaler, Pharma Change ApS, which carried as its only prescription pharmaceutical in its portfolio a generic escitalopram pharmaceutical.
Dr Reddy’s Laboratories (UK) Limited v. Eli Lilly and Company Limited, Court of Appeal (Civil Division), UK, 18 December 2009, Docket No: Case No.A3/2008/2966, with thanks to Robert Fitt,Bristows
The Court of Appeal upheld the decision of Mr Justice Floyd and confirmed that Lilly’s (selection) patent concerning the drug olanzapine is valid.
Olanzapine is one of the 1019 compounds and one of the 86,000 preferred compounds mentioned in the '235 patent. It is not mentioned specifically. Dr Reddy's Research Laboratories (DRL) contention that the specific compound lacks novelty, was rejected (i) as a matter of a priori reasoning (a generalised prior description does not disclose a specific matter within it) and (ii) because it is inconsistent with EPO Board of Appeal Case Law (Hoechst Enantiomers T 0296/87).
The pre-EPC rules, as formulated in I.G. Farbenindustrie's Patents should be regarded as part of legal history, not as part of the living law. The better approach is to see what the EPO Boards do (AgrEvo (T 0939/92) and Wyeth (T133/01). "The EPO jurisprudence is founded firmly around a fundamental question: has the patentee made a novel, non-obvious technical advance and provided sufficient justification for it to be credible?" An 'arbitrary selection' provides no technical contribution.
Dr Reddy's Laboratories (UK) Ltd v. Eli Lilly and Company Limited, High Court of Justice, Chancery Division, Patents Court, 13 October 2008, Case No. [2008] EWHC 2345 (Pat), with thanks to Marc Döring, Simmons & Simmons
The English Patents Court's decisions in Dr Reddy's v Eli Lilly (Floyd J - 13 October 2008) and Generics (UK) v Daiichi (Kitchin J - 15 October 2008) are further welcome news for patentees. In both instances the patent (for a compound within the scope of a "Markush formula" of an earlier patent application in the first case and for an enantiomer in the second case) was upheld.
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