EPLAW Patent Blog

NL - Lundbeck v. Sandoz / escitalopram

H. Lundbeck S/A v. Sandoz B.V., District Court The Hague, The Netherlands, 14 August 2012, Case No. 424154 / KG ZA 12-787, with thanks to Willem Hoyng, Jeroen den Hartog and Geert Theuws, Hoyng Monegier, for sending in the judgment and a translation in English

*** Now with translation in English ***

The Judge in Interlocutory Proceedings of the District Court in The Hague ordered a preliminary injunction against Sandoz based on Lundbeck’s  escitalopram patent.

The Judge followed Lundbeck’s reasoning that an earlier decision of the Dutch Court of Appeal (which may be read here), stating (in brief) that a substance may only be patented if the substance itself is inventive, is likely to be erroneous. The Judge awarded the injunction based on a process claim in the patent. Sandoz, according to the Judge, did not successfully argue that it did not implement the patented process.

Interestingly, the Judge awarded a provisional injunction already at the oral hearing, for the duration of the preliminary injunction proceedings.

Read the decision (in Dutch) here.
Read the decision (in English) here.

FR - Teva v. Sepracor / Invalidity (Enantiomers)

Teva Classics SAS, Teva Sante SASU and Teva Pharmaceutical Industries Ltd v. Sepracor Inc, invalidity proceedings (enantiomers), Tribunal de Grande Instance, Paris, France, 6 October 2009, Docket No. 07/16446, with thanks to Pierre Véron, Véron & Associés

Cetirizine is a chiral molecule likely to exist in the form of two enantiomers, Levocetirizine (-) and Dextrocetirizine (+). The French first instance court invalidates the French part of Sepracor's European Patent 0 663 828 that relates to the use of Levocetirizine for the manufacture of a drug for treating allergic rhinitis or allergic asthma, for insufficient disclosure. On the same day the '828 patent was filed, Sepracor filed a patent application, which claims the use of dextrocetirizine (the (+) cetirizine enantiomer) for treating the same allergies and that it is completely identical to the other patent application except for a word.

The court rules that the absence of any mention of research and result proves the speculative nature of the patent application and, as a consequence, conceals the lack of inventive step. The existence of the 'sister' patent application of the patent in dispute in the view of the court moreover tends to establish that on the filing date of these patent applications Sepracor had no information to decide which one of the two enantiomers was the most efficient one (or had the least adverse effects), or even whether one of the two enantiomers was more efficient (or had less adverse effects) than the racemic form.

Read the judgment (in French) here.
Read the judgment (in English) here.

DE - Lundbeck v. Neolab Ltd. (Escitalopram) / invalidity

Lundbeck A/S v. Neolab Ltd. et al. (Escitalopram), invalidity proceedings, Federal Supreme Court, Germany, 10 September 2009, Docket number Xa ZR 130/07

Patentability of an enantiomer over a known racemate.

The Federal Supreme Court states that a publication from which it is apparent that there must be enantiomers of a chemical compound does not directly and clearly reveal the enantiomers themselves, unless the publication makes it easily possible for the person skilled in the art to obtain these enantiomers.

A marketing authorisation for a medicinal product that contains a chemical compound in racemate form as the active ingredient does not preclude the issuance of a supplementary protection certificate for a medicinal product which contains an enantiomer of the same compound.

Read the judgment (in German) here.
Read the judgment (in English) here.
Read a summary (in English), provided by Bardehle Pagenberg here.

Head note: Tilman Müller-Stoy

UK - Generics v Daiichi / Appeal

Generics (UK) v Daiichi, Court of Appeal, London, UK, 2 July 2009, Case No. [2009] EWCA Civ 646, with thanks to Marc Döring, Simmons & Simmons

In this case, the Court of Appeal has upheld the decision of Kitchin J that, although a course of action was obvious, the skilled person's motivation to pursue it to the point of making the invention was weak; and that accordingly the invention (an enantiomer of an antibiotic) was not obvious.

Read the extended summary (provided by Rowan Freeland and Scott Parker) here.

Read the appeal decision here.

Read the first instance decision here.

UK - Generics (UK) Ltd v. Daiichi Pharmaceutical

Generics (UK) Ltd v. Daiichi Pharmaceutical Co. Ltd and Daiichi Sankyo Co. Ltd, High Court of Justice, Chancery Division, Patents Court, 15 October 2008, 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.

Read the extended summary here.

Read the judgment (in English) here.

UK - Dr Reddy's Laboratories (UK) Ltd v. Eli Lilly

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.

Read the extended summary here.

Read the judgment (in English) here.