EPLAW Patent Blog

BE - Teva v. Sepracor / invalidity

Teva v. Sepracor, Commercial court of Antwerp, 11 December 2009, Docket number A/08/5474

The Antwerp commercial court has annulled the Belgian tier of Sepracor’s European patent (EP 663 828) for “compositions for treating allergic disorders using (-) cetirizine”, as well as the ensuing SPC for “levocetirizin dihydrocholorid”. Applying (a hybrid version of) the problem-solution approach, the court found that the invention of EP ‘828 was obvious for the skilled person, who was held to be a team composed of persons with a medical, chemical and pharmacological background.

According to the court, the skilled person would have been able to solve the objective technical problem (circumscribed as “finding a substance which can be used for the treatment of allergic rhinitis and asthma and which is at least as effective and advantageous as ceterizine, yet having no or fewer side effects than racemic cetirizine”) with a reasonable expectation of success by combining a number of prior art documents. Referring to T 296/87, the court added that a skilled person who wants to preserve the pharmacological properties of a racemic mixture, but with less side effects, would routinely examine both enantiomers separately to see if he can achieve that goal.

Read the decision (in Dutch) here.

Head note: Philippe de Jong

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.