Lek wins patent suit on amlodipine bezilate in Slovenia

12. 2. 1999

On 2 February 1999 the District Court in Ljubljana on remand from the High Court of Ljubljana decided against the patent infringement claim of Pfizer Inc., and stated that Lek is producing the active substance known as amlodipine bezilate according to the process for which Lek has obtained patent protection in Slovenia and several other countries.

This law suit was commenced in April 1993 when Pfizer filed a patent infringement action against Lek d.d., one of Slovenia’s largest pharmaceutical manufacturers. The complaint alleged that Lek still infringed Pfizer’s process patents covering the manufacturing methods for the drug active substance with generic name amlodipine bezilate known by the trademarks Amlopin (Lek) and Norvasc (Pfizer).

Pfizer claimed infringement of its patent rights in Slovenia on the basis of three Slovenian process patents which had been re-registered at the Slovenian Intellectual Property Office on the basis of Yugoslav patents. LEK was successful in showing that the manufacturing process used by LEK is not within the scope of Pfizer’s patent rights. Pfizer had claimed that the process of LEK, even if based on LEK’s own patented method, still fell within the scope of Pfizer’s protection on the basis of the “doctrine of equivalents". The District Court in Ljubljana rejected Pfizer’s claims completely on remand, reaffirming its previous decision.