Lek Decides to File an Appeal Against the Temporary Injunction Issued by the Commercial Court of Zagreb

1. 10. 2002

Ljubljana, 1 October 2002 – Lek Pharmaceuticals d.d., Verovškova 57, Ljubljana, hereby announces that its subsidiary Lek Zagreb d.o.o., Maksimirska 120, Zagreb, Croatia, has received a temporary injunction from the Commercial Court of Zagreb on the ban on the import and distribution of the drug Amlopin upon the proposal by Pfizer Limited due to a patent infringement claim.

Lek Zagreb d.o.o.has been marketing the anti-hypertensive drug Amlopin in the Croatian market since 1993. Amlodipine bezilate, the active ingredient of the drug Amlopin, is manufactured by Lek d.d., following its own patented procedure. Lek d.d. filed a patent application as early as in 1992 for the protection of its procedure in Slovenia, Croatia, Federal Republic of Yugoslavia and in a number of other countries and the patents were granted to Lek d.d. in all named couontries. . Among others also the European Patent Office and the US Patent Office have granted the patent to Lek d.d. Since the year 1992, Lek d.d. has been manufacturing the active substance amlodipine bezilate following its own patented procedure in the Ljubljana production facilities.

The company Pfizer started to market its product in one galenic form in Croatia no sooner than at the end of June 2002, while Lek Zagreb has been marketing it in two galenic forms.

Lek strongly believes that all the above indicated facts form a sound basis for its decision to file an appeal against the temporary injunction, which namely fails to fulfil the conditions for its issuance and lacks the necessary legal basis. In its interpretation of the injunction, the Court demonstrated no probability of Lek infringing the Pfizer’s patent, neither has it demonstrated, according to Lek, any probability of irreparable loss incurred by Pfizer, nor the risk of Lek preventing Pfizer from enforcing its claim or at least obstructing it. On the contrary, Lek, with its presence in the market since 1993, is the party suffering the loss.

The Court’s decision shows the unpredictability of the environment, with the pressures from large pharmaceutical corporations causing the basic rules of generic competition and legal arguments to fail. This applies mostly to emerging countries, which have insufficient experience in this field, as in the developed environment of the EU and the USA similar decisions are rendered only exceptionally.

According to Lek’s estimates, the decision of the Croatian Commercial Court will not affect the company’s operations, since the company will take all the necessary steps to make the drug Amlopin available to patients in Croatia under the previous conditions.

This press release contains statements and predictions about Lek’s future business operations. The predictions comprise estimates made on the basis of all currently available information. If the predictions prove unreliable, the actual business results could differ from the expected.


For additional information please call 386 (01) 580 22 43 Miša Komar Žiberna, Corporate Communications, Lek d.d.