In November we made reference to the investigation started by the Italian Autorità Garante della Concorrenza e del Mercato (here).
It is investigated if Pfizer has tried to artificially extend the protection over EP0364417 until January 2012, trough Divisional Application no. EP1225168 (Latanoprost). The arguments used by the Italian Authority to start the investigation can be read here.
According to the Italian Law (art. 14 ter of Law no. 287/90), companies investigated can offer commitments to exclude anticompetitive effects. If those commitments are accepted by the Italian Authority, the case can be closed.
In this case Pfizer has offered the following commitments:
1.- An open and free non exclusive licence in Italy, Spain and Luxemburg over EP 1225168. Interested parties may become licensees by just submitting a letter of acceptance to Pfizer.
2.- Renounce to actions brought against AIFA e Sifi spa and others at Regional Amministrative Court of Lazio.
3.- Accept claims (legal and administrative costs excluded) filed at Courts of Milan and Rome against Pfizer by following plaintiffs.
• Tubilux Phrama spa
• Alapis sa
• Ratiopharm Italia srl
• Ratiopharm Gmbh
• Mylan spa
• Idustriale Chimica srl
• EG spa
4.- Renounce to preliminary injunction requested by Pfizer against Sifi spa at the Court of Milan
5.- Renounce to the extension requested on January 10, 2011 over the paediatric use.
6.- Inform the consumers though its website (during 3 years) about alternative Latanaprost products available in the market. Inform doctors and pharmaceutics (during 6 months) about available products in the market.
The Italian Authority will take a decision regarding Pfizer's offer before 29 July 2011.
Full text submited by Pfizer here
4 comments:
In the UK EP 0364417 received an SPC extending protection until 17th July 2011. This was further extended by six months by a paediatric SPC until 17th january 2012.
Will the CC investigate the situation in the UK? what about other countries?
After the extension granted on July 27, today October 14 ends the term to take a decision regarding Pfizer's commitments offer. I’m quite curious to see the result
Pfizer's commitments offer rejected by the Italian Authority in a decision published in Bulletin no. 40 dated 24 October 2011. A decision will be taken after January 11.
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