Spanish Supreme Court confirms Bexal and Uso Racional victory over Pfizer (Amlodipine)

On January 3, 2013 the Spanish Supreme Court has dismissed the Cassation appeal filed by Pfizer in its action against Bexal Farmeceutica and Uso Racional.

Court action was filed by Pfizer on 28 October 2005 against Kern Pharma, Bexal Farmaceutica and Uso Racional.

On 26 May 2006 Commercial Court no. 2 of Barcelona approved the agreement reached by Pfizer and Kern Pharma.

On 31 July 2008 Commercial Court of Barcelona recognised patent (product and procedure) infringement and condemned Bexal Farmaceutica and Uso Racional to pay a total amount of Euro 4,681,520.74.

On 24 February 2010 Appeal Court of Barcelona granted the appeal filed by Bexal Farmaceutica and Uso Racional and rejected Pfizer’s action.

The Appeal Court pointed out that:

.- Pfizer’s Product Patent expired on 19 March 2004 while Bexal Farmeceutica and Uso Racional started producing their (Amlodipine) products not before 1 March 2005.

.- Bexal Farmeceutica and Uso Racional proved that the Amlodopine salt was produced by Adamed

.- Procedure used by Adamed was panteted by means of European Patent no. EP 993,447.

.- Pfizer filed an opposition to EP 993,447, based in its procedure patent (EP 244,944) that was rejected by the EPO.

.- An expert who travelled to Adamed premises in Poland confirmed that procedure used by Adamed was the one described in EP 993,447.

Appeal Court concludes that procedure of EP 993,447 is not equivalent to Pfizer’s.

Pfizer called in its Cassation appeal Art. 69 of European Patent Convention and its modification on 29 November 2000, that entered into force on 13 December 2007.

The Spanish Supreme Court rejects now the Cassation appeal filed by Pfizer since Pfizer didn’t use that argument during the first instance or the appeal.

Furthermore, Pfizer’s Spanish Patent over the procedure expired on 31 March 2007 and Appeal Court couldn’t therefore apply the modification, even if the argument was used during the Court procedure (that it wasn’t).

Some questions came to my mind while reading the rulings. The first may be answered by our readers: Has Pfizer started an action against Adamed as producer of the Salt? If so, when and which was the result? 

Other questions are connected with pay for delay agreements, use or abuse of patent system and enforcement…

Those interested in a copy of Appeal Court and Spanish Supreme Court decisions (in Spanish) just have to ask.