The Supreme Court recently dismissed Pfizer's appeal in a patent infringement case regarding the besylate salt of amlodipine (commercialized by Pfizer as NORVAS). The judgment, which was issued on January 3 2013, was served on the parties on January 14 2013.

In 2005 Pfizer sued Bexal and Uso Racional for alleged infringement of the Spanish part of European Patent 244.944 ('EP'944'). This patent claimed a certain process for the manufacture of the besylate salt of amlodipine. The defendants argued that they did not use the process claimed in Pfizer's patent, but rather a process by the Polish company Adamed, which fell outside the scope of Pfizer's patent. The Adamed process is disclosed and claimed in a European patent owned by that company (European Patent 993.447).

The main discrepancy of the litigation was whether the Adamed process of manufacturing amlodipine besylate fell within the scope of Pfizer's patent EP'944 under the doctrine of equivalents.

In the first instance judgment, issued by Barcelona Commercial Court No 3 on July 31 2008, the infringement action was upheld and Bexal and Uso Racional were sentenced to pay damages of more than €4.5 million. Pfizer requested provisional enforcement of the judgment and the defendants paid the above sum.

However, on February 24 2010 the Barcelona Court of Appeal upheld the appeal filed by Bexal and Uso Racional. The court concluded that the Adamed process fell outside the scope of Pfizer's patent even under the doctrine of equivalents, and thus it dismissed Pfizer's infringement action and revoked the first instance decision. Bexal and Uso Racional then claimed and obtained reimbursement of the damages that they had been obliged to pay in 2008, plus interest.

Pfizer appealed the second instance judgment before the Supreme Court, based on the following grounds:

  • An ordinary cassation appeal – appeals before the Supreme Court are admissible only on certain exceptional grounds, which are specifically contemplated in the Civil Procedure Act. One of these exceptional grounds is that the appealed judgment applied a legal provision that has been in force for less than five years, provided that there is no previously consolidated Supreme Court case law on legal provisions with similar content. Pfizer argued that the judgment of the Barcelona Court of Appeal infringed the wording of Article 69.1 of the European Patent Convention and its Protocol of Interpretation (in force since December 2007).
  • An extraordinary appeal for procedural infringement – Pfizer argued that the judgment of the Barcelona Court of Appeal infringed the rules on burden of proof and that the court had assessed the expert evidence on file in a wrong and illogical manner. The Supreme Court can decide on this kind of procedural appeal only if the ordinary cassation appeal is admissible as such.

Bexal and Uso Racional filed an opposition to these appeals, arguing first that the ordinary cassation appeal was inadmissible. In this regard, they explained that Pfizer's infringement action was filed in 2005, whereas the current wording of Article 69.1 of the European Patent Convention and its protocol entered into force in December 2007, and therefore they were not applicable to the case. Moreover, neither Pfizer nor the first and second instance judgments mentioned these provisions. Thus, Bexal and Uso Racional argued that it was simply untrue that the judgment of the Barcelona Court of Appeal had applied rules which entered into force less than five years ago.

The Supreme Court upheld this argument and dismissed Pfizer's cassation appeal on the grounds of inadmissibility. In addition, as argued by Bexal and Uso Racional, the Supreme Court sated that there was previous case law on the doctrine of equivalents, and therefore the requirements of the Civil Procedure Act were not met. In light of this, the Supreme Court concluded that Pfizer's allegation regarding the application of the current wording of Article 69.1 of the European Patent Convention and its protocol was just an excuse for the appeal to be admitted. With the ordinary cassation appeal being inadmissible, the extraordinary appeal for procedural infringement was also dismissed.

For further information on this topic please contact Miguel Gil at Grau & Angulo by telephone (+34 93 202 34 56), fax (+34 93 240 53 83) or email (m.gil@gba-ip.com).

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