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ES – Astellas Pharma v. Synthon Hispania

05 Sep 2014

Astellas Pharma Inc. et al. v Synthon Hispania et al., Barcelona Commercial Court no. 10, 30 June 2014, ordinary declarative action 725/2011 – 2, judgment no. 118/2014 

Patent infringed despite restrictive functional interpretation of product features

Astellas Pharma Inc. (and others) sued Synthon Hispania (and others) for infringement of the Spanish part of European patent 0 661 045. The patent protects a sustained-release hydrogel preparation containing tamsulosin hydrochloride. Synthon Hispania was accused of manufacturing and selling generic tablets which fall within the scope of claims 1 and 6 of the patent.

On 30 June 2014, the Barcelona Commercial Court rendered its judgment in proceedings on the merits. The Court found the patent to be infringed. The judgment is remarkable, as the decision hinges on the functional interpretation of product features which, in the end, lead to a scope which falls short of the literal wording.

One feature at stake related to a “gelation index of 70% or more”, a parameter which describes the amount of gel formed upon contact of the preparation with water. Gel formation was important for the claimed preparation, since it provided for the sustained release. The controversy ensued as to whether or not this index needs to be measured at a certain time.

The patentee took the position that this characterises the material, and thus the index must be determined once equilibrium is reached. The defendants and the Court, however, applied a functional interpretation, whereby they limited the claim to a gelation index of 70% or more after 2 to 5 hours. In effect, the Court thus added a feature to the claims, yet the Synthon tablets also made use of this more specific gelation index.

In a second aspect, the parties were in conflict over a feature relating to an additive, which was indicated to facilitate water penetration into the preparation. The additive was further characterised by the fact that it takes no more than 5ml of water to dissolve 1g of additive. While, in the case of the gelation index, the defendants were advocating a functional interpretation and the patentee was arguing a literal understanding, the parties took opposite positions regarding the additive. The Court, however, maintained its approach and also applied a functional interpretation to this feature.

In the end, and on the basis of the expert reports submitted by both parties, the Barcelona Commercial Court thus decided, in proceedings on the merits, that the Synthon tablets fulfil both features and all other features of the claims invoked by Astellas and that, consequently, Synthon Hispania and the other defendants have infringed the patent in Spain. The Commercial Court has ordered the defendants to pay Astellas the amount of €8,748,713.47 for the damages incurred as a result of the infringement of Astellas’ patent. The judgment can still be appealed by both parties.

Head note: Miquel Montañá, Clifford Chance