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New developments on patent infringement by Section 28 of the High Provincial Court of Madrid

Section 28, specialized on commercial law, including patent matters, of the High Provincial Court of Madrid rendered a Judgment on patent infringement dated 27 December 2012.

The plaintiff filed infringement claims based on two patents concerning the medicine venlafaxine.

 

The plaintiff invoked two patents: one of the patents claiming a specific extended release formulation of venlafaxine and the second claiming the use of venlafaxine for the treatment of the generalized anxiety disorder.

 

In particular the formulation patent claimed a coated spheroid in which the spheroid comprised venlafaxine, microcrystalline cellulose (MC) and hidroxypropylmethylcellulose (HPMC) and was coated with ethyl cellulose (EC) and hydroxypropylmethylcellulose (HPMC).

 

The description of the patent stated that the formulation was comprised of venlafaxine in admixture with MC and HPMC.

 

Furthermore in another paragraph of the description it was stated that the spheroid was prepared by a granulation and extrusion process. In that paragraph it was also stated that the patentee was trying to find out a suitable granulation mix which could be extruded properly. In fact, it was explained that in the extrusion process, heat build up occurred which dried out the extrudate of venlafaxine and MC so much that it was difficult to convert the extruded cylinders into spheroids. This problem was solved by adding HPMC to the admixture of venlafaxine and MC. Those uncoated spheroids are further coated by an extended realise coating of EC and HPMC.

 

The product of the defendant did not present the same problem disclosed in the patent, because the product did not consist of an admixture of venlafaxine and excipients. In that case the venlafaxine was coating an inert sugar sphere. This is because the product is not obtained by an extrusion and granulation process.

 

The Court of Appeal upheld the Judgment under appeal dismissing the infringement claim and interestingly stated that as long as an element which defines the invention is explained in the description of the patent the claim is to be constructed with a more limited scope than the one that would derive from a literal interpretation of the claim. This ground is consistent with the first sentence of art. 1 of the Protocol on the Interpretation of art. 69 EPC.

 

Concerning the second patent on the therapeutically indication the Appeal Court upheld the first instance judgment that also dismissed the infringement claim regarding that second patent since the product of the defendant was not marketed with the indication claimed in the patent.