The Italian Supreme Court on infringement by equivalence of a pharmaceutical patent and the patentability of intermediates

(An Italian version is published on Diritto 24 – Il Sole 24 Ore)

On 2 December 2016, the Italian Supreme Court issued a decision (no. 24658/16) as part of a large pharmaceutical litigation between Bayer Pharma AG and Industriale Chimica s.r.l. The Court confirmed the infringement of a Bayer process patent under the doctrine of equivalence, but excluded the patentability of an intermediate covered by that same patent.

The dispute related to two patents, one belonging to Bayer (EP ‘791) and one to Industriale Chimica (EP ‘222), both covering the production of the drug drospirenone. According to what was stated in the judgment, in EP ‘791 the synthesis of the drug occurred through the intermediate IDROX, which was individually protected in the patent’s claim no. 2. To produce IDROX, ruthenium salts were used. In EP ‘222 the synthesis of the drug was instead made by means of an organic compound which acted as a catalyst in place of the ruthenium salts.

In the judgment under review, the Supreme Court recalled its previous decisions relating to infringement by equivalents (which we mentioned here on this blog) and confirmed the Court of Appeal’s judgement under review, based on which Industriale Chimica’s patent infringed that of Bayer under the doctrine of equivalence: “When dealing with infringement by equivalence, in order to assess whether the contested embodiment can be considered equivalent to that patented, so as to constitute an infringement of the latter, it must be determined whether, in allowing to achieve the same end result, that embodiment appears original, offering a non-trivial or repetitive response. (…) It must however be specified that, in order to exclude infringement by equivalence, the change, even if original, made to a single element of the patented invention, has no relevance, if the variation does not allow to exclude the use, even partial, of the earlier patent”. In this case, the Supreme Court said, the Court of Appeal had correctly applied those principles and had based its decision on thorough technical advice which showed that both processes were focused on the production of the intermediate IDROX. This meant that the single element of differentiation was the catalyst used (ruthenium salts in one case, an organic component in the other): a “marginal modification” that did not exclude infringement.

The judgment under review, while granting Bayer’s infringement claim, actually also confirmed the Court of Appeal’s decision, finding that claim no. 2 of EP ‘791 covering the intermediate IDROX was null and void, since IDROX was not believed to be autonomously patentable. In this respect, the Court recalled its case law according to which “In terms of industrial inventions in the chemical field, the so-called ‘intermediate’, which is the substance that is the obligatory precondition of a synthesis process, is not independently patentable when it can be used only to implement the same process“: in this case, it “is not conceptually separable from the process and is not, therefore, independently patentable“, and in fact it “would be lacking the ability to have an autonomous industrial application“.

In response to Bayer’s objections, the Court replied that it did “not deny the patenting of intermediates in general, but only of the intermediate having no individuality in comparison to the process in which it is comprised“, as IDROX had been found to be by the Court of Appeal.