By decision of December 2nd, 2016, No 24658, Industriale Chimica S.r.l. vs Bayer Pharma AG, the Italian Supreme Court ruled on the infringement by equivalence and on the patentability of intermediates.
Infringement by equivalence
For the first time the Supreme Court has been asked to assess the infringement by equivalence under Article 52 of the Intellectual Property Code (IPC). However, this does not lead the Court to change its earlier settled case law. Indeed, Article 52 IPC did not actually introduce any substantial innovation to Italian law, as similar provisions were already valid and in force in Italy for European patents pursuant to Article 69 EPC and the Protocol.
According to the Supreme Court, the relevant test for the assessment of the equivalence is still that put forward by the Supreme Court in the landmark decision Forel vs Lisec (Cass. 13 January 2004, n. 257) and further clarified by the subsequent case law.
Hence, the Supreme Court noted that the infringement by equivalence must be assessed having regard to the inventive concept underlying the patented invention as claimed, so that an infringement by equivalence is found any time the changes introduced to an infringing process are immaterial. In the case under its scrutiny, the Supreme Court held that “the mere substitution of the catalyst consisting of the ruthenium salt with a catalyst TEMPO was immaterial and did not rule out an infringement by equivalents“.
Protection of intermediates
The appellate court held invalid the claims of the patent covering the intermediate IDROX on the ground that such intermediate would not be patentable subject matter. The intermediate was considered to lack industrial application, since it could have been used only for carrying out the patented process for the manufacture of drospirenone. The patent owner appealed this point of the decision, arguing that there are no statutory provisions requiring that the industrial application of a compound must be independent of the patented process.
The Supreme Court, rejecting the patent owner’s appeal, confirmed its earlier case law according to which “the necessary starting point of a synthesis process cannot be patented, when it can be used only for the satisfaction of a need related to the implementation of such process” (see Cass. 1 September 1997, no 8324; Cass. 16 November 1990, no 11094). Hence, as the Court went on, “the intermediate, regardless it was described and claimed as a product, still must be regarded as an integral part of the process invention and as such can be protected always and only as an element of the patented process“.
The Supreme Court’s decision on the equivalence is in line with the earlier case law and indeed there were no apparent reasons for the Court to change its position.
As far as the protection of intermediates is concerned, the Supreme Court probably felt compelled to be consistent with its earlier case law. The Court based its conclusion on an alleged lack of independent technical meaning of the intermediate vis à vis the process in which the intermediated is to be used. However, no statutory provisions require that a claimed compound must have an independent industrial application, while there may be industrial and technical reasons which may suggest claiming protection on the intermediate as an additional aspect of the invention. Moreover, process claims may also be sought in order to ensure the protection on a product and may be functional thereto, no less than intermediates are in respect of the process. There may be therefore no justified reasons to treat intermediate and process claims differently.