With a recent decision that ended a long dispute between the pharmaceutical company Bayer and the Italian company Chimica Industriale, the Italian Supreme Court denied the independent patentability of an intermediate, declaring the partial invalidity of the patent of the German pharmaceutical company. The issue – that mainly concerns a method to obtain the substance called Drospirenone, used in birth control pills – is related in particular to two claims of a European patent, validated also in Italy: the first claim concerns the method for obtaining the final product Drospirenone and provides, inter alia, the use of the intermediate called IDROX. The second claim is not about a method but instead protected IDROX as a product.


Con decisione del 14 gennaio 2011, il Tribunale di Torino decidendo in prima istanza aveva già escluso la brevettabilità di una sostanza intermedia sottolineando che “non consta la funzionalità e la possibile applicazione industriale del prodotto intermedio in sé ove distaccato e avulso dal procedimento chimico brevettato nel quale si inserisce come composto chimico intermedio.” Il Tribunale era giunto a tale conclusione in quanto soprattutto la descrizione del brevetto non avrebbe evidenziato un’autonoma rilevanza della sostanza intermedia. Essa non risulterebbe avere una funzione autonoma e un’utilità concettualmente separabile dal procedimento di sintesi che conduce alla produzione di Drospirenone.

By decision of 14th January, 2011, the first instance Court of Turin had already excluded the patentability of an intermediate highlighting that “it is not aware of the functionality and possible industrial application of the intermediate product itself when detached from the patented chemical process in which it is included as an intermediate chemical substance.” The Court came to this conclusion because the autonomous importance of the intermediate would have not resulted from the patent specification. The intermediate would not have an autonomous function and utility conceptually separable from the synthesis process that leads to the production of Drospirenone.
By decision of 24th December, 2012, the aforementioned ruling regarding the claim of the intermediate product was confirmed also in the appeal proceedings, and with decision of 2nd December, 2016 the previous rulings have been definitively confirmed by the Supreme Court. In addition to the arguments submitted by the Turin Court, the Supreme Court held that: “… according to the previous decisions of this Court, it makes no sense to claim as a product an intermediate that is exclusively instrumental to a specific process.” In this case the intermediate product would lack the autonomous industrial application, requirement established under article 49 of the Industrial Property Code. And, in fact, with decision no. 11094 of 1990 the Court already noted that “the process and the product are independently enforceable only if each has its own requirements for patentability and since in this case the intermediate is not conceptually separable from the process – said intermediate is not itself patentable as a product, because the chemical substance-intermediate, representing a necessary step of the synthesis process ‘is not usable to satisfy a need different from the one connected to the implementation of the procedure’ …. the intermediate, therefore, even if described and claimed as a product, remains an integral part of a process invention and as such is enforceable just as deriving from the process itself”.

This principle has been confirmed by the Supreme Court in 1997: “The Court observes that the so-called intermediate, i.e. the substance that is a necessary precondition of a synthesis process, is not, as this Supreme Court has already made clear by creating consistent case law from which there are no reasons to deviate, independently patentable when it is usable to satisfy the same need connected to the implementation of the process itself. In that regard the Court of Genova has fully justified its judgment when it denied that in this case a person skilled in the art could identify the aforementioned substance as an industrial product from the elements attached to the application. ”

With the recent decision, however, the Court now indicates more explicitly that it does not intend to deny “the patentability of the intermediate in general”, but at the same time it confirms the approach of the previous case-law: “The intermediate, therefore, even if described and claimed as a product, is still an integral part of a process invention and as such is enforceable just as part of the patented process. In short, according to the case law of this Court, it makes no sense to claim as a product an intermediate that is exclusively instrumental to a specific procedure, which moreover as such would lack the attitude to have an independent industrial application: the petitioner objects the fallacy and the anachronistic character of this statement, but, in fact, beyond this objection, it does not explain what would be wrong. Therefore, there is no reason not to comply within the limits indicated: this reasoning does not deny the patentability of the intermediate in general, but only the one of that intermediate which does not have any individual character in comparison to the process in which it is included. The district Court, in that regard, has deemed that the characters of originality, inventive step and industrial usability (OMISSIS) coincide with those of the patenting process, precisely focused on the production (OMISSIS) through (OMISSIS): it would be different, in other words, if the (OMISSIS) could have been used not only in the production process of (OMISSIS), but also in the one of other final products. ”

From the combined examination of the previous decisions it is clear that the requirement deemed fundamental is the one of the industrial applicability under Article 49 of the Industrial Property Code. It is clear, in addition, that the Court emphasized the need for the claim or the patent specification to indicate precisely the “individual character” of the intermediate product with respect to the production process of the final product where it is included. Considering that the European patent at issue was granted by the EPO, the importance and the need to consider also different approaches of Courts of the States that are part of EPC, in the very process of drafting the original text of the patent, appears evident once again.