This article first appeared in World Intellectual Property Review, published by Newton Media Ltd.

Rulings of the Italian Supreme Court on patentability of intermediate products and infringement by equivalence in the chemical field are infrequent. These two topics were brought under the spotlight in a decision by the court on December 2, 2016 in Industriale Chimica v Bayer Pharma. Bayer Pharma owns the Italian portion of European patent EP918791, which claims a new process to produce drospirenone, an antiprogestinic drug used in hormone therapy. Bayer’s process is characterised by the synthesis of a stable intermediate product, called Idrox, which is subsequently catalytically oxidised to drospirenone by a ruthenium salt. Industriale Chimica owns the Italian portion of European patent EP1828222, which claims a process to produce drospirenone in which the same intermediate Idrox is produced and catalytically oxidised to the end product, with the process making use of the organic compound Tempo as an oxidation catalyst instead of a ruthenium salt. In its decision, the Italian Supreme Court confirmed the ruling of the Court of Appeal of Torino, which declared that the process of the ‘791 patent was infringed by equivalence by the process of ‘222. It held that claim 2 of the ‘791 patent, directed to the intermediate product, was invalid.

Infringement by equivalence According to article 52 of the Italian Industrial Property Code, which implemented in the national law the Protocol of Interpretation of article 69 of the European Patent Convention (EPC), in determining the scope of protection conferred by the claims, due account shall be taken of any element which is equivalent to an element specified in the claims. In its ruling, the Italian Supreme Court substantially confirmed the case law according to which infringement by equivalence must be assessed with regard to the inventive concept underlying the patented invention (the “heart of the patented invention”), which in the present case was identified by the court in the production of a stable intermediate—Idrox—from which the drospirenone can be derived. The court held that even though the two processes are different, “the mere substitution of the ruthenium salt catalyst with the catalyst Tempo did not rule out the infringement by equivalence” and that it is immaterial whether the substitution of the ruthenium salt catalyst with Tempo is non-obvious for the skilled person. The court’s decision does not depart from (part of) the earlier case law on this topic and thus was not totally unexpected. Nevertheless, such a broad interpretation of the concept of equivalence, especially in the chemical field, leaves little room for third parties to design around a patented invention.

Patentability of intermediate products Claim 2 of the ‘791 patent, whose subject matter was the intermediate Idrox per se, was declared invalid by the Court of Appeal on the ground that the claimed intermediate product can be used only for carrying out the process for manufacturing drospirenone. In confirming the decision of the Court of Appeal, the Supreme Court based its reasoning on decisions dating back to the 1990s and upheld that an intermediate product, as in the present case, can only be used in the patented process and lacks autonomous industrial application. The court went on to say that the patentability of intermediates in general cannot be denied—only those intermediate products that are “conceptually separable from the process”. According to the court, the intermediate Idrox would have been patentable “in case it could have been used not only in the process for manufacturing drospirenone, but also for manufacturing other end products”. It appears that on the basis of outdated earlier decisions, the Supreme Court has introduced a further special patentability requirement solely for intermediate products, namely that of having an industrial application independent from the patented product in which they are used. For any product other than an intermediate product, industrial applicability is generally acknowledged if the product can be made or used in at least one field of industrial activity. Thus, the adoption by the court of a special regime for intermediate products is open to criticism. In considering the national portion of European patents, the Italian perspective on the infringement by equivalence and, particularly, on the patentability of intermediate products, is quite unusual and the grounds for the cited decision of the Italian Supreme Court might not be shared by courts of other EPC states. The lack of harmonisation in doctrine and jurisprudence among EPC member states might be a further aspect to take into consideration when the Unified Patent Court package comes into force and patentees will have to decide whether to opt out their “traditional” European patents and patent applications.