NLO Fortify no. 6 2017/2018
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no. 6 | volume 4 | winter 2017/2018

A curious case of ‘substance or composition’

authors: barend bouma and girish tanwar

Second or further medical use claims under the European Patent Convention (EPC) have been heavily debated in the recent past. The Boards of Appeal (BoA) of the European Patent Office (EPO) have dealt with numerous cases with regard to second or further medical use claims. The BoA heavily rely on the earlier decisions of the Enlarged Board of Appeal of the EPO and the decisions of the BoA themselves, as underlined by the numerous cases discussed in the book ‘Case Law of the Boards of Appeal of the European Patent Office’ (8th Ed., July 2016).

While following and studying the ongoing debate related to allowability of second or further medical use claims, we realised that to the best of our knowledge the BoA and also the Enlarged Board of Appeal have up till now and as far as we could find out, always avoided to clearly define the meaning of the terms ‘substance or composition’ in Article 54(5) EPC.

Decision Board of Appeal

A search for the meaning or definition of the term ‘substance’ reveals that one defines it as “a particular kind of matter with uniform properties”. In her decision T 2003/08 point 15, the BoA of the EPO referred to the decision G 5/83 of the Enlarged Board and stated that the ‘substance or composition’ under debate refers at least to products which qualify as “chemical” entities or as compositions of “chemical” entities. In the same decision point 17, the BoA stated that the ‘substance or composition’ should be the active agent in the medical use. It was further clarified in the following paragraphs of said decision T 2003/08 that an assessment of whether or not a “medicament” is used is in fact not needed. Instead, it is necessary to decide whether or not a ‘substance or composition’ within the meaning of G 5/83 is used. Within the meaning of G 5/83, then, a ‘substance or composition’ is determined by the following steps, as stated in T 2003/08: the means by which the therapeutic effect is achieved; and whether that which achieves the therapeutic effect is a chemical entity or composition of chemical entities.

Now referring to point 15 of T 2003/08, the BoA used the term “at least”, as outlined here above, which appears to us to indicate that solely chemical entities or solely a composition of chemical entities are not the only entities that can be considered as being a ‘substance or composition’ within the meaning of Article 54(5) EPC.

Decision T 2003/08 pertained to the interpretation of a column having a coupled ligand for an antibody in the blood circulation of a patient, as a medicament in the context of a second medical use of said ligand. How should then T 2003/08 be interpreted when a different device than such a column provided with a binding partner for an antibody, or even for example electromagnetic radiation with particulate nature (quanta or photons), are used for a certain second or further medical use?

Travaux préparatoires

How could an applicant for a European patent judge if for example photons with particle-like properties, or electrons, or infrared radiation, or for example a source which emits such quanta and particles, used for a certain further medical use, is patentable in view of the EPC? Even the Travaux préparatoires EPC 1973 and Travaux préparatoires for the EPC revision 2000 do not define the terms ‘substance or composition’ in this regard.

With the ongoing technological developments many other ’items’ (for example hybrids between active pharmaceutical ingredients and nano-scale medical devices) are becoming involved in the treatment of various diseases, which ‘items’ appear not always to be straightforwardly caught in the classical definition for a substance or for a composition within the meaning of T 2003/08. Again, examples are sources emitting the aforementioned photons, electrons, infrared radiation, and such e.g. photons themselves, applied in the treatment of a certain disease.

Seeking clarity

So, does the application of the terms ‘substance or compositions’ as chemical entities or compositions of chemical entities as stated in G 5/83 provide a reasonable and sufficiently applicable legal framework? Or should perhaps be decided to discuss and provide for a (new, perhaps broader) legal definition for these terms, which more robust legal definition shall provide clarity to the inventors, applicants and their patent attorneys with regard to what can be patented and what cannot be patented within the meaning of the Articles 53(c) EPC and 54 (5) EPC?

To be continued.

The specific Articles of the EPC that pertain to the discussions are Article 53 (c) EPC “European patents shall not be granted in respect of (a) …, (b)…, (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.”; and Article 54 (5) EPC “Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.”