Claim 1 as granted read:
Use of the botulinum neurotoxins from Clostridium botulinum of type A, B, C, D, E, F or G or a mixture of two or more of these neurotoxins, characterised in that the neurotoxin or mixture of neurotoxins is free from the complexing proteins which naturally form complexes with the botulinurn neurotoxins, for the manufacture of a pharmaceutical preparation for cosmetic treatment or treatment of dystonia or disorders of the nervous system in a human or animal patient who has already formed neutralizing antibodies against botulinum neurotoxin complexes.
Claim 1 of the main request before the Board was identical to Claim 1 as granted.
Claim 2 of the main request read:
Use of a pharmaceutical preparation comprising botulinum neurotoxins from Clostridium botulinum of type A, B, C, D, E, F or G or a mixture of two or more of these neurotoxins, characterised in that the neurotoxin or mixture of neurotoxins is free from the complexing proteins which naturally form complexes with the botulinurn neurotoxins, for cosmetic treatment or treatment of dystonia or disorders of the nervous system in a human or animal patient who has already formed neutralizing antibodies against botulinum neurotoxin complexes.
No such use claim was comprised in the claims as granted.
The Board deals with the question of whether A 123(3) has been infringed. It has some very interesting remarks on A 64(2) and G 2/88.
** Translation from the German **
[6.1] A 123(3) prohibits amendments of the granted claims during opposition proceedings if these amendments extend the extent of protection of the European patent. As confirmed in decision G 2/88 [headnote 1] of the Enlarged Board of appeal (EBA), the extent of protection conferred by the claims before and after the amendments have to be compared. The first step that is required when doing so is to determine the extent of protection conferred by the claims as granted, because it is mandatory to establish what the extent of protection conferred by the unamended patent corresponds to. The determination of the extent of protection has to be carried out in accordance with A 69(1) and its Protocol, which provides a guide to the manner in which the technical features of the claim are to be interpreted. (G 2/88 [4]).
Interpretation of use and process claims
[6.2.1] The EPC allows both process claims and use claims. According to the EBA in decision G 1/83 [11], it is often only a matter of preference whether an applicant claims an activity as a process for carrying out the activity, setting out a sequence of steps, or whether he seeks protection for the activity, which may naturally comprise a series of steps, as the use (Anwendung oder Verwendung) of a thing for a stated purpose. The EBA did not consider this to constitute a substantive (sachlich) difference.
[6.2.2] In its decision T 958/94 [3.4], the Board examined whether there was a substantive difference between a claim directed to “a process for manufacturing a medicament intended for the new therapeutic use, characterised in that the substance is used” and a claim directed to the “use of a substance to manufacture a medicament intended for a new therapeutic use”. Considering the fact that manufacturing a medicament does in practice involve a sequence of mandatory and standardized steps, the Board came to the conclusion that according to decision G 1/83, both claims encompass in the same way the activity of formulating the active substance for a medicament, i.e. the process for manufacturing the medicament. The subject-matter of the claimed invention remained the same, which meant that the two claims were substantively equivalent.
[6.2.3] In the case underlying decision T 292/04 [5-6], claim 1 concerned the use of a substance in the manufacture of an antimicrobial agent and was drafted in the Swiss-claim format. On one hand, the agent was intended for use in methods which are referred to in A 52(4), on the other hand it was also intended for use in processes not referred to in this provision, for example for formulating contact lens solutions. When assessing whether the claim was novel and inventive with respect to the prior art, following the principles set out in G 1/83, the Board came to the verdict that the claim, insofar as it was not restricted to a therapeutic use of the manufactured agent, has to be understood as referring to a process for the manufacture of a liquid antimicrobial agent.
Extent of protection of claim 1 of the patent as granted
[6.3.1] Having in mind this case law of the Boards of appeal, the Board is of the opinion that the aspect of claim 1 as granted which refers to the use of botulinum toxins for the manufacture of a pharmaceutical preparation for cosmetic treatment in a human or animal patient cannot be distinguished, on a substantive level, from a claim directed to a process for the manufacture of a pharmaceutical preparation using botulinum toxins. As both claims concern the same activity and naturally comprise the same process steps, they also confer the same extent of protection (see also T 279/93 [4]).
[6.3.2] A 64(2) provides that if the subject-matter of a European patent is a process, the protection conferred by the patent shall extend to the products directly obtained by such process, even if the latter are not patentable per se. Consequently, the extent of protection conferred by a claim directed to a process for the manufacture of a pharmaceutical preparation using botulinum toxins also extends to the pharmaceutical preparations directly obtained by this method.
[6.3.3] The protection conferred by A 62(4) [sic] for products directly obtained by a process depends on the breadth of the wording of the claimed manufacturing process. In the present case the only step that characterises the manufacturing process is the use of botulinum toxins. Therefore, the Board comes to the conclusion that the protection conferred by A 64(2) extends to all pharmaceutical preparations which are directly obtained by any manufacturing process using botulinum toxins.
[6.3.4] As taught in G 2/88 [5, 3rd §], it is a principle underlying the EPC that the protection conferred by a claim directed to a substance (Stoffanspruch) is “absolute”; that is, it comprises, among other things, any kind of use of the substance, regardless of whether it has been disclosed or known by the inventor. In view of this principle the EBA has come to the understanding that whenever claims directed to a substance or a composition comprising this substance are amended so that the amended claims are directed to the use of that substance or the use of the composition for a particular purpose, the amended claims are not open to objection under A 123(3) [headnote 2].
[6.3.5] In summary, the Board notes that part of claim 1 as granted refers, in substantively equivalent form (in sachlicher Äquivalenz), to a process for the manufacture of a pharmaceutical preparation using botulinum neurotoxin. Pursuant A 64(2) and in view of the fact that granted claim 1 does not comprise any feature defining this manufacturing process in detail (see [6.3.3] above) the protection conferred by this claim would cover any pharmaceutical preparation comprising any botulinum neurotoxin. In view of the principles established by the EBA in G 2/88, present claim 2, which corresponds to the use of a pharmaceutical preparation comprising botulinum neurotoxins for the cosmetic treatment of certain patients, is not open to objection under A 123(3).
Applicability of A 64(2)
[6.4.1] In view of the outcome of the above analysis, the question of whether A 64(2) is applicable in the determination of the extent of protection of claim 1 is crucial.
[6.4.2] In decision G 2/88 [3.3] the EBA has established that there is a clear distinction between the extent of a protection conferred by a patent and the rights which are conferred by a European patent. Whereas the protection conferred by a patent is determined by the content of the claims (A 69(1)) and in particular by the categories of such claims and their technical features, the rights conferred on the proprietor of a European patent (A 64(1)) result from the legal provisions of the designated Contracting States.
[6.3.4.] A 64(2) refers to the “rights conferred by a European patent”. Therefore, the question of whether A 64(2) is to be taken into consideration for the determination of the extent of protection of a granted claim has to be answered.
[6.3.5] In its decision G 2/88, the EBA has examined the effect of A 64(2) on the answer to the question of whether an amendment consisting, for instance, in a change from a claim directed to a substance to a claim directed to a use of this substance increases the extent of protection. Thereby the EBA has indicated that A 64(2) is to be taken into account in the assessment of the extent of protection conferred by a claim.
The EBA has established that an amended “use claim” which is equivalent to a manufacturing process using the originally claimed substance, would extend the protection to the product of this process according to A 64(2), which would correspond to increasing the extent of protection within the meaning of A 123(3). However, in the case that was actually presented to the EBA, wherein the amended “use claim” corresponded to a claim directed to a process using the originally claimed substance in order to achieve an effect (and not to manufacture a product), the EBA came to the conclusion that as a rule, there was no such effect of A 64(2), as this use claim was not a process claim within the meaning of A 64(2).
[6.4.5] A number of decisions of Boards of appeal have followed the EBA in this application of A 64(2) (see, for example, T 5/90 [4.1]; T 73/92 [7]; T 20/94 [4.3.1]; T 277/95 [7]; T 401/95 [4.3.2]; T 570/96 [2.3-6]; T 1013/96 [2]; T 651/03 [4.2]; T 423/04 [3]; T 1026/04 [23.2] and T 304/08 [3.3.2]).
[6.4.6] The Board is aware of decision T 1286/05 [2.5] wherein the competent Board explained in an obiter dictum concerning A 123(3):
“the change from the only independent claim of the patent as granted relating to a process of preparation (“Use of a lipophilic surfactant component for the manufacture of a pharmaceutical composition …”) to a claim referring to a use for achieving a particular effect (“Use of a lipophilic surfactant component for reducing the inhibitory effect of the hydrophilic surfactant …”) would extend the protection conferred.”
However, as this opinion is not reasoned in decision T 1286/05, the Board is not in a position to examine its correctness.
[6.4.7] Therefore, the Board is convinced that A 64(2) is to be taken into account when considering the extent of protection conferred by claims. This holds true both for the assessment of the extent of protection of an amended claim such as the claim in the case presented to the EBA in G 2/88, and for the assessment of the extent of protection of a granted claim.
[6.5] As already mentioned in paragraph [6.3.5] above, the Board is convinced that claim 2 complies with the requirements of A 123(3).
NB: When translating this decision, I encountered the difficulty of translating the term ‘Verfahren’. The EPC itself is not consistent; when the German version says ‘Verfahren’, the English version sometimes has ‘method’ (e.g. A 53c)) and sometimes ‘process’ (e.g. A 64(2)). To make the confusion complete, the present decision also sometimes refers to a ‘Prozess’. As far as I can see, the terms ‘method’ and ‘process’ are used interchangeably in the case law and these terms are strictly equivalent under the EPC.
To read the whole decision, please click here.
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