G 0002/88 - Second non-medical indication / "Friction-reducing additive"- #3

Citation rank: 3
No. of citations: 368

G 2/88 ("Friction reducing additive") and G 6/88 ("Plant growth regulating agent") both looked at changes in the claim category from product claim (specifically: compound or composition) to use claim, namely the use of the compound or composition for a particular purpose.

A Technical Board of Appeal in T 59/87 referred the question to the Enlarged Board of Appeal whether a patent with claims directed to a "compound" and to a "composition including such compound" can be amended during opposition proceedings so that the claims are directed to the "use of that compound in a composition" for a particular purpose, without extending the scope of protection (Art. 123(3) EPC).

The Enlarged Board found that, upon proper interpretation of Art. 123(3) EPC, and taking into account the "absolute" protection that a product claim confers, a change in category from product to use of the product does not normally extend the scope of protection. Art. 123(3) would thus not be infringed.

T 59/87 also referred another question to the Enlarged Board, namely whether novelty can be acknowldedged of a claim claiming the use of a known compound for a particular purpose over prior art disclosing the same use of the same compound, but for a different purpose. Specifically T 59/87 asked:

"Is a claim to the use of a compound for a particular non-medical purpose novel for the purpose of Article 54 EPC, having regard to a prior publication which discloses the use of that compound for a different non-medical purpose, so that the only novel feature in the claim is the purpose for which the compound is used?"

The answer to this question is by no means self-evident. For example, in case T 231/85 (referred to in G 2/88) the  claims in question related to the "Use of (certain compounds) ... for controlling fungi and for preventive fungus control" - and the application contained teaching as to how to carry this out so as to achieve this effect. A prior art document described the use of the same compounds for influencing plant growth. In both the application in suit and the prior art, the respective treatments were carried out in the same way (so the means of realisation was the same). The sole difference between the claim and the prior art was the purpose for which the claimed use was carried out. The purpose - as was argued by a party T 231/85 - is subjective and in principle merely a mental activity. It should not, according to the party, count as a technical feature of the claim. The Enlarged Board, however, decided differently. 

The Enlarged Board found that the different purpose of the claimed use establishes novelty over such prior art. In other words, a claim to the use of the compound for the particular purpose defined in the claim, which use is based on a technical effect described in the patent, is to be interpreted as including that technical effect as a functional technical feature. Hence prior art disclosing the same use of a compound, but for obtaining a different purpose, then such prior art is not novelty-destroying for the "second non-medical use" claim.

Remark: G 2/88 and G 6/88 are consistent with the earlier G 1/83, G 5/83 and G 6/83, which established similar principles for claims directed to second medical indications. The latter decisions held that the stated purpose of making a medicament recited in a "Swiss-type" claim establishes novelty over prior art disclosing the same medicament, but not disclosing the claimed medical indication (i.e., disease to be treated). See here for a brief summary of G 5/83.

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Headnote:

1. A change of category of granted claims in opposition proceedings is not open to objection under Article 123(3) EPC, if it does not result in extension of the protection conferred by the claims as a whole, when they are interpreted in accordance with Article 69 EPC and its Protocol. In this context, the national laws of the Contracting States relating to infringement should not be considered.

2. An amendment of granted claims directed to "a compound" and to "a composition including such compound", so that the amended claims are directed to "the use of that compound in a composition" for a particular purpose, is not open to objection under Article 123(3) EPC.

3. A claim to the use of a known compound for a particular purpose, which is based on a technical effect which is described in the patent, should be interpreted as including that technical effect as a functional technical feature, and is accordingly not open to objection under Article 54(1) EPC provided that such technical feature has not previously been made available to the public.

The full text of the decision can be found here.

G 0005/83 - Second medical indication - #21

Citation rank: 21
No. of citations: 162

G 5/83 is one of seven(!) parallel cases before the Enlarged Board of Appeals, all dealing with the question of whether or how inventions relating to a "second medical indication" of a chemical compound or composition can be protected under the EPC. These seven decisions were also the very first decisions delivered by Enlarged Board of Appeal.

At the time of G 5/83 there was (and still is today) considerable interest in protecting inventions relating to the "second medical use" or "second medical indication" of chemical entities, i.e., where the compounds or compositions were already known to be useful as medicaments, but for a different disease/in a different indication. The difficulty was that Art. 52(4) EPC1973 in did not allow claims to "methods for treatment of the human or animal body by therapy". More specifically, Art. 52(4) EPC1973 stipulated that such methods were not susceptible of industrial application, one of the three basic patentability requirements. (The exclusion from patentability of therpeutic methods is still present in the EPC2000, but it is implemented in a different manner, namely it is formulated as an "exception to patentability" under Art. 53(c) EPC.)

The German High Court ("Bundesgerichtshof", BGH) had already decided that, under German national law, the subject-matter of a claim directed to the use of a chemical substance to treat an illness extends beyond the treatment of the illness, namely to the preparation for use ("augenfällige Herrichtung"), which, according to the BGH, includes at least the packaging of the substance with instructions for use in the treatment of the illness. A claim directed to the use of a compound to treat an illness could therefore be used in German national law to protect the "second (or further) medical indication".

The Enlarged Board, however, did not agree with the findings of the BGH. In particular, the Enlarged Board found that there was in principle no difference between a method claim and a use claim; it was merely a matter of preference of the applicant whether to formulate a method claim as use claim or vice versa. In this regard, the Enlarged Board stated:

11. The European Patent Convention, in general, allows both method claims and use claims but whether any activity is claimed as a method of carrying out the activity (setting out a sequence of steps) or as the use of a thing for a stated purpose (the sequence of steps being implied), is, in the opinion of the Enlarged Board, a matter of preference. For the European Patent Office there is no difference of substance. In the context of the present case, this means that any artificial distinction according to which, when the invention concerns the employment of a substance or composition for therapy, a method claim excludes and a use claim includes at least the preparation of a pharmaceutical product, with instructions for use in the treatment of illness (which has been called in German the "augenfällige Herrichtung"), cannot be accepted, because in both cases the active substance or composition for therapy must be in a state capable of exerting its therapeutic activity and this necessarily means that the active material has been formulated and made up into doses.

Since a second-medical indication claim in the form of a "use claim" was no different than the corresponding claim formulated as "method claim" (the latter being expressly excluded from patentability), no patent could be granted according to the Enlarged Board on a second-medical use claim irrespective of whether it was formulated as "use" or "method claim":

13. For the reasons already given, in the considered opinion of the Enlarged Board, a claim directed to the "use of a substance or composition for the treatment of the human or animal body by therapy" is in no way different in essential content from a claim directed to "a method of treatment of the human or animal body by therapy with the substance or composition". The difference between the two claims is one of form only and the second form of claim is plainly in conflict with Article 52(4) EPC. Since this is so, no patent can be granted including any such claims: Article 97(1) EPC.

The Enlarged Board, however, recognised that Article 54(5) EPC1973 provided for the possibility to protect inventions based on the "first medical indication" of a compound or composition, namely in the form of a purpose-limited product claim. The Enlarged Board noted that, apparently, no problem arose with respect to susceptibility of industrial application of such an invention, within the meaning of Article 57 EPC. Furthermore, from the Articles and Rules of the EPC1973, as well as from its legislative history, the Enlarged Board concluded that

"[n]o intention to exclude second (and further) medical indications generally from patent protection can be deduced from the terms of the European Patent Convention: nor can it be deduced from the legislative history of the articles in question."  (point 22 or reasons)

The Enlarged Board then considered a statement made by the Swiss Federal Intellectual Property Office, stating that they allowed claims to second-medical use inventions in the form of a use claim directed to the use of a substance or composition for the manufacture of a medicament for a specified (new) therapeutic application (point 19 of the reasons).

The Enlarged Board concluded that it is legitimate to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case in which the process of manufacture as such does not differ from known processes using the same active ingredient (point 23 of the reasons).

That claim format was since then referred to as the "Swiss-type claim". It was the claim format of choice to protect second medical indications under the EPC up until G 2/08 ("Dosage regime"). This decision held that under the new wording of the EPC2000 (which allowed purpose-limited product protection for second medical indications, Art. 54(5) EPC), there was no longer room for second-medical use claims in Swiss-type format. The purpose-limited product claim should be used instead.

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Headnote:

I. A European Patent with claims directed to the use may not be granted for the use of a substance or composition for the treatment of the human or animal body by therapy.
II. A European patent may be granted with claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application.

The full text of the decision can be accessed here.