T 1898/07 – Pick And Choose

One could easily make four or five posts from this decision. If you read the whole story, you will find interesting things on T 352/04 and on the requirements of R 80. But there has to be an end, all the more as something tells me that this decision will not be considered to be a landmark decision. Be that as it may, it also contains an interesting passage where the various features of a somewhat unorthodox claim are analysed in view of a novelty assessment:

[33] Claim 1 of auxiliary request 11 refers to a liquid composition which

(a) comprises an interferon-beta,

(b) comprises an amino acid stabilizing agent selected from the group consisting of 0.5% to 5% (w/v) arginine-HC1, 0.50% to 2.0% (w/v) glycine, and 1.47% to 2.94% (w/v) glutamic acid,

(c) has not been reconstituted from lyophilized interferon,

(d) is not further lyophilized,

(e) does not comprise serum albumin,

(f) is contained within a syringe,

(g) wherein the syringe has a head space flushed with inert gas, and

(h) wherein the syringe is contained in a package. […]

[34] The claims shall define the matter for which protection is sought in terms of the technical features of the invention (R 43(1)). The primary aim of the wording used in a claim must therefore be to satisfy such requirements, having regard to the particular nature of the subject[-matter of the] invention, and having regard also to the purpose of such claims. It follows that the technical features of the invention are the physical features which are essential to it. When considering the two basic types of claims (e.g. claims to physical entities and claims to physical activities […]), the technical features of a claim to a physical entity are the physical parameters of the entity (decision G 2/88 [2.5]).

In the present case, the physical parameters defining the structure of the claimed liquid formulation are described in features (a), (b) , (e) and (i) […].

According to established case law of the Boards of Appeal, a product can also be defined in a claim in terms of a process for its production (“product-by-process” claim). However, such claims are admissible only if the product itself fulfils the requirements of patentability (see Case law of the Boards of Appeal of the EPO, 5th Edition 2006, chapter II.B.6). The combination of product parameters and process parameters in one and the same claim has been considered to be admissible (decision T 148/87).

In the present case feature (c) is considered to refer to the process of producing the claimed liquid composition […].

[36] Feature (d), referring to a process step, performed, or rather not performed, on the claimed entity after providing it in the claimed form, does not contribute to the characterisation of the claimed physical entity.

Features (f) , (g) and (h) characterise a container, i. e. a syringe, filled with the claimed physical entity and a further container, i.e. a packaged kit, comprising the syringe. The features do not define the claimed product but describe merely the form in which it is presented.

It follows that features (d), (f), (g) and (h) are not technical features of the claimed liquid formulation in the sense of R 29(1) and decision G 2/88. These features will not be taken into consideration for the examination of novelty under A 54.

[37] Document D2 refers to pharmaceutical compositions of recombinant beta-interferon and formulation processes. The disclosed formulations are for parenteral administration […] and are in liquid form or lyophilized […]. According to claim 2, the compositions comprise an additional solubilising or stabilizing agent. The list of these additional stabilising agents […] includes glycine.

Example 15 […] discloses a liquid composition containing interferon beta and 2% w/v glycine. The composition does not comprise serum albumin and has not been reconstituted from lyophilized interferon. Consequently, the subject-matter of claim 1 of auxiliary request 11 is anticipated by the disclosure in document D2.

If you wish to download the whole decision, you can do so here.