T 2136/15 - Alginate not active ingredient

Key points

• In this appeal against a refusal, claim 1 is for " self-gelling alginate for treating [...] a heart of a patient". The question is if the alginate is a "substance or composition"  in the sense of Article 54(5) EPC.
• The Board holds that Article 54(5) EPC 2000 must be interpreted in conformity with G 5/83.
• The Board concurs with T 2003/08, finding that G 5/83 endorsed the interpretation of the term substance or composition as being the active agent or ingredient of the particular specific medical use.
• In the present invention, the alginate is injected into the heart where it gels. The "alginate acts as a "space-occupying agent" distributed in the myocardium in a suitable pattern. By its presence, the space-occupying agent with its pattern of distribution within the myocardium essentially cinches the baggy globe shaped chamber back to a conical shape that is the most effective pump [...] thereby improving the cardiac function."
• " The therapeutic effect of the use is thus caused by the ensemble of "space-occupying" physical structures formed of the alginate positioned in particular patterns of distribution. These patterned 3D macrostructures do not, however, qualify as a 'chemical entity' or 'composition of chemical entities' within the meaning of G 5/83. As discussed in T 1758/15, [...] such a material qualifies as an initially viscous device rather than as a substance or composition." (emphasis added).
• The applicant had also requested a referral to the Enlarged Board. The applicant submitted "that an invention as the present one should be patentable, for the benefit of innovation, patients and the society as a whole. The Board notes that also Article 53(c) EPC is a compromise. It balances the wish to foster innovation by allowing inventors to gain profit from their ideas, with the wish not to inhibit the free choice of medical practitioners to choose the best available treatment for their patients."

EPO T 2136/15 - link

IV. Claim 1 of the main request reads as follows:

"A self-gelling alginate for treating a dilated left ventricle of a heart of a patient suffering cardiomyopathy, said alginate
being for injection while undergoing gelling into a free myocardial wall of the dilated left ventricle in at least three injection sites respectively containing therapeutically effective amounts of the alginate for thickening the myocardial wall and reducing systolic volume of the left ventricle,
the sites for injection being spaced to have essentially no linkage and being circumferentially distributed in a therapeutically effective pattern across most of the ventricular free wall at or in proximity to the near widest part of the ventricle and along anterior, anterior lateral and posterior lateral surfaces of the heart for globally reducing stress in the free myocardial wall."

Reasons for the Decision

1. Novelty

1.1 The appellant admits that the substance "alginate" per se, as defined in all of the requests, was known in the prior art. This is in accordance with paragraph [0067] of the application which states that the alginate injectate was a commercially available self-gelling alginate formulation.

Thus, novelty of the claimed subject-matter could only be acknowledged by virtue of the purpose-related product claim form authorised for a further medical use of a substance or composition under Article 54(5) EPC.

However, said article imparts novelty only to substances or compositions. It thus has to be examined, whether the claimed self-gelling alginate can be considered a substance or composition within the meaning of Article 54(5) EPC or not.

1.2 Following the general rule of interpretation as advocated in Article 31 of the Vienna Convention on the Law of Treaties, regularly applied by the boards of appeal (see for example G 5/83, points 3 et seq., OJ EPO 1985, 64 and G 1/07, point 3.1, OJ 2011, 134), the appellant was of the opinion that the alginates claimed clearly fell under the term 'substance or composition' in its ordinary meaning. The new uses defined in the respective independent claims thus imparted novelty on the alginates claimed.

1.3 Article 31(1) of the Vienna Convention states that a treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.

Thus, in addition to the ordinary meaning of the terms, due consideration is to be given to their context and to the object and purpose of the treaty.

According to Article 31(2) of the Vienna Convention, the context for the purpose of the interpretation of a treaty shall comprise, in addition to the text, including its preamble and annexes:

(a) ...
(b) any instrument which was made by one or more parties in connection with the conclusion of the treaty and accepted by the other parties as an instrument related to the treaty.

For a proper interpretation of the terms of Article 54(5) EPC following Article 31(1), (2) of the Vienna Convention, it is therefore necessary to take into account the legislative history of said article.

1.4 The final wording of Article 54(4) and (5) EPC 2000, accepted by the diplomatic conference held in Munich from 20 to 29 November 2000, goes back to a proposal of the Swiss delegation made in MR/18/00 dated 21 November 2000 (see MR/24/00, points 138-143). Thus, the object and purpose of Article 54(5) EPC has to be taken from MR/18/00.

The document states that the wording of Article 54(5) EPC was intended to match as closely as possible the scope of protection to the scope provided by a Swiss-type claim, i.e. see MR/24/00, point 139, without extending protection beyond the legal status quo.

In other words, the legislator intended the case law developed by the EPO Enlarged Board of Appeal (i.e. decision G 5/83) to be enshrined in the Convention (see MR/2/00; MR/18/00; and MR/24/00, points 138-143). This is accordingly reflected in the Synoptic presentation EPC 1973/2000 - Part 1: The Articles (Official Journal, Special Edition No. 4, 2007, page 54, point 4).

In view of the so-established context, object and purpose of the amended article, reference needs to be made to Enlarged Board of Appeal decision G 5/83 (OJ EPO 1985, 64) in order to establish the required interpretation of the term "substance or composition".

An interpretation of Article 54(5) EPC following G 5/83 thus clearly corresponds to the explicitly declared intention of the legislator, even if the result were - in the subjective view of the appellant - manifestly absurd and unreasonable.

1.5 In T 2003/08, Board 3.3.04 had analysed Enlarged Board of Appeal decision G 5/83, (see T 2003/08, Reasons points 15-18) and came to the conclusion that G 5/83 endorsed the interpretation of the term substance or composition as being the active agent or ingredient of the particular specific medical use (see G 5/83, the term "active ingredient" is used synonymously with the term "substance or composition" for example in the Reasons points 20 and 23). The present Board concurs with this interpretation.

With this interpretation in mind, Board 3.3.04 developed an approach to determine whether or not "a substance or composition" is used in a treatment (Reasons point 18), an approach which was likewise used in T 1758/15 and which is also helpful in the present case.

In particular, it suggested establishing

(a) the means by which the therapeutic effect is achieved and

(b) whether that which achieves the therapeutic effect is a chemical entity or composition of chemical entities.

A typical example in which these conditions are fulfilled would be a pharmacologically active ingredient, such as the chemical substance 1,4-dihydro-2,6-dimethyl-4-(3'-nitrophenyl)-pyridin-3-ß-methoxyethylester-5-isopropylester active to treat pathologically decreased cerebral functions in T 17/81 of 30 May 1983, the referring decision of G 5/83.

1.6 In the present case, a particular "therapeutically effective pattern" is created by injecting the self-gelling alginate in at least three injection sites, the dose being effective for thickening the myocardial wall and reducing systolic volume of the left ventricle.

The alginate acts as a "space occupying agent" (application, paragraph [0048]), distributed in the myocardium in a suitable pattern. By its presence, the space-occupying agent with its pattern of distribution within the myocardium essentially cinches the baggy globe shaped chamber back to a conical shape that is the most effective pump (application, paragraph [0086]), thereby improving the cardiac function.

The therapeutic effect of the use is thus caused by the ensemble of "space-occupying" physical structures formed of the alginate positioned in particular patterns of distribution. These patterned 3D macrostructures do not, however, qualify as a 'chemical entity' or 'composition of chemical entities' within the meaning of G 5/83. As discussed in T 1758/15, Reasons 5.2.6 and 5.2.8, such a material qualifies as an initially viscous device rather than as a substance or composition.

1.7 The appellant argued that the therapeutically effective pattern of alginate injections could in no way be regarded as a device because the injection sites were isolated and the effect was collective rather than co-operative. However, according to paragraph [0086], the improvements are believed to result from the action of the single circumferential line injections, which essentially cinch the baggy globe shaped chamber back to a conical shape that is the most effective pump. In 'cinching' the baggy globe shaped chamber to a conical shape, the gelled blobs of alginate arranged in the line pattern co-operate to reach the desired effect. Conversely, a collection of such gelled blobs of alginate arranged in a different pattern (e.g. multiple line pattern) reaches a weaker effect. Arranging all gelled blobs for instance in the apex of the heart would not have the effect of shaping the chamber back to a conical shape. The effect of the 'alginate injections circumferentially distributed in a therapeutically effective pattern' is thus not simply cumulative but co-operative. Anyhow, the superstructure in which the alginate injections co-operate cannot be considered a 'chemical' in the above-discussed sense.

1.8 The appellant further argued that while the injection pattern was important, the biochemical and physical properties of the alginate also played a decisive role, which justified eligibility for purpose-related product protection.

However, according to the application (paragraphs [0098] et seq.) many different types of biocompatible materials, some injectable and some implantable, are suitable and may be used. Paragraphs [0115] et seq. mention a myriad of possible such polymers; paragraphs [0124] et seq. further state that implantable mechanical devices such as particles, rods, spheres, expandable small balloons, and struts may also be used as occupying agent. It thus has to be concluded that the beneficial effect of the created patterned superstructure is basically independent of the material from which the space-occupying elements in the pattern are made, as long the space-occupying elements are arranged in the particular therapeutically effective pattern and as long as they are biocompatible.

To put it differently, if the alginate is "active" then it is in building the 3D macro/superstructure. Conversely, it is not active in reshaping the heart chamber, this being the action of the 3D superstructure created. It is also not active in the surgical injections, it being rather the passive object thereof.

The Board further notes that not causing an inflammatory reaction but encapsulation is neither mentioned in the application, nor is part of said use defined in the claim.

The injectates and implants within the pattern not being pro-arrhythmic is mentioned in paragraph [0055], without, however, any link to the particular alginate. Rather, the effect is ascribed to any space-occupying agent within the suitable pattern as described in paragraph [0055] which belongs to the application's section dealing with "Patterns of distribution of Space-Occupying Agent", see paragraph [0053].

Furthermore, the particular stiffness of ionically cross-linked alginate hydrogels is disclosed as controllable "in various ways", including e.g. variation of the molecular weight distribution for controlling and decoupling the viscosity of the pre-gel solution from the post-gel stiffness (paragraph [0117]).

Moreover, the effects mentioned by the appellant are not effects of the alginate as the active agent when interacting with the body. The effects, rather, are in determining the mechanical or biological properties of the particular patterned blob-superstructure formed, just as the elasticity and the degree of tissue interaction of a hip implant depend on the titanium alloy used.

Consequently, the alginate cannot be considered the active ingredient or active principle and thus does not qualify as a "substance or composition" in accordance with Article 54(5) EPC.

1.9 As to the preparation Gaviscon mentioned by the appellant to demonstrate the - in its view - absurdity of interpreting "substance or composition" in the sense of "active ingredient", the Board notes the following:

As pointed out during the oral proceedings, according to its product information sheet, Gaviscon comprises as 'active ingredient' aluminium hydroxide and magnesium carbonate, and as 'inactive ingredients' (among others) alginic acid and sodium bicarbonate. Bicarbonate reacts with the stomach acid to form CO2, such that in combination with the alginic acid a foam-like structure develops - the raft mentioned by the appellant. The terminology used in this product information sheet thus rather supports the Board's conclusion that the 'inactive ingredient' alginate, even though it is involved in the formation of the "raft", is not considered to be the 'active ingredient' of Gaviscon in the meaning of the term used in pharmacology, the field with which G5/83 was dealing.

Contrary to the present case, the antacids aluminium hydroxide and magnesium carbonate are 'active ingredients' within the meaning of G 5/83 and consequently within the meaning of Article 54(5) EPC, and they are thus generally eligible for purpose-related product protection if the other requirements of Article 54(5) are fulfilled.

The example of Gaviscon thus cannot change the Board's above evaluation.

1.10 To conclude, the alginate claimed in all requests does not qualify as a substance or composition within the meaning of Article 54(5) EPC. Claim 1 of all requests is thus not novel.

2. Referral of a question to the Enlarged Board of Appeal

As discussed above, the present case can be decided on the basis of the EPC, the settled Enlarged Board of Appeal case law and the travaux préparatoires. There is thus no need to refer the question posed. The Board can furthermore see no contradiction, in particular with decision T2003/08. Indeed, as can be seen from the reasoning above, the present decision exactly follows the approach developed therein.

During the oral proceedings, the appellant did not focus on why an answer to the formulated question by the Enlarged Board was required in order to decide the case. Rather, the argument was made that an invention as the present one should be patentable, for the benefit of innovation, patients and the society as a whole.

The Board notes that also Article 53(c) EPC is a compromise. It balances the wish to foster innovation by allowing inventors to gain profit from their ideas, with the wish not to inhibit the free choice of medical practitioners to choose the best available treatment for their patients. Necessarily, not allowing patent protection for surgical, therapeutic or diagnostic methods results in possibly highly beneficial inventions not being eligible for patent protection. There is thus no general principle underlying the EPC according to which every great and beneficial (medical) invention should be patentable.

It is true that for "active ingredients" G 5/83 introduced purpose-related product protection in a praetorian way, a development which was later integrated into the EPC 2000. The wish to have such an exception available also for other medicinal products is understandable. However, when deciding on the amendments in the EPC 2000 the legislator had the possibility to amend Article 54 EPC in order to also cover further exceptions. They did not only not do so, but furthermore clearly stated that the article was intended to match the scope of protection provided by a Swiss-type claim as closely as possible.

In view of this clear statement by the legislator, there is no room for further opening, in a praetorian way, patent protection for medicinal products which are not substances or compositions within the meaning of Article 54(5) EPC. This appears to be a desire which would rather need to be pursued in the political arena.

Order

For these reasons it is decided that:

1. The appeal is dismissed.

2. The request for a referral of the case to the Enlarged Board is rejected.