[18] Claim 37 (and claims 38 to 40 dependent thereon) of the application as published refer to a kit for parenteral administration of a liquid interferon formulation.
Contrary to this, claims 1 to 69 as granted do not contain such claim. The independent claims as granted refer to a liquid composition (claim l), to a liquid pharmaceutical composition (claim 32) and to methods for stabilizing interferon in a liquid pharmaceutical composition (claims 43 and 58).
Claim 1 of [patent proprietor’s] main request and of each of auxiliary requests 1 to 10 refers to “[A] packaged kit for parenteral administration of an interferon-beta, the kit containing a syringe pre-filled with a liquid composition comprising the interferon-beta and an amino acid stabilizing agent …”.
[19] A 123(3) provides that during opposition proceedings the claims of the European patent may not be amended in such a way as to extend the protection conferred upon grant. The object of A 123(3) is to prevent any procedural situation where an act which does not infringe the patent as granted becomes an infringing act as a result of an amendment after grant (cf. also T 59/87 [2]; T 604/01 [2.3]). In accordance with the established case law of the Boards of Appeal (cf. T 49/89 [3.2.2]; T 402/89 [2]), the Board holds that the legal notion “protection conferred” in A 123(3) refers to the totality of protection established by the claims as granted and not necessarily to the scope of protection within the wording of each single claim as granted.
Under A 123(3), the patentee is generally allowed to redraft, amend or delete the features of some or al1 claims and is not bound to specific terms used in the claims as granted as long as the new wording of the claims does not extend the scope of protection conferred as a whole by the patent as granted (and does not violate the requirements under A 123(2)). Thus, in order to assess any amendment under A 123(3) after grant, it is necessary to decide whether or not the totality of the claims before amendment in comparison with the totality of the claims after amendment extends the protection conferred.
There are basically two different types of claims, namely claims to a physical entity (e.g. product, apparatus) and claims to a physical activity (e.g. method, process, use). These two basic types of claims are referred to as the two possible “categories” of claims. Within these two basic types of claims various sub-classes are possible (e.g. a compound, a composition, a machine; or a manufacturing method, a process of producing a compound, a method of testing, etc.); (see decision of the Enlarged Board of Appeal (EBA) G 2/88).
Decision G 2/88, which was relied on by the [patent proprietor] in order to substantiate its argument that in the present case the scope of protection has not been expanded, is concerned with the considerations to be taken into account when deciding, with regard to A 123(3), on the admissibility of amendments involving a change of category (from a “compound” claim to “use of that compound in a composition for specified purpose”) . That situation differs from the one underlying the present case. Here claim 1 of the main request refers to a physical entity (a packaged kit). Also claims 1 and 32 of the claims as granted refer to a physical entity, namely a liquid composition, and belong therefore to the same “category”. Claims 43 and 58 of the granted claims refer to a physical activity. The relevant change in claim 1, from a liquid composition to a packaged kit, is not therefore a change in “category”, but a change of sub-class within the same “category”.
The [patent proprietor] argued that a claim referring to a packaged kit containing the liquid composition of claim 1 as granted is in fact narrower in scope than a claim referring to the liquid composition, as this claim encompasses the liquid formulation in any possible container, vessel, package or reservoir. Moreover, granted claim 3 already referred to a liquid composition contained in a vessel, which according to claim 13 was defined as being a syringe.
[22] The Board agrees with the [patent proprietor] in so far as the scope of protection covered by a claim referring to a physical entity should be considered to encompasses the physical entity in any possible package or container. However, it is self-evident that “a packaged kit” is a different physical entity than “a liquid composition”. It must not be overlooked that claim 1 of the main request is not directed to “a liquid composition contained in a packaged kit” but to “a packaged kit containing a syringe pre-filled with a liquid composition.” In the Board’s view the content of a package is not a characterising feature of the package per se. This has the consequence that the scope of protection covered by claim 1 of the main request also encompasses the “packaged kit”, being a box, package or other container, whether it comprises a syringe prefilled with the liquid composition according to the present invention or not. Thus, a procedural situation is created where an act, for instance the production of the box, package or other container, which did not infringe the patent as granted becomes an infringing act as a result of an amendment after grant (cf. T 59/87 and T 604/01). Exactly this situation should be prevented by the requirements of A 123(3).
[23] The [patent proprietor] submitted that a negative decision on this issue would be contradictory to the case law of the Boards of Appeal and would therefore require a referral of questions to the EBA according to A 112(l)(a).
It referred in this respect to decision T 579/01, taken by this Board in a different composition. In this case independent claim 1 and dependent claims 2 to 6 of the new main request were directed to a “vegetable plant”, while the respective claims as granted were directed to a “cell in a vegetable plant”. The Board said that in the understanding of the skilled person the term “a cell of a plant”, not being qualified as “isolated”, included various physiological and morphological states of such a cell, including both differentiated and undifferentiated states. The cells in the different states in which they existed in a (developing) plant fell within the protection conferred by the claim to the “cell of a vegetable plant” as granted, and the protection conferred by such claim also extended to such cells in a plant. Furthermore, the biological notion “cells of a plant” encompassed such differentiated cells which were morphologically and functionally organised to constitute a plant. That implied that morphologically and functionally organised aggregates of plant cells, e.g. plants, likewise fell within the protection conferred by the granted claim to “a cell of a plant”. The Board also decided that any plant as subject-matter of claim 1 of the new main request fell within the protection conferred by a claim to “a cell of a plant”, and finally that the “plant” now claimed was characterised by the same genetic features as recited in the granted claim to “a cell of a plant”. The Board also decided that any plant as subject-matter of claim 1 of the new main request fell within the protection conferred by a claim to “a cell of a plant”, and finally that the “plant” now claimed was characterised by the same genetic features as recited in the granted claim to “a cell of a plant”.
This situation differs drastically from the present one, where it goes without saying that a liquid composition does not differentiate and develop into a packaged kit, and that these two entities are not characterised by the same genetic features. Accordingly decision T 579/01 does not apply to the present case.
[24] A further decision referred to was T 352/04. In this case claim 1 as granted referred to a hair conditioner, characterised by its components, while amended claim 1 referred to the hair conditioner characterised by its components, wherein the conditioner took the form of an aerosol hairspray or of a non-aerosol hairspray with a mechanically driven spraying device ([…] emphasis added by this Board).
Both claim 1 as granted and claim 1 as amended refer to a hair conditioner, thus they belong to the same subclass within the same “category” of claims. As this situation differs from the present one, decision T 352/04 has no bearing for the main request.
[25] In the light of the above considerations (see especially point [22] above), the Board arrives at the decision that the patent according to [patent proprietor’s] main request has been amended in a way as to extend the protection it confers. The main request violates the requirements of A 123(3). The same applies to auxiliary requests 1 to 10.
I have to say that I am not persuaded by this application of A 123(3). When a claim is directed at a packaged kit containing a liquid-filled syringe, how can it be affirmed that the scope of protection extends to a package that does not contain such a syringe? To my eyes, this sort of claim interpretation is flawed. The key sentence in the reasoning of the Board appears to be that “the content of a package is not a characterising feature of the package per se.” Now this may be right, but the claimed subject-matter is not a package per se but a packaged kit containing a syringe. Unless I miss something important, a package without a syringe could never be seen to literally infringe the claim.
This leads me to another thought. I like the teleological reading of A 123(3) proposed by the Board: “The object of A 123(3) is to prevent any procedural situation where an act which does not infringe the patent as granted becomes an infringing act as a result of an amendment after grant.” Having said this, invoking infringement in proceedings before the EPO is not unproblematic. For the time being, the assessment of patent infringement is not within the competence entrusted to the EPO but is left with the national jurisdictions. Some national patent laws, such as for instance French law, retain complex forms of infringement, such as contributory infringement. Under certain, rather strictly defined circumstances, selling a package without a syringe could perhaps constitute a (contributory) infringement of claim 1. But of course, the EPO could never take into consideration such tricky aspects of national patent law. There is simply no legal basis for doing so. Therefore, it would perhaps be more prudent to say: “The object of A 123(3) is to prevent any procedural situation where any product/process which does not reproduce all the features of a claim as granted reproduces all the features of the claim as amended after grant.”
Tomorrow we shall see one more aspect of this decision.
If you wish to download the whole decision, you can do so here.
Tomorrow we shall see one more aspect of this decision.
If you wish to download the whole decision, you can do so here.
For another surprising decision dealing with A 123(2), click here.
6 comments:
There is in fact a big problem with A 123(3), since it refers to the protection conferred. This is usually referred as the "scope" of the patent and is different from the "subject-matter" of the claims.
In infringement a judge has to assess whether a specific product or activity falls within the scope of a patent. He is comparing something concrete with the nebuluous "scope" of the patent.
Under A 123(3) the EPO is asked to compare a nebuluous "scope" of the unamended patent with the nebuluous "scope" of the amended one. This task is much more problematic and is bound to create difficulties.
The solution? I have none, but maybe some perspicuous reader may.
Note how the Board's decision directly contradicts the decision of G2/88:
3.3 Question (i) asks in particular how far should the national laws of Contracting States relating to infringement be considered, when deciding upon admissibility under Article 123(3) EPC. As touched upon previously in paragraph 2.5 above, the protection conferred by a patent is to be determined by interpretation of the terms of the claims, and the rights of the patent proprietor flow from the protection which is conferred. There is a clear distinction between the protection which is conferred and the rights which are conferred by a European patent, however. The protection conferred by a patent is determined by the terms of the claims (Article 69(1) EPC), and in particular by the categories of such claims and their technical features. In this connection, Article 69 EPC and its Protocol are to be applied, both in proceedings before the EPO and in proceedings within the Contracting States, whenever it is necessary to determine the protection which is conferred. In contrast, the rights conferred on the proprietor of a European patent (Article 64(1) EPC) are the legal rights which the law of a designated Contracting State may confer upon the proprietor, for example, as regards what acts of third parties constitute infringement of the patent, and as regards the remedies which are available in respect of any infringement. In other words, in general terms, determination of the "extent of the protection conferred" by a patent under Article 69(1) EPC is a determination of what is protected, in terms of category plus technical features; whereas the "rights conferred" by a patent are a matter solely for the designated Contracting States, and are related to how such subject-matter is protected. It follows that when deciding upon the admissibility of any amendment to the claims of a patent which is proposed in opposition proceedings (whether or not such amendment involves a change of category of claim), what has to be considered and decided is whether the subject-matter which is protected by the claims, as defined by their categories in combination with their technical features, is extended. It is not necessary to consider the national laws of the Contracting States in relation to infringement when making such a decision, however.
4. When considering whether a proposed amendment to the claims is such as to extend the protection conferred, a first step must be to determine the extent of protection which is conferred by the patent before the amendment: it is necessary to be quite clear as to what is the protection conferred by the patent without amendment, before one can decide whether a proposed amendment is such as to extend it. Determination of the extent of protection has to be carried out in accordance with Article 69(1) EPC and its Protocol, which provides a guide to the manner in which the technical features of the claim are to be interpreted. The Protocol was adopted by the Contracting States as an integral part of the EPC in order to provide a mechanism for harmonisation of the various national approaches to the drafting and interpretation of claims discussed in paragraph 2.1 above. The central role of the claims under the EPC would clearly be undermined if the protection and consequently the rights conferred within individual designated Contracting States varied widely as a result of purely national traditions of claim interpretation: and the Protocol was added to the EPC as a supplement primarily directed to providing an intermediate method of interpretation of claims of European patents throughout their life, as a compromise between the various national approaches to interpretation and determination of the protection conferred ("... so as to combine a fair protection for the patentee with a reasonable degree of certainty for third parties"). The object of the Protocol is clearly to avoid too much emphasis on the literal wording of the claims when considered in isolation from the remainder of the text of the patent in which they appear; and also to avoid too much emphasis upon the general inventive concept disclosed in the text of the patent as compared to the relevant prior art, without sufficient regard also to the wording of the claims as a means of definition. This approach to interpretation of claims must be adopted by the EPO when determining the protection conferred for the purpose of Article 123(3) EPC.
How silly a decision. Oliver's first paragraph says it all. A packaged kit is still a kit. How could an empty box possibly infringe a claim to such a kit? Beats me.
If claim 1 somehow protects a (presumably known) packaged kit without a syringe, then claim 1 should equally somehow lack novelty (or inventive step in the case of equivalents).
Of course the Board does not think that claim 1 lacks novelty over a known packaged kit. The Board is simply quite terribly mistaken.
The only way I could imagine to confer some credibility to this decision would be to argue that "a syringe pre-filled with a liquid composition" does not unconditionally implies that the syringe is filled with that liquid when forming part of the package, but that some-when it has been filled with that liquid before being included in the package.
Such an interpretation is quite extreme, in my opinion, in the light of the description it could have been disregarded. However, it seems that the "logic" of the Board is another one, relying in the fact that they are directed to different "entities". However A123(3) do not aims about restricting a change of entities, but a extension of protection.
Post a Comment