WORKING SESSION
The role of intent in patent claims
Rainer MOUFANG - Legally qualified member of the EPO boards of appeal - Use and purpose indications in patent claims
I. The problem
1. Patent claims often include an indication of a specific purpose for which the claimed subject-matter is to be used. That applies both to product claims and to process claims, especially use claims. The significance to be attached to such use or purpose indications is an extremely important issue throughout a patent's life cycle, in examination, opposition, revocation and infringement proceedings. It is particularly relevant in relation to the clarity requirement (Article 84 EPC), to the examination of substantive patentability criteria (novelty, inventive step and sufficient disclosure) and to the extent and effects of patent protection. Understanding such purpose indications is often of critical importance.
2. In the context of European patent law a special effort should be made to settle on a harmonised approach. If European bodies and national courts have a fundamentally different understanding of the invention defined in the claim, major rifts in the system may result. While there will inevitably be cases where different interpretations of a claim's meaning are possible and are followed by the courts, it would be far more serious if the divergence were of a fundamental nature, for example because one authority always considered purpose indications to limit the claim's scope while another always held them to be non-limiting.
II. Use and purpose indications in product claims
3. In product claims, use and purpose indications typically take the form of formulations starting with the preposition "to" or "for" which additionally define the claimed product, going beyond explicit structural and material features, and these formulations are often found in the claim preamble (e.g. injection moulding machine for thermoplastic polymers, characterised in that ...).1 Use and purpose indications may however also occur in other forms, e.g. in compound nouns (fish hook, foodstuff, insect repellent).
4. There are three fundamentally different approaches to their interpretation. The first would be to see them as truly limiting the claim to products intended for the specified use or actually used in the specified manner. Although this approach seeks to give the claim feature its natural meaning, it is not followed in appeal board decisions or in EPO practice. The thinking behind this is that the subject-matter of a product claim is the product itself, so that it would be contradictory to incorporate future uses and purposes in its definition.
5. The second approach is in principle to assign absolutely no limiting effect to use and purpose indications, always mentally deleting them when examining an application.2 The problem with this though is that denying any meaning to features that the applicant deliberately included when drafting his claim runs counter to accepted interpretive methodology.
6. Hence the approach usually followed by EPO bodies is to take a middle way between these extremes, whereby use and purpose indications limit the products defined in the claim to those which are suitable for the indicated purposes or uses. The Guidelines for Examination give the example of a mould for molten steel.3 In this case the use indication implies certain limitations for the mould, such that a plastic ice cube tray with a melting point much lower than that of steel would not come within the claim. For further illustrations see the decisions in T 352/94,4T 132/025 and T 918/02.6
7. However, "suitable" is a rather imprecise term. Is there anticipation or infringement of if the published prior art or the allegedly infringing embodiment is only poorly suitable for the use indicated in the patent7 or would have to be modified or processed for that use (as with an intermediate product)? In some cases too Article 84 EPC's clarity requirement may not be met.8
8. For pharmaceutical inventions, Article 54(4) and (5) EPC provides for exceptions to these principles. If a substance as such was known but not its pharmaceutical use, this prior art does not rule out a claim to the substance as a medicament. In the case of a second (and any further) medical indication, too, under EPC 2000 a product claim to the substance for the specific use in question may be granted.9 The same applies to special forms of application and dosage regimes for medicaments.10 A likely consequence is that the identification of subjective factors may acquire decisive significance in infringement proceedings. Much though remains to be clarified.11
III. Use and purpose indications in process claims
9. For process claims, use and purpose indications seem at first glance to present fewer problems. As a process is as a rule defined by a series of technical steps, its envisaged purpose or use may often be interpreted as an additional qualification of one or more of those technical steps. A process for the manufacture of product A is the same as a method of manufacturing the product; in other words, the manufacture of the product is a feature of the claim. One problem that affects product claims - that a use or purpose indication to a certain extent refers beyond the subject-matter of the claim - is not such an acute issue with process claims.
10. Yet here too there is a range of serious legal issues, centring on two Enlarged Board decisions on non-medical uses (G 2/8812 and G 6/8813) which aroused some considerable controversy in national courts when taken, over twenty years ago, and have implications which still often affect us today. The ideas underlying them may be summarised as follows:
The use of a known substance for a new purpose is new in patent law terms if its means of realisation differs from that of the known uses. This case is clear-cut.
If the means of realisation does not differ from that of known uses, the new purpose cannot be considered new in patent law terms if it is construed as a subjective feature, i.e. as an idea in the mind of the person carrying out the invention. Such subjective features are irrelevant when examining for novelty.
An indication of purpose in a use claim however does not necessarily constitute a purely subjective feature. In fact, it should as a rule be construed as a functional technical feature, in that the used substance gives rise to the particular effect associated with the new purpose.
The fact that the particular effect has already occurred unnoticed in connection with a known use is immaterial (rejection of the doctrine of inherency).
11. In the light of these principles there are three further points that need to be clarified:
(i) If a purpose indication is construed as an objective functional feature of the claim ("achieving the particular effect associated with the purpose"), a patent could be held to be infringed by a person using the substance in a known manner, to the extent that this also inherently involves the effect described in the patent. Yet this goes against the traditional principle that a patent is not allowed to prohibit a technical action which forms part of the state of the art. One way out of this dilemma in infringement proceedings might be after all to take account of subjective factors, i.e. the knowledge and intention of the person taking such action.
(ii) Do the principles of the Enlarged Board's decisions apply not only to "classical" use claims but also to other process claims, e.g. for manufacturing methods? Appeal board case law varies in that respect (see T 1092/0114 but also T 1139/06,15T 1855/0616 and T 1179/0717).
(iii) Exactly where does the boundary lie between a patentable use for a new purpose and the non-patentable mere discovery of an effect mechanism for a known use? Finding an answer to this question may cause problems in individual cases (see T 892/9418, on the one hand, andT 816/0519 on the other hand) and has resulted in the development of extensive case law, especially in relation to medical uses. In locating the boundary it is relevant whether the newly identified mechanism of action involves the treatment of a new group of patients or a new clinical situation (for details see T 486/01,20T 1229/03,21T 406/06,22T 1642/0623 and T 1652/06).24
1 As shown by a recent decision of the US Court of Appeals for the Federal Circuit (Marrin v. Griffin, 94 USPQ2d 1140, dated 22 March 2010), the interpretation of such use indications in the preamble may also give rise to considerable controversy in non-European patent systems. In his dissenting opinion, for example, Judge Newman says (94 USPQ2d 1140, 1146): "The 'for use' preamble phrase in Bicon, and analogous preamble language in [...] countless other cases, have been recognized as providing essential limitations to the claim. The panel majority strays far from precedent, in holding that the Griffins' preamble must be ignored because it states a 'use', and then invalidating the claim as anticipated when freed of the limitations in the preamble."
2 That at least is the trend in recent rulings by Germany's Federal Court of Justice (BGH), see BGH decision of 31 August 2010, X ZB 9/09 (concerning video-assisted catheter navigation), point 11: "However, these legal constraints do not imply that all the linguistic elements of a formulated claim describe features of the subject-matter that the claim is intended to protect. Product and device claims for example may feature indications of purpose, effect or function which, as elements of the claim, contribute only in certain circumstances to its task of identifying the protected subject-matter and hence also limiting it, e.g. in terms of its presumed suitability. In general, though, the product or device is defined as the protected subject-matter by features described in spatial and physical terms, regardless of the purpose for which it is intended to be used according to the indications in the claim (see BGH decisions of 7 June 2006, X ZR 105/04, GRUR 2006, 923, point 15, and of 28 May 2009, Xa ZR 140/05, GRUR 2009, 837, point 5, concerning construction formwork support). In such cases, indications of purpose, effect or function do not identify features of the subject-matter for which protection is sought."
3 Guidelines for Examination in the European Patent Office (April 2010), Part C, Chapter III, 4.13.
4 Decision of Technical Board of Appeal 3.4.02 of 3 February 1998 - Coriolis mass flow meter/MICRO MOTION, Reasons 2.1.2: "[C]haracteristics implied by the particular use of a device should be taken into account when e.g. deciding the novelty of the device, an example being given relating to hook for a crane as compared with a known fish hook of similar shape, the differences in size being implied by the difference in use. As further credibly argued by the respondent, in the present case, the use of the manifold for a parallel path Coriolis mass flow meter clearly implies that flow tubes are to be attached to a manifold compatible with the mechanical oscillations to which the flow tubes are submitted when measuring the mass flow of a fluid transiting through said flow tubes."
5 Decision of Technical Board of Appeal 3.5.01 of 21 June 2005 - Management pattern/IBM, Reasons 5: "A functional feature in a product claim, however, should be construed as an implicit definition of those structural features which are necessary to achieve a particular effect when the product is used or applied in accordance with the teaching inherent in the claim; the effect to be achieved and the use should be disclosed in the application."
6 Decision of Technical Board of Appeal 3.2.06 of 12 November 2004 - Seil als Tragmittel für Aufzüge/INVENTIO, Reasons 2.2: [...] "Hence the indication that the cable is driven by way of a drive pulley is to be regarded as an indication of use, i.e. the claimed cable is suitable for being driven by way of a drive pulley. No further technical features are to be inferred from this indication."
7 T 918/02 of 12 November 2004 (Reasons 2.4) states in this context: "The appellant has argued that it is known from patent D6 that the cable known from D3 is 'not optimal for traction' by way of a drive pulley. However, this indication in D6 merely means that the cable is not the best choice for a traction cable and does not mean that it is totally unsuitable for being driven by way of a drive pulley, merely that there are cables better suited to that use."
8 In T 455/92 of 5 October 1993 though no particularly strict criterion was laid down as regards the requirements of Article 84 EPC; see e.g. Reasons 2.2 and 2.5: "In claim 2 of the main request, which relates to a covering and is to be construed as an independent claim, the purpose for which the covering is to be used is indicated in the preamble. This implies that the covering must be suitable for introduction into a press chamber of a rectangular or round bale press and for wrapping a pressing produced therein. This indication already entails a certain choice of covering in terms of both size range (the normal range of bale sizes) and form (introducible into a press chamber and wrappable)." [...] "While the features expressed by the use indication are capable of very broad interpretation, they are necessary for the definition of the application's subject-matter. Hence they do not breach the Article 84 EPC requirement for claims to be concise." See also T 194/99 of Technical Board of Appeal 3.4.01 of 7 May 2004 - Medical laser/MATSUSHITA, Reasons 3: "In principle, having regard to the clarity of a claim, it is possible in a claim for a first entity to define certain characteristics of that entity as a function of characteristics of a second entity employed when using the first entity."
9 Such purpose-bound product claims supersede the Swiss-type claim familiar from earlier law as recognised in G 1/83, G 5/83 and G 6/83 (OJ EPO 1985, 60, 64, 67). See G 2/08, OJ EPO 2010, 456 - Dosage regime/ABBOTT RESPIRATORY, Reasons 7, setting a time limit for transitional purposes. See also the notice from the EPO dated 20 September 2010 concerning the non-acceptance of Swiss-type claims for second or further medical use following decision G 2/08 of the Enlarged Board of Appeal, OJ EPO 2010, 514: the cut-off date is 29 January 2011; no European patents containing Swiss-type claims are to be granted in respect of applications having a filing date or - if a priority is claimed - an earliest priority date on or after that cut-off date.
10 G 2/08, OJ EPO 2010, 456 - Dosage regime/ABBOTT RESPIRATORY. The Tribunal de grande instance in Paris though has recently taken a divergent view in a decision dated 28 September 2010 (No. 07/16296) concerning the treatment of androgenic alopecia.
11 It will often be clear from the patient information leaflet whether a medicament is to be used for the patented form of application, and in that case the patent proprietor is generally likely to seek action against the maker or importer; but if the leaflet does not mention the patented form of application, doctors and pharmacists are most likely to be seen as infringers, at least where a doctor uses the medicament for treatment or the doctor's prescription makes reference to the patented form of application. To that extent a patent may also be infringed indirectly, despite the fact that it does not extend to the patient's private actions (see e.g. Article 10(3) of the German Patent Law). It would appear that the legislative decision in favour of purpose-bound product protection for the second medical indication means that medical treatment may entail patent infringement more frequently than was the case with Swiss-type claims.
12 G 2/88, OJ EPO 1990, 93 - Friction reducing additive/MOBIL OIL III.
13 G 6/88, OJ EPO 1990, 114 - Plant growth regulating agent/BAYER.
14 Decision of Technical Board of Appeal 3.3.04 of 26 April 2005 - Lutein/INDUSTRIAL ORGANICA; Reasons 17: "... [A]lthough the claims of the patent in suit are directed to a process and not to a use, the rationale of G 2/88 is applicable because here, as well as in the situation underlying G 2/88, the question is whether novelty can rely on a new effect which is brought about by known means, namely a compound in the case underlying decision G 2/88 or a process in the present case." Ultimately though novelty was denied because despite the indication of a new effect (lutein to zeaxanthin isomerisation) the claimed process served the same ultimate purpose of providing pigments for use in the food industry.
15 Decision of Technical Board of Appeal 3.3.02 of 19 February 2009 - Preparation of microcapsules/QUADRANT DRUG DELIVERY, Reasons 4.5.2: "It therefore has to be evaluated whether or not the feature 'use of a material that changes the charge of microcapsules to selectively target the microcapsules to an area of the human or animal body', which constitutes the only potentially distinguishing feature of the claim, can establish novelty. As was pointed out in paragraph 4.4.2 above, the subject-matter of claim 2 concerns a process for preparing hollow microcapsules. A process for preparing a composition is defined by the various process steps which are necessary in order to obtain the desired composition. The above feature, however, defines an effect of a compound used in the preparation of microcapsules, which has no influence whatsoever in their preparation [...]. As a consequence, the above feature has merely an explanatory function and cannot therefore render novel the process for preparing hollow microcapsules as claimed in claim 2 of auxiliary request I. In this context, it is noted that, in view of the fact that the subject-matter of claim 2 concerns a process for preparation rather than a use of a compound for obtaining an effect, decision G 2/88 (OJ EPO 1990, 93) does not apply in the present case."
16 Decision of Technical Board of Appeal 3.3.07 of 18 June 2009 - Schutz von Elastan-Fasern/BAYER, Reasons 5.3: "If, as in the present case, the purported new use is clearly a non-medical use, use of the known compound for the known manufacture of a known product cannot be deemed to be novel on account of a new characteristic of the resultant product. [...] For G 2/88 (above) and G 6/88 (above) to apply at all, the claimed use would then have to refer to a new form of exploiting the newly identified characteristic, not merely to the manufacture of a product possessing that characteristic."
17 Decision of Technical Board of Appeal 3.3.03 of 10 March 2009 - Verminderung des Aldehyd-Gehalts/BASF, Reasons 2.1.3: "In the present case, despite the indication of purpose, the method is clearly directed to the manufacture of a product. [...] If the board were to apply the conclusions of G 2/88 and G 6/88 to the granted method claim, the product of granted method claim 1 would be protected again under Article 64(2) EPC even though that product is known from D1 and was manufactured by exactly the same method as described in D1. Yet it cannot be the object and purpose of Article 64(2) EPC that protection under that article should also extend to a product manufactured by a known method."
18 Decision of Technical Board of Appeal 3.3.02 - Deodorant compositions/ROBERTET S.A., OJ EPO 2000, 1, Reasons 3.4: "Conversely, it can be inferred from decision G 2/88 that no novelty exists if the claim is directed to the use of a known substance for a known non-medical purpose, even if a newly discovered technical effect underlying said known use is indicated in that claim."
19 Decision of Technical Board of Appeal 3.3.04 of 4 May 2007 - Detergent compositions/GENENCOR INTERNATIONAL, Reasons 17: "More importantly, unlike the situations dealt with in decisions T 892/94 or T 706/95, the claimed subject-matter does translate into a new technical application distinct from the known application. In fact, Example 4 of document D1 merely taught using a detergent composition as defined in present claim 1 to obtain improved colour retention/restoration as compared with using the same composition including the whole cellulase. However, the technical teaching of the patent in suit, as embodied by claim 1, enables the skilled person to extend the treatment described in the prior art to cases (and garments) where cotton-containing fabrics need improvement in softness and improvement in colour retention/restoration and improvement in feel and reduced strength loss."
20 Decision of Technical Board of Appeal 3.3.04 of 3 September 2003 - IGF-1/GENENTECH: The treatment of central nervous system injury with IGF-1 was already known. In the board's view the new finding that the agent promoted the survival of a particular type of neuronal cell did not result in a new use. Reasons 11: "For the same reasons the different physiological effects highlighted by the appellant do not allow the identification of a new sub-group of patients to be treated. It is true that two different mechanisms of action of a drug may end in the 'splitting' of the group of patients being treated into two distinct sub-groups, as in the cases considered (supra) and T 893/90 of 22 July 1993. However, that is clearly not the case here, as the patent in suit contains no such teaching. No new sub-groups of patients to be treated for, e.g. 'glial cell-dependent Parkinson's disease' or 'non-cholinergic neural cell-dependent Parkinson's disease' can be recognized as distinguishable from the subjects referred to in document (C17)."
21 Decision of Technical Board of Appeal 3.3.02 of 23 November 2006 - Estrogen compounds for treating neurodegenerative disorders/UNIVERSITY OF FLORIDA, Reasons 2.2.3: "[...] The information given in document (5) under the heading 'Gonadal steroid hormone use in the damaged nervous system' concerns the promotion of neural plasticity which has to do with reparation mechanisms concerning growth-like effects (inter alia, increase of synapses, cell density) but cannot be considered as an anticipation of the treatment of neurodegenerative disorders by protecting a population of nerve cells from death."
22 Decision of Technical Board of Appeal 3.3.04 of 16 January 2008 - Stimulation of beta cell proliferation/NOVO NORDISK. The decision related to a Swiss-type claim directed to the use of GLP-1 in the treatment of Type I and Type II diabetes and reciting the stimulation of beta cell proliferation as a technical effect. Although there had been no prior disclosure of this effect, the board held that the subject-matter of the claim was not new: GLP-1 was already known as a medicament for diabetes patients, and no new therapeutic use arose from the effect described in the patent.
23 In this decision of Technical Board of Appeal 3.3.02 of 23 August 2007 - Sigma receptor/SPRUCE - a potential new clinical application was upheld on the following grounds (Reasons 2.1.1): "Since document (1) and claim 1 are both concerned with the same composition for treating the same disease, it has therefore to be decided whether the now claimed use represents further and different therapeutic use from that disclosed in document (1). Document (1) discloses the use of compositions for the purpose of inducing tumour cell division cycle arrest and/or apoptosis (see e.g., claim 1). Thus, document (1) teaches a direct effect on cancer cells. This is in clear contrast to the technical effect relied upon in claim 1, namely the indirect influence of sigma receptor ligands on tumour cells via the inhibition of the neovascularisation of tumours. This effect, moreover, identifies a new clinical situation, namely one in which it could be preferable to target the supporting vasculature of a tumour rather than the cancer cells themselves, for instance in cases where the cells are resistant to chemotherapeutic drugs."
24 Decision of Technical Board of Appeal 3.3.02 of 12 March 2008 - Treatment of portal hypertension/SUCAMPO AG, Reasons 3.2: "Portal hypertension is an increase in blood pressure in the portal vein. As a consequence, it appears that its treatment, which is disclosed in document (1), inevitably requires suppression of the increased blood pressure in the affected area, i.e. in the portal vein. [...] the subject-matter as claimed and the disclosure in document (1) rely on the same technical effect. The feature 'for suppressing increased portal vein pressure' does not provide any new technical information to the skilled reader with regard to document (1)."