WORKING SESSION
Disclaimers
Brigitte GÜNZEL - Chairwoman of the EPO Legal Board of Appeal - The allowability of disclaimers in accordance with decisions G 1/03, G 2/03 and G 2/10 of the Enlarged Board of Appeal
I. What is a disclaimer within the meaning of these decisions?
"In accordance with consistent practice, the term 'disclaimer' is used hereafter as meaning an amendment to a claim resulting in the incorporation therein of a 'negative' technical feature, typically excluding from a general feature specific embodiments or areas." (G 1/03 and G 2/03, OJ EPO 2004, 413 and 448 - hereinafter cited, unless otherwise specified, as G 1/03 - point 2 of the Reasons, and G 2/10, OJ EPO 2012, 376, point 2 of the Reasons).
II. What is at issue here?
Where, in order to take account of detected prior art or for other reasons, a claim has to be limited by the introduction of positively worded features which must be disclosed, this often has a more limiting effect on the protection sought than would be required in the light of that prior art or other reason. Disclaimers, by contrast, offer a means of excluding from the protection afforded by a general or broadly worded claim only those specific embodiments that are known or otherwise not patentable. As this form of amendment is generally made in response to prior art newly cited in examination or opposition proceedings or to an objection based on another obstacle to patentability, the disclaimer as such is rarely found in the original application documents. Thus, the allowability of subsequently introduced disclaimers must be examined from the point of view of Article 123(2) EPC.
III. What are the possible scenarios and what were the Enlarged Board of Appeal's answers to the points of law referred?
1.1 Scenarios
The scenarios concerned in these cases can be gathered from the wording of the points of law referred to the Enlarged Board of Appeal:
"Is an amendment to a claim by the introduction of a disclaimer unallowable under Article 123(2) EPC for the sole reason that neither the disclaimer nor the subject-matter excluded by it from the scope of the claim have a basis in the application as filed?"
...
(Question 1 in T 507/99, OJ EPO 2003, 225)
"Is the introduction into a claim of a disclaimer not supported by the application as filed admissible, and therefore the claim allowable under Article 123(2) EPC, when ...".
(Question in T 451/99, OJ EPO 2003, 334)
1.2 Full versions of the questions referred
The points of law referred to the Enlarged Board read in full as follows:
"1. (see above)
2. If the answer to question 1 is no, which criteria are to be applied in order to determine whether or not a disclaimer is allowable?
(a) In particular, is it of relevance whether the claim is to be delimited against a state of the art according to Article 54(3) EPC or against a state of the art according to Article 54(2) EPC?
(b) Is it necessary that the subject-matter excluded by the disclaimer be strictly confined to that disclosed in a particular piece of prior art?
(c) Is it of relevance whether the disclaimer is needed to make the claimed subject-matter novel over the prior art?
(d) Is the criterion applicable that the disclosure must be accidental, as established by prior jurisprudence, and, if yes, when is a disclosure to be regarded as being accidental, or
(e) is the approach to be applied that a disclaimer which is confined to disclaiming the prior art and has not been disclosed in the application as filed is allowable under Article 123(2) EPC, but that the examination of the subject-matter claimed for the presence of an inventive step has then to be carried out as if the disclaimer did not exist?"
"(see above)
If yes, what are the criteria to be applied in assessing the admissibility of the disclaimer?"
1.3 The Enlarged Board's answers in G 1/03
The Enlarged Board decided to consider the two sets of questions referred to it in consolidated proceedings and gave the following uniform answer to both:
"I. An amendment to a claim by the introduction of a disclaimer may not be refused under Article 123(2) EPC for the sole reason that neither the disclaimer nor the subject-matter excluded by it from the scope of the claim have a basis in the application as filed.
II. The following criteria are to be applied for assessing the allowability of a disclaimer which is not disclosed in the application as filed:
II.1 A disclaimer may be allowable in order to:
- restore novelty by delimiting a claim against state of the art under Article 54(3) and (4) EPC;
- restore novelty by delimiting a claim against an accidental anticipation under Article 54(2) EPC; an anticipation is accidental if it is so unrelated to and remote from the claimed invention that the person skilled in the art would never have taken it into consideration when making the invention; and
- disclaim subject-matter which, under Articles 52 to 57 EPC, is excluded from patentability for non-technical reasons.
II.2 A disclaimer should not remove more than is necessary either to restore novelty or to disclaim subject-matter excluded from patentability for non-technical reasons.
II.3 A disclaimer which is or becomes relevant for the assessment of inventive step or sufficiency of disclosure adds subject-matter contrary to Article 123(2) EPC.
II.4 A claim containing a disclaimer must meet the requirements of clarity and conciseness of Article 84 EPC."
2. G 2/10
2.1 Background
Subsequent to decisions G 1/03 and G 2/03, different opinions were expressed in the boards' case law as to whether the criteria in headnote II of these decisions apply to the disclaiming of embodiments disclosed as part of the invention in the application as filed (G 2/10, OJ EPO 2012, 376, point 1 of the Reasons; G 1/07, OJ EPO 2011, 134, point 4.2.3 of the Reasons; T 1107/06 of 3 December 2008, point 31 et seq. of the Reasons, and the decisions cited therein). The reasoning in the decisions finding that they did apply was that undisclosed disclaimers within the meaning of headnote II referred to all scenarios where the disclaimer as such was not already disclosed in the initial application.
2.2 Referred question in G 2/10
After the Enlarged Board of Appeal itself had acknowledged, in its decision G 1/07 on interpretation of the exclusion of surgical methods from patentability, that there was a discrepancy, but had been unable to address it as part of that referral, Board of Appeal 3.3.08 referred the following point of law to it by decision T 1068/07 (OJ EPO 2011, 256):
"Does a disclaimer infringe Article 123(2) EPC if its subject-matter was disclosed as an embodiment of the invention in the application as filed?"
2.3 The Enlarged Board's answers in G 2/10
Given that disclaimers do not generally exclude only one specific embodiment from protection, rather they are often defined in much broader terms and - at least potentially - exclude a plurality of embodiments, a whole (sub-)group thereof or a whole, albeit limited, area falling within the ambit of a generic claim, and given that it is precisely cases of this kind which can appear problematic when it comes to deciding whether, after the introduction of such a broad disclaimer, the subject-matter remaining in the claim is still the same as that formerly claimed, the Enlarged Board applied a broader interpretation to the point of law referred to it (point 2.3 of the Reasons), giving the following answer:
"1a. An amendment to a claim by the introduction of a disclaimer disclaiming from it subject-matter disclosed in the application as filed infringes Article 123(2) EPC if the subject-matter remaining in the claim after the introduction of the disclaimer is not, be it explicitly or implicitly, directly and unambiguously disclosed to the skilled person using common general knowledge, in the application as filed.
1b. Determining whether or not that is the case requires a technical assessment of the overall technical circumstances of the individual case under consideration, taking into account the nature and extent of the disclosure in the application as filed, the nature and extent of the disclaimed subject-matter and its relationship with the subject-matter remaining in the claim after the amendment."
IV. The reasons for decision G 2/10
1. The Enlarged Board started by confirming, on the basis of thorough reasoning (point 3 of the Reasons), the view already expressed in T 1107/06 (point 31 et seq. of the Reasons) and national decisions (Napp Pharmaceutical Holdings Ltd v Ratiopharm GmbH and Sandoz Ltd, Court of Appeal (England and Wales) [2009] EWCA Civ 252, point 82 et seq. of the Reasons, citing T 1139/00; and judgment of the Hague District Court of 7 April 2010 in Case No. 340373/09-2029 Mundipharma Pharmaceuticals B.V. v Sandoz B.V., point 4.11 et seq. of the Reasons) that G 1/03 and the criteria set out in headnote II, like the referred questions, related only to the scenario under consideration in headnote I, i.e. that neither the disclaimer as such nor the subject-matter excluded by it from protection had been disclosed in the application as filed.
2. It then analysed the Enlarged Board of Appeal's previous case law on matters relating to interpretation of Article 123(2) EPC (point 4.3 of the Reasons) and noted that the rule, developed as early as opinion G 3/89 and decision G 11/91 (OJ EPO 1993, 117 and 125, relating to amendments by way of correction), was that any amendment to the parts of a European patent application or of a European patent relating to the disclosure was subject to the mandatory prohibition on extension laid down in Article 123(2) EPC and could therefore, irrespective of the context in which it had been made, only be made within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, and seen objectively and relative to the date of filing, from the whole of these documents as filed. Not only did this rule still apply, but indeed it had since become the generally accepted, or even "gold", standard for assessing whether an amendment complies with Article 123 EPC.
This standard was, in principle, confirmed in G 1/93 (OJ EPO 1994, 541, answer 1, first sentence) with respect to the ground of opposition under Article 100(c) EPC and, on a more general level, in G 2/98 (OJ EPO 2001, 413). In the latter decision, the Enlarged Board had also relied on a disclosure test for determining whether the later application was for the same invention as the priority application and explicitly referred to the disclosure test applied under Article 123(2) EPC (G 2/98, answer and points 1 and 9 of the Reasons). In G 1/93, it had decided that, in the event of conflict between the requirements under Article 123(2) and (3) EPC, an undisclosed limiting feature which - without providing a technical contribution to the subject-matter of the claimed invention - merely excluded protection for part of the subject-matter of the claimed invention as covered by the application as filed, could remain in the claim without violating Article 123(2) EPC. At the same time, however, it had generally confirmed the binding nature of Article 123(2) EPC (point 13 of the Reasons).
3. In the Enlarged Board's view, decision G 1/03 did not express the position that introducing a disclaimer could not per se change the technical information in the application and therefore could not modify the subject-matter remaining in the claim (point 4.4 of the Reasons). This was especially clear from the wording used by the Enlarged Board in the first sentence of answer 2 in G 1/03 ("a disclaimer may be allowable") and from point 2.6.5 of the Reasons, in which it had held that a disclaimer was or became inadmissible if it had effects going beyond its purpose of delimiting a claim from prior art within the meaning of Article 54(3) EPC or from an accidental anticipation or of excluding non-patentable subject-matter. The gist of the questions referred to the Enlarged Board for a ruling in G 1/03 and G 2/03 had been to establish whether and, if so, under what circumstances undisclosed disclaimers could be considered allowable at all, as a matter of principle, despite the absence of a basis in the application as filed. It was this question and no more that the Enlarged Board had answered in answer 2 in G 1/03 and G 2/03.
4. In G 2/10, therefore, the Enlarged Board concluded that disclaiming subject-matter disclosed in the application as filed might infringe Article 123(2) EPC if it resulted in the skilled person's being presented with technical information which he would not derive directly and unambiguously, using common general knowledge, from the application as filed (point 4.5.1 of the Reasons).
Transposed to the matter at issue, namely an amendment to a claim, Article 123(2) EPC would read that the claim may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed. Since a disclaimer as such defined subject-matter which was no longer claimed, the compatibility of the amended claim with Article 123(2) EPC could not be decided solely by establishing that the disclaimed subject-matter had been disclosed in the application as filed. Whether the skilled person was presented with new information depended on how he would understand the amended claim, i.e. the subject-matter remaining in the amended claim, and on whether, using common general knowledge, he would regard that subject-matter as at least implicitly disclosed in the application as filed (point 4.5.2 of the Reasons).
5. Whether the subject-matter remaining in the amended claim satisfied this point of reference could not be decided schematically, i.e. according to the so-called rules of logic.
Even if it could be said that the original disclosure was not normally a problem for the remaining subject-matter where originally disclosed specific embodiments, groups thereof or areas were disclaimed from the scope of a more general claim reflecting a more general teaching which had equally been disclosed, the question could nevertheless not be decided schematically.
There was no so-called rule of logic that, where an application disclosed a general teaching and specific embodiments, groups thereof or areas, all other potential embodiments or intermediate generalisations falling within the ambit of the general teaching (but not as such disclosed in the application as filed) were, by implication, inevitably also disclosed. Nor, on the other hand, would any schematic reasoning solely suggesting that the introduction of the disclaimer modified the subject-matter remaining in the claim because the amended claim contained less than the unamended claim, be sufficient to justify an objection under Article 123(2) EPC (point 4.5.3 of the Reasons).
Rather, the technical circumstances of the particular case needed to be assessed to determine whether the skilled person would, using common general knowledge, have derived the remaining claimed subject-matter, explicitly or implicitly, but directly and unambiguously, from the application as filed. This test was the same as that applied when assessing the allowability of a limitation of a claim by a positively defined feature, and there was a whole body of case law on that test which had to be applied equally to amendments of claims by disclaiming disclosed specific embodiments, groups thereof or areas.
6. The fact that the disclaimed subject-matter was originally disclosed as part of the invention had, in itself, no bearing on the right to exclude it from the subject-matter of the claim because it was in principle for the applicant to determine the scope of desired protection by his drafting of the claims. However, the applicant also bore the associated risk, especially when disclaiming a preferred embodiment, because, when it came to determining whether the amended claim fulfilled the remaining EPC requirements, such as support by the description (Article 84 EPC), sufficiency of disclosure (Article 83 EPC) and inventive step (Article 56 EPC), the disclaimed subject-matter could no longer be taken into account. With respect to inventive step, the question whether the problem had been solved over the whole breadth of the claim or whether an advantageous effect obtained by the remaining claimed subject-matter could be deduced from the application as filed might, in particular, become relevant.
7. The Enlarged Board then discussed the coherence of its approach with other substantive patentability criteria linking the applicant's rights to the disclosure made at a specific time. It stressed that its approach did not distort, but rather preserved, the structural relationship established in the EPC and based on the first-to-file system between the provisions defining the state of the art and their impact on patentability and the substantive requirements for validly claiming a priority (concept of same invention) or filing divisional applications and for the right to amend the application. It was vital that a uniform concept of disclosure be applied and the applicant's rights uniformly determined in all those contexts as extending but also limited to the disclosure made at the relevant point in time. This had been emphasised in decision G 2/98 and the same had to apply to any amendment under Article 123(2) EPC, which could not permissibly create novel subject-matter. The approach did not impair either the applicant's right to divide the application, since that right was in any case limited to the subject-matter which could be regarded as disclosed in the earlier (parent) application as filed, or his entitlement to the priority of an earlier application claimed in a later application in which a disclaimer was introduced to disclaim subject-matter disclosed in the priority application. Finally, the same also applied under Article 61(1)(b) EPC, if the entitled person filed a new application and the original application had to be confined to the subject-matter to which the original applicant remained entitled (point 4.6 of the Reasons).
V. Application of principles established in G 2/10, T 1170/07
Board of Appeal 3.3.02's decision of 13 March 2012 in T 1170/07 can be cited as an example of how the principles established in G 2/10 are applied by the technical boards in practice. The patent at issue in this case concerned the use of a substance to manufacture an orally administered preparation for treating type II diabetes mellitus. In auxiliary request III, the intended use was limited to the treatment of non-obese patients. Applying the G 2/10 principles, the board found this disclaimer inadmissible on the following grounds:
The application as filed disclosed that the initial approach in treating obese patients affected with type II diabetes mellitus was weight reduction. The substance used was described as one known to be useful for the control or prevention of obesity and hyperlipidemia, but it was stated elsewhere on the same page that it had now surprisingly been found that tetrahydrolipstatin was useful in the treatment and prevention of type II diabetes mellitus. However, there was no reference in the passage concerned as to whether this treatment was associated with or independent of weight loss. Given the statement that the initial approach in treating obese patients affected with type II diabetes mellitus was weight reduction, treatment of type II diabetes mellitus independently of weight loss and its treatment by weight loss were two sub-categories of the treatment of type II diabetes mellitus in general. The application, however, did not explicitly or implicitly disclose specific sub-categories such as the treatment of type II diabetes mellitus in non-obese subjects.
VI. Relationship between G 1/03 and G 2/10 according to G 2/10
In G 2/10, the Enlarged Board lastly looked at the relationship between its findings in this decision and those in G 1/03 (point 4.7 of the Reasons). Referring to the wording used in the latter decision's answer 2 and reasons which it had already cited (point 4.4.2 of the Reasons), it stated that it did not interpret answer 2 as being intended to determine exhaustively the conditions under which, if fulfilled, an amendment by introduction of an undisclosed disclaimer was to be regarded as allowable under Article 123(2) EPC under all circumstances. Rather, the gist of the questions referred to the Enlarged Board for a ruling in G 1/03 and G 2/03 had been to establish whether and, if so, under what circumstances undisclosed disclaimers could be considered allowable at all, as a matter of principle, despite the absence of a basis in the application as filed. It was this question alone that it had had to decide in answer 2. Hence, it had not been decided in these decisions that, if the requirements in answer 2 were fulfilled, an undisclosed disclaimer would always be allowable under Article 123(2) EPC.
VII. Meaning of these findings - T 2464/10
Admittedly, when deciding on points of law referred to it, the Enlarged Board is not bound by the wording of the questions. However, it must keep to the scope of the matter in dispute mentioned in the referral. In its answer in G 2/10, the Enlarged Board therefore referred to, and confined itself to deciding on, the question before it as to the allowability of disclaiming disclosed subject-matter. The Enlarged Board's findings in G 1/03 show and explain why decision G 2/10 does not conflict with decisions G 1/03 and G 2/03.
Of course, this raises the question of whether, in addition to the criteria set out in headnote II of G 1/03, undisclosed disclaimers must also pass the disclosure test for remaining subject-matter established in G 2/10.
In its decision in T 2464/10 of 25 May 2012, Technical Board of Appeal 3.3.08 found that they did have to pass this test, the catchword reading:
"Remaining subject-matter test of G 2/10 applied. The Enlarged Board of Appeal in G 2/10 did not consider that G 1/03 provided an exhaustive treatment of the conditions under which an undisclosed disclaimer was to be allowable. In addition to the requirements set out in G 1/03, G 2/10 developed the further test of whether the skilled person would, using common general knowledge, regard the remaining claimed subject-matter as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed."
The board found that this requirement was met in the case before it.
The application concerned a method of rendering tissue suitable for transplantation, using tissue cells expressing an anticoagulant protein. According to the application, this could be done either by genetic treatment of the tissue or by preparing a transgenic animal. In addition to the method, the application claimed, above all, suitable biological tissue, organs and animals. There were variously worded disclaimers in the product and method claims, each designed to disclaim application, or specific applications, to humans with a view to overcoming objections under Article 53(a) or Article 53(b) in conjunction with Rule 28(b) and (c) EPC.
Thus, claim 1, which had been directed to animals, was limited to "non-human" animals, while the disclaimers in claims 11 (biological tissue) and 14 (method) excluded methods involving modification of human germ lines or the use of human embryos for industrial or commercial purposes.
Whilst the board did not say so explicitly, it can be gathered from its particular reference to G 1/03 that use of the invention on humans was not specifically disclosed in the application. The application stated that the animal was preferably a mammal and, still more preferably, a transgenic pig or sheep. In that respect, the board found (point 8.1.1 of the Reasons) that the limitation to non-human animals did not lead to disclosure of any particular animal (apparently meaning: none other those specifically mentioned in the application) and that no new teaching was introduced. The relevant passage in the description as filed (reference to mammals and, as especially preferable, transgenic pigs and sheep) was an explicit support for non-human animals. The preparation of a non-human animal, including the introduction of a genetic construct, was based on the same procedure as would be used for a human. Consequently, the subject-matter remaining in the claim did not present the skilled person with any new disclosure going beyond the application as filed.
The board used the same argument in relation to claims 11 and 14 (point 9 et seq. of the Reasons). The method claimed in claim 14 was disclosed only in general terms in the application as filed. The disclaimers served the sole purpose of removing non-patentable subject-matter. They did not introduce any new teaching, nor did they lead to disclosure of any (other) specific animal or to any intermediate generalisation not disclosed in the application as filed.