DISCLAIMER PRACTICE AT THE EPO Summary Under European practice special conditions apply when making an amendment that involves a negative claim limitation (a disclaimer). A disclaimer of subject-matter that was originally disclosed in the application as an embodiment of the invention is known as a “disclosed disclaimer”. In Decision G2/101 the EPO’s Enlarged Board of Appeal ruled that disclosed disclaimers are allowable in principle. However, a disclosed disclaimer will only be permitted if the subject-matter remaining in the claim is “directly and unambiguously disclosed” in the application as filed. A case-specific “technical assessment” is necessary to decide whether this requirement has been met. In its earlier decision G1/032, the Enlarged Board also outlined some exceptional situations where it may be allowable to disclaim subject-matter that was not disclosed at all in the original application (an “undisclosed disclaimer”). The discussion in G2/10 implies that an undisclosed disclaimer in accordance with G1/03 should be subjected to the same “technical assessment” as a disclosed disclaimer. Background A disclaimer is a negative claim feature. Its effect is to exclude some specific subject-matter from the scope of a claim. Where a claim of an application as filed contains a disclaimer this generally does not cause problems under European practice (provided that the scope of protection sought is clear). However, like any other amendment, introduction of a disclaimer 1 2 http://www.epo.org/law-practice/case-law-appeals/pdf/g100002ex1.pdf http://www.epo.org/law-practice/case-law-appeals/pdf/g030001ex1.pdf PATENT ATTORNEYS • TRADE MARK ATTORNEYS www.jakemp.com 2 into a claim after filing must be examined to confirm that it does not add subjectmatter to the application3. It is unusual for an application as filed to contain explicit support for a negative claim feature (e.g. “[Invention] preferably does not include [Disclaimed subjectmatter]”). Much more commonly, the intended disclaimer will not have been disclosed in the original application at all (an undisclosed disclaimer) or will have been originally disclosed as an embodiment of the invention (a disclosed disclaimer). Under these circumstances a careful assessment will be required to determine whether introduction of the disclaimer is permissible. G2/10: Assessment of “disclosed disclaimers” In this Decision, the EPO’s Enlarged Board of Appeal considered whether there is an impermissible addition of subject-matter when an amendment is made to include a disclaimer that was originally disclosed as an embodiment of the invention. The Decision arose due to a conflict in the Board of Appeal case law. For example, in Decision T1102/00 it was suggested that subject-matter could only be excluded if it was expressly disclosed as subject-matter to be excluded from protection. On the other hand T1107/06 suggested a more liberal approach. The Enlarged Board rejected the two extreme positions. Thus, it was held that there is no absolute bar on the use of a disclosed disclaimer. However, the Board also held that a disclosed disclaimer cannot be assumed to be always allowable. The Enlarged Board emphasised that a disclosed disclaimer should not be permitted if the subject-matter remaining in the claim after the introduction of the disclaimer is not “directly and unambiguously disclosed”. Further, the Board ruled that “[d]etermining 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”. It is therefore clear that assessment of a disclosed disclaimer must have regard to the specific facts of the application at issue. The detailed reasoning in G2/10 is complex and it is not yet fully clear how the required “technical assessment” will be implemented by the Examining Divisions, Opposition Divisions and Boards of Appeal at the EPO. Nonetheless, the following general observations do emerge: ● 3 Where a generally worded claim embraces many specific embodiments of an invention, and the disclosed disclaimer is based on a single such embodiment (e.g. the subject-matter of one of a number of working Examples), this is likely to be allowable. That is because the subject-matter remaining in the amended claim does not contain new “technical information” or result in the “singling Article 123(2) EPC prohibits amendments that introduce new subject-matter to an application after filing. This provision is interpreted extremely strictly by the EPO. PATENT ATTORNEYS • TRADE MARK ATTORNEYS www.jakemp.com 3 out” of other embodiments that were not specifically disclosed in the original application. ● On the other hand, a disclosed disclaimer will not be allowed if it results in an amended claim that has special technical characteristics not disclosed in the original application or in which particular combinations of features have been singled out in a manner not disclosed in the original application. That is because the subject-matter in the amended claim would then contain new “technical information” compared with the originally filed application. The practical examples set out in the attached Annex may assist with understanding the nature of the technical assessment envisaged in G2/10. G1/03: Assessment of “undisclosed disclaimers” In this Decision, the EPO’s Enlarged Board of Appeal outlined the following exceptional circumstances4 where an undisclosed disclaimer could be permitted: (a) to restore novelty over disclosure in an earlier unpublished European application citable for novelty only in accordance with Article 54(3) EPC; (b) to restore novelty over an “accidental anticipation” contained in a prior art document; 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; (c) to disclaim subject-matter that is excluded from patentability for nontechnical reasons (e.g., a method of medical treatment). The Enlarged Board added the following conditions: (i) The disclaimer should not remove more than is necessary either to restore novelty or to disclaim subject-matter excluded from patentability for nontechnical reasons. (ii) 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. (iii) A claim containing a disclaimer must meet the requirements of clarity and conciseness of Article 84 EPC. Prior to G2/10, assessment of an undisclosed disclaimer typically involved firstly identifying that one of the exceptional circumstances (a)-(c) applied, and then checking for compliance with the additional conditions (i)-(iii). 4 These exceptional circumstances define situations where the Applicant’s ability to obtain claims of satisfactory scope would otherwise be unduly prejudiced through no fault of their own or for entirely non-technical reasons. PATENT ATTORNEYS • TRADE MARK ATTORNEYS www.jakemp.com 4 However, the discussion in G2/10 implies that an undisclosed disclaimer in accordance with G1/03 ought to be subjected to the same “technical assessment” as a disclosed disclaimer. Several Technical Board of Appeal decisions issued since G2/10 have followed this approach5. It is therefore possible that some undisclosed disclaimers previously accepted by the EPO may now fail in view of the technical assessment requirement set out in G2/10. Again, some practical examples are described in the attached Annex. Summary Amendments involving disclaimers require thorough consideration under European practice. Both disclosed and undisclosed disclaimers are permissible under appropriate circumstances. However careful analysis of the facts of the case at issue is essential, so that the best decision can be made about whether to introduce a disclaimer into a claim or to seek an alternative, albeit potentially more restrictive, positive claim limitation. 1 November 2013 © J A Kemp 14 South Square Gray's Inn London WC1R 5JJ UK + 44 20 3077 8600 www.jakemp.com 5 See, for example, T2464/10, T1870/08 and T1176/09. PATENT ATTORNEYS • TRADE MARK ATTORNEYS www.jakemp.com 5 Annex: Practical Examples Involving Assessment of Disclaimers Claim Desired disclaimer Disclosure of disclaimer Chemical compound defined using general formula Single compound As an embodiment of Likely to be allowable as a G2/10 falling within scope the invention in the disclosed disclaimer, particularly if of general formula application the disclaimed compound is only one of many compounds specifically disclosed in the application as filed (no new “technical information”) Chemical compound defined using general formula Single compound No disclosure in falling within scope application of general formula Chemical compound defined using general formula Single compound Disclosed in a Likely to be allowable as a G1/03 falling within scope novelty-only prior undisclosed disclaimer (and to pass of general formula art document citable “technical assessment” of G2/10) under Article 54(3) EPC Chemical compound defined using general formula, for use in treating cancer Single compound Disclosed in a prior falling within scope art document as a of general formula dye compound Likely to be allowable as a G1/03 undisclosed disclaimer against an “accidental anticipation” (and to pass “technical assessment” of G2/10) Chemical compound defined using general formula, for use in treating cancer Single compound Disclosed in a prior falling within scope art document as an of general formula analgesic No - not an “accidental anticipation” according to current Board of Appeal case law and so not an acceptable G1/03 undisclosed disclaimer Chemical compound defined using general formula, for use in treating cancer Single compound Disclosed in a prior falling within scope art document as an of general formula analgesic; also disclosed as an embodiment of the invention in the application May be allowable as a G2/10 disclosed disclaimer Method of reducing weight of a human subject Therapeutic (i.e., No disclosure in non-cosmetic) application method of reducing weight of a human subject Likely to be allowable as G1/03 undisclosed disclaimer as disclaimer of “therapeutic method” is for purely non-technical reasons Chemical compound where substituent A is methyl, ethyl or propyl and substituent B is methyl, ethyl or propyl Chemical compound where at least one of substituents A and B is either ethyl or propyl As an embodiment of Unlikely to be allowable under the invention in the G2/10, because disclaimer results application in “singling out” of the compound where A is methyl and B is methyl Chemical compound where substituent A is methyl, ethyl or propyl and substituent B is methyl, ethyl or propyl Chemical compound where at least one of substituents A and B is either ethyl or propyl Disclosed in a novelty-only prior art document citable under Article 54(3) EPC PATENT ATTORNEYS • TRADE MARK ATTORNEYS Allowable? No - undisclosed disclaimer not allowable unless an exceptional circumstance of G1/03 applies Unlikely to be allowable even if G1/03 conditions are met, because according to G2/10 there is an impermissible “singling out” of the compound where A is methyl and B is methyl www.jakemp.com