Drafting international applications with Europe in mind Dr. Matthew Barton, UK and European patent attorney, Forresters Introduction The European patent office (EPO) perhaps has a reputation for having unique requirements for its patent applications and for being particularly strict when assessing amendments. This can lead to significant difficulties during prosecution, if thought has not been given at the drafting stage to the EPO s requirements. In practice, especially PCT applications entering the European regional phase can suffer from issues which may not be easily resolved. This article aims to explore some of the important legal and practical points that are specific to the EPO and provide some suggestions as to how applications can be drafted in order to avoid problems during prosecution in Europe. One particular consideration that will be looked in in detail is the allowability of amendments. Many PCT applications which may have been drafted according to the laws of another jurisdiction suffer from serious problems when attempting to formulate suitable amendments in Europe, where the amendments may be seen as not allowable by the examiner. Similarly, while amendments can be made to a new application filed in Europe claiming convention priority the amended application may lose at least part of its priority right if the EPO examiner or an opponent determines that the amendments were not present in the priority-establishing application. Additionally, this article will explore ways to avoid serious or possibly incurable problems due to alleged lack of clarity of the claims at the EPO, including issues commonly encountered during prosecution of chemical cases. Furthermore, the article will identify and discuss the other legal requirements of the European Patent Convention (EPC) for the entire application. It is hoped that this article will assist practitioners in formulating applications which will be suitable for Europe when they enter the European regional phase via the PCT route or when filed as a convention filing. Added matter Many European applications suffer from difficulties when the applicant attempts to amend either for commercial reasons or to overcome the art cited during prosecution. The EPO is seen as being particularly strict regarding added matter and on many occasions the amendment offered by the applicant is not acceptable to the examiner because the examiner believes that the amendment does not have proper basis in the application as originally filed. 1 This can cause the applicant to need to make a more restrictive amendment than they would like or, in the worst case scenario, the applicant may find that it cannot identify a suitable amendment in order to achieve the desired result. 1 Article 123(2) EPC: The European patent application or European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed.
Furthermore, extension of subject matter is a ground of opposition post-grant 2. Therefore, when making amendments the applicant always needs to be aware that opposition is a possibility and should be certain that the amendment is properly based, even when the examiner does not raise any objection. It is therefore important for the applicant to provide adequate basis in the application as originally filed. For a PCT application this means when the PCT application is drafted, which may be in a different jurisdiction than the EPO by a practitioner who does not routinely operate before the EPO. When the application under consideration is a convention application being filed at the European patent office, the date for determining when the application was filed is the European filing date. Therefore, the European practitioner when preparing the convention application should also bear in mind the considerations below and maximise the possibility for later amendment. Of course, new matter included in the European convention application which was not in the priority-establishing application does not constitute added subject matter, but the new matter will not have a valid priority date. In short, the European application, drafted at either the PCT stage or as a priority-claiming case, needs to contain the right kind of information, presented in the right way and in the right level of detail, so that the applicant can later formulate appropriate amendments. As we will see, chemical cases also have their own particular requirements. Legal considerations general Article 123(2) EPC recites that the European patent application or European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed. Of course, many jurisdictions have equivalent provisions but the practitioner may experience that the European patent office exercises this legal requirement particularly strictly. While the primary legislation does not require verbatim basis for amendments, in practice many examiners prefer to see this because it puts the question of added matter beyond doubt. In this regard, the applicant does not receive the benefit of the doubt for matters of Article 123(2) EPC 3. For the purposes of this provision, the content of the application as filed does not include the abstract or the content of the priority document 4 and it is not possible to make amendments merely by reference to the priority document. For these reasons, the application as filed must be complete enough at the drafting stage to provide adequate basis for later amendment. Interpretation of the law The test used by the European patent office is the gold standard set out in the decision of the enlarged Board of Appeal number G 3/89 and confirmed in G2/10. The key phrase here is that an amendment is not allowable if the overall change in content of the application results in the skilled person being presented with information which is not directly and unambiguously derivable, seen objectively and relative to the date filing, from the whole content of the 2 A.100(c) EPC: the subject-matter of the European patent extends beyond the content of the application as filed. 3 Decision of the Technical Board of Appeal T 383/88 of 1 December 1992 (point 2.2.2 of the Reasons). 4 Decisions G 2/95, OJ 1996, 555 and T 382/94, OJ 1998, 24. 2
application as filed, even when account is taken of matter which is implicit to a person skilled in the art using common general knowledge. So, the basis does not need to be verbatim and can be something which is implicit to the skilled person. The Guidelines for examination at the European patent office have recently been amended to place emphasis on the fact that added matter should be assessed through the eyes of the skilled person 5. Nevertheless, the Boards of Appeal at the European patent office have, after this amendment to the Guidelines, re-confirmed that the gold standard for assessment of added matter is unchanged. 6 The portion of the Guidelines mentioned here may be useful when providing arguments to the examiner during prosecution but in an ideal world the application will be drafted from the outset with adequate basis so that one does not need to rely on statements about what the skilled person will understand implicitly. The two-lists principle In general, where subject matter is defined in terms of more than one list (which could be Markush groupings, lists of compounds or other lists) making deletions from two or more lists may not be allowable. Similarly, attempting to select out features from two or more lists of some length to generate an amendment, may be seen to add subject matter by producing a novel selection which was not present in the application as filed. 7 The question is how long the lists need to be, and how severe the amendment or selection, before Article 123(2) EPC is offended. Turning specifically to the chemical arts, particular problems may be encountered when attempting to make amendments to chemical formulae expressed as Markush groups. Lead case law in this area comes from the decision of the Technical Boards of Appeal T 615/95 in which there were three independent lists of sizable length specifying distinct meanings for three residues in a generic chemical formula in a claim. One originally disclosed meaning was deleted from each of the three independent lists. The Board of Appeal decided that this amendment did not result in the singling out or a particular combination of specific meanings i.e. any specific individual compound or a group of compounds but maintained the remaining subject matter as a generic group of compounds differing from the original group only by smaller size. The shrinking of the generic group of chemical compounds did not offend Article 123(2) EPC because it did not lead to a particular combination of specific meanings and therefore did not generate another invention. However, in the same situation if one of the three lists had been reduced to a single member (by way of example hydrides only) then this would have resulted in singling out of a single group of compounds (hydrides) and would have been either unallowable or susceptible to attack in opposition. 5 Guidelines H-IV, 2.2: When assessing the conformity of the amended claims to the requirements of Article 123(2) the focus should be placed on what is really disclosed to the skilled person by the documents as filed as directed to a technical audience. In particular, the examiner should avoid disproportionally focusing on the structure of the claims as filed to the detriment of the subject-matter that the skilled person would directly and unambiguously derive from the application as a whole. 6 Decision T1363/12 7 Decision T12/81 3
Additionally, there exists an intermediate position, for example where several lists are left with a more greatly reduced number of members. The subjective question will arise during examination whether this kind of amendment adds subject matter by presenting a previously undisclosed subgroup. Even if allowed by the examiner, this kind of amendment is a favourite target for opponents post-grant. Bearing in mind that the application cannot be re-expanded after grant (because this would offend Article 123(3) EPC 8 ) the applicant needs to take extreme care when making this kind of amendment to a Markush group and have in mind what kind of further amendments could be made in any opposition proceedings if added matter is raised as an objection post grant. By way of example of where the line might be drawn, in decision T 1733/06 two lists of 18 and 15 in length were allowed to be limited to slightly shorter lists of 16 and 13, respectively, i.e. two residues were deleted from each list. This conservative amendment was viewed by the Board of Appeal as being far from creating a new invention by singling out a hitherto not specifically mentioned individual compound or group of compounds. Level of preference When considering possible amendments to lists or Markush groups, the Boards of Appeal at the EPO have indicated that specifying a level of preference in the application may be a pointer toward allowable amendments (decision T 783/09). In T 783/09 the description generally described a combination of a DPP-IV inhibitor with an anti-diabetic compound. More specifically, the application disclosed a first inhibitor or a second inhibitor together with a further anti-diabetic compound selected from a list of 22. The applicant attempted to claim the first inhibitor (only) together with one of three specific compounds, i.e. 3 specific combinations, and this was surprisingly allowed by the Board of Appeal. The Board essentially decided that the description disclosed the 44 combinations of the first and second inhibitor with the 22 anti-diabetic compounds because the 22 compounds were described as being very preferred. Therefore the skilled person would appreciate that all 44 individual combinations were intended, due to the stated preference for these compounds, so that the 3 claimed combinations were part of the original disclosure. As we shall see below, in practice this could be extended to other lists and Markush groups. Range ends Ranges are often encountered in chemical applications, for example in continuous ranges like ranges of temperature ( 20 to 100 C ) and integer ranges ( alkyl group having 1 to 6 carbon atoms ). The EPO has particular ways to assess these disclosures. For example, where the application as originally filed discloses a range of A to B together with a sub-range of C to D which is within the first range, in order to formulate amendments one can also switch the range ends over so that the application is deemed to also disclose mixed ranges A to D and C to B (decision T 2/81). 8 Article 123(3) EPC: The European patent may not be amended in such a way as to extend the protection it confers. 4
Additionally, the application is seen to explicitly disclose the non-preferred parts of the A to B range, namely A to C and D to B. In terms of temperatures, that could be for example a broad range of 10 to 100 C and a sub-range of 50 to 70 C. The application is also deemed to disclose the non-preferred ranges of 10 to 50 C and 70 to 100 C if the skilled person would seriously consider working in this area (decision T 1170/06). Practical considerations In view of the above brief assessment of the EPO s approach to assessing amendments in the chemical field, we turn now to what the practitioner can do in practice when drafting his or her application in order to achieve a favourable outcome. Intermediate generalisations As we have seen, making combinations of subject matter at the EPO can be problematic if the examiner or opposition division cannot be convinced that the combination is not new matter which was not disclosed in the application as originally filed. It is therefore imperative when drafting the application to include as many intermediate positions (between the most specific and most generic) as possible when drafting. That is to say that as well as the complete listing or Markush group in claim 1 and/or in the description setting out the broadest scope of the invention, as many sub-sets of the Markush groups should be presented in combination to allow for reasonable fall-back positions if necessary during prosecution. It is evidently not possible to draft every single combination of elements, but providing several intermediate positions from broadest to narrowest in the application as originally filed will provide explicit fall-back positions to allow a reduction in claim scope, for example to avoid prior art, without worrying about adding matter to the application by falling foul of the two-list principle. Furthermore when drafting Markush-type claims, it is optimal to provide explanations of what is meant by the terms, for example alkyl means C1-C12 alkyl which is straight chain or branched. Further intermediate positions such as C1-C6 or more preferably C2-C4 should also be included, focussing in on the commercial product. Where groups like alkyl can be optionally substituted, the options for substituents should be listed out in the description. Embodiments One serious problem that is often encountered in Europe is where an application has originally been drafted in terms of embodiments. These embodiments often correspond to what was presented in several independent claims, for example in a first embodiment there is provided [arrangement 1 of the invention] and in a second embodiment there is provided [arrangement 2]. The European patent office sees embodiments as completely separate and self-contained entities and will not allow the interchange of technical features from embodiment one to embodiment two and vice versa. In other words, if the applicant wishes to take a technical feature which is disclosed only in the context of embodiment 2, with embodiment 1, the amendment will likely be determined to add matter to the application. This kind of unallowable amendment is termed an intermediate generalisation. 9 9 Guidelines for examination: H-IV, 3.2.1. 5
The EPO Guidelines state 10, in the context of novelty, that it is not permissible to combine separate items belonging to different embodiments described in one and the same prior art document; the same test is applied when assessing amendments. Furthermore the Boards of Appeal have repeatedly cautioned against the mixing of embodiments. 11 Therefore, the preferred approach in Europe is to avoid the word embodiment and instead use a blander expression like disclosure or aspect. Furthermore it is better to avoid disclosing technical features in separate packets of information. If the technical features are all described together in a single embodiment then this kind of intermediate generalisation objection cannot arise. Additionally, one can refer simply to the invention using phrases such as in the invention, X can be alkyl and in the invention, Y can be halide. This provides an argument that, since both X and Y are disclosed in the same context of the invention they are combinable. However, the author appreciates that referring to the invention in this way and also avoiding the word embodiment may be problematic in other jurisdictions. A compromise may therefore be the bland language like disclosure. Preferred elements As explained above, the European patent office Boards of Appeal have recently determined that a level of preference may decide an argument about added matter in the favour of the applicant because a preference stated in the application as originally filed is a pointer for the skilled person as to what combinations were envisaged. Therefore, if it is known at the drafting stage which elements of the disclosure are particularly preferred from a commercial or scientific point of view then this should be stated, for example in terms of preferred, more preferred and most preferred. When making an argument about allowable amendments, the fact that something has been described as most preferred may well push the examiner toward allowing the amendment rather than refusing it. Combinations As stated above, it is simply not possible to list in an application every single possible combination of either elements and lists or meanings in Markush groups. However, when drafting, one should disclose all of the available information for optimal recombination in order to maximise the chances of success. The drafter should explicitly list combinations of individual features as far as possible, focussing on the most important features while bearing in mind that the European patent office charges excess page fees for pages in excess of 35. Multiple dependencies (or clauses ) It is also imperative to include multiple dependencies (or clauses which correspond to them; see below) at the drafting stage. A typical problem occurs when claim 2 is only dependent on claim 1 and claim 3 is only dependent on claim 1. When the applicant attempts to formulate an 10 Guidelines G-VI, 1. 11 The content of an application must not be considered to be a reservoir from which features pertaining to separate embodiments of the application could be combined in order to artificially create a particular embodiment (T 296/96 ; T 1206/01 ; T 3/06, and more recently see e.g. T 1239/08 and T 1648/11). 6
amendment including all of the features of claims 1, 2 and 3 the applicant will find that the examiner rejects this amendment because the features of claims 2 and 3 were never explicitly disclosed together in combination. For this reason, all of the claims should be provided with multiple dependencies if possible when the application is filed. Again, the author appreciates that this may be problematic in some jurisdictions. Accordingly, instead of placing the multiple dependencies in the claims, the text of the claims can be repeated in the description as clauses including the multiple dependencies as combinations of clauses. The overriding objective is to ensure that there is an explicit combination of all of the clauses with each other, insofar as possible, so that multiple dependencies can be reconstructed when the European application is filed or the European regional phase of the PCT application is initiated. Statements of invention In addition to the clauses mentioned above corresponding to specific combinations of the claimed features, the drafter should also attempt to include statements of invention which are a statement of each independent claim in terms of the invention provides [independent claim features] together with broad statements about the dependent claims, such as conveniently, [insert text of dependent claim]. Again, this may provide the applicant with a pool of information, not restricted by context, which may be recombined later. However, this reservoir of information may only be recombined if the skilled person would seriously contemplate combining the different features cited in that document. 12 Standard paragraphs Sometimes applicants wish to include standard boilerplate language in applications and then rely on this language to defend later amendments. These arguments are not always successful and certainly boilerplate should not be relied on as the only argument in support of amendments. Nevertheless, the Boards of Appeal at the European patent office have issued some decisions in which they have recognised the boilerplate language and allowed amendments. Therefore, it is recommended to unambiguously mention in the description that features from separate lists can be combined (for example, decisions T 296/96 and T 688/99). Furthermore it should be unambiguously indicated that features from the examples can be generalised to the whole disclosure (decisions T 740/91 and T 201/83). This may be helpful though probably not decisive in defending amendments. Numerical ranges and integers In view of the explanation above, it is important to include as many ranges and subranges in the application when it is filed. Again, to take the example of a temperature range of 10 to 100 C, as many nested ranges as possible should be included, for example 10 to 90 C, 20 to 80 C and so on. Bearing in mind the case law developed above regarding range ends, this should provide adequate basis for formulating later amendments, particularly where the range is a continuous range such as temperature or time. 12 Decision T296/96. 7
The same considerations apply for integer ranges, for example an alkyl group having from 1 to 30 carbon atoms. Nested ranges should be included. Staying with the issue of integer ranges, some examiners may be convinced that a disclosure of C1-C6 alkyl includes all of C1, C2, C3, C4, C5 and C6 (because the numbers are integers and cannot be anything else; a skilled person would understand this). Therefore, some examiners might allow the isolation of (for example) C4. However, the vast majority of examiners will not allow this and will only allow the isolation of the range ends, namely C1 and C6 in this example. Therefore, if it is envisaged that any one of C1 to C6 might be selected, then these should be listed out individually in the application at the drafting stage. Consisting essentially of At the European patent office, the words comprising, consisting of and consisting essentially of have defined meanings 13. The phrase consists essentially of also has a meaning laid down by the Boards of Appeal 14 namely the phrase only excludes from the claim any features which would materially affect the invention. Amending a claim from the broader comprising to consists essentially of may be useful for an applicant because it may serve to delimit from the art while not being clearly restrictive, because ineffective features such as aqueous solution and excipients are not excluded from the scope of protection. In the past, it was allowable to simply amend from comprising to consist essentially of without the necessity for any basis for the phrase in the application as originally filed. However, since Board of Appeal decision number T759/10 this is now not possible. Therefore, in order to allow the possibility for future amendment to consists essentially of it is necessary to include in the application text such as the invention comprises, consists essentially of or consists of the following features to provide literal basis for the intermediate consists essentially of position. Clarity Having explored the type of disclosure that should be included in an application at the drafting stage in order to provide for successful amendment, we also need to ensure that the disclosure of the application when filed contains definitions of the invention which are sufficiently clear for the European examiner. While an unclear term in the claims may be objected to, an application can fail if a clearer definition cannot be found somewhere in the description (because of the strictures of Article 123(2) EPC requiring basis for amendments). While lack of clarity is not a ground of opposition after grant, some examiners will examine clarity in great detail for the very reason that clarity of the claims is not open for discussion after grant and the examiner wants to be entirely sure that the claims are clear enough before granting the application. Legal considerations Article 84 EPC requires that the claims shall define the matter for which protection is sought. They [the claims] shall be clear and concise and supported by the description. This is to ensure 13 Guidelines for Examination F-IV, 4.21: While in everyday language the word "comprise" may have both the meaning "include", "contain" or "comprehend" and "consist of", in drafting patent claims legal certainty normally requires it to be interpreted by the broader meaning "include", "contain" or "comprehend" i.e. not consist of. 14 T472/88 and T975/94 8
that third parties are not left in any doubt as to which subject matter is covered by a particular claim and which subject matter falls outside the scope of protection. When attempting to determine the meaning of the claim, the words of the claim should be given their usual meaning. If the applicant intends to impart a different meaning to the words used in the claims then that meaning should be given in the claims because the claims alone define the scope of protection. In Europe a patent document may be used as its own dictionary in this circumstance but the explicit definition must be included in the application (see decision T 500/01). Practical considerations In practice, the person drafting an application which will move forward to the European patent office needs to ensure that the application as a whole (claims and/or description) contains sufficient explanation of the terms being used, particularly if those terms do not have a uniform or well-recognised meaning in the art. This is particularly the case for the chemical inventions where one might wish to use terms like lower alkyl, low temperature and highly polar solvent. Relative terms like these which do not have a uniform meaning need to be defined in the description so that if the examiner objects then the definition can be imported into the claims. This is vital in view of Article 123(2) EPC (added matter); if appropriate definitions are not provided and yet the examiner requires them in the claims for reasons of clarity then the application may be refused for lack of clarity if the applicant is not able to cure the efficiency. As a rule, European examiners will not allow unclear terms in the claims if the term is necessary for the invention. Likewise the applicant cannot rely on an unclear term in order to distinguish the claims from the prior art. Relative terms: lower alkyl etc. The phrase lower alkyl is specifically mentioned in the European patent office Guidelines as being something to avoid. 15 This kind of term can be used in the claims when the application is drafted, because the term may be acceptable in other jurisdictions. However, it is imperative to include a definition of what is meant by lower in the description so that if the examiner objects then the claim can be suitably amended to include the clear definition. As mentioned above in connection with added matter, if lower alkyl is taken to mean C1-C6 alkyl then this should be provided in the description together with nested definitions such as C2-C5 and also listed out as lower alkyl means C1, C2, C3, C4, C5 or C6 alkyl. It should also be noted that terms like protecting group and leaving group can also raise a lack of clarity objection. While one can argue that a skilled chemist knows what is meant by these terms, if the examiner disagrees then the applicant will need to find language in the description to explain in more detail what is meant. The examiner may raise such an objection because there are no defined conditions in the claim for when the groups protect or leave respectively. The description therefore needs to contain examples and definitions of what is meant by these terms. The European patent office also routinely objects the terms like prodrug, metabolite, pharmaceutically-acceptable derivative. Primarily these can be objected to because the 15 See also decision T338/95 9
boundary of the claim is unclear under Article 84 EPC. Other objections can also be raised such as that it is not credible that all metabolites can solve the technical problem (Article 83 EPC) and that it is not plausible (and therefore not inventive) that the problem is solved across the entire scope of all derivatives (Article 56 EPC). Again, the solution is to include in the application what is meant by these terms, in case the objection arises. Measurement methods Examiners may object to claims which contain some kind of measurement method, for example wherein the composition passes a test in accordance with the American National Standards Institute (ANSI) test number XYZ of 2016. The examiner may firstly object that this is a result to be achieved feature 16 (see more below). Additionally the examiner may object that this is a parameter which should only be allowed if it is the only way to characterise the product and if the testing method is explained in sufficient detail in the description or is well-known to the skilled person 17. From a European perspective it is better to avoid such formulations; examiners are always more comfortable with claims which define a product in terms of its concrete technical features rather than its properties. Nevertheless, if reference to a testing method is necessary then full details of the testing method should be included in the description in case the examiner is not persuaded that a skilled person would be aware of the test (even if the test is set down by a standard body like the ANSI). If, during prosecution, this information is missing from the description then the product would anyway need to be claimed using more technical features. The reference to the testing method would need to stay in the claim in order to avoid added matter objections by removing it and the examiner should generally allow the non-essential yet allegedly unclear feature to remain 18. Features which vary with conditions This refers to features in a claim having a value which may change depending on the conditions or method for measurement. One example is viscosity, which value can be different depending upon the temperature of measurement. Another example is particle size which can differ depending upon both the conditions (e.g. pressure) but also the method of measurement (e.g. sieve analysis or dynamic light scattering (DLS)). Because the different methods are not expected to give identical results, it is imperative to include in the application as filed details of how (which conditions and which method) the values were reached. Otherwise the claim may be deemed unclear because the scope varies depending on which method is used, but the method is not identified. A good example of the problems that can be encountered comes from decision of the Board of Appeal T 99/13. In this case the examiner raised a clarity objection during prosecution because the claims referred to a kinematic viscosity without referring to a measurement temperature. 16 Guidelines F-IV, 4.10: As a general rule, claims which attempt to define the invention by a result to be achieved should not be allowed, in particular if they only amount to claiming the underlying technical problem. 17 Guidelines F-IV, 4.11. 18 Guidelines F-IV, 4.6: Where there is no basis in the disclosure for a clear definition and the term is not essential having regard to the invention, it should normally be retained in the claim, because to excise it would generally lead to an extension of the subject-matter beyond the content of the application as filed - in contravention of Article 123(2). 10
Kinematic viscosity is, of course, temperature dependent. The applicant inserted the feature at 25 C on the basis of the examples and the patent was granted, but opponents alleged that this feature added matter because it was not unambiguously disclosed in the application. Eventually the Board of Appeal agreed with the applicant that the feature of 25 C was disclosed in the application as filed (the features could be found in the examples only) so that the amendment did not add matter, but the applicant was rather fortunate in this instance. To avoid having to rely on good fortune, measurement conditions must be included in the application when drafted. Approximately or about These modifiers may be applied to particular values (e.g. about 250 C ) or to a range (e.g. about 5 to about 8 hours reaction time ). Examiners do not always object to this language in the claims and therefore, from the outset, this language can be included in the claims and description when drafted. If the examiner allows the language to remain then the clarity cannot be objected to after grant and the modifier about may provide additional scope of protection when interpreting the claims post grant. However, applicants should be prepared that the examiner may raise an objection. One way to avoid the objection is simply to delete the word about or approximately thereby just leaving the point value. However, if the applicant includes some kind of definition of what is meant by about in the description when the application is filed then this could be imported into the claims, perhaps providing a better scope of protection. For example, if the applicant specified that about means +/-5 C with regard to temperature then this can be imported into claims if necessary during prosecution. Result to be achieved The general rule at the European patent office, unlike other patent offices, is that claims which attempt to define an invention by result to be achieved should not be allowed 19. An example of a result to be achieved formulation is something like wherein the polyurethane provides anti-frost properties to the composition. Ideally, the claim should be formulated in terms of the technical features which give rise to the anti-frost properties, i.e. a more specific definition of the chemical composition, and not does refer to the underlying problem to be solved. Again, best practice is a case of ensuring that the description when filed includes adequate technical features which can be used to define the invention to the satisfaction of the European examiner, if challenged. Result to be achieved formulations may rarely be allowable if the invention can only be defined in such terms or if a concrete technical definition would unduly restrict the scope of the claims. However, this argument is rarely successful because realistically it is usually possible to define an invention in more concrete terms than a result to be achieved. Parameters While the reader will by now be forming the impression that the European patent office prefers claims that are defined in terms of technical features, parameters may exceptionally be allowable 19 Guidelines for Examination Part F, Chapter IV, 4.10. 11
as a definition of the invention. The EPO defines parameters as characteristic values which may be values of directly measurable properties (e.g. the melting point of a substance, the flexural strength of steel, the resistance of an electrical conductor) or may be defined as more or less complicated mathematical combinations of several variables in the form of formulae 20. Again, parameters should only be allowed by the European examiner when the invention cannot adequately be defined in another way, but the parameters must be clearly and reliably determinable through procedures which are usual in the art or described in the description. Accordingly, if a product needs to be defined by way of a parameter then the description needs to contain, at the drafting stage, sufficient detail to enable the reader to calculate the parameter of a particular product. However, because such claims are rarely allowable, again the description needs to contain as many technical details as possible in order to allow a definition of the invention in concrete technical terms if an objection arises. Functional definitions The European patent office may well allow claims which define an invention in terms of function, for example a chemical reaction involving mixing means for mixing reagents or a pharmaceutical product including means for thickening. This may be allowable, even if only one such means is given in the description if the skilled reader would appreciate that other means could be used for the same function. Therefore, the advice here is that when using functional features, ensure that the description is drafted to contain at least one example of the functional feature. An objection may rise if a functional feature is used but the application otherwise implies that the invention is more limited. Summary (clarity) While the European patent office may allow different kinds of claim formulation such as functional claims or (rarely) claims defined by a result to be achieved, the key is to include in the description concrete definitions of the broader terms used in the claims in case objection is raised. Unity of invention Objections regarding alleged lack of unity can be raised at any time during the proceedings but more usually at the search stage when the examiner inspects the claims for the first time. Later amendment to the claims can also lead to a lack of unity. A lack of unity objection will usually not cause an application to fail. If the examiner considers that the application contains more than one invention then a divisional application may be filed at any time up to the day before the grant date and the non-unified invention or inventions can be pursued by way of one or more divisional applications. Furthermore, unity of invention is not a ground of opposition and cannot cause the patent to be revoked after grant. Nevertheless, the application entering Europe should be drafted in such a way as to mitigate unity of invention objections (insofar as that is possible before the search results and prior art are known) and certainly consideration needs to be given 20 Guidelines for Examination Part F, Chapter IV, 4.11. 12
about ordering of subject matter in order to ensure that the most commercially relevant invention is captured in the event of a unity objection. Legal considerations Unity of invention at the European patent office is governed by Article 82 EPC which recites that the European patent application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept. Rule 44 EPC defines the single general inventive concept as being a technical relationship among inventions involving one or more corresponding special technical features that define a contribution which each of the inventions considered as a whole makes over the art. In other words the inventions need to have technical features in common which are novel and inventive over the prior art. In theory, lack of unity should not be raised or persisted on a narrow, literal or academic approach. However, in particular for chemistry cases it should be noted that claims including alternatives, such as Markush claims, may lack unity within the grouping. For example, consider a compound X having a side group R which may be A, B or C. If compound R = A is known in the art and there is nothing to link side groups B and C to one another then B and C will lack unity and one of them will need to be deleted and possibly pursued in a divisional application. Before or after search At the EPO a lack of unity may be noticed by the examiner either before the prior art is taken into account (a priori) or after prior art is taken into account (a posteriori); such as in the example above relating to Markush groups. When the European patent office carries out the search and identifies a lack of unity of invention, under Rule 64(1) EPC the search examiner will make a search on the first invention mentioned in the claims. This has important implications for how the application should be drafted (see below). The applicant can nevertheless have further non-unified inventions searched and can also contest the finding of non-unity, but eventually non-unified invention will need to be deleted from the application in suit and possibly be pursued in divisional applications. The same procedure is true for Euro-PCT applications entering the European regional phase; the search will be conducted on the first invention mentioned in the claims. Where the EPO has acted as the international searching authority, the EPO does not draw up a new search report on European regional phase entry. If the EPO has raised a non-unity objection already in the international phase and the applicant did not request a further search during the international phase then on European regional phase entry the applicant nevertheless has the opportunity to switch to a different invention, albeit through payment of an additional search fee. Claim ordering The wording invention or group of inventions first mentioned in the claims has important implications for how the claims and indeed Markush groups within the claims should be ordered. 13
The claims that are presented to the European patent office either when filing a convention application or when entering the European regional phase should take this into account. For example, where a claim contains a number of different sequence listings, there is the danger that that prior art will reveal one or more sequence listings from within the group thereby rendering the group non-unified. The claims should therefore be drafted including the most important sequence listing first so that should the objection arise, the important sequence listing will be made subject of the search. The same theory holds true for Markush groups. For example, if the applicant knows that compounds having the NO2 moiety are particularly useful, then rather than placing amendments of a Markush group in a standard sequence e.g. hydrogen, alkyl, alkene, etc. the favourite side group should be placed first in the Markush group. Then, if a unity objection is raised at least the important moiety is included as subject of the search. Again, this ordering can be done when the application is drafted as a convention application or when the claims are submitted to the European patent office at the European regional phase. The same holds true when entire claims might be non-unified. For example independent claim 1 relates to a product and independent claim 10 relates to a process. Because the claims could potentially be non-unified, the more important of the two claims should be placed first in the claim set. Double patenting Double patenting is not explicitly excluded by the European patent office for co-pending European applications having the same effective date filed by the same applicant. This includes divisional applications in the same case series. However, in practice examiners will not allow double patenting to take place 21. Nevertheless, the test for double patenting is quite limited at the EPO. The two applications should not claim an identical scope of protection. Therefore, a minor variation to the claim wording in one application should avoid a double patenting objection with respect to another application. Typically, an applicant should be allowed to have granted a first patent containing a narrow embodiment and a second patent claiming a broader embodiment which encompasses the narrow embodiment. For example, a first application could be granted directed to a pharmaceutical composition containing 5 mg of an active ingredient. A second patent could be granted to the range of 1 to 20 mg and this is not deemed to be double patenting, but note that the second application could not include a dependent claim reciting 5 mg exactly (because this would be identical subject matter). Sufficiency of disclosure As in all jurisdictions, the European patent office requires some level of disclosure in return for granting the monopoly of a patent. Article 83 EPC simply recites that the European patent 21 Guideline G-IV, 5.4. 14
application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. Reference to the person skilled in the art means that the skilled person s general knowledge can be used in this assessment, in addition to the explicit disclosure of the application. Common general knowledge is usually limited to information which can be taken from dictionaries, textbooks, handbooks and the like 22. The very important question for the practitioner drafting a patent application for Europe is how much (or how little) information needs to be included in the application as filed in order to meet with the requirements of Article 83 EPC. If there is a fundamental deficiency with regard to sufficient disclosure then this cannot be remedied later because of Article 123(2) EPC (added matter). The inevitable consequence is refusal of the application and therefore sufficiency is a highly important consideration for the drafter. Legal It is important to note that literature referenced in the description can also be used to enable the skilled person to repeat the invention. Therefore, this being the case a reference to the document should be made when drafting the application and the document must be publically available. If the claim is broad then the disclosure in the application needs to take in several alternatives over the broad range of the claim. If only limited examples are given or examples only in one area of a broad range then the examiner is likely to object that the claims are drafted too broadly and are not sufficient over the whole scope, because the skilled person cannot perform the invention over the whole range claimed. Where a composition is defined by its function (see above relating to clarity) the application must disclose technical details regarding how to prepare the composition. It should also be noted that sufficiency of disclosure is a ground of opposition post grant. On the other hand, while lack of sufficiency of disclosure is very often raised in opposition proceedings, it is only found relevant by the opposition divisions in a small number of cases. Practical requirements One aim of Article 83 EPC is to avoid speculative applications. To that end, the application must contain an adequate level of disclosure to satisfy the European patent office that there was really an invention envisaged at the filing date of the European application. As concerns to the chemical field, this can apply to chemical compounds having a pharmaceutical use. As a rule, there has to be at least one way of putting the claimed invention into practice over the whole scope of the claim 23. At a basic level that means that an application which does not describe a single way for implementing the invention, must fail the test of sufficiency of disclosure. Once the threshold of at least one way has been met, the question arises as to the level of detail needed for sufficient disclosure. However, this will depend on the nature of the case. Where the application relates to a medical use the application must disclose the suitability of the product for the claimed therapeutic application. If the application as filed only contains a vague indication of 22 See Decision T 890/02 (OJ 2005, 497). 23 Guidelines F-III, 1; and decision T 292/85. 15
a possible medical use for a chemical compound yet to be identified specifically (i.e. a speculative application), then more detailed evidence cannot be later used to remedy this fundamental insufficiency of disclosure (T 609/02). This is because the application fails the test of at least one way. If the application does disclose at least one way the question is what level of information or data is required. Decision T 609/02 stated that showing a pharmaceutical effect in vitro may be sufficient if this effect directly and unambiguously reflects a therapeutic application. In other words there has to be a clear and accepted established relationship between the effect shown in vitro and the disease. However, this information needs to be in the application as originally filed; post-published evidence can only be used to support the finding already included in an application. As we have seen, in vitro data may be enough and certainly clinical trial data is not necessary in an application at the filing stage. Of course, many patent applications are filed well before clinical trials are initiated. However, the application as drafted must provide some information showing that the claimed chemical compound has a direct effect on a mechanism specifically involved in the disease. Once this basic level of information is available in the patent application, post-published evidence may be taken into account to support the disclosure. In summary, when drafting the application it is recommended of course to include as much data as is available. The application needs to include at least one way of implementing the invention and failing to do so can lead to an irretrievable lack of sufficiency of disclosure. In vitro data can be enough to cross the threshold, as long as there is an accepted link between the in vitro effect and the disease to be treated. Once the threshold test has been met, further data may be presented to the EPO during prosecution in order to support the case for sufficiency. Post-filed data As noted above, in connection with fulfilling the requirements for sufficiency of disclosure under Article 83 EPC, post-filed data may be useful at the European patent office as long as the application as filed passes the threshold test explained above. Post-filed data may also be useful in the assessment of inventive step at the European patent office. Again, the situation is quite similar for inventive step under Article 56 EPC as it is for sufficiency of disclosure under Article 83 EPC. Post-published evidence to support that the claimed subject matter solves the technical problem is taken into account if it is already credible from the disclosure in the patent as filed that the problem is indeed solved. In other words, supplementary post-published evidence may not serve as the sole basis to establish that the problem is solved. The application as filed needs to pass the threshold test of containing information to make it credible that the application solves a technical problem. The postpublished data or evidence can corroborate the disclosure in the application as filed so that the application as filed must contain more than speculation. Therefore, when drafting the application, like for sufficiency of disclosure, as much data as possible needs to be included in the application to demonstrate that the claimed subject matter 16