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5.6.7.3 Support for the claims

Date Published

Key Legislation:

Patents Act:

  • ​​​​​​​s40(3) Claims must be clear and succinct and supported
  • s102 What amendments are not allowable? 

Other referenced materials:

Patent Cooperative Treaty (PCT):

Related Chapters: ​​​​​​​

National:

International:

Overview

Section 40(3) requires the claims to be supported by what is disclosed in the specification.

The requirement for support ensures that:

  • the description contains a basis for each claim; and
  • the scope of the claims is no broader than is justified by the description, the drawings, and the contribution to the art.

An objection of lack of support most commonly occurs where:

  • claims extend beyond the ‘contribution to the art’, that is, the claims are so broadly defined that they encompass embodiments beyond what the specification discloses; and/or
  • claims omit essential features, that is, a claim is missing essential features that appear necessary for the described invention to work and to achieve its stated benefit.

There is often overlap between the grounds of sufficiency and support because s40(2)(a) and s40(3) both require the specification to provide an enabling disclosure of the claimed invention. If an objection applies under both grounds, judgement should be used as to which ground is more appropriate or whether both grounds should be raised. In such cases, the ground under which an objection is raised is not the most important consideration, but the language which is used to explain the issues is a key concern. To avoid confusion and to facilitate a resolution of the issue by the customer, it is important not to mix the language used for s40(2)(a) with that used for s40(3). 

Examination practice 

To comply with s40(3), the scope of the claims must not be broader than is justified by the body of the specification (description, drawings, graphics, photographs, and sequence listing, that is, everything except the claims) and the contribution to the art.

This means that the claims should correspond to the technical contribution to the art. In other words, the scope of the claimed invention should essentially correspond to the scope of the invention disclosed in the description, and the claims should not extend to subject matter not at the disposal of the person skilled in the art after reading the specification.

Examiners should take the following approach, set out in CSR Building Products Limited v United States Gypsum Company (2015) APO 72 to determine whether the claims are supported by the specification: 

  • construe the claims to determine the scope of the invention as claimed;
  • construe the body of the specification to determine the technical contribution to the art; and
  • decide whether the claims are supported by the technical contribution to the art.

See ‘Legal principles’ below for the main points of case law underlying this approach.

Contribution to the art

An inventor’s contribution to the art lies in what has been added to the state of the art as a result of the inventive concept disclosed in the specification, that is, how far has the inventive concept carried the state of the art? One way of identifying the contribution to the art is to determine what is disclosed that is new to the art and not obvious (Generics (UK) Limited and others v H Lundbeck A/S (2009) UKHL 12; (2009) RPC 13 at paragraphs 30 and 95).

In effect, the s40(3) requirement that the scope of the claims must not be broader than is justified by the inventor’s contribution to the art requires that the claims must be restricted to products and/or processes disclosed in the specification that are novel, inventive and enabled by that disclosure.

Principles of general application 

Most claims are generalisations of one or more examples in the specification. The extent of generalisation permissible is a matter which must be judged in each case in the light of the relevant prior art. An inventive idea or step which can be practically applied to open a new field may be claimed more broadly than one which is concerned with advances in a known technology. However, a claim will lack support under s40(3) if it is so broad that it encompasses any embodiment that the inventor has not enabled and/or which owes nothing to the teachings of the specification or any principle which it discloses.

Applicants should be allowed to cover all obvious modifications, equivalents to, and uses of that which they have described in detail. In addition, applicants should be allowed to draft broader claims when it is reasonable to expect or predict that all the embodiments covered by the claims have the properties or uses ascribed to them in the body of the specification.

A claim which is drafted in relatively broad terms is not objectionable just because it is broad. The question is whether the technical contribution represents a general principle that can be applied over the scope of the claims or whether the technical contribution is limited to specific embodiments in the specification (CSR at paragraphs 113 and 117).

Enabling disclosure

Under s40(3), the matter in a claim of a specification must be supported by an ‘enabling disclosure’ in the description and any drawings, graphics, photographs and sequence listing (that is, the body of the specification).

The level of disclosure required under s40(3) is similar to that required under s40(2)(a). The main difference is that for s40(3), the enabling disclosure must be found in the body of the specification, that is, the description and any drawings, graphics, photographs, and sequence listing (see 5.6.7.2 Clear enough and complete enough disclosure).

Scope of claims cannot be broader than is justified by the ‘contribution to the art’ 

The scope of a claim may exceed the contribution to the art in two ways:

  • claiming embodiments which are not enabled, for example a wide class of products when there is an enabling disclosure of only one of those products and no disclosure of a principle which would enable other products to be made; or 
  • claiming every way of achieving a result when there is an enabling disclosure of only one way and it is possible to envisage other ways of achieving the result that make no use of the invention.

After considering whether the body of the specification contains an enabling disclosure, examiners should view the claims more broadly and consider whether the scope of the claims encompasses:

  • alternative products or processes that the disclosure has not enabled, particularly where there is no principle of general application evident or where the claim defines the invention in terms of the result to be achieved; and/or
  • ways of making the product or working the process which owe nothing to the teaching of the specification or any principle it discloses.

​​​​​​​The assessment should be based on material on file concerning the application and information available in any foreign examination reports (FERs). Examiners are not required to search for further information, but they may retrieve other relevant documents if they are aware of them. However, an objection under s40(3) based on a hypothetical embodiment which may be developed later falling within the scope of the claims, should not be raised.

Support in view of later developments in the field

A claim may encompass products or processes which involve the use of technology unknown at the time the claim was drafted. This claim may subsequently be found to lack support if it encompasses a later product or process that the specification does not enable and which makes no use of the invention it discloses.

Examiners may not be aware of such developments during the course of examination, however, this type of information may be introduced with third-party submissions or a re-examination request.  

However, this is not an issue if the later development involves an inventive step beyond the claimed invention. For example, if a later development involves selection of a particular integer falling within a broad term in the claim and improves the way the invention works, the original claim does not subsequently lack support.

Inconsistency between the invention disclosed and the invention claimed

A claim will lack support under s40(3) where there is a serious inconsistency between what is claimed and what is described of the invention in the body of the specification. This is the case even if the claimed invention is enabled.

A serious inconsistency does not arise just because a feature not mentioned in the claims is found in a consistory statement or the described embodiments. However, where it is apparent from the information in the body of the specification that a feature missing from the claims is clearly essential to how the described invention works and how its stated benefits achieved, then there will be a lack of support even if the claim is enabled

This form of support was discussed in Calix Limited v Grenof Pty Ltd [2023] FCA 378 at [128]:

“Although discussion of s40(3) is often focused on the breath of the claim, there may be some claims which lack support not because they are too broad, but because they define an invention that is materially different to what is described in the body of the specification. Hence, a claim that includes a feature not disclosed in the specification, or omits a feature that is disclosed, may lack support because the invention claimed is materially different from the invention disclosed. Whether or not the claim will lack support in such circumstances will depend on the proper characterisation of the invention disclosed in the body of the specification and the invention claimed.”

Serious inconsistencies

Examples of this type of serious inconsistency are:

  • The body of the specification describes the invention as an optical arrangement for a laser where a reduced line-width is achieved through use of an intra-cavity filter with a particular diffraction grating, but the claim does not define the diffraction grating; or
  • The body of the specification describes the invention as a preparation of a stable tablet by mixing the ingredients under moist conditions, but the claims do not define wet processing.

Not inconsistencies

There are cases where an invention is claimed more broadly than described in the body of the specification but there is no serious inconsistency. For example:

  • The body of the specification describes use of a gear arrangement only for bicycles, but the claim defines a gear arrangement for a vehicle. A lack of support objection arises where it is apparent that the gear arrangement will only work and achieve the stated benefits when applied to bicycles; or
  • The body of the specification describes preferred features or embodiments of the invention that are not claimed (for example, comparative examples or embodiments that are excluded from the claims by amendments to overcome objections). This is not a serious inconsistency and it is not necessary to amend the specification to remove this subject matter unless it casts doubt on the meaning of the claims.

Note that sometimes it is appropriate to object to a serious inconsistency under lack of utility (s18(1)(c)). Examiners should use their judgement as to which type of objection is most appropriate in the circumstances. 

Amendment to overcome serious inconsistency

It may be possible to overcome a serious inconsistency by amendment. However, amendment of the description to remove a feature referred to as being essential may only be allowable under s102(1) where:

  • an independent claim that implies (by omission) that the feature is not essential and existed at the filing date; and
  • the applicant can plausibly and credibly demonstrate that it would be clear to a person skilled in the art that the description is incorrect in suggesting that the feature is essential to perform the claimed invention.

Support for features disclosed only in the claims

Where a feature appears only in a claim, with no explicit or implicit disclosure of that feature in the body of the specification, the claim will not be supported. This is the case even if the claim itself may constitute an enabling disclosure for the purpose of s40(2)(a).

In this situation, generally, the applicant can amend the description to include the feature (see 5.7.4.2 Allowability of amendments to complete specifications).

For example, if the description makes it clear that a range of common mechanical fastenings are suitable for use in the invention, but it only mentions nuts and bolts, a claim that specifies screws will not lack support and is not a serious inconsistency. This is because a screw is a common mechanical fastening means and is therefore implicitly disclosed. On the other hand, if the claim requires all components of the device to be coated in titanium nitride and the description says nothing about surface treatments, the claimed invention will not be supported.

Specific scenarios and claim types

The principles outlined above for determining whether there is support for the claims are the same regardless of the claim type.

Alternatives in a claim (‘and/or’)

Claims containing the words ‘and/or’ (or similar expressions signalling alternatives) are supported by matter disclosed in the specification only if the specification discloses both the ‘and’ and the ‘or’ forms of the claim. In other words, the specification must support both alternatives. If there are multiple ‘and/or’ alternatives in the claim, examiners need to consider all the possible combinations of features in order to determine whether the claim is supported.

Imprecise claims to alloys

Alloys are a well-investigated art. In this field it is known that slight changes of constituents or of relative proportions often change the entire character of the resultant alloys. So, a claim that is not limited to the actual alloys disclosed in the specification will lack support if the claim is drafted in a way that includes hypothetical equivalent alloys that have not been investigated at all and, in view of the state of the art, are not part of the invention.

Where it cannot be predicted what changes to the physical properties of an alloy will result due to making slight changes in its composition, the invention will reside in specific alloy compositions which have particular desired properties. Therefore, claims using imprecise terms such as “about”, “including”, including the presence of some undefined alloy components, or claiming component amounts that are outside the ranges described in the specification may not be supported by the specification.

However, applicants are allowed to include a statement in the claim identifying the presence of unavoidable impurities within the alloy, provided there is similar disclosure in the body of the specification.

Claims by result

A claim by result is a claim drafted with reference to the result achieved, rather than the technical features that produce the result. These claims are sometimes referred to as “all means claims” because they may claim all means of achieving the result.​​​​​​​

For example:

“An ash tray receptacle which, without the use of movable parts, retains the smoke arising from objects thrown into it.”

Claims by result are directed to a class of products or processes that possess the specified properties or features. Difficulties can arise in understanding the full scope of such claims. Consistent with the approach to all other claim types, once the scope of the claim has been determined, there are two questions to consider:

  • whether the specification provides enablement across the scope of the claim; and
  • whether the claim extends beyond the contribution to the art.

Broad claims by result may be enabled across their whole scope where the result defined in the claims represents a practical application of a principle disclosed in the specification. However, if the claim extends to subject matter that cannot be performed by application of any principle in the specification, then the claim is not enabled across its full scope.

A claim by result will lack support if it encompasses every way of achieving a result when it enables only one way and it is possible to envisage other ways of achieving that result which owe nothing to the teaching of the specification or any principle it discloses.

A claim by result will lack support also if there is an inconsistency between the invention disclosed and the invention claimed, for example if an essential feature is missing from the claim.

Claims by result may be objectionable under s40(3) and/or s40(2)(a). To decide on which basis to raise an objection, examiners should consider the particular facts of the case and a proper construction of the specification and the claims (see also 5.6.7.2 Clear enough and complete enough disclosure - Claims by result).

Reach-through claims

Reach-through claims define compounds in terms of specified properties identified in a screening method or assay. This type of claim is most prevalent in the chemical and biochemical areas.

In general, claims to 'unspecified' compounds per se, identified from the screening method or assay, are speculative. These claims encompass any compounds identified as possessing the properties being screened for, regardless of whether they are explicitly disclosed in the specification.

Where the relationship between the function of the compounds and their structure is not defined, screening all compounds to identify those with the desired properties would require substantial experimentation by trial and error, which would impose undue burden. Therefore, in most cases, claims to unspecified ‘identified’ compounds per se will not be sufficiently enabled over the whole scope of the claim. For this reason, they will not satisfy s40(3). They will also fail to satisfy s40(2)(a) (see 5.6.7.2 Clear enough and complete enough disclosure – Reach-through claims).

A claim to a 'specified' compound per se, which is explicitly disclosed in the specification, may be enabled by that disclosure if sufficient information is provided to make or otherwise obtain the compound.

Compounds and the Contribution to the Art for reach-through compounds

A screening assay does not produce a new compound, it identifies the properties of an existing compound. Therefore, any compound ‘identified’ by such an assay would have already existed and will not be novel.

So, where the disclosure concerns a method of screening known compounds, the contribution to the art will not be the compound per se, but the consequential uses of the compound (based on the properties identified by the screening assay).

Claims to pre-existing compounds, merely identified as having a particular activity, will be prima facie not novel. Therefore, examiners do not need to provide a citation to support the lack of novelty objection. Claims to 'identified' compounds, whether explicitly disclosed in the specification or not, will also be broader than is justified by the contribution to the art and will lack support under s.40(3). 

If overcoming a novelty objection would fully address any s.40(3) objection, the examination report may simply note either that an opinion under s40(3) is reserved or that the reasons provided for the novelty objection would also form the basis for an objection under s40(3) (see 5.6.5.6 Issues specific to Chemical Compositions - Reach-through claims for further information on novelty considerations).

Claims to the use of Reach-through compounds

In some circumstances, claims to the downstream uses of functionally defined but otherwise undisclosed ‘identified’ compounds may be fully enabled.

It is necessary under s.40(3) to limit the subject matter of the claims to the contribution to the art. If the specification discloses a principle of general application regarding the use of an unspecified ‘identified’ compound, the claim will be supported, provided it is restricted to the use of the functionally defined compound in a practical application of the general principle.

For example, an applicant has discovered that inhibiting the activity of protein X leads to the effective treatment of disease Y. The specification includes data establishing that the treatment is a reality and not just a possibility (see 'Pharmaceutical inventions and methods of treatment' below) and discloses a screening assay to identify compounds capable of inhibiting the activity of protein X. In this situation, the contribution to the art will be the screening assay itself and the method of treating disease Y by inhibition of protein X, provided both are novel and inventive.

Therefore, a claim to the use of an inhibitor of protein X to treat disease Y would be enabled over its whole scope for the purposes of s.40(3) and s.40(2)(a) even though only a small number of the inhibitory compounds are explicitly disclosed. The reason for this is that the feature ‘inhibitor of protein X’ represents a principle of general application. From the disclosure outlined above, the person skilled in the art would reasonably expect the claimed therapeutic method to work using anything that falls within the scope of the term ‘inhibitor of protein X’.

Where the specification exemplifies the method of treatment using one such inhibitor, the method is enabled over the whole scope of the claim. Furthermore, as the specification includes a screening assay, alternative ways of performing the invention are at the disposal of the person skilled in the art, which would be apparent upon reading the description and their common general knowledge.

Note that a specification that has similar claims to a method of treatment (use of an inhibitor of protein X to treat disease Y) but does not provide a screening assay will nevertheless be enabled across the whole scope of the claim if a relevant screening assay would be obvious to the person skilled in the art based on the common general knowledge in the art. In this situation, the specification is not required to detail such an assay. 

Markush claims

Markush claims are a convenient means of defining a large number of compounds by way of a generic core structure with defined substituents (see also 6.1.4.4 Markush practice, Annex AA Markush claims and 5.6.7 Annex A – Examples: Subsections 40(2)(a) and 40(3)).

Markush formulae are a shorthand way of defining a class of compounds based on a more limited number of specific examples. The applicant extrapolates to other chemical moieties based on their similarities to groups that have been specifically made and tested. The allowable extent of the prediction made by the applicant will depend on the facts of the case and the technical contribution made by the invention and construction of the claims should be approached with a “generous measure of common sense” (Eli Lilly and Co Ltd v Apotex Pty Ltd (2013) FCA 214). For example, disclosure of methyl could provide support for other alkyl groups or, depending on the facts of the case, more broadly for other lipophilic groups such as halo and alkenyl.

For Markush claims to be supported over their whole scope, the body of the specification must provide sufficient information to enable the person skilled in the art to make every compound falling within the scope of the claims. If the activity of the compound is a feature of the claim, the class of compounds must be such that the person skilled in the art would have a reasonable expectation that all of the class members will behave in the same way, in the context of the specification.

For instance, if the invention relates to a new genus of compounds having a particular pharmacophore linked to their biological activity, then there may be support for a relatively wide range of variation provided that the pharmacophore is retained. The technical contribution is the genus of compounds with a potential use associated with the pharmacophore.

For Markush claims to new compounds, support will generally extend to terms such as ‘prodrugs’, ‘salts’, ‘stereoisomers’, ‘polymorphs’, and ‘solvates’. These are products that the skilled person, using the new knowledge provided by the specification and the common general knowledge in the art, would be able to prepare by routine methods, with reasonable expectation that these products will behave as described in the specification. While the number of these additional products is potentially large, that does not detract from the routine nature of such experimentation. Such claims are supported if the additional products are clearly encompassed by the inventive concept and the technical contribution to the art. Subsequent applications that claim specific polymorphs, salts, stereoisomers and the like may still be filed, in which case novelty and inventive step are likely to be key considerations, rather than support.

Similar considerations apply to other generic terms such as ‘pharmaceutically acceptable derivatives’, ‘metabolites’, and ‘isomers’, among others. Such claims are not always supported. If, by including these terms, claims are extended beyond the technical contribution then an objection should be raised.

Substituents in chemical structures

The scope of terms such as ‘leaving group’ and ‘protecting group’ is well understood in the chemical arts. These terms represent a principle of general application where the person skilled in the art would reasonably expect the invention to work with anything that falls within the general term. An example of one member of the group would normally provide an enabling disclosure for a claim referring to all members.

Broader terms, such as ‘optionally substituted’, where the substituents are not defined, are unlikely to be supported over their entire scope. An undefined substituent will encompass a diverse range of possibilities and cannot represent an underlying principle of general application. An example of one substituent, or even several examples, cannot enable all others. In most cases, such claims will not be enabled over their full width, and the scope of the claims will exceed the contribution to the art, contrary to s40(2)(a) and s40(3). 

Genetic markers or biochemical markers

In the biotechnology field, claims often refer to methods for detecting physiological and pathological conditions, using multiple genetic or biochemical markers. Often the claims define a large number of potential markers and possible combinations but the body of the specification provides only a few examples of these. In the absence of relevant examples over the whole scope of the claims and/or an indication of the response of any given marker or marker combination for a specific condition in comparison to controls, the claims are unlikely to be enabled over their full scope. Therefore, they will lack support under s40(3). If so, an objection under s40(2)(a) will also apply.

Pharmaceutical inventions and methods of treatment

Claims to the use of known pharmaceutical compounds for a new therapeutic use will lack support in the absence of any evidence of the compound working for the new use. Similarly, even where a pharmaceutical compound per se is new, a claim to the therapeutic use of the compound will lack support if there is no evidence of the therapy working over the whole scope of the use as claimed.

Where the claims are for methods of treatment, the description should not only identify a condition that may be treated but also demonstrate, by reference to tests, that the treatment is a reality and not just a possibility.

The tests that must be disclosed to support a claim to a therapeutic method depend on the nature of the invention. Rudimentary tests will suffice. Full, detailed, rigorous, and conclusive testing of a drug for its ability to treat a condition is not necessary. ‘Rudimentary’ tests may include in vivo tests or in silico modelling that credibly and plausibly demonstrate that the specified compounds possess an activity that could lead to the treatment of the identified condition.

Claims to methods of treatment based on a mere assertion in the specification that a pharmaceutical composition or medication will act in a particular manner to treat a medical condition will not be supported if there is no technically credible basis for that assertion (Prendergast’s Applications [2000] RPC 446). Furthermore, a statement in the specification that the claimed invention has been tested will not be adequate to support the claims if no details of the tests are provided (Consultant Suppliers Ltd's Application [1996] RPC 348).

Where there is a well-established link between a physiological process (such as a molecular interaction or biochemical pathway in the body) and a particular disease, tests demonstrating a relevant activity may support claims to the use of a compound for the treatment of diseases associated with the interaction or pathway.

For example, disclosure in the body of the specification of in vitro tests demonstrating that a compound restores p53 function will adequately support claims to the use of the compound to treat specified p53-mediated cancer conditions. Similarly, support for the use of a compound to treat diseases caused by harmful prions will be provided by in silico tests that credibly and plausibly demonstrate that a specified compound binds a cavity in a prion protein, thereby stabilising its normal conformation and reducing the amount of harmful prion.

An example where method of treatment claim was not supported. In Consultant Suppliers Ltd's Application [1996] RPC 348, claim 1 was to the:

“Use of a benzoic acid derivative of [a specified general formula] for the treatment of disease by inhibition of nuclear ADP-ribosyl and similar transferase enzymes.”  

A dependant claim specified particular diseases to be treated.  

The description referred to the medical use and provided some statements indicating that certain compounds had been tested and found to exhibit the specified enzyme inhibiting activity, but no data or details of the testing procedures were provided.  In the absence of even rudimentary data regarding the testing done and the results obtained, showing that the claimed therapeutic activity was a reality for each disease falling within the scope of the claims, the claims were not supported.

As a separate issue, the description contained suggestions that not all derivatives falling within the scope of the claims had the specified enzyme-inhibiting activity.  In this situation, the term ‘benzoic acid derivative’ in the claims could not represent a principle of general application, because given the statements in the description, it was not reasonable to expect that everything falling within the term had the relevant activity.  Since only some of the compounds within the scope of the claims had the activity, and the specification provided no testing procedure to identify the derivatives with the relevant activity (and a procedure was not apparent from the common general knowledge in the art), the claims were not enabled over their full scope and for this reason did not comply with the requirements of s40(3) (or s40(2)(a)). 

Overlap between support and usefulness

With pharmaceutical inventions and methods of treatment, there is considerable overlap between the requirements of s40(3) and those of s18(1)(c) and s18(1A)(c) (that the invention must be useful). In some cases, where the claims are not supported (s.40(3)), the claimed invention will also not meet the usefulness requirements, and vice versa (see also Therapeutic or pharmacological use in 5.6.8.19 Useful (specific, substantial, and credible use)).

Where objections under both grounds apply, examiners should use their judgement as to which objection (or both) is preferable.

Objections under s40(3)

Claims are considered to satisfy s40(3) if there is no apparent reason to suppose either that the invention cannot be performed over the whole scope of the claims or that the claims encompass matter that owes nothing to the teachings or principles disclosed in the specification.

Examiners should not raise objections under s40(3) based on speculation that an alternative embodiment that is within the scope of the claims but not enabled by the specification may be developed at a later date.

Otherwise, unless examiners are reasonably satisfied, on the balance of probabilities, that the claims comply with s40(3), the objection should be raised. The objection must include logically-sound reasons for the assertion that a claim is not supported by an enabling disclosure and/or is broader than is justified by the extent of the disclosure and the contribution to the art.

If the claimed subject matter is not novel and/or does not involve an inventive step (s7), it will be broader than is justified by the applicant’s contribution to the art. Therefore, it will lack support in an academic sense. However, objections should not be raised as to a lack of support merely because of a lack of novelty and inventiveness of a claim. This is because if the novelty and/or inventive step objection is overcome, it would fully address any objection under s40(3).

Evidence to overcome a lack of support objection

In response to a lack of support objection, the applicant can submit evidence or other submissions. For example, they may provide experimental data or a statement by a skilled person. To overcome the objection, these submissions must be credible and plausible and must adequately address the examiner’s concerns. A mere assertion that the claim is supported is not sufficient.

However, the applicant cannot add new matter that would contravene s102(1) (amendments that are not allowable). Therefore, if the applicant cannot overcome the objection, the claims will need to be restricted accordingly. (see also 5.7.4.2 Allowability of amendments​​​​​​​)

Where an issue is not resolved despite subsequent adverse reports, the supervising examiner should consult Patent Oppositions on the further progress of the case, including whether to set the matter for hearing with the intent to refuse the application.

Legal principles

Test for support

The test for whether a claim is supported by the description is:

"... the definitions in the claims [i.e. the claimed invention] should essentially correspond to the scope of the invention as disclosed in the description. In other words … the claims should not extend to subject-matter which, after reading the description, would still not be at the disposal of the person skilled in the art." (Generics (UK) Ltd v H Lundbeck A/S (2009) RPC 13 at paragraph 36, affirming T 409/01)

The mere mention in the description of features appearing in the claims is not necessarily sufficient support. The word ‘support’ means more than just coincidence of language; it requires the disclosure to be the base which supports grant of a monopoly of the width claimed (Schering Biotech Corp.’s Application [1993] RPC 249 at pages 252 and 253).

Enabling disclosure

The level of disclosure required under s40(3) is similar to that required for s40(2)(a) (Asahi at 536 approved by the House of Lords in Biogen Inc. v Medeva Plc (1997) RPC 1 at page 49).

Contribution to the art

An inventor’s contribution to the art lies in what is added to the state of the art as a result of the inventive concept disclosed in the specification (that is, how far forward has the inventive concept carried the state of the art? One way of identifying the contribution to the art is to determine what is disclosed that is new to the art and not obvious (Generics (UK) Limited and others v H Lundbeck A/S (2009) UKHL 12; (2009) RPC 13 at paragraphs 30 and 95).

For innovation patents, the words ‘inventive’ and ‘obvious’ in this context should be read as ‘innovative’.

In effect, the s40(3) requirement that the scope of the claims must not be broader than is justified by the inventor’s contribution to the art requires that the claims must be restricted to products/processes disclosed in the specification that are novel, inventive and enabled by that disclosure.

A product may be a contribution to the art even where it is a known and desired goal and/or the only inventive step lies in the method by which it is made (Generics (UK) [2009] at paragraph 98; H Lundbeck A/S v Generics (UK) Ltd (2008) RPC 19 at paragraphs 36 – 40, 63, and 98).

What the applicant asserts to be the contribution(s) to the art will be apparent from the claims. Where the claims are overly broad and/or define the invention by the result to be achieved, reference to the description may provide an understanding of what the inventor has contributed to the art.

A discovery does not constitute a ‘contribution to the art’ for the purposes of s40(3). A patentable invention is a practical product or process, not information about the natural world (Kirin-Amgen Inc. v Hoechst Marion Roussel Ltd (2005) RPC 9 at paragraph 77). However, if a discovery can be practically applied to produce a useful product or process, this may result in a patentable contribution to the art. For example, finding that a length of iron treated in a certain way will always point to the north is a discovery; a practical application of the discovery would be to make a compass which, if it were novel and inventive, would be a contribution to the art (Genentech Inc’s Patent [1987] RPC 553 at page 566).

Claims broader than the contribution to the art

The breadth of a claim may exceed the contribution to the art generally in 2 ways (for example, Biogen supra at page 51):

  • It may claim results which are not enabled, such as the making of a wide class of products when it enables only one of those products and discloses no principle which would enable others to be made; or
  • It may claim every way of achieving a result when it enables only one way and it is possible to envisage other ways of achieving that result which make no use of the invention.

These 2 scenarios raise separate issues (for example, Biogen supra at page 50):

  • whether the disclosure ‘could, so to speak, deliver the goods across the full width’ of the claims (that is, whether the disclosure enables the claimed invention); and
  • ‘not whether the claimed invention could deliver the goods, but whether the claims cover other ways in which they might be delivered: ways which owe nothing to the teaching of the [specification] or any principle which it disclosed’.

Claims by result

Claims by result may be objectionable under s40(3) and/or s40(2)(a) if the specification enables the production of only one member of a class defined by the known desirable properties of the class (H. Lundbeck A/S v Generics (UK) Ltd (2008) EWCA Civ 311; (2008) RPC 19 at paragraph 60). However, this will depend on the particular facts of the case. For example:

"... if a man finds a particular way of making a new substance which is 10 times harder than diamond, he cannot just claim ‘a substance which is 10 times harder than diamond.’ He can claim his particular method and he can claim the actual new substance produced by his method, either by specifying its composition and structure or … by reference to the method … but no more. The reason he cannot claim more is that he has not enabled more – he has claimed the entire class of products which have the known desirable properties yet he has only enabled one member of that class. … Such a case is to be contrasted with the [situation] where the desirable end is indeed fully enabled ... (H. Lundbeck supra at paragraph 61).

Enablement for claims by result

If the claim extends to something that cannot be performed by applying any principle in the specification, the claim is not enabled across its full scope.

For example, where a problem is simply how to do automatically what can already be done by a skilled worker, the principle applied to solve the problem lies in the way a machine operates. In this case:

"Assuming [the] principle to be new, it might be possible for the inventor, having shown one method of applying it to the solution of the problem, to protect himself for the life of his patent from any other method of applying it for the same purpose, but I do not think that the novelty of the principle applied would enable him to make a valid claim for all means of solving the problem whether the same or a different principle were applied to its solution." (Biogen v Medeva Plc (1997) RPC 1 at page 51).

It follows that the scope of a claim will not be enabled or supported if it extends further than alternative applications of the principle in a way that, while not explicitly disclosed, would nevertheless be apparent to the skilled person who has read the specification (T484/92).

Similarly, for claims comprising a combination of features:

"When a combination claim states an invention which gives an old result by a new means, the monopoly is limited, at any rate prima facie, to the new means. But when by a new application of principle the inventor has obtained a new result or thing, even when it is done by a combination, he may claim all the alternative means by which the thing or result may be achieved [by applying the principle]." (Shave v H V McKay Massey Harris Pty Ltd (1935) 52 CLR 701).

Support required for pharmaceutical inventions and methods of treatment

Claims to the use of known pharmaceutical compounds for a new therapeutic use will lack support in the absence of evidence of the idea working for the new use (Prendergast’s Applications [2000] RPC 446). Similarly, even where a pharmaceutical compound per se is new, a claim to the therapeutic use of the compound will lack support if there is no evidence of the therapy working over the whole scope of the use as claimed. If there is no evidence of this kind, it cannot be asserted in the disclosure that the treatment will work.

Where an application claims methods of treatment, the description should not only identify a condition that may be treated but also demonstrate, by reference to tests, that the treatment is a reality and not just a possibility (Hoerrmann’s Application [1996] RPC 341, Consultant Suppliers Ltd’s Application [1996] RPC 348). Rudimentary tests will suffice: full, detailed, rigorous, and conclusive testing of a drug for its ability to treat a condition is not necessary (Prendergast’s Applications [2000] RPC 446).

Where an application claims the treatment of a number of different medical conditions, the description should demonstrate, by in vivo or in vitro tests, that the specified compounds are indeed effective against each of the claimed conditions (Hoerrmann’s Application [1996] RPC 341). In silico tests may also provide support in some circumstances.

The tests that must be disclosed in order to support a claim to a therapeutic method depend on the nature of the invention. The question of support in each case should be considered on its merits. However, ‘rudimentary’ tests may include in vivo tests, or in silico modelling, that credibly and plausibly demonstrate that the specified compounds possess an activity that could lead to the treatment of a given disorder.

It is not enough to just assert in the specification that a pharmaceutical composition or medicament will treat a medical condition (Prendergast’s Applications [2000] RPC 446). Furthermore, if no details of the tests are provided, it is not enough to just provide a mere statement in the specification that the claimed invention has been tested (Consultant Suppliers Ltd’s Application [1996] RPC 348).

Where there is a well-established link between a physiological process (such as a molecular interaction or biochemical pathway in the body) and a particular disease, tests demonstrating a relevant activity may support claims to the use of a compound for the treatment of diseases associated with the interaction or pathway. For example, disclosure in the body of the specification of in vitro tests demonstrating that a compound restores p53 function will adequately support claims to the use of the compound to treat specified p53-mediated cancer conditions. Similarly, support for the use of a compound to treat diseases caused by harmful prions will be provided by in silico tests that credibly and plausibly demonstrate that a specified compound binds a cavity in a prion protein, thereby stabilising its normal conformation and reducing the amount of harmful prion.

In Consultant Suppliers Ltd’s Application [1996] RPC 348, claim 1 was to:

"Use of a benzoic acid derivative of [a specified general formula] for the treatment of disease by inhibition of nuclear ADP-ribosyl and similar transferase enzymes."

A dependant claim specified particular diseases to be treated.

The description referred to the medical use and included some statements indicating that certain compounds had been tested and found to exhibit the specified enzyme-inhibiting activity, but no data or details of the testing procedures were provided. In the absence of even rudimentary data regarding the testing done and the results obtained, the claims were not supported. In order for the claims to be supported, the description needed to provide testing data and results showing that the claimed therapeutic activity was a reality for each disease falling within the scope of the claims.

A separate issue is that the description contained suggestions that not all derivatives falling within the scope of the claims had the specified enzyme-inhibiting activity. In this situation, the term ‘benzoic acid derivative’ in the claims could not represent a principle of general application because, given the statements in the description, it was not reasonable to expect that every benzoic acid derivative had the relevant activity. Since only some of the compounds within the scope of the claims had the activity, and the specification provided no testing procedure to identify the derivatives with the relevant activity (and a procedure was not apparent from the common general knowledge in the art), the claims were not enabled over their full scope. For this reason, they did not comply with the requirements of s.40(3) (or s.40(2)(a)).

Subsequent lack of support in view of later developments in the field

A claim may encompass products or processes which involve the use of technology unknown at the time the claim was drafted (Kirin-Amgen Inc v Hoeschst Marion Rousel Ltd (2005) RPC 9 at paragraph 80).

However, there may be a later improvement to a claimed method that involves an inventive step, although the original invention could still be worked by using the improvement. In that case the specification does not become insufficient merely because it does not enable the skilled person to make the inventive improvement. For example, if a further invention involving selection of a particular integer falls within a broad term in a claim, and it improves the way the invention works, the selection of the integer does not have to be described in the original specification (Kirin-Amgen supra at paragraphs 117 – 118 and 130).

Amended Reasons

Amended Reason Date Amended

Published for testing
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