Antibody Claims: Routinely Sufficient?

Acknowledgments

Tamaris Bucher is employee of Novartis Pharma AG

The author is very grateful to the following people for their input, review and feedback:
Harvey Adams of Carpmaels & Ransford LLP
And the following Novartis colleagues: Meabh Brennan, Sarah Thompson
The views expressed in the article do not necessarily reflect the opinions of Novartis or Carpmaels & Ransford LLP

Introduction

The standards applied to the patenting of antibodies at the EPO play an integral role in supporting innovation in the biotechnological sector. This article aims to continue the analysis of those standards as published in a series of three articles in EPI Information concerning the inventive step assessment of antibodies Bucher, T. “The Barrier Around Antibody Inventions at the European Patent Office” Parts 1 & 2; epi Information 4/2024, Dec 2024, pages 22- 31 and Part 3, epi Information 1/25, March 2025, pages 6-14. Those articles focused on the inventive step standards outlined in the EPO Guidelines Part G.II.6.2 (2024 version), in particular on how those standards were being applied to antibodies claimed by their sequence information. They investigated the presumption of obviousness embedded in the Guidelines and the related concept of the ‘routine methods’ analysis. The latter has become a mindset which has intruded into the examination of this field of antibody engineering, unfettered from the original context from which it arose in relation to murine antibodies suitable for in vitro use. This article will continue this work and examine this ‘routine methods mindset’ in relation to the disclosure requirements under Art. 83 EPC.

Functionally defined antibody claims: Art. 83 EPC

Art. 83 aims to govern one of the fundamental concepts of the patent system – a patent is granted giving the patentee certain rights over a new invention as claimed, in exchange for disclosing to the public sufficient details to be able to carry out the invention. The subject matter must, of course, also be inventive and, as a result, there is a necessary interplay between on the one hand, the assessment of inventive step, and on the other, the disclosure of this inventive subject matter.

The 2020 article by StorzStorz, U “The nine lives of epitope-based antibody patents”; Human Antibodies; Vol. 28, Issue 2; May 2020; pages 89-110 discusses functionally defined antibody claims in relation to these two criteria of inventive step and disclosure. Storz postulates that the justification of the EPO for granting these claims which have a broad scope, despite a minimal disclosure in the application itself, is the assumption that work in this area is ‘routine.’

“In target-based claims, which do not only protect the one or more antibodies that are explicitly disclosed in a patent application, but all antibodies binding the respective target, the test the EPO applies is quite simple. De facto, the finding and proper characterization of a new target, e.g., a new receptor or cytokine, combined with any kind of data that suggest a physiological role thereof which may [sic] antibody binding appear feasible to cause some effect, is deemed sufficient to meet the inventive step criterion. This has been confirmed even in cases where the respective applicant has only made and demonstrated a single antibody, or even no antibody at all (T18/09).

EPO’s rationale to award such broad scope for such little disclosure is that, once a target is sufficiently characterized, making of an antibody against the same would be in the routine of the skilled person.“Ibid, at page 92

Thus, according to this view, the disclosure requirements of Art. 83 can be satisfied for a functionally defined antibody, e.g. an antibody binding to a new target, by the somewhat diffuse concept that making antibodies is routine work. Storz presents this rationale as an explanation for the granting of such broad claims, but it must be pointed out that the EPO does not explicitly state this reasoning in their Guidelines.

It would be a very bold position to take in patent law that a constantly developing field of technology is inherently routine. Therefore, the appropriateness of this mindset deserves to be carefully analysed. On the one hand, and in relation to Art. 83, the question must be addressed – is it necessary to assert this view in order to enable broad, functionally defined antibody claims? A concern may arise that without this mindset the applicant may be unable to sufficiently disclose such claims and obtain adequate breadth to protect their invention. On the other hand, its appropriateness must be evaluated in relation to Art. 56 EPC and the consequence in the obviousness assessment of assuming the field is routine.

The following analysis will examine the sufficiency standard – i) the general height of the standard itself and ii) the amount of detail required to meet the standard.

The height of the sufficiency standard

• Art. 83 EPC: The European patent 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.

Art. 83 ensures that the invention is clearly and completely described, so that the information can be understood and so that the disclosure is not lacking in the essential information needed to work the invention. However, it is interesting that the adverb “sufficiently” is used to qualify the level of the clear and complete disclosure. The word “sufficiently_”_ in its ordinary meaning implies that there needs to be enough information to meet the hurdle, but the information only needs to be adequate to meet that hurdle. It does not imply it needs to be more than that i.e. not copiously or profusely described beyond that threshold or beyond all doubt. In practice, the assessment focuses on the standard in the negative – what information is lacking to reproduce the invention and thus has it been insufficiently described?

The question of when an objection to a lack of sufficient disclosure can be validly raised has been addressed by various Boards of Appeal. The well-established case law in this area is reflected in the instructions to examiners in the EPO Guidelines:

“With regard to Art. 83, an objection for lack of sufficient disclosure presupposes that there are serious doubts, substantiated by verifiable facts (see T 409/91 and T 694/92).”EPO Guidelines (GL) Part F. III.1 Sufficiency of Disclosure, para 3 (version 2026)

Furthermore, in opposition proceedings, the opponent has the burden of proof when raising an objection of lack of sufficient disclosureCase Law of the BoA (CLBA) II.C.9.1 para 1 (11^th edition, July 2025) and thus to establish that this threshold of ‘serious doubts, substantiated by verifiable facts’, is met.

Therefore, this means an objection of a lack of sufficiency of disclosure is far from a facile objection to make. Conversely, from the perspective of the applicant/patentee, the sufficiency standard is in practice a comparatively low standard to meet.

The amount of detail required to meet the sufficiency standard: the test under Art. 83

The burden on the applicant to meet this comparatively low standard is further alleviated by the ability to rely on common general knowledge to supplement the information disclosed in the patent application. Consequently, not every detail concerning how to work the invention has to be disclosed within the application itself.CLBA II.C.4.1, para 1, (11^th edition, July 2025)

It would appear that for a broad, functionally defined claim to an antibody to a new target, as described above by Storz, in which one or only a very small number of antibodies are specifically exemplified, there may be a desire to fill in any gaps in explicit description by the belief that it is common general knowledge that making antibodies is routine work.

It is important then to look at the assessment of Art. 83 that has been developed in the case law for broad, functionally defined claims: is it a necessary and/or sufficient condition to establish that ‘routine methods’ are present?

In fact, the biotech case law with respect to broad claims having functionally defined features generally focuses on the concept of whether the invention can be reproduced over the whole area claimed without ‘undue burden’ and without ‘inventive skill’See, for example, T 0694/92 relating to an invention in the field of biotechnology, which generally articulated the principles to be applied in Reason 5: “….In certain cases a description of one way of performing the claimed invention may be sufficient to support broad claims with functionally defined features … However, in all these cases, the guiding principle is always that the skilled person should, after reading of the description, be able to readily perform the invention over the whole area claimed. Moreover, in keeping with the examination of whether there has been a lack of sufficient disclosure, the test more appropriately is around the concept of whether something is lacking, rather than whether ‘routine methods’ are available. As such, a reliance on ‘routine methods’ does not seem to be necessary.

The Guidelines themselves in relation to antibodies, also do not refer to ‘routine methods’, but confirm that the test is that:

“The application must enable the skilled person to produce further antibodies having the claimed functional property without undue burden…”EPO GL Part G.II.6.1.3, para 4 (version 2026)

This ‘undue burden’ test has been applied in many cases concerning antibody claims with broad scope. This was confirmed for example, in T 2045/09, involving a claimT 2045/09 Claim 8. An antibody which binds to the epitope bound by the 8B8 antibody obtainable from the hybridoma cell line ATCC no. HB-12070. to any antibody binding to the same epitope as a particular antibody obtainable from a deposited hybridoma cell line. Interestingly, the broad claim was held to be sufficiently disclosed, yet the word “routine” does not appear in the reasoning of the decision.

The next question that arises is whether invoking an assumption of ‘routine methods’ is sufficient to fill gaps in the disclosure?

Assumption of ‘routine methods’: not sufficient to fill in all gaps of a disclosure under Art. 83

Importantly, a ‘routine methods mindset’ is not enough to off-set any ‘undue burden’, and thus to prevent a finding of insufficient disclosure in the following two situations i) if certain critical details are deemed lacking in the specification to be able to reproduce the invention and ii) if there is too much experimentation needed to test whether the compound meets the parameters of the claim.

In relation to the first category, see for example, T 1466/05, which related to a claim to an antibody with a particular selectivity for different forms of its target.Claim 1 of the main request in T 1466/05: 1. An antibody reactive with the pyridinoline in peptide-linkedpyridinoline[sic] and not free pyridinoline which is useful in an assay to indicate bone resorption. The Board noted that there was an ‘undue burden’ because although techniques for the production and screening of hybridomas were available in the art,T 1466/05 Reason 14 the disclosure was

“…insufficient with respect to both the antigen required to raise further antibodies as claimed, and the screening process for the specific selection of the same”.T 1466/05 Reason 25

The functional effect was a feature in the claim – a functionally defined binding specificity – so without a disclosure of both the antigen and a screening assay able to achieve the generation of that particular selective binding ability, the ‘routine methods mindset’ was not enough.T 1466/05 Reason 22 “…This lack of disclosure forces the skilled person to embark on further experimentation which goes beyond the routine experiments required typically - i.e. when sufficient guidance is provided in the application - for the identification of monoclonal antibodies of a desired specificity.“

‘Undue burden’ was also established in T 2164/21, which related to a claim to a method of producing an antibody with reduced susceptibility to deamidation.T 2164/21 Claim 1 of the auxiliary request read as follows:
“1. A method of producing an antibody with reduced susceptibility to deamidation, wherein the method produces a mutant antibody, wherein the method comprises the step of substituting a glycine that is located adjacent to the C-terminal side of an asparagine of the original antibody with another amino acid, wherein the mutant antibody has a reduced susceptibility to deamidation relative to the original antibody before the amino acid substitution, wherein the mutant antibody has the same binding specificity as the original antibody, and wherein the asparagine exists in the complementary determining region 2 (CDR2) of the heavy chain as determined by Kabat numbering and wherein the antigen-binding activity of the mutant antibody is 70% or more of the antigen-binding activity of the original antibody before the amino acid substitution.” The application was refused on the grounds of insufficient disclosure. The Technical Board of Appeal found that there was insufficient disclosure on the basis that:

“…without the confidence that such result can be achieved at all, this constitutes an undue burden, even if it involves routine experimentation”T 2164/21 Reason 49

Interestingly, it was also acknowledged that ‘routine methods’ existed, yet nevertheless there was an ‘undue burden.’T 2164/21 Reason 48. “The fact that methods for generating an antibody with a specific mutation, methods for assessing deamidation and methods for antigen-binding activity were described in the application, were well known to the skilled person of the application and were routine on the priority date of the application does not mean that the invention can be put into practice without undue burden.” See also Reason 52. That the existence of ‘routine methods’ did not lead to a finding of no ‘undue burden’ was because of the doubt in the expectation that such a result could be achieved.T 2164/21 Reasons 47- 49 This seemingly acknowledges the unpredictability inherent in the generation of specific antibodies for a given function.T 2164/21 Reasons 44- 46

So, even an abstract assumption that work in the field is routine, does not mean that there still could not be a finding of insufficient disclosure. Techniques exist which are part of the common general knowledge, and yet, nevertheless, the specific facts in these cases did not support a finding of no ‘undue burden’. Interestingly, these two cases where insufficient disclosure was found, reflect another wider principle applied under Art. 83.

The assessment of the detail required to meet the sufficiency standard: an abstract mindset encouraged?

The case law does not encourage the use of an abstract mindset in the analysis of Art. 83. Rather, the analysis should be fact specific, as explained in the following excerpt from the Case Law of the Boards of Appeal of the EPO (CLBA):

“The issue of whether the invention is disclosed in a manner sufficiently clear and complete and whether the claims have a basis in the description is a question of fact that has to be answered on the basis of the available evidence and on the balance of probabilities in each specific case.”CLBA II.C.1, para 4 (11^th edition, July 2025) (underlining added)

Therefore, the assessment of a broad, functionally defined antibody claim should have regard to the particulars of the claim and invention in question, this being irrespective of whether the claim involves binding to a new target or some other function. In other words, a fact specific assessment should not encourage a situation in which all functionally defined claims are automatically held to be sufficiently disclosed, across their full scope, by the inflation into that space of the diffuse concept that the work in the field is routine - like simply blowing hot air into a balloon.

This emphasis on an examination of the specific case, the available evidence, and of the assessment being a question of fact, is crucial to prevent claims to mere desiderata – essentially wishes to have protection for features, but which side-step the fundamental requirement of providing sufficient information on actually how to perform the inventions with those features. The focus of the patent bargain is on what is provided – the public must actually be taught how to reproduce the invention. This then necessitates an investigation of the particular information itself to understand what exactly has been disclosed, and not disclosed, to understand if the invention has been taught. It calls for the facts to be considered in each category of information: the (functional and/or structural) features in the claim, the exemplified disclosure in the specification itself, and the common general knowledge of the skilled person. Logically, the common general knowledge in turn should concern the knowledge in relation to the specific feature(s) in the claim and in relation to the missing information not explicitly disclosed that it needs to supplement. Abstract analysis and mindsets are not encouraged in this approach.

In summary, therefore, the test under sufficiency of disclosure under Art. 83 is whether there is an ‘undue burden’ to perform the invention. The invocation of the ‘routine methods mindset’ is neither a necessary, nor a sufficient condition to prove that there was no ‘undue burden’. An abstract mindset cannot automatically be applied to a category of invention, as the disclosure requirement is necessarily a fact specific analysis.

This is not to say, however, that the word “routine” has never appeared in the analysis of Art. 83 in connection to a positive finding of a sufficient disclosure of a broad, functionally defined antibody claim. In this regard, an examination of the facts and context in which it has arisen is important to understand how the abstract notion of ‘routine methods’ has been applied.

Early case law and application of the concept of ‘routine methods’

The CLBA lists case T 431/96 at the beginning of the section entitled ‘Level of disclosure required for antibodies’CLBA II.C.7.3, para 1 (11^th Edition, July 2025). This case related to a claimT 431/96 Claim 1. A monoclonal antibody raised against non-denatured D-dimer that may be utilised in a method of diagnosis of disseminated intravascular coagulation (DIC) or other thrombotic states using body fluid, such as lymph, serum, plasma or exudate, said monoclonal antibody having the essential characteristic of reactivity with D-dimer and other cross-linked fibrin derivatives and non-reactivity with fibrinogen or fibrinogen degradation products inclusive of fragment D and fragment E. to a diagnostic antibody with a particular selectivity. The decision firstly confirms that the test under Art. 83 is without ‘undue burden’ and without ‘inventive skill.’T 431/96 Reason 5 The BoA further commented in Reason 6 that:

“..the skilled person seeking to reproduce the invention will have to produce monoclonal antibodies by routine methods and test them singly in an assay. This may possibly involve some tedious and time-consuming work, but nothing out of the ordinary since the techniques for the production and selection of hybridomas were common routine techniques at the priority date of the patent in suit (i.e. 17 March 1983).“ (emphasis added)

This very early case concerned a murine monoclonal antibody made by hybridoma technology. The statement referring to “routine techniques” should be understood in the context of making an antibody that was suitable for the claimed feature of diagnostic use. This in vitro use implied nothing more than being able to specifically bind to the target. A method was disclosed to produce monoclonal antibodies, and a description was provided of the screening and testing of these monoclonal antibodies. In that particular case, for an antibody which merely had to be suitable for in vitro use, there was sufficient information to meet the no ‘undue burden’ test.

Overapplication of ‘routine methods mindset’

Before the reasoning set out in this early case concerning a murine antibody for in vitro use is more broadly applied, and in particular to pharmaceutical antibodies for in vivo use, such as therapeutic antibodies, it should be questioned whether it is actually technically correct to characterise the field of antibody engineering as routine. Perhaps, if there was only one generation method for antibodies available, which had become entirely routine over time, there may be some justification to this notion. However, the attempt to apply a ‘routine methods mindset’ to the entire field of antibody engineering as it has developed, comes into immediate tension with the technical reality of the skilled person. Furthermore, it underestimates the serious challenges that must be overcome, in particular in the production of therapeutic antibodies.

Firstly, multiple methods to produce an antibody that binds to a target are available, but there are, very often, no clear pointers about which method or sub-method to choose in a given instance. Different methods can give different results. More importantly, however, not just one method step is involved in the development of a pharmaceutical antibody, as the product is required to do more than simply bind to its target antigen. Other characteristics/functional effects are usually important and multiple (often sequential) methods are utilised. For example, an antibody for therapeutic use may need to meet several criteria, including, for instance, selectivity for the target antigen, species cross-reactivity, immunogenicity profile in preclinical tests, stability in solution, solubility, viscosity, aggregation tendency, purity, and the absence of undesirable post-translational modifications such as proteolysis – all while retaining its biological activity. The sequence of the antibody may need to be optimised to meet these criteria. Antibody engineering typically involves sequences within the variable regions, including in the CDRs, and, accordingly, a claim to a defined set of CDRs or VH/VL sequences for a pharmaceutical antibody for in vivo use does not represent a mere arbitrary selection from the antibodies obtained from a process of immunisation or from the panning of an antibody display library. It is therefore inaccurate to view the sequence-defined product as claimed as resulting from routine work. That would ignore both i) the technical complexity involved in attaining each individual characteristic and ii) the additional complexity faced when a combination of characteristics needs to be optimised in parallel via multiple methods. Crucially also, the optimisation of one criterion may negatively impact another (e.g. stability may negatively impact affinity, and vice versa). This means the development project as a whole does not have an obvious trajectory and there is no reasonable expectation of success of obtaining a therapeutic antibody solely for the reason that methods of antibody generation and selection are allegedly ‘routine methods’.For further reading on this topic see Bucher, T. “The Barrier Around Antibody Inventions at the European Patent Office” Parts 1 & 2; epi Information 4/2024, Dec 2024, pages 22- 31 and Part 3, epi Information 1/25, March 2025, pages 6-14

It is therefore a technically inaccurate view that ALL antibodies are routine to make. In particular, when taken out of the context of diagnostic antibodies for in vitro use and applied to the entire class of antibodies per se, it becomes an inaccurate prejudice. This important area of biotechnological innovation has developed to produce therapeutic antibody products that meet a complex set of functional criteria. It is disconcerting that the complexity involved in their development may be trivially dismissed by confusing the development of these products with the early generation of in vitro use products.

Consequence of applying a ‘routine methods mindset’ in the obviousness analysis under Art. 56 and the 2026 version of the Guidelines

It is important next to understand the effect of applying this ‘routine methods mindset’ to the entire field of antibody engineering in the obviousness analysis under Art. 56. The ordinary meaning of ‘routine’ implies the work is easily done, according to a set way or method, without creativity or inventive skill. Thus, the ‘routine method mindset’ has seemingly evolved into the position on obviousness as stated in the EPO Guidelines Part G.II.6.2:

“Arriving at alternative antibodies exclusively by applying techniques known in the art is considered to be obvious to the skilled person.”

This means that all new antibody inventions are prima facie obvious if one antibody to that target is already known. This is a position which is in immediate tension with the wording of Art. 56 and one that is simply not tenable.

This negative statement unfortunately remains in the 2026 version of the Guidelines. A brief mention must be made that this version, which will come into force on 1 April 2026, has softened the negative presumption of obviousness somewhat in comparison to the 2025 version. The opening phrase of the inventive step section has been changed from “The subject-matter of a claim defining a novel antibody binding to a known antigen

’does not involve an inventive step unless….“ to “involves an inventive step if….(bold added).

However, the 2026 Guidelines still retain the restrictive framework of listing four ways in which it is acceptable to show inventive step,Namely, a surprising technical effect, no reasonable expectation of success of obtaining antibodies having the required properties, difficulties in generating or manufacturing the claimed antibody, or a novel type of functional antibody format and one way in which it is not.“Inventive step cannot be not acknowledged solely on the basis that an antibody is structurally different from the prior-art antibodies” and “The fact that an antibody’s structure, i.e. its amino acid sequence, is not predictable is not a reason for considering the antibody to be non-obvious” The restriction that “However, inventive step cannot be established solely on the basis that an antibody is structurally different from the prior-art antibodies”, goes against the reasoning in case law like T 67/11T 67/11 Reasons 20-24 and see also Bucher, T. “The Barrier Around Antibody Inventions at the European Patent Office” Part 2; EPI Information 4/2024, Dec 2024; pp 27-31, in particular pp 30-31. Moreover, no other field of technology is subject to such a restrictive framework or, more importantly, subject to a suppression of using a source of non-obviousness arguments.

Thus, the detrimental consequence of applying an underlying assumption of ‘routine methods’ to an entire field of developing technology is still evident in the inventive step section of the 2026 Guidelines.

The role of the functional feature: comparison of functional claims and sequence defined claims

In light of the above considerations, it is critical that an assumption of ‘routine methods’ is not overapplied in the wrong context. With that objective in mind, the following analysis shows how the functional effect of a claimed antibody can be taken into account in the assessment under both Art. 83 and Art. 56 to prevent this problem from occurring. It will look at this issue from the perspective of purely structurally defined claims and purely functionally defined claims.

It will also look at claims to antibodies which are both structurally and functionally defined – an interesting middle ground to be explored that is supported by the Guidelines:

“Antibodies can also be defined by both functional properties and structural features. It is possible to claim an antibody characterised by the sequences of both variable domains or CDRs with less than 100% sequence identity when combined with a clear functional feature.“EPO Guidelines Part G.II.6.1.4 (2026 version)

Interestingly, in T 617/07, which involved a claim to an anti-TrkA antibody that was functionally defined and structurally defined as having at least one of a set of specified CDR sequencesT 617/07 Claim 20. Monoclonal antibody, synthetic and biotechnological derivatives thereof, able to recognise and bind the high affinity tyrosine kinase receptor of NGF (Nerve Growth factor), named TrkA, and act as antagonist for the binding of NGF to TrkA, and which prevents the functional activation of TrkA by NGF, and characterised by at least one CDR selected from: light chain CDRs defined by aa 46-55 of SEQ ID No 2, aa 71-77 of SEQ ID No 2 and aa 110-119 of SEQ ID No 2 and heavy chain CDRs defined by aa 176-185 of SEQ ID No. 2, aa 200-216 of SEQ ID No 2 and aa 249-262 of SEQ ID No 2., the Board found the claim to be sufficiently disclosed. They reasoned that, although the structural definition included antibodies that did not have the desired function, it would not be burdensome for the skilled person to sort out the non-functional variants within the structural definition.T 617/07 see Reason 32 “…Therefore, because the skilled person knows how to achieve antibodies with the desired function on the basis of a particular known antibody, he/she is not in the situation of having to sort out non-functional variants in a burdensome manner.“

The Table below will look at how the functional effect, which is sometimes explicitly included in the claim, and other times implicitly included, has a bearing on the subset of antibodies that is being claimed and, in turn, on the analysis under Art. 83 and Art. 56.

The analysis above highlights the critical role of the functional effect of the claimed antibody in the assessment under Art. 83 and Art. 56. The functional effect has a role in defining which subset of antibodies is being claimed and it is a fact specific analysis whether there is an ‘undue burden’ to make that subset. A consideration of the actual antibodies being claimed is important to prevent assessments made, for example, about an antibody simply for in vitro use, being overapplied to each and every functionally defined antibody claim.

Functionally defined claims: other issues

The above analysis focused on the issues relating to Art. 83 and Art. 56, but mention should also briefly be made of other issues relating to broad, functionally defined antibody claims. While using a broad definition may be advantageous to the patentee in relation to the scope of protection, such claims may lack clarity from an infringement perspective and thus lead to a lack of legal certainty for the public. The Guidelines now try to prevent this with the inclusion of the following requirement:

“In addition, the functional definition must allow the skilled person to easily and unambiguously verify whether they are working inside or outside the scope of the claim. The claim should therefore normally include the relevant characteristics of the method used to determine and define the functional property”EPO Guidelines G.II.6.1.3, para 4 (2026 version, essentially unchanged from requirement introduced in 2024 version)..

From the applicant’s perspective, in order to include these relevant details in the claim itself, this then may lead to issues with Art. 123(2), a requirement that is strictly dealt with at the EPO.

Furthermore, if any other prior art antibody binding to the same target antigen is known, the Guidelines specify that it is to be assumed that it will have the same functional properties as the claimed antibody. The functionally defined claim is then presumed to lack novelty, unless proven otherwise by the applicant.EPO Guidelines G.II.6.1.3, para 3 (2026 version) This becomes a resource burden for the applicant to overturn this negative presumption with experimental data.

Therefore, it seems that functionally defined claims face other potential significant hurdles (novelty, clarity, Art. 123(2)) in order to be granted. Thus, for these claims which in any event face these difficulties, the impact of maintaining the (erroneous) belief that all the work in the field is routine - simply to satisfy what is, after all, the low hurdle of Art. 83 - must be carefully considered. It must also surely be weighed against the serious consequence of regarding the entire field as routine as part of the Art. 56 analysis. Even narrowly defined sequence claims are then negatively impacted by the view that “Arriving at alternative antibodies exclusively by applying techniques known in the art is considered to be obvious to the skilled person.”

Conclusion

The mindset that making antibodies is routine work has a detrimental effect on the assessment of the inventive step of the products in this field. This article has therefore dissected this mindset, to show that it is not technically accurate when applied to the entire class of products, in particular to antibodies which have been engineered to meet the complex requirements of a therapeutic antibody. It has also challenged the mindset in relation to Art. 83. Specifically, the article has established that it is neither necessary, nor sufficient, to assert this view of ‘routine methods’ to satisfy the disclosure requirements for broad, functionally defined antibody claims. Abstract mindsets do not have a role under Art. 83, as this is necessarily a fact specific analysis to prevent claims being granted to mere desiderata. Therefore, it is also crucial to consider the actual subset of antibodies being claimed, as defined by the functional feature. Art. 83 is a low hurdle and allowing the view to perpetuate that making antibodies is routine, merely to (over)satisfy this requirement, must be balanced against the serious consequence of viewing the field in this way in relation to Art. 56.

The presumption of obviousness is still evident in the 2026 version of the Guidelines, and this inappropriate view of the field of antibody technology needs to be removed. Finally, it must be stressed that a characterisation of the field of antibody engineering as only involving ‘routine methods’ is not only technically inaccurate, but a position adverse to supporting further innovation in the biotech sector.

Comments