The General Court (‘GC’) has refused an appeal by Hasbro Inc. (‘Hasbro’) regarding the decision to partially invalidate a registration of its MONOPOLY mark on the ground of bad faith.
Background
Once registered, an EUTM must be put to genuine use within five years of its registration date. Third parties may apply to revoke a registration which is more than five years old in respect of any goods/services for which the mark is registered in relation to which the mark has not been put to genuine use in the EU. In order to maintain the registration, the registrant must file proof that its mark has been genuinely used. Moreover, the registrant may be required to prove use of a registration which is older than five years if it relies on that registration in opposition, invalidation and/or infringement proceedings.
Hasbro filed an application for the mark MONOPOLY in April 2010 (the ‘2010 application’) for a broad range of goods and services in classes 9, 16, 28 and 41. It proceeded to registration in March 2011. Hasbro already owned three earlier EU registrations for the mark MONOPOLY which covered a range of goods also covered by the 2010 application.
In 2015, Kreativni Događaji d.o.o. (‘Kreativni’), applied to invalidate the registration of the 2010 application on the ground that the application had been filed in bad faith since it was allegedly a repeat filing by Hasbro of its existing registrations. The Cancellation Division rejected the application for invalidity on the basis that the 2010 application was not a clear indication of an intention to evade the obligation to prove use, and that no evidence had been put forward by Kreativni to support its allegations of bad faith. This decision was appealed by Kreativni, and the Second Board of Appeal of the EUIPO partially annulled the Cancellation Division’s decision, declaring the registration of the 2010 application invalid in respect of some of the goods and services covered (those which had been covered in Hasbro’s earlier registrations). The Board of Appeal found that the 2010 application had been filed in bad faith in respect of those goods and services. Hasbro then appealed this decision to the GC.
The General Court’s decision
The GC has now issued its decision. We have summarised some of the key points in the decision below.
The GC held that Hasbro’s filing strategy, which sought to circumvent the rule relating to proof of use, was effectively an abuse of law. Hasbro attempted to justify the 2010 application on the basis that it had sought to protect its mark in respect of other goods and services in order to keep up with developments in technology and its expanding business. The GC upheld the Board of Appeal’s decision to invalidate the registration for the goods and services which had previously been covered, but not to invalidate the registration in relation to goods and services which were not covered by the earlier registrations.
Hasbro argued that allowing the contested decision to stand would lead to the Cancellation Division being swamped with similar cases of bad faith; that its mark was so famous that it would be fanciful to conceive that the mark had not been used in relation to games; and that its actions had not caused harm. The GC rejected the argument regarding the lack of harm caused, as this was not relevant to the assessment of bad faith. The arguments that Hasbro could have proven use and the potential swamping of the Cancellation Division were also rejected as they were irrelevant.
Hasbro also argued that the strategy of repeat filings was common and widely accepted, although the GC highlighted that this argument had not been substantiated: “the simple fact that other companies may be using a specific filing strategy does not necessarily make that strategy legal and acceptable.”
The GC upheld the Board of Appeal’s decision and ordered Hasbro to repay the costs incurred by Kreativni in the proceedings before the EUIPO.
Comment
This decision makes clear the position that attempted ‘evergreening’ of a trade mark registration in an attempt to take advantage of the grace period for non-use can result in a finding of bad faith. It establishes that a trade mark owner cannot unfairly maintain a monopoly over a certain mark for goods and services for which it has an earlier registration and in relation to which it has made no use of that mark once the grace period for non-use has expired. This makes it clear that, when filing a fresh application for a trade mark that already exists on the register owned by the applicant, careful consideration should be given to the scope of the goods and services of that new application.
The European Patent Office (EPO)’s Technical Board of Appeal 3.3.01, in recent decision T 1553/15, has provided guidance on the patentability exclusion under Article 53(a) EPC, which prescribes that inventions cannot be patented when their commercial exploitation would be contrary to “ordre public” or morality. The decision considers the balance between the suffering of animals and the benefit to mankind as set out in previous case law. In the present case, the availability of alternative compounds that act by the same mechanism was a key factor in the Board’s decision to reject the patent application.
The patentability exclusion of Article 53(a) EPC has been applied rarely, and there are only a few decisions at the EPO that set out under what conditions animal suffering would be considered as contrary to “ordre public” or morality. In seminal decision T 19/90, the Board considered the provisions of Article 53(a) EPC in the context of a transgenic animal model for cancer. The Board concluded: “The decision as to whether or not Article 53(a) EPC is a bar to patenting the present invention would seem to depend mainly on a careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention’s usefulness to mankind on the other”. In T 19/90, the Board considered that the transgenic animal model “opened up new research avenues in the field of oncology at the cost of the suffering of a limited number of animals”.
The decision in T 1553/15 concerns a pharmaceutical preparation containing an extract of nucleic acids and amino acids from rabbit skin. According to the application, the rabbit skin is obtained by sacrificing vaccinia-virus-infected rabbits, and 5ml extract solution (corresponding to 200g rabbit skin) is used to prepare a volume of around 305ml analgesic injection solution, or 50ml extract solution (corresponding to the skin of roughly 6 to 11 rabbits) is used to prepare an analgesic tablet or around 1050ml of “health food”. The resulting preparations were claimed to have analgesic, anti-allergic, anti-ulcer and sedative effects.
The appellant argued that the suffering of the rabbits was reduced as far as possible and was clearly balanced against the usefulness to mankind because there was no other way to produce the pharmaceutical preparation.
Although the Board accepted that the pharmaceutical preparation was new, it noted that it does not have different mechanisms of action or target different pathways from other widely available compounds of the prior art. The Board therefore held that there are plenty of alternative medicaments on the market that achieve the same or a comparable therapeutic effect without involving the same amount of animal suffering. This reasoning applies even if rabbit skin is the only way of producing the pharmaceutical preparation. The Board also noted that the animal suffering involved is not limited to a given number of animals needed for testing, but rather is always required when the pharmaceutical preparation is produced.
The Board therefore concluded that the suffering of animals is not commensurate with any benefits to mankind brought by the claimed invention according to the balancing test of T 19/90. This decision thus provides further insight into the factors to be considered when assessing whether inventions involving animal suffering can be balanced against the invention’s benefit to mankind and thus comply with Article 53(a) EPC.
The launch of Mathys & Squire Consulting follows the exciting acquisition of leading IP consulting firm Coller IP in 2017, when Mathys & Squire sought to develop its IP strategy and valuation service line.
Since this acquisition, the two firms have developed their relationship to a point at which their legal and commercial services fit seamlessly together, and are now in a position to bring these resources in-house, offering clients a one-stop-shop experience for all IP matters under the Mathys & Squire umbrella. From today, 14 April onwards, the existing Coller IP team will be integrated into Mathys & Squire, bringing together the expertise and experience of both businesses.
Commenting on the news, partner Alan MacDougall said: “Having an IP strategy in place is an integral part of any successful business, and we are proud to be able to offer our existing and prospective clients the full range of commercial IP advice and services they need to help their business grow under the Mathys & Squire umbrella. Being part of the innovation environment means we are always seeking to identify innovative ways of enhancing our range of services to clients and help them manage all IP aspects of their businesses.”
For further information, download our Mathys & Squire Consulting services brochure here.
Coverage of the Mathys & Squire Consulting launch has been featured in articles by Intellectual Property Magazine, World Trademark Review and The Patent Lawyer (registrations required).
Like many patent offices, the EPO does not allow applicants to claim methods for treatment of the human or animal body by surgery or therapy (Article 53(c) EPC). Such exclusions are historically founded upon the principles of free exercise of the medical profession. The EPO has, nevertheless, allowed applicants to navigate around such exclusions by protecting new and innovative medical treatments by means of purpose-limited product claims (i.e. “compound X for treatment of disease Y”), where the use to which the claim is directed determines patentability.
The claiming of non-therapeutic (e.g. cosmetic) methods (rather than purpose-limited product claims) is allowed at the EPO. However, such claims have not always been so readily accommodated under EPO practice, specifically where there is the potential for a non-therapeutic method to have an underlying (even if unintended) therapeutic benefit. Once there is considered to be an inevitable therapeutic element to any such method, the exclusions relating to methods of treatment have often prevented applicants successfully pursuing such claims at the EPO, even if there is a legitimate intent not to cover a therapeutic treatment.
However, a recent decision from the technical Boards of Appeal of the EPO – T1916/19 – suggests that the EPO may be becoming more accepting of such claims, which will be welcome news to certain innovators, particularly those operating in the cosmetic, functional food or nutraceutical fields, for instance. This article discusses the background and some of the more interesting developments in EPO case law around non-therapeutic method claims, particularly where the non-therapeutic application is accompanied by a possibility for a potential therapeutic benefit.
In general, a method may only be considered to be therapeutic at the EPO if it involves the curing of a disease or malfunction, or has a prophylactic (i.e. preventative) effect (EPO Board of Appeal Decision T 19/86 holding that both prophylactic and curative treatments of diseases are within the meaning of the word “therapy”). Historically, the EPO has allowed applicants to exclude unpatentable therapeutic treatments from a non-therapeutic method claim by means of a disclaimer. In Board of Appeal decision T 36/83, for instance, a claim directed to “Use as a cosmetic product of thenoyl peroxide” was found to be allowable – the Board considering the “cosmetic” disclaimer to be sufficient to separate the subject-matter of the claim from the medical use of thenoyl peroxide. In particular, the Board in that case commented:
“To avoid any possible conflict with the provisions of Article 52(4) EPC in a use or indication claim, it would have been possible to envisage the exclusion of the non-patentable invention within the meaning of that article by means of a disclaimer. In the present case the Board considers use of the term “cosmetic” to be sufficiently precise.”
The Board’s decision in T 36/83 was influenced by the distinction, clearly set out in the description of the application as filed, between the therapeutic and non-therapeutic methods (Reasons for the Decision point 6). It may therefore, on first sight, seem that there should be no great barrier to the protection of various non-therapeutic methods, if the applicant can rely on disclaimers to exclude any potential non-patentable methods of treatment. However, complexity arises when a method potentially provides for both therapeutic and non-therapeutic effects.
Established EPO case law (e.g. Board of Appeal decision T 290/86) has historically stipulated that non-therapeutic methods must be directed solely to a non-therapeutic effect so as not to encompass anything that falls foul of the exclusions directed towards therapeutic methods. In T 290/86, a cosmetic treatment relating to the removal of plaque from teeth was not considered allowable as this method was considered to inevitably have a therapeutic effect of preventing tooth decay. In taking this line, the Board deviated from an earlier decision – T 144/83 – which concerned a weight loss drug that was able to provide both a cosmetic weight loss effect, as well as a therapeutic cure for obesity. Whilst the Board in T 144/83 acknowledged that the two uses were “adjoined”, it was felt that this should not be allowed to work to the disadvantage of an applicant claiming protection for the cosmetic method.
One notable difference in the formulation of the claims in T 144/83 (appetite suppressant) and those of T 290/86 (plaque removal) was a reference to attaining a “cosmetically beneficial” result in the earlier case, which may have helped the Board reach the conclusion it did. Nevertheless, the use of disclaimers to carve out non-therapeutic methods has had mixed results before the EPO, where there has been the potential for therapeutic effects to accompany the non-therapeutic benefits of an invention. Where non-therapeutic and therapeutic uses have been considered to be “inseparably associated” with each other (T 1635/09), a disclaimer to the therapeutic use in a claim has either been considered to have no effect in isolating the non-therapeutic use or has been considered to mean that the whole subject-matter of the claim is in effect disclaimed so as to be completely void (T 767/12) – leading to a fundamental lack of clarity in either case.
Decision T 1635/09, for instance, concerned use of an oral contraceptive for a woman of fertile age making use of a low oestrogen dosage. Whilst it is worth noting that the EPO does not consider contraception to be a medical method, use of the low oestrogen contraceptive in question was nevertheless seen to encompass a medical treatment because the technical problem solved by the invention was one of reducing harmful side effects, as compared to a higher oestrogen dosage, rather than an increased efficacy of contraception. Thus, although the claim related to a contraceptive use which is non-therapeutic per se, the selected concentrations of active substance defined in the claim simultaneously prevent pathological secondary effects likely to arise in the case of that contraceptive use (and passages in the applicant’s own application outlining the advantageous reduction in pathological side effects were considered particularly relevant). The presence of a “non-therapeutic” disclaimer in the claim was thus considered to be insufficient to overcome an objection under Article 53(c) EPC in view of the inseparable association with an unpatentable method of treatment.
These cases demonstrate that separating therapeutic and non-therapeutic methods in a claim is not always straightforward, and this is particularly the case where the potential therapeutic benefit relates to prophylaxis (i.e. preventative treatment). In decision T 780/89, claims to the use of certain compounds for non-therapeutic immunostimulation were found not to be allowable. The Board in that case took the view that immunostimulation, or stimulation of the body’s own defences, constituted a prophylactic treatment because infection is prevented. Since the therapeutic use could not be separated from the non-therapeutic use, the inevitable therapeutic/pharmacological effect of the active substance could not be cancelled out by the use of the “non-therapeutic” disclaimer.
Nevertheless, in decision T 358/09, use of a “non-therapeutic” disclaimer was allowable and considered able to differentiate a claim directed to a non-therapeutic method of cooling cows to lure them to a milking stall from an excluded medical method of cooling cows as a treatment for overheating. The Board in that case opined that the purpose of therapy was invariably to restore the organism from a pathological state to its original condition, or to prevent pathology in the first place, whereas a non-therapeutic improvement of performance took as its starting point a “normal state”.
However, it is not clear how much consideration was given to the potential prophylactic benefit associated with the method in T 358/09. If prophylaxis is to be defined as preventing a pathological state by maintaining the “normal state”, it would seem that there is a far greater opportunity for overlap of non-therapeutic and prophylactic uses, and in some cases it may be more of challenge to carve out the non-therapeutic use in a claim. Does it, for instance, matter how much at risk a subject might be of developing a disease/pathology, when considering whether a potential prophylactic benefit may also arise as a result of a non-therapeutic method?
Recent decision T 1916/19 could therefore be a welcome development to certain innovators, since it appears to signal that there must be a real possibility of a prophylactic benefit for a healthy subject in order for this to prevent the legitimate claiming of a non-therapeutic method (i.e. for therapeutic and non-therapeutic effects to be considered genuinely “inseparable”). In this decision, the claimed invention related to a non-therapeutic method comprising the application of an anti-microbial composition to the skin for the purpose of improving body odour. Whilst this method is primarily a cosmetic treatment, the Examining Division refused the application at first instance on the basis that pathogenic bacteria would be removed as an inevitable result of carrying out the method. As a consequence, the claim scope was seen to impermissibly cover prophylaxis against infectious agents by the Examining Division, meaning the claim impermissibly embraced a method of treatment.
In following this line, the Examining Division saw therapeutic and non-therapeutic effects of the anti-microbial skin treatment as being “inextricably linked”, i.e.one would occur as an inevitable result of carrying out the other. Nevertheless, on appeal the Board in T 1916/19 ultimately reversed the decision of the Examining Division, accepting the appellant’s arguments that removal of pathogenic bacteria from a healthy person’s skin does not in fact constitute a prophylactic treatment. In reaching its decision, the Board acknowledged (point 4.6.1 of the Reasons) that:
“Undoubtedly, at least some realisations of the claimed method of providing an anti-microbial effect on skin are therapeutic in nature, e. g. in case the composition is applied to individuals suffering from a bacterial skin infection or a wound. There may be also realisations of the method which, depending on the circumstances, may be of a therapeutic/prophylactic nature or not, e. g. applying the composition to the hands…”
The Board, however, went on to state (point 4.6.2 of the Reasons) that:
“Even in case potentially pathogenic bacteria are present on its skin a healthy individual is not likely to develop a pathological state only because of the presence of such bacteria. Not disinfecting one’s armpits or feet may have unpleasant consequences, but will not, as such, lead to a pathological condition.”
Whilst it could of course be argued that the presence of a pathogen on the body poses a non-zero degree of risk in developing a pathology, the Board clearly felt this risk to be negligible, meaning that the claimed method was not “inseparably associated” or “inextricably linked” with a method of prophylaxis and the Board went on to conclude (point 4.6.3 of the Reasons):
Thus, the Board does not share the reasoning of the Examining Division that the claims only define methods in which non-therapeutic and therapeutic effects are inextricably linked.
The Board comes to the conclusion that there are realisations of the claimed methods that are of a non-therapeutic nature, others that are of a therapeutic nature, and others that may be mixed.
In this scenario, the Board considered the disclaimer in the claim limiting to non-therapeutic methods to be allowable and also capable of excluding therapeutic methods, thereby avoiding contravention of Article 53(c) EPC, and the Board remitted the case back to the Examining Division for further examination accordingly.
This case is interesting in as much as the Board acknowledged that there are certain “realisations” of the claimed method that involved therapy/prophylaxis, but it seems that the Board was satisfied that there are alternative “realisations” of the method that do not, ostensibly where the method is applied to a “healthy individual” (presumably exhibiting the “normal state” as referred to in T 358/09 (cow cooling case)).
One question that arises as result of T 1916/19 is to what extent the possibility of prophylaxis can exist before there can be considered an “inextricable link” between the claimed method and a therapeutic/prophylactic treatment. In other words, what proportion of the possible “realisations” of the claimed method need to necessarily involve a prophylactic element, for prophylaxis to be “inextricably linked” with the method? This seemingly puts a focus on the scope of the “healthy individual” to which the non-therapeutic method is applied and whether prophylaxis would be inherent having regard to that subject.
It therefore seems that further development in the case law might be required to understand the full impact of T 1916/19 on the assessment of non-therapeutic methods going forward. Nevertheless, this case offers some reassurance to applicants that the possibility of a prophylactic benefit to a claimed non-therapeutic method does not automatically preclude the allowability of the non-therapeutic method, particularly where any prophylactic benefit might be remote or would not be enjoyed by a healthy subject to which application of the non-therapeutic method is intended. This seems like a pragmatic approach to the assessment of non-therapeutic methods in order to avoid applicants being unfairly disadvantaged and so as not to stifle legitimate innovation.
Another consideration that T 1916/19 opens up is whether applicants can more freely claim a non-therapeutic method, as well as a therapeutic use in treating a specific patient group that could feasibly take a prophylactic (or other therapeutic) benefit (i.e. in certain “realisations” of the method) in the same patent application. The current state of EPO case law does support this possibility. For instance, in decision T36/83, it was stated:
“A product’s first use in a method of treatment of the human or animal body by therapy and also its use cosmetically may therefore be claimed in one and the same patent application”
However, as discussed above, such allowability would appear to be conditional on the therapeutic and non-therapeutic uses not being “inextricably linked” or “inseparably associated” with each other. It also remains to be seen whether the existence of such medical use claims in the same patent application could potentially undermine arguments that any possible prophylaxis in the case of the non-therapeutic method claimed was sufficiently remote from the “healthy individual” to which the non-therapeutic method was directed. Consequently, it is likely that in such cases careful construction of the patent application at the drafting stage will be of paramount importance in placing the application in the best possible position in order for non-therapeutic and therapeutic uses to be successfully claimed in the single application.
We at Mathys & Squire have seen several examples of such cases nevertheless making it through EPO examination. For instance, EP3316876 B1 (“Arginine Silicate Inositol for Improving Cognitive Function”) granted with the following claims:
“Inositol-stabilized arginine silicate for use in treating and/or preventing a cognitive disorder in a subject”; and
“A non-therapeutic method of improving cognitive function in a subject comprising administering inositol-stabilized arginine silicate to the subject”.
In this case, the treatment of a subject in need of cognitive enhancement in order to return to, or maintain, a “normal state”, e.g. patients suffering from dementia, can be separated from healthy individuals simply making use of a method of improving cognitive function over the normal state, meaning that both claims were found to be allowable in the same patent application.
Clearly, the specific technical facts underpinning inventions having both therapeutic and non-therapeutic elements will play a large part in whether a claim to the non-therapeutic method is allowable (and whether therefore an alternative therapeutic use may be claimed in the same patent application). Nevertheless, applicants may be encouraged that the EPO will take a more pragmatic approach to assessing such claims in the future, to the benefit of innovation.
For further information, visit our Life sciences & chemistry page, or contact the author, Michael Stott, directly.
In this article for PCR, Mathys & Squire Partner Andrew White and Technical Assistant Conor McGuinness, look at the patentability of computer games in Europe and the UK and address the common misconception that computer games are not patentable.
It was announced recently that US video game publisher, Electronic Arts has agreed to purchase UK-based video game publisher Codemasters for approximately $1.2 billion. UK-based companies are, therefore, clearly playing a leading role in video game development and publication. The UK consumer market is of similar scale. The UK gaming market is currently the sixth biggest globally with UK consumers spending an estimated £5.35 billion on game hardware and software.
As the UK video game industry looks set to only grow, developing a bespoke intellectual property (IP) strategy is of the utmost importance. Obtaining suitable IP rights provide you with the opportunity to ‘fence off’ your innovations from competitors and potentially lock-in your customers. IP rights can also significantly push up the value of your company.
Patenting computer games in Europe
In essence, a modern computer game is a piece of software describing a set of abstract game rules configured to be executed by hardware such as a PC or a games console. The European Patent Office (EPO) will grant patents to inventions that they consider provide a technical solution to technical problem, but does not recognise, among other things, programs for computers, playing games or mathematical methods, in and of themselves as inventions (Art. 52 (2),(3) EPC).
On the face of it, the ability to obtain patent protection for computer games, therefore, looks bleak.
However, the EPO will consider a computer program product an invention (and, therefore, potentially patentable) if, when it is run on a computer, it produces a further technical effect which goes beyond the ‘normal’ physical interactions between program (software) and computer (hardware) (see Headnote of T 1173/97).
So, when it comes to video games, although patents cannot be sought for the rules of a game in and of themselves, there may be patentable subject-matter in the way the rule of the game are implemented, provided there is some technical effect which goes beyond the ‘normal’ physical interactions between program and computer.
What is patentable?
As an example of what is considered to be patentable, an application claiming a game wherein the probability for a character appearing on a game map was varied was, in contrast to the previous case, found to be patentable. The probability calculation was considered to be technical because it solved the problem of how to modify the game program such that it generated encounters in a less predictable manner (see T 0012/08).
As another example, it was found that a guide display device for use in a video game system was allowable subject-matter. In more detail, the guide display device highlighting a first character so that the player could identify them and also a pass guide mark which allowed identification of a second character to whom a ball is to be passed. The pass guide mark continued to be displayed on the edge of the display area when the second character left the visible area. It was argued that the technical problem here related to conflicting technical requirements, namely: a portion of an image is desired to be displayed on a relatively large scale (e.g. zoom in); and, the display area of the screen may then be too small to show a complete zone of interest. which has to be considered in the inventive step discussion. The Board asserted that resolving the conflict by technical means implies a technical contribution (T 0928/03).
From the above review, it is clear that computer games, or at least aspects of the computer games, are patentable. Bearing in mind the size of the potential UK market, computer game developers and publishers should be actively considering the patentability of their creations, as part of a wider holistic IP review that also includes other IP rights such as trade marks, copyright and confidential information.
This article was originally published in PCR Magazine in March 2021.
A new edition of the EPO Guidelines for Examination (‘the guidelines’) came into force on 1 March 2021. Relevant to life sciences, this edition includes a new subsection detailing EPO practice with respect to the interpretation of terms relating to amino or nucleic acid sequences, as well as a new section on the examination of claims to antibodies.
Terms in relation to amino or nucleic acid sequences (F-IV, 4.24)
In the field of biotechnology, claims often include nucleotide or amino acid sequences that are defined in terms of their percentage identity or percentage similarity (amino acid sequences only) to a specified reference sequence. The new guidelines now provide written guidance on how these different terms are interpreted.
Firstly, they confirm that when an amino acid or nucleic acid sequence is defined by using percentage sequence identity language, this is determined by the number of identical residues over a defined length in a given alignment. If no algorithm or calculation method for determining the percentage of identity is defined, the broadest interpretation will be applied using any reasonable method known at the relevant filing date.
In addition, it is confirmed that amino acid sequences can also be defined by a degree of similarity, expressed as a percentage of similarity. Similarity is considered broader than identity, as it allows conservative substitutions of amino acid residues having similar physicochemical properties over a defined length of a given alignment. The percentage of similarity is determinable only if a similarity-scoring matrix is defined. If no such matrix is defined, a claim referring to a sequence displaying a percentage of similarity to a recited sequence is considered to cover any sequence fulfilling the similarity requirement as determined with any reasonable similarity-scoring matrix known at the relevant filing date.
Finally, for amino acid sequences, the guidelines now state that if a percentage of homology is used by the applicant as the only feature to distinguish the subject matter of a claim from the prior art, its use is objected to under Article 84 EPC unless the determination or calculation of the percentage of homology is clearly defined in the application as filed. However, for nucleic acid sequences, homology percentage and identity percentage are usually considered to have the same meaning.
Antibodies (G-II, 5.6)
A new section, summarising EPO practice and case law on how an antibody may be defined (e.g. by sequence, functional feature, or epitope), and the inventive step requirement for new antibodies binding to a known antigen, has also been included in the 2021 guidelines.
Claiming antibodies
They also outline how conventional antibodies, recombinant antibody derivatives (such as antibody fragments, bispecific antibodies or antibody fusions) or new antibody formats (such as heavy-chain-only antibodies) can be defined in a claim by reference to one or more of the following features:
(a) their own structure (amino acid sequences);
(b) nucleic acid sequences encoding the antibody;
(c) reference to the target antigen;
(d) target antigen and further functional features;
(e) functional and structural features;
(f) the production process;
(g) the epitope; and
(h) the hybridoma producing the antibody.
Definition by structure of the antibody
Conventional antibodies defined by their structure are to be defined by at least six complementary-determining regions (CDRs). CDRs, when not defined by their specific sequence, must be defined according to a numbering scheme, for example, chosen from that of Kabat, Chothia or IMGT. If the claim has fewer than six, it will be objected to under Article 84 EPC because it lacks an essential technical feature. An exception applies only if it is experimentally shown that one or more of the six CDRs do not interact with the target epitope or if it concerns a specific antibody format allowing for epitope recognition by fewer CDRs (such as the heavy-chain-only antibodies which have an antigen-binding region with only three CDRs).
Definition by reference to the target antigen
An antibody can be functionally defined by the antigen it binds to, as long as the antigen is clearly defined in the claims. If the antigen is defined by a protein sequence, no sequence variability and no open language (e.g. ‘comprising’) can be used in the definition of the antigen. Examples of accepted antigen-defined antibody claim wording are:
(i) antibody binding to X;
(ii) anti-X antibody;
(iii) antibody reacting with X;
(iv) antibody specific for antigen X; or
(v) antibody binding to antigen X consisting of the sequence defined by SEQ ID NO:Y.
Definition by target antigen and further functional features
Antibody claims can be further characterised by functional features defining further properties of the antibodies; for example, the binding affinity, neutralising properties, induction of apoptosis, internalisation of receptors, inhibition or activation of receptors. The burden of proof of novelty resides with the applicant and it has to be carefully assessed whether the application provides an enabling disclosure across the whole scope claimed and whether the functional definition allows the skilled person to clearly determine the limits of the claim.
Definition by functional and structural features
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.
Definition by the production process
Antibodies can be defined by the process of their production; for example, either by the immunisation protocol of a non-human animal with a well-characterised antigen or by the specific cell line used to produce them. However, if the process is based on an antigen comprising a sequence less than 100% identical to a defined sequence, it does not fulfil the requirements of Article 84 EPC because the use of variants renders the scope of the antibodies obtained by the immunisation process unclear.
Definition by the epitope
An antibody may be defined by its epitope. If the epitope is a ‘linear epitope’, whereby the antibody interacts with continuous amino acids on the antigen, it needs to be defined as a clearly limited fragment using closed wording, such as ‘an epitope consisting of’. If the epitope is ‘non-linear’ or ‘discontinuous’, whereby the antibody interacts with multiple, distinct segments from the primary amino-acid sequence of the antigen, the specific amino acid residues of the epitope need to be clearly identified.
Inventive step
The new guidelines now state that a novel, further antibody binding to a known antigen does not involve an inventive step unless a surprising technical effect is shown by the application, such as an improved affinity, an improved therapeutic activity, a reduced toxicity or immunogenicity, an unexpected species cross-reactivity, or a new type of antibody format with proven binding activity.
If inventive step relies on an improved property in comparison to the antibodies of the prior art (which must be enabled), the main characteristics of the method for determining the property must also be indicated in the claim or by reference to the description. Notably, in the case of binding affinity, the structural requirements for conventional antibodies inherently reflecting this affinity must typically comprise the six CDRs and the framework regions because the framework regions also can influence the affinity.
An inventive step can also be acknowledged if the application overcomes technical difficulties in producing or manufacturing the claimed antibodies.
A version of this article was published by Life Sciences IP Review in April 2021.
Further to our article in July 2020 on the EPO Enlarged Board of Appeal’s hearing in G1/19, the Enlarged Board has now published its long-awaited decision relating to the patentability of computer-implemented simulations. While the decision specifically relates to computer-implemented simulations, it is likely to have implications for the assessment of technicality and inventive step across the whole field of computer-implemented inventions.
In short, the conclusions are that:
- in principle, computer simulations can be patentable (this was generally as expected/hoped);
- the mere fact that a simulation is based on technical principles underlying the simulated system is not enough to confer patentability (instead the decision seems to indicate that the intended technical purpose resulting in the alleged technical effect needs to at least be implied in the claims); and
- whether or not a design process is involved is irrelevant (as expected).
While the decision appears to indicate that computer simulations in principle may be patentable, it also indicates that in the Enlarged Board’s view most computer-implemented simulations are unlikely to be patentable as ‘most “simulations as such” may have few technical effects as far as input and output are concerned’, unless the intended technical purpose of the simulation giving rise to the alleged technical effect is at least implied in the claims. This appears to be in disagreement with T1227/05, and seems to narrow the scope of patentability of such computer-implemented simulations in future.
The decision in detail
As a re-cap, the Enlarged Board was posed three questions:
1. In the assessment of inventive step, can the computer-implemented simulation of a technical system or process solve a technical problem by producing a technical effect which goes beyond the simulation’s implementation on a computer, if the computer-implemented simulation is claimed as such?
2. [2A] If the answer to the first question is yes, what are the relevant criteria for assessing whether a computer-implemented simulation claimed as such solves a technical problem? [2B] In particular, is it a sufficient condition that the simulation is based, at least in part, on technical principles underlying the simulated system or process?
3. What are the answers to the first and second questions if the computer-implemented simulation is claimed as part of a design process, in particular for verifying a design?
The Enlarged Board slightly re-framed question 2 to only answer [2B] (holding part 2A as inadmissible) as follows:
[2B]: “For the assessment of whether a computer-implemented simulation claimed as such solves a technical problem, is it a sufficient condition that the simulation is based, at least in part, on technical principles underlying the simulated system or process?”
Answer to question 1: Patentability of simulations per se
“A computer-implemented simulation of a technical system or process that is claimed as such can, for the purpose of assessing inventive step, solve a technical problem by producing a technical effect going beyond the simulation’s implementation on a computer”.
The Enlarged Board held that computer-implemented simulations are, in principle, patentable, noting that “no group of computer-implemented inventions can a priori be excluded from patent protection.” The Board further noted that there is no statement in the EPC that a “simulation as such” is excluded as a “non-invention” in the same way that “a computer program as such” is. The Enlarged Board clarified that they understand a “simulation as such” “to be a simulation process comprising only numerical input and output (irrespective of whether such numerical input/output is based on physical parameters), i.e. without interaction with external physical reality”, distinguishing these from physical simulations such as wind tunnel experiments or processes which include the measurement of physical values, which are not simulations as such.
However, when discussing the patentability of such computer-implemented simulations, the Enlarged Board noted that “whether a simulation can solve a technical problem by producing a technical effect which goes beyond the simulation’s implementation, can be understood only in the context of the COMVIK approach” (reasons 49) which is part of “case law developed over decades” (reasons 65). When applying this, the Board noted that it is not decisive whether the simulated system or process is technical or not. Rather, it is relevant whether the simulation of the system or process contributes to the solution of a technical problem. It was specifically noted that computer-implemented simulations should not be treated differently when answering this question.
In order to assess whether the simulation contributes to the solution of a technical problem, under the EPO’s problem-solution approach one must look at the technical effect achieved by the invention, and that in the context of computer-implemented inventions, these must be technical effects that go beyond the simulation’s implementation on a computer – or in other words “any further technical effect going beyond the normal physical (electrical) interactions between the program and the computer on which the simulation is run”. The Enlarged Board further clarified that the technical effect going beyond the simulation’s implementation can be rephrased as a “technical effect going beyond the simulation’s straightforward or unspecified implementation on a standard computer system”.
In so doing, the Enlarged Board touched on the ideas of a “virtual technical effect”, a “potential technical effect” and a “tangible technical effect”, noting that they “fully support the view that a tangible effect is not a requirement under the EPC” and that potential technical effects may be considered if the data resulting from a claimed process is specifically adapted for the purpose of its intended technical use. However, the Enlarged Board noted that “either the technical effect that would result from the intended use of the data could be considered “implied” by the claim, or the intended use of the data (i.e. the use in connection with a technical device) could be considered to extend across substantially the whole scope of the claimed data processing method.” (reasons 94). The Board considered these potential technical effects therefore to necessarily become real technical effects when put to their intended use.
On a positive note the Enlarged Board did indicate that computer-implemented simulations “may contribute to technicality if they are, for example, a reason for adapting the computer or the way in which the computer operates, or if they contribute to technical effects relating to the results of the simulation” and that “the accuracy of a simulation is a factor that may have an influence on the technical effect going beyond the simulation’s implementation and may therefore be taking into consideration in the assessment under Article 56 EPC.”. However, in contrast to this, the Enlarged Board noted that “all a simulation does is provide information about the model underlying it” and that: “it would appear that most “simulations as such” may have few technical effects as far as input and output (which consist of data in “simulations as such”) are concerned.
Answer to question 2: Technical principles
“For that assessment it is not a sufficient condition that the simulation is based, in whole or in part, on technical principles underlying the simulated system or process”.
The Enlarged Board held that it is neither sufficient nor necessary that a numerical simulation is based on technical principles that underlie the simulated system or process, noting at reasons 88 that “the Enlarged Board does not see a need to require a direct link with (external) physical reality in every case” … “While a direct link with physical reality, based on features that per se are technical and/or non-technical, is in most cases sufficient to establish technicality, it cannot be a necessary condition, if only because the notion of technicality needs to remain open” (emphasis added). The Enlarged Board went on to confirm at reasons 141 that “were it sufficient … for the simulation to be based on technical principles, then computer-implemented simulations would hold a privileged position within the wider group of computer-implemented inventions without there being any legal basis for such a privilege”.
When discussing the potential patentability of such simulations in terms of their technical contribution, the Enlarged Board held at reasons 119 that: “It may be that some simulations of technical system do not contribute to inventive step. Conversely, following the COMVIK approach, it is possible to envisage simulations of non-technical system (such as weather simulations) that do contribute to inventive step”. Later at reasons 131, the Board indicated that use of weather forecast data (obtained from a simulation or modelling system) could contribute to inventive step “if the weather forecasting data is used, for example, to automatically open or close window shutters on a building.” However, while the Board stated that technical principles underlying the simulated system or process are not a sufficient condition, it indicated with reference to T625/11 (relating to nuclear fuel rods), which “implied physically controlling the real nuclear reactor underlying the simulation”, that the technical effects or potential uses of the computer-implemented simulation which may give rise to the alleged technical effects need to at least be implied by the claims, holding that “when the COMVIK approach is applied to simulations, the underlying models form boundaries, which may be technical or non-technical … they may contribute to technicality if … they form the basis for a further technical use of the outcomes of the simulation (e.g. a use having an impact on physical reality). In order to avoid patent protection being granted to non-patentable subject-matter, such further use has to be at least implicitly specified in the claim” (emphasis added).
At reasons 124, the Board again noted that: “Only those technical effects that are at least implied in the claims should be considered in the assessment of inventive step. If the claimed process results in a set of numerical values, it depends on the further use of such data whether a resulting technical effect can be considered in the assessment. If such further use is not, at least implicitly, specified in the claim, it will be disregarded for this purpose”.
In an apparent disagreement with the oft-cited decision of T1227/05 (discussed in our earlier article) the Board stated at reasons 128: “in the Enlarged Board’s view, calculated numerical data reflecting the physical behaviour of a system modelled in a computer usually cannot establish the technical character of an invention in accordance with the COMVIK approach, even if the calculated behaviour adequately reflects the behaviour of a real system underlying the system. Only in exceptional cases may such calculated effects be considered implied technical effects (for example, if the potential use of such data is limited to technical purposes)”.
Question 3: The design process
“The answers to the first and second questions are no different if the computer-implemented simulation is claimed as part of a design process, in particular for verifying a design.”
On the issue of whether a design process affects the patentability of simulation inventions, the Board commented that “a design process is normally a cognitive exercise. However, it certainly cannot be ruled out that in future case[s] there may be steps within a design process involving simulations which contribute to the technical character of the invention”. So it seems that at present the EPO would be minded to consider that a design process, if incorporated into a simulation claim, wouldn’t improve the prospects for patentability – but that they can’t say for definite that this may not change in future, and so leave the door open on this for now.
Conclusion
In summary, this rather lengthy and detailed decision seems more negative than positive. In positive terms it holds that computer-implemented simulations are patentable and should be treated no differently than any other computer-implemented inventions. However, the use of features relating to the simulation for supporting inventive step under the COMVIK approach now seems somewhat restricted (compared to that defined in previous case law such as T 1227/05) to cases where there is a need to adapt the computer or its functioning or if there is a further technical use of the outcomes of the simulation, with such further use having to be at least implicitly specified in the claim.
At the heart of many of these complex decisions lies the tricky question of what is and what is not “technical” under European patent law. Whilst the Enlarged Board had an opportunity to give guidance on this specific issue, they refrained from doing so, noting that ‘the term “technical” must remain open, not least in anticipation of potential new developments’. The Board did, however, discuss differences between computer-implemented simulations of a technical system or process and that of a natural process (such as the weather), noting that “a technical system or process implies that an object is created or a process is run with some purpose based on human creativity” – perhaps giving us some closer definition of what the term “technical” might mean.
In this article for Intellectual Property Magazine, Mathys & Squire associate Max Thoma and technical assistant Oliver Parish consider the importance of drawings in determining the scope of a registered design.
In this recent design case – Rothy’s Inc v Giesswein Walkwaren AG [2020] EWHC 3391 (IPEC) – before the Intellectual Property Enterprise Court (IPEC), the judge decided that the Austrian company Giesswein Walkwaren AG’s “Pointy Flat” shoe infringed a Registered Community Design (RCD) held by the California-based fashion company Rothy’s Inc.
Background
Rothy’s claimed that Giesswein’s knitted “Pointy Flat” shoe (pictured below) infringed its RCD (also pictured below) as well as its Unregistered Community Design (UCD) rights subsisting in its own knitted “Pointed Loafer” shoe. Both of the “Pointy Flat” and “Pointy Loafer” shoes were made of a knitted fabric.
Giesswein counterclaimed for invalidity of Rothy’s RCD on the basis of two prior designs, the “Allegra K” and the “Bonnibel” shoes (pictured below). Both the “Allegra K” and the “Bonnibel” were made from suede (or variants thereof).
The Registered Community Design
The pivotal issue in dispute was how to interpret the fine black lines shown on the shoe upper in Rothy’s RCD.
The defendant, Giesswein, argued that the black lines merely showed that the shoe is a three-dimensional shape, and that if the black lines did indicate any surface design feature, that feature was a textured appearance generally (including any knitted, woven or animal hide materials, but excluding smooth textures) rather than any specific material.
The claimant, Rothy’s, encouraged the Judge to zoom in on the high-resolution digital images of the RCD which show that the black lines radiate in a circular pattern at the heel and toe of the shoe. Such a pattern, it was argued, is specifically indicative of a knitted fabric rather than a textured appearance more generally.
The judge agreed with the claimant, noting that certain aspects of the patterning of the lines were inconsistent with a woven fabric or unprinted animal hide such as nubuck or suede. The lines were therefore held to indicate a knitted fabric (such as that present in the “Pointy Flat” shoe), rather than any of the alternative textures suggested by the defendant.
The judge went on to find that, whilst knitted fabrics were known for shoe uppers on gym shoes and sneakers, the notional informed user would not be aware that they had been applied to the types of shoe in question. The use of a knitted fabric on such a shoe would thus stand out to the informed user as a significant departure from existing designs.
As such, the judge decided that the “Allegra K” and “Bonnibel” suede shoes of the prior art would produce a different overall impression on the informed user than the knitted shoe of the RCD. For this reason, the RCD was found to be valid.
Similarly, the judge decided that the knitted shoe of the RCD would produce the same overall impression on the informed user as Giesswein’s knitted “Pointy Flat” shoe. Giesswein’s “Pointy Flat” shoe was therefore found to infringe the RCD.
The Unregistered Community Design
For similar reasons, it was decided that the UCD subsisting in Rothy’s own knitted “Pointed Loafer” shoe produced the same overall impression on the informed user as Giesswein’s knitted “Pointy Flat” shoe, and a different overall impression than the suede shoes of the prior art.
However, on the question of whether Giesswein’s “Pointy Flat” shoe was copied from Rothy’s “Pointed Loafer” – an essential criterion for establishing infringement of the UCD – the judge decided that the designers of Giesswein’s shoe had sufficiently explained how the shoe was independently designed. Therefore, Rothy’s UCD was found to be valid but not infringed.
Practical guidance
Rothy’s succeeded in their registered design claim due to their carefully prepared design drawings, which effectively gave them IP protection over the material and texture of their shoes.
This decision serves as a reminder, further to PMS International Group Plc v Magmatic Limited (i.e. the “Trunki” case), as to the importance of the drawings of a registered design. Care should be taken in the preparation of suitable drawings for a registered design application so as to optimise the scope of protection provided. Creative design drawings should also be considered to protect important features. This decision also shows that that a Court may ‘zoom in’ to design drawings to look at subtle details – emphasising the importance of high-resolution images showing such details.
Lastly, while this decision relates to the infringement and validity of Community (EU) registered and unregistered designs (which, following the end of the Brexit transition period, would no longer extend to the UK), it is still relevant under UK practice (as are other decisions relating to EU design law). This because the UK legal provisions governing the infringement and validity of UK registered and unregistered designs are very similar to those that related to EU registered and unregistered designs.
This article was originally published in Intellectual Property Magazine in March 2021.
Women throughout history continue to make their mark creating innovations and discoveries that impact our lives today. To celebrate International Women’s Day 2021, we reflect on inspiring female inventors in each decade since 1910 – when Mathys & Squire was first founded – to demonstrate the significant value that realising new ideas and inventions can bring.
1910s
- 1914: Florence Parpart
Parpart invented and filed a patent for the first modern electric refrigerator, which she initially marketed and sold to companies in America. The refrigerator represented a revolution for conserving food and is today an integral appliance in any kitchen.
1920s
- 1921: Ida Hyde
Hyde created one of the earliest models of an intracellular micropipette electrode, which can be used to stimulate and monitor individual cells. This technology is still widely used in science laboratories today.
1930s
- 1935: Katharine Blodgett
An American physicist and chemist, Blodgett is known for her work on surface chemistry and invented a revolutionary ‘invisible’, or non-reflective, glass coating, which is used in making camera lenses, microscopes and eyeglasses.
1940s
- 1941: Hedy LaMarr
Although primarily an actress, during World War II LaMarr created a frequency-hopping communication system, which could guide torpedoes without being detected. Her work paved the way for the introduction of Wi-Fi, GPS and Bluetooth to the modern world.
1950s
- 1957: Gertrude Belle Elion
Elion helped to develop numerous life-saving drugs for the treatment of diseases such as malaria, herpes, cancer and AIDS. Along with George Herbert Hitchings, she invented the first immunosuppressive drug, Azathioprine which was initially used for chemotherapy patients, and eventually for organ transplants. She was awarded the 1988 Nobel Prize for Physiology or Medicine.
1960s
- 1965: Stephanie Kwolek
In 1965, Kwolek discovered that polyamide molecules can be manipulated at low temperatures to form incredibly strong and stiff materials, which is used to make Kevlar®. Originally Kevlar® was used to create lightweight, strong tyres for vehicles, but today is best known for body armour, such as bulletproof vests.
1970s
- 1971: Evelyn Berezin
An American computer designer, Berezin created the world’s first computerised word processor and founded her own company to bring her inventions to market. The first model was the size of a small refrigerator. She also developed computer-controlled systems for airline reservations.
1980s
- 1984: Rachel Zimmerman
At the age of just 12, Zimmerman invented a device called the ‘Blissymbol Printer’ that allowed people with speech disabilities to communicate non-verbally – using symbols on a touchpad translated to written language. Her invention has been recognised globally and she has received several awards for her achievements.
1990s
- 1991: Ann Tsukamoto
Tsukamoto is an inventor and stem cell researcher who made a significant breakthrough in cancer research. She co-patented a process for identifying and isolating human stem cells found in bone marrow, which is today used to treat blood cancer, saving hundreds of thousands of lives.
2000s
- 2009: Pratibha Gai
Gai created the in-situ atomic-resolution environmental transmission electron microscope (ETEM), which allows for visualisation of chemical reactions at the atomic scale. Her invention has been used worldwide by microscope manufacturers, chemical companies and researchers.
2010s
- 2012: Deepika Kurup
Kurup is a clean water advocate and as a teenager, after seeing children in India drinking dirty water, she invented a water purification system (photocatalytic composite material) that removes 100% of faecal coliform bacteria from contaminated water using solar energy.
2020s
- 2020: Sarah Gilbert & Catherine Green
Gilbert & Green are two of the leading scientists behind the Oxford/Astra Zeneca Coronavirus vaccine developed in record time amidst the unprecedented COVID-19 pandemic, saving lives and bringing hope to the entire world.
The inventors listed above are just a small selection of the vast number of women who have developed and, in some instances, patented innovative products that revolutionise the world we live in. At Mathys & Squire, we are privileged to work with innovators across a range of highly dynamic sectors and celebrate their significant technical contributions not just on International Women’s Day, but every day.
World Trademark Review has featured Mathys & Squire in its latest edition of the WTR 1000 directory, highlighting the firm’s “professional, responsive and wide-ranging service” and its ‘unimpeachable record in protecting and enforcing the cornerstone brands of top UK and international companies’. Trade mark partners Margaret Arnott and Gary Johnston have also maintained their statuses as recommended individuals in the 2021 directory.
Now in its eleventh year, the WTR 1000 shines a spotlight on the firms and individuals that are deemed outstanding in this critical area of trade mark practice. The WTR 1000 remains the only standalone publication to recommend individual practitioners and their firms exclusively in the trade mark field, and identifies the leading players in over 80 key jurisdictions globally. Mathys & Squire has been recommended for its outstanding work in the trade mark field, specifically in the ‘United Kingdom: England’ jurisdiction, under the ‘Firms: trade mark attorneys’ category.
In this latest edition, published on 15 February 2021, partners Margaret Arnott (recommended in the categories of ‘Enforcement & Litigation’ and ‘Prosecution & Strategy’), and Gary Johnston (recommended in the category of ‘Prosecution & Strategy’), who co-head the Mathys & Squire trade mark team, have received the following feedback:
For more information and to see the full WTR 1000 rankings, please click here.
