Patents and Licenses (02, 2019) - "Antibody patents: Claims expressing essence of invention"

Antibodies have a great potential, being a versatile, understandable and a very convenient building set of direct acting drugs. Therefore, the correct characterization of antibody-related inventions in claims is crucial for stimulating progress in relevant areas of medicine as considered by Sojuzpatent LLC key specialists M. V. Kuptsova and T. N. Badaeva,

Keywords: antibody, Fc, amino acid sequence, patent, claims, essential feature, problem to be solved, contribution to the state of the art.

Introduction

The particularities of antibody-related characteristics in claims are given unreasonably little attention in the Russian professional literature. Therefore, the article by E. B. Gavrilova and T. S. Babakova “Characterization of an Antibody as a Technical Solution” and the authors’ appeal for discussion are good news. We decided to respond to this appeal, and we hope that other specialists working with similar subject matters will also express their opinion on the issues raised in this article.

First, we turn to the inventive thinking development in the field of antibodies and related economic aspects.

Some history and economy

In 1889, Paul Ehrlich, conducting experiments on rabbits, realized that certain protein molecules were overproduced during immunization. Passive immunization of a human was carried out in 1891. In 1959, G. M. Edelman and R. R. Porter independently clarified almost completely the most significant issues concerning the nature and function of antibodies and won the Nobel Prize in 1972. In 1975, G. J. F. Köhler and C. Milstein presented a method for producing monoclonal antibodies to the world; in 1977, A. F. Williams showed that a monoclonal antibody can be obtained for any molecule of interest. Recent discoveries have created a fertile ground for application of recombinant DNA technologies already known for producing antibodies. In 1989, US Patent # 4816567 with a priority from 1983 on the genetic engineering method for producing antibodies was granted to Genentech, Inc.

The recombinant DNA method, coupled with the impressive ability of the immune system to generate a specific antibody to essentially any substance, making negligible changes to its “slingshot structure,” is a universal, understandable and very convenient building set. The possibilities of researchers working with it are essentially limited only by their imagination and market needs.

As for the latter, according to the Grand View Research, in 2016, the global market for research in the field of antibodies was estimated at $ 2.52 billion. At the same time, by 2025 the expected market growth will be 6%. The amount of funds invested in the development of innovative products is impressive. For example, in 2016, Novartis invested $ 9.0 billion, and Pfizer invested $ 7.9 billion. The growing cancer incidence and other chronic diseases incidence contribute to the growth of investments. For example, over the past 10 years, the annual number of first diagnosed malignant neoplasms cases in Russia increased by 120 thousand.

Four of the five drugs with the highest sales in the world are antibody-based drugs. Herewith the commercial success of therapeutic antibodies is generally associated with their higher efficiency and with fewer side effects as compared to those of chemically synthesized drugs.

However, the financial risk associated with the development of new products or the creation of new knowledge has always been and remains great. Therefore, companies investing in the creation of new antibodies must have a definite guarantee of financial return from investments in R&D in the form of know-how and patents, which are given the greatest preference, since antibodies can be reproduced by reverse engineering. For example, some companies offer to determine a sequence of antibodies for $ 840 for six days.

Thus, patent protection of intellectual property in the antibodies-related development area in the territory of the Russian Federation is of paramount importance.

Technical solutions embodied in antibodies

In our opinion, essentially different technical solutions characterized by sets of their inherent essential features can be embodied in antibodies. Meanwhile, depending on the problems to be solved and the effects to be achieved, such solutions can be divided into at least five groups, and own essential features can be revealed for each of them.

The first group is related to identifying a new useful target. The unlimited examples of such targets include a substance involved in the occurrence/development of a disease, markers of biological structures and biological processes. Detecting such targets requires an enormous amount of work with minimum guarantees of success and a return of investments. While obtaining antibodies to this new target will normally cause no further problems. Therefore, the essential features of the first group solutions adequately reflecting their essence and contribution to the art will be features of the antigen to be bond, for example, its structure and location. The essential features can also include the effect provided by binding of the antibody to the target.

The second group includes the inventions based on identifying the optimal epitope on the target. In particular, sometimes it is not insufficient to have knowledge of antigen for obtaining its specific antibodies. For example, the target antigen structure can almost repeat the structure of another substance, affecting of which is highly undesirable. In these cases, in order to obtain antibodies of the desired specificity, a work is required for finding the optimal epitope, for example, one that distinguishes the antigen of interest from non-target substances. When compared with the search for a new target, the work of identifying the optimal epitope on the target requires less effort, and the success and return of the investments can be more or less guaranteed. Therefore, the adequate essential features of such inventions of the second group are the features of the identified optimal epitope.

The third group includes the inventions related to the production of new, more effective antibodies against a known target antigen or epitope. The development of such inventions is usually a painstaking and rather routine work. Therefore, with a certain amount of time and money spent, success is almost guaranteed. The essential features of such solutions may be the sequences of antigen-binding sites, namely the CDRs, since the effectiveness of antibodies largely depends on the configuration of such sites. Generating cell line (hybridoma) can also characterize antibodies that include these technical solutions.

The fourth group includes the inventions related to the production of new antibody derivatives. Here note that, although conventional four-chain antibodies are highly specific, some of their properties, such as large size, often bifunctionality and immunogenicity, create great difficulties in practice. Therefore, there is a need to obtain derivatives of molecules that differ from traditional antibodies by a number of properties with the exception of antigen specificity. Obtaining such derivatives requires the discovery of new functional relationships between the individual structural units of the antibody and its behavior in the body. This is a difficult task, but in case of success, the invention receives the widest application, since it allows you to create "superbinding" agents with new properties to a variety of targets. The difference between antibody derivatives and conventional antibodies will be the structure and/or arrangement of the parts that are not antigen-binding. Therefore, the essential features of such inventions are the compilation and mutual arrangement of the functional parts of the antibody.

The fifth group includes the inventions related to the creation of antibody derivatives. Their development is due to the need to change the properties of antibodies or their known derivatives, such as half-life, penetration power, etc., including properties that lead to the occurrence of adverse reactions during therapeutic use in the desired direction. For this purpose, minor changes are made to the conservative regions of already existing molecules, which, as a rule, do not affect the CDRs. The conservatism of regions needed to be changed makes the probability of success small, since making changes to it often disrupts the functioning of the molecule. However, if the desired beneficial change is detected, then, as a rule, a variety of antibodies to different antigens or their derivatives can be improved. Therefore, such inventions are of great social interest. The essential features of such inventions are the specific variation in the structure, location and characteristic of the improvement provided thereby.

Here note that the diversity of inventions in the field of antibodies is constantly increasing. Therefore, there is an actual problem of identifying the adequate antibody features in claims.

Antigen features in claims, regulatory requirements and world practice

As it is known, Russian and Eurasian patents are valid in the Russian Federation. Further, we focus on the regulatory documents of the Russian Federation.

According to item 53(3) of the Requirements to an application filed for granting a patent of an invention (hereinafter referred to as the Requirements), claims must clearly express the essence of an invention and contain a set of essential features providing achievement of the technical result. Thus, claims should comprise only essential features of an invention rather than a template set of characteristics inherent in one or another subject matter.

Indeed, the regulatory documents comprise a number of formal requirements to characterization of the subject matter in claims. However, they shall not become the “Procrustean bed” into which the invention is squeezed, cutting off undesirable essential parts and pulling insignificant ones to the forefront. On the contrary, all these requirements are designed to help describe the created invention and provide an adequate (correct) scope of protection.

The complex structure of antibodies can be attributed to both polypeptides and protein structures. Accordingly, taking into account items 53(13) and 53(20) of the Requirements, the following its optional characterizations in claims are possible:

• characterization by the complete amino acid sequence;
• characterization by the part of the amino acid sequence;
• characterization by structural design features;
• characterization by other properties and, possibly, further by physicochemical features if they distinguish it from known antibodies.

Regarding the latter optional characterization, there are some ambiguities. Thus, item 10.8.3 of the Administrative Regulations contained a similar condition for polypeptide characterization in claims: "physicochemical and other features that allow distinguishing the given compound from others."

However, according to the interpretation of this condition in item 10.3 of the Guide for substantive examining applications for inventions (hereinafter referred to as the Guide), the indication of physicochemical properties was not mandatory but actually it is allowed to characterize a polypeptide by other features only.

It is still unknown how exactly the similar provision of the Requirements will be interpreted in the future. In our opinion, in the case of polypeptides, physicochemical features are often inessential and rarely distinguishing. Therefore, as we see, these features should not be mentioned separately in the regulatory documents among the features that can be used to characterize a polypeptide in claims.

Refer to the experience of foreign patent offices. First, note that none of relevant regulatory documents comprises a closed list of features that could characterize a polypeptide or antibody in claims (see, for example, chapter V of the European Patent Convention on patenting of biotechnological inventions). As it follows from the processing practice of applications at the European Patent Office, an antibody can be characterized by a target to which it is directed, features of an epitope on a target, a functional property (for example, determining a new therapeutic use), a sequence, a hybridoma or other method of preparation.

In our opinion, the antibody features prescribed in the regulatory documents of the Russian Federation to be used in claims in general allow implementing the antibody characterization approaches that are practiced by other patent offices and are due to the current art development. This fact should inspire optimism in light that the prior art is needed to be taken into account while estimating sufficiency of one or another characterization of an invention, given that the prior art is defined equally in most patent offices and includes any information that has become publicly available in the world before the priority date of the invention.

In our opinion, a positive feature of the existing regulatory documents of the Russian Federation, is that there is no close list of features that can be used for characterization of polypeptides, including antibodies in claims. As we understand, there is an indisputable recognizable fact that it is impossible to predict in advance the course of inventive thinking and to determine the essential features that can characterize really pioneering future inventions in the field of polypeptides and, in particular, antibodies.

For the future development in this field, it is very important to retain the existing ability to characterize antibodies by other features.

“Problematic” variants of antibody characterization

Indeed, uniform characterization of inventions (for example, characterization of inventions in the field of antibodies only by amino acid sequences of CDRs) is always more clear and convenient. Therefore, we are aware that our opinion that antibodies can and should be characterized by different features, depending on the essence of the inventions embodied in them, may be unshared. We also realize that there may be concerns about certain antibody characterizations that are often found in international applications filed under the PCT procedure. Refer to the “alarming” characterizations of antibodies.

Well, an antibody produced by hybridoma which is deposited (the international depositary abbreviation and deposit number are indicated). Such characteristics may raise questions as they reveal neither the antibody features nor those ones of the producing hybridoma, in particular, the features of the latter are replaced by a reference to the physical location of this cell line, which is inaccessible, for example, for testing by a patent examiner.

To begin with, each individual hybridoma synthesizes an antibody of a certain specificity with the same unique structure, being capable of unlimited growth in an artificial medium and reproducible only by cloning. By obtaining an antibody from a hybridoma, one can be sure that it is unique and has not been obtained by anyone else. Therefore, if the hybridoma is deposited, and the properties of the antibody are verified and confirmed, it can be said that the applicant has given all the comprehensive information about the antibody, which allows it to be obtained, used and distinguished from others.

The article by E. B. Gavrilova and T. S. Babakova described a case when different groups of researchers announced the production of hybridomas producing the same antibody. However, such a case is the result of unfair competition rather than the evidence that the above is incorrect. For example, in the case under discussion, the possible unfairness of one of the research teams is evidenced by the fact that the same hybridoma was obtained twice (which is unlikely by itself), and that it was obtained almost at the same time (which is almost impossible). Therefore, this case was successfully resolved.

What guarantees does the deposition of a hybridoma give? First of all, it is a guarantee of reproducibility. However, this is a guarantee not only of the possibility of obtaining an antibody from this hybridoma, but also of that the hybridoma produces it.

Thus, in accordance with the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, the viability of the deposited hybridoma, as well as its uncontaminated status, should be maintained by the International Depositary. In particular, item 9.1 of Rule 9 of the Guide to the Budapest Treaty stipulates that a deposited microorganism should be stored so that it remains viable and uncontaminated for at least 30 years from the date of deposit. Regarding the latter provision, it should be clarified that the loss of capacity of producing antibodies or an antibody with the original structure clearly indicates that the initial deposited hybridoma is contaminated or completely replaced by  degenerate cells not being the hybridoma.

Though neither the Guide nor the Budapest Treaty regulates conditions of storage of deposited material in depositories, nevertheless, the said provision of item 9.1 in Rule 9 of the Guide imposes certain obligations on international depositaries, whereby said conditions must safety retain viability and microbial non-contamination. For example, this is ensured by the fact that a depository stores a frozen or lyophilized biological material that ensures its safety for many years.

The particular storage conditions are determined by properties of the material and, on the one hand, cannot be described for all types of microorganisms and hybridomas that can be deposited, and, on the other hand, storage conditions for each specific deposited material are communicated by  persons making a deposit to an international depositary as prescribed under item 6.1 in Rule 6 of the Guides to the Budapest Treaty. These persons should be certainly interested in the safety of the deposited material, since the absence of the deposit of a patented hybridoma may lead to revocation of a patent.

Therefore, there is no doubt that a deposited hybridoma retains the ability to produce the claimed antibody for the entire term of a patent since the opposite would indicate the illegitimacy of the Budapest Treaty itself and/or the inability of international depositaries to fulfill the obligations under item 9.1 of Rule of the Guides to the Budapest Treaty.

An antibody that binds to antigen X/epitope of sequence Z

 The main objections to this feature relate to reproducibility of such an invention, as well as to distinguishing an antibody comprising this feature from others when evaluating patentability of an invention.

First of all, remind that patent offices of different countries accept this feature if an antigen X (or epitope Z, which is a specific place on the antigen) is disclosed, i.e. the given characterization is sufficient to obtain an antibody. Indeed, as was noted in the historical section, methods for producing antibodies to existing antigens are already well known and developed. For example, a single-step immunization of a mammal with an antigen can result in producing numerous antibodies having required antigen specificity and different CDRs, since this is the basic property of a healthy immune system. Accordingly, it is hardly to omit producing of antibodies of the desired specificity by use of such a method.

In this regard, characterization of antibodies at the functional level may be justified if no antibody has been earlier obtained to antigen X/epitope Z. In addition, this feature does not break the RF regulatory documents prescribing applicability of functional generalization for a feature characterized in the claims (see, for example, item 45 of the Requirements).

As for the distinguishing ability of this feature, if the antigen to which the antibody is produced was not previously known, then it is obvious that the feature “antibody binding to the said new antigen” automatically distinguishes all antibodies produced against this antigen from other antibodies described in the art.

When an antibody is characterized in a claim as binding to epitope Z on antigen X, herewith antibodies against X are known, only at a first glance it seems that it is impossible to estimate the novelty and inventive step of such an invention. Generally, binding of antibodies to a specific epitope of an antigen leads to certain effects. Therefore, judging whether the already known antibodies do encompass those that bind this particular epitope can be for instance based on whether these effects are known or not known .

In any case if the examiner will have any doubts, he can send the applicant an official action, saying that examination cannot estimate whether some of already known antibodies bind the epitope and what advantages arise from such ability. Further, in the course of such conversation it will be possible to establish the truth: whether the pending invention satisfies the patentability conditions of novelty and inventive step or not.

Finally, we shall  not forget that an unlawfully granted patent can be nullified by the member of market who has interests in this area on the basis of evidence provided (for example, in the form of relevant experimental data), that the epitope on which the invention is based can be bound by antibodies known before the priority date of said invention.

Antibody … having altered Fc fragment …

When such characteristic is given, usually the antigenic specificity of an antibody is not indicated, instead its improved property is indicated. Therefore, the stumbling block in this case is how we shall express the purpose of an antibody in claims: whether its activity (antigenic specificity) should be specified, or some other biological properties of this substance can be indicated to determine its purpose. In the broader sense this question is: whether an invention’s purpose equals to the function of the subject, embodying the invention, or whether an invention’s purpose equals to the problem to be solved by the authors of the invention? In our opinion, both answers may be correct.

This view is supported by item 10.3. of the Guide, that indicates  “the characteristic of modified forms of natural polypeptides known from the prior art in claims might be sufficient if the name of the known substance (or basic structure) is indicated, its modified part (region, position of amino acid residue, site) is given, as well as the nature of the change made and property that shall be acquired”.

As it can be seen from the citied phrase, for modified polypeptide its activity is not indicated as its purpose, instead properties that are acquired by it as a result of the modification are given, that is the problem to be solved by the inventors.

Referring again to the antibodies, characterized as “an antibody having effect ...”, it shall be noted that  such an indication actually reflects the purpose of an invention, that is, for what specific purpose it can be used in that or those field. In particular, indication of a positive effect does not only reflect what new beneficial biological properties the given substance has but actually shows us the specific purpose for which it can be used in industry, healthcare or other fields. For instance an invention “antibody with an extended half-life” can be used in healthcare with respect to various therapeutic antibodies with very different antigen specificity for obtaining drugs with improved pharmacokinetics on their basis.

In addition, we shall not forget that the very title “antibody”  makes possible purpose of such subject matter evident, since antibody’s fields of application are generally known. They comprise therapy, diagnostics, and various studies, where antibodies can be used as a label, and many others.

It is understood that in cases when no specific antigen specificity is indicated in claims, it can be a matter of the validity of the scope of claims expressed by the broad generic term “antibody”, in view of item 56 of the Rules for drafting, filing and processing the documents serving the basis for performing legally significant actions on the state registration of inventions, and forms thereof. However, as it is already noted, a useful mutation in the Fc region allows  to improve antibodies with very different antigenic specificity (that is, regardless of antigen specificity). Therefore, in such case, the requested scope of protection in part relating to the purpose, which obviously follow from the name “an antibody”, appears legitimate and should not be limited by antigen specificity.

In summary, we need to note that the purpose of such invention as an antibody (actually as well as in any other polypeptide), should express its intended use. However, it does not have to coincide with its type of activity and may be associated with other biological function. In case of inventions related to detection of useful mutations in the Fc region, the purpose is determined by a new biological property of interest, which appears as a result of mutation, and it seems impractical to restrict it further with indication of antibody’s activity.

Possible consequences for cases when “problematic” antibody characteristic variants are given in the claims

There are concerns that the above-described “problematic” variants of antibody characteristic in claims may lead to conflicts between bona fide market participants who may inadvertently violate a patent, and to the emergence of so-called umbrella and evergreen patents. But only at a first and a very superficial glance it may seem that to prevent such situations it would be beneficial to give a limited scope of patent protection to antibodies, regardless of the essence of an invention andits contribution to the prior art.

It will be recalled that antibody based drugs can be are quite easily reproduced by reverse engineering, and the volume, and, therefore, the cost of the clinical trials required for the state registration of for reproduced drugs (generics) is lower than that of the original ones. In particular, according to item 10 in Article 18 of the Russian Federal Drug Circulation Act No. 61-FZ of April 12, 2010, “for the state registration of reproduced drugs for medical use it is allowed to submit … instead of full clinical studies ... a report with the results of bioequivalence studies of the reproduced drug for medical use”.

Thus, having narrow patent protection in the scope of particular amino acid sequence, the original drug developer might only suspend the market introduction of corresponding generic drugs only for those who are not actually involved in development of antibodies, but will not protect against clearly numerous real competitors, for the following reasons:

• expected growth in the global antibody market will be 6% until 2025;
• numerous different antibodies can be produced against the same antigen;

current developers have access not only to animal immunization technology followed by humanization of the  antibody obtained, but also to technologies using libraries of antibodies or its fragments, which allow to quickly select an appropriate human antibody against the antigen, as well as technologies of antibody affinity maturation, which allow to allow required antigen binding characteristics.

Accordingly, patent protection in the scope of the amino acid sequence of antibodies cannot ensure the return of funds spent on research, not to mention profit, for example, if the developer has not just created a specific antibody against known substance, but conducted very laborious and knowledge-intensive research to develop antibody against substance, whose contribution to pathogenesis of the disease was just revealed. If the product turns out to be commercially successful, it will attract the attention of other market participants, who can create their own antibody against this antigen without violating the developer's patent.

In the authors’ opinion, the more global problem is solved by the invention, the more resources are required to create it, and the more patent rights are needed by concerned persons in order to even take a decide on investments. In addition, concerns mentioned in the first paragraph do not seem to be fully justified.

For instance, an umbrella patent by its definition a patent unsupported by practice in which claims are made all-embracing in order to give some color of right for litigating against those alleged to infringe it.

Meanwhile, the patent applications for an antibody-related invention generally contain relevant experimental data demonstrating the provided beneficial effect, for example, the effect of an antibody binding a new antigen or the effect of introducing a mutation into the Fc region of an antibody.

Here is shall also be noted that in most cases, the purpose of these patents is not to provide obstacles to clinically significant products entering the market, but crucial protection of the field of art being developed, which is very important in particular, due to the abundant known opportunities of circumventing antibody patents. For example, if an invention relates to introducing mutations in the Fc region, we shall remember that the mutation is introduced into a previously known amino acid sequence of this region. This means that all previously known antibodies do not include such a mutation (otherwise the patent would not be granted due to non-compliance of the invention with the patentability condition of novelty) and do not violate the patent, while developers of new antibodies can use the well-known Fc without mutation or even obtain a new product in a format that does not principally require an Fc region to be present.

It should be recognized that the patents protecting antibody that binds to antigen X provide a very wide scope of protection, but it cannot be classified as overly general or unjustified. After all, if an antigen or its contribution to the pathogenesis of the disease is unknown, than development of a therapeutic antibody will require more global studies to take place compared to the studies that take place when the antigen and its function are known. Herewith when the obtained information about the antigen and the effect of exposure to it is disclosed, the developer essentially provides everyone with the opportunity to develop and patent the own antibody against this antigen. Therefore, the only possible protection of funds invested by the developer in discovery of a new antigen and identification of its role will only be a patent for an antibody characterized at the functional level, namely, binding to the antigen, and such scope of claims is fully justified.

In relation to evergreen patents, first of all, the terms should be defined. So, evergreen patents can be considered as a series of patents related to the same substance, where the invention in the subsequent patent differs from the invention in the previous patent by minor modifications.

Note that quite often one can observe the situation of misusing this term, that is, when a series of patents obtained during the development of a medical substance are referred to as evergreen patents. This situation will be explained in more detail in connection with antibodies.

The development of a therapeutic antibody begins with the definition of an antigen and its role in the pathogenesis of the disease. If both are known, then first of all must be obtained, the set of “draft” antibodies (to put it simply) that bind to the antigen more or less specifically. Often, laboratory animals are used to obtain them and create hybridomas that produce antibodies that are not intended to be administered to humans. Therefore, patent for a hybridoma and an antibody produced by a hybridoma is often a patent for a product that will never be marketed as a therapeutic product.

Next, the researchers determine the sequence of the best “draft” antibodies as the basis for obtaining humanized or fully human antibodies by genetic engineering. Moreover, an antibody in the claims of the corresponding patent is characterized by a sequence that is not generally a sequence of a “draft” antibody. Thus, in view of developing a new therapeutic antibody and the logic of relevant patenting, a patent for an antibody characterized by hybridomas and a patent for an antibody characterized by a sequence cannot be considered as patents for the same substance.

Finally, we should discuss the possible situation of a conflict of interest caused by the fact that the developers of therapeutically significant antibodies to specific antigens unintentionally created an antibody that falls within the scope of protection established by the patent with a “problematic” antibody characteristic. For simplicity and clarity of discussion, refer to the same example as the authors of the aforementioned article, viz. to an antibody characterized by mutations in the Fc region.

So, if the developer unexpectedly developed an antibody with a mutation in the Fc region, which is protected by a patent, then remind that, in accordance with Article 1359 of the Civil Code of the Russian Federation, there is no violation of the exclusive right to an invention in “...scientific research of a product …or the conduct of an experiment with such a product,..” . Therefore, if investigator are only conducting scientific research of an antibody containing a mutation under the patented invention, they cannot violate the patent.

Further, the investigators found out that they developed an antibody having remarkable properties and they decided to market it. Here we should bring into memory the peculiarities of such object as an “antibody” and the process of its introduction into civil circulation.

In particular, in the laboratory and even more so in the industry, antibodies are usually obtained with genetic engineering techniques, that is, by means of cells with specially introduced genes encoding an antibody. Thus, a developer always knows the complete information about his antibody, including its amino acid sequence. In the case of a spontaneous mutation, which the developer has not even thought about, already in the course of production, this information will be provided by those responsible for the product quality control, which usually exist in production.

Remind that patent freedom to operate is usually performed for a product to be introduced into the civil commerce. For a comprehensive analysis of an antibody, the developer needs to know the complete sequence, which can be easily determined due to available analysis of the protein primary structure. Thus, there is virtually no chance for an unconscious introduction into civil commerce of an antibody containing a mutation according to some patented invention.

Proposals on changing regulatory requirements

Though the existing regulatory documents of the Russian Federation seem to be satisfactory, in practice, there are successors of standardized characteristics of inventions in the claims who treat individual terms of regulatory documents as prescribing the obligatory indication of the complete amino acid sequences or CDR sequences of antibodies in the claims. Thus, taking into account the aforementioned economic aspects, the positions of the developers of pioneering and most y interesting inventions in the field of antibodies are vulnerable. Therefore, we would like to propose the following changes that would strengthen the position of such developers.

To set forth item 53(13) of the Requirements as follows: “the claims characterizing a nucleic acid, protein, polypeptide or peptide, ..., shall include the name of the substance, biological function (type of activity, biological property) that determines its purpose unless it apparently following from the name, and, when necessary, other features that allow to distinguish this compound from others, in particular, number of the corresponding nucleotide or amino acid sequence (if identified) [in the sequence listing], basic structure and modifications made to the sequence of nucleotides or amino acids, presence of certain stretches of polynucleotides or amino acids and their functional peculiarities or other characteristics thereof”.

To set forth item 53(20) of the Requirements as follows: “the claims relating to a protein construct, where one or more components are polypeptides, should include its name with indication of the purpose or the biological function that determines its purpose, and features that characterize its structural implementation”.

Conclusions

Considering that technical progress entails the creation of new objects, as well as changes to existing objects that could not be imagined before, the possibilities for characterizing the invention in the claims should only expand to keep pace with this progress. Therefore, it is important not only not to reduce the variants of antibody characteristic in the claims, but, on the contrary, to look for and propose new approaches to characterize antibody in view of the state of art and prospects of development in biotechnology, and appropriately supplement the regulatory documents and comments thereto

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