On March 1, 2021, the new Guidelines for Examination of the European Patent Office (EPO) came into force. These Guidelines set the rules by which Examiners at the EPO analyze the patent applications prosecuted therein to evaluate whether they are in conditions to be granted as European patents, thus providing more homogeneity and transparency to said prosecutions.
The new Guidelines include a section devoted to the patentability of antibodies, inexistent thus far, which essentially sets in stone the criteria by which the Examiners at the EPO have been conducting their examinations on applications related to antibodies lately. Said criteria are based in decisions issued in the last few years by the Technical Board of Appeals of the EPO on antibodies-related issues, used so far by the Examiners to carry out their analyses in lieu of specific indications in the Guidelines.
The new section of the Guidelines (section G-II-5.6), on one hand, establishes requisites for the proper definition of antibodies in claims, and on the other, provides considerations on how to demonstrate the inventive step involved in the development of novel antibodies.
Antibodies are proteins (i.e., polypeptides) and, as such, they structurally consist of a series of linear amino acids chains. They are part of the immune system of many living organisms, and every antibody is adapted to bind to a particular antigen (i.e., a substance which generates an immune response in the organism) by specific regions in its amino acids sequence named complementarity-determining regions (CDRs). Each antibody has 6 CDRs, which define to which antigen they will bind.
According to the new Guidelines, the EPO accepts defining a claimed antibody by either structural or functional features, as well as by its production process.
- Structural features The essential structural feature of antibodies is their amino acid sequence. Since the CDRs are the parts of an antibody which determine their ability to bind to a certain antigen, the EPO establishes that the structural definition of an antibody must include, at least, the amino acid sequences of the 6 CDRs thereof. The EPO will only accept a structural definition of an antibody including less than all 6 CDRs if it is unequivocally proven that not all CDRs are involve in the binding to the antigen. Another way to define an antibody structurally would be by means of the nucleotide sequence codifying it (i.e., the specific portion of a nucleic acid molecule, for instance DNA, which may be used by a cell to generate the corresponding antibody).
- Functional features The EPO contemplates the possibility of defining an antibody by several types of functional features, such as the antigen to which it binds, the affinity therefor it exhibits, the specific regions of the antigen to which it binds (named epitopes), etc., as well as combinations thereof. Even though this kind of definitions may be desirable because they are usually of a broader scope than structural definitions, it is important to note the new EPO Guidelines clearly establish that in these cases it is especially important for the Examiner to verify whether the specification of the patent application under analysis provides a sufficient description of the invention, so that it may by reproduced by a person of skill in the art (i.e., that the description of the invention allows for it to be reproduced without any ambiguity). On the other hand, the Guidelines clarify that, if there is any prior art disclosing an antibody directed to the same antigen as the one being claimed, which is also obtained by a process as the one used for the claimed antibody, it will be assumed that the prior art inherently disclosed the functional features by means of which the same is defined, which would deny its novelty.
- Production process The EPO allows defining an antibody by means of the process by which it is obtained. For instance, the antibody could be defined by the immunization protocol used to generate it. However, it should be noted that in these cases the antigen used for the generation of the antibody should be defined by its sequence without any ambiguity whatsoever.
Regarding inventive step, the new section of the EPO Guidelines establishes that a novel antibody which binds to a known antigen must exhibit an unexpected property over antibodies known in the prior art for the same antigen. Examples of such properties might be a greater affinity, a higher therapeutic efficacy, reduced toxicity or secondary effects, etc. A mere structural difference with the antibodies of the prior art would not be considered enough in this case to provide an inventive step, since such a difference would be considered an “alternative solution” to a technical problem previously solved, which the EPO considers obvious in view of the prior art as a general rule in this technical field.
Situation in Argentina
Even though the Argentinean PTO (INPI, National Institute of Industrial Property) included in its Patentability Guidelines a section directed to biotechnological inventions by means of Resolution INPI N° P-283 of September 25, 2015, they do not provide specific indications regarding inventions related to antibodies. However, there are some tendencies which Examiners at the INPI usually follow when analyzing this kind of applications.
Regarding the definition of claimed antibodies, the INPI only accepts a structural definition thereof. Unlike the EPO, neither a functional definition nor a definition by means of the production process for the claimed antibody are acceptable. This means that some inventions which would be potentially patentable in Europe would not be accepted in Argentina, or at least they would be accepted with a much more limited scope (for instance, having to limit a broad functional claim to a narrower one defined by the specific sequences of the claimed antibody).
For a proper structural definition of a claimed antibody, Examiners at the INPI usually require that all 6 CDRs of the antibody to be defined. On the other hand, defining an antibody solely by means of the nucleotide sequence which codifies it is generally not accepted, as it should be complemented specifying as well the codified amino acid sequence (as mentioned, al least the 6 CDRs).
Regarding the evaluation of inventive step, the INPI does not have a criterion as clear as the EPO in this aspect. However, as a general rule, Examiners at the INPI tend to expect a patent application to include comparative results to the closest prior art, showing any surprising effect. In the specific case of antibodies, this would imply a similar criterion to that of the EPO, which is why it would be appropriate to include results in the specification showing some unexpected advantageous property of the claimed antibody in comparison to those of the prior art directed to the same antigen.
Pat-INFORMED, A PATENT INFORMATION TOOL FOR PHARMACEUTICALS
“Pat-INFORMED” (Patent Information Initiative for Medicines) by WIPO is a database containing information on granted patents of invention directed to small-molecule pharmaceutical drugs.
It is part of a program developed by several global research-based biopharmaceutical companies that voluntarily provide information to the database as holders of the corresponding patent rights. The program is supported by WIPO and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
The database only contains information regarding granted patents of products that are marketed and/or approved in at least one country.
Patents are listed according to the drug international non-proprietary name (INN), allowing users a simple way of accessing data. This is a remarkable and advantageous feature for those not used to dealing with other patent databases.
Besides the information provided by the participating volunteers, WIPO provides supplementary information and links to other public databases, like WIPO’s Patentscope.
Pat-INFORMED database may be accessed through the following link: https://www.wipo.int/patinformed/
USPTO Pilot Program enables deferred-fee payment related to filing of provisional patent applications that combat COVID-19
The United States Patent and Trademark Office (USPTO) launched a pilot program that allows deferring the payment of filing official fees for provisional patent applications that combat COVID-19, until the filing of a corresponding non-provisional application.
The applicants must agree that the technical subject matter disclosed in their provisional applications will be available to the public on USPTO’s website.
In this way, two objectives are achieved: by disseminating the technology, applicants contribute to the fight against COVID-19 while at the same time protecting their patent rights.
To qualify for the program, the subject matter disclosed in the provisional must concern a product or process related to COVID-19, and such product or process requires Food and Drug Administration (FDA) approval for COVID-19 use.
The program accepts applications as from September 17, 2020, for a duration of 12 months.
For more information, please click here.
Assists in proving the existence of innovations, trade secrets and confidential information
The World Intellectual Property Organization (WIPO) has launched a new “digital fingerprint” service that provides a certain time and date to digital files containing, for example, intellectual creations such as innovations, trade secrets, confidential information, research and data.
This “digital fingerprint” is conceived as a complement to existing IP protection systems (trademarks, patents, designs, etc.) and, particularly, as evidence to solve disputes related to the use of confidential information or certain innovations before they are formally registered as IP rights.
Although WIPO PROOF does not create IP rights, the possibility of demonstrating that certain content existed at a given moment may assist in protecting assets during each stage of the innovative development process. This technology may also be applied to other related matters, for example, as supplementary evidence of the existence of a contract or as additional assurance when exchanging information during precontractual negotiations.
WIPO PROOF is an online service that utilizes the user’s local server to create a unique code or “digital fingerprint” for the contents of that file, date- and time-stamped by WIPO. The user receives a token containing said code and WIPO stores a copy of the token on its secure servers in Switzerland. Since files are not uploaded nor stored in external servers, confidentiality of information is not compromised, which is of relevance when dealing with sensitive information. The code can easily be verified online for free, at any time. The system will determine if the code of the original digital file matches the one stored in the token. If the original digital file has been modified, the code will not be verified.
By means of this new service, WIPO offers users a creative and accessible solution to some of the challenges posed by the era of digital transformation.
Personalized medicine is based on the administration of active ingredients to individuals sharing a specific biological feature. It relates to targeted therapies that search for the most appropriate treatment for a given patient, and that are usually presented as the promising future of medicine.
In many cases, the active ingredients used in these treatments are known compounds. However, determining the effective doses and the population for which such administration is therapeutically effective may involve experimental developments, as well as considerable economic efforts. In this context, it is of interest to know whether this “personalized medical use” resulting from research can be protected by a patent.
In other words, is it possible to claim a compound X for the treatment of disease Y administered to patients that share feature Z or, alternatively, a treatment for disease Y comprising administering a compound X to patients that share feature Z?
Under the European patent system, the possibility of second medical uses claims is provided by Art 54(5) EPC. A medical use of a known compound X may confer novelty to a claim directed to compound X for the treatment of disease Y, as long as said treatment does not form part of the state of the art. If a related technical effect is demonstrated, the therapeutic indication may be considered as a functional feature of the claim, conferring novelty to the claim in accordance with decision G 2/88 of the Enlarged Board of Appeal.
Later on, in decision G 2/08 of 2010, the Enlarged Board stated that a new mode of administration or dosage regime of compound X, or even the treatment of the same disease Y in a new group of patients, could contribute to the novelty of a medical use even if the general use of compound X for the treatment of disease Y were already known. This decision also set forth the prohibition of “Swiss type” claims for second medical uses under the European system.
In 2019, decision T 694/16 of a Technical Board of Appeal reaffirmed these principles and extended them specifically to personalized medicine. The case at issue was related to a known compound for the treatment of dementia, where the use of such compound in patients presenting a specific biological marker detectable in cerebrospinal fluid was claimed. According to patent EP2170104, this marker allows to distinguish between patients in prodromal phase, who will develop dementia, and patients presenting cognitive symptoms but who will not necessarily develop dementia. For the Board of Appeal, the selection of a subgroup of patients based on a feature Z (the common biological marker) may contribute to the novelty of a personalized medicine claim: the functional relationship between markers that characterize patients and the therapeutic effect which is sought is an essential technical feature of the claim. Moreover, prior art describing the use of compound X for the treatment of a disease Y in a group of patients including the subgroup having feature Z does not inherently or inevitably disclose this functional relationship and does not affect novelty of the claim.
With this decision, the European Patent Office confirms that it is possible to obtain European patents related to personalized medicine, even if the general use of an active principle in a determined treatment is known in the state of the art. To obtain a valid patent, the personalized treatment must also meet the inventive step requirement, meaning that it must not be obviously derivable from the prior art.
In Argentina, according to a Joint Ministry Resolution issued by the Patent Office and the Ministry of Health in 2012, second medical uses are not deemed patentable: nowadays, personalized medicine may hardly be the object of a patent of invention, regardless of whether novelty and inventive step criteria are met. Other Latin American countries accept second medical uses, as long as they are claimed according to local practice and all other patentability requirements are met.
In general, claims directed to uses are not accepted in the United States, although therapeutic methods for treatment are permitted. Nonetheless, the doctrine of inherency and anticipation practice under the US patent system may make it difficult to protect personalized medicine as compared to the European system.
The Enlarged Board of Appeal of the European Patent Office (EPO) confirmed in its most recent decision that plants and animals exclusively obtained by essentially biological processes are excluded from patentability.
This would be the final chapter in a debate that had the Technical Boards of Appeal of the EPO against the European Commission and the Administrative Council of the European Patent Organisation, and which may be summarised as follows:
- Article 53(b) EPC excludes from patentability essentially biological processes for the production of plants or animals.
- In 2015, the Enlarged Board of Appeal had concluded that this exclusion did not extend to plants or animals exclusively obtained by means of an essentially biological process, according to decisions G 2/12 (“Tomato II”) and G 2/13 (“Broccoli II”).
- In 2017, the European Commission promoted the amendment of Rule 28 EPC by the Administrative Council, based on the interpretation of Directive 98/44/CE, thus explicitly excluding plants and animals obtained exclusively by means of essentially biological processes.
- Recently, a Technical Board of Appeal refrained from applying amended R28, arguing that it would be contrary to the European Patent Convention, referring to the Enlarged Board’s decision of 2015.
- In the face of this legal uncertainty, the President of the EPO referred the question to the Enlarged Board in 2019.
- In Decision G 3/19 “Pepper”, the Enlarged Board changed its position and ruled that the exclusion from Art 53(b) also applies to plants and animals exclusively obtained by means of an essentially biological process.
In reaching this conclusion, the Enlarged Board adopted a dynamic interpretation of the Convention, recognising that the 2017 Rule amendment leads to an interpretation that is contrary to the 2015 decisions.
Furthermore, the Enlarged Board claims that this decision shall not have retroactive effect on European patents granted, or pending applications filed, before 1 July 2017, date on which the amended Rule came into force.
The foregoing would not modify patentability before the EPO of plants and animals that are not exclusively obtained from essentially biological processes. For instance, it would be possible to obtain a European patent for genetically modified plants or animals, as long as they are not obtained from traditional reproduction and selection methods.
The AR PTO joins WIPO’s Digital Access Service for the exchange of priority documents of patents and utility models. As from October 01, 2019, the AR PTO will be an Accessing Office and as from March 02, 2020, a Depositing Office.