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I. Patentability
  1. Home
  2. Legal texts
  3. Case Law of the Boards of Appeal
  4. Case Law of the Boards of Appeal of the European Patent Office
  5. I. Patentability
  6. C. Novelty
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C. Novelty

Overview

C. Novelty

1.General

2.State of the art

2.1.General
2.2.Applications with same filing or priority date
2.3.Relevant date of documents
2.4.Prior rights – Article 54(3) EPC
2.4.1European prior rights
2.4.2Applicability of Article 54(3) EPC in cases of potentially colliding European parent and divisional applications
2.4.3Excluded national prior rights
2.4.4PCT applications as state of the art
2.5.Non-prejudicial disclosures under Article 55 EPC
2.6.In-house knowledge not published before the priority date
2.7.Prior art acknowledged in a patent application
2.8.Common general knowledge
2.8.1Definition of "common general knowledge"
2.8.2Patent specifications as common general knowledge
2.8.3Specialist journals as common general knowledge
2.8.4Databases as common general knowledge
2.8.5Proof of common general knowledge

3.Availability to the public

3.1.General
3.2.Ways of making information available to the public
3.2.1Publications and other printed documents
a)General
b)Company papers
c)Advertising brochure
d)Report available in the specialist field
e)Books
f)Instruction manual
g)Patent and utility models
h)Trade names
i)Abstracts of documents
3.2.2Lectures and oral disclosure
3.2.3Internet disclosures
a)General
b)Public availability of a document stored on the World Wide Web
c)Publication date
3.2.4Public prior use
a)General
b)Public prior use occurred
c)No public prior use
d)Internal structure or composition of a product
3.2.5Biological material
3.3.The concept of "the public"
3.3.1Sale to a single customer
3.3.2Making available to a person not skilled in the art
3.3.3A limited circle of people
3.3.4Public library
3.4.Obligation to maintain secrecy
3.4.1General
3.4.2Parts for serial production
3.4.3Distribution of prospectuses, technical descriptions
3.4.4Commercial relationships and interests
3.4.5Demonstrating products for presentation purposes
3.4.6Presenting the product in writing
3.4.7Making samples/products available for test purposes
3.4.8Conferences
3.4.9Public availability of documents submitted for standardisation
3.4.10Joint venture and other commercial agreements
3.4.11Paper submitted to obtain an academic degree
3.4.12Medical field
3.4.13Notary
3.5.Evidence
3.5.1Burden of proof
3.5.2Standard of proof
a)General
b)Public prior use
c)Internet – proof of the date of availability

4.Determining the disclosure of the relevant prior art

4.1.General rules of interpretation
4.2.Combinations within a prior art document
4.3.Taking implicit features into account
4.4.Taking intrinsic features into account
4.5.Taking equivalents into account
4.6.Taking drawings into account
4.7.Taking examples into account
4.8.Broad claims
4.9.Deficiencies and mistakes in a disclosure
4.10.Accidental disclosure
4.11.Reproducibility of the content of the disclosure

5.Ascertaining differences

5.1.Comparing each individual item from the prior art
5.2.Distinguishing features
5.2.1Difference in wording
5.2.2Differences in values
5.2.3Difference in parameters
5.2.4Difference in composition
5.2.5Functional features
5.2.6Generic disclosure
5.2.7Product claim with process features
5.2.8Non-technical distinguishing features

6.Chemical inventions and selection inventions

6.1.General
6.2.Novelty of chemical compounds and groups of compounds
6.2.1Anticipation of certain compounds
a)Definition of a substance by its structural formula or other parameters
b)Selection of starting substances from different lists
c)Selection on the basis of a general formula
6.2.2Novelty of groups of substances
6.2.3Novelty of enantiomers
6.2.4Achieving a higher degree of purity
6.3.Selection of parameter ranges
6.3.1Selection from a broad range
6.3.2Overlapping ranges
6.3.3Multiple selection
6.4.Subject-matter group

7.First and second medical use

7.1.First medical use
7.1.1Introduction
7.1.2Scope of a purpose-related product claim
7.1.3Protection of a preparation in the form of a "kit-of-parts"
7.1.4Further technical information as compared with the state of the art
7.2.Second (or further) medical use
7.2.1Introduction
7.2.2Transitional provisions
7.2.3Purpose-limited product claims and Swiss-type claims – scope of protection
7.2.4Novelty of the therapeutic application
a)General
b)New therapeutic application based on the group of subjects to be treated
c)New technical effect
d)Same illness
e)New dosage regimen
f)New therapy with a different mode of administration
g)Interpretation of "substance or composition"
h)Statement of purpose of surgical use for a known instrument
i)Discovery of a previously unknown property of a compound underlying the known effect
j)Whether there is a therapeutic method

8.Second (or further) non-medical use

8.1.Novelty criteria for use claims and process claims containing a purpose feature
8.1.1General issues decided before the Enlarged Board of Appeal
8.1.2Non-therapeutic treatment of animals
a)Non-therapeutic application
8.1.3Applicability of G 2/88 and G 6/88 to process claims
a)General
b)Different treatment of use and process claims
c)Interpretation of process claims
d)Use of a known process for a particular purpose
e)Discovery of new properties/technical effects underlying the known use
f)Use of a substance to achieve a technical effect only attained in special circumstances
8.1.4Statement of purpose in non-medical use claims in view of Article 52(4) EPC 1973
8.1.5Novelty criteria for product claims with purpose characteristics
New decisions
T 1356/21

Catchword: 

1. Novelty in the case of purpose-limited product claims pursuant to Article 54(5) EPC relying on a dosage regimen defined by a numerical range, see point 2.6 of the reasons.  2. Limits to the application of the concept of bonus effect, see point 3.4.3 of the reasons.

T 1688/20

Catchword:

Novelty of selection inventions - selection from a broad range - "gold standard" - see point 3.4

T 1252/20

Catchword:

The question of whether a material or an object is a "substance or composition" in the sense of Articles 53(c) and 54(4)or (5) EPC should be decided, in the first place, on the basis of the claimed material or object as such. If this analysis leads to the conclusion that indeed a substance or composition is present, this requirement of Article 54(4) or (5) EPC is fulfilled. No additional restrictions relating to its mode of action are derivable from the EPC (reasoning, point 12) .

T 857/20

Catchword:

Neuheitsschädlich sind nur solche Vorrichtungen, deren offenbarte Merkmale all jene der Erfindung vorwegnehmen, einschließlich etwaiger Strukturen und Funktionalitäten, die durch ein Verfahrensmerkmal bedingt sind. Wenn eine Vorrichtung ihre beanspruchte Funktionalität im Zusammenwirken mit einer nicht mitbeanspruchten Gegenstruktur entfalten kann, so ist auch diese Erfindung nur neuheitsschädlich vorweggenommen, wenn ihre strukturellen und funktionalen Merkmale bereits vor dem Anmeldetag unmittelbar und eindeutig offenbart worden sind. Auch wenn die Gegenstruktur nicht mitbeansprucht ist, erscheint es im Rahmen der Prüfung von Artikel 54 EPÜ unzulässig, sich eine beliebige Struktur auszudenken, die für die Erreichung der Funktionalität eingesetzt werden könnte, wenn eine solche im Stand der Technik nirgends auch nur ansatzweise gezeigt ist. (Siehe Gründe 3.5 bis 4.2)

T 670/20

Catchword:

The clinical trials were carried out in accordance with the EMEA Guidelines for Good Clinical Practice. These guidelines explicitly require adherence to the prescribed protocol and assurance of drug accountability. This set-up of the trials implies that the patients who decided to participate in the trials agreed, following their informed consent, to use the provided medication according to instruction or to return the unused medication. Accordingly, the participating patients who were provided with the tablets under investigation entered into a special relationship with the investigators of the trials and were with regard to the provided tablets not members of the public that could freely dispose over these tablets. (see section 4.3)

T 558/20

Catchword: 

On the assessment of novelty under Article 54(5) EPC (point 2 of the reasoning), in particular when a claim defines a combined surgical and therapeutic method (points 3.2 and 5 of the reasoning)

T 468/20

Catchword:  No protection according to Article 54(5) EPC for a device

T 1553/19

Catchword: 

The normal rule of claim construction of reading a feature specified in a claim in its broadest technically meaningful sense corresponds to determining the broadest scope encompassed by the subject-matter being claimed according to a technically sensible reading. In the case of a feature defined in a positive manner, which imposes the presence of a specific element, this is effectively achieved by giving to the element in question its broadest technically sensible meaning. However, for a feature defined in a negative manner, which excludes the presence of a specific element, the broadest scope of the claim corresponds to the narrowest (i.e. most limited) technically sensible definition of the element to be excluded. (Reasons, point 5.7)

T 1362/19

Catchword:

If an abstract feature is not defined in more concrete terms either in the relevant claim or in the description of the application, it has to be understood in a broad sense. This may be important when assessing the implicit disclosure of a document of the state of the art. In particular, for this assessment it may be irrelevant whether there are several alternatives for implementing the abstract feature in concrete terms (Reasons 2.3.7).

T 438/19

Catchword:

The following questions are referred to the Enlarged Board of Appeal for decision:

1. Is a product put on the market before the date of filing of a European patent application to be excluded from the state of the art within the meaning of Article 54(2) EPC for the sole reason that its composition or internal structure could not be analysed and reproduced without undue burden by the skilled person before that date? 2. If the answer to question 1 is no, is technical information about said product which was made available to the public before the filing date (e.g. by publication of technical brochure, non-patent or patent literature) state of the art within the meaning of Article 54(2) EPC, irrespective of whether the composition or internal structure of the product could be analysed and reproduced without undue burden by the skilled person before that date? 3. If the answer to question 1 is yes or the answer to question 2 is no, which criteria are to be applied in order to determine whether or not the composition or internal structure of the product could be analysed and reproduced without undue burden within the meaning of opinion G 1/92? In particular, is it required that the composition and internal structure of the product be fully analysable and identically reproducible?

T 989/22

Abstract

Dans l'affaire T 989/22, la requérante avait soumis un tableau comparant la revendication 1 du brevet attaqué à la divulgation de D10. Il ressortait de ce tableau et du tableau de la décision attaquée qu'il n'y avait pas de divulgation directe et sans équivoque dans D10 d'un alliage ayant une composition telle que définie dans la revendication 1 du brevet attaqué. Pour arriver à un tel alliage la personne du métier aurait dû faire plusieurs choix parmi les plages et valeurs spécifiques divulguées dans D10, ce qui n'était pas considéré comme une divulgation directe et sans équivoque. La combinaison de différentes valeurs limites de différentes plages de valeurs n'était pas considérée comme divulguée (voir T 900/18, citant T 1634/13). En outre les plages de valeurs ne devaient pas être comparées séparément mais ensemble (voir T 2623/19, citant T 261/15).

La chambre rappelle que le critère à appliquer pour évaluer la nouveauté de plages de valeurs est la divulgation directe et sans équivoque (voir T 1688/20, citant G 1/03 et G 2/10). Le concept "d'envisager sérieusement" cité par la requérante a été initialement décrit dans la décision T 26/85 et repris dans la décision T 666/89 et utilisé dans beaucoup d'autres décisions concernant le recoupement de domaines (Jurisprudence des chambres de recours, 10e édition, 2022, I.C.6.3.2). Dans la décision T 666/89, la chambre a estimé que le concept "d'envisager sérieusement" était un concept de la nouveauté. La chambre a cependant noté que, comme indiqué ci-dessous, entre-temps il est bien établi que la divulgation directe et sans équivoque est le critère incontestable pour l'évaluation de la nouveauté. La chambre est d'avis que le concept "d'envisager sérieusement" implique que la personne du métier doit évaluer si l'enseignement technique du document antérieur est à appliquer dans la plage de valeurs commune (voir T 26/85 et T 666/89) ce qui est, de l'avis de la présente chambre, directement lié à l'effet recherché. C'est pourquoi le concept "d'envisager sérieusement" est difficilement conciliable avec le critère primordial d'une divulgation directe et sans équivoque dans le cas de multiples plages de valeurs.

Il est aussi à noter que dans l'affaire T 26/85, la chambre avait conclu que la nouveauté était donnée car l'état de la technique dissuadait clairement l'homme du métier de travailler dans la plage de valeurs revendiquée.

Dans le cas d'espèce, même si le critère "d'envisager sérieusement" était accepté contrairement à ce qui a été écrit ci-dessus, il aurait été à noter que tous les alliages selon l'invention de D10 donnés à titre d'exemples avaient des concentrations de Mg > 0,7 et Li > 1 en % en poids. Il semblait peu probable qu'une personne du métier envisage alors sérieusement de travailler à des concentrations plus basses.

L'objet de la revendication 1 et des revendications 2 à 15, incorporant directement ou indirectement l'objet de la revendication 1, étaient donc nouveaux.

T 2510/18

Abstract

Dans l'affaire T 2510/18 la chambre a considéré comme nouvelles par rapport aux documents D2, D3 et D5 les revendications 1 à 6 du brevet en cause qui a pour objet une molécule, la Simalikalactone E (ci-après la SkE), qui peut être extraite de la plante Quassia amara, ainsi que son utilisation comme médicament dans la prévention et le traitement du paludisme.

D2 est un article qui décrit une étude sur les remèdes antipaludiques utilisés en Guyane française. Il ressort de l'étude que l'espèce la plus utilisée est Quassia amara seule ou en combinaison avec d'autres espèces végétales. D2 décrit que cette plante est utilisée sous forme de décoctions administrée par voie orale ou est appliquée sur le corps du patient.

D3 est un article qui concerne l'évaluation de l'activité antipaludique de 23 espèces différentes de plantes utilisées en Guyane française dont la Quassia amara. D3 décrit que la décoction préparée avec les feuilles fraîches de Quassia amara n'est pas toxique à 1000 mg/jour et peut être administrée sans problème pendant plusieurs jours, quel que soit le principe actif. La décoction de feuilles de Quassia amara est donc présentée comme un remède antipaludique intéressant.

D5 est un article qui concerne l'effet de l'âge des feuilles de Quassia amara et l'état de dessication sur l'activité antipaludique d'infusions traditionnelles préparées à partir des feuilles à différents états de maturité et de fraîcheur. Dans une étude antérieure, la molécule Simalikalactone D "SkD" avait été identifiée comme le composé actif. Quatre infusions avaient été préparées avec des feuilles. Les concentrations de la SkD dans chaque préparation et leur activité antipaludique y sont comparées. Il est également indiqué dans D5 que l'infusion de jeunes feuilles séchées possède une activité in vivo très puissante qui ne semble pas provenir uniquement de la molécule SkD. Selon la chambre, aucun de ces documents D2, D3 et D5 ne décrivait explicitement la molécule active SkE. Ces documents divulguent plutôt des remèdes traditionnels antipaludiques, c.-à-d. des préparations dérivées des feuilles ou des tiges d'une plante particulière, Quassia amara.

La chambre a interprété la revendication 1 comme couvrant toutes les compositions contenant la molécule SkE y compris les extraits de D2, D3 et D5, dans la mesure où ils contiennent la molécule SkE. Cependant, la question de savoir si les extraits de D2, D3 ou D5 entrent dans la portée de la revendication 1 n'était pas le critère correct pour évaluer si l'objet de cette revendication est nouveau. Pour évaluer si l'objet d'une revendication a été rendu accessible au public et donc manque de nouveauté, la "norme de référence" est le seul critère à appliquer.

Le fait que la molécule SkE puisse être contenue dans les extraits de D2, D3 et D5 n'équivalait pas non plus à une divulgation implicite. Selon G 2/88 (points 10 et 10.1 des motifs), la question qui se pose est de savoir ce qui a été rendu accessible au public, et non pas ce qui pouvait y être contenu intrinsèquement. Il n'y avait pas non plus de divulgation implicite de l'objet de la revendication 1 au regard de G 1/92: il aurait été nécessaire que la personne du métier identifie la SkE dans les extraits de D2, D3 ou D5. Étant donné que l'identification de la SkE aurait représenté un effort excessif et donc impliqué une activité inventive, la chambre a décidé que SkE ne faisait pas partie de l'état de la technique accessible au public.

La chambre a également relevé que la question en l'espèce était différente de celle dans la saisine T 438/19. Il ne pouvait ici y avoir de divulgation implicite de la SkE dans lesdits extraits, à tout le moins parce que leur identification aurait impliqué un effort excessif pour la personne du métier.

La chambre n'a pas non plus été convaincue par l'argument des requérants qui avaient fait valoir que l'objet d'une revendication ne pouvait pas être considéré comme nouveau s'il était contrefait par une utilisation existante, par exemple, par les extraits de D2, D3 ou D5. En d'autres termes, la protection conférée par le brevet donnerait à l'intimé le droit d'interdire aux populations autochtones d'utiliser les feuilles de Quassia amara pour la préparation de leurs remèdes traditionnels. Par analogie avec G 2/88, la chambre a expliqué qu'en vertu de l'art. 54(2) CBE, la question était de savoir ce qui a été "rendu accessible" au public, et non pas ce qui pouvait être "contenu intrinsèquement" dans ce qui a été rendu accessible. En conséquence, la question du "contenu intrinsèque" ne se posait pas en tant que telle dans le cadre de l'art. 54 CBE.

T 939/22

Abstract

In T 939/22 claim 1 of the main request was directed to "(a( vaccine comprising a recombinant nonpathogenic Marek's Disease Virus (rMDVnp) comprising a first nucleic acid (…) and wherein the rMDVnp is a recombinant herpesvirus of turkeys (rHVT)." The construction of rMDVnp was relevant for assessing novelty over D8.

The definition of rMDVnp in the description (page 7, lines 19 to 20 of the patent in suit) stated that the term rMDVnp referred to a rMDVnp that included heterologous nucleotide sequences (i.e. sequences from pathogens other than MDV). In other words, the definition in the description equated the term rMDVnp to a specific recombinant vector with inserts of nucleotide sequences encoding proteins from other pathogens. According to the board, this definition could not change the common understanding of the terms of art rMDVnp and rHVT as used in claim 1 nor was this definition consistent with how a skilled person would understand the claim. Indeed, the skilled person would understand the terms rMDVnp and rHVT as used in claim 1 to refer to the genome of a viral vector stemming from a non-pathogenic strain of an MDV serotype. No further limitations were implied by the terms rMDVnp and rHVT. The skilled person would not understand the term rHVT to exclude viral vectors in which a specific region of the genome of HVT (which is MDV serotype 3, i.e. MDV3) has been replaced by the corresponding region of a different MDV serotype, as is the case for novel avian herpesvirus (NAHV). Of course, claim 1 further required that nucleotide sequences of at least two specified pathogens other than MDV, i.e. Newcastle disease virus (NDV) and infectious laryngotracheitis virus (ILTV), be inserted into the rMDVnp/rHVT vector. Hence, the claim was directed to a construct formed by the rMDVnp/rHVT vector and inserts of nucleotide sequences from other pathogens.

The board held that the exclusion of viral constructs comprising nucleotide sequences from different MDV serotypes from the term MDVnp (page 7, lines 14 to 17 of the patent in suit) was in line with how the skilled person would understand the term MDVnp, as it did not include recombinant viral constructs but referred only to the naturally occurring viruses. Claim 1, however, was specifically directed to a vaccine comprising a recombinant non-pathogenic MDV (rMDVnp), specifically rHVT. Even if the definition of MDVnp in the description were intended to include rMDVnp in a way that excluded chimeric viruses, this could not change the skilled person's understanding of the terms rMDVnp and rHVT.

In the board's view, excluding chimeric viruses from the claimed subject-matter appeared contradictory for the following reasons. The term chimeric virus, as understood by the skilled person, related to a specific type of recombinant virus that contains genetic material from different viruses within a single viral genome construct. This typically implied that the resulting viral construct exhibits characteristics derived from each of the parental viruses. Accordingly, inserting nucleotide sequences of NDV and ILTV into the rHVT vector as claimed resulted in a chimeric virus. Therefore, chimeric viruses could not be excluded from the subject-matter of claim 1, let alone a (recombinant) NAHV that included nucleotide sequences from NDV and ILTV.

The board also noted that, due to the comprising language, claim 1 did not exclude that the rMDVnp could be engineered to comprise additional nucleic acid inserts encoding antigens of pathogens other than NDV and ILTV.

It was clear from the wording and structure of claims 3, 4, 9 and 11 that the inventors of D8 had envisaged both (i) a multivalent vaccine that was a mixture of different NAHV constructs, each encoding a separate foreign gene (claim 19), and (ii) a multivalent vaccine based on a single NAHV construct encoding a plurality of foreign genes (claim 11, to which vaccine claim 18 refers). A multivalent vaccine encoding more than one heterologous antigen was furthermore addressed in several passages of the description. D8 provided detailed instructions on how to prepare the recombinant chimeric virus and clear protocols on how to test them for their suitability as vaccines. Thus, sufficient information was provided to enable the skilled person to produce and test a composition suitable as a multivalent vaccine as defined in claim 18 of D8.

In addition, it was credible that a recombinant MDV comprising more than one insert from two different heterologous viruses in the non-essential US2 site, encoding thus one additional foreign antigen to those tested in Examples 1 to 3 of D8, could be prepared and would provide protection by preventing or reducing the severity of a disease caused by at least one of the viruses whose antigens were encoded by the recombinant MDV construct.

Case Law Suppl.
2023 compilation “Abstracts of decisions”

Annual report: case law 2022
Summaries of decisions in the language of the proceedings
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