C. Nouveauté

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.

Catchword:

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

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) .

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)

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)

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)

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

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)

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).

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?