PATENT LAW
Second medical indication need not be treatment of another disease
• there can be only one sensible way of construing the requirement underlying the specificity of the use, namely merely by contrast to the generic broad protection conferred by the first claimed medical application of a substance or composition, which is in principle not confined to a particular indication.
• This is confirmed by the preparatory documents, which normally witness the intention of the legisla-tor and constitute an ancillary means of interpretation of dispositions of law at least when it comes to their ratio legis.
• The first sentence of Article 53(c) EPC, prohibit-ing patent protection of methods for treatment by therapy, is to be read and understood together with the provisions of its second sentence and with those of Articles 54(4) and (5) EPC respectively so that far from being mutually exclusive they are complemen-tary.
• By virtue of a legal fiction Article 54(4) and (5) EPC acknowledges the notional novelty of sub-stances or compositions even when they are as such already comprised in the state of the art, provided they are claimed for a new use in a method which Article 53(c) EPC excludes as such from patent pro-tection.
• Seamless fit between (i) a patentable method using a composition that is not a treatment by therapy and (ii) a non-patentable treatment by therapy method but the use of a composition for making a medicament for use in such a treatment by therapy that is patentable
Dosage regimes
• there is no reason to give to a feature consisting in a new dosage regime of a known medicament a different treatment than the one given to any other specific use acknowledged in case law
• The claimed definition of the dosage regime must not only be verbally different from what was described in the state of the art but also reflect a different technical teaching.
• Furthermore, assuming for the sake of argument that the claimed modalities of the dosage regime would only consist in a mere selection within the teaching of a broader prior disclosure in the state of the art, then novelty could only be acknowledged if the criteria developed in the jurisprudence of the boards of appeal with respect to selection inventions would be fulfilled. One typical issue in such kinds of cases is whether the dosage regime defined in the claim has been shown to provide a particular technical effect as compared with what was known in the state of the art.
Swiss type claims no longer necessary
• the old law did not contain any notional acknowledgement of novelty of a claim directed to a known product based on a feature relating to an intended further - therapeutic - use of that product The new provisions of Article 54(5) EPC were precisely intended to fill this lacuna. In respect of second and further medical indications the EPC now allows use-related product claims directed to the substance itself whereas under EPC 1973 decision G 5/83 allowed claims directed to the use of a substance for the manufacture of the drug for a therapeutic indication
("Swiss-type claims").
Freedom of medical practitioners to prescribe generics may be restricted
• If deemed necessary, the freedom of medical practitioners may be protected by other means on the national level
IPPT20100219, EBA-EPO, Abbott Respiratory – Dosage regime
