The therapeutic use of that substance cannot be patented because that use is a method of treatment of a human or animal body by surgery, therapy or diagnosis which is practiced on that human or animal body.

Methods of treatment are regarded in Europe as not being capable of industrial application and are consequently not patentable.  The Swiss Patent Office came up with the following solution in the early 1980’s:

“Use of compound X in the manufacture of a medicament for the treatment of disorder Y”.

Thus, the Swiss-type claim was born.

European patent application No. 94306847.8, “Nicotinic acid compositions for treating hyperlipidemi,” originally filed by Kos Life Sciences, Inc., now Abbott Respiratory LLC, was refused by a decision of the Examining Division on the grounds of lack of novelty under Articles 54(1) and (2) EPC 1973 and because it did not meet the requirements of Article 52(4) EPC 1973.

This decision was based on a Claim 1 which reads as follows:

“1. The use of nicotinic acid or a compound metabolized to nicotinic acid by the body selected from a group consisting of d-glucitol hexanicotinate, aluminium nicotinate, niceritrol, d,1-alpha-tocopheryl nicotinate and nicotinyl alcohol tartrate, for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia characterised in that the medicament does not comprise in admixture, 5-30% hydroxypropyl methylcellulose, 2-15% of a water soluble pharmaceutical binder, 2-20% of a hydrophobic component and 30-90% nicotinic acid.”

As set out in the decision under appeal, the Examining Division was of the opinion that the subject-matter of Claim 1 was anticipated by the disclosure in earlier documents, which contemplated the use of nicotinic acid for the manufacture of a sustained release medicament for use in the treatment of hyperlipidaemia by oral administration.

In that respect, the first instance, referring in particular to decisions T 317/95 and T 584/97, concluded that the feature of Claim 1 relating to a specific drug regime, i.e. once per day prior to sleep, reflected a medical activity excluded from patentability under Article 52(4) EPC 1973, which could not therefore be considered to represent a further medical indication from which novelty can be derived (points 27 and 28 of the Reasons).

The Board of Appeal held that the question whether medicaments for use in methods for treatment by therapy, where the only feature likely to confer novelty on the claim is a dosage regime, are patentable under Articles 53(c) and 54(5) EPC 2000 is an important point of law (decision T 1319/04, OJ EPO 2009, 36).

Under Article 53(c) EPC 2000 European patents may not be granted for methods for treatment by therapy or surgery of the human or animal body, neither may they be granted for diagnostic methods practiced on them. They may however be granted for medicinal products for use in such methods.

Already under the EPC 1973, to compensate for this exclusion, substances and compositions although already known in the art could nonetheless as such be patented for their first new and inventive use in one of these methods.

No express provision in the EPC 1973 allowed in contrast purpose-related product claims for second or further medical indications of known substances or compositions already used as medicines.

New Article 54(5) EPC contains an express permission of purpose-related product claims provided the new and inventive use of the substance or composition already known as a medicine be specific. However, the EPC does not give any definition of the precise meaning of this requirement that could encompass a new illness to be treated as well as the very disease that was already the object of a prior application, in which case the novelty of the use could be drawn from another distinguishing feature (e.g. different subjects to be healed or different modes of administration of the substance).

Therefore, the first sentence of Article 53(c) EPC, prohibiting 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 complementary.

By virtue of a legal fiction Article 54(4) and (5) EPC acknowledges the notional novelty of substances 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 protection.

In such cases the notional novelty and following it the non-obviousness, if any, is not derived from the substance or composition as such but from the purpose the claimed substance or composition is related to, namely from its intended therapeutic use.

Swiss-type claims could be (and have been) considered objectionable as regards the question as to whether they fulfill the patentability requirements, due to the absence of any functional relationship of the features (belonging to therapy) conferring novelty and inventiveness, if any, and the claimed manufacturing process. Therefore, where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so called Swiss-type claim as instituted by decision G 5/83.

In Case Number: G 0002/08; Dosage regime/Abbott Respiratory LLC, the EPO Enlarged Board of Appeal decided that:

Question 1: Where it is already known to use a particular medicament to treat a particular illness, can this known medicament be patented under the provisions of Articles 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness?

Answer: Where it is already known to use a medicament to treat an illness, Article 54(5) EPC does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness.

Question 2: If the answer to question 1 is yes, is such patenting also possible where the only novel feature of the treatment is a new and inventive dosage regime?

Answer: Such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.

Question 3: Where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so called Swiss-type claim as instituted by decision G 5/83.

Answer:A time-limit of three months after publication of the present decision in the Official Journal of the European Patent Office is set in order that future applicants comply with this new situation.

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  1. The claim is basically directed to nighttime dosing of any SR formulation, so long as that formulation is not already claimed in US 5268181. How can that possibly be novel and not obvious??

    ‘181 teaches nighttime administration of the excluded formulations, and other references teach other formulations for niacin. That’s about as good an obviousness case as an examiner could hope for.

  2. Well… even a small step can be inventive if presented the right way.