The discussion before the European Patent Office on patentability of second medical use claims has now entered another round. In the most recent decision by the Board of Appeal T1319/04 dated 30 April 2008, the question of allowability of dosage regimens of medicaments was referred to the Enlarged Board of Appeal of the European Patent Office.

The questions referred were:

  1. Where it is already known to use a particular medicament to treat a particular illness, can this medicament be patented under the provision of Article 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness? If the answer to question 1) is yes, is such a patenting also possible where the only novel feature is
  2. the treatment is a new and inventive dosage regime?
  3. Are any special considerations applicable when interpreting and applying Article 53(c) and 54(5) EPC 200?

In the case underlying the referral, the Examining Division of the EPO had refused an application, essentially relating to the use of nicotinic acid for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep of hyperlipidaemia. The Examining Division argued that the feature relating to a specific drug regimen, i.e. once per day prior to sleep, reflected a medical activity excluded from patentability. The applicant lodged an appeal against this decision.

In the appeal stage, it was argued by the applicant that two decisions of the EPO (T1020/03 and G5/83) required a broad allowability of claims in second medical use format, without any restriction on which area could be novel.

The Board of Appeal found that the only feature of the invention not disclosed in the prior art was the specific dosage regimen of “once per day prior to sleep”.

The question arising under the newly applicable Article 54(5) EPC 2000, which came into force on 13 December 2007, was therefore whether a dosage regimen can be recognised as a specific use in a method referred to in Article 53(c) EPC 2000. New Article 54(5) EPC 2000 specifies that patentability of any substance or composition is not excluded for any specific use in a method for treatment of the human and animal body, by surgery or therapy, and diagnostic methods practised on the human or animal body.

The Board of Appeal analysed the case law available on the “old” EPC 1973 and came to the conclusion that, in particular, decision G5/83 uses a language which is prima facie broad enough to allow patenting of a substance or composition for use in a new and inventive treatment by therapy, characterised by being a new dosage regimen for treating the same illness with the same substance. The question arising is therefore whether there might be sufficient reasons for giving the language used in the decision a more restricted meaning which excludes this possibility from patentability?

Additionally, there is one decision by a Board of Appeal T1020/03 which for the first time recognised a pure dosage regimen as not being excluded from patentability. The Board of Appeal, in view of this case law, saw it necessary to refer the question of allowability of second medical use claims which only differentiated from the prior art by way of a novel and inventive dosage regime to the Enlarged Board of Appeal as it was an important question of law.

The considerations which should be taken into account by the Enlarged Board of Appeal are that categorically denying patent protection for medicaments for use in methods of treatment where the only novel feature is a dosage regime would:

a. make it simpler to refuse patent applications or invalidate such patents;

b. avoid problems for the courts in deciding what evidence is satisfactory to show that an (old) medicament was already being manufactured and/or marketed for use in a new dosage regime;

c. value medical confidentiality to preserve the physician/patient relationship; and

d. preserve physicians’ freedom to treat their patients.

Therefore, the decision of the Enlarged Board of Appeal will now ultimately construe the regulations on the protection of the second medical use of medicaments with regard to a novel dosage regime. Since the protection of novel dosage regimes is critical for extending the protection of important medicaments, it will be a significant step to clarifying the options for protection before the European Patent Office. 

This issue of second medical use claims for novel dosage regimes has also recently been considered by the UK Court of Appeal in Actavis UK Ltd v Merck & Co Inc, reported below.