FIRST INSTANCE COURT OF PARIS, DECISION OF 28 SEPTEMBER 2010, ACTAVIS GROUP AND ALFRED E. TIEFENBACHER GMBH V. MERCK SHARP & DOHME CORP

The First Instance Court of Paris decided that a dosage regime is not patentable because it is not a second therapeutic application (patentable) but a therapeutic method (excluded from patentability under Art. 53(c) EPC).

The First Instance Court of Paris said that it considered both decisions by the English Court of Appeal and by the Federal Patent Court in 2008 which had dealt with the same European patent and held that, as a general principle, a dosage regime is patentable. Nevertheless, the court reached a strictly divergent conclusion.

The patent at issue related to a medicament for the treatment of androgenic alopecia (i.e. the permanent loss of hair). The main claim 1 of the patent set out three main characteristics:

  • Use of finasteride for the preparation of a medicament for oral administration,
  • Useful for treating androgenic alopecia,
  • The daily dose of the active ingredient finasteride ranging from 0.05 to 1 mg.

Merck Sharp & Dohme Corp. claimed that, based on the latest decision of the EPO1, the court should nullify the claim as it was drafted as a so-called Swiss-type claim ("use of [an active ingredient] for the preparation of a drug").

The First Instance Court of Paris, however, stated that “the French courts are not bound by the decisions of the EPO (...) so that these decisions - even if issued by the Enlarged Board of Appeal - are merely indications of the analysis made by the EPO to grant European patents."

The court assessed the validity of claim 1, noting that the use of finasteride for treating androgenic alopecia was already known and therefore "only the dosage of about 0.05 to 1.0 mg is claimed as novel and protectable". It found that “a specific dosage for the treatment of an illness constitutes neither a first nor a second therapeutic application but simply an indication of the range within which this substance is efficacious so as to treat this illness in light of the tests and research completed and explained in the patent."

As the qualification of a dosage regime as a second therapeutic application was excluded, the court, quoting the 1 EPO decision G2/08 of 19 February 2010 German Federal Court, held that developing "a specific therapeutic care plan for a patient which includes the prescription and the dosage of the medicaments is an essential part of the treating doctor’s activity." Accordingly, so the court, a dosage regime was to be considered a therapeutic method and, thus, was excluded from patentability by the EPC.

Since claim 1 of the patent at issue was only novel over the prior art because of the specified dosage and as such "excluded from patentability", the court decided that it "should consequently be held invalid pursuant to Article 53(c) EPC 2000."

An appeal is pending.