Feb 21, 2010

2010.02.19 EPO拡大審判部審決 G2/08 (dosage regime)

投与方法(dosage regimen)にだけ特徴があるクレームの特許性について、EPO拡大審判部(Enlarged Board of Appeal)が審理していましたが、2010年2月19日に審決が公表されました(G02/08)。審判部はSwiss-type claimの意義にも言及しています。

問題となったのはAbbottの下記Swiss-type claim(一部省略)で、下線部(dosage regimen)以外の「高脂血症に対してニコチン酸徐放性製剤を経口投与する」ことは既に知られていました。

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..."

審理に付された各問題と、それに対するEPO拡大審判部の判断は下記の通り。

  • 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:
    Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?

    Answer:
    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.

    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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