"Once per day, prior to sleep"

With its decision of 22 April 2008, the 3.3.02. Board of Appeal referred the following questions to the Enlarged Board of Appeal of the EPO:

"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?
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?
3. Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000."

The subject matter claimed in the referring case was drawn to
"The use of nicotinic acid or a compound metabolized to nicotinic acid by the body [..] for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia [..]."

Prior art to this claim was the use of the same substance (nicotinic acid) for the same indication (hyperlipidaemia), however, without reference to a guidance to take the medicament "once per day prior to sleep" (prior art e.g. suggested to take nicotinic acid (in sustained release form) twice daily for the treatment of hyperlipidaemia). Hyperlipidaemia is the presence of raised or abnormal levels of lipids and/or lipoproteins in the blood.

The effect of taking the drug only once per day before sleep is that well-known side effects (severe liver toxicity) can be prevented.

In the present case it was undisputed that prior art did not disclose the "once per day prior to sleep" administration and that liver toxicity can be eliminated by this regimen.

The questions now in front of the Enlarged Board of Appeal should clarify whether such inventions are excluded from patentability because they relate to a therapeutic method as such (which was the "old" decision practice of the Boards of Appeal) or whether they do not fall under this exception (as accepted due to the "new" decision practice, established by decision T 1020/03). In Austria, the former decision practice is still applied; the Austrian Patent Office so far hesitates to accept patentability of a new administration regimen.

The present question will clarify whether inventions which are solely based on such new and inventive administration regimen (which also need a lot of investments for proving effectiveness (proving inventiveness) in clinical trials, but could be (ab)used to artificially prolong patent protection for original drugs) will get reward by the patent system or not. Needless to say that specifically for this question where a lot of money is involved (both, in development and in the market) there are two sides with opposite interests: the pharmaceutical companies which develop new drugs and new drug regimen on the one side and the generic industry (and governments wanting cheap drugs) on the other side. Hopefully, the Enlarged Board of Appeal comes to a decision which clarifies the situation and enables a proper way to reward real innovations and, at the same time, to prevent abuse of the patent system.

Daniel Alge