G 2/08 (Dosage Regimes) decision is now out

The IPKat has just learned that the EPO Enlarged Board have announced their decision in G 2/08, which relates to the question of whether a new dosage regime can result in a European patent.  This is a particularly interesting one for the IPKat, because it was his announcement of the referral being made back in May 2008 that apparently resulted in an unusual postscript being added to the Court of Appeal's judgment in Actavis v Merck (IPKat commentary here, decision in full here).

To recall, the questions being asked were the following:
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 ?
These questions have now been answered as follows:
Question 1: 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: 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.
Interestingly, the Enlarged Board have now set a time limit of three months after publication of the decision in the EPO Official Journal "in order that future applicants comply with this new situation". The IPKat is not an expert in this particular field, but he thinks that this will probably also apply to plenty of current applicants too.

The decision is available from the EPO here.
G 2/08 (Dosage Regimes) decision is now out G 2/08 (Dosage Regimes) decision is now out Reviewed by David Pearce on Friday, February 19, 2010 Rating: 5


  1. It's not entirely clear what the 3 month deadline applies to. I'm sure I wasn't the only one confused by this aspect of the decision.

    The decision makes clear that the EBA is aware that patents with 2nd medical use claims have been granted and many are currently pending, and it is not the intention to mess with these ("... the new law shall...shall therefore have no retroactive effect...").

    The decision states clearly that the "time limit of three months" is to allow "future applications to comply with this new situation". It doesn't refer to current applications or currently pending applications.

    Given this, it might be that the EPO will not object to 2nd medical use type claims if they are contained in a pending application, or in an application filed before the 3 months is up. There may be some advantage in doing the latter for some clients and some types of inventions.

    One would hope that detailed guidance will be published on the EPO website over the next few weeks.

  2. my reading is that pending applications (with priority date prior to the 3m cut-off from pubn in the OJ, whenever that turns out to be) and already granted patents are not affected - the decision clearly says it shall have no retroactive effect and that the 'relevant date' is the filing/priority date (reasons 7.1.4)

    this has the consequence that we could still be prosecuting swiss claims for ages after they become 'illegal' - priority applications being filed now can still have them in, and these may not see the light of day in EPO examination for many years...

  3. I would be very curious to know when the G 3/08 decision (on software patents) will be made, now that all other "G x/08" decisions have been made.

    If "patent pope" Joseph Straus' recommendation is followed, it is simply not admissible, based on a hard rule in the EPC. And why wouldn't professor Straus be right?? Then we have waited a year and a half for a disappointment.

    Does anybody have indications when to expcet the G 3/08 decision?

  4. Maybe that, if G 3/08 is not held inadmissible, the dissapointment would still be greater?

  5. We are also still waiting for G 2/07 and G 1/08 (essentially biological processes) both of which were referred before G 3/08. Also they have yet to have the oral proceedings for G 3/08. It may be some time off yet (admissible or not).

  6. Since there are no parties, I don't think there will be oral proceedings for G 3/08.

  7. Just to show that popes *can* be wrong, have a look at decision R 5/08 and the corresponding file.

    During the petition procedure, the respondent filed a legal opinion by Prof. Straus (letter of 29.01.2009) in which he argued inter alia that the respondent should have been summoned to oral proceedings held in the preliminary proceedings pursuant to Rule 109(2)(a) EPC. This position is rather surprising (to put it mildly) and indeed the EBA did not at all agree: "In the judgement of the Enlarged Board, the respondent wholly misunderstood the two distinct stages provided by Article 112a and Rule 109 EPC for the treatment of petitions for review."

    (Actually, the EBA did not admit the late filed legal opinion into the procedure, but it seems pretty clear that it would not have followed this aspect of the opinion anyway. Personally I'm at a loss to understand what the respondent was thinking when it objected to not having been summoned in the R. 109(2)(a) procedure.)


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