Saturday, 20 February 2010

G 2/08 – The Way You Take It Matters

Good and bad things come in threes, and so do the most recent Enlarged Board decisions. Three questions had been referred to the Enlarged Board by interlocutory decision T 1319/04.

The claim that triggered the question read as follows:

1. The use of nicotinic acid or a compound metabolized to nicotinic acid by the body selected from a group consisting of d-glucitol hexanicotinate, aluminium nicotinate, niceritrol, d,1-alpha-tocopheryl nicotinate and nicotinyl alcohol tartrate, for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia characterised in that the medicament does not comprise in admixture, 5-30% hydroxypropyl methylcellulose, 2-15% of a water soluble pharmaceutical binder, 2-20% of a hydrophobic component and 30-90% nicotinic acid.

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 A 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness?

The EBA considers that the issues of importance are the construction of the provisions of A 53(c) together with those of A 54(4) and (5) and the answer to the question whether there is any need to reconcile them. As always, the Vienna Convention on the Law of Treaties is used to interpret the EPC provisions.

As far as A 53(c) is concerned, the EBA considers that its provisions are clear and unambiguous and allow to draw a borderline between (unallowable) method claims directed to a therapeutic treatment and (allowable) claims to products for use in such methods. It refuses to interpret the second sentence of A 53(c) as a lex specialis that has to be interpreted narrowly.

A 54(4) deals with the first medical application for which broad generic use-related product claims may be granted.

A 54(5) now expressly allows protection of specific further medical applications. The EBA finds that this provision does not define the nature of the further therapeutic use of a substance already known as a medicine further than by saying that it must be specific. There are two ways of construing this requirement: (i) by contrast to the generic broad protection conferred by A 54(4) for the first therapeutic application – in this case the second or further use need not consist in the treatment of a different disease; (ii) understanding it as a lex specialis with respect to the general prohibition expressed in A 53(c), which implies a narrow interpretation – only a disease not yet treated by the known substance would constitute a specific use. The Board adopts the broad interpretation, in particular because the wording of the law does not make a distinction (following the principle of Roman law ubi lex non distinguit, nec nos distinguere debemus). The EBA comes to the conclusion that the respective provisions of A 53(c) in fine, A 54(4), and A 54(5) do not constitute exceptions to the absolute prohibition of patenting therapeutic methods but constitute provisions allowing patent protection for products for use in therapeutic methods and enjoy a ranking identical to that of the prohibition.

This approach is also found to correspond to the will of the legislator as expressed in the preparatory documents.

The EBA therefore comes to the following conclusion:

Answer: Where it is already known to use a medicament to treat an illness, A 54(5) 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?

In line with its response to the first question, the Board considers that as A 54(5) may be used in cases of the treatment of the same illness, the “specific use” in the sense of this provision may reside in something else than the treatment of a different illness and may cover a specific dosage regime.

Therefore, the EBA answers the second question as follows:

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.

The EBA insists on the fact that this approach should not be interpreted as a departure from the established principles for assessing novelty and inventive step. Beyond the legal fiction of A 54(5), for the assessment of novelty and inventive step of a claim in which the only novel feature would be the dosage regime, the whole body of jurisprudence relating to the assessment of novelty and inventive step is to be applied. In order to be patentable, the new dosage regime must provide a technical teaching. that is different from the teachings of the prior art. If the new regime corresponds to a selection within the teaching of the prior art, the criteria developed by the case law for selection inventions apply.

Question 3: Are any special considerations applicable when interpreting and applying A 53(c) and 54(5) EPC 2000?

The EBA concentrates on the question of whether Swiss-type claims are still allowable. It considers that the loophole existing in the provisions of the EPC 1973 was closed by new A 54(5). Following the principle of Roman law cessante ratione legis, cessat et ipsa lex, it comes to the conclusion that Swiss-type claims should no longer be used:

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.

This conclusion makes it necessary to introduce some transitional provisions:

The EBA is aware of the fact that patents have been granted and many applications are still pending seeking patent protection for claims of this type. In order to ensure legal certainty and to protect legitimate interests of applicants, the abolition of this possibility by the interpretation of the new law given by the EBA in this decision shall therefore have no retroactive effect, and an appropriate time limit of three months after publication of the present decision in the Official Journal of the EPO is set in order for future applications to comply with this new situation. In this respect the relevant date for future applications is their date of filing or, if priority has been claimed, their priority date. [7.1.4]

The present decision is clear-cut and confirms the liberal tendencies observed so far in the handling of further medical use claims. I just wonder whether claims the novelty of which is based on a dosage regime have any practical use. Given that the dosage regime applied by a physician is covered by medical confidentiality, the only practical use of such a claim appears to consist in the possibility of hindering the competitors from mentioning the new dosage regime in their package inserts. Much ado about very little ? If any of my readers can shed light on this question, please do so.

Added on 21/2 : As pointed out in one of the comments, my impression was wrong. The decision is very relevant with respect to generic drugs. Never trust a mechanic!

To download this decision, click here

NB: As usual, I am far behind my fellow bloggers. As far as I can see, the race was won by Laurent Teyssèdre (here), followed by IPKat David Pearce (here). The blue riband is theirs. Those interested in the point of view of a French lawyer should have a look here.


Rimbaud said...

Decision G2/08 contravenes A.14 and R.3 EPC: Latin is not an official language of the EPO.
Already a breach in the brand new fortress erected by G4/08.
Thank you Oliver for the neat highlighting of key sentences.

Oliver G. Randl said...

I can't help but like this Latin stuff.

Dying species, I know ;-)

Ave Rimbaud, morituri te salutant.

Rimbaud said...

Requiescas In Pace, Oliver... istis nocte.
(not sure ; you're right, my latin is dying too and I don't feel like a latin rescuer).

Anonymous said...

Dear Oliver,

Your summary is fantastic. Just to shed light on the only point I disagree:

This decision is vital and will have a big impact in infringement cases. If a dosage regime is the only regime included in the medicines instruction (known as Summary of product Characteristics), something which happens with some medicines, and with more in the future due this decision, then the manufacturer of a generic will not be able to sell such product without doing incredibly expensive clinical trials to prove that other regime is safe and effective, if he succeed. For some products, this could mean some more years of exclusivity for the owner.

The problem is that the EPO, being patentable such kind of claims, is going to grant patents if the the dosage is novel and inventive step might easily be not properly examined due to workload at the EPO and other well known reasons.


Oliver G. Randl said...

Thank you, Alfredo. I see much clearer now.

I've added a sentence to my post so as to refer the readers to your helpful comment.