Friday 15 June 2012

T 2256/08 – Inconsistency


This appeal was against the refusal of the application under consideration.

Claim 1 of the main request before the Board read:
A pharmaceutical composition comprising (a) an oral contraceptive for preventing pregnancy in a subject and (b) folic acid in the manufacture of a medicament for use in a method of reducing the risk of neural tube defects in an embryo developing in said subject following becoming pregnant.
The Board found this claim not to comply with A 84:

[3.1] A 84 requires that the claims shall define the matter for which protection is sought. They must be clear and concise and supported by the description.

[3.2] Claim 1 of the main request is in the form of a purpose-related product claim and seeks protection for a composition for use in a medical treatment. In particular, claim 1 concerns a composition comprising an oral contraceptive and folic acid to be administered to a subject, and the medical use is a method of reducing the risk of neural tube defects in an embryo developing in said subject following becoming pregnant. The subject of claim 1 therefore concerns the concomitant and continuous administration of an oral contraceptive and folic acid to any subject or group of subjects to reduce the risk of neural tube defects in the embryo.

The subject-matter of claim 1 is seen as consistent only in particular situations. Such cases comprise an accidental discontinuation of the oral contraception or an unintentional pregnancy under oral contraception. In both cases the woman would temporarily continue to take the composition of folic acid together with the contraceptive, as long as it is not known whether pregnancy has have occurred.

The subject-matter of claim 1 is however not restricted to this particular situation or group of subjects.

On the other hand, the subject-matter of claim 1 is inconsistent with a situation concerning a group of women wishing to become pregnant and discontinuing oral contraception for that purpose. Such a group of women cannot be concerned by the treatment as claimed in claim 1, which relates exclusively to subjects taking concomitantly and continuously an oral contraceptive and folic acid.

Thus, claim 1 of the main request does not define the invention in a complete manner and is inconsistent. Consequently, the claim does not meet the requirements of A 84.

[3.3] In the applicant’s view, the subject-matter of claim 1 must be seen as the chronic administration of a prophylactic composition. The prophylaxis benefits a person different from the person receiving the treatment, since at the time of the administration, the embryo is not present. This situation does not present any contradiction; the prophylaxis stops when the embryo is formed.

[3.4] The board could however not follow this opinion.

The subject-matter of claim 1 has to be analysed in its whole scope and exact wording. It is sufficient that one single alternative encompassed by the subject-matter of the claim presents a contradiction or inconsistency to render the said claim unclear.

Claim 1 relates to the chronic administration of a prophylactic composition comprising inter alia an oral contraceptive. There is no further restriction in claim 1 regarding a specific group of subject or a subsequent administration of the composition without the contraceptive. The presence of an oral contraceptive in the composition has the consequence that the treatment should only concern a specific group of subject, namely subjects not wishing to get pregnant.

However, the claim does not make any distinction regarding the group of patients to be treated, and therefore covers all possible situations and groups of subjects.

Oral contraception is however inconsistent with the treatment of some groups of subjects. Such a group is for instance discussed in the description (see description, page 3, lines 26-30); this particular group of subjects “become pregnant within three to six months following discontinuation of oral contraception”. The further administration of a composition comprising inter alia an oral contraceptive to these subjects is inconsistent and contra-indicated.

Consequently, the subject-matter of claim 1 presents an inherent contradiction.

[3.5] The main request does not meet the requirements of A 84.

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1 comments:

Sander van Rijnswou said...

It took me a while to understand what is the matter here. At first sight the claim looks fine to me.

It seems the board’s problem is the following.

The final part of the claims reads: a method of reducing the risk of neural tube defects in an embryo developing in said subject following becoming pregnant.

This is rather broad. An example of such a method is taking folic acid by a woman wanting to become pregnant. Prescribing a composition comprising a contraceptive to such a woman makes no sense.

I did not review the prosecution history, so I don't know how we got here, but I do get the impression of a 'system failure', when a patent is denied on such academic grounds.

There is a valid inventive step argument for the composition. It is a pity it wasn't addressed by the board.