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:
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.
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