Il miglioramento del grado di purezza di un composto chimico è una invenzione brevettabile? Astrattamente si, non c’è dubbio: probabilmente è anzi cosa non infrequente nella storia delle invenzioni farmaceutiche.
E come si colloca il giudizio di novità (distacco dallo stato della tecnica) nel caso specifico? Lo spiega il Bord of appeal dell’EPO 01 giugno 2022, caso T 0043/ 18 – 3.3.02, ” Pharmaceutical dosage form comprising oxycodone hydrochloride
having less than 25 ppm 14-hydroxycodeinone “, titoalre del vrevetto comntetao EURO-CELTIQUE S.A..
Il Board si basa sulla decisione T 1085/13 di cui riporta i passaggi conclusivi fatti propri:
<< 2.4 “A claim defining a compound as having a certain purity
therefore lacks novelty over a prior-art disclosure
describing the same compound only if the prior art
discloses the claimed purity at least implicitly, for
example by way of a method for preparing said compound,
the method inevitably resulting in the purity as
claimed.
Such a claim, however, does not lack novelty if the
disclosure of the prior art needs to be supplemented,
for example by suitable (further) purification methods
allowing the skilled person to arrive at the claimed
purity.
3.8 The question of whether such (further) purification
methods for the prior-art compound are within the
common general knowledge of those skilled in the art
and, if applied, would result in the claimed purity, is
not relevant to novelty, but is rather a matter to be
considered in the assessment of inventive step.”
(emphasis added by the present board) >>
E quindi aplicandolo al caso sub iudice:
<< 2.6 As stated above, it was accepted in the contested
decision that D1-D3 and D15 [cioè le anteriortà dedotte] did not, even implicitly,
disclose the purity recited in claim 1. Furthermore,
the opposition division concluded a lack of novelty
despite accepting that the evidence on file
demonstrated, at the effective date of the patent, that
there was “no specific [oxycodone hydrochloride]
preparation available on the market which would have
met the claimed purity criteria” (contested decision,
3.3.3, second paragraph, final sentence).
It is abundantly clear therefore that in the present case,
the prior art D1-D3 and D15 would need to be
supplemented with suitable further purification methods
in order to (potentially) arrive at the claimed purity,
which, as stated in the second and third paragraph
cited from T 1085/13 above, cannot lead to a lack of
novelty of the claimed subject-matter, but is rather a
matter to be considered in the assessment of inventive
step >>.
Soluzione convincente.
Si v.no le Guidelines dell’EPO al § 6.2.4 Achieving a higher degree of purity.
(notizia dal post di Rose Hughes in IPKat del 30 agosto u.s.)